Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part I - rationale and aims.

PubMed

Davis, Bruce H; Wood, Brent; Oldaker, Teri; Barnett, David

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part I - Rationale and aims. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

A Novel Approach to Improving Utilization of Laboratory Testing.

PubMed

Zhou, Yaolin; Procop, Gary W; Riley, Jacquelyn D

2018-02-01

- The incorporation of best practice guidelines into one's institution is a challenging goal of utilization management, and the successful adoption of such guidelines depends on institutional context. Laboratorians who have access to key clinical data are well positioned to understand existing local practices and promote more appropriate laboratory testing. - To apply a novel approach to utilization management by reviewing international clinical guidelines and current institutional practices to create a reliable mechanism to improve detection and reduce unnecessary tests in our patient population. - We targeted a frequently ordered genetic test for HFE-related hereditary hemochromatosis, a disorder of low penetrance. After reviewing international practice guidelines, we evaluated 918 HFE tests and found that all patients with new diagnoses had transferrin saturation levels that were significantly higher than those of patients with nonrisk genotypes (72% versus 42%; P < .001). - Our "one-button" order that restricts HFE genetic tests to patients with transferrin saturation greater than 45% is consistent with published practice guidelines and detected 100% of new patients with HFE-related hereditary hemochromatosis. - Our proposed algorithm differs from previously published approaches in that it incorporates both clinical practice guidelines and local physician practices, yet requires no additional hands-on effort from pathologists or clinicians. This novel approach to utilization management embraces the role of pathologists as leaders in promoting high-quality patient care in local health care systems.

Evolution of Toxoplasma-PCR methods and practices: a French national survey and proposal for technical guidelines.

PubMed

Roux, Guillaume; Varlet-Marie, Emmanuelle; Bastien, Patrick; Sterkers, Yvon

2018-06-08

The molecular diagnosis of toxoplasmosis lacks standardisation due to the use of numerous methods with variable performance. This diversity of methods also impairs robust performance comparisons between laboratories. The harmonisation of practices by diffusion of technical guidelines is a useful way to improve these performances. The knowledge of methods and practices used for this molecular diagnosis is an essential step to provide guidelines for Toxoplasma-PCR. In the present study, we aimed (i) to describe the methods and practices of Toxoplasma-PCR used by clinical microbiology laboratories in France and (ii) to propose technical guidelines to improve molecular diagnosis of toxoplasmosis. To do so, a yearly self-administered questionnaire-based survey was undertaken in proficient French laboratories from 2008 to 2015, and guidelines were proposed based on the results of those as well as previously published work. This period saw the progressive abandonment of conventional PCR methods, of Toxoplasma-PCR targeting the B1 gene and of the use of two concomitant molecular methods for this diagnosis. The diversity of practices persisted during the study, in spite of the increasing use of commercial kits such as PCR kits, DNA extraction controls and PCR inhibition controls. We also observed a tendency towards the automation of DNA extraction. The evolution of practices did not always go together with an improvement in those, as reported notably by the declining use of Uracil-DNA Glycosylase to avoid carry-over contamination. We here propose technical recommendations which correspond to items explored during the survey, with respect to DNA extraction, Toxoplasma-PCR and good PCR practices. Copyright © 2018 Australian Society for Parasitology. Published by Elsevier Ltd. All rights reserved.

[Perception of health and safety risks among workers pathology laboratories].

PubMed

Alvarado-Cabrero, Isabel; Valencia-Cedillo, Raquel

2015-01-01

Health care workers are experiencing increasing numbers of occupational illnesses. Safety practices in anatomical pathology laboratories (APL) are crucial to prevent unnecessary exposures to both chemical and biological agents. The main goal of this study was to determine if pathologists perceptions and actual practice mirror regulatory guidelines. Current available recommendations for APL were reviewed and used to construct an online survey distributed to pathologists. The survey was completed by 121 participants. Eighty-seven (72 %) of respondents reported receiving inadequate safety training. Most pathologists (82 %) were not well-informed about biosafety practices. Sixty-three (52 %) participants felt that the risks of chemical and infectious disease exposures in the APL were low. Most respondents reported having a needle stick or cut (71 %). Eighty-six (71 %) of participants reported musculo skeletal problems. This study indicated that there is a need for improving training in anatomical pathology safety practices in Mexican laboratories as daily practices do not reflected current guidelines.

Diagnosis of complicated parapneumonic effusion by pleural pH measurement is jeopardized by inadequate physician knowledge and guideline-discordant laboratory practice.

PubMed

Ng, Lauren; Dabscheck, Eli; Hew, Mark

2017-01-01

Pleural fluid pH is a crucial determinant of complicated parapneumonic effusion diagnosis and the need for drainage. It is best measured by blood gas analyzer. We examined whether physicians were aware of this, and whether their laboratories measured pleural pH according to their expectations. Only 53% of physicians understood the need for blood gas analyzer measurements, only 50% of laboratories used blood gas analyzers, and only 35% of physicians correctly identified the method performed in their laboratory. Diagnosis of complicated parapneumonic effusion is jeopardized by inadequate physician knowledge and guideline-discordant laboratory practice. We recommend cooperation between thoracic and biochemistry specialty societies to rectify this issue. Copyright © 2016 Elsevier Ltd. All rights reserved.

Best practice guidelines for molecular genetic diagnosis of cystic fibrosis and CFTR-related disorders--updated European recommendations.

PubMed

Dequeker, Els; Stuhrmann, Manfred; Morris, Michael A; Casals, Teresa; Castellani, Carlo; Claustres, Mireille; Cuppens, Harry; des Georges, Marie; Ferec, Claude; Macek, Milan; Pignatti, Pier-Franco; Scheffer, Hans; Schwartz, Marianne; Witt, Michal; Schwarz, Martin; Girodon, Emmanuelle

2009-01-01

The increasing number of laboratories offering molecular genetic analysis of the CFTR gene and the growing use of commercial kits strengthen the need for an update of previous best practice guidelines (published in 2000). The importance of organizing regional or national laboratory networks, to provide both primary and comprehensive CFTR mutation screening, is stressed. Current guidelines focus on strategies for dealing with increasingly complex situations of CFTR testing. Diagnostic flow charts now include testing in CFTR-related disorders and in fetal bowel anomalies. Emphasis is also placed on the need to consider ethnic or geographic origins of patients and individuals, on basic principles of risk calculation and on the importance of providing accurate laboratory reports. Finally, classification of CFTR mutations is reviewed, with regard to their relevance to pathogenicity and to genetic counselling.

Quality Assurance Program for Molecular Medicine Laboratories

PubMed Central

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Background: Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. Methods: We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Results: Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Conclusion: Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level. PMID:23865028

Quality assurance program for molecular medicine laboratories.

PubMed

Hajia, M; Safadel, N; Samiee, S Mirab; Dahim, P; Anjarani, S; Nafisi, N; Sohrabi, A; Rafiee, M; Sabzavi, F; Entekhabi, B

2013-01-01

Molecular diagnostic methods have played and continuing to have a critical role in clinical laboratories in recent years. Therefore, standardization is an evolutionary process that needs to be upgrade with increasing scientific knowledge, improvement of the instruments and techniques. The aim of this study was to design a quality assurance program in order to have similar conditions for all medical laboratories engaging with molecular tests. We had to design a plan for all four elements; required space conditions, equipments, training, and basic guidelines. Necessary guidelines was prepared and confirmed by the launched specific committee at the Health Reference Laboratory. Several workshops were also held for medical laboratories directors and staffs, quality control manager of molecular companies, directors and nominees from universities. Accreditation of equipments and molecular material was followed parallel with rest of program. Now we are going to accredit medical laboratories and to evaluate the success of the program. Accreditation of medical laboratory will be succeeding if its basic elements are provided in advance. Professional practice guidelines, holding training and performing accreditation the molecular materials and equipments ensured us that laboratories are aware of best practices, proper interpretation, limitations of techniques, and technical issues. Now, active external auditing can improve the applied laboratory conditions toward the defined standard level.

Primary care guidelines on consultation practices: the effectiveness of computerized versus paper-based versions. A cluster randomized controlled trial among newly qualified primary care physicians.

PubMed

Jousimaa, Jukkapekka; Mäkelä, Marjukka; Kunnamo, Ilkka; MacLennan, Graeme; Grimshaw, Jeremy M

2002-01-01

To compare the effects of computerized and paper-based versions of guidelines on recently qualified physicians' consultation practices. Two arm cluster randomized controlled trial. Physicians were randomized to receive computerized or textbook-based versions of the same guidelines for a 4-week study period. Physicians' compliance with guideline recommendations about laboratory, radiological, physical and other examinations, procedures, nonpharmacologic and pharmacologic treatments, physiotherapy, and referrals were measured by case note review. There were 139 recently qualified physicians working in 96 primary healthcare centers in Finland who participated in the study. Data on 4,633 patient encounters were abstracted, of which 3,484 were suitable for further analysis. Physicians' compliance with guidelines was high (over 80% for use of laboratory, radiology, physical examinations, and referrals). There were no significant differences in physicians' consultation practices in any of the measured outcomes between the computerized and textbook group. Guidelines are a useful source of information for recently qualified physicians working in primary care. However, the method of presentation of the guidelines (electronic or paper) does not have an effect on guideline use or their impact on decisions. Other factors should be considered when choosing the method of presentation of guidelines, such as information-seeking time, ease of use during the consultation, ability to update, production costs, and the physician's own preferences.

Laboratory compliance with the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 testing guidelines: a 3-year comparison of validation procedures.

PubMed

Dyhdalo, Kathryn S; Fitzgibbons, Patrick L; Goldsmith, Jeffery D; Souers, Rhona J; Nakhleh, Raouf E

2014-07-01

The American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) published guidelines in 2007 regarding testing accuracy, interpretation, and reporting of results for HER2 studies. A 2008 survey identified areas needing improved compliance. To reassess laboratory response to those guidelines following a full accreditation cycle for an updated snapshot of laboratory practices regarding ASCO/CAP guidelines. In 2011, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program identical to the 2008 survey. Of the 1150 surveys sent, 977 (85.0%) were returned, comparable to the original survey response in 2008 (757 of 907; 83.5%). New participants submitted 124 of 977 (12.7%) surveys. The median laboratory accession rate was 14,788 cases with 211 HER2 tests performed annually. Testing was validated with fluorescence in situ hybridization in 49.1% (443 of 902) of the laboratories; 26.3% (224 of 853) of the laboratories used another IHC assay. The median number of cases to validate fluorescence in situ hybridization (n = 40) and IHC (n = 27) was similar to those in 2008. Ninety-five percent concordance with fluorescence in situ hybridization was achieved by 76.5% (254 of 332) of laboratories for IHC(-) findings and 70.4% (233 of 331) for IHC(+) cases. Ninety-five percent concordance with another IHC assay was achieved by 71.1% (118 of 168) of the laboratories for negative findings and 69.6% (112 of 161) of the laboratories for positive cases. The proportion of laboratories interpreting HER2 IHC using ASCO/CAP guidelines (86.6% [798 of 921] in 2011; 83.8% [605 of 722] in 2008) remains similar. Although fixation time improvements have been made, assay validation deficiencies still exist. The results of this survey were shared within the CAP, including the Laboratory Accreditation Program and the ASCO/CAP panel revising the HER2 guidelines published in October 2013. The Laboratory Accreditation Program checklist was changed to strengthen HER2 validation practices.

Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

PubMed

Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

2014-07-01

The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

Culturing Stool Specimens for Campylobacter spp., Pennsylvania, USA

PubMed Central

M’ikanatha, Nkuchia M.; Dettinger, Lisa A.; Perry, Amanda; Rogers, Paul; Reynolds, Stanley M.

2012-01-01

In 2010, we surveyed 176 clinical laboratories in Pennsylvania regarding stool specimen testing practices for enteropathogens, including Campylobacter spp. Most (96.3%) routinely test for Campylobacter spp. In 17 (15.7%), a stool antigen test is the sole method for diagnosis. We recommend that laboratory practice guidelines for Campylobacter spp. testing be developed. PMID:22377086

Audit of clinical-laboratory practices in haematology and blood transfusion at Muhimbili National Hospital in Tanzania.

PubMed

Makubi, Abel N; Meda, Collins; Magesa, Alex; Minja, Peter; Mlalasi, Juliana; Salum, Zubeda; Kweka, Rumisha E; Rwehabura, James; Quaresh, Amrana; Magesa, Pius M; Robert, David; Makani, Julie; Kaaya, Ephata

2012-10-01

In Tanzania, there is paucity of data for monitoring laboratory medicine including haematology. This therefore calls for audits of practices in haematology and blood transfusion in order to provide appraise practice and devise strategies that would result in improved quality of health care services. This descriptive cross-sectional study which audited laboratory practice in haematology and blood transfusion at Muhimbili National Hospital (MNH) aimed at assessing the pre-analytical stage of laboratory investigations including laboratory request forms and handling specimen processing in the haematology laboratory and assessing the chain from donor selection, blood component processing to administration of blood during transfusion. A national standard checklist was used to audit the laboratory request forms (LRF), phlebotomists' practices on handling and assessing the from donor selection to administration 6f blood during transfusion. Both interview and observations were used. A total of 195 LRF were audited and 100% of had incomplete information such as patients' identification numbers, time sample ordered, reason for request, summary of clinical assessment and differential diagnoses. The labelling of specimens was poorly done by phlebotomists/clinicians in 82% of the specimens. Also 65% (132/202) of the blood samples delivered in the haematology laboratory did not contain the recommended volume of blood. There was no laboratory request form specific for ordering blood and there were no guidelines for indication of blood transfusion in the wards/ clinics. The blood transfusion laboratory section was not participating in external quality assessment and the hospital transfusion committee was not in operation. It is recommended that a referral hospital like MNH should have a transfusion committee to provide an active forum to facilitate communication between those involved with transfusion, monitor, coordinate and audit blood transfusion practices as per national guidelines.

Current status of accreditation for drug testing in hair.

PubMed

Cooper, Gail; Moeller, Manfred; Kronstrand, Robert

2008-03-21

At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair. A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities. Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their methods within 2-3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for guidelines to encourage best practice.

The quality of laboratory aspects of troponin testing in clinical practice guidelines and consensus documents needs to be improved.

PubMed

Aakre, Kristin M; Langlois, Michel R; Barth, Julian H; Misra, Shivani; Watine, Joseph; Oosterhuis, Wytze P

2014-11-01

The European Federation of Laboratory Medicine (EFLM) and the Union of European Medical Specialists (UEMS) joint Working Group on guidelines recently proposed a checklist to help standardize the description of laboratory investigations in clinical practice guidelines (CPG). Nine CPGs or consensus documents published from 2011 to 2013 describing the investigation of chest pain, diagnosis of acute coronary syndrome, or myocardial infarction were evaluated against the published checklist. Clinical use of troponin analysis are commonly dealt with but the publications present variable, vague and sometimes conflicting information regarding this laboratory test being very much relied on upon making a diagnosis of acute coronary syndrome. Most of the laboratory related checklist items are not considered or need to be updated e.g. suggested analytical quality goals are not applicable for the high sensitive assays and important interferences that may lead to false positive or negative diagnoses are commonly not mentioned. The current paper sums up important analytical and biological issues related to troponin assays and gives suggestions for analytical quality goals that could be included in CPG's. Copyright © 2014 Elsevier B.V. All rights reserved.

EMQN/CMGS best practice guidelines for the molecular genetic testing of Huntington disease.

PubMed

Losekoot, Monique; van Belzen, Martine J; Seneca, Sara; Bauer, Peter; Stenhouse, Susan A R; Barton, David E

2013-05-01

Huntington disease (HD) is caused by the expansion of an unstable polymorphic trinucleotide (CAG)n repeat in exon 1 of the HTT gene, which translates into an extended polyglutamine tract in the protein. Laboratory diagnosis of HD involves estimation of the number of CAG repeats. Molecular genetic testing for HD is offered in a wide range of laboratories both within and outside the European community. In order to measure the quality and raise the standard of molecular genetic testing in these laboratories, the European Molecular Genetics Quality Network has organized a yearly external quality assessment (EQA) scheme for molecular genetic testing of HD for over 10 years. EQA compares a laboratory's output with a fixed standard both for genotyping and reporting of the results to the referring physicians. In general, the standard of genotyping is very high but the clarity of interpretation and reporting of the test result varies more widely. This emphasizes the need for best practice guidelines for this disorder. We have therefore developed these best practice guidelines for genetic testing for HD to assist in testing and reporting of results. The analytical methods and the potential pitfalls of molecular genetic testing are highlighted and the implications of the different test outcomes for the consultand and his or her family members are discussed.

European guidelines for workplace drug testing in urine.

PubMed

Taskinen, Sanna; Beck, Olof; Bosch, Tessa; Brcak, Michaela; Carmichael, Duncan; Fucci, Nadia; George, Claire; Piper, Mark; Salomone, Alberto; Schielen, Wim; Steinmeyer, Stefan; Weinmann, Wolfgang

2017-06-01

These European Guidelines for Workplace Drug Testing in Urine have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). The first version of these urine guidelines was published in 2002. Since then, the guidelines have been followed by many laboratories in different European countries and their role has been essential particularly in countries lacking legislation for workplace drug testing. In 2014, the EWDTS started a guidelines updating project and published a new version of the urine guidelines in 2015. Here we represent this updated version of the urine guidelines. The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing should use these guidelines as a template for accreditation. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Laboratory practice guidelines for detecting and reporting JAK2 and MPL mutations in myeloproliferative neoplasms: a report of the Association for Molecular Pathology.

PubMed

Gong, Jerald Z; Cook, James R; Greiner, Timothy C; Hedvat, Cyrus; Hill, Charles E; Lim, Megan S; Longtine, Janina A; Sabath, Daniel; Wang, Y Lynn

2013-11-01

Recurrent mutations in JAK2 and MPL genes are genetic hallmarks of BCR-ABL1-negative myeloproliferative neoplasms. Detection of JAK2 and MPL mutations has been incorporated into routine diagnostic algorithms for these diseases. This Special Article summarizes results from a nationwide laboratory survey of JAK2 and MPL mutation analysis. Based on the current practice pattern and the literature, this Special Article provides recommendations and guidelines for laboratory practice for detection of mutations in the JAK2 and MPL genes, including clinical manifestations for prompting the mutation analysis, current and recommended methodologies for testing the mutations, and standardization for reporting the test results. This Special Article also points to future directions for genomic testing in BCR-ABL1-negative myeloproliferative neoplasms. Copyright © 2013 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Consensus and controversies in best practices for molecular genetic testing of spinocerebellar ataxias

PubMed Central

Sequeiros, Jorge; Seneca, Sara; Martindale, Joanne

2010-01-01

Many laboratories worldwide are offering molecular genetic testing for spinocerebellar ataxias (SCAs). This is essential for differential diagnosis and adequate genetic counselling. The European Molecular Genetics Quality Network (EMQN) started an SCA external quality assessment scheme in 2004. There was a clear need for updated laboratory guidelines. EMQN and EuroGentest organized a Best Practice (BP) meeting to discuss current practices and achieve consensus. A pre-meeting survey showed that 36 laboratories (20 countries) conducted nearly 18 000 SCA tests the year before, and identified issues to discuss. Draft guidelines were produced immediately after the meeting and discussed online for several months. The final version was endorsed by EMQN, and harmonized with guidelines from other oligonucleotide repeat disorders. We present the procedures taken to organize the survey, BP meeting, as well as drafting and approval of BP guidelines. We emphasize the most important recommendations on (1) pre-test requirements, (2) appropriate methodologies and (3) interpretation and reporting, and focus on the discussion of controversial issues not included in the final document. In addition, after an extensive review of scientific literature, and responding to recommendations made, we now produce information that we hope will facilitate the activities of diagnostic laboratories and foster quality SCA testing. For the main loci, this includes (1) a list of repeat sequences, as originally published; (2) primers in use; and (3) an evidence-based description of the normal and pathogenic repeat-size ranges, including those of reduced penetrance and those in which there is still some uncertainty. This information will be maintained and updated in http://www.scabase.eu. PMID:20179748

C-B3-03: Development and Pilot Testing of Guidelines to Monitor High-Risk Medications in the Ambulatory Setting

PubMed Central

Tjia, Jennifer; Field, Terry; Garber, Lawrence; Raebel, Marsha; Donovan, Jennifer; Kanaan, Abir; Fischer, Shira; Gagne, Shawn; Zhao, Yanfang; Fuller, Jackie; Gurwitz, Jerry

2010-01-01

Background: Inadequate laboratory monitoring of high-risk medications contributes to preventable adverse drug events. One barrier to appropriate monitoring is lack of standardized monitoring guidelines. The study aims were to develop guidelines to monitor high-risk medications and to assess the prevalence of laboratory testing for these medications in a multispecialty group practice. Methods: We developed guidelines for laboratory monitoring of high-risk medications as part of a patient safety intervention trial. An advisory committee of national experts and local leaders (clinicians, pharmacists, pharmacoepidemiologists, and patient safety experts) used a two-round, internet-based Delphi process to select guideline medications based on the importance of monitoring for efficacy, safety, and drug-drug interactions. Test frequency recommendations were developed by academic pharmacists based on literature review and local interdisciplinary consensus. To estimate the potential impact of the intervention, we determined the prevalence of high-risk drug dispensings and laboratory testing for guideline medications between January 1, 2008 and July 31, 2008. Results: Consensus on medications to include in the guidelines was achieved in two rounds. Final guidelines included 35 drugs/drug classes and 61 laboratory tests. The prevalence of monitoring ranged from <50% to >90%, with infrequently prescribed drugs having a lower prevalence of recommended testing. When more than one test was recommended for a selected medication, monitoring within a medication sometimes differed by > 50%. Conclusions: Even among drugs where there is general consensus that laboratory monitoring is important, prevalence of monitoring is highly variable. Further, infrequently prescribed medications are at higher risk for poor monitoring.

Microcomputers for Young Children: Procedures and Practices in the Laboratory Classroom.

ERIC Educational Resources Information Center

Baker, Betty Ruth

These guidelines are designed to give preservice teachers information to use in selecting techniques and planning learning experiences for young children in the microcomputer laboratory. The main purpose of this laboratory experience is for children to develop computer awareness/literacy and keyboard knowledge, and to improve skills in following…

[Continuous challenges in Japanese forensic toxicology practice: strategy to address specific goals].

PubMed

Kageura, Mitsuyoshi

2002-09-01

In this paper, the status quo of forensic toxicology in Japan and the West is surveyed and a strategy to address future goals of Japanese forensic toxicology is proposed. Forensic toxicology in the West consists of three main areas--post-mortem forensic toxicology, human-performance forensic toxicology and forensic urine drug testing. In Japan, post-mortem forensic toxicology is practiced in university forensic medicine departments while most of the human-performance forensic toxicology is carried out in police laboratories. However, at least at present, strictly controlled workplace urine drug testing is not being performed, despite the abuse of drugs even by uniformed members of the National Defence Forces and police. For several years, the author has been introducing Western forensic toxicology guidelines and recommendations, translated into Japanese with the help of Western forensic toxicologists, to Japanese forensic toxicologists. Western forensic toxicology practice is at an advanced stage, whereas Japanese practice is in a critical condition and holds many problems awaiting solution, as exemplified by the urine drug testing in police laboratories. There is never any sample left for re-examination by the defence in all cases, though the initial volume of the urine sample available for examination is 30-50 ml. Only one organisation carries out everything from sampling to reporting and, in addition, the parent drug and its metabolites are not quantified. It is clear that the police laboratories do not work within good laboratory practice guidelines, nor do they have quality manuals or standard operating procedures manuals. A basic change in Japanese forensic toxicology practice is now essential. The author strongly recommends that, first of all, Japanese toxicologists should prepare forensic toxicology guidelines based on the Western models. The guidelines would progress the following objectives for forensic toxicology laboratories: 1) to have documented good laboratory practice standards; 2) to have a quality control system including a quality manual and standard operating procedures manual; 3) to have some degree of compulsion to implement quality assurance both through their own internal efforts and by appropriate remedial actions based on the results of an external proficiency testing scheme. For forensic toxicologists, the implications are that they should be: 1) responsible for ensuring that laboratory practices are performed under satisfactory conditions and 2) required to be certified as a forensic toxicology specialist in order to prove their forensic toxicology ability. For their part, governments should: 1) carry out administrative reforms related to forensic toxicology; 2) simplify the procedure for obtaining certified reference materials; 3) introduce a strict workplace urine drug testing programme for government employees, at least for those related to law enforcement. When all of these objectives have been realised, the specific goal will be achieved through which Japanese forensic toxicology is able, in practice, to fulfill its responsibility to society.

Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion.

PubMed

2014-10-01

This document provides a general overview for physicians of the qualities and conditions necessary for good management practices within the endocrinology, andrology, and embryology laboratories in the United States. It is intended as an addendum to previously published guidelines that further detail these responsibilities. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Safety in Academic Chemistry Laboratories. Fourth Edition.

ERIC Educational Resources Information Center

American Chemical Society, Washington, DC.

This booklet provides guidelines for safety in the chemical laboratory. Part I, "Guides for Instructors and Administrators," includes safety rules, safety practices and facilities, preparation for emergencies, safety committees, accident reporting, fire insurance, and listings of some hazardous chemicals. Part II, "Student Guide to…

IAP Guidelines on Rickettsial Diseases in Children.

PubMed

Rathi, Narendra; Kulkarni, Atul; Yewale, Vijay

2017-03-15

To formulate practice guidelines on rickettsial diseases in children for pediatricians across India. Rickettsial diseases are increasingly being reported from various parts of India. Due to low index of suspicion, nonspecific clinical features in early course of disease, and absence of easily available, sensitive and specific diagnostic tests, these infections are difficult to diagnose. With timely diagnosis, therapy is easy, affordable and often successful. On the other hand, in endemic areas, where healthcare workers have high index of suspicion for these infections, there is rampant and irrational use of doxycycline as a therapeutic trial in patients of undifferentiated fevers. Thus, there is a need to formulate practice guidelines regarding rickettsial diseases in children in Indian context. A committee was formed for preparing guidelines on rickettsial diseases in children in June 2016. A meeting of consultative committee was held in IAP office, Mumbai and scientific content was discussed. Methodology and results were scrutinized by all members and consensus was reached. Textbook references and published guidelines were also used in few instances to make recommendations. Various Indian and international publications pertinent to present study were collated and guidelines were approved by all committee members. Future updates in these guidelines will be dictated by new scientific data in the field of rickettsial diseases in children. Indian tick typhus and scrub typhus are commonly seen rickettsial diseases in India. It is recommended that practicing pediatricians should be well conversant with compatible clinical scenario, suggestive epidemiological features, differential diagnoses and suggestive laboratory features to make diagnosis and avoid over diagnosis of these infections, as suggested in these guidelines. Doxycycline is the drug of choice and treatment should begin promptly without waiting for confirmatory laboratory results.

[Biosafety in laboratories concerning exposure to biological agents].

PubMed

Vonesch, N; Tomao, P; Di Renzi, S; Vita, S; Signorini, S

2006-01-01

Laboratory workers are exposed to a variety of potential occupational health hazards including those deriving from infectious materials and cultures, radiations, toxic and flammable chemicals, as well as mechanical and electrical hazard. Although all of them are significant, this paper will focus on biological hazards present in clinical and research laboratories. In fact, in spite of numerous publications, guidelines and regulations, laboratory workers are still subject to infections acquired in the course of their researches. This paper describes some aspects that include good microbiological practices (GMPs), appropriate containment equipment, practices and operational procedures to minimize workers' risk of injury or illness.

Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI).

PubMed

Janetzki, Sylvia; Panageas, Katherine S; Ben-Porat, Leah; Boyer, Jean; Britten, Cedrik M; Clay, Timothy M; Kalos, Michael; Maecker, Holden T; Romero, Pedro; Yuan, Jianda; Kast, W Martin; Hoos, Axel

2008-03-01

The Cancer Vaccine Consortium of the Sabin Vaccine Institute (CVC/SVI) is conducting an ongoing large-scale immune monitoring harmonization program through its members and affiliated associations. This effort was brought to life as an external validation program by conducting an international Elispot proficiency panel with 36 laboratories in 2005, and was followed by a second panel with 29 participating laboratories in 2006 allowing for application of learnings from the first panel. Critical protocol choices, as well as standardization and validation practices among laboratories were assessed through detailed surveys. Although panel participants had to follow general guidelines in order to allow comparison of results, each laboratory was able to use its own protocols, materials and reagents. The second panel recorded an overall significantly improved performance, as measured by the ability to detect all predefined responses correctly. Protocol choices and laboratory practices, which can have a dramatic effect on the overall assay outcome, were identified and lead to the following recommendations: (A) Establish a laboratory SOP for Elispot testing procedures including (A1) a counting method for apoptotic cells for determining adequate cell dilution for plating, and (A2) overnight rest of cells prior to plating and incubation, (B) Use only pre-tested serum optimized for low background: high signal ratio, (C) Establish a laboratory SOP for plate reading including (C1) human auditing during the reading process and (C2) adequate adjustments for technical artifacts, and (D) Only allow trained personnel, which is certified per laboratory SOPs to conduct assays. Recommendations described under (A) were found to make a statistically significant difference in assay performance, while the remaining recommendations are based on practical experiences confirmed by the panel results, which could not be statistically tested. These results provide initial harmonization guidelines to optimize Elispot assay performance to the immunotherapy community. Further optimization is in process with ongoing panels.

Standardization of laboratory lipid profile assessment: A call for action with a special focus on the 2016 ESC/EAS dyslipidemia guidelines - Executive summary: A consensus endorsed by the Cardiovascular Risk and Prevention Group of the Portuguese Internal Medicine Society, the Portuguese Atherosclerosis Society, the Portuguese Society of Cardiology, the Portuguese Society of Laboratory Medicine, and the Portuguese Association of Clinical Chemistry.

PubMed

da Silva, Pedro Marques; Sequeira Duarte, João; von Hafe, Pedro; Gil, Victor; Nunes de Oliveira, Jorge; de Sousa, Germano

2018-04-01

Even with improvements in lifestyle interventions, better control of cardiovascular (CV) risk factors, and improvements in CV outcomes, cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in Portugal and Europe. Atherogenic dyslipidemias, particularly hypercholesterolemia, have a crucial causal role in the development of atherosclerotic CVD. The clinical approach to a patient with dyslipidemia requires an accurate diagnosis, based on harmonized and standardized lipid and lipoprotein laboratory assessments. Results and reports of these tests, together with assessment of total CV risk and the respective therapeutic targets, will help ensure that clinical guidelines and good clinical practices are followed, increasing the reliability of screening for lipid disorders, producing more accurate diagnoses and CV risk stratification, and improving CV prevention. To this end, this consensus aims to provide clinicians with practical guidance for the harmonization and standardization of laboratory lipid tests, focusing on the most recent dyslipidemia management guidelines. Copyright © 2018 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

PubMed Central

Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

2012-01-01

Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

Adapting heart failure guidelines for nursing care in home health settings: challenges and solutions.

PubMed

Radhakrishnan, Kavita; Topaz, Maxim; Masterson Creber, Ruth

2014-07-01

Nurses provide most of home health services for patients with heart failure, and yet there are no evidence-based practice guidelines developed for home health nurses. The purpose of this article was to review the challenges and solutions for adapting generally available HF clinical practice guidelines to home health nursing. Appropriate HF guidelines were identified and home health nursing-relevant guidelines were extracted by the research team. In addition, a team of nursing academic and practice experts evaluated the extracted guidelines and reached consensus through Delphi rounds. We identified 172 recommendations relevant to home health nursing from the American Heart Association and Heart Failure Society of America guidelines. The recommendations were divided into 5 groups (generic, minority populations, normal ejection fraction, reduced ejection fraction, and comorbidities) and further subgroups. Experts agreed that 87% of the recommendations selected by the research team were relevant to home health nursing and rejected 6% of the selected recommendations. Experts' opinions were split on 7% of guideline recommendations. Experts mostly disagreed on recommendations related to HF medication and laboratory prescription as well as HF patient assessment. These disagreements were due to lack of patient information available to home health nurses as well as unclear understanding of scope of practice regulations for home health nursing. After 2 Delphi rounds over 8 months, we achieved 100% agreement on the recommendations. The finalized guideline included 153 recommendations. Guideline adaptation projects should include a broad scope of nursing practice recommendations from which home health agencies can customize relevant recommendations in accordance with available information and state and agency regulations.

Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.

PubMed

Hyde, Tiffany D

2014-01-01

The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.

[Evaluation of the quality of clinical practice guidelines published in the Annales de Biologie Clinique with the help of the EFLM checklist].

PubMed

Wils, Julien; Fonfrède, Michèle; Augereau, Christine; Watine, Joseph

2014-01-01

Several tools are available to help evaluate the quality of clinical practice guidelines (CPG). The AGREE instrument (Appraisal of guidelines for research & evaluation) is the most consensual tool but it has been designed to assess CPG methodology only. The European federation of laboratory medicine (EFLM) recently designed a check-list dedicated to laboratory medicine which is supposed to be comprehensive and which therefore makes it possible to evaluate more thoroughly the quality of CPG in laboratory medicine. In the present work we test the comprehensiveness of this check-list on a sample of CPG written in French and published in Annales de biologie clinique (ABC). Thus we show that some work remains to be achieved before a truly comprehensive check-list is designed. We also show that there is some room for improvement for the CPG published in ABC, for example regarding the fact that some of these CPG do not provide any information about allowed durations of transport and of storage of biological samples before analysis, or about standards of minimal analytical performance, or about the sensitivities or the specificities of the recommended tests.

[Costs and prices of laboratory services].

PubMed

Magid, E; Bartels, P D; Brandslund, I; Christensen, M S; Fahrenkrug, J; Hørder, M; Olsen, H; Pedersen, K O; Riber, E

1991-09-23

Cost accounting is performed in private and public laboratories. Guidelines for these activities are required and with this objective in mind, the Board of the Danish Society of Clinical Chemistry commissioned a working group to produce a position paper which is presented now in this report. The report discusses the objectives, the principles and the general requirements for cost accounting. The significance of information on costs for the clinicians' rational use of the laboratory is also illustrated. The working group points out that prerequisites for lucid and appropriate costing guidelines are clarification of which purposes information on costs are meant to serve, identification of the relevant cost centers and quality assurance of laboratory services to a defined extent. It is common practice to express laboratory costs as costs per test. The report advocates calculation of the cost per patient contact, i.e. the overall costs for laboratory service in a given investigative situation.

Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

PubMed

2012-04-06

Biochemical genetic testing and newborn screening are essential laboratory services for the screening, detection, diagnosis, and monitoring of inborn errors of metabolism or inherited metabolic disorders. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). Laboratories that perform biochemical genetic testing are required by CLIA regulations to meet the general quality systems requirements for nonwaived testing and the personnel requirements for high-complexity testing. Laboratories that perform public health newborn screening are subject to the same CLIA regulations and applicable state requirements. As the number of inherited metabolic diseases that are included in state-based newborn screening programs continues to increase, ensuring the quality of performance and delivery of testing services remains a continuous challenge not only for public health laboratories and other newborn screening facilities but also for biochemical genetic testing laboratories. To help ensure the quality of laboratory testing, CDC collaborated with the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health to develop guidelines for laboratories to meet CLIA requirements and apply additional quality assurance measures for these areas of genetic testing. This report provides recommendations for good laboratory practices that were developed based on recommendations from the Clinical Laboratory Improvement Advisory Committee, with additional input from the Secretary's Advisory Committee on Genetics, Health, and Society; the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and representatives of newborn screening laboratories. The recommended practices address the benefits of using a quality management system approach, factors to consider before introducing new tests, establishment and verification of test performance specifications, the total laboratory testing process (which consists of the preanalytic, analytic, and postanalytic phases), confidentiality of patient information and test results, and personnel qualifications and responsibilities for laboratory testing for inherited metabolic diseases. These recommendations are intended for laboratories that perform biochemical genetic testing to improve the quality of laboratory services and for newborn screening laboratories to ensure the quality of laboratory practices for inherited metabolic disorders. These recommendations also are intended as a resource for medical and public health professionals who evaluate laboratory practices, for users of laboratory services to facilitate their collaboration with newborn screening systems and use of biochemical genetic tests, and for standard-setting organizations and professional societies in developing future laboratory quality standards and practice recommendations. This report complements Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions (CDC. Good laboratory practices for molecular genetic testing for heritable diseases and conditions. MMWR 2009;58 [No. RR-6]) to provide guidance for ensuring and improving the quality of genetic laboratory services and public health outcomes. Future recommendations for additional areas of genetic testing will be considered on the basis of continued monitoring and evaluation of laboratory practices, technology advancements, and the development of laboratory standards and guidelines.

Do laboratories follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE).

PubMed

Hammerer-Lercher, Angelika; Collinson, Paul; van Dieijen-Visser, Marja P; Pulkki, Kari; Suvisaari, Janne; Ravkilde, Jan; Stavljenic-Rukavina, Ana; Baum, Hannsjörg; Laitinen, Päivi

2013-06-01

Natriuretic peptides (NP) are well-established markers of heart failure (HF). During the past 5 years, analytical and clinical recommendations for measurement of these biomarkers have been published in guidelines. The aim of this follow-up survey was to investigate how well these guidelines for measurement of NP have been implemented in laboratory practice in Europe. Member societies of the European Federation of Clinical Chemistry and Laboratory Medicine were invited in 2009 to participate in a web-based audit questionnaire. The questionnaire requested information on type of tests performed, decision limits for HF, turn-around time and frequency of testing. There was a moderate increase (12%) of laboratories measuring NP compared to the initial survey in 2006. The most frequently used HF decision limits for B-type NP (BNP) and N-terminal BNP (NT-proBNP) were, respectively, 100 ng/L and 125 ng/L, derived from the package inserts in 55%. Fifty laboratories used a second decision limit. Age or gender dependent decision limits were applied in 10% (8.5% in 2006). The vast majority of laboratories (80%) did not have any criteria regarding frequency of testing, compared to 33% in 2006. The implementation of NP measurement for HF management was a slow process between 2006 and 2009 at a time when guidelines had just been established. The decision limits were derived from package insert information and literature. There was great uncertainty concerning frequency of testing which may reflect the debate about the biological variability which was not published for most of the assays in 2009.

Laboratory guidelines for the diagnosis and follow-up of patients with monoclonal gammopathies.

PubMed

Bravo García-Morato, M; Padilla-Merlano, B; Nozal, P; Espiño, M; Juárez, C; Villar, L M; López-Trascasa, M

2016-04-01

We present guidelines from the Immunochemistry group of the Spanish Society for Immunology that are designed to provide a practical tool for the diagnosis and follow-up of monoclonal gammopathies. We review the clinical and analytical features of various monoclonal gammopathies, international consensus guidelines and techniques used to detect and follow-up monoclonal components. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan. Part 1: ASC software quality engineering practices, Version 2.0.

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

Sturtevant, Judith E.; Heaphy, Robert; Hodges, Ann Louise

2006-09-01

The purpose of the Sandia National Laboratories Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. The plan defines the ASC program software quality practices and provides mappings of these practices to Sandia Corporate Requirements CPR 1.3.2 and 1.3.6 and to a Department of Energy document, ASCI Software Quality Engineering: Goals, Principles, and Guidelines. This document also identifies ASC management and software project teams responsibilities in implementing the software quality practices and in assessing progress towards achieving their software quality goals.

Voluntary Guidelines for Methamphetamine Laboratory Cleanup - Document

EPA Pesticide Factsheets

provides technical guidance for state and local personnel responsible for meth lab cleanup, based on an extensive review of the best available science and practices, and addresses general cleanup activities, specific items/materials, sampling.

Assuring the Quality of Next-Generation Sequencing in Clinical Microbiology and Public Health Laboratories.

PubMed

Gargis, Amy S; Kalman, Lisa; Lubin, Ira M

2016-12-01

Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

A survey of current practices for genomic sequencing test interpretation and reporting processes in US laboratories.

PubMed

O'Daniel, Julianne M; McLaughlin, Heather M; Amendola, Laura M; Bale, Sherri J; Berg, Jonathan S; Bick, David; Bowling, Kevin M; Chao, Elizabeth C; Chung, Wendy K; Conlin, Laura K; Cooper, Gregory M; Das, Soma; Deignan, Joshua L; Dorschner, Michael O; Evans, James P; Ghazani, Arezou A; Goddard, Katrina A; Gornick, Michele; Farwell Hagman, Kelly D; Hambuch, Tina; Hegde, Madhuri; Hindorff, Lucia A; Holm, Ingrid A; Jarvik, Gail P; Knight Johnson, Amy; Mighion, Lindsey; Morra, Massimo; Plon, Sharon E; Punj, Sumit; Richards, C Sue; Santani, Avni; Shirts, Brian H; Spinner, Nancy B; Tang, Sha; Weck, Karen E; Wolf, Susan M; Yang, Yaping; Rehm, Heidi L

2017-05-01

While the diagnostic success of genomic sequencing expands, the complexity of this testing should not be overlooked. Numerous laboratory processes are required to support the identification, interpretation, and reporting of clinically significant variants. This study aimed to examine the workflow and reporting procedures among US laboratories to highlight shared practices and identify areas in need of standardization. Surveys and follow-up interviews were conducted with laboratories offering exome and/or genome sequencing to support a research program or for routine clinical services. The 73-item survey elicited multiple choice and free-text responses that were later clarified with phone interviews. Twenty-one laboratories participated. Practices highly concordant across all groups included consent documentation, multiperson case review, and enabling patient opt-out of incidental or secondary findings analysis. Noted divergence included use of phenotypic data to inform case analysis and interpretation and reporting of case-specific quality metrics and methods. Few laboratory policies detailed procedures for data reanalysis, data sharing, or patient access to data. This study provides an overview of practices and policies of experienced exome and genome sequencing laboratories. The results enable broader consideration of which practices are becoming standard approaches, where divergence remains, and areas of development in best practice guidelines that may be helpful.Genet Med advance online publication 03 Novemeber 2016.

Consensus Guidelines for Practical Competencies in Anatomic Pathology and Laboratory Medicine for the Undifferentiated Graduating Medical Student

PubMed Central

Shah, Darshana T.; Cambor, Carolyn L.; Conran, Richard M.; Lin, Amy Y.; Peerschke, Ellinor I.B.; Pessin, Melissa S.; Harris, Ilene B.

2015-01-01

The practice of pathology is not generally addressed in the undergraduate medical school curriculum. It is desirable to develop practical pathology competencies in the fields of anatomic pathology and laboratory medicine for every graduating medical student to facilitate (1) instruction in effective utilization of these services for optimal patient care, (2) recognition of the role of pathologists and laboratory scientists as consultants, and (3) exposure to the field of pathology as a possible career choice. A national committee was formed, including experts in anatomic pathology and/or laboratory medicine and in medical education. Suggested practical pathology competencies were developed in 9 subspecialty domains based on literature review and committee deliberations. The competencies were distributed in the form of a survey in late 2012 through the first half of 2013 to the medical education community for feedback, which was subjected to quantitative and qualitative analysis. An approval rate of ≥80% constituted consensus for adoption of a competency, with additional inclusions/modifications considered following committee review of comments. The survey included 79 proposed competencies. There were 265 respondents, the majority being pathologists. Seventy-two percent (57 of 79) of the competencies were approved by ≥80% of respondents. Numerous comments (N = 503) provided a robust resource for qualitative analysis. Following committee review, 71 competencies (including 27 modified and 3 new competencies) were considered to be essential for undifferentiated graduating medical students. Guidelines for practical pathology competencies have been developed, with the hope that they will be implemented in undergraduate medical school curricula. PMID:28725750

Consensus Guidelines for Practical Competencies in Anatomic Pathology and Laboratory Medicine for the Undifferentiated Graduating Medical Student.

PubMed

Magid, Margret S; Shah, Darshana T; Cambor, Carolyn L; Conran, Richard M; Lin, Amy Y; Peerschke, Ellinor I B; Pessin, Melissa S; Harris, Ilene B

2015-01-01

The practice of pathology is not generally addressed in the undergraduate medical school curriculum. It is desirable to develop practical pathology competencies in the fields of anatomic pathology and laboratory medicine for every graduating medical student to facilitate (1) instruction in effective utilization of these services for optimal patient care, (2) recognition of the role of pathologists and laboratory scientists as consultants, and (3) exposure to the field of pathology as a possible career choice. A national committee was formed, including experts in anatomic pathology and/or laboratory medicine and in medical education. Suggested practical pathology competencies were developed in 9 subspecialty domains based on literature review and committee deliberations. The competencies were distributed in the form of a survey in late 2012 through the first half of 2013 to the medical education community for feedback, which was subjected to quantitative and qualitative analysis. An approval rate of ≥80% constituted consensus for adoption of a competency, with additional inclusions/modifications considered following committee review of comments. The survey included 79 proposed competencies. There were 265 respondents, the majority being pathologists. Seventy-two percent (57 of 79) of the competencies were approved by ≥80% of respondents. Numerous comments (N = 503) provided a robust resource for qualitative analysis. Following committee review, 71 competencies (including 27 modified and 3 new competencies) were considered to be essential for undifferentiated graduating medical students. Guidelines for practical pathology competencies have been developed, with the hope that they will be implemented in undergraduate medical school curricula.

ICSH guidelines for the verification and performance of automated cell counters for body fluids.

PubMed

Bourner, G; De la Salle, B; George, T; Tabe, Y; Baum, H; Culp, N; Keng, T B

2014-12-01

One of the many challenges facing laboratories is the verification of their automated Complete Blood Count cell counters for the enumeration of body fluids. These analyzers offer improved accuracy, precision, and efficiency in performing the enumeration of cells compared with manual methods. A patterns of practice survey was distributed to laboratories that participate in proficiency testing in Ontario, Canada, the United States, the United Kingdom, and Japan to determine the number of laboratories that are testing body fluids on automated analyzers and the performance specifications that were performed. Based on the results of this questionnaire, an International Working Group for the Verification and Performance of Automated Cell Counters for Body Fluids was formed by the International Council for Standardization in Hematology (ICSH) to prepare a set of guidelines to help laboratories plan and execute the verification of their automated cell counters to provide accurate and reliable results for automated body fluid counts. These guidelines were discussed at the ICSH General Assemblies and reviewed by an international panel of experts to achieve further consensus. © 2014 John Wiley & Sons Ltd.

Competency Guidelines for Public Health Laboratory Professionals: CDC and the Association of Public Health Laboratories.

PubMed

Ned-Sykes, Renée; Johnson, Catherine; Ridderhof, John C; Perlman, Eva; Pollock, Anne; DeBoy, John M

2015-05-15

These competency guidelines outline the knowledge, skills, and abilities necessary for public health laboratory (PHL) professionals to deliver the core services of PHLs efficiently and effectively. As part of a 2-year workforce project sponsored in 2012 by CDC and the Association of Public Health Laboratories (APHL), competencies for 15 domain areas were developed by experts representing state and local PHLs, clinical laboratories, academic institutions, laboratory professional organizations, CDC, and APHL. The competencies were developed and reviewed by approximately 170 subject matter experts with diverse backgrounds and experiences in laboratory science and public health. The guidelines comprise general, cross-cutting, and specialized domain areas and are divided into four levels of proficiency: beginner, competent, proficient, and expert. The 15 domain areas are 1) Quality Management System, 2) Ethics, 3) Management and Leadership, 4) Communication, 5) Security, 6) Emergency Management and Response, 7) Workforce Training, 8) General Laboratory Practice, 9) Safety, 10) Surveillance, 11) Informatics, 12) Microbiology, 13) Chemistry, 14) Bioinformatics, and 15) Research. These competency guidelines are targeted to scientists working in PHLs, defined as governmental public health, environmental, and agricultural laboratories that provide analytic biological and/or chemical testing and testing-related services that protect human populations against infectious diseases, foodborne and waterborne diseases, environmental hazards, treatable hereditary disorders, and natural and human-made public health emergencies. The competencies support certain PHL workforce needs such as identifying job responsibilities, assessing individual performance, and providing a guiding framework for producing education and training programs. Although these competencies were developed specifically for the PHL community, this does not preclude their broader application to other professionals in a variety of different work settings.

Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?--A pilot study and a proposal.

PubMed

Jassam, Nuthar; Yundt-Pacheco, John; Jansen, Rob; Thomas, Annette; Barth, Julian H

2013-08-01

The implementation of national and international guidelines is beginning to standardise clinical practice. However, since many guidelines have decision limits based on laboratory tests, there is an urgent need to ensure that different laboratories obtain the same analytical result on any sample. A scientifically-based quality control process will be a pre-requisite to provide this level of analytical performance which will support evidence-based guidelines and movement of patients across boundaries while maintaining standardised outcomes. We discuss the finding of a pilot study performed to assess UK clinical laboratories readiness to work to a higher grade quality specifications such as biological variation-based quality specifications. Internal quality control (IQC) data for HbA1c, glucose, creatinine, cholesterol and high density lipoprotein (HDL)-cholesterol were collected from UK laboratories participating in the Bio-Rad Unity QC programme. The median of the coefficient of variation (CV%) of the participating laboratories was evaluated against the CV% based on biological variation. Except creatinine, the other four analytes had a variable degree of compliance with the biological variation-based quality specifications. More than 75% of the laboratories met the biological variation-based quality specifications for glucose, cholesterol and HDL-cholesterol. Slightly over 50% of the laboratories met the analytical goal for HBA1c. Only one analyte (cholesterol) had a performance achieving the higher quality specifications consistent with 5σ. Our data from IQC do not consistently demonstrate that the results from clinical laboratories meet evidence-based quality specifications. Therefore, we propose that a graded scale of quality specifications may be needed at this stage.

Guidelines for the identification of unknown samples for laboratories performing forensic analyses for chemical terrorism.

PubMed

Magnuson, Matthew L; Satzger, R Duane; Alcaraz, Armando; Brewer, Jason; Fetterolf, Dean; Harper, Martin; Hrynchuk, Ronald; McNally, Mary F; Montgomery, Madeline; Nottingham, Eric; Peterson, James; Rickenbach, Michael; Seidel, Jimmy L; Wolnik, Karen

2012-05-01

Since the early 1990s, the FBI Laboratory has sponsored Scientific Working Groups to improve discipline practices and build consensus among the forensic community. The Scientific Working Group on the Forensic Analysis of Chemical, Biological, Radiological and Nuclear Terrorism developed guidance, contained in this document, on issues forensic laboratories encounter when accepting and analyzing unknown samples associated with chemical terrorism, including laboratory capabilities and analytical testing plans. In the context of forensic analysis of chemical terrorism, this guidance defines an unknown sample and addresses what constitutes definitive and tentative identification. Laboratory safety, reporting issues, and postreporting considerations are also discussed. Utilization of these guidelines, as part of planning for forensic analysis related to a chemical terrorism incident, may help avoid unfortunate consequences not only to the public but also to the laboratory personnel. 2011 American Academy of Forensic Sciences. Published 2011. This article is a U.S. Government work and is in the public domain in the U.S.A.

[Prostate cancer screening using prostate-specific antigen: The views of general and laboratory physicians].

PubMed

Giménez, N; Filella, X; Gavagnach, M; Allué, J A; Pedrazas, D; Ferrer, F

2018-03-21

It is currently recommended to provide individualised information on benefit-risk balance and shared decision-making in prostate cancer screening using prostate-specific antigen (PSA). To determine the usual practice and the views of general and laboratory practitioners in the screening of prostate cancer using PSA. A cross-sectional study based on a questionnaire and on PSA screening requests from Primary Health Care (PHC) in men older than 49 years with no prostatic symptoms. In 2015, PHC in Catalonia requested PSA on 15.2% of males. A total of 114 general practitioners and 227 laboratory practitioners participated in the questionnaire. The mean age of those who responded was 43 years with a mean of 17 years' experience, and included 64% women. According to general practitioners, 61% of PSA was performed at the patient's request. The uncertainty score when requesting PSA was 5 points for general practitioners and 5.7 for laboratory professionals. Interest in having clinical recommendations received 7.2 points in PHC, and 8.8 in the laboratory. Knowledge about the different clinical practice guidelines received was less than 5 points overall. General practitioners requested PSA screening in almost one-sixth of men over the age of 49 without prostate disease, often at the patient's request, and after informing them of the benefits and risks. PHC and laboratory physicians were interested in having recommendations and information, although they did not usually consult clinical practice guidelines immediately. Copyright © 2018 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

A Pathway to National Guidelines for Laboratory Diagnostics of Chronic Kidney Disease – Examples from Diverse European Countries

PubMed Central

Aakre, Kristin Moberg; Yucel, Dogan; Bargnoux, Anne-Sophie; Cristol, Jean-Paul; Piéroni, Laurence

2017-01-01

The principal benefit of guidelines is to improve the quality of care received by patients. In the 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (KDIGO) was released and it is designed to provide information and assist decision making. This review gives a brief overview of a various national CKD guidelines that rely on the newly released KDIGO guidelines. All of the included countries (France, Turkey, Norway and Croatia) are non-English speaking countries and they differ in population and socio economic aspects. Examples shown in this review may provide valuable experience for countries that are in process of creating their national CKD guidelines. PMID:29333148

Guidelines for safe work practices in human and animal medical diagnostic laboratories. Recommendations of a CDC-convened, Biosafety Blue Ribbon Panel.

PubMed

Miller, J Michael; Astles, Rex; Baszler, Timothy; Chapin, Kimberle; Carey, Roberta; Garcia, Lynne; Gray, Larry; Larone, Davise; Pentella, Michael; Pollock, Anne; Shapiro, Daniel S; Weirich, Elizabeth; Wiedbrauk, Danny

2012-01-06

Prevention of injuries and occupational infections in U.S. laboratories has been a concern for many years. CDC and the National Institutes of Health addressed the topic in their publication Biosafety in Microbiological and Biomedical Laboratories, now in its 5th edition (BMBL-5). BMBL-5, however, was not designed to address the day-to-day operations of diagnostic laboratories in human and animal medicine. In 2008, CDC convened a Blue Ribbon Panel of laboratory representatives from a variety of agencies, laboratory organizations, and facilities to review laboratory biosafety in diagnostic laboratories. The members of this panel recommended that biosafety guidelines be developed to address the unique operational needs of the diagnostic laboratory community and that they be science based and made available broadly. These guidelines promote a culture of safety and include recommendations that supplement BMBL-5 by addressing the unique needs of the diagnostic laboratory. They are not requirements but recommendations that represent current science and sound judgment that can foster a safe working environment for all laboratorians. Throughout these guidelines, quality laboratory science is reinforced by a common-sense approach to biosafety in day-to-day activities. Because many of the same diagnostic techniques are used in human and animal diagnostic laboratories, the text is presented with this in mind. All functions of the human and animal diagnostic laboratory--microbiology, chemistry, hematology, and pathology with autopsy and necropsy guidance--are addressed. A specific section for veterinary diagnostic laboratories addresses the veterinary issues not shared by other human laboratory departments. Recommendations for all laboratories include use of Class IIA2 biological safety cabinets that are inspected annually; frequent hand washing; use of appropriate disinfectants, including 1:10 dilutions of household bleach; dependence on risk assessments for many activities; development of written safety protocols that address the risks of chemicals in the laboratory; the need for negative airflow into the laboratory; areas of the laboratory in which use of gloves is optional or is recommended; and the national need for a central site for surveillance and nonpunitive reporting of laboratory incidents/exposures, injuries, and infections.

Current worldwide nuclear cardiology practices and radiation exposure: results from the 65 country IAEA Nuclear Cardiology Protocols Cross-Sectional Study (INCAPS).

PubMed

Einstein, Andrew J; Pascual, Thomas N B; Mercuri, Mathew; Karthikeyan, Ganesan; Vitola, João V; Mahmarian, John J; Better, Nathan; Bouyoucef, Salah E; Hee-Seung Bom, Henry; Lele, Vikram; Magboo, V Peter C; Alexánderson, Erick; Allam, Adel H; Al-Mallah, Mouaz H; Flotats, Albert; Jerome, Scott; Kaufmann, Philipp A; Luxenburg, Osnat; Shaw, Leslee J; Underwood, S Richard; Rehani, Madan M; Kashyap, Ravi; Paez, Diana; Dondi, Maurizio

2015-07-07

To characterize patient radiation doses from nuclear myocardial perfusion imaging (MPI) and the use of radiation-optimizing 'best practices' worldwide, and to evaluate the relationship between laboratory use of best practices and patient radiation dose. We conducted an observational cross-sectional study of protocols used for all 7911 MPI studies performed in 308 nuclear cardiology laboratories in 65 countries for a single week in March-April 2013. Eight 'best practices' relating to radiation exposure were identified a priori by an expert committee, and a radiation-related quality index (QI) devised indicating the number of best practices used by a laboratory. Patient radiation effective dose (ED) ranged between 0.8 and 35.6 mSv (median 10.0 mSv). Average laboratory ED ranged from 2.2 to 24.4 mSv (median 10.4 mSv); only 91 (30%) laboratories achieved the median ED ≤ 9 mSv recommended by guidelines. Laboratory QIs ranged from 2 to 8 (median 5). Both ED and QI differed significantly between laboratories, countries, and world regions. The lowest median ED (8.0 mSv), in Europe, coincided with high best-practice adherence (mean laboratory QI 6.2). The highest doses (median 12.1 mSv) and low QI (4.9) occurred in Latin America. In hierarchical regression modelling, patients undergoing MPI at laboratories following more 'best practices' had lower EDs. Marked worldwide variation exists in radiation safety practices pertaining to MPI, with targeted EDs currently achieved in a minority of laboratories. The significant relationship between best-practice implementation and lower doses indicates numerous opportunities to reduce radiation exposure from MPI globally. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

[The Nutritional Care Experience of a Post-Operative Periampullary Cancer Patient With Cachexia].

PubMed

Liou, Yan-Ting; Chiang, Pin-Yi; Shun, Shiow-Ching

2016-04-01

Cachexia is one of the most widely overlooked of the syndromes that are experienced by cancer patients. This syndrome is especially prevalent among patients with gastroenterology tract cancer. Although the National Comprehensive Cancer Network (NCCN) issued palliative-care practice guidelines for cachexia in 2015, guidelines have yet to be issued for the clinical setting. The authors reviewed the literature and applied their clinical experience to create an approach for identifying the degree of cachexia in a post-operative patient with periampullary cancer. This approach assesses the nutritional status, physical status, laboratory results, and gastrointestinal system functions of the patient using the Cachexia Assessment Scale (CAS) and NCCN Practice Guidelines for Cachexia. The patient improved under nursing care with an increase in nutritional intake and physical activity facilitating their process of post-surgical physical recovery. The authors hope that this experience using the combined CAS-NCCN Practice Guidelines will help clinical caregivers better understand how to apply the relevant guidelines in clinical settings. The developed approach may help nurses assess the comprehensive nutrition status of patients and related factors in order to provide interventions that will decrease the progression of cachexia effectively and promote quality of life.

Recommended safety guides for industrial laboratories and shops

NASA Technical Reports Server (NTRS)

Allison, W. W.

1971-01-01

Booklet provides references to 29 publications providing information on hazard control and approved safety practices. Areas include pressurized gas and vacuum systems. Guidelines are presented for safeguarding facilities where machinery, equipment, electrical devices, or hazardous chemicals are used.

Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.

PubMed

Tomlinson, Lindsay; Boone, Laura I; Ramaiah, Lila; Penraat, Kelley A; von Beust, Barbara R; Ameri, Mehrdad; Poitout-Belissent, Florence M; Weingand, Kurt; Workman, Heather C; Aulbach, Adam D; Meyer, Dennis J; Brown, Diane E; MacNeill, Amy L; Bolliger, Anne Provencher; Bounous, Denise I

2013-09-01

The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices. © 2013 American Society for Veterinary Clinical Pathology.

Cairo consensus on the IVF laboratory environment and air quality: report of an expert meeting.

PubMed

Mortimer, D; Cohen, J; Mortimer, S T; Fawzy, M; McCulloh, D H; Morbeck, D E; Pollet-Villard, X; Mansour, R T; Brison, D R; Doshi, A; Harper, J C; Swain, J E; Gilligan, A V

2018-03-02

This proceedings report presents the outcomes from an international Expert Meeting to establish a consensus on the recommended technical and operational requirements for air quality within modern assisted reproduction technology (ART) laboratories. Topics considered included design and construction of the facility, as well as its heating, ventilation and air conditioning system; control of particulates, micro-organisms (bacteria, fungi and viruses) and volatile organic compounds (VOCs) within critical areas; safe cleaning practices; operational practices to optimize air quality while minimizing physicochemical risks to gametes and embryos (temperature control versus air flow); and appropriate infection-control practices that minimize exposure to VOC. More than 50 consensus points were established under the general headings of assessing site suitability, basic design criteria for new construction, and laboratory commissioning and ongoing VOC management. These consensus points should be considered as aspirational benchmarks for existing ART laboratories, and as guidelines for the construction of new ART laboratories. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

Laboratory compliance with the American Society of Clinical Oncology/college of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: a College of American Pathologists survey of 757 laboratories.

PubMed

Nakhleh, Raouf E; Grimm, Erin E; Idowu, Michael O; Souers, Rhona J; Fitzgibbons, Patrick L

2010-05-01

To ensure quality human epidermal growth receptor 2 (HER2) testing in breast cancer, the American Society of Clinical Oncology/College of American Pathologists guidelines were introduced with expected compliance by 2008. To assess the effect these guidelines have had on pathology laboratories and their ability to address key components. In late 2008, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program. It included questions regarding pathology practice characteristics and assay validation using fluorescence in situ hybridization or another IHC laboratory assay and assessed pathologist HER2 scoring competency. Of the 907 surveys sent, 757 (83.5%) were returned. The median laboratory accessioned 15 000 cases and performed 190 HER2 tests annually. Quantitative computer image analysis was used by 33% of laboratories. In-house fluorescence in situ hybridization was performed in 23% of laboratories, and 60% of laboratories addressed the 6- to 48-hour tissue fixation requirement by embedding tissue on the weekend. HER2 testing was performed on the initial biopsy in 40%, on the resection specimen in 6%, and on either in 56% of laboratories. Testing was validated with only fluorescence in situ hybridization in 47% of laboratories, whereas 10% of laboratories used another IHC assay only; 13% used both assays, and 12% and 15% of laboratories had not validated their assays or chose "not applicable" on the survey question, respectively. The 90% concordance rate with fluorescence in situ hybridization results was achieved by 88% of laboratories for IHC-negative findings and by 81% of laboratories for IHC-positive cases. The 90% concordance rate for laboratories using another IHC assay was achieved by 80% for negative findings and 75% for positive cases. About 91% of laboratories had a pathologist competency assessment program. This survey demonstrates the extent and characteristics of HER2 testing. Although some American Society of Clinical Oncology/College of American Pathologists guidelines have been implemented, gaps remain in validation of HER2 IHC testing.

Recommended approach to software development, revision 3

NASA Technical Reports Server (NTRS)

Landis, Linda; Waligora, Sharon; Mcgarry, Frank; Pajerski, Rose; Stark, Mike; Johnson, Kevin Orlin; Cover, Donna

1992-01-01

Guidelines for an organized, disciplined approach to software development that is based on studies conducted by the Software Engineering Laboratory (SEL) since 1976 are presented. It describes methods and practices for each phase of a software development life cycle that starts with requirements definition and ends with acceptance testing. For each defined life cycle phase, guidelines for the development process and its management, and for the products produced and their reviews are presented.

Gap Between Official Guidelines and Clinical Practice for the Treatment of Rheumatoid Arthritis in São Paulo, Brazil.

PubMed

de Camargo, Iara Alves; Almeida Barros, Bruna Cipriano; do Nascimento Silveira, Miriam Sanches; Osorio-de-Castro, Claudia Garcia Serpa; Guyatt, Gordon; Lopes, Luciane Cruz

2016-05-01

Biological agents used for the treatment of rheumatoid arthritis (RA) are associated with serious adverse events. Guidelines provide standards for the prescribing and monitoring of these drugs. In São Paulo, health litigation for access to medicines has fueled the demand for biological therapy. The extent to which biological agents are being appropriately prescribed and patients are being appropriately monitored is uncertain. Our goal was to determine whether RA clinical guidelines are being translated into clinical practice for patients receiving treatment as a result of lawsuits against the government. We identified patients through records of the State Secretary of Health of São Paulo from 2003 to 2011. We consulted guidelines from 5 countries and chose those recommendations endorsed by all of the guidelines reviewed as standards. Pharmacy records provided data regarding biologic use. The guidelines recommended the use of biological agents only when patients had been receiving treatment with at least 1 disease-modifying antirheumatic drug (DMARD) and recommended annual monitoring of laboratory blood tests. Of the 238 patients identified in the database, 216 patients were interviewed, and 124 (57.4%) patients were still using biological agents at the time of the survey. Of the patients interviewed, 167 patients (77.3%) started biological treatment when using ≥2 DMARDs before, 22 patients (10.2%) were using 1 DMARD before, and 27 patients (12.5%) had never taken a DMARD. Of the 124 patients still taking biological drugs, 117 patients (94.3%) had visited a doctor at least once per year, but 28 patients (22.6%) did not undergo the recommended laboratory blood testing. Only 43 of the 124 patients (34.7%) still taking biological agents met the guideline criteria for both the use of previous agents and the appropriate monitoring. An important gap between clinical practice and the national guidelines exists among treatments prescribed for plaintiffs obtaining medicines for RA in São Paulo. The results suggest the need for intervention by health authorities. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories.

PubMed

Stuart, Lauren N; Volmar, Keith E; Nowak, Jan A; Fatheree, Lisa A; Souers, Rhona J; Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Astles, J Rex; Nakhleh, Raouf E

2017-09-01

- A cooperative agreement between the College of American Pathologists (CAP) and the United States Centers for Disease Control and Prevention was undertaken to measure laboratories' awareness and implementation of an evidence-based laboratory practice guideline (LPG) on immunohistochemical (IHC) validation practices published in 2014. - To establish new benchmark data on IHC laboratory practices. - A 2015 survey on IHC assay validation practices was sent to laboratories subscribed to specific CAP proficiency testing programs and to additional nonsubscribing laboratories that perform IHC testing. Specific questions were designed to capture laboratory practices not addressed in a 2010 survey. - The analysis was based on responses from 1085 laboratories that perform IHC staining. Ninety-six percent (809 of 844) always documented validation of IHC assays. Sixty percent (648 of 1078) had separate procedures for predictive and nonpredictive markers, 42.7% (220 of 515) had procedures for laboratory-developed tests, 50% (349 of 697) had procedures for testing cytologic specimens, and 46.2% (363 of 785) had procedures for testing decalcified specimens. Minimum case numbers were specified by 85.9% (720 of 838) of laboratories for nonpredictive markers and 76% (584 of 768) for predictive markers. Median concordance requirements were 95% for both types. For initial validation, 75.4% (538 of 714) of laboratories adopted the 20-case minimum for nonpredictive markers and 45.9% (266 of 579) adopted the 40-case minimum for predictive markers as outlined in the 2014 LPG. The most common method for validation was correlation with morphology and expected results. Laboratories also reported which assay changes necessitated revalidation and their minimum case requirements. - Benchmark data on current IHC validation practices and procedures may help laboratories understand the issues and influence further refinement of LPG recommendations.

Analysis of on-line clinical laboratory manuals and practical recommendations.

PubMed

Beckwith, Bruce; Schwartz, Robert; Pantanowitz, Liron

2004-04-01

On-line clinical laboratory manuals are a valuable resource for medical professionals. To our knowledge, no recommendations currently exist for their content or design. To analyze publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content. We conducted an Internet search for clinical laboratory manuals written in English with individual test listings. Four individual test listings in each manual were evaluated for 16 data elements, including sample requirements, test methodology, units of measure, reference range, and critical values. Web sites were also evaluated for supplementary information and search functions. We identified 48 on-line laboratory manuals, including 24 academic or community hospital laboratories and 24 commercial or reference laboratories. All manuals had search engines and/or test indices. No single manual contained all 16 data elements evaluated. An average of 8.9 (56%) elements were present (range, 4-14). Basic sample requirements (specimen and volume needed) were the elements most commonly present (98% of manuals). The frequency of the remaining data elements varied from 10% to 90%. On-line clinical laboratory manuals originate from both hospital and commercial laboratories. While most manuals were user-friendly and contained adequate specimen-collection information, other important elements, such as reference ranges, were frequently absent. To ensure that clinical laboratory manuals are of maximal utility, we propose the following 13 data elements be included in individual test listings: test name, synonyms, test description, test methodology, sample requirements, volume requirements, collection guidelines, transport guidelines, units of measure, reference range, critical values, test availability, and date of latest revision.

European guidelines for workplace drug and alcohol testing in hair.

PubMed

Salomone, A; Tsanaclis, L; Agius, R; Kintz, P; Baumgartner, M R

2016-10-01

Guidelines for Legally Defensible Workplace Drug Testing have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). They are based on the 2010 version published by Pascal Kintz and Ronald Agius (Guidelines for European workplace drug and alcohol testing in hair. Drug Test. Anal. 2010, 2, 367) and in concordance with the Society of Hair Testing guidelines (Society of Hair Testing guidelines for drug testing in hair. Forensic Sci. Int. 2012, 218, 20-24). The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing use these guidelines as a template for accreditation. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

The OSHA hazardous chemical occupational exposure standard for laboratories.

PubMed

Armbruster, D A

1991-01-01

OSHA's chemical occupational exposure standard for laboratories is an outgrowth of the previously issued Hazard Communication Standard. The standard relieves laboratories from complying with general industry standards but does require compliance with specific laboratory guidelines. The heart of the standard is the creation of a Chemical Hygiene Plan (CHP). The CHP addresses major issues such as safety equipment and procedures, work practices, training, the designation of a chemical hygiene officer, and the provision of medical consultation and examination for affected employees. This new standard, in full effect as of January 31, 1991, presents yet another regulatory challenge to laboratory managers but also ensures a safer environment for laboratory workers.

Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling

PubMed Central

Nikolac, Nora; Šupak-Smolčić, Vesna; Šimundić, Ana-Maria; Ćelap, Ivana

2013-01-01

Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60–80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations. The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with significant differences and additional information. PMID:24266294

Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling.

PubMed

Nikolac, Nora; Supak-Smolcić, Vesna; Simundić, Ana-Maria; Celap, Ivana

2013-01-01

Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60-80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations. The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with significant differences and additional information.

Challenges to laboratory hematology practice: Egypt perspective.

PubMed

Rizk, S H

2018-05-01

Laboratory hematology is an integral part of all clinical laboratories along the extensive healthcare facilities in Egypt. The aim of this review is to portrait the laboratory hematology practice in Egypt including its unique socioeconomic background, blood disease pattern, education and training, regulatory oversight, and the related challenges. Current practice varies widely between different parts of the healthcare system in terms of the range of tests, applied techniques, workforce experience, and quality of service. The national transfusion service (NBTS) in Egypt has been recently upgraded and standardized according to the World Health Organization (WHO) guidelines. Formal postgraduate education roughly follows the British system. Laboratory hematology specialization is achieved through 2-3 years masters' degree followed by 2-4 years doctorate degree in clinical pathology with training and research in hematology. Improvement of laboratory hematology education is recently undergoing a reform as a part of the modernization of higher education policy and following the standards developed by the National Quality Assurance and Accreditation Agency (NQAAA). Accreditation of medical laboratories is recently progressing with the development of the "Egyptian Accreditation Council" (EGAC) as the sole accreditation body system and training of assessors. Current laboratory system has many challenges, some are related to the inadequate system performance, and others are unique to laboratory hematology issues. The rapid technological advances and therapeutic innovations in hematology practice call for an adapting laboratory system with continuous upgrading. © 2018 John Wiley & Sons Ltd.

Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA).

PubMed

Simundic, Ana-Maria; Cornes, Michael; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Kovalevskaya, Svjetlana; Sprongl, Ludek; Sumarac, Zorica; Church, Stephen

2013-08-01

European questionnaire survey was conducted by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PA) to assess how phlebotomy is performed in EFLM countries, including differences in personnel, level of education and skills, and to investigate the presence and compliance of national phlebotomy guidelines on this matter. A questionnaire was constructed containing questions elucidating different aspects of the organization behind the phlebotomy praxis on a national basis, including questions on the staff performing phlebotomy, the education of these staff members, and the existence of and adherence to national guidelines. All 39 EFLM member countries were invited to participate. In total 28/39 (72%) EFLM member countries responded. Seven out of the 28 (25%) have national phlebotomy guidelines and five have implemented other guidelines. The estimated compliance with phlebotomy guidance for the laboratories in the countries that have national guidelines available is poor, regardless to whether the phlebotomy was under the laboratory control or not. Most countries were interested in EFLM guidelines and to participate in a pilot EFLM preanalytical phase external quality assessment (EQA) scheme. In the responding EFLM member countries, the majority of phlebotomy is performed by nurses and laboratory technicians. Their basic education is generally 4-5 years of high school, followed by 2-5 years of colleague or university studies. Only a third (10/28; 36%) of the participating member countries has any specific training available as a continuous educational resource. A specific training for phlebotomy is not part of the education required to become qualified in 6/28 (21%) and 9/28 (32%) of countries for nurses and laboratory technicians, respectively. In countries and professions where training is required, most require more than 5 h of training. Based on the results of this survey we conclude the following: 1) There is a need to assess the quality of current practices, compliance to the CLSI H3-A6 guidelines and to identify some most critical steps which occur during phlebotomy, in different healthcare settings, across Europe; 2) Existing CLSI H3-A6 phlebotomy guidelines should be adapted and used locally in all European countries which do not have their own guidelines; 3) National EFLM societies need to be engaged in basic training program development and continuous education of healthcare phlebotomy staff (implementing the certification of competence).

Improving access to clinical practice guidelines with an interactive graphical interface using an iconic language

PubMed Central

2014-01-01

Background Clinical practice guidelines are useful for physicians, and guidelines are available on the Internet from various websites such as Vidal Recos. However, these guidelines are long and difficult to read, especially during consultation. Similar difficulties have been encountered with drug summaries of product characteristics. In a previous work, we have proposed an iconic language (called VCM, for Visualization of Concepts in Medicine) for representing patient conditions, treatments and laboratory tests, and we have used these icons to design a user interface that graphically indexes summaries of product characteristics. In the current study, our objective was to design and evaluate an iconic user interface for the consultation of clinical practice guidelines by physicians. Methods Focus groups of physicians were set up to identify the difficulties encountered when reading guidelines. Icons were integrated into Vidal Recos, taking human factors into account. The resulting interface includes a graphical summary and an iconic indexation of the guideline. The new interface was evaluated. We compared the response times and the number of errors recorded when physicians answered questions about two clinical scenarios using the interactive iconic interface or a textual interface. Users’ perceived usability was evaluated with the System Usability Scale. Results The main difficulties encountered by physicians when reading guidelines were obtaining an overview and finding recommendations for patients corresponding to “particular cases”. We designed a graphical interface for guideline consultation, using icons to identify particular cases and providing a graphical summary of the icons organized by anatomy and etiology. The evaluation showed that physicians gave clinical responses more rapidly with the iconic interface than the textual interface (25.2 seconds versus 45.6, p < 0.05). The physicians appreciated the new interface, and the System Usability Scale score value was 75 (between good and excellent). Conclusion An interactive iconic interface can provide physicians with an overview of clinical practice guidelines, and can decrease the time required to access the content of such guidelines. PMID:25158762

Improving access to clinical practice guidelines with an interactive graphical interface using an iconic language.

PubMed

Pereira, Suzanne; Hassler, Sylvain; Hamek, Saliha; Boog, César; Leroy, Nicolas; Beuscart-Zéphir, Marie-Catherine; Favre, Madeleine; Venot, Alain; Duclos, Catherine; Lamy, Jean-Baptiste

2014-08-26

Clinical practice guidelines are useful for physicians, and guidelines are available on the Internet from various websites such as Vidal Recos. However, these guidelines are long and difficult to read, especially during consultation. Similar difficulties have been encountered with drug summaries of product characteristics. In a previous work, we have proposed an iconic language (called VCM, for Visualization of Concepts in Medicine) for representing patient conditions, treatments and laboratory tests, and we have used these icons to design a user interface that graphically indexes summaries of product characteristics. In the current study, our objective was to design and evaluate an iconic user interface for the consultation of clinical practice guidelines by physicians. Focus groups of physicians were set up to identify the difficulties encountered when reading guidelines. Icons were integrated into Vidal Recos, taking human factors into account. The resulting interface includes a graphical summary and an iconic indexation of the guideline. The new interface was evaluated. We compared the response times and the number of errors recorded when physicians answered questions about two clinical scenarios using the interactive iconic interface or a textual interface. Users' perceived usability was evaluated with the System Usability Scale. The main difficulties encountered by physicians when reading guidelines were obtaining an overview and finding recommendations for patients corresponding to "particular cases". We designed a graphical interface for guideline consultation, using icons to identify particular cases and providing a graphical summary of the icons organized by anatomy and etiology. The evaluation showed that physicians gave clinical responses more rapidly with the iconic interface than the textual interface (25.2 seconds versus 45.6, p < 0.05). The physicians appreciated the new interface, and the System Usability Scale score value was 75 (between good and excellent). An interactive iconic interface can provide physicians with an overview of clinical practice guidelines, and can decrease the time required to access the content of such guidelines.

Standards of teeth preparations for anterior resin bonded all-ceramic crowns in private dental practice in Jordan

PubMed Central

AL-DWAIRI, Ziad Nawaf; AL-HIYASAT, Ahmad Saleh; ABOUD, Haitham

2011-01-01

Objectives To investigate if general dental practitioners (GDPs) in private practice in Jordan follow universal guidelines for preparation of anterior teeth for resin bonded all-ceramic crowns (RBCs). Material and Methods A sample (n=100) of laboratory models containing 208 tooth preparations for IPS Empress and In Ceram, featuring work from different GDPs, was obtained from 8 commercial dental laboratories. Aspects of preparations were quantified and compared with accepted criteria defined following a review of the literature and recommendations of the manufactures' guidelines. Results Subgingival margins on the buccal aspect were noticed in 36% of the preparations, 54% demonstrated overpreparation with a tendency to overprepare the teeth on the mesiodistal plane more than buccolingual plane. Twenty percent of samples presented a shoulder finish line while a chamfer margin design was noticed in 39%. Twenty-nine percent and 12% of samples had either a feathered or no clear margin design respectively. Incisal under preparation was observed in 18% of dies of each type. Only 17% of all preparations were found to follow the recommended anatomical labial preparations while 29% of the RBC preparations were found to have the recommended axial convergence angle. In total, 43% of preparations were found to have the recommended depth of the finish line. Conclusions It was found that relevant guidelines for RBC preparations were not being fully adhered to in private practice in Jordan. PMID:21710098

Magnesium degradation under physiological conditions - Best practice.

PubMed

Gonzalez, Jorge; Hou, Rui Qing; Nidadavolu, Eshwara P S; Willumeit-Römer, Regine; Feyerabend, Frank

2018-06-01

This review focusses on the application of physiological conditions for the mechanistic understanding of magnesium degradation. Despite the undisputed relevance of simplified laboratory setups for alloy screening purposes, realistic and predictive in vitro setups are needed. Due to the complexity of these systems, the review gives an overview about technical measures, defines some caveats and can be used as a guideline for the establishment of harmonized laboratory approaches.

Drugs in the Workplace: Legal Developments.

ERIC Educational Resources Information Center

Scholick, Gary P.

1989-01-01

An update on legal aspects of drug testing in the workplace looks at pre-employment screening, reasonable suspicion testing, routine testing in periodic physical examinations, random testing, and unionized employers. Practical guidelines are given for minimizing obtrusiveness, confirmatory tests, laboratory selection, notification of policy,…

A cost-analysis of two approaches to infection control in a lung function laboratory.

PubMed

Side, E A; Harrington, G; Thien, F; Walters, E H; Johns, D P

1999-02-01

The Thoracic Society of Australia and New Zealand (TSANZ) guidelines for infection control in respiratory laboratories are based on a 'Universal Precautions' approach to patient care. This requires that one-way breathing valves, flow sensors, and other items, be cleaned and disinfected between patient use. However, this is impractical in a busy laboratory. The recent introduction of disposable barrier filters may provide a practical solution to this problem, although most consider this approach to be an expensive option. To compare the cost of implementing the TSANZ infection control guidelines with the cost of using disposable barrier filters. Costs were based on the standard tests and equipment currently used in the lung function laboratory at The Alfred Hospital. We have assumed that a barrier filter offers the same degree of protection against cross-infection between patients as the TSANZ infection control guidelines. Time and motion studies were performed on the dismantling, cleaning, disinfecting, reassembling and re-calibrating of equipment. Conservative estimates were made as to the frequency of replacing pneumotachographs and rubber mouthpieces based on previous equipment turnover. Labour costs for a scientist to reprocess the equipment was based on $20.86/hour. The cost of employing a casual cleaner at an hourly rate of $14.07 to assist in reprocessing equipment was also investigated. The new high efficiency HyperFilter disposable barrier filter, costing $2.95 was used in this cost-analysis. The cost of reprocessing equipment required for spirometry alone was $17.58 per test if a scientist reprocesses the equipment, and $15.56 per test if a casual cleaner is employed to assist the scientist in performing these duties. In contrast, using a disposable filter would cost only $2.95 per test. Using a filter was considerably less expensive than following the TSANZ guidelines for all tests and equipment used in this cost-analysis. The TSANZ infection control guidelines are expensive and impractical to implement. However, disposable barrier filters provide a practical and inexpensive method of infection control.

Impact of age on the selection of nuclear cardiology stress protocols: The INCAPS (IAEA nuclear cardiology protocols) study.

PubMed

Al-Mallah, Mouaz H; Pascual, Thomas N B; Mercuri, Mathew; Vitola, João V; Karthikeyan, Ganesan; Better, Nathan; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

2018-05-15

There is growing concern about radiation exposure from nuclear myocardial perfusion imaging (MPI), particularly among younger patients who are more prone to develop untoward effects of ionizing radiation, and hence US and European professional society guidelines recommend age as a consideration in weighing radiation risk from MPI. We aimed to determine how patient radiation doses from MPI vary across age groups in a large contemporary international cohort. Data were collected as part of a global cross-sectional study of centers performing MPI coordinated by the International Atomic Energy Agency (IAEA). Sites provided information on each MPI study completed during a single week in March-April 2013. We compared across age groups laboratory adherence to pre-specified radiation-related best practices, radiation effective dose (ED; a whole-body measure reflecting the amount of radiation to each organ and its relative sensitivity to radiation's deleterious effects), and the proportion of patients with ED ≤ 9 mSv, a target level specified in guidelines. Among 7911 patients undergoing MPI in 308 laboratories in 65 countries, mean ED was 10.0 ± 4.5 mSv with slightly higher exposure among younger age groups (trend p value < 0.001). There was no difference in the proportion of patients with ED ≤ 9 mSv across age groups, or in adherence to best practices based on the median age of patients in a laboratory. In contemporary nuclear cardiology practice, the age of the patient appears not to impact protocol selection and radiation dose, contrary to professional society guidelines. Copyright © 2018. Published by Elsevier B.V.

Immunohistochemistry practices of cytopathology laboratories: a survey of participants in the College of American Pathologists Nongynecologic Cytopathology Education Program.

PubMed

Fischer, Andrew H; Schwartz, Mary R; Moriarty, Ann T; Wilbur, David C; Souers, Rhona; Fatheree, Lisa; Booth, Christine N; Clayton, Amy C; Kurtyz, Daniel F I; Padmanabhan, Vijayalakshmi; Crothers, Barbara A

2014-09-01

Immunohistochemistry (IHC) is important for cytology but poses special challenges because preanalytic conditions may differ from the conditions of IHC-positive controls. To broadly survey cytology laboratories to quantify preanalytic platforms for cytology IHC and identify problems with particular platforms or antigens. To discover how validation guidelines for HER2 testing have affected cytology. A voluntary survey of cytology IHC practices was sent to 1899 cytology laboratories participating in the College of American Pathologists Nongynecologic Cytopathology Education Program in the fall of 2009. A total of 818 laboratories (43%) responded to the survey by April 2010. Three hundred fourty-five of 791 respondents (44%) performed IHC on cytology specimens. Seventeen different fixation and processing platforms prior to antibody reaction were reported. A total of 59.2% of laboratories reported differences between the platforms for cytology specimens and positive controls, but most (155 of 184; 84%) did not alter antibody dilutions or antigen retrieval for cytology IHC. When asked to name 2 antibodies for which staining conditions differed between cytology and surgical samples, there were 18 responses listing 14 antibodies. A total of 30.6% of laboratories performing IHC offered HER2 testing before publication of the 2007 College of American Pathologists/American Society of Clinical Oncologists guidelines, compared with 33.6% afterward, with increased performance of testing by reference laboratories. Three laboratories validated a nonformalin HER2 platform. The platforms for cytology IHC and positive controls differ for most laboratories, yet conditions are uncommonly adjusted for cytology specimens. Except for the unsuitability of air-dried smears for HER2 testing, the survey did not reveal evidence of systematic problems with any antibody or platform.

Strategies for preventing group B streptococcal infections in newborns: a nation-wide survey of Italian policies.

PubMed

Tzialla, Chryssoula; Berardi, Alberto; Farina, Claudio; Clerici, Pierangelo; Borghesi, Alessandro; Viora, Elsa; Scollo, Paolo; Stronati, Mauro

2017-11-02

There are no Italian data regarding the strategies for preventing neonatal group B streptococcal (GBS) infection. We conducted a national survey in order to explore obstetrical, neonatal and microbiological practices for the GBS prevention. Three distinct questionnaires were sent to obstetricians, neonatologists and microbiologists. Questionnaires included data on prenatal GBS screening, maternal risk factors, intrapartum antibiotic prophylaxis, microbiological information concerning specimen processing and GBS antimicrobial susceptibility. All respondent obstetrical units used the culture-based screening approach to identify women who should receive intrapartum antibiotic prophylaxis, and more than half of the microbiological laboratories (58%) reported using specimen processing consistent with CDC guidelines. Most neonatal units (89 out of 107, 82%) reported using protocols for preventing GBS early-onset sepsis consistent with CDC guidelines. The screening-based strategy is largely prevalent in Italy, and most protocols for preventing GBS early-onset sepsis are consistent with CDC guidelines. However, we found discrepancies in practices among centers that may reflect the lack of Italian guidelines issued by public health organizations.

The Pathology Laboratory Act 2007 explained.

PubMed

Looi, Lai-Meng

2008-06-01

The past century has seen tremendous changes in the scope and practice of pathology laboratories in tandem with the development of the medical services in Malaysia. Major progress was made in the areas of training and specialization of pathologists and laboratory technical staff. Today the pathology laboratory services have entered the International arena, and are propelled along the wave of globalization. Many new challenges have emerged as have new players in the field. Landmark developments over the past decade include the establishment of national quality assurance programmes, the mushrooming of private pathology laboratories, the establishment of a National Accreditation Standard for medical testing laboratories based on ISO 15189, and the passing of the Pathology Laboratory Act in Parliament in mid-2007. The Pathology Laboratory Act 2007 seeks to ensure that the pathology laboratory is accountable to the public, meets required standards of practice, participates in Quality Assurance programmes, is run by qualified staff, complies with safety requirements and is subject to continuous audit. The Act is applicable to all private laboratories (stand alone or hospital) and laboratories in statutory bodies (Universities, foundations). It is not applicable to public laboratories (established and operated by the government) and side-room laboratories established in clinics of registered medical or dental practitioners for their own patients (tests as in the First and Second Schedules respectively). Tests of the Third Schedule (home test blood glucose, urine glucose, urine pregnancy test) are also exempted. The Act has 13 Parts and provides for control of the pathology laboratory through approval (to establish and maintain) and licensing (to operate or provide). The approval or license may only be issued to a sole proprietor, partnership or body corporate, and then only if the entity includes a registered medical practitioner. Details of personnel qualifications and laboratory practices are left to be specified by the Director-General of Health, providing for a formal recognition process and room for revision as pathology practices evolve. Encompassed in the responsibilities of the licensee is the requirement that samples are received and results issued through, and management vested in, a registered medical or dental practitioner. This effectively prohibits "walk-ins" to the laboratory and indiscriminate public screening. The requirement for a person-in-charge in accordance with class and speciality of laboratory ensures that the laboratory is under the charge of the pathology profession. Examined carefully, the requirements of the Act are similar to laboratory accreditation, but are backed by legislation. Many of these details will be spelt out in the Regulations, and these in turn are likely to fall back on National professional guidelines, as accreditation does. Although not at first obvious, enforcement of the Act is based on self-regulation by pathology laboratory professionals. Sincere professional input is thus required to embrace its philosophy, ensure rational and transparent enforcement of legislation, and develop National guidelines for good pathology practices upon which enforcement may be based.

Position Statement Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

PubMed Central

Arnold, Mark; Bakris, George L.; Bruns, David E.; Horvath, Andrea Rita; Kirkman, M. Sue; Lernmark, Ake; Metzger, Boyd E.; Nathan, David M.

2011-01-01

BACKGROUND Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. CONTENT In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A1c (HbA1c) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended. PMID:21617111

Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence-Based Laboratory Medicine Committee of the American Association for Clinical Chemistry jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A(1c) (HbA(1c)) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of HbA(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended.

Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence Based Laboratory Medicine Committee of the AACC jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A(1c) (Hb A(1c)) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of Hb A(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended.

Position statement executive summary: guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A(1c) (HbA(1c)) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

Current worldwide nuclear cardiology practices and radiation exposure: results from the 65 country IAEA Nuclear Cardiology Protocols Cross-Sectional Study (INCAPS)

PubMed Central

Einstein, Andrew J.; Pascual, Thomas N. B.; Mercuri, Mathew; Karthikeyan, Ganesan; Vitola, João V.; Mahmarian, John J.; Better, Nathan; Bouyoucef, Salah E.; Hee-Seung Bom, Henry; Lele, Vikram; Magboo, V. Peter C.; Alexánderson, Erick; Allam, Adel H.; Al-Mallah, Mouaz H.; Flotats, Albert; Jerome, Scott; Kaufmann, Philipp A.; Luxenburg, Osnat; Shaw, Leslee J.; Underwood, S. Richard; Rehani, Madan M.; Kashyap, Ravi; Paez, Diana; Dondi, Maurizio

2015-01-01

Aims To characterize patient radiation doses from nuclear myocardial perfusion imaging (MPI) and the use of radiation-optimizing ‘best practices’ worldwide, and to evaluate the relationship between laboratory use of best practices and patient radiation dose. Methods and results We conducted an observational cross-sectional study of protocols used for all 7911 MPI studies performed in 308 nuclear cardiology laboratories in 65 countries for a single week in March–April 2013. Eight ‘best practices’ relating to radiation exposure were identified a priori by an expert committee, and a radiation-related quality index (QI) devised indicating the number of best practices used by a laboratory. Patient radiation effective dose (ED) ranged between 0.8 and 35.6 mSv (median 10.0 mSv). Average laboratory ED ranged from 2.2 to 24.4 mSv (median 10.4 mSv); only 91 (30%) laboratories achieved the median ED ≤ 9 mSv recommended by guidelines. Laboratory QIs ranged from 2 to 8 (median 5). Both ED and QI differed significantly between laboratories, countries, and world regions. The lowest median ED (8.0 mSv), in Europe, coincided with high best-practice adherence (mean laboratory QI 6.2). The highest doses (median 12.1 mSv) and low QI (4.9) occurred in Latin America. In hierarchical regression modelling, patients undergoing MPI at laboratories following more ‘best practices’ had lower EDs. Conclusion Marked worldwide variation exists in radiation safety practices pertaining to MPI, with targeted EDs currently achieved in a minority of laboratories. The significant relationship between best-practice implementation and lower doses indicates numerous opportunities to reduce radiation exposure from MPI globally. PMID:25898845

Course-based undergraduate research experiences in molecular biosciences-patterns, trends, and faculty support.

PubMed

Wang, Jack T H

2017-08-15

Inquiry-driven learning, research internships and course-based undergraduate research experiences all represent mechanisms through which educators can engage undergraduate students in scientific research. In life sciences education, the benefits of undergraduate research have been thoroughly evaluated, but limitations in infrastructure and training can prevent widespread uptake of these practices. It is not clear how faculty members can integrate complex laboratory techniques and equipment into their unique context, while finding the time and resources to implement undergraduate research according to best practice guidelines. This review will go through the trends and patterns in inquiry-based undergraduate life science projects with particular emphasis on molecular biosciences-the research-aligned disciplines of biochemistry, molecular cell biology, microbiology, and genomics and bioinformatics. This will provide instructors with an overview of the model organisms, laboratory techniques and research questions that are adaptable for semester-long projects, and serve as starting guidelines for course-based undergraduate research. © FEMS 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Evidence based practice: laboratory feedback informs forensic specimen collection in NSW.

PubMed

Nittis, Maria; Stark, Margaret

2014-07-01

The importance of having clear, evidence-based guidelines for the taking of forensic samples from suspects detained in police custody (persons of interest) and complainants of crime is essential for forensic practitioners. The need for such guidelines was seen as desirable in New South Wales (NSW) and a working group was set up comprising scientists, practitioners and police. Feedback from the laboratory regarding the results of the specimens taken by forensic practitioners throughout the State was received and analysed. This has resulted in changes to current practice and highlighted the need for further research in this area. It has also highlighted areas that have not changed in response to evidence A quality service demands transparency, process review, relevant research and feedback in order to progress. Examiners need to obtain the results for their cases in order to reinforce the value of the service they provide as well as to monitor and, where necessary, improve their forensic collection skills. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

Module Architecture for in Situ Space Laboratories

NASA Technical Reports Server (NTRS)

Sherwood, Brent

2010-01-01

The paper analyzes internal outfitting architectures for space exploration laboratory modules. ISS laboratory architecture is examined as a baseline for comparison; applicable insights are derived. Laboratory functional programs are defined for seven planet-surface knowledge domains. Necessary and value-added departures from the ISS architecture standard are defined, and three sectional interior architecture options are assessed for practicality and potential performance. Contemporary guidelines for terrestrial analytical laboratory design are found to be applicable to the in-space functional program. Densepacked racks of system equipment, and high module volume packing ratios, should not be assumed as the default solution for exploration laboratories whose primary activities include un-scriptable investigations and experimentation on the system equipment itself.

Closing the loop on improvement: Packaging experience in the Software Engineering Laboratory

NASA Technical Reports Server (NTRS)

Waligora, Sharon R.; Landis, Linda C.; Doland, Jerry T.

1994-01-01

As part of its award-winning software process improvement program, the Software Engineering Laboratory (SEL) has developed an effective method for packaging organizational best practices based on real project experience into useful handbooks and training courses. This paper shares the SEL's experience over the past 12 years creating and updating software process handbooks and training courses. It provides cost models and guidelines for successful experience packaging derived from SEL experience.

Clinical trials of boron neutron capture therapy [in humans] [at Beth Israel Deaconess Medical Center][at Brookhaven National Laboratory

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

Wallace, Christine

2001-05-29

Assessment of research records of Boron Neutron Capture Therapy was conducted at Brookhaven National Laboratory and Beth Israel Deaconess Medical Center using the Code of Federal Regulations, FDA Regulations and Good Clinical Practice Guidelines. Clinical data were collected from subjects' research charts, and differences in conduct of studies at both centers were examined. Records maintained at Brookhaven National Laboratory were not in compliance with regulatory standards. Beth Israel's records followed federal regulations. Deficiencies discovered at both sites are discussed in the reports.

[Implementation of the German S3 guidelines on dementia in clinical practice: wish or reality?

PubMed

Lohmann, H; Kulessa, F; Holling, H; Johnen, A; Reul, S; Lueg, G; Duning, T

2017-08-01

Published in 2009, the German S3 guidelines on dementia define a milestone in quality improvement of the diagnostics and treatment of dementia. In clinical practice patients suffering from dementia are primarily treated by physicians in private practice; therefore, this study examined how the guidelines are implemented in outpatient clinical settings. Furthermore, it aimed at the identification of behavioral determinants that govern the actual diagnostic and therapeutic approach in clinical practice. Physicians involved in the primary care of dementia patients were asked to participate in a nationwide internet survey. The questionnaire covered aspects on the diagnostic and therapeutic care of dementia patients as recommended by the S3 guidelines. Behavioral determinants of the implementation of the guidelines (e. g. treatment decisions) were derived from an established psychological prediction model. Out of a total of 2755 physicians contacted, the data of 225 participants could be used in this study. The diagnostic recommendations of the S3 guidelines were implemented in satisfactory measures (e.g. combined cognitive screening in at least 68%, cerebral neuroimaging in at least 93% and specific laboratory diagnostics in at least 27% of cases); however, only two thirds of the patients with indications for a guideline-conform therapy were treated in accordance with the S3 guidelines. There was a substantial prescription of non-recommended drugs and a notable long-term use of antipsychotic drugs (prescription by at least 14% of non-neurological medical specialists and by 8% of neurologists and psychiatrists). When considering the behavioral determinants in the implementation of the guidelines, normative assumptions ("my colleagues and patients expect me to comply with the guidelines") surprisingly had the highest impact, which was then followed by attitudes towards the behavior ("utilization of the guidelines improves diagnostics and therapy"). The German S3 guidelines on dementia were satisfactorily implemented in outpatient clinical practice; however, deficits existed in the frequency of the pharmaceutical treatment of patients with indications for therapy, the prescription of non-recommended drugs and the relatively common use of permanent neuroleptic medications. Interestingly, the motivation for implementation of the guidelines was not primarily influenced by the physicians' personal convictions but mainly stimulated by the expectations of others.

Laboratory performance of sweat conductivity for the screening of cystic fibrosis.

PubMed

Greaves, Ronda F; Jolly, Lisa; Massie, John; Scott, Sue; Wiley, Veronica C; Metz, Michael P; Mackay, Richard J

2018-03-28

There are several complementary English-language guidelines for the performance of the sweat chloride test. These guidelines also incorporate information for the collection of conductivity samples. However, recommendations for the measurement and reporting of sweat conductivity are less clear than for sweat chloride. The aim of the study was to develop an understanding of the testing and reporting practices of sweat conductivity in Australasian laboratories. A survey specifically directed at conductivity testing was sent to the 12 laboratories registered with the Royal College of Pathologists of Australasia Quality Assurance Programs. Nine (75%) laboratories participated in the survey, seven of whom used Wescor Macroduct® for collecting sweat and the Wescor SWEAT·CHEK™ for conductivity testing, and the remaining two used the Wescor Nanoduct®. There was considerable variation in frequency and staffing for this test. Likewise, criteria about which patients it was inappropriate to test, definitions of adequate collection sweat rate, cutoffs and actions recommended on the basis of the result showed variations between laboratories. Variations in sweat conductivity testing and reporting reflect many of the same issues that were revealed in sweat chloride test audits and have the potential to lead to uncertainty about the result and the proper action in response to the result. We recommend that sweat testing guidelines should include clearer statements about the use of sweat conductivity.

EMQN best practice guidelines for the molecular genetic diagnosis of hereditary hemochromatosis (HH).

PubMed

Porto, Graça; Brissot, Pierre; Swinkels, Dorine W; Zoller, Heinz; Kamarainen, Outi; Patton, Simon; Alonso, Isabel; Morris, Michael; Keeney, Steve

2016-04-01

Molecular genetic testing for hereditary hemochromatosis (HH) is recognized as a reference test to confirm the diagnosis of suspected HH or to predict its risk. The vast majority (typically >90%) of patients with clinically characterized HH are homozygous for the p.C282Y variant in the HFE gene, referred to as HFE-related HH. Since 1996, HFE genotyping was implemented in diagnostic algorithms for suspected HH, allowing its early diagnosis and prevention. However, the penetrance of disease in p.C282Y homozygotes is incomplete. Hence, homozygosity for p.C282Y is not sufficient to diagnose HH. Neither is p.C282Y homozygosity required for diagnosis as other rare forms of HH exist, generally referred to as non-HFE-related HH. These pose significant challenges when defining criteria for referral, testing protocols, interpretation of test results and reporting practices. We present best practice guidelines for the molecular genetic diagnosis of HH where recommendations are classified, as far as possible, according to the level and strength of evidence. For clarification, the guidelines' recommendations are preceded by a detailed description of the methodology and results obtained with a series of actions taken in order to achieve a wide expert consensus, namely: (i) a survey on the current practices followed by laboratories offering molecular diagnosis of HH; (ii) a systematic literature search focused on some identified controversial topics; (iii) an expert Best Practice Workshop convened to achieve consensus on the practical recommendations included in the guidelines.

EMQN best practice guidelines for the molecular genetic diagnosis of hereditary hemochromatosis (HH)

PubMed Central

Porto, Graça; Brissot, Pierre; Swinkels, Dorine W; Zoller, Heinz; Kamarainen, Outi; Patton, Simon; Alonso, Isabel; Morris, Michael; Keeney, Steve

2016-01-01

Molecular genetic testing for hereditary hemochromatosis (HH) is recognized as a reference test to confirm the diagnosis of suspected HH or to predict its risk. The vast majority (typically >90%) of patients with clinically characterized HH are homozygous for the p.C282Y variant in the HFE gene, referred to as HFE-related HH. Since 1996, HFE genotyping was implemented in diagnostic algorithms for suspected HH, allowing its early diagnosis and prevention. However, the penetrance of disease in p.C282Y homozygotes is incomplete. Hence, homozygosity for p.C282Y is not sufficient to diagnose HH. Neither is p.C282Y homozygosity required for diagnosis as other rare forms of HH exist, generally referred to as non-HFE-related HH. These pose significant challenges when defining criteria for referral, testing protocols, interpretation of test results and reporting practices. We present best practice guidelines for the molecular genetic diagnosis of HH where recommendations are classified, as far as possible, according to the level and strength of evidence. For clarification, the guidelines' recommendations are preceded by a detailed description of the methodology and results obtained with a series of actions taken in order to achieve a wide expert consensus, namely: (i) a survey on the current practices followed by laboratories offering molecular diagnosis of HH; (ii) a systematic literature search focused on some identified controversial topics; (iii) an expert Best Practice Workshop convened to achieve consensus on the practical recommendations included in the guidelines. PMID:26153218

Barriers to Implementation of Optimal Laboratory Biosafety Practices in Pakistan

PubMed Central

Shafaq, Humaira; Hasan, Rumina; Qureshi, Shahida M.; Dojki, Maqboola; Hughes, Molly A.; Zaidi, Anita K. M.; Khan, Erum

2016-01-01

The primary goal of biosafety education is to ensure safe practices among workers in biomedical laboratories. Despite several educational workshops by the Pakistan Biological Safety Association (PBSA), compliance with safe practices among laboratory workers remains low. To determine barriers to implementation of recommended biosafety practices among biomedical laboratory workers in Pakistan, we conducted a questionnaire-based survey of participants attending 2 workshops focusing on biosafety practices in Karachi and Lahore in February 2015. Questionnaires were developed by modifying the BARRIERS scale in which respondents are required to rate barriers on a 1-4 scale. Nineteen of the original 29 barriers were included and subcategorized into 4 groups: awareness, material quality, presentation, and workplace barriers. Workshops were attended by 64 participants. Among barriers that were rated as moderate to great barriers by at least 50% of respondents were: lack of time to read biosafety guidelines (workplace subscale), lack of staff authorization to change/improve practice (workplace subscale), no career or self-improvement advantages to the staff for implementing optimal practices (workplace subscale), and unclear practice implications (presentation subscale). A lack of recognition for employees' rights and benefits in the workplace was found to be a predominant reason for a lack of compliance. Based on perceived barriers, substantial improvement in work environment, worker facilitation, and enabling are needed for achieving improved or optimal biosafety practices in Pakistan. PMID:27400192

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

Operating Procedures to Improve Efficiencies of In vitro Exposure Systems at the Air-Liquid Interface

EPA Science Inventory

The expanding use of in vitro exposure systems for toxicity assessments has created regulatory concerns. Many of these same concerns surround the proper conduct of in vivo inhalation toxicology studies that are addressed in guidelines and Good Laboratory Practice (GLPs) regulatio...

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

PubMed Central

Arnold, Mark; Bakris, George L.; Bruns, David E.; Horvath, Andrea Rita; Kirkman, M. Sue; Lernmark, Ake; Metzger, Boyd E.; Nathan, David M.

2011-01-01

BACKGROUND Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence-Based Laboratory Medicine Committee of the American Association for Clinical Chemistry jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. CONTENT In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A1c (HbA1c) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended. PMID:21617108

Treatment of gonorrhoea in Auckland, New Zealand: marked variation in prescriber adherence to treatment guidelines.

PubMed

Forster, Rose; Ng, Diana; Upton, Arlo; Franklin, Rick; Thomas, Mark

2017-06-01

The relentless emergence and spread of strains of Neisseria gonorrhoeae that are resistant to many antimicrobial agents has led to frequent changes in treatment guidelines, with a consequent risk that prescribers may not be aware of current guidelines. To determine the proportion of patients with gonorrhoea who were treated with a regimen consistent with the New Zealand Sexual Health Society (NZSHS) guidelines. We audited the treatment given to adult patients with laboratory-proven gonorrhoea in Auckland, New Zealand, during the first 6 months of 2015. Treatment compliant with the current NZSHS guidelines was administered in only 65% (458/706) episodes overall. Guideline-compliant treatment was much more likely to be prescribed for patients who presented to a sexual health clinic (89%) than for patients who presented to either a general practice or other community clinic (52%) or to a hospital (56%) (P < 0.0001). Overall, 52 of 706 (7%) episodes were not treated with any antimicrobial regimen by the service that diagnosed the patients' gonorrhoea, 13 of 62 (21%) episodes in patients who presented to a hospital, 34 of 403 (8%) episodes in patients who presented to a general practice or other community clinic and 5 of 241 (2%) episodes in patients who presented to a sexual health clinic (P < 0.0001). Low levels of compliance with treatment guidelines increase the risk that antibiotic-resistant strains of N. gonorrhoeae will spread within the Auckland region. Improved compliance with treatment guidelines, particularly in patients who present either to general practice or to hospitals, is necessary to maintain the efficacy of current treatment regimens. © 2017 Royal Australasian College of Physicians.

Proportion of adults fasting for lipid testing relative to guideline changes in Alberta.

PubMed

Ma, Irene; Viczko, Jeannine; Naugler, Christopher

2017-04-01

Guidelines have historically recommended measuring lipid profile tests in a fasting state. However, in April 2011 and 2014, the Canadian city of Calgary and its province of Alberta, respectively, have changed their lipid guidelines to allow testing for individuals in any fasting state; several years prior to the release of the 2016 Canadian Cardiovascular Society and Hypertension Canada guidelines. The purpose of this study was to document the proportion of individuals in Calgary who fasted for a lipid encounter in relation to the change in various guidelines and policies. Counts were collected each month per gender from January 1, 2010 to June 30, 2016 for community-based adults ≥18years old who fasted (≥8h) or did not fast (<8h) for a lipid encounter. During the study period, 793,719 community-based lipid profiles were performed, 590,174 in a fasting state. The proportion of adults who fasted declined from 98.59%±0.379% (mean±SD) in 2010 to 41.65%±1.295% (mean±SD) in 2016. However, a marked decline in the proportion of adults fasting for a lipid encounter was not observed until February 2015, which coincided with the release of Alberta's Toward Optimized Practice Clinical Practice Guidelines. This documentation of individuals fasting for a lipid encounter may assist other jurisdictions in Canada with the new nonfasting lipid guideline changes. We recommend releasing provincial clinical practice guidelines, in addition to laboratory bulletins and continuing medical education presentations, regarding the new nonfasting lipid recommendations in other jurisdictions to ensure community patients are aware of this change. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Update of Standard Practices for New Method Validation in Forensic Toxicology.

PubMed

Wille, Sarah M R; Coucke, Wim; De Baere, Thierry; Peters, Frank T

2017-01-01

International agreement concerning validation guidelines is important to obtain quality forensic bioanalytical research and routine applications as it all starts with the reporting of reliable analytical data. Standards for fundamental validation parameters are provided in guidelines as those from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the German speaking Gesellschaft fur Toxikologie und Forensische Chemie (GTFCH) and the Scientific Working Group of Forensic Toxicology (SWGTOX). These validation parameters include selectivity, matrix effects, method limits, calibration, accuracy and stability, as well as other parameters such as carryover, dilution integrity and incurred sample reanalysis. It is, however, not easy for laboratories to implement these guidelines into practice as these international guidelines remain nonbinding protocols, that depend on the applied analytical technique, and that need to be updated according the analyst's method requirements and the application type. In this manuscript, a review of the current guidelines and literature concerning bioanalytical validation parameters in a forensic context is given and discussed. In addition, suggestions for the experimental set-up, the pros and cons of statistical approaches and adequate acceptance criteria for the validation of bioanalytical applications are given. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Guidelines for point-of-care testing: haematology.

PubMed

Briggs, Carol; Guthrie, David; Hyde, Keith; Mackie, Ian; Parker, Norman; Popek, Mary; Porter, Neil; Stephens, Clare

2008-09-01

This guideline provides a framework for the arrangement of point-of-care testing (POCT) services, previously known as near patient testing (patient self-testing not covered). POCT is defined as any analytical test performed outside the laboratory. Primary users are often non-laboratory healthcare workers. The guidance applies to units within hospitals as well as general practioner surgeries, community clinics and pharmacies. The head of the haematology laboratory or a point of care coordinator must take responsibility for all aspects of the POCT service, including quality and training. Depending on the size and nature of the POCT practice, a local POCT manager may also be required. Equipment selected should have received a successful independent performance evaluation. If an independent evaluation has not been performed the purchaser should assess the device according to the protocol in this document. POCT devices should generate results that are comparable to those of the local laboratory. An accredited external quality assessment programme and internal quality control system must be established. Manufacturers promoting POCT devices designed for non-laboratory sites, e.g. pharmacies, should undertake training and annual competency assessment, perhaps using a web-based system. A diagram to illustrate the stages for the implementation of a POCT service is illustrated.

HPV Testing of Head and Neck Cancer in Clinical Practice.

PubMed

Robinson, Max

The pathology laboratory has a central role in providing human papillomavirus (HPV) tests for patients with head and neck cancer. There is an extensive literature around HPV testing and a large number of proprietary HPV tests, which makes the field difficult to navigate. This review provides a concise contemporary overview of the evidence around HPV testing in head and neck cancer and signposts key publications, guideline documents and the most commonly used methods in clinical practice.

Laboratory security and emergency response guidance for laboratories working with select agents. Centers for Disease Control and Prevention.

PubMed

Richmond, Jonathan Y; Nesby-O'Dell, Shanna L

2002-12-06

In recent years, concern has increased regarding use of biologic materials as agents of terrorism, but these same agents are often necessary tools in clinical and research microbiology laboratories. Traditional biosafety guidelines for laboratories have emphasized use of optimal work practices, appropriate containment equipment, well-designed facilities, and administrative controls to minimize risk of worker injury and to ensure safeguards against laboratory contamination. The guidelines discussed in this report were first published in 1999 (U.S. Department of Health and Human Services/CDC and National Institutes of Health. Biosafety in microbiological and biomedical laboratories [BMBL]. Richmond JY, McKinney RW, eds. 4th ed. Washington, DC: US Department of Health and Human Services, 1999 [Appendix F]). In that report, physical security concerns were addressed, and efforts were focused on preventing unauthorized entry to laboratory areas and preventing unauthorized removal of dangerous biologic agents from the laboratory. Appendix F of BMBL is now being revised to include additional information regarding personnel risk assessments, and inventory controls. The guidelines contained in this report are intended for laboratories working with select agents under biosafety-level 2, 3, or 4 conditions as described in Sections II and III of BMBL. These recommendations include conducting facility risk assessments and developing comprehensive security plans to minimize the probability of misuse of select agents. Risk assessments should include systematic, site-specific reviews of 1) physical security; 2) security of data and electronic technology systems; 3) employee security; 4) access controls to laboratory and animal areas; 5) procedures for agent inventory and accountability; 6) shipping/transfer and receiving of select agents; 7) unintentional incident and injury policies; 8) emergency response plans; and 9) policies that address breaches in security. The security plan should be an integral part of daily operations. All employees should be well-trained and equipped, and the plan should be reviewed annually, at least.

Does the practice of blood film microscopy for detection and quantification of malaria parasites in northwest Ethiopia fit the standard?

PubMed

Biadglegne, Fantahun; Belyhun, Yeshambel; Ali, Jemal; Walle, Fisha; Gudeta, Nigussu; Kassu, Afework; Mulu, Andargachew

2014-11-01

The diagnosis of malaria in clinical laboratories mainly depends on blood smear microscopy and this technique remains the most widely used in Ethiopia. Despite the importance of blood smear microscopy for patient's diagnosis and treatment, little effort has been made to precisely determine and identify sources of error in malaria smear microscopic diagnosis and quantification of parasitaemia. The main objective of the present study was to assess the laboratory practices of health care laboratories carrying out blood films microscopy. A cross sectional study was conducted in northwestern Ethiopia involving 29 health care institutes. A structured and pretested questionnaire were used to collect relevant information on the physical conditions, laboratory logistics and laboratory practices carrying out blood smear microscopy. There was inadequacy of laboratory reagents, guidelines and materials. Most of the health institutes have been practicing re-utilization of microscope slides for malaria microscopy. The technical procedure (preparing of reagents, making of blood films and staining of the slides) were found to be below the standard in 50% of the health institutes. Refresher training and quality assessment has been done only in two and six of the health institutes in the past five years, respectively. In most of the health care laboratories studied, availability of laboratory logistics and technical practices for malaria microscopy were found to be below the standard set by World Health Organization. Improving logistics access for malaria microscopy at all level of health care is important to increase accuracy of diagnosis and quantification of malaria parasites. Moreover, continued training and regular supervision of the staff and implementation of quality control program in the area is also crucial.

Could accreditation bodies facilitate the implementation of medical guidelines in laboratories?

PubMed

Aakre, Kristin M; Oosterhuis, Wytze P; Misra, Shivani; Langlois, Michel R; Joseph, Watine; Twomey, Patrick J; Barth, Julian H

2017-05-01

Several studies have shown that recommendations related to how laboratory testing should be performed and results interpreted are limited in medical guidelines and that the uptake and implementation of the recommendations that are available need improvement. The EFLM/UEMS Working Group on Guidelines conducted a survey amongst the national societies for clinical chemistry in Europe regarding development of laboratory-related guidelines. The results showed that most countries have guidelines that are specifically related to laboratory testing; however, not all countries have a formal procedure for accepting such guidelines and few countries have guideline committees. Based on this, the EFLM/UEMS Working Group on Guidelines conclude that there is still room for improvement regarding these processes in Europe and raise the question if the accreditation bodies could be a facilitator for an improvement.

Physicians' knowledge, expectations, and practice regarding antibiotic use in primary health care.

PubMed

Al-Homaidan, Homaidan T; Barrimah, Issam E

2018-01-01

Physicians' knowledge of antibiotics, their attitudes, expectations, and practices regarding antibiotic prescription is fundamental for controlling the irrational antibiotic use. This study evaluates primary health care (PHC) physicians' knowledge, expectation, and practices regarding antibiotics use in upper respiratory tract infections. A cross-sectional study conducted in the Qassim region where 32 PHC centers were selected randomly. A total of 294 PHC physicians were surveyed. A pre-tested questionnaire was used after an orientation of participating physicians. Response rate was 80.3%. There is a significant belief among participants that the use of antibiotics leads to relief of symptoms in the case of viral disease and that taking antibiotics without rational indication increases the side effects. Participants identified that inadequate prescription, use without prescription, and non-compliance of patients are the most important factors contributing to the development of bacterial resistance. Participants often blamed the pharmacist for contributing mostly to the development of the problem of antibiotic resistance. Most physicians identified that they feel under pressure if patients expect an antibiotic prescription. In the absence of laboratory confirmation, most physicians selected high fever as the symptom that makes them prescribe antibiotics. Although having practice guidelines, participants demonstrated that these guidelines do not consider individual variations of patients' need. They do not support a regulation to prohibit antibiotic prescription without laboratory confirmation. The distribution of PHC physicians' knowledge, attitudes, and practices did not significantly vary between urban and rural centers. Therefore, whichever measures will be taken to improve the antibiotics practices can be applied to any PHC setting.

National survey of cardiologists' standard of practice for continuous ST-segment monitoring.

PubMed

Sandau, Kristin E; Sendelbach, Sue; Frederickson, Joel; Doran, Karen

2010-03-01

Continuous ST-segment monitoring can be used to detect early and transient cardiac ischemia. The American Heart Association and American Association of Critical-Care Nurses recommend its use among specific patients, but such monitoring is routine practice in only about half of US hospitals. To determine cardiologists' awareness and practice standards regarding continuous ST-segment monitoring and the physicians' perceptions of appropriate patient selection, benefits and barriers, and usefulness of this technology. An electronic survey was sent to a random sample of 915 US cardiologists from a pool of 4985 certified cardiologists. Of 200 responding cardiologists, 55% were unaware of the consensus guidelines. Of hospitals where respondents admitted patients, 49% had a standard of practice for using continuous ST-segment monitoring for cardiac patients. Most cardiologists agreed or strongly agreed that patients in the cardiovascular laboratory (87.5%) and intensive care unit (80.5%) should have such monitoring. Cardiologists routinely ordered ST monitoring for patients with acute coronary syndrome (67%) and after percutaneous coronary intervention (60%). The primary factor associated with higher perceptions for benefits, clinical usefulness, and past use of continuous ST-segment monitoring was whether or not hospitals in which cardiologists practiced had a standard of practice for using this monitoring. A secondary factor was awareness of published consensus guidelines for such monitoring. Respondents (55%) were unaware of published monitoring guidelines. Hospital leaders could raise awareness by multidisciplinary review of evidence and possibly incorporating continuous ST-segment monitoring into hospitals' standards of practice.

Management of clandestine drug laboratories: need for evidence-based environmental health policies.

PubMed

Al-Obaidi, Tamara A; Fletcher, Stephanie M

2014-01-01

Clandestine drug laboratories (CDLs) have been emerging and increasing as a public health problem in Australia, with methamphetamine being the dominant illegally manufactured drug. However, management and remediation of contaminated properties are still limited in terms of regulation and direction, especially in relation to public and environmental health practice. Therefore, this review provides an update on the hazards and health effects associated with CDLs, with a specific look at the management of these labs from an Australian perspective. Particularly, the paper attempts to describe the policy landscape for management of CDLs, and identifies current gaps and how further research may be utilised to advance understanding and management of CDLs and inform public health policies. The paper highlights a significant lack of evidence-based policies and guidelines to guide regulatory authority including environmental health officers in Australia. Only recently, the national Clandestine Drug Laboratory Guidelines were developed to assist relevant authority and specialists manage and carry out investigations and remediation of contaminated sites. However, only three states have developed state-based guidelines, some of which are inadequate to meet environmental health requirements. The review recommends well-needed inter-sectoral collaborations and further research to provide an evidence base for the development of robust policies and standard operating procedures for safe and effective environmental health management and remediation of CDLs.

Procurement of Human Tissues for Research Banking in the Surgical Pathology Laboratory: Prioritization Practices at Washington University Medical Center

PubMed Central

Chernock, Rebecca D.; Leach, Tracey A.; Kahn, Ajaz A.; Yip, James H.; Rossi, Joan; Pfeifer, John D.

2011-01-01

Academic hospitals and medical schools with research tissue repositories often derive many of their internal human specimen acquisitions from their site's surgical pathology service. Typically, such acquisitions come from appropriately consented tissue discards sampled from surgical resections. Because the practice of surgical pathology has patient care as its primary mission, competing needs for tissue inevitably arise, with the requirement to preserve adequate tissue for clinical diagnosis being paramount. A set of best-practice gross pathology guidelines are summarized here, focused on the decision for tissue banking at the time specimens are macroscopically evaluated. These reflect our collective experience at Washington University School of Medicine, and are written from the point of view of our site biorepository. The involvement of trained pathology personnel in such procurements is very important. These guidelines reflect both good surgical pathology practice (including the pathologic features characteristic of various anatomic sites) and the typical objectives of research biorepositories. The guidelines should be helpful to tissue bank directors, and others charged with the procurement of tissues for general research purposes. We believe that appreciation of these principles will facilitate the partnership between surgical pathologists and biorepository directors, and promote both good patient care and strategic, value-added banking procurements. PMID:23386925

[Safety in the Microbiology laboratory].

PubMed

Rojo-Molinero, Estrella; Alados, Juan Carlos; de la Pedrosa, Elia Gómez G; Leiva, José; Pérez, José L

2015-01-01

The normal activity in the laboratory of microbiology poses different risks - mainly biological - that can affect the health of their workers, visitors and the community. Routine health examinations (surveillance and prevention), individual awareness of self-protection, hazard identification and risk assessment of laboratory procedures, the adoption of appropriate containment measures, and the use of conscientious microbiological techniques allow laboratory to be a safe place, as records of laboratory-acquired infections and accidents show. Training and information are the cornerstones for designing a comprehensive safety plan for the laboratory. In this article, the basic concepts and the theoretical background on laboratory safety are reviewed, including the main legal regulations. Moreover, practical guidelines are presented for each laboratory to design its own safety plan according its own particular characteristics. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

National audit of cerebrospinal fluid testing.

PubMed

Holbrook, Ian; Beetham, Robert; Cruickshank, Anne; Egner, William; Fahie-Wilson, Mike; Keir, Geoff; Patel, Dina; Watson, Ian; White, Peter

2007-09-01

UK National External Quality Assessment Service (NEQAS) Specialist Advisory Group for EQA of CSF Proteins and Biochemistry was interested in current practice for the biochemical investigation of cerebrospinal fluid (CSF) in the UK. A questionnaire was sent to laboratories via regional audit committees and the results collated. Most laboratories were analysing CSF in a satisfactory manner. There was some variation in the reference ranges used for glucose, protein and lactate. There was concern about the rejection policies of some laboratories on these unrepeatable samples and the wavelengths used to measure bilirubin. The survey revealed the lack of spectrophotometric scanning for haem pigments and bilirubin in some hospitals. The current practice for the measurement of CSF samples in the UK is satisfactory in most laboratories responding to the questionnaire. National agreement on reference ranges for glucose, protein and lactate should be achievable. Those performing spectrophotometric scanning of the CSF were doing so in concordance with the national guidelines. Some hospitals in the UK may not have responded to the questionnaire because they did not offer spectrophotometric scanning.

Policies and practices pertaining to the selection, qualification requirements, and training programs for nuclear-reactor operating personnel at the Oak Ridge National Laboratory

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

Culbert, W.H.

1985-10-01

This document describes the policies and practices of the Oak Ridge National Laboratory (ORNL) regarding the selection of and training requirements for reactor operating personnel at the Laboratory's nuclear-reactor facilities. The training programs, both for initial certification and for requalification, are described and provide the guidelines for ensuring that ORNL's research reactors are operated in a safe and reliable manner by qualified personnel. This document gives an overview of the reactor facilities and addresses the various qualifications, training, testing, and requalification requirements stipulated in DOE Order 5480.1A, Chapter VI (Safety of DOE-Owned Reactors); it is intended to be in compliancemore » with this DOE Order, as applicable to ORNL facilities. Included also are examples of the documentation maintained amenable for audit.« less

[Knowledge management system for laboratory work and clinical decision support].

PubMed

Inada, Masanori; Sato, Mayumi; Yoneyama, Akiko

2011-05-01

This paper discusses a knowledge management system for clinical laboratories. In the clinical laboratory of Toranomon Hospital, we receive about 20 questions relevant to laboratory tests per day from medical doctors or co-medical staff. These questions mostly involve the essence to appropriately accomplish laboratory tests. We have to answer them carefully and suitably because an incorrect answer may cause a medical accident. Up to now, no method has been in place to achieve a rapid response and standardized answers. For this reason, the laboratory staff have responded to various questions based on their individual knowledge. We began to develop a knowledge management system to promote the knowledge of staff working for the laboratory. This system is a type of knowledge base for assisting the work, such as inquiry management, laboratory consultation, process management, and clinical support. It consists of several functions: guiding laboratory test information, managing inquiries from medical staff, reporting results of patient consultation, distributing laboratory staffs notes, and recording guidelines for laboratory medicine. The laboratory test information guide has 2,000 records of medical test information registered in the database with flexible retrieval. The inquiry management tool provides a methos to record all questions, answer easily, and retrieve cases. It helps staff to respond appropriately in a short period of time. The consulting report system treats patients' claims regarding medical tests. The laboratory staffs notes enter a file management system so they can be accessed to aid in clinical support. Knowledge sharing using this function can achieve the transition from individual to organizational learning. Storing guidelines for laboratory medicine will support EBM. Finally, it is expected that this system will support intellectual activity concerning laboratory work and contribute to the practice of knowledge management for clinical work support.

Sandia National Laboratories Advanced Simulation and Computing (ASC) software quality plan. Part 1 : ASC software quality engineering practices version 1.0.

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

Minana, Molly A.; Sturtevant, Judith E.; Heaphy, Robert

2005-01-01

The purpose of the Sandia National Laboratories (SNL) Advanced Simulation and Computing (ASC) Software Quality Plan is to clearly identify the practices that are the basis for continually improving the quality of ASC software products. Quality is defined in DOE/AL Quality Criteria (QC-1) as conformance to customer requirements and expectations. This quality plan defines the ASC program software quality practices and provides mappings of these practices to the SNL Corporate Process Requirements (CPR 1.3.2 and CPR 1.3.6) and the Department of Energy (DOE) document, ASCI Software Quality Engineering: Goals, Principles, and Guidelines (GP&G). This quality plan identifies ASC management andmore » software project teams' responsibilities for cost-effective software engineering quality practices. The SNL ASC Software Quality Plan establishes the signatories commitment to improving software products by applying cost-effective software engineering quality practices. This document explains the project teams opportunities for tailoring and implementing the practices; enumerates the practices that compose the development of SNL ASC's software products; and includes a sample assessment checklist that was developed based upon the practices in this document.« less

Current safety practices in nano-research laboratories in China.

PubMed

Zhang, Can; Zhang, Jing; Wang, Guoyu

2014-06-01

China has become a key player in the global nanotechnology field, however, no surveys have specifically examined safety practices in the Chinese nano-laboratories in depth. This study reports results of a survey of 300 professionals who work in research laboratories that handle nanomaterials in China. We recruited participants at three major nano-research laboratories (which carry out research in diverse fields such as chemistry, material science, and biology) and the nano-chemistry session of the national meeting of the Chinese Chemical Society. Results show that almost all nano-research laboratories surveyed had general safety regulations, whereas less than one third of respondents reported having nanospecific safety rules. General safety measures were in place in most surveyed nano-research laboratories, while nanospecific protective measures existed or were implemented less frequently. Several factors reported from the scientific literature including nanotoxicology knowledge gaps, technical limitations on estimating nano-exposure, and the lack of nano-occupational safety legislation may contribute to the current state of affairs. With these factors in mind and embracing the precautionary principle, we suggest strengthening or providing nanosafety training (including raising risk awareness) and establishing nanosafety guidelines in China, to better protect personnel in the nano-workplace.

Teaching about genetic testing issues in the undergraduate classroom: a case study.

PubMed

Rogers, Jill Cellars; Taylor, Ann T S

2011-06-01

Educating undergraduates about current genetic testing and genomics can involve novel and creative teaching practices. The higher education literature describes numerous pedagogical approaches in the laboratory designed to engage science and liberal arts students. Often these experiences involve students analyzing their own genes for various polymorphisms, some of which are associated with disease states such as an increased risk for developing cancer. While the literature acknowledges possible ethical ramifications of such laboratory exercises, authors do not present recommendations or rubrics for evaluating whether or not the testing is, in fact, ethical. In response, we developed a laboratory investigation and discussion which allowed undergraduate science students to explore current DNA manipulation techniques to isolate their p53 gene, followed by a dialogue probing the ethical implications of examining their sample for various polymorphisms. Students never conducted genotyping on their samples because of ethical concerns, so the discussion served to replace actual genetic testing in the class. A basic scientist led the laboratory portion of the assignment. A genetic counselor facilitated the discussion, which centered around existing ethical guidelines for clinical genetic testing and possible challenges of human genotyping outside the medical setting. In their final papers, students demonstrated an understanding of the practice guidelines established by the genetics community and acknowledged the ethical considerations inherent in p53 genotyping. Given the burgeoning market for personalized medicine, teaching undergraduates about the psychosocial and ethical dimensions of human gene testing seems important and timely, and introduces an additional role genetic counselors can play in educating consumers about genomics.

Evaluating performance in sweat testing in medical biochemistry laboratories in Croatia.

PubMed

Aralica, Merica; Krleza, Jasna Lenicek

2017-02-15

Sweat test has a diagnostic role in evaluation of cystic fibrosis. Its performance includes sweat stimulation, collection and analysis. All listed may be sources of inconsistencies in everyday practice. The aim of this study was an evaluation of external quality assessment (EQA) of sweat chloride measurement including sweat test performance in medical biochemistry laboratories in Croatia. EQA for sweat chloride measurement was provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) in five consecutive exercises to medical biochemistry laboratories (MBL) that offered sweat testing. A questionnaire regarding all phases of testing was mailed to involved MBL (N = 10). Survey results were compared to current guidelines for sweat test performance. Reported results of EQA in 2015 exercises showed coefficients of variation (CV) from 28.9%, 29.0% to 35.3%, respectively. An introduction of uniform sweat chloride measurement protocol resulted in CV of 15.5% and 14.7% reported in following two exercises in 2016. All MBL included in this study replied to the questionnaire. Results reported by MBL indicated: lack of patient information policy (7/10), use of unacceptable electrodes (6/9), misuse of minimum of acceptable sweat weight (6/9), lack of internal quality assessment (5/9) and recommended reference ranges (5/9 and 4/9). Agreements to guidelines were found in approach to unsuitable patients (9/10) and sweat collection (8/9). Presented results indicate major weak points of current practice in sweat test performance in Croatian MBL and stress the need for its standardization on a national level.

Evaluating performance in sweat testing in medical biochemistry laboratories in Croatia

PubMed Central

Aralica, Merica; Krleza, Jasna Lenicek

2017-01-01

Introduction Sweat test has a diagnostic role in evaluation of cystic fibrosis. Its performance includes sweat stimulation, collection and analysis. All listed may be sources of inconsistencies in everyday practice. The aim of this study was an evaluation of external quality assessment (EQA) of sweat chloride measurement including sweat test performance in medical biochemistry laboratories in Croatia. Materials and methods EQA for sweat chloride measurement was provided by Croatian Centre for Quality Assessment in Laboratory Medicine (CROQALM) in five consecutive exercises to medical biochemistry laboratories (MBL) that offered sweat testing. A questionnaire regarding all phases of testing was mailed to involved MBL (N = 10). Survey results were compared to current guidelines for sweat test performance. Results Reported results of EQA in 2015 exercises showed coefficients of variation (CV) from 28.9%, 29.0% to 35.3%, respectively. An introduction of uniform sweat chloride measurement protocol resulted in CV of 15.5% and 14.7% reported in following two exercises in 2016. All MBL included in this study replied to the questionnaire. Results reported by MBL indicated: lack of patient information policy (7/10), use of unacceptable electrodes (6/9), misuse of minimum of acceptable sweat weight (6/9), lack of internal quality assessment (5/9) and recommended reference ranges (5/9 and 4/9). Agreements to guidelines were found in approach to unsuitable patients (9/10) and sweat collection (8/9). Conclusion Presented results indicate major weak points of current practice in sweat test performance in Croatian MBL and stress the need for its standardization on a national level. PMID:28392735

Prostate needle biopsy processing: a survey of laboratory practice across Europe.

PubMed

Varma, Murali; Berney, Daniel M; Algaba, Ferran; Camparo, Philippe; Compérat, Eva; Griffiths, David F R; Kristiansen, Glen; Lopez-Beltran, Antonio; Montironi, Rodolfo; Egevad, Lars

2013-02-01

To determine the degree of variation in the handling of prostate needle biopsies (PBNx) in laboratories across Europe. A web based survey was emailed to members of the European Network of Uropathology and the British Association of Urological Pathologists. Responses were received from 241 laboratories in 15 countries. PNBx were generally taken by urologists (93.8%) or radiologists (23.7%) but in 8.7% were also taken by non-medical personnel such as radiographers, nurses or biomedical assistants. Of the responding laboratories, 40.8% received cores in separate containers, 42.3% processed one core/block, 54.2% examined three levels/block, 49.4% examined one H&E section/level and 56.1% retained spare sections for potential immunohistochemistry. Of the laboratories, 40.9% retained unstained spares for over a year while 36.2% discarded spares within 1 month of reporting. Only two (0.8%) respondents routinely performed immunohistochemistry on all PNBx. There were differences in laboratory practice between the UK and the rest of Europe (RE). Procurement of PNBx by non-medical personnel was more common in the UK. RE laboratories more commonly received each core in a separate container, processed one core/block, examined fewer levels/block and examined more H&E sections/level. RE laboratories also retained spares for potential immunohistochemistry less often and for shorter periods. Use of p63 as the sole basal cell marker was more common in RE. There are marked differences in procurement, handling and processing of PNBx in laboratories across Europe. This data can help the development of best practice guidelines.

Stakeholder perspectives on implementing a universal Lynch syndrome screening program: a qualitative study of early barriers and facilitators.

PubMed

Schneider, Jennifer L; Davis, James; Kauffman, Tia L; Reiss, Jacob A; McGinley, Cheryl; Arnold, Kathleen; Zepp, Jamilyn; Gilmore, Marian; Muessig, Kristin R; Syngal, Sapna; Acheson, Louise; Wiesner, Georgia L; Peterson, Susan K; Goddard, Katrina A B

2016-02-01

Evidence-based guidelines recommend that all newly diagnosed colon cancer be screened for Lynch syndrome (LS), but best practices for implementing universal tumor screening have not been extensively studied. We interviewed a range of stakeholders in an integrated health-care system to identify initial factors that might promote or hinder the successful implementation of a universal LS screening program. We conducted interviews with health-plan leaders, managers, and staff. Interviews were audio-recorded and transcribed. Thematic analysis began with a grounded approach and was also guided by the Practical Robust Implementation and Sustainability Model (PRISM). We completed 14 interviews with leaders/managers and staff representing involved clinical and health-plan departments. Although stakeholders supported the concept of universal screening, they identified several internal (organizational) and external (environment) factors that promote or hinder implementation. Facilitating factors included perceived benefits of screening for patients and organization, collaboration between departments, and availability of organizational resources. Barriers were also identified, including: lack of awareness of guidelines, lack of guideline clarity, staffing and program "ownership" concerns, and cost uncertainties. Analysis also revealed nine important infrastructure-type considerations for successful implementation. We found that clinical, laboratory, and administrative departments supported universal tumor screening for LS. Requirements for successful implementation may include interdepartmental collaboration and communication, patient and provider/staff education, and significant infrastructure and resource support related to laboratory processing and systems for electronic ordering and tracking.

Dietitians' opinions regarding refeeding syndrome, clinical guidelines and extended scope of practice.

PubMed

Matthews, Kylie L; Palmer, Michelle A; Capra, Sandra M

2018-04-30

Refeeding syndrome (RFS) prevalence rates vary across studies depending on the criteria used for assessment and identification. For registered dietitians, the assessment and management of RFS is highly reliant on daily serum electrolyte values; however, registered dietitians working within Australia do not currently possess laboratory test ordering privileges. We aimed to examine the opinions of registered dietitians regarding RFS identification, management and guidelines and the option of using extended scope of practice to order electrolyte monitoring autonomously. A multi-method action research approach was used, incorporating two projects. The first was a survey examining Australian registered dietitians' (n = 187) opinions regarding RFS identification, management and guidelines, and autonomous electrolyte monitoring. To establish if results were similar internationally, an interview was conducted with 22 registered dietitians working within 10 different countries. Data were analysed using chi-square tests and thematic analysis. Australian registered dietitians (75%) identify patients at risk of RFS at a high rate of more than once per fortnight, with 74% reporting that they have previously worked with a patient diagnosed with RFS. Results varied internationally, with respondents from eight countries reporting that RFS is a problem within acute care versus respondents from five countries having never treated a patient with RFS. The majority (≥89%) of registered dietitians desire new guidelines and the option to order patient electrolyte monitoring autonomously. Our findings suggest that more stringent tools for the identification of RFS are necessary. There was limited uniformity across countries, and updated practice guidelines are needed. © 2018 Dietitians Association of Australia.

A practical approach for linearity assessment of calibration curves under the International Union of Pure and Applied Chemistry (IUPAC) guidelines for an in-house validation of method of analysis.

PubMed

Sanagi, M Marsin; Nasir, Zalilah; Ling, Susie Lu; Hermawan, Dadan; Ibrahim, Wan Aini Wan; Naim, Ahmedy Abu

2010-01-01

Linearity assessment as required in method validation has always been subject to different interpretations and definitions by various guidelines and protocols. However, there are very limited applicable implementation procedures that can be followed by a laboratory chemist in assessing linearity. Thus, this work proposes a simple method for linearity assessment in method validation by a regression analysis that covers experimental design, estimation of the parameters, outlier treatment, and evaluation of the assumptions according to the International Union of Pure and Applied Chemistry guidelines. The suitability of this procedure was demonstrated by its application to an in-house validation for the determination of plasticizers in plastic food packaging by GC.

Perspectives on Validation of High-Throughput Assays Supporting 21st Century Toxicity Testing1

PubMed Central

Judson, Richard; Kavlock, Robert; Martin, Matt; Reif, David; Houck, Keith; Knudsen, Thomas; Richard, Ann; Tice, Raymond R.; Whelan, Maurice; Xia, Menghang; Huang, Ruili; Austin, Christopher; Daston, George; Hartung, Thomas; Fowle, John R.; Wooge, William; Tong, Weida; Dix, David

2014-01-01

Summary In vitro, high-throughput screening (HTS) assays are seeing increasing use in toxicity testing. HTS assays can simultaneously test many chemicals, but have seen limited use in the regulatory arena, in part because of the need to undergo rigorous, time-consuming formal validation. Here we discuss streamlining the validation process, specifically for prioritization applications in which HTS assays are used to identify a high-concern subset of a collection of chemicals. The high-concern chemicals could then be tested sooner rather than later in standard guideline bioassays. The streamlined validation process would continue to ensure the reliability and relevance of assays for this application. We discuss the following practical guidelines: (1) follow current validation practice to the extent possible and practical; (2) make increased use of reference compounds to better demonstrate assay reliability and relevance; (3) deemphasize the need for cross-laboratory testing, and; (4) implement a web-based, transparent and expedited peer review process. PMID:23338806

Cutaneous Lyme borreliosis: Guideline of the German Dermatology Society.

PubMed

Hofmann, Heidelore; Fingerle, Volker; Hunfeld, Klaus-Peter; Huppertz, Hans-Iko; Krause, Andreas; Rauer, Sebastian; Ruf, Bernhard

2017-01-01

This guideline of the German Dermatology Society primarily focuses on the diagnosis and treatment of cutaneous manifestations of Lyme borreliosis. It has received consensus from 22 German medical societies and 2 German patient organisations. It is the first part of an AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V.) interdisciplinary guideline: "Lyme Borreliosis - Diagnosis and Treatment, development stage S3". The guideline is directed at physicians in private practices and clinics who treat Lyme borreliosis. Objectives of this guideline are recommendations for confirming a clinical diagnosis, recommendations for a stage-related laboratory diagnosis (serological detection of IgM and IgG Borrelia antibodies using the 2-tiered ELISA/immunoblot process, sensible use of molecular diagnostic and culture procedures) and recommendations for the treatment of the localised, early-stage infection (erythema migrans, erythema chronicum migrans, and borrelial lymphocytoma), the disseminated early-stage infection (multiple erythemata migrantia, flu-like symptoms) and treatment of the late-stage infection (acrodermatitis chronica atrophicans with and without neurological manifestations). In addition, an information sheet for patients containing recommendations for the prevention of Lyme borreliosis is attached to the guideline.

Cutaneous Lyme borreliosis: Guideline of the German Dermatology Society

PubMed Central

Hofmann, Heidelore; Fingerle, Volker; Hunfeld, Klaus-Peter; Huppertz, Hans-Iko; Krause, Andreas; Rauer, Sebastian; Ruf, Bernhard

2017-01-01

This guideline of the German Dermatology Society primarily focuses on the diagnosis and treatment of cutaneous manifestations of Lyme borreliosis. It has received consensus from 22 German medical societies and 2 German patient organisations. It is the first part of an AWMF (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V.) interdisciplinary guideline: “Lyme Borreliosis – Diagnosis and Treatment, development stage S3”. The guideline is directed at physicians in private practices and clinics who treat Lyme borreliosis. Objectives of this guideline are recommendations for confirming a clinical diagnosis, recommendations for a stage-related laboratory diagnosis (serological detection of IgM and IgG Borrelia antibodies using the 2-tiered ELISA/immunoblot process, sensible use of molecular diagnostic and culture procedures) and recommendations for the treatment of the localised, early-stage infection (erythema migrans, erythema chronicum migrans, and borrelial lymphocytoma), the disseminated early-stage infection (multiple erythemata migrantia, flu-like symptoms) and treatment of the late-stage infection (acrodermatitis chronica atrophicans with and without neurological manifestations). In addition, an information sheet for patients containing recommendations for the prevention of Lyme borreliosis is attached to the guideline. PMID:28943834

Revisiting KDIGO clinical practice guideline on chronic kidney disease-mineral and bone disorder: a commentary from a Kidney Disease: Improving Global Outcomes controversies conference.

PubMed

Ketteler, Markus; Elder, Grahame J; Evenepoel, Pieter; Ix, Joachim H; Jamal, Sophie A; Lafage-Proust, Marie-Hélène; Shroff, Rukshana; Thadhani, Ravi I; Tonelli, Marcello A; Kasiske, Bertram L; Wheeler, David C; Leonard, Mary B

2015-03-01

A new definition and classification of chronic kidney disease-mineral and bone disorder (CKD-MBD) was proposed in 2005 and it was later followed by a guideline publication on this topic from Kidney Disease: Improving Global Outcomes (KDIGO) in 2009. This work recognized that CKD-MBD is a syndrome of bone abnormalities, laboratory abnormalities, and vascular calcification linked to fractures, cardiovascular disease, and mortality. Because of limited data at the time of the original guideline systematic review, many of the recommendations were cautiously vague. KDIGO convened a Controversies Conference in October 2013 to review the CKD-MBD literature published since the 2009 guideline. Specifically, the objective of this conference was to determine whether sufficient new data had emerged to support a reassessment of the CKD-MBD guideline and if so to determine the scope of these potential revisions. This report summarizes the results of these proceedings, highlighting important new studies conducted in the interval since the original KDIGO CKD-MBD guideline.

Guidelines for Biosafety Training Programs for Workers Assigned to BSL-3 Research Laboratories.

PubMed

Homer, Lesley C; Alderman, T Scott; Blair, Heather Ann; Brocard, Anne-Sophie; Broussard, Elaine E; Ellis, Robert P; Frerotte, Jay; Low, Eleanor W; McCarthy, Travis R; McCormick, Jessica M; Newton, JeT'Aime M; Rogers, Francine C; Schlimgen, Ryan; Stabenow, Jennifer M; Stedman, Diann; Warfield, Cheryl; Ntiforo, Corrie A; Whetstone, Carol T; Zimmerman, Domenica; Barkley, Emmett

2013-03-01

The Guidelines for Biosafety Training Programs for Workers Assigned to BSL-3 Research Laboratories were developed by biosafety professionals who oversee training programs for the 2 national biocontainment laboratories (NBLs) and the 13 regional biocontainment laboratories (RBLs) that participate in the National Institute of Allergy and Infectious Diseases (NIAID) NBL/RBL Network. These guidelines provide a general training framework for biosafety level 3 (BSL-3) high-containment laboratories, identify key training concepts, and outline training methodologies designed to standardize base knowledge, understanding, and technical competence of laboratory personnel working in high-containment laboratories. Emphasis is placed on building a culture of risk assessment-based safety through competency training designed to enhance understanding and recognition of potential biological hazards as well as methods for controlling these hazards. These guidelines may be of value to other institutions and academic research laboratories that are developing biosafety training programs for BSL-3 research.

75 FR 75485 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-03

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were... Laboratories and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen...

Guidelines for biosafety laboratory competency: CDC and the Association of Public Health Laboratories.

PubMed

Delany, Judy R; Pentella, Michael A; Rodriguez, Joyce A; Shah, Kajari V; Baxley, Karen P; Holmes, David E

2011-04-15

These guidelines for biosafety laboratory competency outline the essential skills, knowledge, and abilities required for working with biologic agents at the three highest biosafety levels (BSLs) (levels 2, 3, and 4). The competencies are tiered to a worker's experience at three levels: entry level, midlevel (experienced), and senior level (supervisory or managerial positions). These guidelines were developed on behalf of CDC and the Association of Public Health Laboratories (APHL) by an expert panel comprising 27 experts representing state and federal public health laboratories, private sector clinical and research laboratories, and academic centers. They were then reviewed by approximately 300 practitioners representing the relevant fields. The guidelines are intended for laboratorians working with hazardous biologic agents, obtained from either samples or specimens that are maintained and manipulated in clinical, environmental, public health, academic, and research laboratories.

The use of instructional design guidelines to increase effectiveness of postpartum hemorrhage simulation training.

PubMed

de Melo, Brena C P; Falbo, Ana R; Muijtjens, Arno M M; van der Vleuten, Cees P M; van Merriënboer, Jeroen J G

2017-04-01

To compare learning outcomes of postpartum hemorrhage simulation training based on either instructional design guidelines or best practice. A pretest-post-test non-equivalent groups study was conducted among obstetrics and gynecology residents in Recife, Brazil, from June 8 to August 30, 2013. The instructional design group included 13 teams, whereas the best practice group included seven teams. A standardized task checklist was used for scenario analysis and the proportion of correctly executed tasks compared (post-test minus pretest). The instructional design group scored higher than the best practice group for total number of tasks completed (median difference 0.46 vs 0.17; P<0.001; effect size [r]=0.72). Similar results were observed for communication (median difference 0.56 vs 0.22; P=0.004; r=0.58), laboratory evaluation (median difference 0.83 vs 0.00; P<0.001; r=0.76), and mechanical management (median difference 0.25 vs -0.15; P=0.048; r=0.39). Speed of learning was also increased. The median differences were 0.20 for the instructional design group compared with 0.05 for the best practice group at 60 seconds (P=0.015; r=0.49), and 0.49 versus 0.26 (P=0.001; r=0.65) at 360 seconds. The use of simulation training for postpartum hemorrhage that was based on instructional design guidelines yielded better learning outcomes than did training based on best practice. © 2016 International Federation of Gynecology and Obstetrics.

Photovoltaic Calibrations at the National Renewable Energy Laboratory and Uncertainty Analysis Following the ISO 17025 Guidelines

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

Emery, Keith

The measurement of photovoltaic (PV) performance with respect to reference conditions requires measuring current versus voltage for a given tabular reference spectrum, junction temperature, and total irradiance. This report presents the procedures implemented by the PV Cell and Module Performance Characterization Group at the National Renewable Energy Laboratory (NREL) to achieve the lowest practical uncertainty. A rigorous uncertainty analysis of these procedures is presented, which follows the International Organization for Standardization (ISO) Guide to the Expression of Uncertainty in Measurement. This uncertainty analysis is required for the team’s laboratory accreditation under ISO standard 17025, “General Requirements for the Competence ofmore » Testing and Calibration Laboratories.” The report also discusses additional areas where the uncertainty can be reduced.« less

The role of laboratory testing in detection and classification of chronic kidney disease: national recommendations

PubMed Central

Biljak, Vanja Radišić; Honović, Lorena; Matica, Jasminka; Krešić, Branka; Vojak, Sanela Šimić

2017-01-01

Chronic kidney disease (CKD) is a common clinical condition with significant adverse consequences for the patient and it is recognized as a significant public health problem. The role of laboratory medicine in diagnosis and management of CKD is of great importance: the diagnosis and staging are based on estimation of glomerular filtration rate (eGFR) and assessment of albuminuria (or proteinuria). Therefore, the joint working group of the Croatian society of medical biochemistry and laboratory medicine and Croatian chamber of medical biochemists for laboratory diagnostics in CKD issued this national recommendation regarding laboratory diagnostics of CKD.
Key factors for laboratories implementing the national guidelines for the diagnosis and management of CKD are:
1. Ensure good communication between laboratory professionals and clinicians, such as nephrologists or specialists in general/family medicine,
2. Ensure all patients are provided with the same availability of laboratory diagnostics,
3. Ensure creatinine assays are traceable to isotope dilution mass spectrometry (IDMS) method and have minimal bias and acceptable imprecision,
4. Select the appropriate GFR estimating formula. Recommended equation is the 2009 Chronic Kidney Disease Epidemiology Collaboration (CKD – EPI) equation,
5. In reporting the key laboratory tests (creatinine, eGFR, urine albumin-to-creatinine ratio, urine protein-to-creatinine ratio) use the appropriate reporting units,
6. Provide adequate information on limitations of creatinine measurement.
The manuscript has been organized to identify critical points in laboratory tests used in basic laboratory diagnostics of CKD and is based on the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. PMID:28392738

Report of the FELASA Working Group on evaluation of quality systems for animal units.

PubMed

Howard, B; van Herck, H; Guillen, J; Bacon, B; Joffe, R; Ritskes-Hoitinga, M

2004-04-01

This report compares and considers the merits of existing, internationally available quality management systems suitable for implementation in experimental animal facilities. These are: the Good Laboratory Practice Guidelines, ISO 9000:2000 (International Organization for Standardization) and AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). Good laboratory practice (GLP) is a legal requirement for institutions undertaking non-clinical health and environmental studies for the purpose of registering or licensing for use and which have to be 'GLP-compliant'. GLP guidelines are often only relevant for and obtainable by those institutions. ISO is primarily an external business standard, which provides a management tool to master and optimize a business activity; it aims to implement and enhance 'customer satisfaction'. AAALAC is primarily a peer-reviewed system of accreditation which evaluates the organization and procedures in programmes of animal care and use to ensure the appropriate use of animals, safeguard animal well-being (ensuring state-of-the-art housing, management, procedural techniques, etc.) as well as the management of health and safety of staff. Management needs to determine, on the basis of a facility's specific goals, whether benefits would arise from the introduction of a quality system and, if so, which system is most appropriate. The successful introduction of a quality system confers peer-recognition against an independent standard, thereby providing assurance of standards of animal care and use, improving the quality of animal studies, and contributing to the three Rs-reduction, refinement and replacement.

Infection control in cystic fibrosis: barriers to implementation and ideas for improvement.

PubMed

Saiman, Lisa; Garber, Elizabeth

2009-11-01

This review will focus on recent research documenting baseline adherence to infection control recommendations and barriers to their implementation as experienced by multidisciplinary cystic fibrosis (CF) care providers. In addition, controversies regarding optimal infection control will be discussed. Finally, suggestions to improve infection control in CF will be proposed. Compliance with recent guidelines was assessed for clinical microbiology laboratories and for infection control policies at CF care centers in the United States. Unlike earlier reports, the vast majority of laboratories used selective media for Burkholderia cepacia complex and identified all species of nonlactose fermenting Gram-negative bacilli. Fewer used selective media for Staphylococcus aureus or used agar-based susceptibility testing assays for Pseudomonas aeruginosa. Only 103 (65%) of 158 CF care centers provided written infection control policies for review and these were more likely to address inpatient than outpatient settings. Surveys of healthcare professionals showed that access to a copy of the CF infection control guidelines reduced barriers to adherence to selected infection control practices. These data suggest that access to national infection control guidelines and written local policies are critically important to improving infection control for CF.

Current issues of personnel and laboratory practices in genetic testing

PubMed Central

Mark, Hon Fong Louie; Kelly, Thaddeus; Watson, Michael S; Hoeltge, Gerald; Miller, Wayne A; Beauregard, Laurent

1995-01-01

As genetic testing is an area with implications extending far beyond that of the primary patient, it is appropriately an area that is under increased scrutiny. To ensure that high quality is maintained in the delivery of genetic services, several agencies have developed standards and guidelines. The present article summarises important recommendations made by the American College of Medical Genetics (ACMG), the College of American Pathologists (CAP), the US Health Care Financing Administration (HCFA), and the US Food and Drug Administration (FDA) as they relate to genetic testing. Some of the standards are based on voluntary compliance, whereas others have the force of regulation. They all address issues of personnel credentials, laboratory operations, and the most critical quality assurance and control measures for diagnostic laboratories from the perspective of various agencies. In most instances, the standards promulgated by these agencies are offered as minimum criteria. The exact impact of these regulations on the practice of medical genetics has yet to be established. Images PMID:8558555

A study of cellular counting to determine minimum thresholds for adequacy for liquid-based cervical cytology using a survey and counting protocol.

PubMed

Kitchener, Henry C; Gittins, Matthew; Desai, Mina; Smith, John H F; Cook, Gary; Roberts, Chris; Turnbull, Lesley

2015-03-01

Liquid-based cytology (LBC) for cervical screening would benefit from laboratory practice guidelines that define specimen adequacy for reporting of slides. The evidence base required to define cell adequacy should incorporate both ThinPrep™ (TP; Hologic, Inc., Bedford, MA, USA) and SurePath™ (SP; BD Diagnostics, Burlington, NC, USA), the two LBC systems used in the UK cervical screening programmes. The objectives of this study were to determine (1) current practice for reporting LBC in England, Wales and Scotland, (2) a reproducible method for cell counting, (3) the cellularity of slides classified as inadequate, negative or abnormal and (4) the impact of varying cellularity on the likelihood of detecting cytological abnormalities. The study involved four separate arms to pursue each of the four objectives. (1) A questionnaire survey of laboratories was conducted. (2) A standard counting protocol was developed and used by three experienced cytopathologists to determine a reliable and reproducible cell counting method. (3) Slide sets which included a range of cytological abnormalities were each sent to three laboratories for cell counting to study the correlation between cell counts and reported cytological outcomes. (4) Dilution of LBC samples by fluid only (unmixed) or by dilution with a sample containing normal cells (mixed) was performed to study the impact on reporting of reducing either the total cell count or the relative proportion of abnormal to normal cells. The study was conducted within the cervical screening programmes in England, Wales and Scotland, using routinely obtained cervical screening samples, and in 56 participating NHS cervical cytology laboratories. The study involved only routinely obtained cervical screening samples. There was no clinical intervention. The main outcome measures were (1) reliability of counting method, (2) correlation of reported cytology grades with cellularity and (3) levels of detection of abnormal cells in progressively diluted cervical samples. Laboratory practice varied in terms of threshold of cellular adequacy and of morphological markers of adequacy. While SP laboratories generally used a minimum acceptable cell count (MACC) of 15,000, the MACC employed by TP laboratories varied between 5000 and 15,000. The cell counting study showed that a standard protocol achieved moderate to strong inter-rater reproducibility. Analysis of slide reporting from laboratories revealed that a large proportion of the samples reported as inadequate had cell counts above a threshold of 15,000 for SP, and 5000 and 10,000 for TP. Inter-rater unanimity was greater among more cellular preparations. Dilution studies demonstrated greater detection of abnormalities in slides with counts above the MACC and among slides with more than 25 dyskaryotic cells. Variation in laboratory practice demonstrates a requirement for evidence-based standards for designating a MACC. This study has indicated that a MACC of 15,000 and 5000 for SP and TP, respectively, achieves a balance in terms of maintaining sensitivity and low inadequacy rates. The findings of this study should inform the development of laboratory practice guidelines. The National Institute for Health Research Health Technology Assessment programme.

HEW to Set Laboratory Safety Standards.

ERIC Educational Resources Information Center

Chemical and Engineering News, 1978

1978-01-01

Describes Department of Health, Education and Welfare (HEW) proposed guidelines for laboratories using chemical carcinogens. The guidelines are designed to provide protection for laboratory workers and their environment from exposure to all types of carcinogenic agents. (GA)

Compliance with infection control practices in sputum microscopy centres: a study from Kerala, India

PubMed Central

Ubaid, N. P.; Nagaraja, S. B.; Shewade, H. D.; Padmanabhan, K. V.; Naik, B. R.; Satpati, M.; Blesson, S.; Jayasree, A. K.

2015-01-01

Background: One of the strategies of the Revised National Tuberculosis Control Programme in India to achieve tuberculosis control is by increasing case detection through a nationwide network of designated microscopy centres (DMC). Practice of standard precautions for infection control in these DMCs is very important to prevent transmission of infection not only to the laboratory personnel, but also to the general population. However, in India this has not been evaluated by an external agency. Method: A cross-sectional study was carried out to assess knowledge, facilities and compliance regarding infection control practices (ICP) in all 38 DMCs in Kannur district, Kerala, India, in 2015. Using observations and interviews, the investigators collected data in a structured format. Results: Overall knowledge about infection control was found to be satisfactory among 29% of laboratory technicians. Overall facilities for infection control were satisfactory in 61% of the DMCs, while adherence to ICP was satisfactory in 45% of the DMCs. Knowledge regarding ICP was better in government DMCs, whereas facilities for ICP and adherence to biomedical waste management guidelines were better in private DMCs. Conclusion: Given the higher risk of infection among laboratory technicians, there is an urgent need to address the shortcomings in infection control practices. PMID:26767180

Practical Management of HIV-Associated Anemia in Resource-Limited Settings: Prospective Observational Evaluation of a New Mozambican Guideline

PubMed Central

Silva, Wilson P.; Vermund, Sten H.; Valverde, Emilio; Buene, Manuel; Moon, Troy D.

2016-01-01

Abstract Mozambique's updated guideline for management of HIV-associated anemia prompts clinicians to consider opportunistic conditions, adverse drug reactions, and untreated immunosuppression in addition to iron deficiency, intestinal helminthes, and malaria. We prospectively evaluated this guideline in rural Zambézia Province. Likely cause(s) of anemia were determined through prespecified history, physical examination, and laboratory testing. Diagnoses were “etiologic” if laboratory confirmed (sputum microscopy, blood culture, Plasmodium falciparum malaria rapid test) or “syndromic” if not. To assess hemoglobin response, we used serial point-of-care measurements. We studied 324 ambulatory, anemic (hemoglobin <10 g/dl) HIV-infected adults. Study clinicians treated nearly all [315 (97.2%)] for suspected iron deficiency and/or helminthes; 56 (17.3%) had laboratory-confirmed malaria. Other assigned diagnoses included tuberculosis [30 (9.3%)], adverse drug reactions [26 (8.0%)], and bacteremia [13 (4.1%)]. Etiologic diagnosis was achieved in 79 (24.4%). Of 169 (52.2%) subjects who improved (hemoglobin increase of ≥1 g/dl without indications for hospitalization), only 65 (38.5%) received conventional management (iron supplementation, deworming, and/or antimalarials) alone. Thirty (9.3%) died and/or were hospitalized, and 125 (38.6%) were lost to follow-up. Multivariable linear and logistic regression models described better hemoglobin responses and/or outcomes in subjects with higher CD4+ T-lymphocyte counts, pre-enrollment antiretroviral therapy and/or co-trimoxazole prophylaxis, discontinuation of zidovudine for suspected adverse reaction, and smear-positive tuberculosis. Adverse outcomes were associated with fever, low body mass index, bacteremia, esophageal candidiasis, and low or missing CD4+ T cell counts. In this severely resource-limited setting, successful anemia management often required interventions other than conventional presumptive treatment, thus supporting Mozambique's guideline revision. PMID:26178574

Could a revision of the current guidelines for cancer drug use improve the quality of cancer treatment?

PubMed

Lippert, Theodor H; Ruoff, Hans-Jörg; Volm, Manfred

2014-01-01

Clinical practice guidelines are indispensable for such a variable disease as malignant solid tumors, with the complex possibilities of drug treatment. The current guidelines may be criticized on several points, however. First, there is a lack of information on the outcome of treatment, such as the expected success and failure rates. Treating not only drug responders but also nonresponders, that is, patients with drug resistance, must result in failures. There is no mention of the possibility of excluding the drug nonresponders, identifiable by special laboratory tests and no consideration is given to the different side effects of the recommended drug regimens. Nor are there any instructions concerning tumor cases for which anticancer drug treatment is futile. In such cases, early palliative care may lead to significant improvements in both life quality and life expectancy. Not least, there is no transparency concerning the preparation of the guidelines: persons cannot be identified who could give a statement of conflicts of interest, and responsibility is assumed only by anonymous medical associations. A revision of the current guidelines could considerably improve cancer treatment.

Evaluation of Statin Eligibility, Prescribing Practices, and Therapeutic Responses Using ATP III, ACC/AHA, and NLA Dyslipidemia Treatment Guidelines in a Large Urban Cohort of HIV-Infected Outpatients.

PubMed

Levy, Matthew E; Greenberg, Alan E; Magnus, Manya; Younes, Naji; Castel, Amanda

2018-02-01

Statin coverage has been examined among HIV-infected patients using Adult Treatment Panel III (ATP III) and American College of Cardiology/American Heart Association (ACC/AHA) guidelines, although not with newer National Lipid Association (NLA) guidelines. We investigated statin eligibility, prescribing practices, and therapeutic responses using these three guidelines. Sociodemographic, clinical, and laboratory data were collected between 2011 and 2016 for HIV-infected outpatients enrolled in the DC Cohort, a multi-center, prospective, observational study in Washington, DC. This analysis included patients aged ≥21 years receiving primary care at their HIV clinic site with ≥1 cholesterol result available. Of 3312 patients (median age 52; 79% black), 52% were eligible for statins based on ≥1 guideline, including 45% (NLA), 40% (ACC/AHA), and 30% (ATP III). Using each guideline, 49% (NLA), 56% (ACC/AHA), and 73% (ATP III) of eligible patients were prescribed statins. Predictors of new prescriptions included older age (aHR = 1.16 [1.08-1.26]/5 years), body mass index ≥30 (aHR = 1.50 [1.07-2.11]), and diabetes (aHR = 1.35 [1.03-1.79]). Hepatitis C coinfection was inversely associated with statin prescriptions (aHR = 0.67 [0.45-1.00]). Among 216 patients with available cholesterol results pre-/post-prescription, 53% achieved their NLA cholesterol goal after 6 months. Hepatitis C coinfection was positively associated (aHR = 1.87 [1.06-3.32]), and depression (aHR = 0.56 [0.35-0.92]) and protease inhibitor use (aHR = 0.61 [0.40-0.93]) were inversely associated, with NLA goal achievement. Half of patients were eligible for statins based on current US guidelines, with the highest proportion eligible based on NLA guidelines, yet, fewer received prescriptions and achieved treatment goals. Greater compliance with recommended statin prescribing practices may reduce cardiovascular disease risk among HIV-infected individuals.

Evidence-based guidelines for use of probiotics in preterm neonates.

PubMed

Deshpande, Girish C; Rao, Shripada C; Keil, Anthony D; Patole, Sanjay K

2011-08-02

Current evidence indicates that probiotic supplementation significantly reduces all-cause mortality and definite necrotising enterocolitis without significant adverse effects in preterm neonates. As the debate about the pros and cons of routine probiotic supplementation continues, many institutions are satisfied with the current evidence and wish to use probiotics routinely. Because of the lack of detail on many practical aspects of probiotic supplementation, clinician-friendly guidelines are urgently needed to optimise use of probiotics in preterm neonates. To develop evidence-based guidelines for probiotic supplementation in preterm neonates. To develop core guidelines on use of probiotics, including strain selection, dose and duration of supplementation, we primarily used the data from our recent updated systematic review of randomised controlled trials. For equally important issues including strain identification, monitoring for adverse effects, product format, storage and transport, and regulatory hurdles, a comprehensive literature search, covering the period 1966-2010 without restriction on the study design, was conducted, using the databases PubMed and EMBASE, and the proceedings of scientific conferences; these data were used in our updated systematic review. In this review, we present guidelines, including level of evidence, for the practical aspects (for example, strain selection, dose, duration, clinical and laboratory surveillance) of probiotic supplementation, and for dealing with non-clinical but important issues (for example, regulatory requirements, product format). Evidence was inadequate in some areas, and these should be a target for further research. We hope that these evidence-based guidelines will help to optimise the use of probiotics in preterm neonates. Continued research is essential to provide answers to the current gaps in knowledge about probiotics.

How to evaluate a potential merger or acquisition.

PubMed

Horowitz, Richard E; Provizer, Harold; Barry, Michael J

2013-12-01

Economic imperatives in health care financing are compelling a variety of mergers, acquisitions, integrations, and other forms of amalgamation. As hospitals merge, their pathology practices are merging. Physicians are forming clinically integrated groups, both with and without hospitals. Universities, commercial laboratories, and even insurance companies are acquiring laboratories and pathology practices. There are few standards or guidelines to help the practicing pathologist respond to such new undertakings. In the present study, we present a "how-to" guide or template to assist pathologists in evaluating proposals to amalgamate and in managing the alliance. The procedure begins with an articulation of the cons and pros, followed by a series of assessments of the cultures, the market, the organization, and operations, as well as a legal and financial assessment and human resources appraisal of each of the entities. We then outline the method for developing an organizational and operational model for the new merged entity and for performing the feasibility analysis, making a final decision, drafting a contract, and developing the business plan for the new venture.

Review and comparison of quality standards, guidelines and regulations for laboratories.

PubMed

Datema, Tjeerd A M; Oskam, Linda; Klatser, Paul R

2012-01-01

The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system. There is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories. We reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services . Differences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents. Each laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.

[Technical guideline for human rabies prevention and control (2016)].

PubMed

Zhou, H; Li, Y; Chen, R F; Tao, X Y; Yu, P C; Cao, S C; Li, L; Chen, Z H; Zhu, W Y; Yin, W W; Li, Y H; Wang, C L; Yu, H J

2016-02-01

In order to promote the prevention and control programs on rabies in our country, to regulate the prevention and disposition of rabies and to reduce the deaths caused by rabies, the Chinese Center for Disease Control and Prevention has organized a panel of experts, in the reference with Guidelines issued by WHO, American Advisory Committee on Immunization Practices, and the latest research progress from home and abroad, and compiled this document-"Technical Guidelines for Human Rabies Prevention and Control (2016)". The Guidelines conducted a systematic review on the etiology, clinical characteristics, laboratory diagnosis, epidemiology of rabies and provided evidence on varieties, mechanisms, effects, side-effects and security of rabies vaccine, as well as on other preparations on passive immunity of its kind, on methods related to prevention and disposition of exposure etc, finally to have come up with the recommendation on the above mentioned various techniques. The guidelines will be used by staff working on prevention and control of rabies from the Center for Disease Control and Prevention at all levels, from the departments of outpatient and divisions of infection and emergency control in all the medical institutions. The guideline will be updated and revised, following the research progress from home and abroad.

Optimizing the design of a reproduction toxicity test with the pond snail Lymnaea stagnalis.

PubMed

Charles, Sandrine; Ducrot, Virginie; Azam, Didier; Benstead, Rachel; Brettschneider, Denise; De Schamphelaere, Karel; Filipe Goncalves, Sandra; Green, John W; Holbech, Henrik; Hutchinson, Thomas H; Faber, Daniel; Laranjeiro, Filipe; Matthiessen, Peter; Norrgren, Leif; Oehlmann, Jörg; Reategui-Zirena, Evelyn; Seeland-Fremer, Anne; Teigeler, Matthias; Thome, Jean-Pierre; Tobor Kaplon, Marysia; Weltje, Lennart; Lagadic, Laurent

2016-11-01

This paper presents the results from two ring-tests addressing the feasibility, robustness and reproducibility of a reproduction toxicity test with the freshwater gastropod Lymnaea stagnalis (RENILYS strain). Sixteen laboratories (from inexperienced to expert laboratories in mollusc testing) from nine countries participated in these ring-tests. Survival and reproduction were evaluated in L. stagnalis exposed to cadmium, tributyltin, prochloraz and trenbolone according to an OECD draft Test Guideline. In total, 49 datasets were analysed to assess the practicability of the proposed experimental protocol, and to estimate the between-laboratory reproducibility of toxicity endpoint values. The statistical analysis of count data (number of clutches or eggs per individual-day) leading to ECx estimation was specifically developed and automated through a free web-interface. Based on a complementary statistical analysis, the optimal test duration was established and the most sensitive and cost-effective reproduction toxicity endpoint was identified, to be used as the core endpoint. This validation process and the resulting optimized protocol were used to consolidate the OECD Test Guideline for the evaluation of reproductive effects of chemicals in L. stagnalis. Copyright © 2016 Elsevier Inc. All rights reserved.

Are nutrition messages lost in transmission? Assessing the quality and consistency of diabetes guideline recommendations on the delivery of nutrition therapy.

PubMed

Hale, Kelli; Capra, Sandra; Bauer, Judy

2016-12-01

To provide an overview of (1) the consistency of Type 2 Diabetes Clinical Practice Guidelines recommendations on the delivery of nutrition therapy and (2) Clinical Practice Guideline quality. Large international clinical practice guideline repositories, diabetes organisation websites, and electronic databases (Pubmed, Scopus), were searched to identify Clinical Practice Guidelines for adults with type 2 diabetes published 2005 to August 2014. Recommendations on the delivery of nutrition therapy were extracted and inductive content analysis was used to analyse consistency. Two researchers independently assessed guideline quality using the AGREE II tool. Nine topics were identified from the recommendations. Overall the consistency of the recommendations was related to guideline type. Compared with nutrition-specific guidelines, the broad ones had a broader focus and included more patient-focused recommendations. The ten Clinical Practice Guidelines assessed included six broad guidelines and four nutrition specific guidelines. Based on AGREE II analysis, the broad guidelines were higher quality than nutrition-specific ones. Broad Clinical Practice Guidelines were higher quality and included more patient-focused recommendations than nutrition-specific ones. Our findings suggest a need for nutrition-specific guidelines to be modified to include greater patient-focus, or for practitioners delivering nutrition therapy to adopt broad Clinical Practice Guidelines. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Quality in the pharmaceutical industry - A literature review.

PubMed

Haleem, Reham M; Salem, Maissa Y; Fatahallah, Faten A; Abdelfattah, Laila E

2015-10-01

The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry. The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices. It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices.

42 CFR 438.236 - Practice guidelines.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Practice guidelines. 438.236 Section 438.236 Public... Improvement Standards § 438.236 Practice guidelines. (a) Basic rule: The State must ensure, through its...) Adoption of practice guidelines. Each MCO and, when applicable, each PIHP and PAHP adopts practice...

Laboratory safety aspects of SARS at Biosafety Level 2.

PubMed

Barkham, T M S

2004-03-01

The severe acute respiratory syndrome (SARS)-associated coronavirus causes severe disease, is transmissible to the community and there is no effective prophylaxis or treatment--perhaps fulfilling the criteria for biohazard group 3 or 4. The recommendation to use Biosafety Level (BSL)3 practices within a BSL2 environment appears to have been a practical decision based on available resources; most diagnostic laboratories operate at BSL2. Safety is achieved with controls in administration, engineering and personal protective equipment/behaviour. At the heart of every safety policy is a risk assessment based on the exact manipulations employed. Excessive administrative and engineering controls are less important than the training and personal attitudes, abilities and understanding of the staff. The SARS outbreak focused our attention on the safety aspects of common mundane tasks, such as decapping blood tubes. Laboratories often claim they follow certain practices but casual observation does not always support these claims. Guidelines differed and created uncertainty. This was stressful for laboratory staff held accountable for their implementation. Attempts to categorise risks and their management into neatly wrapped parcels are attractive, but closer inspection reveals a subjective element that allows doubt to creep in with varying interpretations of the literature. Staff most at risk were those handling respiratory samples. Staff receiving samples via pneumatic tubes had least control over their exposure and were potentially exposed to aerosols from leaking samples. Risk assessment remains a balance between cost and benefit.

Guidelines to Language Teaching in Classroom and Laboratory.

ERIC Educational Resources Information Center

Iodice, Don R.

Guidelines for evaluating, establishing, and administrating classroom and laboratory language programs are offered in this report. Attention is focused on the language laboratory, with sections on its use, scheduling, materials and texts, preparation of audio materials, preparation of tests, supervision, discipline, and maintenance. Briefer…

[Team approaches to critical bleeding (massive bleeding and transfusion) - chairmen's introductory remarks. Questionnaire survey on current status of hospital clinical laboratories evaluating critical hemorrhage].

PubMed

Kino, Shuichi; Suwabe, Akira

2014-12-01

In 2007, "the Guidelines for Actions against Intraoperative Critical Hemorrhage" were established by the Japanese Society of Anaesthesiologists and the Japanese Society of Blood transfusion and Cell Therapy. The documentation of in-hospital procedures for critical hemorrhage, especially about how to select RBC units, has widely standardized hospital practice. Patients with intraoperative critical hemorrhage sometimes suffer from massive blood loss. In this situation, some patients develop coagulopathy. To treat them, we need to evaluate their coagulation status based on laboratory test results. So, we performed a nationwide questionnaire survey on the current status of hospital clinical laboratories evaluating critical hemorrhage. From the results of this survey, it was recommended that central hospital laboratories should try to reduce the turn-around time required to test for coagulation parameters as much as possible for appropriate substitution therapy. (Review).

Clonality Testing in Veterinary Medicine: A Review With Diagnostic Guidelines.

PubMed

Keller, S M; Vernau, W; Moore, P F

2016-07-01

The accurate distinction of reactive and neoplastic lymphoid proliferations can present challenges. Given the different prognoses and treatment strategies, a correct diagnosis is crucial. Molecular clonality assays assess rearranged lymphocyte antigen receptor gene diversity and can help differentiate reactive from neoplastic lymphoid proliferations. Molecular clonality assays are commonly used to assess atypical, mixed, or mature lymphoid proliferations; small tissue fragments that lack architecture; and fluid samples. In addition, clonality testing can be utilized to track neoplastic clones over time or across anatomic sites. Molecular clonality assays are not stand-alone tests but useful adjuncts that follow clinical, morphologic, and immunophenotypic assessment. Even though clonality testing provides valuable information in a variety of situations, the complexities and pitfalls of this method, as well as its dependency on the experience of the interpreter, are often understated. In addition, a lack of standardized terminology, laboratory practices, and interpretational guidelines hinders the reproducibility of clonality testing across laboratories in veterinary medicine. The objectives of this review are twofold. First, the review is intended to familiarize the diagnostic pathologist or interested clinician with the concepts, potential pitfalls, and limitations of clonality testing. Second, the review strives to provide a basis for future harmonization of clonality testing in veterinary medicine by providing diagnostic guidelines. © The Author(s) 2016.

[Progress in methodological characteristics of clinical practice guideline for osteoarthritis].

PubMed

Xing, D; Wang, B; Lin, J H

2017-06-01

At present, several clinical practice guidelines for the treatment of osteoarthritis have been developed by institutes or societies. The ultimate purpose of developing clinical practice guidelines is to formulate the process in the treatment of osteoarthritis effectively. However, the methodologies used in developing clinical practice guidelines may place an influence on the transformation and application of that in treating osteoarthritis. The present study summarized the methodological features of individual clinical practice guideline and presented the tools for quality evaluation of clinical practice guideline. The limitations of current osteoarthritis guidelines of China are also indicated. The review article might help relevant institutions improve the quality in developing guide and clinical transformation.

Crafting practice guidelines in the world of evidence-based medicine.

PubMed

Chung, Kevin C; Shauver, Melissa J

2009-10-01

In the era of exponential increase in the medical literature, physicians and health policy-makers are relying on well-constructed, evidence-based practice guidelines to help ensure that the care given to patients is based on valid, scientific data. The construction of practice guidelines, however, may not always adhere to accepted research protocol. In this article, the authors detail the steps required to produce effective, evidence-based practice guidelines. The seven essential steps in crafting a practice guideline are presented: (1) defining a topic, (2) selecting a work group, (3) performing a literature review, (4) writing the guideline, (5) peer review, (6) making plans for review and revision, and (7) dissemination. Given the importance of practice guidelines in supporting everyday practice, this article strives to provide a practical guide in the development of this key component of evidence-based medicine.

ASVCP quality assurance guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories.

PubMed

Camus, Melinda S; Flatland, Bente; Freeman, Kathleen P; Cruz Cardona, Janice A

2015-12-01

The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included. © 2015 American Society for Veterinary Clinical Pathology.

Quality in the pharmaceutical industry – A literature review

PubMed Central

Haleem, Reham M.; Salem, Maissa Y.; Fatahallah, Faten A.; Abdelfattah, Laila E.

2013-01-01

Objectives The aim of this study is to:a.Highlight the most important guidelines and practices of quality in the pharmaceutical industry.b.Organize such guidelines and practices to create a guide to pave the way for other researchers who would like to dig deeper into these guidelines and practices. Design A review was conducted of 102 publications; 56 publications were concerned with the pharmaceutical quality directly while 46 publications were concerned with the general quality practices. The content of those sources was analyzed and the following themes were identified:a.Research theme 1: Guidelines of the pharmaceutical quality.b.Research theme 2: General practices recently applied in the pharmaceutical industry. Main outcome measures The following guidelines were identified and reviewed: WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines in the research theme I. In research theme II; the following topics were identified and reviewed: quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, ISO series and HACCP. Results Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, it was noticed that there is an abundant number of papers and articles that explain the general guidelines and practices but the literature lack those describing application; case studies of the pharmaceutical factories applying those guidelines and significance of those guidelines and practices. Conclusions It is recommended that the literature would invest more in the area of application and significance of guidelines and practices. New case studies should be done to prove the feasibility of such practices. PMID:26594110

Implementation of national comprehensive cancer network evidence-based guidelines to prevent and treat cancer-related infections.

PubMed

Wood, Sylvia K; Payne, Judith K

2012-06-01

Clinical practice guidelines are an important result of evidence-based research. However, current clinical practice remains out of step with the rapid pace of research advancements. Often, decades pass before research is translated into clinical practice. The National Comprehensive Cancer Network (NCCN) has created evidence-based clinical guidelines to promote effective clinical practice. Formerly, the NCCN established guidelines to reduce cancer-related infections only for neutropenic patients; however, they have expanded their guidelines beyond neutropenia to prevent and treat cancer-related infections. Implementing scientific evidence into clinical practice is challenging and complex, and healthcare professionals should understand barriers to implementing clinical practice guidelines to ensure successful translation into practice. This article provides a brief review of NCCN guidelines and describes common barriers encountered during implementation. In addition, a conceptual framework is offered to help identify and address potential concerns before and after adoption of guidelines.

Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

Krleza, Jasna Lenicek; Dorotic, Adrijana; Grzunov, Ana; Maradin, Miljenka

2015-01-01

Capillary blood sampling is a medical procedure aimed at assisting in patient diagnosis, management and treatment, and is increasingly used worldwide, in part because of the increasing availability of point-of-care testing. It is also frequently used to obtain small blood volumes for laboratory testing because it minimizes pain. The capillary blood sampling procedure can influence the quality of the sample as well as the accuracy of test results, highlighting the need for immediate, widespread standardization. A recent nationwide survey of policies and practices related to capillary blood sampling in medical laboratories in Croatia has shown that capillary sampling procedures are not standardized and that only a small proportion of Croatian laboratories comply with guidelines from the Clinical Laboratory Standards Institute (CLSI) or the World Health Organization (WHO). The aim of this document is to provide recommendations for capillary blood sampling. This document has been produced by the Working Group for Capillary Blood Sampling within the Croatian Society of Medical Biochemistry and Laboratory Medicine. Our recommendations are based on existing available standards and recommendations (WHO Best Practices in Phlebotomy, CLSI GP42-A6 and CLSI C46-A2), which have been modified based on local logistical, cultural, legal and regulatory requirements. We hope that these recommendations will be a useful contribution to the standardization of capillary blood sampling in Croatia. PMID:26524965

Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Krleza, Jasna Lenicek; Dorotic, Adrijana; Grzunov, Ana; Maradin, Miljenka

2015-01-01

Capillary blood sampling is a medical procedure aimed at assisting in patient diagnosis, management and treatment, and is increasingly used worldwide, in part because of the increasing availability of point-of-care testing. It is also frequently used to obtain small blood volumes for laboratory testing because it minimizes pain. The capillary blood sampling procedure can influence the quality of the sample as well as the accuracy of test results, highlighting the need for immediate, widespread standardization. A recent nationwide survey of policies and practices related to capillary blood sampling in medical laboratories in Croatia has shown that capillary sampling procedures are not standardized and that only a small proportion of Croatian laboratories comply with guidelines from the Clinical Laboratory Standards Institute (CLSI) or the World Health Organization (WHO). The aim of this document is to provide recommendations for capillary blood sampling. This document has been produced by the Working Group for Capillary Blood Sampling within the Croatian Society of Medical Biochemistry and Laboratory Medicine. Our recommendations are based on existing available standards and recommendations (WHO Best Practices in Phlebotomy, CLSI GP42-A6 and CLSI C46-A2), which have been modified based on local logistical, cultural, legal and regulatory requirements. We hope that these recommendations will be a useful contribution to the standardization of capillary blood sampling in Croatia.

Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials.

PubMed

Coecke, Sandra; Bernasconi, Camilla; Bowe, Gerard; Bostroem, Ann-Charlotte; Burton, Julien; Cole, Thomas; Fortaner, Salvador; Gouliarmou, Varvara; Gray, Andrew; Griesinger, Claudius; Louhimies, Susanna; Gyves, Emilio Mendoza-de; Joossens, Elisabeth; Prinz, Maurits-Jan; Milcamps, Anne; Parissis, Nicholaos; Wilk-Zasadna, Iwona; Barroso, João; Desprez, Bertrand; Langezaal, Ingrid; Liska, Roman; Morath, Siegfried; Reina, Vittorio; Zorzoli, Chiara; Zuang, Valérie

This chapter focuses on practical aspects of conducting prospective in vitro validation studies, and in particular, by laboratories that are members of the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) that is coordinated by the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). Prospective validation studies involving EU-NETVAL, comprising a multi-study trial involving several laboratories or "test facilities", typically consist of two main steps: (1) the design of the validation study by EURL ECVAM and (2) the execution of the multi-study trial by a number of qualified laboratories within EU-NETVAL, coordinated and supported by EURL ECVAM. The approach adopted in the conduct of these validation studies adheres to the principles described in the OECD Guidance Document on the Validation and International Acceptance of new or updated test methods for Hazard Assessment No. 34 (OECD 2005). The context and scope of conducting prospective in vitro validation studies is dealt with in Chap. 4 . Here we focus mainly on the processes followed to carry out a prospective validation of in vitro methods involving different laboratories with the ultimate aim of generating a dataset that can support a decision in relation to the possible development of an international test guideline (e.g. by the OECD) or the establishment of performance standards.

75 FR 62842 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-13

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were... and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen...

Critical factors influencing physicians' intention to use computerized clinical practice guidelines: an integrative model of activity theory and the technology acceptance model.

PubMed

Hsiao, Ju-Ling; Chen, Rai-Fu

2016-01-16

With the widespread use of information communication technologies, computerized clinical practice guidelines are developed and considered as effective decision supporting tools in assisting the processes of clinical activities. However, the development of computerized clinical practice guidelines in Taiwan is still at the early stage and acceptance level among major users (physicians) of computerized clinical practice guidelines is not satisfactory. This study aims to investigate critical factors influencing physicians' intention to computerized clinical practice guideline use through an integrative model of activity theory and the technology acceptance model. The survey methodology was employed to collect data from physicians of the investigated hospitals that have implemented computerized clinical practice guidelines. A total of 505 questionnaires were sent out, with 238 completed copies returned, indicating a valid response rate of 47.1 %. The collected data was then analyzed by structural equation modeling technique. The results showed that attitudes toward using computerized clinical practice guidelines (γ = 0.451, p < 0.001), organizational support (γ = 0.285, p < 0.001), perceived usefulness of computerized clinical practice guidelines (γ = 0.219, p < 0.05), and social influence (γ = 0.213, p < 0.05) were critical factors influencing physicians' intention to use computerized clinical practice guidelines, and these factors can explain 68.6 % of the variance in intention to use computerized clinical practice guidelines. This study confirmed that some subject (human) factors, environment (organization) factors, tool (technology) factors mentioned in the activity theory should be carefully considered when introducing computerized clinical practice guidelines. Managers should pay much attention on those identified factors and provide adequate resources and incentives to help the promotion and use of computerized clinical practice guidelines. Through the appropriate use of computerized clinical practice guidelines, the clinical benefits, particularly in improving quality of care and facilitating the clinical processes, will be realized.

Evidence-based guidelines for use of probiotics in preterm neonates

PubMed Central

2011-01-01

Background Current evidence indicates that probiotic supplementation significantly reduces all-cause mortality and definite necrotising enterocolitis without significant adverse effects in preterm neonates. As the debate about the pros and cons of routine probiotic supplementation continues, many institutions are satisfied with the current evidence and wish to use probiotics routinely. Because of the lack of detail on many practical aspects of probiotic supplementation, clinician-friendly guidelines are urgently needed to optimise use of probiotics in preterm neonates. Aim To develop evidence-based guidelines for probiotic supplementation in preterm neonates. Methods To develop core guidelines on use of probiotics, including strain selection, dose and duration of supplementation, we primarily used the data from our recent updated systematic review of randomised controlled trials. For equally important issues including strain identification, monitoring for adverse effects, product format, storage and transport, and regulatory hurdles, a comprehensive literature search, covering the period 1966-2010 without restriction on the study design, was conducted, using the databases PubMed and EMBASE, and the proceedings of scientific conferences; these data were used in our updated systematic review. Results In this review, we present guidelines, including level of evidence, for the practical aspects (for example, strain selection, dose, duration, clinical and laboratory surveillance) of probiotic supplementation, and for dealing with non-clinical but important issues (for example, regulatory requirements, product format). Evidence was inadequate in some areas, and these should be a target for further research. Conclusion We hope that these evidence-based guidelines will help to optimise the use of probiotics in preterm neonates. Continued research is essential to provide answers to the current gaps in knowledge about probiotics. PMID:21806843

Daily Laboratory Monitoring is of Poor Health Care Value in Adolescents Acutely Hospitalized for Eating Disorders.

PubMed

Ridout, Kathryn K; Kole, Jonathan; Fitzgerald, Kelly L; Ridout, Samuel J; Donaldson, Abigail A; Alverson, Brian

2016-07-01

This study investigates how the clinical practice guideline-recommended laboratory monitoring for refeeding syndrome impacts management and outcomes of adolescents with eating disorders hospitalized for acute medical stabilization and examines the value of laboratory monitoring (defined as the patient health outcomes achieved per dollar spent). A retrospective chart review of medical admissions in a children's hospital between October 2010 and February 2014 was performed. Encounters were identified using International Classification of Diseases, Ninth Revision codes of eating disorders as primary or secondary diagnoses. Exclusion criteria included systemic diseases associated with significant electrolyte abnormalities. Chart abstraction was performed using a predetermined form. Costs were estimated by converting hospital-fixed Medicaid charges using a statewide cost-to-charge ratio. Of the 196 patient encounters, there were no cases of refeeding syndrome. A total of 3,960 key recommended laboratories were obtained; 1.9% were below normal range and .05% were critical values. Of these, .28% resulted in supplementation; none were associated with a change in inpatient management. Total laboratory costs were $269,250.85; the calculated health care value of this monitoring is 1.04 × 10(-8) differential outcomes per dollar spent. This study provides evidence to suggest that daily laboratory monitoring for refeeding syndrome is a poor health care value in the management of adolescents hospitalized for acute medical stabilization with eating disorders. This initial analysis suggests that starting at a relatively low caloric level and advancing nutrition slowly may negate the need for daily laboratory assessment, which may have important implications for current guidelines. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

A pan-Canadian practice guideline and algorithm: screening, assessment, and supportive care of adults with cancer-related fatigue

PubMed Central

Howell, D.; Keller–Olaman, S.; Oliver, T.K.; Hack, T.F.; Broadfield, L.; Biggs, K.; Chung, J.; Gravelle, D.; Green, E.; Hamel, M.; Harth, T.; Johnston, P.; McLeod, D.; Swinton, N.; Syme, A.; Olson, K.

2013-01-01

Purpose The purpose of the present systematic review was to develop a practice guideline to inform health care providers about screening, assessment, and effective management of cancer-related fatigue (crf) in adults. Methods The internationally endorsed adapte methodology was used to develop a practice guideline for pan-Canadian use. A systematic search of the literature identified a broad range of evidence: clinical practice guidelines, systematic reviews, and other guidance documents on the screening, assessment, and management of crf. The search included medline, embase, cinahl, the Cochrane Library, and other guideline and data sources to December 2009. Results Two clinical practice guidelines were identified for adaptation. Seven guidance documents and four systematic reviews also provided supplementary evidence to inform guideline recommendations. Health professionals across Canada provided expert feedback on the adapted recommendations in the practice guideline and algorithm through a participatory external review process. Conclusions Practice guidelines can facilitate the adoption of evidence-based assessment and interventions for adult cancer patients experiencing fatigue. Development of an algorithm to guide decision-making in practice may also foster the uptake of a guideline into routine care. PMID:23737693

Practical guidelines for familial combined hyperlipidemia diagnosis: an up-date

PubMed Central

Gaddi, Antonio; Cicero, AFG; Odoo, FO; Poli A, A; Paoletti, R

2007-01-01

Familial combined hyperlidemia (FCH) is a common metabolic disorder characterized by: (a) increase in cholesterolemia and/or triglyceridemia in at least two members of the same family, (b) intra-individual and intrafamilial variability of the lipid phenotype, and (c) increased risk of premature coronary heart disease (CHD). FCH is very frequent and is one of the most common genetic hyperlipidemias in the general population (prevalence estimated: 0.5%–2.0%), being the most frequent in patients affected by CHD (10%) and among acute myocardial infarction survivors aged less than 60 (11.3%). This percentage increases to 40% when all the myocardial infarction survivors are considered without age limits. However, because of the peculiar variability of laboratory parameters, and because of the frequent overlapping with the features of metabolic syndrome, this serious disease is often not recognized and treated. The aim of this review is to define the main characteristics of the disease in order to simplify its detection and early treatment by all physicians by mean of practical guidelines. PMID:18200807

Practical guidelines for familial combined hyperlipidemia diagnosis: an up-date.

PubMed

Gaddi, Antonio; Cicero, A F G; Odoo, F O; Poli, A A; Paoletti, R

2007-01-01

Familial combined hyperlidemia (FCH) is a common metabolic disorder characterized by: (a) increase in cholesterolemia and/or triglyceridemia in at least two members of the same family, (b) intra-individual and intrafamilial variability of the lipid phenotype, and (c) increased risk of premature coronary heart disease (CHD). FCH is very frequent and is one of the most common genetic hyperlipidemias in the general population (prevalence estimated: 0.5%-2.0%), being the most frequent in patients affected by CHD (10%) and among acute myocardial infarction survivors aged less than 60 (11.3%). This percentage increases to 40% when all the myocardial infarction survivors are considered without age limits. However, because of the peculiar variability of laboratory parameters, and because of the frequent overlapping with the features of metabolic syndrome, this serious disease is often not recognized and treated. The aim of this review is to define the main characteristics of the disease in order to simplify its detection and early treatment by all physicians by mean of practical guidelines.

IPEM guidelines on dosimeter systems for use as transfer instruments between the UK primary dosimetry standards laboratory (NPL) and radiotherapy centres1

NASA Astrophysics Data System (ADS)

Morgan, A. M.; Aird, E. G. A.; Aukett, R. J.; Duane, S.; Jenkins, N. H.; Mayles, W. P. M.; Moretti, C.; Thwaites, D. I.

2000-09-01

United Kingdom dosimetry codes of practice have traditionally specified one electrometer for use as a secondary standard, namely the Nuclear Enterprises (NE) 2560 NPL secondary standard therapy level exposure meter. The NE2560 will become obsolete in the foreseeable future. This report provides guidelines to assist physicists following the United Kingdom dosimetry codes of practice in the selection of an electrometer to replace the NE2560 when necessary. Using an internationally accepted standard (BS EN 60731:1997) as a basis, estimated error analyses demonstrate that the uncertainty (one standard deviation) in a charge measurement associated with the NE2560 alone is approximately 0.3% under specified conditions. Following a review of manufacturers' literature, it is considered that modern electrometers should be capable of equalling this performance. Additional constructural and operational requirements not specified in the international standard but considered essential in a modern electrometer to be used as a secondary standard are presented.

Care Model Design for E-Health: Integration of Point-of-Care Testing at Dutch General Practices.

PubMed

Verhees, Bart; van Kuijk, Kees; Simonse, Lianne

2017-12-21

Point-of-care testing (POCT)-laboratory tests performed with new mobile devices and online technologies outside of the central laboratory-is rapidly outpacing the traditional laboratory test market, growing at a rate of 12 to 15% each year. POCT impacts the diagnostic process of care providers by yielding high efficiency benefits in terms of turnaround time and related quality improvements in the reduction of errors. However, the implementation of this disruptive eHealth technology requires the integration and transformation of diagnostic services across the boundaries of healthcare organizations. Research has revealed both advantages and barriers of POCT implementations, yet to date, there is no business model for the integration of POCT within general practice. The aim of this article is to contribute with a design for a care model that enables the integration of POCT in primary healthcare. In this research, we used a design modelling toolkit for data collection at five general practices. Through an iterative design process, we modelled the actors and value transactions, and designed an optimized care model for the dynamic integration of POCTs into the GP's network of care delivery. The care model design will have a direct bearing on improving the integration of POCT through the connectivity and norm guidelines between the general practice, the POC technology, and the diagnostic centre.

[The experimental surgery and your relation with the university: an experience report].

PubMed

Yamaki, Vitor Nagai; Teixeira, Renan Kleber Costa; Feijo, Daniel Haber; Silva, José Antonio Cordero da; Botelho, Nara Macedo; Henriques, Marcus Vinicius

2014-01-01

The laboratory of experimental surgery represents one of the key points for the university, especially in the biomedical area. This focuses on the university's tripod of primary structure that are teaching, research and extension, which are essential for formation of humanistic and practice of a good doctor that is based, first of all, on scientific evidence and critical knowledge. The importance of a laboratory of experimental surgery centers for medical education was regulated from the new curriculum guidelines of the Ministério da Educação e Cultura, establishing a mandatory laboratory within college centers. Therefore, it is of great importance to the contribution of the laboratories of experimental surgery in the curriculum, both in the discipline of surgical technics and experimental surgery, and an incentive for basic research. Thus, the study presents the experience of 15 years of the Laboratory of Experimental Surgery from Universidade do Estado do Pará, with the goal show the importance of this to medical graduation and the university.

Challenges in Transgender Healthcare: The Pathology Perspective

PubMed Central

Gupta, Sarika; Imborek, Katherine L.; Krasowski, Matthew D.

2016-01-01

Background: The transgender community is one of the most marginalized sections of our society. The literature is scarce regarding the pathology and laboratory medicine challenges associated with caring for transgender patients. Objective: To summarize the available gender-transitioning options and to discuss healthcare challenges, from a pathology/laboratory medicine perspective, in the care of transgender patients. Method: We reviewed the current terminology and epidemiology relevant to the transgender population in preparing our analysis. Conclusions: The main transgender healthcare challenges in pathology/laboratory medicine practice include the inflexibility of electronic medical records in documenting affirmed gender, unfamiliarity among medical and laboratory professional with the needs of and terminology related to the transgender population, lack of reference ranges for laboratory tests, unclear guidelines regarding gender classification for blood donation eligibility criteria, and paucity of experience in handling and interpreting surgical and cytologic specimens from gender-transitioning individuals. Directed efforts to overcome these shortcomings, coupled with a more welcoming posture, are essential to achieving the highest standards of care for the transgender population. PMID:27287942

[New methodological approaches to the detection and quantitative registration of Salmonella in the study of water objects].

PubMed

Aleshnia, V V; Panasovets, O P; Zhuravlev, P V; Sukhanova, S M; Golubenko, I A; Nedachin, A E; Talaeva, Iu G; Artemova, T Z; Gipp, E K; Butorina, N N; Zagaĭnova, A V; Shvager, M M; Mitrofanova, T V

2011-01-01

The paper gives data on the use of techniques to detect and register Salmonella in the water objects, by applying a new liquid nutrient medium. Experimental and field studies have shown its advantage over the accumulation media widely used in practical healthcare. It has been ascertained that the nutrient medium not only accumulates biomass, but also provides the restoration of the biological properties of uncultivated Salmonella species. The use of the nutrient medium at practical laboratories makes it possible to unify guidelines for the examination of water objects with varying degrees of biological pollution and to obtain the comparable results of analyses.

Diagnosis of Acute Gout: A Clinical Practice Guideline From the American College of Physicians.

PubMed

Qaseem, Amir; McLean, Robert M; Starkey, Melissa; Forciea, Mary Ann

2017-01-03

The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the diagnosis of gout. This guideline is based on a systematic review of published studies on gout diagnosis, identified using several databases, from database inception to February 2016. Evaluated outcomes included the accuracy of the test results; intermediate outcomes (results of laboratory and radiographic tests, such as serum urate and synovial fluid crystal analysis and radiographic or ultrasonography changes); clinical decision making (additional testing and pharmacologic or dietary management); short-term clinical (patient-centered) outcomes, such as pain and joint swelling and tenderness; and adverse effects of the tests. This guideline grades the evidence and recommendations by using the ACP grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. The target audience for this guideline includes all clinicians, and the target patient population includes adults with joint inflammation suspected to be gout. ACP recommends that clinicians use synovial fluid analysis when clinical judgment indicates that diagnostic testing is necessary in patients with possible acute gout. (Grade: weak recommendation, low-quality evidence).

Guide to data collection

NASA Technical Reports Server (NTRS)

1981-01-01

Guidelines and recommendations are presented for the collection of software development data. Motivation and planning for, and implementation and management of, a data collection effort are discussed. Topics covered include types, sources, and availability of data; methods and costs of data collection; types of analyses supported; and warnings and suggestions based on software engineering laboratory (SEL) experiences. This document is intended as a practical guide for software managers and engineers, abstracted and generalized from 5 years of SEL data collection.

Technical standards and guidelines: molecular genetic testing for ultra-rare disorders.

PubMed

Maddalena, Anne; Bale, Sherri; Das, Soma; Grody, Wayne; Richards, Sue

2005-10-01

These standards and guidelines are designed primarily as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These standards and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the clinical molecular geneticist should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the laboratory record the rationale for any significant deviation from these standards and guidelines.

Pressure Ulcers in Adults: Prediction and Prevention. Clinical Practice Guideline Number 3.

ERIC Educational Resources Information Center

Agency for Health Care Policy and Research (DHHS/PHS), Rockville, MD.

This package includes a clinical practice guideline, quick reference guide for clinicians, and patient's guide to predicting and preventing pressure ulcers in adults. The clinical practice guideline includes the following: overview of the incidence and prevalence of pressure ulcers; clinical practice guideline (introduction, risk assessment tools…

Clinical practice guidelines and consensus statements in oncology--an assessment of their methodological quality.

PubMed

Jacobs, Carmel; Graham, Ian D; Makarski, Julie; Chassé, Michaël; Fergusson, Dean; Hutton, Brian; Clemons, Mark

2014-01-01

Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than the others over both domains. No journals adhered to all the items related to the transparency of document development. One journal's consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases. Guidance documents are an essential part of oncology care and should be subjected to a rigorous and validated development process. Consensus statements had lower methodological quality than clinical practice guidelines using AGREE II. At a minimum, journals should ensure that that all consensus statements and clinical practice guidelines adhere to AGREE II criteria. Journals should consider explicitly requiring guidelines to declare pharmaceutical company sponsorship and to identify the sponsor's product to enhance transparency.

World Association for the Advancement of Veterinary Parasitology (W.A.A.V.P.) second edition: guidelines for evaluating the efficacy of parasiticides for the treatment, prevention and control of flea and tick infestations on dogs and cats.

PubMed

Marchiondo, A A; Holdsworth, P A; Fourie, L J; Rugg, D; Hellmann, K; Snyder, D E; Dryden, M W

2013-05-01

These second edition guidelines, updated from the 2007 version (Marchiondo et al., 2007), are intended to assist the planning and conduct of laboratory and clinical studies to assess the efficacy of ectoparasiticides applied to dogs or cats for the purpose of treating, preventing and controlling flea and tick infestations. Major revisions to this second edition include guidelines on the assessment of systemic flea and tick products, an update of the geographical distribution of the common fleas and ticks species on dogs and cats, determination of flea and tick efficacy based on geometric versus arithmetic means with respect to geographic regulatory agencies, modification of tick categorization in the assessment of efficacy, expanded guidelines on repellency and anti-feeding effects, enhanced practical field study guidance, and considerations on the ranges of flea and ticks for infestations in laboratory studies. The term ectoparasiticide includes insecticidal and acaricidal compounds, as well as insect growth regulators. The range of biological activities from animal treatment that are considered include: repellency and anti-feeding effects, knockdown, speed of kill, immediate and persistent lethal effects, and interference with egg fertility and subsequent development of off-host life cycle stages. Information is provided on the selection of animals, dose determination, dose confirmation and field studies, record keeping, interpretation of results and animal welfare. These guidelines are also intended to assist regulatory authorities involved in the approval and registration of new topical or systemic ectoparasiticides, and to facilitate the worldwide adoption of harmonized procedures.

A patient-based study on the adherence of physicians to guidelines for the management of type 2 diabetes in Turkey.

PubMed

Satman, Ilhan; Imamoglu, Sazi; Yilmaz, Candeger

2012-10-01

To evaluate physicians' adherence to guidelines by Diabetes Study Group of The Society of Endocrinology and Metabolism of Turkey (SEMT). The medical records of 1790 patients with type 2 diabetes (mean age, 58.7 ± 10.9 years; diabetes duration, 7.7 ± 7.5 years) followed by 180 physicians during last 12 months were reviewed. Adherence to SEMT guidelines was analysed under medical history, physical examination and laboratory evaluations subheadings, each scored on a 10-point scale. Effects of patients' age, gender, diabetes duration, body mass index, chronic complications, physicians' specialty and institution on guideline adherence were evaluated. Follow-up procedures were >75% compliant for 52% of patients. Full adherence to medical history, physical examination and laboratory aspects of SEMT guidelines were met in 68.6%, 8.3% and 19.2% of patients, respectively. Older patients and males fared better for laboratory evaluations. All aspects of guideline adherence were poor in patients with short duration of diabetes and in the absence of chronic complications. State institutions and family practitioners had lower adherence scores for physical examination and laboratory evaluation. Overall guideline adherence of physicians was suboptimal. Educational programs emphasizing the preventive aspect of diabetes management, targeted towards family practitioners and state institutions, may improve guideline adherence and patient outcome. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Adherence to Clinical Practice Guidelines (CPG) management of dengue infection in adults (revised 2nd edition)

PubMed Central

Suli, Zailiza; Singh Gill, Balvinder; Rudra Deva, Shanti; Abdullah Sani, Ana Fizalinda; Romli, Erni Zurina; Mohamed Ghazali, Izzuna Mudla; Mohd. Yusof, Mohd. Aminuddin; Ahmad Lutfi, Nafisah; Shuib, Shahril Effendi; Mohd Darus, Noormah; Bakri, Rugayah

2017-01-01

The Malaysian Dengue Clinical Practice Guidelines (CPG) have been developed to provide evidence-based guidance in the management of dengue infections. The use of these guidelines is essential to ensure its recommendations are being practiced. However, the adherence to the guidelines for management of dengue (revised 2nd edition) by healthcare providers still remains unknown. Therefore, the aim of this study was to evaluate the proportion among healthcare providers that adhere to this Dengue CPG. A retrospective cohort study of dengue cases registered from 1 January 2014 to 1 June 2015 was conducted in public hospitals and health clinics in Selangor, Putrajaya and Kuala Lumpur. Adherence to the CPG recommendations were recorded by reviewing patients’ case notes. Overall proportion of adherence in clinical components of the recommendation were (7.1 to 100.0% versus 7.7 to 73.8%) in history taking, (6.7 to 100.0% versus 12.3 to 60.0%) in physical examinations, (18.4 to 100.0% versus 23.1 to 83.2%) in assessment of warning signs, (0.6 to 100.0% versus 12.3 to 87.7%) in assessment of haemodynamic status, (60.0 to 100.0% versus 27.7 to 40.0%) in diagnosis, (46.6 to 80.0% versus 52.3%) in case notifications, (73.2 to 100.0% versus 89.2 to 96.9%) in performing specific laboratory investigations and (7.9 to 100.0% versus 21.5%) in monitoring, for outpatient versus inpatient, respectively. Adherence trends were demonstrated to be higher in hospital settings compared to outpatient settings. Adherence to this Dengue CPG varies widely with overall good clinical outcomes observed. PMID:29095822

75 FR 39023 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

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Translating knowledge into best practice care bundles: a pragmatic strategy for EBP implementation via moving postprocedural pain management nursing guidelines into clinical practice.

PubMed

Saunders, Hannele

2015-07-01

To describe quantitative and qualitative best evidence as sources for practical interventions usable in daily care delivery in order to integrate best evidence into clinical decision-making at local practice settings. To illustrate the development, implementation and evaluation of a pain management nursing care bundle based on a clinical practice guideline via a real-world clinical exemplar. Successful implementation of evidence-based practice requires consistent integration of best evidence into daily clinical decision-making. Best evidence comprises high-quality knowledge summarised in systematic reviews and translated into guidelines. However, consistent integration of guidelines into care delivery remains challenging, partly due to guidelines not being in a usable form for daily practice or relevant for the local context. A position paper with a clinical exemplar of a nurse-led, evidence-based quality improvement project to design, implement and evaluate a pain management care bundle translated from a national nursing guideline. A pragmatic approach to integrating guidelines into daily practice is presented. Best evidence from a national nursing guideline was translated into a pain management care bundle and integrated into daily practice in 15 medical-surgical (med-surg) units of nine hospitals of a large university hospital system in Finland. Translation of best evidence from guidelines into usable form as care bundles adapted to the local setting may increase implementation and uptake of guidelines and improve quality and consistency of care delivery. A pragmatic approach to translating a nursing guideline into a pain management care bundle to incorporate best evidence into daily practice may help achieve more consistent and equitable integration of guidelines into care delivery, and better quality of pain management and patient outcomes. © 2015 John Wiley & Sons Ltd.

Use of clinical practice guidelines by dentists: findings from the Japanese dental practice-based research network.

PubMed

Kakudate, Naoki; Yokoyama, Yoko; Sumida, Futoshi; Matsumoto, Yuki; Gordan, Valeria V; Gilbert, Gregg H

2017-02-01

The objectives of this study were to: (1) examine differences in the use of dental clinical practice guidelines among Japanese dentists, and (2) identify characteristics associated with the number of guidelines used by participating dentists. We conducted a cross-sectional study consisting of a questionnaire survey in Japan between July 2014 and May 2015. The study queried dentists working in outpatient dental practices who are affiliated with the Dental Practice-Based Research Network Japan (n = 148). They were asked whether they have used each of 15 Japanese dental clinical guidelines. Associations between the number of guidelines used by participants and specific characteristics were analysed via negative binomial regression analysis. The mean number of guidelines used by participating dentists was 2.5 ± 2.9 [standard deviation (SD)]. Rate of use of guidelines showed substantial variation, from 5% to 34% among dentists. The proportion of dentists that used guidelines was the highest among oral medicine specialists, who had the highest proportion for 10 of 15 guidelines. Negative binomial regression analysis identified three factors significantly associated with the number of guidelines used: 'years since graduation from dental school', 'specialty practice' and 'practice busyness'. These results suggest that the use of clinical practice guidelines by Japanese dentists may still be inadequate. Training in the use of the guidelines could be given to dental students as undergraduate education and to young clinicians as continuing education. © 2016 John Wiley & Sons, Ltd.

Computerized provider order entry in the clinical laboratory

PubMed Central

Baron, Jason M.; Dighe, Anand S.

2011-01-01

Clinicians have traditionally ordered laboratory tests using paper-based orders and requisitions. However, paper orders are becoming increasingly incompatible with the complexities, challenges, and resource constraints of our modern healthcare systems and are being replaced by electronic order entry systems. Electronic systems that allow direct provider input of diagnostic testing or medication orders into a computer system are known as Computerized Provider Order Entry (CPOE) systems. Adoption of laboratory CPOE systems may offer institutions many benefits, including reduced test turnaround time, improved test utilization, and better adherence to practice guidelines. In this review, we outline the functionality of various CPOE implementations, review the reported benefits, and discuss strategies for using CPOE to improve the test ordering process. Further, we discuss barriers to the implementation of CPOE systems that have prevented their more widespread adoption. PMID:21886891

Laboratory diagnosis of creatine deficiency syndromes: a technical standard and guideline of the American College of Medical Genetics and Genomics.

PubMed

Sharer, J Daniel; Bodamer, Olaf; Longo, Nicola; Tortorelli, Silvia; Wamelink, Mirjam M C; Young, Sarah

2017-02-01

Disclaimer: These ACMG Standards and Guidelines are intended as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines is voluntary and does not necessarily assure a successful medical outcome. These Standards and Guidelines should not be considered inclusive of all proper procedures and tests or exclusive of others that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, clinical laboratory geneticists should apply their professional judgment to the specific circumstances presented by the patient or specimen. Clinical laboratory geneticists are encouraged to document in the patient's record the rationale for the use of a particular procedure or test, whether or not it is in conformance with these Standards and Guidelines. They also are advised to take notice of the date any particular guideline was adopted, and to consider other relevant medical and scientific information that becomes available after that date. It also would be prudent to consider whether intellectual property interests may restrict the performance of certain tests and other procedures.Cerebral creatine deficiency syndromes are neurometabolic conditions characterized by intellectual disability, seizures, speech delay, and behavioral abnormalities. Several laboratory methods are available for preliminary and confirmatory diagnosis of these conditions, including measurement of creatine and related metabolites in biofluids using liquid chromatography-tandem mass spectrometry or gas chromatography-mass spectrometry, enzyme activity assays in cultured cells, and DNA sequence analysis. These guidelines are intended to standardize these procedures to help optimize the diagnosis of creatine deficiency syndromes. While biochemical methods are emphasized, considerations for confirmatory molecular testing are also discussed, along with variables that influence test results and interpretation.Genet Med 19 2, 256-263.

Practice guidelines need to address the 'how' and the 'what' of implementation.

PubMed

McKillop, Ann; Crisp, Jackie; Walsh, Kenneth

2012-01-01

The aim of this study was to explore the realities of everyday nursing practice associated with the implementation of a guideline for the assessment and management of cardiovascular risk. The use of clinical practice guidelines is pivotal to improving health outcomes. However, the implementation of guidelines into practice is complex, unpredictable and, in spite of much investigation, remains resistant to explanation of what works and why. Exploration of the nature of guideline implementation has the potential to illuminate the complexities of guideline implementation by focussing on the nature of practice. Nurses are well placed at the front line of primary health care to contribute to an understanding of how guideline implementation plays out in their everyday practice. Qualitative description was used, involving focus groups and interviews with 32 participants (20 nurses, four doctors, five managers and three funder/planners), to explore the use of a guideline in everyday primary health-care practice. Thematic analysis of data was managed through an inductive process of familiarisation, coding, categorising and generation of themes. Four themes were generated from the data portraying the realities of guideline implementation for primary health-care nurses: self-managing patient, everyday nursing practice, developing new relationships in the health team and impact on health-care delivery. The findings reveal that, even with the best of intentions to implement the guideline, health professionals were frustrated and at a loss as to how to achieve that in practice. Consequently, cardiovascular risk assessment and management was uneven and fragmented. Primary health-care practice environments vary so much that solutions to the difficulties of implementing evidence into practice requires context-specific solution-finding through collaborative teamwork. Furthermore, the attention of guideline developers, health-care policymakers, funders and researchers requires direct focus on the 'how' and the 'what' of evidence implementation.

Clinical practice guidelines in hypertension: a review.

PubMed

Álvarez-Vargas, Mayita Lizbeth; Galvez-Olortegui, José Kelvin; Galvez-Olortegui, Tomas Vladimir; Sosa-Rosado, José Manuel; Camacho-Saavedra, Luis Arturo

2015-10-23

The aim of this study is the methodological evaluation of Clinical Practice Guidelines (CPG) in hypertension. This is the first in a series of review articles, analysis, assessment in methodology and content of clinical practice guidelines in Cardiology. Of all clinical practice guidelines, three were selected and the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument was used to assess each guide. The guidelines obtained the lowest score in the domain of applicability (mean 43.8%); while the highest score was for clarity of presentation (mean 81.5%). The lowest percentage was found in the applicability domain (European guideline) and the highest of all scores was found in two domains: scope and purpose, and clarity of presentation (Canadian guideline). Assessing the quality of the clinical practice guidelines analyzed, the Canadian is one with the best scores obtained by applying the AGREE II instrument, and it is advised to be used without modifications.

Clinical Laboratory Practice Recommendations for the Use of Cardiac Troponin in Acute Coronary Syndrome: Expert Opinion from the Academy of the American Association for Clinical Chemistry and the Task Force on Clinical Applications of Cardiac Bio-Markers of the International Federation of Clinical Chemistry and Laboratory Medicine.

PubMed

Wu, Alan H B; Christenson, Robert H; Greene, Dina N; Jaffe, Allan S; Kavsak, Peter A; Ordonez-Llanos, Jordi; Apple, Fred S

2018-04-01

This document is an essential companion to the third iteration of the National Academy of Clinical Biochemistry [NACB, 8 now the American Association for Clinical Chemistry (AACC) Academy] Laboratory Medicine Practice Guidelines (LMPG) on cardiac markers. The expert consensus recommendations were drafted in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on Clinical Applications of Bio-Markers (IFCC TF-CB). We determined that there is sufficient clinical guidance on the use of cardiac troponin (cTn) testing from clinical practice groups. Thus, in this expert consensus document, we focused on clinical laboratory practice recommendations for high-sensitivity (hs)-cTn assays. This document utilized the expert opinion class of evidence to focus on the following 10 topics: ( a ) quality control (QC) utilization, ( b ) validation of the lower reportable analytical limits, ( c ) units to be used in reporting measurable concentrations for patients and QC materials, ( d ) 99th percentile sex-specific upper reference limits to define the reference interval; ( e ) criteria required to define hs-cTn assays, ( f ) communication with clinicians and the laboratory's role in educating clinicians regarding the influence of preanalytic and analytic problems that can confound assay results, ( g ) studies on hs-cTn assays and how authors need to document preanalytical and analytical variables, ( h ) harmonizing and standardizing assay results and the role of commutable materials, ( i ) time to reporting of results from sample receipt and sample collection, and ( j ) changes in hs-cTn concentrations over time and the role of both analytical and biological variabilities in interpreting results of serial blood collections. © 2017 American Association for Clinical Chemistry.

Test result communication in primary care: a survey of current practice

PubMed Central

Litchfield, Ian; Bentham, Louise; Lilford, Richard; McManus, Richard J; Hill, Ann; Greenfield, Sheila

2015-01-01

Background The number of blood tests ordered in primary care continues to increase and the timely and appropriate communication of results remains essential. However, the testing and result communication process includes a number of participants in a variety of settings and is both complicated to manage and vulnerable to human error. In the UK, guidelines for the process are absent and research in this area is surprisingly scarce; so before we can begin to address potential areas of weakness there is a need to more precisely understand the strengths and weaknesses of current systems used by general practices and testing facilities. Methods We conducted a telephone survey of practices across England to determine the methods of managing the testing and result communication process. In order to gain insight into the perspectives from staff at a large hospital laboratory we conducted paired interviews with senior managers, which we used to inform a service blueprint demonstrating the interaction between practices and laboratories and identifying potential sources of delay and failure. Results Staff at 80% of practices reported that the default method for communicating normal results required patients to telephone the practice and 40% of practices required that patients also call for abnormal results. Over 80% had no fail-safe system for ensuring that results had been returned to the practice from laboratories; practices would otherwise only be aware that results were missing or delayed when patients requested results. Persistent sources of missing results were identified by laboratory staff and included sample handling, misidentification of samples and the inefficient system for collating and resending misdirected results. Conclusions The success of the current system relies on patients both to retrieve results and in so doing alert staff to missing and delayed results. Practices appear slow to adopt available technological solutions despite their potential for reducing the impact of recurring errors in the handling of samples and the reporting of results. Our findings will inform our continuing work with patients and staff to develop, implement and evaluate improvements to existing systems of managing the testing and result communication process. PMID:26243888

Outsourcing cytological samples to a referral laboratory for EGFR testing in non-small cell lung cancer: does theory meet practice?

PubMed

Vigliar, E; Malapelle, U; Bellevicine, C; de Luca, C; Troncone, G

2015-10-01

Guidelines from the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC) and the Association for Molecular Pathology (AMP) consider cytology suitable for testing epidermal growth factor receptor (EGFR) mutations in lung adenocarcinoma. The guidelines recommend that cytopathologists first discuss the possibility of testing squamous cell carcinomas (SqCC) in multidisciplinary meetings. Second, cell blocks should be analysed rather than smear preparations and, third, specimens should be sent to external molecular laboratories within three working days of receiving requests. This study monitored how these recommendations are met in practice. Our laboratory received 596 requests from cytologists from 13 different institutions. For each case, the cytological diagnosis, cytopreparation type, and time between the request and sample mailing were compared with the recommendations. Of the 596 samples, 32 (5.4%) had been reported as SqCC. Three of these (9.4%) showed EGFR mutation. Cytological slides, either ThinPrep(™) (51.2%) or direct smears (43.2%), were more frequently received than cell blocks (5.7%). The mean time between the oncologist's request and specimen dispatching was 5.8 working days. The occurrence of mutations in samples reported as SqCC was higher than expected. This questions the reliability of the original diagnosis, which reinforced the recommendation to evaluate the opportunity for testing non-adenocarcinoma cytology on a case-by-case basis. In spite of CAP/IASLC/AMP recommendations, cell blocks were underutilized for EGFR testing, but cytological slides were suitable for DNA analyses. Significant efforts are needed to avoid delays in outsourcing cytological samples for EGFR testing. © 2014 John Wiley & Sons Ltd.

Current Approaches and Clinician Attitudes to the Use of Cerebrospinal Fluid Biomarkers in Diagnostic Evaluation of Dementia in Europe.

PubMed

Miller, Anne-Marie; Balasa, Mircea; Blennow, Kaj; Gardiner, Mary; Rutkowska, Aleksandra; Scheltens, Philip; Teunissen, Charlotte E; Visser, Pieter Jelle; Winblad, Bengt; Waldemar, Gunhild; Lawlor, Brian

2017-01-01

BIOMARKAPD seeks to diminish the barriers associated with the clinical use of cerebrospinal fluid (CSF) biomarker analysis by reducing variation in CSF laboratory methodologies and generating consensus recommendations on their clinical interpretation and application for dementia diagnosis. To examine the disparity in practitioner attitudes and clinical practice relating to the use of CSF biomarkers for dementia diagnosis across Europe. Clinical dementia experts were surveyed on the prevalence of national consensus guidelines and analytical reimbursement across Europe, their biomarker platform preferences, lumbar puncture methodologies and application of reference values and cut-offs for CSF analysis. 74% of respondents (total n = 51) use CSF biomarkers in clinical practice and 69% perform lumbar punctures on an outpatient basis. Most use CSF biomarkers to diagnose atypical (84%) and early-onset cases of cognitive impairment (71%) and for the differential diagnosis of other dementias (69%). 82% state they are sufficiently informed about CSF biomarkers yet 61% report a lack of national consensus guidelines on their use for dementia diagnosis. 48% of countries represented do not reimburse clinical CSF analysis costs. 43% report using normal reference ranges derived from publications. Variations in attitude and practice relating to CSF biomarkers, widely recognised as barriers to their clinical acceptance, remain evident within and between countries across Europe, even in expert centres. These shortcomings must be addressed by developing consensus guidelines on CSF-related methodologies and their clinical application, to further their use for the diagnostic evaluation of dementia.

DNA decontamination methods for internal quality management in clinical PCR laboratories.

PubMed

Wu, Yingping; Wu, Jianyong; Zhang, Zhihui; Cheng, Chen

2018-03-01

The polymerase chain reaction (PCR) technique, one of the most commonly applied methods in diagnostic and molecular biology, has a frustrating downside: the occurrence of false-positive signals due to contamination. In previous research, various DNA decontamination methods have been developed to overcome this limitation. Unfortunately, the use of random or poorly focused sampling methods for monitoring air and/or object surfaces leads to the incomplete elimination during decontamination procedures. We herein attempted to develop a novel DNA decontamination method (environmental surveillance, including surface and air sampling) and quality management program for clinical molecular diagnostic laboratories (or clinical PCR laboratories). Here, we performed a step-by-step evaluation of current DNA decontamination methods and developed an effective procedure for assessing the presence of decontaminating DNA via PCR analysis. Performing targeted environmental surveillance by sampling, which reached optimal performance over 2 weeks, and the decontamination process had been verified as reliable. Additionally, the process was validated to not affect PCR amplification efficiency based on a comparative study. In this study, effective guidelines for DNA decontamination were developed. The method employed ensured that surface DNA contamination could be effectively identified and eliminated. Furthermore, our study highlighted the importance of overall quality assurance and good clinical laboratory practices for preventing contamination, which are key factors for compliance with regulatory or accreditation requirements. Taken together, we provided the evidence that the presented scheme ranged from troubleshooting to the elimination of surface contamination, could serve as critical foundation for developing regular environmental surveillance guidelines for PCR laboratories. © 2017 Wiley Periodicals, Inc.

Test Guideline Methods for Bed Bug Pesticide Products Now Available

EPA Pesticide Factsheets

EPA’s final test guidelines, 810.3900 - Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products, provides recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products.

Guidelines for use of fishes in research: revised and expanded

USGS Publications Warehouse

Jenkins, Jill A.; Bart, Henry L.; Bowker, James D.; Bowser, Paul R.; MacMillan, J. Randy; Nickum, John G.; Rachlin, Joseph W.; Rose, James D.; Sorensen, Peter W.; Warkentine, Barbara E.; Whitledge, Greg W.

2014-01-01

The Guidelines for the Use of Fishes in Research (2014; 2014 Guidelines), now available through the American fisheries Society (AFS) website and in print from the AFS bookstore, is a resource to aid researchers and regulatory authorities regarding responsible, scientifically valid research on fish and aquatic wildlife. The Guidelines for the Use of Fishes in Field Research (American Society of Ichthyologists and Herpetologists [ASIH] et al. 1987, 1988) emphasized field research and was followed by the 2004 Guidelines including laboratory research topics. Each version of the Guidelines has been jointly endorsed and/or published by the ASIH, the American Institute of Fishery Research Biologists (AIFRB), and AFS--each focusing on the scientific understanding, global conservation, and sustainability of aquatic animals, fisheries, and ecosystems. Changes with time necessitate revisions to make the Guidelines consistent with contemporary practices and scientific literature so to remain relevant as a technical resource. This document provides not only general principles relevant for field and laboratory research endeavors but includes specific requirements for researchers working within the United States and outside of the country. Within the scope of their expertise, the 2014 Uses of Fishers in Research (UFR) Committee members updated and revised sections, resulting in a 90-page 2014 Guidelines having undergone through peer review. As before, topical areas were addressed (see Table of Contents on page 416). Expanded coverage was provided on U.S. and international agencies and programs relevant to research with fishes. The Surgical Procedures and the Marking and Tagging section received special focus by a UFR Subcommittee. Feeds and Feeding and the Administration of Drugs, Biologics and Other Chemicals are just some of the newly added topics. The 2014 Guidelines is user-friendly by way of hyperlinks to external Internet sites, intradocument sections, and tables of acronyms with corresponding terms, low regulatory priority drugs, and Office of International des Epizooties notifiable disease agents. Again, the Institutional Animal Care and Use Committee (IACUC) role is explained, expectations for research are provided, and a brief checklist for IACUC readiness is included. Overall, the ,i>2014 Guidelines is the taxon-specific resource for our professional societies and is a principal document for standards on the care and use of fish and aquatic vertebrates in research.

[Assessment of biological sampling's quality in a medical laboratory: case of Côte d' Ivoire Institute Pasteur].

PubMed

Kouassi-M'Bengue, Alphonsine; Koffi, Stephane; Manizan, Pascale; Ouattara, Abdoulaye; N'Douba, Adele Kacou; Dosso, Mireille

2008-01-01

Assurance quality is important in medical laboratory, but in Africa, few laboratories are involved in this process. The aim of this study was to assess biological sampling's quality in a bacteriological laboratory. A cross sectional study was undertaken in medical bacteriological laboratory of Côte d' Ivoire Institute Pasteur during 6 months. All urines, saddles, and bronchial expectorations collected from ambulatory patients during this period were included in the study. The quality of urine's, saddles and bronchial expectorations' sampling for a bacteriological analysis was evaluated. An interview based on Guidelines of good laboratories practices and referential ISO 15189 was used. A total of 300 samples were indexed. On a total of 300 recorded biological samples, 224 (74.7%) were not in conformity. In 87.5% of the cases of nonconformities, an antibiotic's treatment were preliminary instituted before the sampling. Corrective actions were carried in the laboratory on 30 samples with 56.6% for the urines, 26.7% for the saddles and 16.7% for the bronchial expectorations. At the end of this study, it arises that the quality of the biological sampling received at the medical bacteriology laboratory need to be improved.

Basic Exploratory Research versus Guideline-Compliant Studies Used for Hazard Evaluation and Risk Assessment: Bisphenol A as a Case Study

PubMed Central

Tyl, Rochelle W.

2009-01-01

Background Myers et al. [Environ Health Perspect 117:309–315 (2009)] argued that Good Laboratory Practices (GLPs) cannot be used as a criterion for selecting data for risk assessment, using bisphenol A (BPA) as a case study. They did not discuss the role(s) of guideline-compliant studies versus basic/exploratory research studies, and they criticized both GLPs and guideline-compliant studies and their roles in formal hazard evaluation and risk assessment. They also specifically criticized our published guideline-compliant dietary studies on BPA in rats and mice and 17β-estradiol (E2) in mice. Objectives As the study director/first author of the criticized E2 and BPA studies, I discuss the uses of basic research versus guideline-compliant studies, how testing guidelines are developed and revised, how new end points are validated, and the role of GLPs. I also provide an overview of the BPA guideline-compliant and exploratory research animal studies and describe BPA pharmacokinetics in rats and humans. I present responses to specific criticisms by Myers et al. Discussion and conclusions Weight-of-evidence evaluations have consistently concluded that low-level BPA oral exposures do not adversely affect human developmental or reproductive health, and I encourage increased validation efforts for “new” end points for inclusion in guideline studies, as well as performance of robust long-term studies to follow early effects (observed in small exploratory studies) to any adverse consequences. PMID:20049112

Best practice guidelines for stroke in Cameroon: An innovative and participatory knowledge translation project.

PubMed

Cockburn, Lynn; Fanfon, Timothy N; Bramall, Alexa; Ngole, Eta M; Kuwoh, Pius; Anjonga, Emmanuel; Difang, Brenda M E; Kiani, Shirin; Muso, Petra S; Trivedi, Navjyot; Sama, Julius; Teboh, Sylvian

2014-01-01

Although the adherence to stroke guidelines in high-income countries has been shown to be associated with improved patient outcomes, the research, development and implementation of rehabilitation related guidelines in African countries is lacking. The purpose of this article is to describe how a group of front-line practitioners collaborated with academics and students to develop best practice guidelines (BPG) for the management and rehabilitation of stroke in adult patients in Cameroon. A working group was established and adapted internationally recognised processes for the development of best practice guidelines. The group determined the scope of the guidelines, documented current practices, and critically appraised evidence to develop guidelines relevant to the Cameroon context. The primary result of this project is best practice guidelines which provided an overview of the provision of stroke rehabilitation services in the region, and made 83 practice recommendations to improve these services. We also report on the successes and challenges encountered during the process, and the working group's recommendations aimed at encouraging others to consider similar projects. This project demonstrated that there is interest and capacity for improving stroke rehabilitation practices and for stroke guideline development in Africa.

Why do four NICUs using identical RBC transfusion guidelines have different gestational age-adjusted RBC transfusion rates?

PubMed

Henry, E; Christensen, R D; Sheffield, M J; Eggert, L D; Carroll, P D; Minton, S D; Lambert, D K; Ilstrup, S J

2015-02-01

To compare neonatal red blood cell (RBC) transfusion rates in four large Intermountain Healthcare NICUs, all of which adhere to the same RBC transfusion guidelines. This retrospective analysis was part of a transfusion-management quality-improvement project. De-identified data included RBC transfusions, clinical and laboratory findings, the anemia-prevention strategies in place in each NICU, and specific costs and outcomes. Of 2389 NICU RBC transfusions given during the 4-year period studied, 98.9 ± 2.1% (mean ± S.D.) were compliant with our transfusion guidelines, with no difference in compliance between any of the four NICUs. However, RBC transfusion rates varied widely between the four, with averages ranging from 4.6 transfusions/1000 NICU days to 21.7/1000 NICU days (P < 0.00001). Gestational age-adjusted transfusion rates were correspondingly discordant (P < 0.00001). The lower-transfusing NICUs had written anemia-preventing guidelines, such as umbilical cord milking at very low birth weight delivery, use of cord blood for admission laboratory studies, and darbepoetin dosing for selected neonates. Rates of Bell stage ⩾ 2 necrotizing enterocolitis and grade ⩾ 3 intraventricular hemorrhage were lowest in the two lower-transfusing NICUs (P < 0.0002 and P < 0.0016). Average pharmacy costs for darbepoetin were $84/dose, with an average pharmacy cost of $269 per transfusion averted. With a cost of $900/RBC transfusion, the anemia-preventing strategies resulted in an estimated cost savings to Intermountain Healthcare of about $6970 per 1000 NICU days, or about $282,300 annually. Using transfusion guidelines has been shown previously to reduce practice variability, lower transfusion rates and diminish transfusion costs. Based on our present findings, we maintain that even when transfusion guidelines are in place and adhered to rigorously, RBC transfusion rates are reduced further if anemia-preventing strategies are also in place.

Developmental procedures for the clinical practice guidelines for conscious sedation in dentistry for the Korean Academy of Dental Sciences.

PubMed

An, So-Youn; Seo, Kwang-Suk; Kim, Seungoh; Kim, Jongbin; Lee, Deok-Won; Hwang, Kyung-Gyun; Kim, Hyun Jeong

2016-12-01

Evidence-based clinical practice guidelines (CPGs) are defined as "statements that are scientifically reviewed about evidence and systematically developed to assist in the doctors' and patients' decision making in certain clinical situations." This recommendation aims to promote good clinical practice for the provision of safe and effective practices of conscious sedation in dentistry. The development of this clinical practice guideline was conducted by performing a systematic search of the literature for evidence-based CPGs. Existing guidelines, relevant systematic reviews, policy documents, legislation, or other recommendations were reviewed and appraised. To supplement this information, key questions were formulated by the Guideline Development Group and used as the basis for designing systematic literature search strategies to identify literature that may address these questions. Guideline documents were evaluated through a review of domestic and international databases for the development of a renewing of existing conscious sedation guidelines for dentistry. Clinical practice guidelines were critically appraised for their methodologies using Appraisal of guidelines for research and evaluation (AGREE) II. A total of 12 existing CPGs were included and 13 recommendations were made in a range of general, adult, and pediatric areas. The clinical practice guidelines for conscious sedation will be reviewed in 5 years' time for further updates to reflect significant changes in the field.

[Clinical practice guidelines (II): searching and critical evaluation].

PubMed

Alonso, P; Bonfill, X

2007-01-01

Clinical practice guidelines have unique characteristics of the Internet era in which they are starting to be increasingly popular. The fact that they are often elaborated by governmental agencies and are not published in conventional journals means that they may not be accessible using the usual search methods employed for other types of scientific studies and documents (clinical trials, reviews, etc.). The Internet has become an essential tool for locating clinical practice guidelines, and meta-search engines, specific databases, directories, and elaborating institutions are of special importance. The relative lack of indexing of clinical practice guides means that Medline and Embase are not as useful in this context as in searching for original studies. With the aim of evaluating the validity, reproducibility, and reliability of clinical practice guidelines, a series of European institutions designed a tool to evaluate clinical practice guidelines at the end of the 1990s. This instrument, named AGREE, aims to offer a framework for the evaluation of the quality of clinical practice guidelines. It can also be useful in the design of new clinical practice guidelines as well as in the evaluation of the validity of guidelines to be updated or adapted. The AGREE instrument has become the reference for those that use guidelines, those that elaborate them, and for healthcare providers.

[How to assess clinical practice guidelines with AGREE II: The example of neonatal jaundice].

PubMed

Renesme, L; Bedu, A; Tourneux, P; Truffert, P

2016-03-01

Neonatal jaundice is a very frequent condition that occurs in approximately 50-70% of term or near-term (>35 GA) babies in the 1st week of life. In some cases, a high bilirubin blood level can lead to kernicterus. There is no consensus for the management of neonatal jaundice and few countries have published national clinical practice guidelines for the management of neonatal jaundice. The aim of this study was to assess the quality of these guidelines. We conducted a systematic review of the literature for national clinical practice guidelines for the management of neonatal jaundice in term or near-term babies. Four independent reviewers assessed the quality of each guideline using the AGREE II evaluation. For each of the clinical practice guidelines, the management modalities were analyzed (screening, treatment, follow-up, etc.). Seven national clinical practice guidelines were found (South Africa, USA AAP, UK NICE, Canada, Norway, Switzerland, and Israel). The AGREE II score showed widespread variation regarding the quality of these national guidelines. There was no major difference between the guidelines concerning the clinical management of these babies. The NICE guideline is the most valuable guideline regarding the AGREE II score. NICE showed that, despite a strong and rigorous methodology, there is no evidenced-based recommended code of practice (RCP). Comparing RCPs, we found no major differences. The NICE guideline showed the best quality. The AGREE II instrument should be used as a framework when developing clinical practice guidelines to improve the quality of the future guideline. In France, a national guideline is needed for a more standardized management of neonatal jaundice. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Opportunities for improvement on current nuclear cardiology practices and radiation exposure in Latin America: Findings from the 65-country IAEA Nuclear Cardiology Protocols cross-sectional Study (INCAPS).

PubMed

Vitola, João V; Mut, Fernando; Alexánderson, Erick; Pascual, Thomas N B; Mercuri, Mathew; Karthikeyan, Ganesan; Better, Nathan; Rehani, Madan M; Kashyap, Ravi; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

2017-06-01

Comparison of Latin American (LA) nuclear cardiology (NC) practice with that in the rest of the world (RoW) will identify areas for improvement and lead to educational activities to reduce radiation exposure from NC. INCAPS collected data on all SPECT and PET procedures performed during a single week in March-April 2013 in 36 laboratories in 10 LA countries (n = 1139), and 272 laboratories in 55 countries in RoW (n = 6772). Eight "best practices" were identified a priori and a radiation-related Quality Index (QI) was devised indicating the number used. Mean radiation effective dose (ED) in LA was higher than in RoW (11.8 vs 9.1 mSv, p < 0.001). Within a populous country like Brazil, a wide variation in laboratory mean ED was found, ranging from 8.4 to 17.8 mSv. Only 11% of LA laboratories achieved median ED <9 mSv, compared to 32% in RoW (p < 0.001). QIs ranged from 2 in a laboratory in Mexico to 7 in a laboratory in Cuba. Three major opportunities to reduce ED for LA patients were identified: (1) more laboratories could implement stress-only imaging, (2) camera-based methods of ED reduction, including prone imaging, could be more frequently used, and (3) injected activity of 99m Tc could be adjusted reflecting patient weight/habitus. On average, radiation dose from NC is higher in LA compared to RoW, with median laboratory ED <9 mSv achieved only one third as frequently as in RoW. Opportunities to reduce radiation exposure in LA have been identified and guideline-based recommendations made to optimize protocols and adhere to the "as low as reasonably achievable" (ALARA) principle.

Medicolegal affairs. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

PubMed

Frable, W J; Austin, R M; Greening, S E; Collins, R J; Hillman, R L; Kobler, T P; Koss, L G; Mitchell, H; Perey, R; Rosenthal, D L; Sidoti, M S; Somrak, T M

1998-01-01

Increasing litigation over alleged false negative cervical cytologic (CC) smears threatens the viability of this test for cervical cancer detection. The problem appears to be largely American but is beginning to appear in some other countries. In the vast majority of cases there is either a settlement or jury verdict for the plaintiff based largely on the testimony of expert witnesses. Cases are judged on an individual basis without significant consideration of the general performance of the CC smear in laboratories operating in compliance with a wide array of laboratory regulations and with documented and comprehensive quality control practices in place. It is acknowledged that there are problem laboratories and cytology practitioners. There is an emerging issue of automated preparation and screening devices and issues of informed patient consent. Cytology professionals have done an extraordinary and commendable job of educating the public about the benefits of the CC smear. We have been less successful and conscientious about explaining and defining the limitations of the CC test. There is a need for public and professional education as to the benefits and limitations of the CC smear for cervical cancer detection. The process suggested is to work with women's groups, public health agencies, government agencies, and state and national legislatures and to coordinate professional committees working on liability issues. Contextual information could be included with the CC smear report to indicate that a negative report confers a low probability of developing cervical cancer. It is suggested that appropriate language and a menu of statements be developed. Increased efforts should be directed to physician education with respect to informed consent concerning the benefits and limitations of CC smear testing and the application of new technology to improve smear accuracy. The process should include development of appropriate statements on the use of alternative technology. The profession should develop "process guidelines" for review of CC smears in the context of possible litigation, including standardized methods for blind slide review of smears that reduce or eliminate context and outcome bias. It is suggested that review panels be anonymous, that the process be standardized and that there be limitations on liability for participating organizations. Professional cytopathology and pathology societies should formulate acceptable guidelines for expert witnesses. The standards should be applicable to both defendant and plaintiff experts. All materials to the extent practical, including consultant opinions, should be available for peer review. Professional cytopathology and pathology societies should monitor expert testimony for objectivity and scientific accuracy. For the near future, litigation will continue to focus on false negative CC smears on a case-by-case basis. Laboratories and individuals can reduce the risk of malpractice liability by directing their attention to proactive quality control and quality assurance methods. In the final analysis, consumer education about the benefits and limitations of the test is key to limiting malpractice claims. To stem the tide of continued medicolegal challenges to the integrity of cytology practice, the cytology community has now focused its efforts on developing and utilizing standards that convey to patients, attorneys and cytologists the contemporary status of and reasonable expectations for the practice of cytology. Guidelines such as those for uniform reporting terminology and clinical management of cervical abnormalities form the basis of cytology practice standards on which legal standards of practice can be based. Consensus conference reports, clinical management trials and scientifically valid studies of false negative rates that analyze the type, frequency and cause of missed cases represent sounder methods of establishing defensible

Attitudes, knowledge and behavior of Japanese physical therapists with regard to evidence-based practice and clinical practice guidelines: a cross-sectional mail survey

PubMed Central

Fujimoto, Shuhei; Kon, Noriko; Takasugi, Jun; Nakayama, Takeo

2017-01-01

[Purpose] This study aimed to investigate Japanese physical therapists’ attitudes of evidence-based practice and clinical practice guidelines. [Subjects and Methods] In 2014, a cross-sectional postal mail survey using a self-administered questionnaire was conducted. Of 2,982 physical therapists belonging to the Chiba Prefecture Physical Therapist Association, 1,000 were randomly selected. The questionnaire comprised 42 items pertaining to the attitudes of and behavior toward evidence-based practice and clinical practice guidelines. It was investigated to reveal the relationship between clinical practice guidelines/evidence-based practice and therapist characteristics. [Results] The response rate was 39.6%, and 384 questionnaires were available. The main results were as follows: 83.3% participants agreed to the importance of evidence-based practice, 77.1% agree to that evidence-based practice supports clinical decision of physical therapists, and about 11% agreed to have been educated about evidence-based practice. Then, 29.2% used, 54.9% agreed to the importance of, and 13.3% agreed to the utility of clinical practice guidelines. An important factor related mostly to a positive attitude, knowledge and behavior of evidence-based practice and clinical practice guidelines was participating in research activities. [Conclusion] Many of physical therapists do not use and understand the importance of clinical practice guidelines. Participating in research activities may partially contribute to improving these conditions. PMID:28265139

Statistical benchmarking for orthogonal electrostatic quantum dot qubit devices

NASA Astrophysics Data System (ADS)

Gamble, John; Frees, Adam; Friesen, Mark; Coppersmith, S. N.

2014-03-01

Quantum dots in semiconductor systems have emerged as attractive candidates for the implementation of quantum information processors because of the promise of scalability, manipulability, and integration with existing classical electronics. A limitation in current devices is that the electrostatic gates used for qubit manipulation exhibit strong cross-capacitance, presenting a barrier for practical scale-up. Here, we introduce a statistical framework for making precise the notion of orthogonality. We apply our method to analyze recently implemented designs at the University of Wisconsin-Madison that exhibit much increased orthogonal control than was previously possible. We then use our statistical modeling to future device designs, providing practical guidelines for devices to have robust control properties. Sandia National Laboratories is a multi-program laboratory managed and operated by Sandia Corporation, a wholly owned subsidiary of Lockheed Martin Corporation, for the U.S. Department of Energy Nuclear Security Administration under contract DE-AC04-94AL85000. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressly or implied, of the US Government. This work was supported in part by the Laboratory Directed Research and Development program at Sandia National Laboratories, by ARO (W911NF-12-0607), and by the United States Department of Defense.

Highway crash rates and age-related driver limitations: Literature review and evaluation of data bases

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

Hu, P.S.; Young, J.R.; Lu, An

1993-08-01

American society is undergoing a major demographic transformation that is resulting in a larger proportion of older individuals in the population. Moreover, recent travel surveys show that an increasing number of older individuals are licensed to drive and that they drive more than their same age cohort a decade ago. However, they continue to take shorter trips than younger drivers and they avoid driving during congested hours. This recent demographic transformation in our society, the graying of America, coupled with the increasing mobility of the older population impose a serious highway safety issue that cannot be overlooked. Some of themore » major concerns are the identification of ``high-risk`` older drivers and the establishment of licensing guidelines and procedures that are based on conclusive scientific evidence. Oak Ridge National Laboratory`s (ORNL) objectives in this project can be characterized by the following tasks: Review and evaluate the 1980 American Association of Motor Vehicle Administrators (AAMVA) and National Highway Traffic Safety Administration (NHTSA) licensing guidelines. Determine whether the license restriction recommended in the 1980 AAMVA and NHTSA guidelines was based on scientific evidence or on judgement of medical advisors. Identify in the scientific literature any medical conditions which are found to be highly associated with highway crashes, and which are not mentioned in the 1980 guidelines. Summarize States` current licensing practices for drivers with age-related physical and mental limitations. Identify potential data sources to establish conclusive evidence on age-related functional impairments and highway crashes.« less

Guidelines to the Practice of Anesthesia - Revised Edition 2018.

PubMed

Dobson, Gregory; Chong, Matthew; Chow, Lorraine; Flexman, Alana; Kurrek, Matthew; Laflamme, Claude; Lagacé, Annie; Stacey, Shean; Thiessen, Barton

2018-01-01

The Guidelines to the Practice of Anesthesia Revised Edition 2018 (the Guidelines) were prepared by the Canadian Anesthesiologists' Society (CAS), which reserves the right to determine their publication and distribution. The Guidelines are subject to revision and updated versions are published annually. The Guidelines to the Practice of Anesthesia Revised Edition 2018 supersedes all previously published versions of this document. Although the CAS encourages Canadian anesthesiologists to adhere to its practice guidelines to ensure high-quality patient care, the CAS cannot guarantee any specific patient outcome. Anesthesiologists should exercise their own professional judgement in determining the proper course of action for any patient's circumstances. The CAS assumes no responsibility or liability for any error or omission arising from the use of any information contained in its Guidelines to the Practice of Anesthesia.

[Hot topics of circulating tumor DNA testing in breast cancer].

PubMed

Liu, Y H; Zhou, B; Xu, L; Xin, L

2017-02-01

The progress of gene detection technologies represented by next generation sequencing (NGS) and digital PCR laid a foundation for studies of circulating tumor DNA (ctDNA) in breast cancer. In 2014, the NGS workgroup organized by the College of American Pathologists (CAP) published the College of American Pathologists ' Laboratory Standards for Next - Generation Sequencing Clinical Tests, which provides a blueprint for the standardization of gene testing. In 2015, the Guidelines for Diagnostic Next - generation Sequencing published by the European Society of Human Genetics claimed that NGS is unacceptable in clinical practice before studies guided by guidelines are approved. Although existing studies show the benefits of ctDNA testing in disease monitoring and prognosis analyzing, we have a ways to go to normalize the procedure and build strict detection criteria.

Guidelines for European workplace drug testing in oral fluid.

PubMed

Cooper, Gail; Moore, Christine; George, Claire; Pichini, Simona

2011-05-01

Over the past decade, oral fluid has established itself as a robust testing matrix for monitoring drug use or misuse. Commercially available collection devices provide opportunities to collect and test oral fluid by the roadside and near-patient testing with both clinical and criminal justice applications. One of the main advantages of oral fluid relates to the collection of the matrix which is non-invasive, simple, and can be carried out under direct observation making it ideal for workplace drug testing. Laboratories offering legally defensible oral fluid workplace drug testing must adhere to national and international quality standards (ISO/IEC 17025); however, these standards do not address issues specific to oral fluid testing. The European Workplace Drug Testing Society (EWDTS) recognizes the importance of providing best practice guidelines to organizations offering testing and those choosing to use oral fluid drug testing to test their employees. The aim of this paper is to present the EWDTS guidelines for oral fluid workplace drug testing. Copyright © 2011 John Wiley & Sons, Ltd.

LABORATORY GUIDELINES FOR ANALYSIS OF BIOTERRORISM SAMPLES

EPA Science Inventory

With advent of deaths associated with Bacillus anthracis spore contaminated mail, a worldwide need was apparent for increased laboratory capacity to safely analyze bioterrorism samples. The U.S. Department of Health and Human Services has furnished guidelines for microbiological...

Biosafety Recommendations for Work with Influenza Viruses Containing a Hemagglutinin from the A/goose/Guangdong/1/96 Lineage.

PubMed

Gangadharan, Denise; Smith, Jacinta; Weyant, Robbin

2013-06-28

The CDC and National Institutes of Health (NIH) Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual describes biosafety recommendations for work involving highly pathogenic avian influenza (HPAI) (US Department of Health and Human Services [HHS], CDC. Biosafety in microbiological and biomedical laboratories, 5th ed. Atlanta, GA: CDC; 2009. HHS publication no. [CDC] 21-1112. Available at http://www.cdc.gov/biosafety/publications/bmbl5). The U.S. Department of Agriculture Guidelines for Avian Influenza Viruses builds on the BMBL manual and provides additional biosafety and biocontainment guidelines for laboratories working with HPAI (US Department of Agriculture, Animal and Plant Health Inspection Service, Agricultural Select Agent Program. Guidelines for avian influenza viruses. Washington, DC: US Department of Agriculture; 2011. Available at http://www.selectagents.gov/Guidelines_for_Avian_Influenza_Viruses.html). The recommendations in this report, which are intended for laboratories in the United States, outline the essential baseline biosafety measures for working with the subset of influenza viruses that contain a hemagglutinin (HA) from the HPAI influenza A/goose/Guangdong/1/96 lineage, including reassortant influenza viruses created in a laboratory setting. All H5N1 influenza virus clades known to infect humans to date have been derived from this lineage (WHO/OIE/FAO H5N1 Evolution Working Group. Continued evolution of highly pathogenic avian influenza A [H5N1]: updated nomenclature. Influenza Other Respir Viruses 2012;6:1-5). In 2009, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules were amended to include specific biosafety and biocontainment recommendations for laboratories working with Recombinant Risk Group 3 influenza viruses, including HPAI H5N1 influenza viruses within the Goose/Guangdong/1/96-like H5 lineage. In February 2013, the NIH guidelines were further revised to provide additional biosafety containment enhancements and practices for research with HPAI H5N1 viruses that are transmissible among mammals by respiratory droplets (i.e., mammalian-transmissible HPAI H5N1) (National Institutes of Health, Office of Biotechnology Activities. NIH guidelines for research involving recombinant or synthetic nucleic acid molecules. Appendix G-II-C-5: biosafety level 3 enhanced for research involving risk group 3 influenza viruses. Bethesda, MD: National Institutes of Health; 2013. Available at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html). The recent revisions to the NIH guidelines focus on a smaller subset of viruses but are applicable and consistent with the recommendations in this report. The biosafety recommendations in this report were developed by CDC with advice from the Intragovernmental Select Agents and Toxins Technical Advisory Committee, which is a panel composed of federal government subject-matter experts, and from public input received in response to the request for information that was published in the Federal Register on October 17, 2012 (US Department of Health and Human Services, CDC. Influenza viruses containing the hemagglutinin from the Goose/ Guangdong/1/96 lineage; proposed rule; request for information and comment. 42 CFR, Part 73. Federal Register 2012;77:63783-5). Work with HPAI H5N1 virus should be conducted, at a minimum, at biosafety level 3 (BSL-3), with specific enhancements to protect workers, the public, animal health, and animal products. Original clinical specimens suspected of containing viruses of this lineage can only be handled at BSL-2 if the procedures do not involve the propagation of the virus. An appropriate biosafety level should be determined in accordance with a biosafety risk assessment. Additional information on performing biosafety risk assessments and establishing effective biosafety containment is available in the BMBL manual.

Critical appraisal of clinical practice guidelines in pediatric infectious diseases.

PubMed

Wilby, Kyle John; Black, Emily Kathleen; MacLeod, Claire; Wiens, Matthew; Lau, Tim T Y; Paiva, Maria A; Gorman, Sean

2015-10-01

There is a need to critically appraise clinical practice guidelines in order to ensure safe and effective practices are being implemented to optimize patient care. Appraising guidelines within one therapeutic area enable recommendations for improvement during guideline creation and dissemination. Study objectives were to systematically appraise selected published guidelines used in the treatment of pediatric infectious diseases and to make recommendations for improvement throughout the development and dissemination processes. The study occurred between collaborative academic and practice-based institutions located in Canada and Qatar. A literature search identified guidelines for management of pediatric infectious diseases from 1997 to 2013. Each guideline was appraised by four independent assessors, according to the appraisal of guidelines for research and evaluation II (AGREE II) instrument. Standardized domain scores were calculated for each guideline and pooled. Final endorsements for use in clinical practice were also determined. Inter-rater reliability was assessed using intraclass correlation coefficients. Standardized domain scores according to the AGREE II instrument. Twenty guidelines met inclusion criteria and were appraised. Pooled domain scores were: scope and purpose (69.9), stakeholder involvement (40.1), rigour of development (47.1), clarity of presentation (73.4), applicability (23.7), editorial independence (46.7), and overall assessment (55.8). Two (10%) guidelines were recommended for use without revision, 13 (65%) guidelines were recommended with modifications, and 5 (25%) guidelines were not recommended for implementation into practice. Inter-rater reliability was moderate to good with intra-class correlations of 0.65-0.93 per guideline. The majority of appraised guidelines were moderately rated, with a 25% of guidelines not recommended for use. Strategies for improvement require the involvement of all key stakeholders (caregivers, patients, and allied health professionals), and consideration of facilitators, barriers and resource implications during implementation. Additionally, critical appraisal of guidelines should become standard practice prior to adoption into clinical settings.

Financial Relationships between Organizations That Produce Clinical Practice Guidelines and the Biomedical Industry: A Cross-Sectional Study.

PubMed

Campsall, Paul; Colizza, Kate; Straus, Sharon; Stelfox, Henry T

2016-05-01

Financial relationships between organizations that produce clinical practice guidelines and biomedical companies are vulnerable to conflicts of interest. We sought to determine whether organizations that produce clinical practice guidelines have financial relationships with biomedical companies and whether there are associations between organizations' conflict of interest policies and recommendations and disclosures provided in guidelines. We conducted a cross-sectional survey and review of websites of 95 national/international medical organizations that produced 290 clinical practice guidelines published on the National Guideline Clearinghouse website from January 1 to December 31, 2012. Survey responses were available for 68% (65/95) of organizations (167/290 guidelines, 58%), and websites were reviewed for 100% (95/95) of organizations (290/290 guidelines, 100%). In all, 63% (60/95) of organizations producing clinical practice guidelines reported receiving funds from a biomedical company; 80% (76/95) of organizations reported having a policy for managing conflicts of interest. Disclosure statements (disclosing presence or absence of financial relationships with biomedical companies) were available in 65% (188/290) of clinical practice guidelines for direct funding sources to produce the guideline, 51% (147/290) for financial relationships of the guideline committee members, and 1% (4/290) for financial relationships of the organizations producing the guidelines. Among all guidelines, 6% (18/290) disclosed direct funding by biomedical companies, 40% (117/290) disclosed financial relationships between committee members and biomedical companies (38% of guideline committee members, 773/2,043), and 1% (4/290) disclosed financial relationships between the organizations producing the guidelines and biomedical companies. In the survey responses, 60 organizations reported the procedures that they included in their conflict of interest policies (158 guidelines): guidelines produced by organizations reporting more comprehensive conflict of interest policies (per additional procedure, range 5-17) included fewer positive (rate ratio [RR] 0.91, 95% CI 0.86-0.95) and more negative (RR 1.32, 95% CI 1.09-1.60) recommendations regarding patented biomedical products. The clinical practice guidelines produced by organizations reporting more comprehensive conflict of interest policies were also more likely to include disclosure statements for direct funding sources (odds ratio [OR] 1.31, 95% CI 1.10-1.56) and financial relationships of guideline committee members (OR 1.36, 95% CI 1.09-1.79), but not financial relationships of the organizations (0 disclosures). Limitations of the study include the use of the National Guideline Clearinghouse as the single source of clinical practice guidelines and the self-report of survey responses and organizations' website postings. Financial relationships between organizations that produce clinical practice guidelines and biomedical companies are common and infrequently disclosed in guidelines. Our study highlights the need for an effective policy to manage organizational conflicts of interest and disclosure of financial relationships.

[Accreditation of medical laboratories].

PubMed

Horváth, Andrea Rita; Ring, Rózsa; Fehér, Miklós; Mikó, Tivadar

2003-07-27

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the official acceptance of ISO 15189 the clauses of this harmonized guideline fulfill the requirements of the new international standard as well. Accreditation of medical laboratories in Hungary may not only facilitate quality improvement of laboratory services, but also the development of a quality-based purchasing and reimbursement policy of the health insurance fund.

Meeting patient needs trumps adherence. A cross-sectional study of adherence and adaptations when national guidelines are used in practice.

PubMed

Kakeeto, Mikael; Lundmark, Robert; Hasson, Henna; von Thiele Schwarz, Ulrica

2017-08-01

In the evidence-to-practice pathway, guidelines are developed to provide a practical summary of evidence and stimulate change. However, when guidelines are used in practice, adherence to the recommendations in guidelines is limited, and adaptations are common. Thus, we need more detailed knowledge about adherence and adaptations when guidelines are used in practice to understand the end of the evidence-to-practice pathway. Subsequently, the aim is to examine adherence to and adaptations of recommendations in the Swedish National Guidelines for Methods of Preventing Disease. A questionnaire was sent to healthcare professionals and managers in Stockholm between January and March 2014. Adherence to the recommendations was compared between practice settings, and the frequency of different adaptations and reasons for adaptations was analysed. Partial adherence to the guidelines was found. The adherence was significantly greater within primary care than at the hospitals (P < .001). Modifications formed the most common category of adaptations (55%) and included mainly prioritization of specific patient groups and increased patient customization. The most common reason for adaptations (25%) was to meet the patients' specific needs and capabilities. This study provides insight into adherence and adaptation when guidelines are used in practice. Work with lifestyle habits was partially done in accordance with the guidelines. Lack of time and lack of resources were not the most common reasons for adaptations. Rather, the findings suggest that when patient needs and capabilities contrast with guideline recommendations, patient needs trump adherence to guidelines. © 2017 John Wiley & Sons, Ltd.

QUALITY ASSURANCE GUIDELINES FOR LABORATORIES PERFORMING FORENSIC ANALYSIS OF CHEMICAL TERRORISM

EPA Science Inventory

The Scientific Working Group on Forensic Analysis of Chemical Terrorism (SWGFACT) has developed the following quality assurance guidelines to provide laboratories engaged in forensic analysis of chemical evidence associated with terrorism a framework to implement a quality assura...

VALIDATION GUIDELINES FOR LABORATORIES PERFORMING FORENSIC ANALYSIS OF CHEMICAL TERRORISM

EPA Science Inventory

The Scientific Working Group on Forensic Analysis of Chemical Terrorism (SWGFACT) has developed the following guidelines for laboratories engaged in the forensic analysis of chemical evidence associated with terrorism. This document provides a baseline framework and guidance for...

Lyme disease

PubMed Central

Henry, Bonnie; Crabtree, Alexis; Roth, David; Blackman, Doug; Morshed, Muhammad

2012-01-01

Abstract Objective To determine physicians’ level of awareness and knowledge of Lyme disease (LD) in a low-prevalence area and whether physicians’ practices align with current guidelines for treatment of LD. Design A 23-item questionnaire assessing demographic characteristics, general knowledge about LD, laboratory testing for LD, and responses to 3 clinical scenarios. Setting British Columbia (BC). Participants Pediatricians, FPs, and internal medicine specialists who were licensed to practise in BC. Main outcome measures Knowledge of signs and symptoms of LD, beliefs about risk of LD, attitudes toward LD in patients in their practices, and application of accepted practice guidelines for the treatment of LD in clinical scenarios. Results Overall, 80.6% of respondents were FPs. Average knowledge score was 72.5% for FPs and 75.0% for other specialists. Most respondents (75.6% of FPs and 71.8% of other specialists) underestimated the occurrence of erythema migrans (EM), and only 26.1% and 28.3%, respectively, knew that EM alone was diagnostic for LD. A total of 30.5% of FPs and 12.1% of other specialists reported having treated a patient for the disease despite not believing that the patient had LD. Of all the respondents, 62.1% knew that LD was a reportable disease in BC. Respondents’ reports of risk of LD in their areas were appropriately associated with actual risk based on ecological niche. Conclusion Physicians are knowledgeable about the clinical signs and symptoms of LD and aware of the risk of the disease despite being in a low-endemic area. Physicians in BC are comfortable with treating patients empirically for LD. Education is needed to inform physicians that EM is diagnostic and no laboratory testing is indicated before treatment. Raising awareness among physicians that LD is reportable might improve reporting of future cases. PMID:22734172

Survey of point-of-care instrumentation, analysis, and quality assurance in veterinary practice.

PubMed

Bell, Regan; Harr, Kendal; Rishniw, Mark; Pion, Paul

2014-06-01

While there have been ASVCP meeting discussions regarding quality assurance plans and lack thereof for in-clinic analyzers, there are little published data regarding in-clinic quality assurance and control practices. The purpose of this study was the identification of the common equipment used in hematologic, biochemical, urinalysis, and other testing, and assessment of quality control and assurance programs currently being performed in-clinic. All members of the Veterinary Information Network (VIN) were solicited to participate in an online survey between July and September 2007. In total, 452 complete or partial responses were received. Eighty-nine percent of respondents (361/404) said that veterinary technicians (unlicensed, licensed, and registered) performed the majority of analyses. Eighty-eight percent (366/417) of respondents performed some quality assurance on their laboratory equipment, most commonly on chemistry (91%, 324/357), and hematology (84%, 292/347) analyzers, and least commonly on fecal analyses (57%, 148/260) and ELISA assays (25%, 65/256). Ignorance of how to perform quality assurance was the most commonly stated reason (49%, 25/51) for lack of a quality assurance program. The majority of practices (316/374) utilized manufacturer-provided reference intervals without further adjustment or assessment. Roughly one-third of respondents (126/374) used reference intervals from textbooks, which is discouraged by ASVCP guidelines. This study found that the majority of respondents were not in compliance with ASVCP guidelines, illustrating the need for improved education of technical staff, veterinary students, and veterinarians regarding limitations of in-clinic laboratory equipment and the importance of regular quality control, maintenance, training, and reference interval development. © 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

Coordination and resource-related difficulties encountered by Quebec's public health specialists and infectious diseases/medical microbiologists in the management of A (H1N1)--a mixed-method, exploratory survey.

PubMed

Nhan, Charles; Laprise, Réjean; Douville-Fradet, Monique; Macdonald, Mary Ellen; Quach, Caroline

2012-02-10

In Quebec, the influenza A (H1N1) pandemic was managed using a top-down style that left many involved players with critical views and frustrations. We aimed to describe physicians' perceptions--infectious diseases specialists/medical microbiologists (IDMM) and public health/preventive medicine specialists (PHPMS)--in regards to issues encountered with the pandemics management at the physician level and highlight suggested improvements for future healthcare emergencies. In April 2010, Quebec IDMM and PHPMS physicians were invited to anonymously complete a web-based learning needs assessment. The survey included both open-ended and multiple-choice questions. Descriptive statistics were used to report on the frequency distribution of multiple choice responses whereas thematic content analysis was used to analyse qualitative data generated from the survey and help understand respondents' experience and perceptions with the pandemics. Of the 102 respondents, 85.3% reported difficulties or frustrations in their practice during the pandemic. The thematic analysis revealed two core themes describing the problems experienced in the pandemic management: coordination and resource-related difficulties. Coordination issues included communication, clinical practice guidelines, decision-making, roles and responsibilities, epidemiological investigation, and public health expert advisory committees. Resources issues included laboratory resources, patient management, and vaccination process. Together, the quantitative and qualitative data suggest a need for improved coordination, a better definition of roles and responsibilities, increased use of information technologies, merged communications, and transparency in the decisional process. Increased flexibility and less contradiction in clinical practice guidelines from different sources and increased laboratory/clinical capacity were felt critical to the proper management of infectious disease emergencies.

Nonpharmacological, Blood Conservation Techniques for Preventing Neonatal Anemia—Effective and Promising Strategies for Reducing Transfusion

PubMed Central

Carroll, Patrick D.; Widness, John A.

2012-01-01

The development of anemia after birth in very premature, critically ill newborn infants is a universal well-described phenomenon. Although preventing anemia in this population, along with efforts to establish optimal red blood cell (RBC) transfusion and pharmacologic therapy continue to be actively investigated, the present review focuses exclusively on nonpharmacological approaches to the prevention and treatment of neonatal anemia. We begin with an overview of topics relevant to nonpharmacological techniques. These topics include neonatal and fetoplacental hemoglobin levels and blood volumes, clinical and laboratory practices applied in critically ill neonates, and current RBC transfusion practice guidelines. This is followed by a discussion of the most effective and promising nonpharmacological blood conservation strategies and techniques. Fortunately, many of these techniques are feasible in most neonatal intensive care units. When applied together, these techniques are more effective than existing pharmacotherapies in significantly decreasing neonatal RBC transfusions. They include increasing hemoglobin endowment and circulating blood volume at birth; removing less blood for laboratory testing; and optimizing nutrition. PMID:22818543

The development of clinical practice guidelines and guidance statements of the American College of Physicians: summary of methods.

PubMed

Qaseem, Amir; Snow, Vincenza; Owens, Douglas K; Shekelle, Paul

2010-08-03

The American College of Physicians (ACP) established its evidence-based clinical practice guidelines program in 1981. The ACP's Guidelines Committee and the staff of the Clinical Programs and Quality of Care Department develop the clinical recommendations. The ACP develops 2 different types of clinical recommendations: clinical practice guidelines and clinical guidance statements. The ACP clinical practice guidelines and guidance statements follow a multistep development process that includes a systematic review of the evidence, deliberation of the evidence by the committee, summary recommendations, and evidence and recommendation grading. All ACP clinical practice guidelines and clinical guidance statements, if not updated, are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.

Comprehensive evaluation of contemporary assisted reproduction technology laboratory operations to determine staffing levels that promote patient safety and quality care.

PubMed

Alikani, Mina; Go, Kathryn J; McCaffrey, Caroline; McCulloh, David H

2014-11-01

To consider how staffing requirements have changed with evolving and increasingly more complex assisted reproduction technology (ART) laboratory practice. Analysis by four laboratory directors from three different ART programs of the level of complexity and time requirements for contemporary ART laboratory activities to determine adequate staffing levels. University-based and private ART programs. None. None. Human resource requirements for ART procedures. Both complexity and time required for completion of a contemporary ART cycle have increased significantly compared with the same requirements for the "traditional cycle" of the past. The latter required roughly 9 personnel hours, but a contemporary cycle can require up to 20 hours for completion. Consistent with this increase, a quantitative analysis shows that the number of embryologists required for safe and efficient operation of the ART laboratory has also increased. This number depends on not only the volume but also the types of procedures performed: the higher the number of complex procedures, the more personnel required. An interactive Personnel Calculator is introduced that can help determine staffing needs. The increased complexity of the contemporary ART laboratory requires a new look at the allocation of human resources. Our work provides laboratory directors with a practical, individualized tool to determine their staffing requirements with a view to increasing the safety and efficiency of operations. The work could serve as the basis for revision of the 2008 American Society for Reproductive Medicine (ASRM) staffing guidelines. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Medical Physics Practice Guideline 4.a: Development, implementation, use and maintenance of safety checklists

PubMed Central

de los Santos, E. Fong; Evans, Suzanne; Ford, Eric C.; Gaiser, James E.; Hayden, Sandra E.; Huffman, Kristina E.; Johnson, Jennifer L.; Mechalakos, James G.; Stern, Robin L.; Terezakis, Stephanie; Thomadsen, Bruce R.; Pronovost, Peter J.; Fairobent, Lynne A.

2015-01-01

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8,000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized. The following terms are used in the AAPM practice guidelines: Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline.Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances. PMID:26103502

Medical Physics Practice Guideline 4.a: Development, implementation, use and maintenance of safety checklists.

PubMed

Fong de Los Santos, Luis E; Evans, Suzanne; Ford, Eric C; Gaiser, James E; Hayden, Sandra E; Huffman, Kristina E; Johnson, Jennifer L; Mechalakos, James G; Stern, Robin L; Terezakis, Stephanie; Thomadsen, Bruce R; Pronovost, Peter J; Fairobent, Lynne A

2015-05-08

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8,000 members and is the principal organization of medical physicists in the United States.The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner.Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized.The following terms are used in the AAPM practice guidelines:Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline.Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances.

AAPM Medical Physics Practice Guideline 5.a.: Commissioning and QA of Treatment Planning Dose Calculations — Megavoltage Photon and Electron Beams

PubMed Central

Das, Indra J.; Feygelman, Vladimir; Fraass, Benedick A.; Kry, Stephen F.; Marshall, Ingrid R.; Mihailidis, Dimitris N.; Ouhib, Zoubir; Ritter, Timothy; Snyder, Michael G.; Fairobent, Lynne

2015-01-01

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8,000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized. The following terms are used in the AAPM practice guidelines: Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline.Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances. PMID:26699330

AAPM Medical Physics Practice Guideline 5.a.: Commissioning and QA of Treatment Planning Dose Calculations - Megavoltage Photon and Electron Beams.

PubMed

Smilowitz, Jennifer B; Das, Indra J; Feygelman, Vladimir; Fraass, Benedick A; Kry, Stephen F; Marshall, Ingrid R; Mihailidis, Dimitris N; Ouhib, Zoubir; Ritter, Timothy; Snyder, Michael G; Fairobent, Lynne

2015-09-08

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8,000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized. The following terms are used in the AAPM practice guidelines:• Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline.• Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances.

AAPM Medical Physics Practice Guideline 3.a: Levels of supervision for medical physicists in clinical training.

PubMed

Seibert, J Anthony; Clements, Jessica B; Halvorsen, Per H; Herman, Michael G; Martin, Melissa C; Palta, Jatinder; Pfeiffer, Douglas E; Pizzutiello, Robert J; Schueler, Beth A; Shepard, S Jeff; Fairobrent, Lynne A

2015-05-08

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8,000 members and is the principal organization of medical physicists in the United States.The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner.Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized.The following terms are used in the AAPM practice guidelines:Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline.Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances.

Overcoming the four toughest management challenges. Increase your effectiveness by using situational leadership.

PubMed

Ketchum, S M

1991-01-01

The high-pressure work environment of the clinical laboratory presents significant challenges for managers. Often thrust into supervisory roles without formal management training, laboratory managers must find ways to delegate tasks, mediate conflict, minimize office politics, and build effective teams out of employees who may be quite diverse in their experience levels, motivation levels, and cultural backgrounds. This article explores the concept of situational leadership, which was developed by Ken Blanchard and Paul Hersey, and its applicability within the clinical laboratory. This practical paradigm involves matching one of four distinct management styles to the four development levels of employees. Each leadership style is explained, along with guidelines for giving performance feedback to employees, so that managers can evaluate their own supervisory styles. Finally, step-by-step recommendations for coping with the four management roles of delegator, referee, influencer, and team builder are presented.

The Role of Health Services Research in Developing Practice Policy: Development of Practice Guidelines.

ERIC Educational Resources Information Center

Crall, James J.

1990-01-01

The paper offers guidance for the incorporation of treatment effectiveness research into clinical dental practice guidelines. Recommended is inclusion of patients' preferences for different outcomes as well as of clinical outcomes in development of valid practice guidelines. (DB)

The AGNP-TDM Expert Group Consensus Guidelines: focus on therapeutic monitoring of antidepressants

PubMed Central

Baumann, Pierre; Ulrich, Sven; Eckermann, Gabriel; Gerlach, Manfred; Kuss, Hans-Joachim; Laux, Gerd; Müller-Oerlinghausen, Bruno; Rao, Marie Luise; Riederer, Peter; Zernig, Gerald; Hiemke, Christoph

2005-01-01

Therapeutic drug monitoring (TDM) of psychotropic drugs such as antidepressants has been widely introduced for optimization of pharmacotherapy in psychiatric patients. The interdisciplinary TDM group of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) has worked out consensus guidelines with the aim of providing psychiatrists and TDM laboratories with a tool to optimize the use of TDM. Five research-based levels of recommendation were defined with regard to routine monitoring of drug plasma concentrations: (i) strongly recommended; (ii) recommended; (iii) useful; (iv) probably useful; and (v) not recommended. In addition, a list of indications that justify the use of TDM is presented, eg, control of compliance, lack of clinical response or adverse effects at recommended doses, drug interactions, pharmacovigilance programs, presence of a genetic particularity concerning drug metabolism, and children, adolescents, and elderly patients. For some drugs, studies on therapeutic ranges are lacking, but target ranges for clinically relevant plasma concentrations are presented for most drugs, based on pharmacokinetic studies reported in the literature. For many antidepressants, a thorough analysis of the literature on studies dealing with the plasma concentration–clinical effectiveness relationship allowed inclusion of therapeutic ranges of plasma concentrations. In addition, recommendations are made with regard to the combination of pharmacogenetic (phenotyping or genotyping) tests with TDM, Finally, practical instructions are given for the laboratory practitioners and the treating physicians how to use TDM: preparation of TDM, drug analysis, reporting and interpretation of results, and adequate use of information for patient treatment. TDM is a complex process that needs optimal interdisciplinary coordination of a procedure implicating patients, treating physicians, clinical pharmacologists, and clinical laboratory specialists. These consensus guidelines should be helpful for optimizing TDM of antidepressants. PMID:16156382

Concussion Care Practices and Utilization of Evidence-Based Guidelines in the Evaluation and Management of Concussion: A Survey of New England Emergency Departments.

PubMed

Stern, Robert A; Seichepine, Daniel; Tschoe, Christine; Fritts, Nathan G; Alosco, Michael L; Berkowitz, Oren; Burke, Peter; Howland, Jonathan; Olshaker, Jonathan; Cantu, Robert C; Baugh, Christine M; Holsapple, James W

2017-02-15

Evidence-based clinical practice guidelines can facilitate proper evaluation and management of concussions in the emergency department (ED), often the initial and primary point of contact for concussion care. There is no universally adopted set of guidelines for concussion management, and extant evidence suggests that there may be variability in concussion care practices and limited application of clinical practice guidelines in the ED. This study surveyed EDs throughout New England to examine current practices of concussion care and utilization of evidence-based clinical practice guidelines in the evaluation and management of concussions. In 2013, a 32-item online survey was e-mailed to 149/168 EDs throughout New England (Connecticut, Rhode Island, Massachusetts, Vermont, New Hampshire, Maine). Respondents included senior administrators asked to report on their EDs use of clinical practice guidelines, neuroimaging decision-making, and discharge instructions for concussion management. Of the 72/78 respondents included, 35% reported absence of clinical practice guidelines, and 57% reported inconsistency in the type of guidelines used. Practitioner preference guided neuroimaging decision-making for 57%. Although 94% provided written discharge instructions, there was inconsistency in the recommended time frame for follow-up care (13% provided no specific time frame), the referral specialist to be seen (25% did not recommend any specialist), and return to activity instructions were inconsistent. There is much variability in concussion care practices and application of evidence-based clinical practice guidelines in the evaluation and management of concussions in New England EDs. Knowledge translational efforts will be critical to improve concussion management in the ED setting.

Librarian contributions to clinical practice guidelines.

PubMed

Cruse, Peggy; Protzko, Shandra

2014-01-01

Librarians have become more involved in developing high quality systematic reviews. Evidence-based practice guidelines are an extension of systematic reviews and offer another significant area for librarian involvement. This column highlights opportunities and challenges for the librarian working on guideline panels and provides practical considerations for meaningful contributions to the guideline creation process.

Health care delivery for head-and-neck cancer patients in Alberta: a practice guideline

PubMed Central

Harris, J.R.; Lau, H.; Surgeoner, B.V.; Chua, N.; Dobrovolsky, W.; Dort, J.C.; Kalaydjian, E.; Nesbitt, M.; Scrimger, R.A.; Seikaly, H.; Skarsgard, D.; Webster, M.A.

2014-01-01

Background The treatment of head-and-neck cancer is complex and requires the involvement of various health care professionals with a wide range of expertise. We describe the process of developing a practice guideline with recommendations about the organization and delivery of health care services for head-and-neck cancer patients in Alberta. Methods Outcomes of interest included composition of the health care team, qualification requirements for team members, cancer centre and team member volumes, infrastructure needs, and wait times. A search for existing practice guidelines and a systematic review of the literature addressing the organization and delivery of health care services for head-and-neck cancer patients were conducted. The search included the Standards and Guidelines Evidence (sage) directory of cancer guidelines and PubMed. Results One practice guideline was identified for adaptation. Three additional practice guidelines provided supplementary evidence to inform guideline recommendations. Members of the Alberta Provincial Head and Neck Tumour Team (consisting of various health professionals from across the province) provided expert feedback on the adapted recommendations through an online and in-person review process. Selected experts in head-and-neck cancer from outside the province participated in an external online review. SUMMARY The recommendations outlined in this practice guideline are based on existing guidelines that have been modified to fit the Alberta context. Although specific to Alberta, the recommendations lend credence to similar published guidelines and could be considered for use by groups lacking the resources of appointed guideline panels. The recommendations are meant to be a guide rather than a fixed protocol. The implementation of this practice guideline will depend on many factors, including but not limited to availability of trained personnel, adequate funding of infrastructure, and collaboration with other associations of health care professionals in the province. PMID:25302041

Validation of pharmaceutical potency determinations by quantitative nuclear magnetic resonance spectrometry.

PubMed

Webster, Gregory K; Marsden, Ian; Pommerening, Cynthia A; Tyrakowski, Christina M

2010-05-01

With the changing development paradigms in the pharmaceutical industry, laboratories are challenged to release materials for clinical studies with rapid turnaround times. To minimize cost demands, many businesses are looking to develop ways of using early Good Manufacturing Practice (GMP) materials of active pharmaceutical ingredients (API) for Good Laboratory Practice (GLP) toxicology studies. To make this happen, the analytical laboratory releases the material by one of three scenarios: (1) holding the GLP release until full GMP testing is ready, (2) issuing a separate lot number for a portion of the GMP material and releasing the material for GLP use, or (3) releasing the lot of material for GLP using alternate (equivalent) method(s) not specified for GMP release testing. Many companies are finding the third scenario to be advantageous in terms of cost and efficiency through the use of quantitative nuclear magnetic resonance (q-NMR). The use of q-NMR has proved to be a single-point replacement for routine early development testing that previously combined elements of identity testing, chromatographic assay, moisture analysis, residual solvent analysis, and elemental analysis. This study highlights that q-NMR can be validated to meet current regulatory analytical method guidelines for routine pharmaceutical analysis.

Teaching practices of the undergraduate introductory biomechanics faculty: a North American survey.

PubMed

Garceau, Luke R; Ebben, William P; Knudson, Duane V

2012-11-01

Instruction and assessment strategies of undergraduate introductory biomechanics instructors have yet to be comprehensively examined. The purpose of this study was to identify the current instruction and assessment practices of North American undergraduate introductory biomechanics instructors and equipment needed for effective instruction in lecture and laboratory sessions. One hundred and sixty-five respondents (age: 42.5 +/- 10.3 years) who currently teach or have taught an introductory biomechanics course in North America were recruited by electronic mail. Subjects completed a web-based survey, consisting of 60 open- and closed-ended questions. Pearson's correlation coefficients were used to assess relationships between instructor's familiarity with either the Biomechanics Concept Inventory or the NASPE Guidelines for Undergraduate Biomechanics, and instructor and course characteristics (number of years teaching, age, faculty rank, number of quizzes given, etc.) A number of variables were significantly (p < 0.05) correlated. Answers to open-ended questions were processed using content analysis, with results categorized in content areas including: instructor and course characteristics; lecture instruction; assessment and equipment; laboratory instruction; assessment and equipment; and instructor's perspectives. Many active learning strategies for lecture and laboratory instruction were identified by faculty. Limited student preparation and limited resources were noted as the instructor's most common challenges.

75 FR 16813 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of [[Page 16814

A Review of the Centers for Disease Control and Prevention's Guidelines for the Clinical Laboratory Diagnosis of Lyme Disease.

PubMed

Miraglia, Caterina M

2016-12-01

The purpose of this paper is to review information regarding the current guidelines for the clinical laboratory diagnosis of Lyme disease as set forth by the Centers for Disease Control and Prevention (CDC) to chiropractic physicians and to discuss the clinical utility of this testing. The CDC's website was reviewed to determine what their current recommendations are for the clinical laboratory testing of Lyme disease. The CDC's established guidelines recommend the use of a 2-tiered serologic testing algorithm for the evaluation of patients with suspected Lyme disease. This review provides doctors of chiropractic with information to remain current with the CDC's recommended guidelines for Lyme disease testing because patients may present to their office with the associated signs and symptoms of Lyme disease.

Bridging the gap between guidelines and practice in the management of emerging infectious diseases: a qualitative study of emergency nurses.

PubMed

Lam, Stanley Kk; Kwong, Enid Wy; Hung, Maria Sy; Pang, Samantha Mc

2016-10-01

To explore the difficulties and strategies regarding guideline implementation among emergency nurses. Emerging infectious diseases remain an underlying source of global health concern. Guidelines for accident and emergency departments would require adjustments for infectious disease management. However, disparities between guidelines and nurses' practice are frequently reported, which undermines the implementation of these guidelines into practice. This article explores the experience of frontline emergency nurses regarding guideline implementation and provides an in-depth account of their strategies in bridging guideline-practice gaps. A qualitative descriptive design was used. Semi-structured, face-to-face, individual interviews were conducted between November 2013-May 2014. A purposive sample of 12 frontline emergency nurses from five accident and emergency departments in Hong Kong were recruited. The audio-recorded interviews were transcribed verbatim and analysed with a qualitative content analysis approach. Four key categories associated with guideline-practice gaps emerged, including getting work done, adapting to accelerated infection control measures, compromising care standards and resolving competing clinical judgments across collaborating departments. The results illustrate that the guideline-practice gaps could be associated with inadequate provision of corresponding organisational supports after guidelines are established. The nurses' experiences have uncovered the difficulties in the implementation of guidelines in emergency care settings and the corresponding strategies used to address these problems. The nurses' experiences reflect their endeavour in adjusting accordingly and adapting themselves to their circumstances in the face of unfeasible guidelines. It is important to customise guidelines to the needs of frontline nurses. Maintaining cross-departmental consensus on guideline interpretation and operation is also indicated as an important component for effective guideline implementation. © 2016 John Wiley & Sons Ltd.

National survey on the pre-analytical variability in a representative cohort of Italian laboratories.

PubMed

Lippi, Giuseppe; Montagnana, Martina; Giavarina, Davide

2006-01-01

Owing to remarkable advances in automation, laboratory technology and informatics, the pre-analytical phase has become the major source of variability in laboratory testing. The present survey investigated the development of several pre-analytical processes within a representative cohort of Italian clinical laboratories. A seven-point questionnaire was designed to investigate the following issues: 1a) the mean outpatient waiting time before check-in and 1b) the mean time from check-in to sample collection; 2) the mean time from sample collection to analysis; 3) the type of specimen collected for clinical chemistry testing; 4) the degree of pre-analytical automation; 5a) the number of samples shipped to other laboratories and 5b) the availability of standardised protocols for transportation; 6) the conditions for specimen storage; and 7) the availability and type of guidelines for management of unsuitable specimens. The questionnaire was administered to 150 laboratory specialists attending the SIMEL (Italian Society of Laboratory Medicine) National Meeting in June 2006. 107 questionnaires (71.3%) were returned. Data analysis revealed a high degree of variability among laboratories for the time required for check-in, outpatient sampling, sample transportation to the referral laboratory and analysis upon the arrival. Only 31% of laboratories have automated some pre-analytical steps. Of the 87% of laboratories that ship specimens to other facilities without sample preparation, 19% have no standardised protocol for transportation. For conventional clinical chemistry testing, 74% of the laboratories use serum evacuated tubes (59% with and 15% without serum separator), whereas the remaining 26% use lithium-heparin evacuated tubes (11% with and 15% without plasma separator). The storage period and conditions for rerun/retest vary widely. Only 63% of laboratories have a codified procedure for the management of unsuitable specimens, which are recognised by visual inspection (69%) or automatic detection (29%). Only 56% of the laboratories have standardised procedures for the management of unsuitable specimens, which vary widely on a local basis. The survey highlights broad heterogeneity in several pre-analytical processes among Italian laboratories. The lack of reliable guidelines encompassing evidence-based practice is a major problem for the standardisation of this crucial part of the testing process and represents a major challenge for laboratory medicine in the 2000s.

International Society for the Advancement of Cytometry Cell Sorter Biosafety Standards

PubMed Central

Holmes, Kevin L.; Fontes, Benjamin; Hogarth, Philip; Konz, Richard; Monard, Simon; Pletcher, Charles H.; Wadley, Robert B.; Schmid, Ingrid; Perfetto, Stephen P.

2014-01-01

Flow cytometric cell sorting of biological specimens has become prevalent in basic and clinical research laboratories. These specimens may contain known or unknown infectious agents, necessitating precautions to protect instrument operators and the environment from biohazards arising from the use of sorters. To this end the International Society of Analytical Cytology (ISAC) was proactive in establishing biosafety guidelines in 1997 (Schmid et al., Cytometry 1997;28:99–117) and subsequently published revised biosafety standards for cell sorting of unfixed samples in 2007 (Schmid et al., Cytometry Part A J Int Soc Anal Cytol 2007;71A:414–437). Since their publication, these documents have become recognized worldwide as the standard of practice and safety precautions for laboratories performing cell sorting experiments. However, the field of cytometry has progressed since 2007, and the document requires an update. The new Standards provides guidance: (1) for laboratory design for cell sorter laboratories; (2) for the creation of laboratory or instrument specific Standard Operating Procedures (SOP); and (3) on procedures for the safe operation of cell sorters, including personal protective equipment (PPE) and validation of aerosol containment. PMID:24634405

A quality management systems approach for CD4 testing in resource-poor settings.

PubMed

Westerman, Larry E; Kohatsu, Luciana; Ortiz, Astrid; McClain, Bernice; Kaplan, Jonathan; Spira, Thomas; Marston, Barbara; Jani, Ilesh V; Nkengasong, John; Parsons, Linda M

2010-10-01

Quality assurance (QA) is a systematic process to monitor and improve clinical laboratory practices. The fundamental components of a laboratory QA program include providing a functional and safe laboratory environment, trained and competent personnel, maintained equipment, adequate supplies and reagents, testing of appropriate specimens, internal monitoring of quality, accurate reporting, and external quality assessments. These components are necessary to provide accurate and precise CD4 T-cell counts, an essential test to evaluate start of and monitor effectiveness of antiretroviral therapy for HIV-infected patients. In recent years, CD4 testing has expanded dramatically in resource-limited settings. Information on a CD4 QA program as described in this article will provide guidelines not only for clinical laboratory staff but also for managers of programs responsible for supporting CD4 testing. All agencies involved in implementing CD4 testing must understand the needs of the laboratory and provide advocacy, guidance, and financial support to established CD4 testing sites and programs. This article describes and explains the procedures that must be put in place to provide reliable CD4 determinations in a variety of settings.

Challenges in Transgender Healthcare: The Pathology Perspective.

PubMed

Gupta, Sarika; Imborek, Katherine L; Krasowski, Matthew D

2016-08-01

The transgender community is one of the most marginalized sections of our society. The literature is scarce regarding the pathology and laboratory medicine challenges associated with caring for transgender patients. To summarize the available gender-transitioning options and to discuss healthcare challenges, from a pathology/laboratory medicine perspective, in the care of transgender patients. We reviewed the current terminology and epidemiology relevant to the transgender population in preparing our analysis. The main transgender healthcare challenges in pathology/laboratory medicine practice include the inflexibility of electronic medical records in documenting affirmed gender, unfamiliarity among medical and laboratory professional with the needs of and terminology related to the transgender population, lack of reference ranges for laboratory tests, unclear guidelines regarding gender classification for blood donation eligibility criteria, and paucity of experience in handling and interpreting surgical and cytologic specimens from gender-transitioning individuals. Directed efforts to overcome these shortcomings, coupled with a more welcoming posture, are essential to achieving the highest standards of care for the transgender population. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Financial Relationships between Organizations That Produce Clinical Practice Guidelines and the Biomedical Industry: A Cross-Sectional Study

PubMed Central

Campsall, Paul; Colizza, Kate; Straus, Sharon; Stelfox, Henry T.

2016-01-01

Background Financial relationships between organizations that produce clinical practice guidelines and biomedical companies are vulnerable to conflicts of interest. We sought to determine whether organizations that produce clinical practice guidelines have financial relationships with biomedical companies and whether there are associations between organizations’ conflict of interest policies and recommendations and disclosures provided in guidelines. Methods and Findings We conducted a cross-sectional survey and review of websites of 95 national/international medical organizations that produced 290 clinical practice guidelines published on the National Guideline Clearinghouse website from January 1 to December 31, 2012. Survey responses were available for 68% (65/95) of organizations (167/290 guidelines, 58%), and websites were reviewed for 100% (95/95) of organizations (290/290 guidelines, 100%). In all, 63% (60/95) of organizations producing clinical practice guidelines reported receiving funds from a biomedical company; 80% (76/95) of organizations reported having a policy for managing conflicts of interest. Disclosure statements (disclosing presence or absence of financial relationships with biomedical companies) were available in 65% (188/290) of clinical practice guidelines for direct funding sources to produce the guideline, 51% (147/290) for financial relationships of the guideline committee members, and 1% (4/290) for financial relationships of the organizations producing the guidelines. Among all guidelines, 6% (18/290) disclosed direct funding by biomedical companies, 40% (117/290) disclosed financial relationships between committee members and biomedical companies (38% of guideline committee members, 773/2,043), and 1% (4/290) disclosed financial relationships between the organizations producing the guidelines and biomedical companies. In the survey responses, 60 organizations reported the procedures that they included in their conflict of interest policies (158 guidelines): guidelines produced by organizations reporting more comprehensive conflict of interest policies (per additional procedure, range 5–17) included fewer positive (rate ratio [RR] 0.91, 95% CI 0.86–0.95) and more negative (RR 1.32, 95% CI 1.09–1.60) recommendations regarding patented biomedical products. The clinical practice guidelines produced by organizations reporting more comprehensive conflict of interest policies were also more likely to include disclosure statements for direct funding sources (odds ratio [OR] 1.31, 95% CI 1.10–1.56) and financial relationships of guideline committee members (OR 1.36, 95% CI 1.09–1.79), but not financial relationships of the organizations (0 disclosures). Limitations of the study include the use of the National Guideline Clearinghouse as the single source of clinical practice guidelines and the self-report of survey responses and organizations’ website postings. Conclusions Financial relationships between organizations that produce clinical practice guidelines and biomedical companies are common and infrequently disclosed in guidelines. Our study highlights the need for an effective policy to manage organizational conflicts of interest and disclosure of financial relationships. PMID:27244653

Derived concentration guideline levels for Argonne National Laboratory's building 310 area.

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

Kamboj, S., Dr.; Yu, C ., Dr.

2011-08-12

The derived concentration guideline level (DCGL) is the allowable residual radionuclide concentration that can remain in soil after remediation of the site without radiological restrictions on the use of the site. It is sometimes called the single radionuclide soil guideline or the soil cleanup criteria. This report documents the methodology, scenarios, and parameters used in the analysis to support establishing radionuclide DCGLs for Argonne National Laboratory's Building 310 area.

Recommendations for the management of biofilm: a consensus document.

PubMed

Bianchi, T; Wolcott, R D; Peghetti, A; Leaper, D; Cutting, K; Polignano, R; Rosa Rita, Z; Moscatelli, A; Greco, A; Romanelli, M; Pancani, S; Bellingeri, A; Ruggeri, V; Postacchini, L; Tedesco, S; Manfredi, L; Camerlingo, Maria; Rowan, S; Gabrielli, A; Pomponio, G

2016-06-01

The potential impact of biofilm on healing in acute and chronic wounds is one of the most controversial current issues in wound care. A significant amount of laboratory-based research has been carried out on this topic, however, in 2013 the European Wound Management Association (EWMA) pointed out the lack of guidance for managing biofilms in clinical practice and solicited the need for guidelines and further clinical research. In response to this challenge, the Italian Nursing Wound Healing Society (AISLeC) initiated a project which aimed to achieve consensus among a multidisciplinary and multiprofessional international panel of experts to identify what could be considered part of 'good clinical practice' with respect to the recognition and management of biofilms in acute and chronic wounds. The group followed a systematic approach, developed by the GRADE working group, to define relevant questions and clinical recommendations raised in clinical practice. An independent librarian retrieved and screened approximately 2000 pertinent published papers to produce tables of levels of evidence. After a smaller focus group had a multistep structured discussion, and a formal voting process had been completed, ten therapeutic interventions were identified as being strongly recommendable for clinical practice, while another four recommendations were graded as being 'weak'. The panel subsequently formulated a preliminary statement (although with a weak grade of agreement): 'provided that other causes that prevent optimal wound healing have been ruled out, chronic wounds are chronically infected'. All members of the panel agreed that there is a paucity of reliable, well-conducted clinical trials which have produced clear evidence related to the effects of biofilm presence. In the meantime it was agreed that expert-based guidelines were needed to be developed for the recognition and management of biofilms in wounds and for the best design of future clinical trials. This is a fundamental and urgent task for both laboratory-based scientists and clinicians.

How GPs implement clinical guidelines in everyday clinical practice--a qualitative interview study.

PubMed

Le, Jette V; Hansen, Helle P; Riisgaard, Helle; Lykkegaard, Jesper; Nexøe, Jørgen; Bro, Flemming; Søndergaard, Jens

2015-12-01

Clinical guidelines are considered to be essential for improving quality and safety of health care. However, interventions to promote implementation of guidelines have demonstrated only partial effectiveness and the reasons for this apparent failure are not yet fully understood. To investigate how GPs implement clinical guidelines in everyday clinical practice and how implementation approaches differ between practices. Individual semi-structured open-ended interviews with seven GPs who were purposefully sampled with regard to gender, age and practice form. Interviews were recorded, transcribed verbatim and then analysed using systematic text condensation. Analysis of the interviews revealed three different approaches to the implementation of guidelines in clinical practice. In some practices the GPs prioritized time and resources on collective implementation activities and organized their everyday practice to support these activities. In other practices GPs discussed guidelines collectively but left the application up to the individual GP whilst others again saw no need for discussion or collective activities depending entirely on the individual GP's decision on whether and how to manage implementation. Approaches to implementation of clinical guidelines vary substantially between practices. Supporting activities should take this into account. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Practice Guidelines for Nutrition in Critically Ill Patients: A Relook for Indian Scenario.

PubMed

Mehta, Yatin; Sunavala, J D; Zirpe, Kapil; Tyagi, Niraj; Garg, Sunil; Sinha, Saswati; Shankar, Bhuvaneshwari; Chakravarti, Sanghamitra; Sivakumar, M N; Sahu, Sambit; Rangappa, Pradeep; Banerjee, Tanmay; Joshi, Anshu; Kadhe, Ganesh

2018-04-01

Intensive-care practices and settings may differ for India in comparison to other countries. While international guidelines are available to direct the use of enteral nutrition (EN), there are no recommendations specific to Indian settings. Advisory board meetings were arranged to develop the practice guidelines specific to Indian context, for the use of EN in critically ill patients and to overcome challenges in this field. Various existing guidelines, meta-analyses, randomized controlled trials, controlled trials, and review articles were reviewed for their contextual relevance and strength. A systematic grading of practice guidelines by advisory board was done based on strength of the supporting evidence. Wherever Indian studies were not available, references were taken from the international guidelines. Based on the literature review, the recommendations for developing the practice guidelines were made as per the grading criteria agreed upon by the advisory board. The recommendations were to address challenges regarding EN versus parenteral nutrition; nutrition screening and assessment; nutrition in hemodynamically unstable; route of nutrition; tube feeding and challenges; tolerance; optimum calorie-protein requirements; selection of appropriate enteral feeding formula; micronutrients and immune-nutrients; standard nutrition in hepatic, renal, and respiratory diseases and documentation of nutrition practices. This paper summarizes the optimum nutrition practices for critically ill patients. The possible solutions to overcome the challenges in this field are presented as practice guidelines at the end of each section. These guidelines are expected to provide guidance in critical care settings regarding appropriate critical-care nutrition practices and to set up Intensive Care Unit nutrition protocols.

Practice Guidelines for Nutrition in Critically Ill Patients: A Relook for Indian Scenario

PubMed Central

Mehta, Yatin; Sunavala, J. D.; Zirpe, Kapil; Tyagi, Niraj; Garg, Sunil; Sinha, Saswati; Shankar, Bhuvaneshwari; Chakravarti, Sanghamitra; Sivakumar, M. N.; Sahu, Sambit; Rangappa, Pradeep; Banerjee, Tanmay; Joshi, Anshu; Kadhe, Ganesh

2018-01-01

Background and Aim: Intensive-care practices and settings may differ for India in comparison to other countries. While international guidelines are available to direct the use of enteral nutrition (EN), there are no recommendations specific to Indian settings. Advisory board meetings were arranged to develop the practice guidelines specific to Indian context, for the use of EN in critically ill patients and to overcome challenges in this field. Methods: Various existing guidelines, meta-analyses, randomized controlled trials, controlled trials, and review articles were reviewed for their contextual relevance and strength. A systematic grading of practice guidelines by advisory board was done based on strength of the supporting evidence. Wherever Indian studies were not available, references were taken from the international guidelines. Results: Based on the literature review, the recommendations for developing the practice guidelines were made as per the grading criteria agreed upon by the advisory board. The recommendations were to address challenges regarding EN versus parenteral nutrition; nutrition screening and assessment; nutrition in hemodynamically unstable; route of nutrition; tube feeding and challenges; tolerance; optimum calorie-protein requirements; selection of appropriate enteral feeding formula; micronutrients and immune-nutrients; standard nutrition in hepatic, renal, and respiratory diseases and documentation of nutrition practices. Conclusion: This paper summarizes the optimum nutrition practices for critically ill patients. The possible solutions to overcome the challenges in this field are presented as practice guidelines at the end of each section. These guidelines are expected to provide guidance in critical care settings regarding appropriate critical-care nutrition practices and to set up Intensive Care Unit nutrition protocols. PMID:29743765

Attitudes Toward Practice Guidelines Among ICU Personnel: A Cross-Sectional Anonymous Survey

PubMed Central

Quiros, Dave; Lin, Susan; Larson, Elaine L

2007-01-01

Objectives To assess attitudes of ICU staff members toward practice guidelines in general and toward a specific guideline, CDC's Guideline for Hand Hygiene in Healthcare Settings; to correlate these attitudes with staff and hospital characteristics; and to examine the impact of staff attitudes toward the Hand Hygiene Guideline on self reported implementation of the Guideline. Methods A cross-sectional survey of staff in 70 ICUs in 39 U.S. hospitals, members of The National Nosocomial Infection Surveillance (NNIS) System. A survey, “Attitudes Regarding Practice Guidelines”, was administered anonymously to all willing staff during a site visit at each hospital; 1,359 ICU personnel: 1,003 nurses (74%), 228 physicians (17%), and 128 others (10%) responded. Results Significantly more positive attitudes toward practice guidelines were found among staff in pediatric as compared with adult ICUs (p<0.001). Nurses and other staff when compared with physicians had more positive attitudes toward guidelines in general but not toward the specific Hand Hygiene Guideline. Those with more positive attitudes were significantly more likely to report that they had implemented recommendations of the Guideline (p<0.001) and used an alcohol product for hand hygiene (p=0.002). Conclusions The majority of staff members were familiar with the CDC Hand Hygiene Guideline. Staff attitudes toward practice guidelines varied by type of ICU and by profession, and more positive attitudes were associated with significantly better self-reported guideline implementation. Because differences in staff attitudes might hinder or facilitate their acceptance and adoption of evidence-based practice guidelines, these results may have important implications for the education and/or socialization of ICU staff. PMID:17628198

Concussion Care Practices and Utilization of Evidence-Based Guidelines in the Evaluation and Management of Concussion: A Survey of New England Emergency Departments

PubMed Central

Seichepine, Daniel; Tschoe, Christine; Fritts, Nathan G.; Alosco, Michael L.; Berkowitz, Oren; Burke, Peter; Howland, Jonathan; Olshaker, Jonathan; Cantu, Robert C.; Baugh, Christine M.; Holsapple, James W.

2017-01-01

Abstract Evidence-based clinical practice guidelines can facilitate proper evaluation and management of concussions in the emergency department (ED), often the initial and primary point of contact for concussion care. There is no universally adopted set of guidelines for concussion management, and extant evidence suggests that there may be variability in concussion care practices and limited application of clinical practice guidelines in the ED. This study surveyed EDs throughout New England to examine current practices of concussion care and utilization of evidence-based clinical practice guidelines in the evaluation and management of concussions. In 2013, a 32-item online survey was e-mailed to 149/168 EDs throughout New England (Connecticut, Rhode Island, Massachusetts, Vermont, New Hampshire, Maine). Respondents included senior administrators asked to report on their EDs use of clinical practice guidelines, neuroimaging decision-making, and discharge instructions for concussion management. Of the 72/78 respondents included, 35% reported absence of clinical practice guidelines, and 57% reported inconsistency in the type of guidelines used. Practitioner preference guided neuroimaging decision-making for 57%. Although 94% provided written discharge instructions, there was inconsistency in the recommended time frame for follow-up care (13% provided no specific time frame), the referral specialist to be seen (25% did not recommend any specialist), and return to activity instructions were inconsistent. There is much variability in concussion care practices and application of evidence-based clinical practice guidelines in the evaluation and management of concussions in New England EDs. Knowledge translational efforts will be critical to improve concussion management in the ED setting. PMID:27112592

Standards and Guidelines in Telemedicine and Telehealth

PubMed Central

Krupinski, Elizabeth A.; Bernard, Jordana

2014-01-01

The development of guidelines and standards for telemedicine is an important and valuable process to help insure effective and safe delivery of quality healthcare. Some organizations, such as the American Telemedicine Association (ATA), have made the development of standards and guidelines a priority. The practice guidelines developed so far have been well received by the telemedicine community and are being adopted in numerous practices, as well as being used in research to support the practice and growth of telemedicine. Studies that utilize published guidelines not only help bring them into greater public awareness, but they also provide evidence needed to validate existing guidelines and guide the revision of future versions. Telemedicine will continue to grow and be adopted by more healthcare practitioners and patients in a wide variety of forms not just in the traditional clinical environments, and practice guidelines will be a key factor in fostering this growth. Creation of guidelines is important to payers and regulators as well as increasingly they are adopting and integrating them into regulations and policies. This paper will review some of the recent ATA efforts in developing telemedicine practice guidelines, review the role of research in guidelines development, review data regarding their use, and discuss some of areas where guidelines are still needed. PMID:27429261

The SUCCESS model for laboratory performance and execution of rapid molecular diagnostics in patients with sepsis.

PubMed

Dekmezian, Mhair; Beal, Stacy G; Damashek, Mary Jane; Benavides, Raul; Dhiman, Neelam

2015-04-01

Successful performance and execution of rapid diagnostics in a clinical laboratory hinges heavily on careful validation, accurate and timely communication of results, and real-time quality monitoring. Laboratories must develop strategies to integrate diagnostics with stewardship and evidence-based clinical practice guidelines. We present a collaborative SUCCESS model for execution and monitoring of rapid sepsis diagnostics to facilitate timely treatment. Six months after execution of the Verigene Gram-Positive Blood Culture (BC-GP) and the AdvanDx PNA-FISH assays, data were collected on 579 and 28 episodes of bacteremia and fungemia, respectively. Clinical testing was executed using a SUCCESS model comprising the following components: stewardship, utilization of resources, core strategies, concierge services, education, support, and surveillance. Stewardship needs were identified by evaluating the specialty services benefiting from new testing. Utilization of resources was optimized by reviewing current treatment strategies and antibiogram and formulary options. Core strategies consisted of input from infectious disease leadership, pharmacy, and laboratory staff. Concierge services included automated Micro-eUpdate and physician-friendly actionable reports. Education modules were user-specific, and support was provided through a dedicated 24/7 microbiology hotline. Surveillance was performed by daily audit by the director. Using the SUCCESS model, the turnaround time for the detailed report with actionable guidelines to the physician was ∼3 hours from the time of culture positivity. The overall correlation between rapid methods and culture was 94% (546/579). Discrepant results were predominantly contaminants such as a coagulase-negative staphylococci or viridans streptococci in mixed cultures. SUCCESS is a cost-effective and easily adaptable model for clinical laboratories with limited stewardship resources.

The rural health care workforce implications of practice guideline implementation.

PubMed

Yawn, B P; Casey, M; Hebert, P

1999-03-01

Rural health care workforce forecasting has not included adjustments for predictable changes in practice patterns, such as the introduction of practice guidelines. To estimate the impact of a practice guideline for a single health condition on the needs of a rural health professional workforce. The current care of a cohort of rural Medicare recipients with diabetes mellitus was compared with the care recommended by a diabetes practice guideline. The additional tests and visits that were needed to comply with the guideline were translated into additional hours of physician services and total physician full-time equivalents. The implementation of a practice guideline for Medicare recipients with diabetes in rural Minnesota would require over 30,000 additional hours of primary care physician services and over 5,000 additional hours of eye care professionals' time per year. This additional need represents a 1.3% to 2.4% increase in the number of primary care physicians and a 1.0% to 6.6% increase in the number of eye-care clinicians in a state in which the rural medical provider to population ratios already meet some recommended workforce projections. The implementation of practice guidelines could result in an increased need for rural health care physicians or other providers. That increase, caused by guideline implementation, should be accounted for in future rural health care workforce predictions.

Impact of Clinical Practice Guidelines on Use of Intra-Articular Hyaluronic Acid and Corticosteroid Injections for Knee Osteoarthritis.

PubMed

Bedard, Nicholas A; DeMik, David E; Glass, Natalie A; Burnett, Robert A; Bozic, Kevin J; Callaghan, John J

2018-05-16

The efficacy of corticosteroid and hyaluronic acid injections for knee osteoarthritis has been questioned. The purpose of this study was to determine the impact of the American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines on the use of these injections in the United States and determine if utilization differed by provider specialty. Patients with knee osteoarthritis were identified within the Humana database from 2007 to 2015, and the percentage of patients receiving a knee injection relative to the number of patients having an encounter for knee osteoarthritis was calculated and was trended for the study period. The impact of each edition of the AAOS clinical practice guidelines on injection use was evaluated with segmented regression analysis. Injection trends were also analyzed relative to the specialty of the provider performing the injection. Of 1,065,175 patients with knee osteoarthritis, 405,101 (38.0%) received a corticosteroid injection and 137,005 (12.9%) received a hyaluronic acid injection. The rate of increase in hyaluronic acid use, per 100 patients with knee osteoarthritis, decreased from 0.15 to 0.07 injection per quarter year (p = 0.02) after the first clinical practice guideline, and the increase changed to a decrease at a rate of -0.12 injection per quarter (p < 0.001) after the second clinical practice guideline. After the first clinical practice guideline, the rate of increase in utilization of corticosteroids, per 100 patients with knee osteoarthritis, significantly lessened to 0.12 injection per quarter (p < 0.001), and after the second clinical practice guideline, corticosteroid injection use plateaued (p = 0.72). The trend in use of hyaluronic acid injections by orthopaedic surgeons and pain specialists decreased with time following the second-edition clinical practice guideline but did not change for primary care physicians or nonoperative musculoskeletal providers. Subtle but significant changes in hyaluronic acid and corticosteroid injections occurred following the publication of both clinical practice guidelines. Although the clinical practice guidelines did impact injection use, given the high costs of these injections and their questionable clinical efficacy, further interventions beyond publishing clinical practice guidelines are needed to encourage higher-value care for patients with knee osteoarthritis.

Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

PubMed

Garber, Jeffrey R; Cobin, Rhoda H; Gharib, Hossein; Hennessey, James V; Klein, Irwin; Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Singer, Peter A; Woeber, Kenneth A

2012-12-01

Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients. The development of these guidelines was commissioned by the American Association of Clinical Endocrinologists (AACE) in association with American Thyroid Association (ATA). AACE and the ATA assembled a task force of expert clinicians who authored this article. The authors examined relevant literature and took an evidence-based medicine approach that incorporated their knowledge and experience to develop a series of specific recommendations and the rationale for these recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach outlined in the American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Guidelines-2010 update. Topics addressed include the etiology, epidemiology, clinical and laboratory evaluation, management, and consequences of hypothyroidism. Screening, treatment of subclinical hypothyroidism, pregnancy, and areas for future research are also covered. Fifty-two evidence-based recommendations and subrecommendations were developed to aid in the care of patients with hypothyroidism and to share what the authors believe is current, rational, and optimal medical practice for the diagnosis and care of hypothyroidism. A serum thyrotropin is the single best screening test for primary thyroid dysfunction for the vast majority of outpatient clinical situations. The standard treatment is replacement with L-thyroxine. The decision to treat subclinical hypothyroidism when the serum thyrotropin is less than 10 mIU/L should be tailored to the individual patient.

Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

PubMed

Garber, Jeffrey R; Cobin, Rhoda H; Gharib, Hossein; Hennessey, James V; Klein, Irwin; Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Singer, Peter A; Woeber, Kenneth A

2012-01-01

Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients. The development of these guidelines was commissioned by the American Association of Clinical Endocrinologists (AACE) in association with American Thyroid Association (ATA). AACE and the ATA assembled a task force of expert clinicians who authored this article. The authors examined relevant literature and took an evidence-based medicine approach that incorporated their knowledge and experience to develop a series of specific recommendations and the rationale for these recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach outlined in the American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Guidelines-2010 update. Topics addressed include the etiology, epidemiology, clinical and laboratory evaluation, management, and consequences of hypothyroidism. Screening, treatment of subclinical hypothyroidism, pregnancy, and areas for future research are also covered. Fifty-two evidence-based recommendations and subrecommendations were developed to aid in the care of patients with hypothyroidism and to share what the authors believe is current, rational, and optimal medical practice for the diagnosis and care of hypothyroidism. A serum thyrotropin is the single best screening test for primary thyroid dysfunction for the vast majority of outpatient clinical situations. The standard treatment is replacement with L-thyroxine. The decision to treat subclinical hypothyroidism when the serum thyrotropin is less than 10 mIU/L should be tailored to the individual patient.

[Neumonía acquired in the community. Practical guide elaborated by a committee intersocieties].

PubMed

Luna, Carlos M; Calmaggi, Aníbal; Caberloto, Oscar; Gentile, Jorge; Valentini, Ricardo; Ciruzzi, Julian; Clara, Liliana; Rizzo, Oscar; Lasdica, Sergio; Blumenfeld, Marcelo; Benchetrit, Guillermo; Famiglietti, Angela; Apezteguia, Carlos; Monteverde, Alfredo

2003-01-01

Clinical practice guidelines for community-acquired pneumonia (CAP) contribute to improve patient's management. CAP undergoes continuous changes in etiology, epidemiology and antimicrobial sensitivity, requiring periodic guidelines revisions. An inter-society committee designed this guidelines dividing it into several topics based on prior guidelines and recent clinical studies. CAP compromises annually more than 1% of the population; most of the cases only require outpatient care but others are severe cases, reaching the 6th cause of death in Argentina. The cases are distributed unevenly into ambulatory, admitted in the general ward or in the intensive care unit. There is no way to predict the etiology. Unfavorable outcome predictors include age, antecedents and physical, laboratory and radiography findings. Ten to 25% of inpatients need to be admitted to the intensive care unit at the onset or during the follow-up, for mechanical ventilation or hemodynamic support (severe CAP). Severe CAP is associated with high mortality and requires adequate and urgent therapy. Pregnant, COPD and nursing home patients require special recommendations. Diagnosis is clinical, while complementary methods are useful to define etiology and severity; chest X-ray is the only one universally recommended. Other studies, including microbiologic evaluation are particularly appropriate in the hospitalized patients. The initial therapy is empiric, it must begin early, using antimicrobials active against the target microorganisms, avoiding their inappropriate use which can lead to the development of resistance. Length of therapy must not be unnecessarily prolonged. Hydratation, nutrition, oxygen and therapy of complications must complement antibiotic treatment. Prevention is based on influenza prophylaxis, anti-pneumococcal vaccine, aspiration prevention and other general measures.

Guidelines on treatment of perinatal depression with antidepressants: An international review

PubMed Central

Kamperman, Astrid M; Boyce, Philip; Bergink, Veerle

2018-01-01

Objective: Several countries have developed Clinical Practice Guidelines regarding treatment of perinatal depressive symptoms and perinatal use of antidepressant. We aimed to compare guidelines to guide clinicians in best clinical practice. Methods: An extensive search in guideline databases, MEDLINE and PsycINFO was performed. When no guidelines were (publicly) available online, we contacted psychiatric-, obstetric-, perinatal- and mood disorder societies of all first world countries and the five largest second world countries. Only Clinical Practice Guidelines adhering to quality criteria of the Appraisal of Guidelines for Research and Evaluation instrument and including a systematic review of evidence were included. Data extraction focussed on recommendations regarding continuation or withdrawal of antidepressants and preferred treatment in newly depressed patients. Results: Our initial search resulted in 1094 articles. After first screening, 40 full-text articles were screened. Of these, 24 were excluded for not being an official Clinical Practice Guidelines. In total, 16 Clinical Practice Guidelines were included originating from 12 countries. Eight guidelines were perinatal specific and eight were general guidelines. Conclusion: During pregnancy, four guidelines advise to continue antidepressants, while there is a lack of evidence supporting this recommendation. Five guidelines do not specifically advise or discourage continuation. For new episodes, guidelines agree on psychotherapy (especially cognitive behavioural therapy) as initial treatment for mild to moderate depression and antidepressants for severe depression, with a preference for sertraline. Paroxetine is not preferred treatment for new episodes but switching antidepressants for ongoing treatment is discouraged (three guidelines). If mothers use antidepressants, observation of the neonate is generally recommended and breastfeeding encouraged. PMID:29506399

Guidelines on treatment of perinatal depression with antidepressants: An international review.

PubMed

Molenaar, Nina M; Kamperman, Astrid M; Boyce, Philip; Bergink, Veerle

2018-04-01

Several countries have developed Clinical Practice Guidelines regarding treatment of perinatal depressive symptoms and perinatal use of antidepressant. We aimed to compare guidelines to guide clinicians in best clinical practice. An extensive search in guideline databases, MEDLINE and PsycINFO was performed. When no guidelines were (publicly) available online, we contacted psychiatric-, obstetric-, perinatal- and mood disorder societies of all first world countries and the five largest second world countries. Only Clinical Practice Guidelines adhering to quality criteria of the Appraisal of Guidelines for Research and Evaluation instrument and including a systematic review of evidence were included. Data extraction focussed on recommendations regarding continuation or withdrawal of antidepressants and preferred treatment in newly depressed patients. Our initial search resulted in 1094 articles. After first screening, 40 full-text articles were screened. Of these, 24 were excluded for not being an official Clinical Practice Guidelines. In total, 16 Clinical Practice Guidelines were included originating from 12 countries. Eight guidelines were perinatal specific and eight were general guidelines. During pregnancy, four guidelines advise to continue antidepressants, while there is a lack of evidence supporting this recommendation. Five guidelines do not specifically advise or discourage continuation. For new episodes, guidelines agree on psychotherapy (especially cognitive behavioural therapy) as initial treatment for mild to moderate depression and antidepressants for severe depression, with a preference for sertraline. Paroxetine is not preferred treatment for new episodes but switching antidepressants for ongoing treatment is discouraged (three guidelines). If mothers use antidepressants, observation of the neonate is generally recommended and breastfeeding encouraged.

Blood gas testing and related measurements: National recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Dukić, Lora; Kopčinović, Lara Milevoj; Dorotić, Adrijana; Baršić, Ivana

2016-10-15

Blood gas analysis (BGA) is exposed to risks of errors caused by improper sampling, transport and storage conditions. The Clinical and Laboratory Standards Institute (CLSI) generated documents with recommendations for avoidance of potential errors caused by sample mishandling. Two main documents related to BGA issued by the CLSI are GP43-A4 (former H11-A4) Procedures for the collection of arterial blood specimens; approved standard - fourth edition, and C46-A2 Blood gas and pH analysis and related measurements; approved guideline - second edition. Practices related to processing of blood gas samples are not standardized in the Republic of Croatia. Each institution has its own protocol for ordering, collection and analysis of blood gases. Although many laboratories use state of the art analyzers, still many preanalytical procedures remain unchanged. The objective of the Croatian Society of Medical Biochemistry and Laboratory Medicine (CSMBLM) is to standardize the procedures for BGA based on CLSI recommendations. The Working Group for Blood Gas Testing as part of the Committee for the Scientific Professional Development of the CSMBLM prepared a set of recommended protocols for sampling, transport, storage and processing of blood gas samples based on relevant CLSI documents, relevant literature search and on the results of Croatian survey study on practices and policies in acid-base testing. Recommendations are intended for laboratory professionals and all healthcare workers involved in blood gas processing.

Blood gas testing and related measurements: National recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

Dukić, Lora; Kopčinović, Lara Milevoj; Dorotić, Adrijana; Baršić, Ivana

2016-01-01

Blood gas analysis (BGA) is exposed to risks of errors caused by improper sampling, transport and storage conditions. The Clinical and Laboratory Standards Institute (CLSI) generated documents with recommendations for avoidance of potential errors caused by sample mishandling. Two main documents related to BGA issued by the CLSI are GP43-A4 (former H11-A4) Procedures for the collection of arterial blood specimens; approved standard – fourth edition, and C46-A2 Blood gas and pH analysis and related measurements; approved guideline – second edition. Practices related to processing of blood gas samples are not standardized in the Republic of Croatia. Each institution has its own protocol for ordering, collection and analysis of blood gases. Although many laboratories use state of the art analyzers, still many preanalytical procedures remain unchanged. The objective of the Croatian Society of Medical Biochemistry and Laboratory Medicine (CSMBLM) is to standardize the procedures for BGA based on CLSI recommendations. The Working Group for Blood Gas Testing as part of the Committee for the Scientific Professional Development of the CSMBLM prepared a set of recommended protocols for sampling, transport, storage and processing of blood gas samples based on relevant CLSI documents, relevant literature search and on the results of Croatian survey study on practices and policies in acid-base testing. Recommendations are intended for laboratory professionals and all healthcare workers involved in blood gas processing. PMID:27812301

Guidelines for human epidermal growth factor receptor 2 testing: biologic and methodologic considerations.

PubMed

Sauter, Guido; Lee, James; Bartlett, John M S; Slamon, Dennis J; Press, Michael F

2009-03-10

The goal of this review is to systematically address a number of issues raised in the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines on testing for the human epidermal growth factor receptor 2 (HER-2) alteration. A group of investigators who are experienced in the conduct and interpretation of HER-2 assay methods reviewed the ASCO-CAP guidelines and address several areas of the HER-2 testing guidelines with a particular emphasis on biologic and methodologic considerations. Although HER-2 status determined by immunohistochemistry (IHC) and the status determined by fluorescent in situ hybridization (FISH) are significantly correlated, we feel that standard considerations of laboratory testing, including test accuracy, reproducibility, and precision, as well as the current data favor FISH over IHC assay methods for determining HER-2 status. These considerations are clearly important in clinical practice because HER2 amplification is directly linked to protein expression levels in breast cancer. However, this protein is not consistently analyzed in formalin-fixed tissues as a result of variability in fixation methods and times and the impact of fixation on HER-2 protein antigenicity. Conversely, gene amplification and FISH are significantly less dependent on tissue fixation methods, making this assay more reproducible between central and peripheral laboratories than IHC. Moreover, review of the existing data demonstrate that FISH is more strongly correlated with responsiveness to either trastuzumab or lapatinib treatment. Until other methods achieve similar test accuracy, reproducibility, and predictive value, we suggest FISH as the primary HER-2 testing modality for women with breast cancer who are candidates for HER-2-targeted therapies.

Laboratory assays evaluate the influence of physical guidelines on subterranean termite (Isoptera: Rhinotermitidae) tunneling, bait discovery, and consumption.

PubMed

Swoboda, L E; Miller, D M

2004-08-01

Laboratory assays were conducted to determine whether physical guidelines could direct subterranean termite foraging behavior. Several materials (wood, plastics, and wood thermoplastic composites) were evaluated for their potential to serve as termite guidelines. Termite tunneling along the different types of guidelines was measured. The proportion of baits discovered when connected by a guideline was compared with the proportion of unconnected baits discovered. Termite consumption of baits also was quantified. Assay results indicated that the termites did not respond to all guideline materials in the same way. Termites built significantly longer tunnels along wood guidelines than they did along any of the plastic guidelines tested. However, tunnel length along the wood and the wood thermoplastic composites was not significantly different. The probability of two baits being discovered when they were connected by wood guidelines was significantly greater than when the baits were connected by plastic guidelines or left unconnected (no guideline). Pairs of baits connected by wood thermoplastic composites were also significantly more likely to be discovered than unconnected baits. Bait consumption was not enhanced by the presence of the guidelines. It is likely that guidelines made of wood competed with the baits as a termite food resource.

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.

Specialty Guidelines for Forensic Psychology

ERIC Educational Resources Information Center

American Psychologist, 2013

2013-01-01

In the past 50 years forensic psychological practice has expanded dramatically. Because the practice of forensic psychology differs in important ways from more traditional practice areas (Monahan, 1980) the "Specialty Guidelines for Forensic Psychologists" were developed and published in 1991 (Committee on Ethical Guidelines for Forensic…

Applying clinical guidelines in general practice: a qualitative study of potential complications.

PubMed

Austad, Bjarne; Hetlevik, Irene; Mjølstad, Bente Prytz; Helvik, Anne-Sofie

2016-07-22

Clinical guidelines for single diseases often pose problems in general practice work with multimorbid patients. However, little research focuses on how general practice is affected by the demand to follow multiple guidelines. This study explored Norwegian general practitioners' (GPs') experiences with and reflections upon the consequences for general practice of applying multiple guidelines. Qualitative focus group study carried out in Mid-Norway. The study involved a purposeful sample of 25 Norwegian GPs from four pre-existing groups. Interviews were audio-recorded, transcribed and analyzed using systematic text condensation, i.e. applying a phenomenological approach. The GPs' responses clustered around two major topics: 1) Complications for the GPs of applying multiple guidelines; and, 2) Complications for their patients when GPs apply multiple guidelines. For the GPs, applying multiple guidelines created a highly problematic situation as they felt obliged to implement guidelines that were not suited to their patients: too often, the map and the terrain did not match. They also experienced greater insecurity regarding their own practice which, they admitted, resulted in an increased tendency to practice 'defensive medicine'. For their patients, the GPs experienced that applying multiple guidelines increased the risk of polypharmacy, excessive non-pharmacological recommendations, a tendency toward medicalization and, for some, a reduction in quality of life. The GPs experienced negative consequences when obliged to apply a variety of single disease guidelines to multimorbid patients, including increased risk of polypharmacy and overtreatment. We believe patient-centered care and the GPs' courage to non-comply when necessary may aid in reducing these risks. Health care authorities and guideline developers need to be aware of the potential negative effects of applying a single disease focus in general practice, where multimorbidity is highly prevalent.

Medical Malpractice Implications of Clinical Practice Guidelines.

PubMed

Ruhl, Douglas S; Siegal, Gil

2017-08-01

Clinical practice guidelines aim to improve medical care by clarifying and making useful recommendations to providers. Although providers should account for patients' unique characteristics when determining a treatment plan, it is generally perceived as good practice to follow guidelines when applicable. This is of interest in malpractice litigation, where it is essential to establish a standard of care to evaluate the performances of providers. Although the opinions of expert witnesses are used to determine standards of care, guidelines are expected to play a leading role. Guidelines alone should not establish a legal standard but may help inform this discussion in the courtroom. Therefore, it is incumbent that excellent, practical, and timely guidelines are continually created and updated in a transparent way. These guidelines must be very clear and underscore the various strengths of recommendation based on the quality of available evidence.

[Practical guideline of Parkinson's disease in Japan: evaluation and mission of future].

PubMed

Yamamoto, Mitsutoshi

2013-01-01

Japanese Society of Neurology (JSN) published Practical guideline for Parkinson's Disease (PD) in 2002 and revised version in 2012. This guideline was prepared according to the method of evidence-based medicine. We surveyed the daily practice of PD to expert neurologists for PD nationwide in Japan. Many specialists for PD reported that patients with PD had poor treatment by neurologists and neurosurgeons that was out of PD practical guideline. Some patients were treated with small dose levodopa despite of Hoehn-Yahr 3 stage. Another disabled patients were treated with dopamine agonists alone despite of over aged of 80. Many neurologists treated PD patients out of guideline. It is important to educate guideline to neurologists and general practioner.

Implementing clinical guidelines for chronic obstructive pulmonary disease: barriers and solutions

PubMed Central

Overington, Jeff D.; Huang, Yao C.; Abramson, Michael J.; Brown, Juliet L.; Goddard, John R.; Bowman, Rayleen V.; Fong, Kwun M.

2014-01-01

Chronic obstructive pulmonary disease (COPD) is a complex chronic lung disease characterised by progressive fixed airflow limitation and acute exacerbations that frequently require hospitalisation. Evidence-based clinical guidelines for the diagnosis and management of COPD are now widely available. However, the uptake of these COPD guidelines in clinical practice is highly variable, as is the case for many other chronic disease guidelines. Studies have identified many barriers to implementation of COPD and other guidelines, including factors such as lack of familiarity with guidelines amongst clinicians and inadequate implementation programs. Several methods for enhancing adherence to clinical practice guidelines have been evaluated, including distribution methods, professional education sessions, electronic health records (EHR), point of care reminders and computer decision support systems (CDSS). Results of these studies are mixed to date, and the most effective ways to implement clinical practice guidelines remain unclear. Given the significant resources dedicated to evidence-based medicine, effective dissemination and implementation of best practice at the patient level is an important final step in the process of guideline development. Future efforts should focus on identifying optimal methods for translating the evidence into everyday clinical practice to ensure that patients receive the best care. PMID:25478199

AAPM-RSS Medical Physics Practice Guideline 9.a. for SRS-SBRT.

PubMed

Halvorsen, Per H; Cirino, Eileen; Das, Indra J; Garrett, Jeffrey A; Yang, Jun; Yin, Fang-Fang; Fairobent, Lynne A

2017-09-01

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education, and professional practice of medical physics. The AAPM has more than 8,000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized. The following terms are used in the AAPM practice guidelines: Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline. Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances. Approved by AAPM Professional Council 3-31-2017 and Executive Committee 4-4-2017. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

AAPM medical physics practice guideline 6.a.: Performance characteristics of radiation dose index monitoring systems.

PubMed

Gress, Dustin A; Dickinson, Renee L; Erwin, William D; Jordan, David W; Kobistek, Robert J; Stevens, Donna M; Supanich, Mark P; Wang, Jia; Fairobent, Lynne A

2017-07-01

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8,000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized. The following terms are used in the AAPM practice guidelines: •Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline. •Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Reference intervals: current status, recent developments and future considerations.

PubMed

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term 'RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area. 
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.

Reference intervals: current status, recent developments and future considerations

PubMed Central

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area.
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs. PMID:26981015

Supportive Care Treatment Guidelines: Value, Limitations, and Opportunities

PubMed Central

Peterson, Douglas E.; Bensadoun, Rene-Jean; Lalla, Rajesh V.; McGuire, Deborah B.

2013-01-01

Evidence-based guidelines in clinical oncology practice are now prominent, with emphasis on clinical, health outcome and economic perspectives. Given the complexity of cancer management, a multidisciplinary approach is essential. Evidence-based guidelines to address supportive cancer care have merged expert opinion, systematic evaluation of clinical and research data, and meta-analyses of clinical trials. Production of supportive care guidelines by the interdisciplinary team is dependent on sufficient high-quality research studies. Once published, it is essential they be customized at institutional and national levels. Implementation in clinical practice is perhaps the greatest challenge. Optimal management occurs through integration of country-specific issues, including care access, healthcare resources, information technology, and national coordination of healthcare practices. The purpose of this article is to: (1) provide an overview of interdisciplinary cancer management using evidence-based guidelines; (2) delineate the theory and practice of guideline dissemination, utilization and outcome assessment; and (3) recommend future research strategies to maximize guidelines use in clinical practice. PMID:21600365

'By the work, one knows the workman': the practice and profession of the embryologist and its translation to quality in the embryology laboratory.

PubMed

Go, Kathryn J

2015-10-01

The embryologist presides over the fulfillment of a patient's treatment in the laboratory for IVF through use of assisted reproduction techniques, and is in a unique position to impart quality to the process. Although the technical skill of the embryologist is critical, the embryologist's contribution to quality is equally conveyed through a knowledge of reproductive biology, keen observation and judgment, astute decision-making, the 'grit' to work under pressure and time constraints, and a sense of mission in the provision and continual development of a safe and effective laboratory. The embryologist also ensures that the laboratory complies with the regulations of federal, state, local and institutional authorities and the recommendations and guidelines of professional associations. In these roles, the embryologist assumes unique responsibilities counterbalanced by the unique rewards of assisting patients in having a family. This article aspires to illuminate this singular profession for those who may be contemplating a career in embryology and act as a resource for those who seek insight into this amalgam of basic science, technical proficiency, and managerial skill and acumen that characterize the practice of clinical embryology and the myriad of ways that practitioners contribute to the quality of assisted reproduction techniques and patient care. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Canadian physicians' attitudes about and preferences regarding clinical practice guidelines.

PubMed

Hayward, R S; Guyatt, G H; Moore, K A; McKibbon, K A; Carter, A O

1997-06-15

To assess Canadian physicians' confidence in, attitudes about and preferences regarding clinical practice guidelines. Cross-sectional, self-administered mailed survey. Stratified random sample of 3000 Canadian physicians; 1878 (62.6%) responded. Canada. Physicians' use of various information sources; familiarity with and confidence in guidelines; attitudes about guidelines and their effect on medical care; rating of importance of guidelines and other sources of information in clinical decision-making; rating of importance of various considerations in deciding whether to adopt a set of guidelines; and rating of usefulness of different formats for presenting guidelines. In all, 52% of the respondents reported using guidelines at least monthly, substantially less frequently than traditional information sources. Most of the respondents expressed confidence in guidelines issued by various physician organizations, but 51% to 77% were not confident in guidelines issued by federal or provincial health ministries or by health insurance plans. The respondents were generally positive about guidelines (e.g., over 50% strongly agreed that they are a convenient source of advice and good educational tools); however, 22% to 26% had concerns about loss of autonomy, the rigidity of guidelines and decreased satisfaction with medical practice. Endorsement by respected colleagues or major organizations was identified as very important by 78% and 62% of the respondents respectively in deciding whether to adopt a set of guidelines in their practice. User friendliness of the guidelines format was thought to be very important by 62%; short pamphlets, manuals summarizing a number of guidelines, journal articles and pocket cards summarizing guidelines were the preferred formats (identified as most useful by 50% to 62% of the respondents). Canadian physicians, although generally positive about guidelines and confident in those developed by clinicians, have not yet integrated the use of guidelines into their practices to a large extent. Our results suggest that respected organizations and opinion leaders should be involved in the development of guidelines and that the acceptability of any proposed format and medium for guidelines presentation should be pretested.

Influence of Institutional Guidelines on Oral Hygiene Practices in Intensive Care Units.

PubMed

Kiyoshi-Teo, Hiroko; Blegen, Mary

2015-07-01

Maintaining oral hygiene is a key component of preventing ventilator-associated pneumonia; however, practices are inconsistent. To explore how characteristics of institutional guidelines for oral hygiene influence nurses' oral hygiene practices and perceptions of that practice. Oral hygiene section of a larger survey study on prevention of ventilator-associated pneumonia. Critical care nurses at 8 hospitals in Northern California that had more than 1000 ventilator days in 2009 were recruited to participate in the survey. Twenty-one questions addressed oral hygiene practices and practice perceptions. Descriptive statistics, analysis of variance, and Spearman correlations were used for analyses. A total of 576 critical care nurses (45% response rate) responded to the survey. Three types of institutional oral hygiene guidelines existed: nursing policy, order set, and information bulletin. Nursing policy provided the most detail about the oral hygiene care; however, adherence, awareness, and priority level were higher with order sets (P < .05). The content and method of disseminating these guidelines varied, and nursing practices were affected by these differences. Nurses assessed the oral cavity and used oral swabs more often when those practices were included in institutional guidelines. The content and dissemination method of institutional guidelines on oral hygiene do influence the oral hygiene practices of critical care nurses. Future studies examining how institutional guidelines could best be incorporated into routine workflow are needed. ©2015 American Association of Critical-Care Nurses.

Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits.

PubMed

Hyltoft Petersen, Per; Klee, George G

2014-03-20

Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2013 Elsevier B.V. All rights reserved.

Reprint of "Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits".

PubMed

Hyltoft Petersen, Per; Klee, George G

2014-05-15

Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2014. Published by Elsevier B.V.

Optimizing the pre-referral workup for gastroenterology and hepatology specialty care: consensus using the Delphi method.

PubMed

Ho, Chanda K; Boscardin, Christy K; Gleason, Nathaniel; Collado, Don; Terdiman, Jonathan; Terrault, Norah A; Gonzales, Ralph

2016-02-01

Specialty care referrals have doubled in the last decade. Optimization of the pre-referral workup by a primary care doctor can lead to a more efficient first specialty visit with the patient. Guidance regarding pre-referral laboratory testing is a first step towards improving the specialty referral process. Our aim was to establish consensus regarding appropriate pre-referral workup for common gastrointestinal and liver conditions. The Delphi method was used to establish local consensus for recommending certain laboratory tests prior to specialty referral for 13 clinical conditions. Seven conditions from The University of Michigan outpatient referral guidelines were used as a baseline. An expert panel of three PCPs and nine gastroenterologists from three academic hospitals participated in three iterative rounds of electronic surveys. Each panellist ranked each test using a 5-point Likert scale (strongly disagree to strongly agree). Local panellists could recommend additional tests for the initial diagnoses, and also recommended additional diagnoses needing guidelines: iron deficiency anaemia, abdominal pain, irritable bowel syndrome, fatty liver disease, liver mass and cirrhosis. Consensus was defined as ≥70% of experts scoring ≥4 (agree or strongly agree). Applying Delphi methodology to extrapolate externally developed referral guidelines for local implementation resulted in considerable modifications. For some conditions, many tests from the external group were eliminated by the local group (abdominal bloating; iron deficiency anaemia; irritable bowel syndrome). In contrast, for chronic diarrhoea, abnormal liver enzymes and viral hepatitis, all/most original tests were retained with additional tests added. For liver mass, fatty liver disease and cirrhosis, there was high concordance among the panel with few tests added or eliminated. Consideration of externally developed referral guidelines using a consensus-building process leads to significant local tailoring and adaption. Our next steps include implementation and dissemination of these guidelines and evaluating their impact on care efficiency in clinical practice. © 2015 John Wiley & Sons, Ltd.

Using the e-Chasqui, web-based information system, to determine laboratory guidelines and data available to clinical staff.

PubMed

Blaya, Joaquin A; Yagui, Martin; Contreras, Carmen C; Palma, Betty; Shin, Sonya S; Yale, Gloria; Suarez, Carmen; Fraser, Hamish S F

2008-11-06

13% of all drug susceptibility tests (DSTs) performed at a public laboratory in Peru were duplicate. To determine reasons for duplicate requests an online survey was implemented in the e-Chasqui laboratory information system. Results showed that 59.6% of tests were ordered because clinical staff was unaware of ordering guidelines or of a previous result. This shows a benefit of using a web-based system and the lack of laboratory information available to clinical staff in Peru.

Test result communication in primary care: a survey of current practice.

PubMed

Litchfield, Ian; Bentham, Louise; Lilford, Richard; McManus, Richard J; Hill, Ann; Greenfield, Sheila

2015-11-01

The number of blood tests ordered in primary care continues to increase and the timely and appropriate communication of results remains essential. However, the testing and result communication process includes a number of participants in a variety of settings and is both complicated to manage and vulnerable to human error. In the UK, guidelines for the process are absent and research in this area is surprisingly scarce; so before we can begin to address potential areas of weakness there is a need to more precisely understand the strengths and weaknesses of current systems used by general practices and testing facilities. We conducted a telephone survey of practices across England to determine the methods of managing the testing and result communication process. In order to gain insight into the perspectives from staff at a large hospital laboratory we conducted paired interviews with senior managers, which we used to inform a service blueprint demonstrating the interaction between practices and laboratories and identifying potential sources of delay and failure. Staff at 80% of practices reported that the default method for communicating normal results required patients to telephone the practice and 40% of practices required that patients also call for abnormal results. Over 80% had no fail-safe system for ensuring that results had been returned to the practice from laboratories; practices would otherwise only be aware that results were missing or delayed when patients requested results. Persistent sources of missing results were identified by laboratory staff and included sample handling, misidentification of samples and the inefficient system for collating and resending misdirected results. The success of the current system relies on patients both to retrieve results and in so doing alert staff to missing and delayed results. Practices appear slow to adopt available technological solutions despite their potential for reducing the impact of recurring errors in the handling of samples and the reporting of results. Our findings will inform our continuing work with patients and staff to develop, implement and evaluate improvements to existing systems of managing the testing and result communication process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Optimization and Validation of the TZM-bl Assay for Standardized Assessments of Neutralizing Antibodies Against HIV-1

PubMed Central

Sarzotti-Kelsoe, Marcella; Bailer, Robert T; Turk, Ellen; Lin, Chen-li; Bilska, Miroslawa; Greene, Kelli M.; Gao, Hongmei; Todd, Christopher A.; Ozaki, Daniel A.; Seaman, Michael S.; Mascola, John R.; Montefiori, David C.

2014-01-01

The TZM-bl assay measures antibody-mediated neutralization of HIV-1 as a function of reductions in HIV-1 Tat-regulated firefly luciferase (Luc) reporter gene expression after a single round of infection with Env-pseudotyped viruses. This assay has become the main endpoint neutralization assay used for the assessment of preclinical and clinical trial samples by a growing number of laboratories worldwide. Here we present the results of the formal optimization and validation of the TZM-bl assay, performed in compliance with Good Clinical Laboratory Practice (GCLP) guidelines. The assay was evaluated for specificity, accuracy, precision, limits of detection and quantitation, linearity, range and robustness. The validated manual TZM-bl assay was also adapted, optimized and qualified to an automated 384-well format. PMID:24291345

Developing Practice Guidelines for Psychoanalysis

PubMed Central

GRAY, SHEILA HAFTER

1996-01-01

Consensus-based practice guidelines codify clinical intelligence and the rich oral tradition in medicine. Because they reflect actual practice, they are readily accepted by clinicians as a basis for external review. This article illustrates the development of guidelines for a psychoanalytic approach to the large pool of patients who present with a depression. It suggests an integrated biopsychosocial approach to these individuals that is useful in current practice, and it offers propositions that may be tested in future research undertakings. Eventually, practice guidelines such as these may form the basis of economical systems of health care that avoid arbitrary, clinically untenable limitations on services. PMID:22700290

A Review of Best Practices for Intravenous Push Medication Administration.

PubMed

Lenz, Janelle R; Degnan, Daniel D; Hertig, John B; Stevenson, James G

In 2015, the Institute for Safe Medication Practices (ISMP) released safe practice guidelines for adult intravenous (IV) push medications. ISMP's most recent set of guidelines has added to a growing list of recommendations from professional groups on the safe use of IV medications. These recommendations and guidelines vary with regard to their audience, scope, and terminology. In some ways, these variations may contribute to confusion and delayed adoption of the standards. This report attempts to provide clarity about the rationale and background regarding the need for practice improvement, discussion of various guidelines, and practice mitigation strategies to improve patient safety.

Closing the gap between science and practice: the need for professional leadership.

PubMed

Eagle, Kim A; Garson, Arthur J; Beller, George A; Sennett, Cary

2003-01-01

Major opportunity exists to better align clinical science and clinical practice. To do so will require efforts not only to develop clinical practice guidelines, but to facilitate their application in practice. The American College of Cardiology operates a program to develop and assess the effectiveness of tools that facilitate the application of guidelines in practice. Here we review what we have learned about the process of guideline implementation, lay out the major research questions that need to be addressed, and argue that professional societies play a critical role in moving from guideline development to application.

Adherence To Diabetes Mellitus Treatment Guidelines From Theory To Practice: The Missing Link.

PubMed

Hashmi, Noreen Rahat; Khan, Shahzad Ali

2016-01-01

Diabetes mellitus is a complex multisystem disease that requires high quality care. Clinical practice guidelines help physicians and patients make the best possible health care decisions and improve health care management of diabetic patients. These guidelines provide the norms for clinical management as well as monitoring of diabetes care. They are not simple algorithms but are based on structured evidence based diabetic management protocols developed from randomized controlled trials. Despite the widespread availability of this diabetic guideline, their use is suboptimal at best. There are several factors blamed for contributing to this missing link from available theoretical guideline recommendations to practical applications of these guidelines. We present a brief review based on available literature review for an ongoing interventional study being done by authors in two tertiary care hospital in Lahore Pakistan for improving adherence to diabetes guidelines. We will discuss guideline implementation cycle and also present a framework encompassing various factors involved in adherence to guidelines. Until recently the emphasis to improve the guideline adherence targeted the factors relating to individual health care professionals in reference to their knowledge, attitude practice of the guidelines. However, we will discuss that broader range of health care systems, organizational factors, and factors relating to patients which may also significantly impact the adherence to the guidelines. The framework emphasises that it is important to understand the factors that act as barriers and contribute to the missing link between theory and practice of diabetic guidelines. This will help plan appropriate strategies in the pre-implementation stage for effective and improved diabetes guidelines adherence and management.

Guidelines for use of fishes in research

USGS Publications Warehouse

Use of Fishes in Research Committee (joint committee of the American Fisheries Society, the American Institute of Fishery Research Biologists

2014-01-01

The 2004 and 2014 Guidelines were developed to provide a structure that advances appropriate attention toward valid experimental designs and procedures with aquatic animals while ensuring humane treatment of the experimental subjects. At a practical level, the Guidelines are intended to provide general recommendations on field and laboratory endeavors, such as sampling, holding, and handling fishes; to offer information on administrative matters, including regulations and permits; and to address typical ethical concerns, such as perceptions of pain or discomfort experienced by experimental subjects. These Guidelines must be recognized as guidelines. They are not intended to provide detailed instructions but rather to alert investigators to a broad array of topics and concerns to consider prior to initiating study. At a comprehensive level, the principles upon which these Guidelines are based are broadly applicable, and many of the described practices and approaches can be adapted to situations involving other aquatic animal species and conditions. Understanding the differences between fishes and other vertebrates, especially mammals, is critically important to conducting scientifically sound research with fishes. Disparities in life histories and mortality rates in fishes versus other vertebrates are critical in designing sustainable sampling levels in fish populations. The UFR Committee points out that (1) compared to mammalian populations, adult populations of many fish species persist despite very high natural mortality rates in juvenile stages by virtue of the fact that most species lay thousands or tens of thousands of eggs; (2) because of these mortality patterns, research on fishes, especially field research or research on early life stages, can involve, and often requires, much larger numbers of research subjects than does research on mammals; and (3) the animal handling and husbandry requirements for fishes are fundamentally different from those for mammals and other vertebrates, in general. Policies, regulations, and recommendations developed for research on mammals, birds, reptiles, or even amphibians are frequently inappropriate for research with fishes. The Guidelines also address some of the ethical concerns that motivate guidelines used for research with other vertebrates, while being mindful of the unique physiology and general nature of fishes. The Guidelines were developed for general use by investigators within the United States; therefore, the roles, responsibilities, and informational needs of Institutional Animal Care and Use Committees (IACUCs) were given specific attention. All United States institutions that use vertebrate animals for research, teaching, research training, and biological testing are required to create an IACUC to oversee and evaluate all aspects of the institution’s animal care and use program. Investigators from other nations who read this document may disregard specific references to U.S. state and federal laws and regulations, as their institutional infrastructure and processes may differ from those of an internal committee such as IACUCs. The principles described herein, however, are applicable to research on fishes regardless of geographic location. Investigators in other nations may benefit by modifying any of the specific provisions pertaining to the United States, thereby adopting guidelines consistent with the laws and regulations of their own government. The UFR Committee urges that the Guidelines be endorsed and adopted (adapted, where necessary) by those state and federal authorities with regulatory responsibilities for fishes, offices with federal oversight (e.g., National Institutes of Health, Office of Laboratory Animal Welfare; http://grants.nih.gov/grants/olaw/olaw.htm) as well as by universities and other institutions and authorities using fishes and aquatic animals within their research and teaching programs.

Quality appraisal of clinical practice guidelines on the use of physiotherapy in rheumatoid arthritis: a systematic review.

PubMed

Hurkmans, Emalie J; Jones, Anamaria; Li, Linda C; Vliet Vlieland, Theodora P M

2011-10-01

To assess the quality of guidelines published in peer-reviewed literature concerning the role of physiotherapy in the management of patients with RA. A systematic literature search for clinical practice guidelines that included physiotherapy interventions was performed in four electronic databases. We assessed the quality of the selected guidelines using the appraisal of guidelines for research and evaluation (AGREE) instrument. In addition, the recommendations of guidelines with the highest quality scores were summarized. Eight clinical practice guidelines fulfilled the inclusion criteria. Scope/purpose was the most often adequately addressed AGREE domain (in seven of the eight guidelines) and applicability the least (in two of the eight guidelines). Based on the AGREE domain scores, six guidelines could be recommended or strongly recommended for clinical use. Five out of these six (strongly) recommended guidelines included a recommendation on exercise therapy and/or patient education, with these interventions being recommended in every case. Transcutaneous electrical nerve stimulation and thermotherapy were recommended in four of these six guidelines. US, thermotherapy, low-level laser therapy, massage, passive mobilization and balneotherapy were addressed in one or two of these six guidelines. Six of eight clinical practice guidelines addressing physiotherapy interventions were recommended or strongly recommended according to the AGREE instrument. In general, guideline recommendations on physiotherapy intervention, from both the recommended guidelines as well as from the not recommended guidelines, lacked detail concerning mode of delivery, intensity, frequency and duration.

The impact of qualitative research on gynaecologic oncology guidelines.

PubMed

How, Jeffrey Andrew; Abitbol, Jeremie; Lau, Susie; Gotlieb, Walter Henri; Abenhaim, Haim Arie

2015-02-01

Inherent in the care provided to patients with cancer is an important psychosocial element which has been explored scientifically through qualitative research. The purpose of our study was to evaluate the availability of qualitative research in gynaecologic oncology and to measure its integration in gynaecologic oncology practice guidelines. We searched Medline, CINHAL, Scopus, and Web of Science databases to identify the availability of qualitative research conducted in the past 20 years on the three most prevalent gynaecologic cancers: endometrial, ovarian, and cervical cancer. National and international practice guidelines on management of gynaecologic cancers were selected using the National Guideline Clearinghouse website, the Society of Obstetricians and Gynaecologists of Canada website, and the Standards and Guidelines Evidence directory of cancer guidelines. Bibliometric analysis was used to determine the frequency of qualitative references cited in these guidelines. One hundred thirteen qualitative research papers on gynaecologic cancers were identified focusing on psychological impacts, social dynamics, and doctor-patient interactions during cancer treatment and recovery. Among the 15 national and international clinical practice guidelines identified on management of gynaecologic cancer, there were a total of 2272 references, and of these only three references citing qualitative research were identified (0.1%) in only one of the 15 practice guidelines. Although qualitative research is being carried out in gynaecologic oncology, its integration into clinical practice guidelines is essentially absent. Efforts to narrow the gap between qualitative research and clinical practice are essential in ensuring a comprehensive approach to the treatment of patients with gynaecologic cancer.

Reporting potential conflicts of interest among authors of professional medical societies' guidelines.

PubMed

Khalil, Bassem; Aung, KoKo; Mansi, Ishak A

2012-08-01

Limited attention is directed to the potential conflicts of interest (COI) of the authors of practice guidelines writing groups of professional medical societies (PMS) and industry. The objective of this study was to report the proportion of authors with potential COI among guidelines writing groups of PMS. A systematic search in PubMed to identify practice guidelines of a convenience sample of 12 publicly known PMS for a period of 3 years. The authors' disclosures of COI were reviewed for the identified guidelines. We identified 126 guidelines, of which 107 (85%) reported authors' disclosures of COI and 19 (15%) did not. With the exception of the US Preventive Services Task Force, all of the reviewed guidelines writing groups of PMS had potential COI to some extent. The maximum percentage of authors with potential COI varied among PMS from 25% to 100%. A substantial variation of percentage of authors with potential COI exists among guidelines writing groups of different PMS. Several practice guidelines of PMS fail to include the disclosures of potential COI in their published guidelines. We made several suggestions to promote the transparency of potential COI in clinical practice guidelines.

Laboratory Directed Research and Development annual report, fiscal year 1997

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

NONE

1998-03-01

The Department of Energy Order 413.2(a) establishes DOE`s policy and guidelines regarding Laboratory Directed Research and Development (LDRD) at its multiprogram laboratories. As described in 413.2, LDRD is research and development of a creative and innovative nature which is selected by the Laboratory Director or his or her designee, for the purpose of maintaining the scientific and technological vitality of the Laboratory and to respond to scientific and technological opportunities in conformance with the guidelines in this Order. DOE Order 413.2 requires that each laboratory submit an annual report on its LDRD activities to the cognizant Secretarial Officer through themore » appropriate Operations Office Manager. The report provided in this document represents Pacific Northwest National Laboratory`s LDRD report for FY 1997.« less

Development of practice guidelines for psychological interventions in the rehabilitation of patients with oncological disease (breast, prostate, or colorectal cancer): Methods and results.

PubMed

Reese, Christina; Weis, Joachim; Schmucker, Dieter; Mittag, Oskar

2017-10-01

The goal of this project was to develop evidence- and consensus-based practice guidelines for psychological interventions in the rehabilitation of patients with oncological disease (breast, prostate, or colorectal cancer). First of all, we conducted a literature search and survey of all oncological rehabilitation centers in Germany (N = 145) to obtain a thorough perspective of the recent evidence, guidelines, the structural framework, and practice of psychological services in oncological rehabilitation. Next, an expert workshop was held with national experts from scientific departments, clinicians from rehabilitation centers, and patients. In this workshop, we drafted and agreed upon an initial version of the practice guidelines. Afterwards, the practice guidelines were sent to all head physicians and senior psychologists at oncological rehabilitation centers in Germany for approval (N = 280 questionnaires). In addition, key recommendations were discussed with a group of rehabilitation patients. Finally, the practice guidelines were revised by the expert panel and made available online to the public. The practice guidelines have been widely accepted by both the expert panel and the surveyed clinicians and patients. They include recommendations for psycho-oncological interventions that should be offered to all rehabilitation patients with breast, prostate, or colorectal cancer. They also comprise recommendations for specific problem areas concerning psychological functions, body functions, and environmental and personal factors. The practice guidelines provide detailed recommendations for high-quality psychosocial care in an oncological rehabilitation context. It is their aim to guide the multidisciplinary team, especially psychologists and physicians, in their daily practice. Copyright © 2016 John Wiley & Sons, Ltd.

Systematic review of recent dementia practice guidelines.

PubMed

Ngo, Jennifer; Holroyd-Leduc, Jayna M

2015-01-01

dementia is a highly prevalent acquired cognitive disorder that interferes with activities of daily living, relationships and quality of life. Recognition and effective management strategies are necessary to provide comprehensive care for these patients and their families. High-quality clinical practice guidelines can improve the quality and consistency of care in all aspects of dementia diagnosis and management by clarifying interventions supported by sound evidence and by alerting clinicians to interventions without proven benefit. we aimed to offer a synthesis of existing practice recommendations for the diagnosis and management of dementia, based upon moderate-to-high quality dementia guidelines. we performed a systematic search in EMBASE and MEDLINE as well as the grey literature for guidelines produced between 2008 and 2013. thirty-nine retrieved practice guidelines were included for quality appraisal by the Appraisal of Guidelines Research and Evaluation II (AGREE-II) tool, performed by two independent reviewers. From the 12 moderate-to-high quality guidelines included, specific practice recommendations for the diagnosis and/or management of any aspect of dementia were extracted for comparison based upon the level of evidence and strength of recommendation. there was a general agreement between guidelines for many practice recommendations. However, direct comparisons between guidelines were challenging due to variations in grading schemes. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Developing a practice guideline for the occupational health services by using a community of practice approach: a process evaluation of the development process.

PubMed

Kwak, Lydia; Wåhlin, Charlotte; Stigmar, Kjerstin; Jensen, Irene

2017-01-18

One way to facilitate the translation of research into the occupational health service practice is through clinical practice guidelines. To increase the implementability of guidelines it is important to include the end-users in the development, for example by a community of practice approach. This paper describes the development of an occupational health practice guideline aimed at the management of non-specific low back pain (LBP) by using a community of practice approach. The paper also includes a process evaluation of the development providing insight into the feasibility of the process. A multidisciplinary community of practice group (n = 16) consisting of occupational nurses, occupational physicians, ergonomists/physical therapists, health and safety engineers, health educators, psychologists and researchers from different types of occupational health services and geographical regions within Sweden met eleven times (June 2012-December 2013) to develop the practice guideline following recommendations of guideline development handbooks. Process-outcomes recruitment, reach, context, satisfaction, feasibility and fidelity were assessed by questionnaire, observations and administrative data. Group members attended on average 7.5 out of 11 meetings. Half experienced support from their workplace for their involvement. Feasibility was rated as good, except for time-scheduling. Most group members were satisfied with the structure of the process (e.g. presentations, multidisciplinary group). Fidelity was rated as fairly high. The described development process is a feasible process for guideline development. For future guideline development expectations of the work involved should be more clearly communicated, as well as the purpose and tasks of the CoP-group. Moreover, possibilities to improve support from managers and colleagues should be explored. This paper has important implications for future guideline development; it provides valuable information on how practitioners can be included in the development process, with the aim of increasing the implementability of the developed guidelines.

The utility of an automated electronic system to monitor and audit transfusion practice.

PubMed

Grey, D E; Smith, V; Villanueva, G; Richards, B; Augustson, B; Erber, W N

2006-05-01

Transfusion laboratories with transfusion committees have a responsibility to monitor transfusion practice and generate improvements in clinical decision-making and red cell usage. However, this can be problematic and expensive because data cannot be readily extracted from most laboratory information systems. To overcome this problem, we developed and introduced a system to electronically extract and collate extensive amounts of data from two laboratory information systems and to link it with ICD10 clinical codes in a new database using standard information technology. Three data files were generated from two laboratory information systems, ULTRA (version 3.2) and TM, using standard information technology scripts. These were patient pre- and post-transfusion haemoglobin, blood group and antibody screen, and cross match and transfusion data. These data together with ICD10 codes for surgical cases were imported into an MS ACCESS database and linked by means of a unique laboratory number. Queries were then run to extract the relevant information and processed in Microsoft Excel for graphical presentation. We assessed the utility of this data extraction system to audit transfusion practice in a 600-bed adult tertiary hospital over an 18-month period. A total of 52 MB of data were extracted from the two laboratory information systems for the 18-month period and together with 2.0 MB theatre ICD10 data enabled case-specific transfusion information to be generated. The audit evaluated 15,992 blood group and antibody screens, 25,344 cross-matched red cell units and 15,455 transfused red cell units. Data evaluated included cross-matched to transfusion ratios and pre- and post-transfusion haemoglobin levels for a range of clinical diagnoses. Data showed significant differences between clinical units and by ICD10 code. This method to electronically extract large amounts of data and linkage with clinical databases has provided a powerful and sustainable tool for monitoring transfusion practice. It has been successfully used to identify areas requiring education, training and clinical guidance and allows for comparison with national haemoglobin-based transfusion guidelines.

Dissemination of the CDC's Hand Hygiene Guideline and impact on infection rates

PubMed Central

Larson, Elaine L.; Quiros, Dave; Lin, Susan X.

2007-01-01

Background The diffusion of national evidence-based practice guidelines and their impact on patient outcomes often go unmeasured. Methods Our objectives were to (1) evaluate implementation and compliance with clinical practices recommended in the new Centers for Disease Control and Prevention (CDC) Hand Hygiene Guideline, (2) compare rates of health care-associated infections (HAI) before and after implementation of the Guideline recommendations, and (3) examine the patterns and correlates of changes in rates of HAI. We used pre- and post-Guideline implementation site visits and surveys in the setting of 40 US hospitals—members of the National Nosocomial Infections Surveillance System—and measured HAI rates 1 year before and after publication of the CDC Guideline and used direct observation of hand hygiene compliance and Guideline implementation scores. Results All study hospitals had changed their policies and procedures and provided products in compliance with Guideline recommendations; 89.8% of 1359 staff members surveyed anonymously reported that they were familiar with the Guideline. However, in 44.2% of the hospitals (19/40), there was no evidence of a multidisciplinary program to improve compliance. Hand hygiene rates remained low (mean, 56.6%). Rates of central line-associated bloodstream infections were significantly lower in hospitals with higher rates of hand hygiene (P < .001). No impact of Guideline implementation or hand hygiene compliance on other HAI rates was identified. Other factors occurring over time could affect rates of HAI. Observed hand hygiene compliance rates were likely to overestimate rates in actual practice. The study may have been of too short duration to detect the impact of a practice guideline. Conclusion Wide dissemination of this Guideline was not sufficient to change practice. Only some hospitals had initiated multidisciplinary programs; practice change is unlikely without such multidisciplinary efforts and explicit administrative support. PMID:18063132

Dissemination of the CDC's Hand Hygiene Guideline and impact on infection rates.

PubMed

Larson, Elaine L; Quiros, Dave; Lin, Susan X

2007-12-01

The diffusion of national evidence-based practice guidelines and their impact on patient outcomes often go unmeasured. Our objectives were to (1) evaluate implementation and compliance with clinical practices recommended in the new Centers for Disease Control and Prevention (CDC) Hand Hygiene Guideline, (2) compare rates of health care-associated infections (HAI) before and after implementation of the Guideline recommendations, and (3) examine the patterns and correlates of changes in rates of HAI. We used pre- and post-Guideline implementation site visits and surveys in the setting of 40 US hospitals--members of the National Nosocomial Infections Surveillance System--and measured HAI rates 1 year before and after publication of the CDC Guideline and used direct observation of hand hygiene compliance and Guideline implementation scores. All study hospitals had changed their policies and procedures and provided products in compliance with Guideline recommendations; 89.8% of 1359 staff members surveyed anonymously reported that they were familiar with the Guideline. However, in 44.2% of the hospitals (19/40), there was no evidence of a multidisciplinary program to improve compliance. Hand hygiene rates remained low (mean, 56.6%). Rates of central line-associated bloodstream infections were significantly lower in hospitals with higher rates of hand hygiene (P < .001). No impact of Guideline implementation or hand hygiene compliance on other HAI rates was identified. Other factors occurring over time could affect rates of HAI. Observed hand hygiene compliance rates were likely to overestimate rates in actual practice. The study may have been of too short duration to detect the impact of a practice guideline. Wide dissemination of this Guideline was not sufficient to change practice. Only some hospitals had initiated multidisciplinary programs; practice change is unlikely without such multidisciplinary efforts and explicit administrative support.

Cancer related fatigue: implementing guidelines for optimal management.

PubMed

Pearson, Elizabeth J M; Morris, Meg E; McKinstry, Carol E

2017-07-18

Cancer-related fatigue (CRF) is a key concern for people living with cancer and can impair physical functioning and activities of daily living. Evidence-based guidelines for CRF are available, yet inconsistently implemented globally. This study aimed to identify barriers and enablers to applying a cancer fatigue guideline and to derive implementation strategies. A mixed-method study explored the feasibility of implementing the CRF guideline developed by the Canadian Association for Psychosocial Oncology (CAPO). Health professionals, managers and consumers from different practice settings participated in a modified Delphi study with two survey rounds. A reference group informed the design of the study including the surveys. The first round focused on guideline characteristics, compatibility with current practice and experience, and behaviour change. The second survey built upon and triangulated the first round. Forty-five health practitioners and managers, and 68 cancer survivors completed the surveys. More than 75% of participants endorsed the CAPO cancer related fatigue guidelines. Some respondents perceived a lack of resources for accessible and expert fatigue management services. Further barriers to guideline implementation included complexity, limited practical details for some elements, and lack of clinical tools such as assessment tools or patient education materials. Recommendations to enhance guideline applicability centred around four main themes: (1) balancing the level of detail in the CAPO guideline with ease of use, (2) defining roles of different professional disciplines in CRF management, (3) how best to integrate CRF management into policy and practice, (4) how best to ensure a consumer-focused approach to CRF management. Translating current knowledge on optimal management of CRF into clinical practice can be enhanced by the adoption of valid guidelines. This study indicates that it is feasible to adopt the CAPO guidelines. Clinical application may be further enhanced with guideline adaptation, professional education and integration with existing practices.

From evidence to action

PubMed Central

Verheyen, Cees CPM; Kerkhoffs, Gino M; Bhandari, Mohit; Schünemann, Holger J

2009-01-01

ABSTRACT Good guidelines will help us to take evidence into practice. In a survey among Dutch orthopedic surgeons, development and use of evidence-based guidelines was perceived as one of the best ways of moving from opinion-based to evidence-based orthopedic practice. The increasing number of guidelines means that knowing how to make a critical appraisal of guidelines is now a key part of every surgeon’s life. This is particularly true because guidelines use varying systems to judge the quality of evidence and the strength of recommendations. In this manuscript we discuss what a guideline is, where we can find guidelines, how to evaluate the quality of guidelines, and finally provide an example on the different steps of guideline development. Thus, we show that good guidelines are a summary of the best available evidence and that they provide a graded recommendation to help surgeons in evidence-based practice. PMID:19234892

[Factors influencing the quality of clinical practice guidelines in ovarian cancer].

PubMed

Castillo-Londoño, J S; Medina-Torres, Y A; Sandoval-Salinas, C; Buitrago-Gutierrez, G; Torres-Ibargüen, M Z; Gonzalez-Rangel, A L

To identify the characteristics of the published clinical practice guidelines for the management of epithelial ovarian cancer that suggest a good methodological quality. A literature review was performed on 25 clinical practice guidelines for epithelial ovarian cancer that were identified in different databases (MEDLINE, Guidelines International Network, National Guidelines Clearing house) published between 2007 and 2014. The quality of the guidelines was evaluated using the Appraisal of Guidelines Research and Evaluation II tool. Descriptive and bivariate analyses were performed to assess the association between the quality of the guidelines and of some of their features and their developers. Just under half (48%) of the guidelines were rated as low quality. Scientific societies or independent centres and private funding, or under-reporting the source of funding, were statistically associated with lower quality of clinical practice guidelines (P<.01). The guidelines developed by National Program Guidelines had a median of consistently higher scores in all domains of the Appraisal of Guidelines Research and Evaluation II, with significant differences in the definition of scope and objectives, the participation of stakeholders, the methodological rigour of development, and applicability to the context. Features such as the nature of the developer and funding of the guidelines are predictors of quality that should be taken into account prior to the use of the recommendations of a document. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Current status of therapeutic drug monitoring in Australia and New Zealand: a need for improved assay evaluation, best practice guidelines, and professional development.

PubMed

Norris, Ross L; Martin, Jennifer H; Thompson, Erin; Ray, John E; Fullinfaw, Robert O; Joyce, David; Barras, Michael; Jones, Graham R; Morris, Raymond G

2010-10-01

The measurement of drug concentrations, for clinical purposes, occurs in many diagnostic laboratories throughout Australia and New Zealand. However, the provision of a comprehensive therapeutic drug monitoring (TDM) service requires the additional elements of pre- and postanalytical advice to ensure that concentrations reported are meaningful, interpretable, and clinically applicable to the individual patient. The aim of this project was to assess the status of TDM services in Australia and New Zealand. A range of professions involved in key aspects of TDM was surveyed by questionnaire in late 2007. Information gathered included: the list of drugs assayed; analytical methods used; interpretation services offered; interpretative methods used; and further monitoring advice provided. Fifty-seven responses were received, of which 42% were from hospitals (public and/or private); 11% a hospital (public and/or private) and pathology provider; and 47% a pathology provider only (public and/or private). Results showed that TDM is applied to a large number of different drugs. Poorly performing assay methods were used in some cases, even when published guidelines recommended alternative practices. Although there was a wide array of assays available, the evidence suggested a need for better selection of assay methods. In addition, only limited advice and/or interpretation of results was offered. Of concern, less than 50% of those providing advice on aminoglycoside dosing in adults used pharmacokinetic tools with six of 37 (16.2%) respondents using Bayesian pharmacokinetic tools, the method recommended in the Australian Therapeutic Guidelines: Antibiotic. In conclusion, the survey highlighted deficiencies in the provision of TDM services, in particular assay method selection and both quality and quantity of postanalytical advice. A range of recommendations, some of which may have international implications, are discussed. There is a need to include measures of impact on clinical decision-making when assessing assay methodologies. Best practice guidelines and professional standards of practice in TDM are needed, supported by an active program of professional development to ensure the benefits of TDM are realized. This will require significant partnerships between the various professions involved.

THE U.S. EPA NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS RESEARCH LABORATORY'S APPROACH TO AUDITING HEALTH EFFECTS STUDIES

EPA Science Inventory

This is an abstract of a proposed presentation and does not necessarily reflect EPA policy.

The Health Divisions of the US EPA National Health and Environmental Effects Research Laboratory have a guideline for conducting technical systems audits. As part of the guideline ...

A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement.

PubMed

Chen, Yaolong; Yang, Kehu; Marušic, Ana; Qaseem, Amir; Meerpohl, Joerg J; Flottorp, Signe; Akl, Elie A; Schünemann, Holger J; Chan, Edwin S Y; Falck-Ytter, Yngve; Ahmed, Faruque; Barber, Sarah; Chen, Chiehfeng; Zhang, Mingming; Xu, Bin; Tian, Jinhui; Song, Fujian; Shang, Hongcai; Tang, Kun; Wang, Qi; Norris, Susan L

2017-01-17

The quality of reporting practice guidelines is often poor, and there is no widely accepted guidance or standards for such reporting in health care. The international RIGHT (Reporting Items for practice Guidelines in HealThcare) Working Group was established to address this gap. The group followed an existing framework for developing guidelines for health research reporting and the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach. It developed a checklist and an explanation and elaboration statement. The RIGHT checklist includes 22 items that are considered essential for good reporting of practice guidelines: basic information (items 1 to 4), background (items 5 to 9), evidence (items 10 to 12), recommendations (items 13 to 15), review and quality assurance (items 16 and 17), funding and declaration and management of interests (items 18 and 19), and other information (items 20 to 22). The RIGHT checklist can assist developers in reporting guidelines, support journal editors and peer reviewers when considering guideline reports, and help health care practitioners understand and implement a guideline.

[Evidence-based clinical oral healthcare guidelines 4. Adherence requires an implementation strategy].

PubMed

Braspenning, J C C; Mettes, T G P H; van der Sanden, W J M; Wensing, M J P

2015-03-01

Adherence to clinical guidelines requires support in practice. However, systematic implementation of evidence-based guidelines is not common practice in oral healthcare. The Knowledge Institute Oral Care (KiMo) offers the opportunity to take into account potential barriers and facilitators during the development of evidence-based clinical practice guidelines. These factors which are relevant to the guideline and the oral healthcare practice provide the ingredients for a tailor-made programme of implementation that has a scientific basis. Elements of any implementation programme are the quality indicators derived from the oral healthcare guidelines. These indicators should fit, on the one hand, the specific goals of the guidelines (patient safety, effectiveness, efficiency, patient-centred, timeliness, accessibility) and, onthe other hand, the various perspectives of the different stakeholders, such as patients, caregivers, health insurers and inspectorate. These quality indicators provide information on adherence to the guidelines, the results of a certain treatment and the success of the implementation strategy, all with the aim to improve the quality of oral healthcare.

Changing clinical practice: management of paediatric community-acquired pneumonia

PubMed Central

Elemraid, Mohamed A; Rushton, Stephen P; Thomas, Matthew F; Spencer, David A; Eastham, Katherine M; Gennery, Andrew R; Clark, Julia E

2014-01-01

Rationale and aim To compare clinical features and management of paediatric community-acquired pneumonia (PCAP) following the publication of UK pneumonia guidelines in 2002 with data from a similar survey at the same hospitals in 2001–2002 (pre-guidelines). Methods A prospective survey of 11 hospitals in Northern England was undertaken during 2008–2009. Clinical and laboratory data were recorded on children aged ≤16 years who presented with clinical and radiological features of pneumonia. Results 542 children were included. There was a reduction in all investigations performed (P < 0.001) except C-reactive protein (P = 0.448) between surveys. These included full blood count (76% to 61%); blood culture (70% to 53%) and testing of respiratory secretions for viruses (24% to 12%) and bacteria (18% to 8%). Compared to pre-guidelines, there was a reduction in the use of intravenous antibiotics as a proportion of the total prescribed from 47% to 36% (P < 0.001) and a change in the route of antibiotic administration with increasing preference for oral alone (16% pre-compared to 50% post-guidelines, P < 0.001). Conclusion Apart from the acute phase reactants that should not be measured routinely, these changes are in line with the guideline recommendations. Improvements in antibiotic use are possible and have implications for future antimicrobial stewardship programmes. Further work using cost-effectiveness analysis may also demonstrate a financial benefit to health services from adoption of guidelines. PMID:24118607

Use of Biologics in Private Practice: Nine Years of Lessons and Learning.

PubMed

Correa-Selm, Lilia M; Alamgir, Mahin; Rao, Babar K

2017-03-01

Over a decade ago, the FDA approved biologics for psoriasis, which changed how the disease is treated and, in most cases, has a significant positive impact on the lives of patients. Side effects primarily identified during the investigational and research phase led to the development of specific guidelines for treatment. The treatment guidelines have been amended to incorporate better understandings of side-effects over the years that the disease has been treated. In this study, we focused on a chart review that included assessing the current guidelines and their alignment with modern patient management and the recent side effects presented. This life-cycle evaluation included over 100 patients, management of their treatment, laboratory abnormalities, criteria for choosing or changing to a different biologic, and the effects of the treatments management throughout the years. The review identified some recommended changes in the application and treatment of psoriasis with biologics. To further evidence our findings, we hope to expand this study to a larger scale with more patients.

J Drugs Dermatol. 2017;16(3):215-217.

Practical guidelines addressing ethical issues pertaining to the curation of human locus-specific variation databases (LSDBs)

PubMed Central

Povey, Sue; Al Aqeel, Aida I; Cambon-Thomsen, Anne; Dalgleish, Raymond; den Dunnen, Johan T; Firth, Helen V; Greenblatt, Marc S; Barash, Carol Isaacson; Parker, Michael; Patrinos, George P; Savige, Judith; Sobrido, Maria-Jesus; Winship, Ingrid; Cotton, Richard GH

2010-01-01

More than 1,000 Web-based locus-specific variation databases (LSDBs) are listed on the Website of the Human Genetic Variation Society (HGVS). These individual efforts, which often relate phenotype to genotype, are a valuable source of information for clinicians, patients, and their families, as well as for basic research. The initiators of the Human Variome Project recently recognized that having access to some of the immense resources of unpublished information already present in diagnostic laboratories would provide critical data to help manage genetic disorders. However, there are significant ethical issues involved in sharing these data worldwide. An international working group presents second-generation guidelines addressing ethical issues relating to the curation of human LSDBs that provide information via a Web-based interface. It is intended that these should help current and future curators and may also inform the future decisions of ethics committees and legislators. These guidelines have been reviewed by the Ethics Committee of the Human Genome Organization (HUGO). Hum Mutat 31:–6, 2010. © 2010 Wiley-Liss, Inc. PMID:20683926

Assessment of clinical practice guideline methodology for the treatment of knee osteoarthritis with intra-articular hyaluronic acid.

PubMed

Altman, Roy D; Schemitsch, Emil; Bedi, Asheesh

2015-10-01

Clinical practice guidelines are of increasing importance in the decision making for the treatment of knee osteoarthritis. Inconsistent recommendations regarding the use of intra-articular hyaluronic acid for the treatment of knee osteoarthritis have led to confusion among treating physicians. Literature search to identify clinical practice guidelines that provide recommendations regarding the use of intra-articular hyaluronic acid treatment for knee osteoarthritis was conducted. Included guidelines were appraised using the AGREE II instrument. Guideline development methodologies, how the results were assessed, the recommendation formation, and work group composition were summarized. Overall, 10 clinical practice guidelines were identified that met our inclusion criteria. AGREE II domain scores were variable across the included guidelines. The methodology utilized across the guidelines was heterogeneous regarding the evidence inclusion criteria, analysis of evidence results, formulation of clinical practice recommendations, and work group composition. The recommendations provided by the guidelines for intra-articular hyaluronic acid treatment for knee osteoarthritis are highly inconsistent as a result of the variability in guideline methodology. Overall, 30% of the included guidelines recommended against the use of intra-articular hyaluronic acid in the treatment of knee osteoarthritis, while 30% deemed the treatment an appropriate intervention under certain scenarios. The remaining 40% of the guidelines provided either an uncertain recommendation or no recommendation at all, based on the high variability in reviewed evidence regarding efficacy and trial quality. There is a need for a standard "appropriate methodology" that is agreed upon for osteoarthritis clinical practice guidelines in order to prevent the development of conflicting recommendations for intra-articular hyaluronic acid treatment for knee osteoarthritis, and to assure that treating physicians who are utilizing these guidelines are making their clinical decisions on the best available evidence. At present, the inconsistent recommendations provided for intra-articular hyaluronic acid treatment make it difficult for clinical professionals to determine its appropriateness when treating patients with knee osteoarthritis. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Adherence of healthcare professionals to evidence-based clinical practice guidelines in the management of hemodialysis patients, Khartoum State, Sudan.

PubMed

Abdelwahab, Hisham; Shigidi, Mazin; El-Tohami, Alyaa; Ibrahim, Lamees

2013-05-01

Hemodialysis (HD) is a complex procedure with many specifications and requires adherence to a set of particular clinical practice guidelines. These guidelines had already been established by globally acclaimed renal authorities and their implementation was shown to correlate with patients' morbidity and mortality. This study was conducted to evaluate the adherence of healthcare professionals to the evidence-based clinical practice patterns in Khartoum State HD units. A cross-sectional study was conducted in Khartoum State HD units during the period from September 2010 to January of 2011. Data was collected from the healthcare professionals using a specially designed checklist. The checklist included the evidence-based clinical practice guidelines for the HD vascular access, HD adequacy, anemia of chronic kidney disease (CKD), nutrition, cardiovascular risk assessment, and hepatitis B and C virus infection control. Implementation of these guidelines was evaluated, and further graded using a Likert-type scale. Four randomly selected HD units were included in the study. The rate of implementation of the HD vascular access guidelines was 54.8%, adequacy guidelines 57%, anemia of CKD 68.8%, nutrition 58.4%, cardiovascular risk assessment 57%, and hepatitis B and C infection control guidelines was 79.2%. Overall, the four HD units assessed showed moderate deviations from the practice guidelines of anemia of CKD and hepatitis B and C infection control. Extreme deviations from the clinical practice guidelines were seen in HD vascular access practices, adequacy assessments, nutrition and cardiovascular risk assessment. Hemodialysis services in Khartoum State are in need of great improvements regarding adherence to protocols and the standards of care.

American, European, and Chinese practice guidelines or consensuses of polycystic ovary syndrome: a comparative analysis.

PubMed

Wang, Fang-Fang; Pan, Jie-Xue; Wu, Yan; Zhu, Yu-Hang; Hardiman, Paul J; Qu, Fan

2018-05-01

Polycystic ovary syndrome (PCOS) is the most common metabolic and endocrine disorder in women. However, there is no agreement concerning how to diagnose and treat PCOS worldwide. Three practice guidelines or consensuses, including consensus from the European Society of Human Reproduction and Embryology (ESHRE)/the American Society for Reproductive Medicine (ASRM) in Rotterdam, diagnosis criteria and consensus in China, and clinical practice guideline from the Endocrine Society (ES) in the United States are widely recognized. The present paper may provide some guidance for clinical practice based on a comparative analysis of the above three practice guidelines or consensuses.

Transition to adult care in pediatric solid-organ transplant: development of a practice guideline.

PubMed

Gold, Anna; Martin, Kathy; Breckbill, Katie; Avitzur, Yaron; Kaufman, Miriam

2015-06-01

Transition to adult-centered care is becoming an increasingly important area of practice in pediatric organ transplant. Standardized, best-practice guidelines are needed to assist transplant practitioners in providing optimal transitional care for this population of patients. To describe the development and implementation of a practice guideline for the transitional care of pediatric transplant recipients. A quality improvement project was undertaken in a pediatric multiorgan transplant program setting. Strategies employed included (1) creation of an interdisciplinary working group, (2) survey of transition-related practices and learning needs of transplant practitioners, (3) review of the literature and existing transition-related materials, and (4) creation of transition guidelines. An interdisciplinary survey of transplant practitioners at our institution identified practice strengths related to transitional care and learning needs. Review of relevant literature and other materials revealed limited but emerging research related to the transition of pediatric transplant recipients from pediatric to adult care. Existing transition tools were examined and applicable items identified. A practice guideline for use with pediatric transplant recipients transitioning to adult care was developed. Strategies to educate staff about the guideline and promote ongoing guideline use were implemented. Preparing pediatric transplant recipients and their families for transition to adult-centered care is an emerging challenge for transplant teams. These guidelines provide practitioners with a developmentally sensitive overview of important transition-related domains and strategies directed toward patients and their caregivers, who may experience the process of transition differently. Dissemination of the pediatric transplant transition guideline will make transition information more widely available to transplant practitioners.

Chiropractic quality assurance: standards and guidelines

PubMed Central

Gatterman, Meridel I; Dobson, Thomas P; LeFevbre, Ron

2001-01-01

Chiropractic quality assurance involves development of both clinical guidelines and standards. Confusion generated by poor differentiation of guidelines from standards contributes to mistrust of the guideline development process. Guidelines are considered to be recommendations that allow for flexibility and individual patient differences. Standards are more binding and require a high level of supporting evidence. While guidelines serve as educational tools to improve the quality of practice, standards that outline minimum competency are used more as administrative tools on which to base policy. Barriers to development of clinical guidelines and standards include fear that they will create prescriptive “cookbook” practice, and the distrust that guidelines are developed primarily for cost containment. Clinicians also criticize guidelines developed by academics that don't relate to practice, and those based on evidence that lacks clinical relevance. Conflicting guidelines perceived to be based on strong bias or conflict of interest are also suspect. To reduce barriers to acceptance and implementation, guidelines should be inclusive, patient-centered, and based on a variety of evidence and clinical experience.

Implementation of study results in guidelines and adherence to guidelines in clinical practice.

PubMed

Waldfahrer, Frank

2016-01-01

Guidelines were introduced in hospital- and practice-based otorhinolaryngology in the 1990ies, and have been undergoing further development ever since. There are currently 20 guidelines on file at the German Society of Oto-Rhino-Laryngology, Head & Neck Surgery. The society has cooperated in further 34 guidelines. The quality of the guidelines has been continuously improved by concrete specifications put forward by the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V., AWMF). Since increasing digitalization has made access to scientific publications quicker and simpler, relevant study results can be incorporated in guidelines more easily today than in the analog world. S2e and S3 guidelines must be based on a formal literature search with subsequent evaluation of the evidence. The consensus procedure for S2k guidelines is also regulated. However, the implementation of guidelines in routine medical practice must still be considered inadequate, and there is still a considerable need for improvement in adherence to these guidelines.

Implementation of study results in guidelines and adherence to guidelines in clinical practice

PubMed Central

Waldfahrer, Frank

2016-01-01

Guidelines were introduced in hospital- and practice-based otorhinolaryngology in the 1990ies, and have been undergoing further development ever since. There are currently 20 guidelines on file at the German Society of Oto-Rhino-Laryngology, Head & Neck Surgery. The society has cooperated in further 34 guidelines. The quality of the guidelines has been continuously improved by concrete specifications put forward by the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V., AWMF). Since increasing digitalization has made access to scientific publications quicker and simpler, relevant study results can be incorporated in guidelines more easily today than in the analog world. S2e and S3 guidelines must be based on a formal literature search with subsequent evaluation of the evidence. The consensus procedure for S2k guidelines is also regulated. However, the implementation of guidelines in routine medical practice must still be considered inadequate, and there is still a considerable need for improvement in adherence to these guidelines. PMID:28025601

The ethical implications of genetic testing in the classroom.

PubMed

Taylor, Ann T S; Rogers, Jill Cellars

2011-07-01

The development of classroom experiments where students examine their own DNA is frequently described as an innovative teaching practice. Often these experiences involve students analyzing their genes for various polymorphisms associated with disease states, like an increased risk for developing cancer. Such experiments can muddy the distinction between classroom investigation and medical testing. Although the goals and issues surrounding classroom genotyping do not directly align with those of clinical testing, instructors can use the guidelines and standards established by the medical genetics community when evaluating the ethics of human genotyping. We developed a laboratory investigation and discussion which allowed undergraduate science students to explore current DNA manipulation techniques to isolate their p53 gene, followed by a dialogue probing the ethical implications of examining their sample for various polymorphisms. Students never conducted genotyping on their samples because of the ethical concerns presented in this paper, so the discussion replaced the actual genetic testing in the class. A science faculty member led the laboratory portion, while a genetic counselor facilitated the discussion of the ethical concepts underlying genetic counseling: autonomy, beneficence, confidentiality, and justice. In their final papers, students demonstrated an understanding of the practice guidelines established by the genetics community and acknowledged the ethical considerations inherent in p53 genotyping. Given the burgeoning market for personalized medicine, teaching undergraduates about the psychosocial and ethical dimensions of human genetic testing is important and timely. Moreover, incorporating a genetic counselor in the classroom discussion provided a rich and dynamic discussion of human genetic testing. Copyright © 2011 Wiley Periodicals, Inc.

A critical analysis of Australian policies and guidelines for water immersion during labour and birth.

PubMed

Cooper, Megan; McCutcheon, Helen; Warland, Jane

2017-10-01

Accessibility of water immersion for labour and/or birth is often dependent on the care provider and also the policies/guidelines that underpin practice. With little high quality research about the safety and practicality of water immersion, particularly for birth, policies/guidelines informing the practice may lack the evidence necessary to ensure practitioner confidence surrounding the option thereby limiting accessibility and women's autonomy. The aims of the study were to determine how water immersion policies and/or guidelines are informed, who interprets the evidence to inform policies/guidelines and to what extent the policy/guideline facilitates the option for labour and birth. Phase one of a three-phase mixed-methods study critically analysed 25 Australian water immersion policies/guidelines using critical discourse analysis. Policies/guidelines pertaining to the practice of water immersion reflect subjective opinions and views of the current literature base in favour of the risk-focused obstetric and biomedical discursive practices. Written with hegemonic influence, policies and guidelines impact on the autonomy of both women and practitioners. Policies and guidelines pertaining to water immersion, particularly for birth reflect opinion and varied interpretations of the current literature base. A degree of hegemonic influence was noted prompting recommendations for future maternity care policy and guidelines'. The Human Research Ethics Committee of the University of South Australia approved the research. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Practice Guidelines for Operative Performance Assessments.

PubMed

Williams, Reed G; Kim, Michael J; Dunnington, Gary L

2016-12-01

To provide recommended practice guidelines for assessing single operative performances and for combining results of operative performance assessments into estimates of overall operative performance ability. Operative performance is one defining characteristic of surgeons. Assessment of operative performance is needed to provide feedback with learning benefits to surgical residents in training and to assist in making progress decisions for residents. Operative performance assessment has been a focus of investigation over the past 20 years. This review is designed to integrate findings of this research into a set of recommended operative performance practices. Literature from surgery and from other pertinent research areas (psychology, education, business) was reviewed looking for evidence to inform practice guideline development. Guidelines were created along with a conceptual and scientific foundation for each guideline. Ten guidelines are provided for assessing individual operative performances and 10 are provided for combing data from individual operative performances into overall judgments of operative performance ability. The practice guidelines organize available information to be immediately useful to program directors, to support surgical training, and to provide a conceptual framework upon which to build as the base of pertinent knowledge expands through future research and development efforts.

[The costs of urinary tract infection therapy with implementation of pharmacoeconomic guidelines at the Clinic for Infectious Diseases of the Clinical Center of Vojvodina].

PubMed

Stefan-Mikić, Sandra; Sević, Sinisa; Doder, Radoslava; Cvjetković, Dejan; Jovanović, Natasa; Ruzić, Maja

2012-08-01

The Serbian health system does not have strict guidelines for the treatment of bacterial infections. The choice of treatment is empirical which is not necessarily the same compared to the treatment guidelines from countries with a developed pharmacotherapeutic practice. In this study we compared the difference between the current treatment and the treatment taking into account the latest pharmacotherapeutic and pharmacoeconomic guidelines in order to estimate clinical efficiency of antibacterial drugs that were given as a therapy of urinary tract infections and to evaluate pharmacoeconomic aspect of this therapy as well. Our study included 100 patients that were randomly chosen and divided into 2 groups. The first group was treated in an ordinary way, while the second one was treated strictly in accordance with the guidelines (British National Formulary - BNF, and Senford Guide). In both groups of the patients we compared length of hospitalization, combination of the used antibiotics, progress as a whole in clinical picture, laboratory analyses and the price of the whole treatment. Analyzing these values independently and according to statistical tests we proved that there were no significant differences between two groups with regard to the progress in a clinical picture as a whole and the length of hospitalization. According to this analysis, however suggested treatment based on guidelines showed a saving of 34.48% in comparison with the usual system of therapy. Efficacy of current treatment of urinary tract infection and the treatment according to foreign guidelines is the same, but the costs of the treatment are lower if the guidelines of developed health care systems are applied.

The Wrong Tool for the Job: Diabetes Public Health Programs and Practice Guidelines

PubMed Central

López, Andrea; Black, Karen; Schillinger, Dean

2011-01-01

We surveyed state diabetes programs to determine whether they develop and disseminate diabetes guidelines. We found they largely disseminate clinical practice guidelines developed from subspecialty organizations, do not prioritize among the many recommendations contained in diabetes guidelines, and have not adapted guidelines to focus on population rather than individual health. An opportunity exists for state diabetes control programs to better align guidelines with public health goals. PMID:21852653

Guideline from Japanese Society of Echocardiography: 2018 focused update incorporated into Guidance for the Management and Maintenance of Echocardiography Equipment.

PubMed

Daimon, Masao; Akaishi, Makoto; Asanuma, Toshihiko; Hashimoto, Shuji; Izumi, Chisato; Iwanaga, Shiro; Kawai, Hiroya; Toide, Hiroyuki; Hayashida, Akihiro; Yamada, Hirotsugu; Murata, Mitsushige; Hirano, Yutaka; Suzuki, Kengo; Nakatani, Satoshi

2018-03-01

Echocardiography plays a pivotal role as an imaging modality in the modern cardiology practice. Information derived from echocardiography is definitely helpful for a patient care. The Japanese Society of Echocardiography has promoted echocardiography for a routine clinical and research use. One of the missions of the Society is to provide information that is useful for high-quality examinations. To ensure it, we believe equipment in good conditions and a comfortable environment are important for both a patient and an examiner. Thus, the Committee for Guideline Writing, the Japanese Society of Echocardiography published brief guidance for the routine use of echocardiography equipment in 2015. Recently, the importance of international standardization has been emphasized in the medical laboratories. Accordingly, the committee has revised and updated our guidance for the routine use of echocardiography equipment.

Critical Appraisal Tools and Reporting Guidelines for Evidence-Based Practice.

PubMed

Buccheri, Robin K; Sharifi, Claire

2017-12-01

Nurses engaged in evidence-based practice (EBP) have two important sets of tools: Critical appraisal tools and reporting guidelines. Critical appraisal tools facilitate the appraisal process and guide a consumer of evidence through an objective, analytical, evaluation process. Reporting guidelines, checklists of items that should be included in a publication or report, ensure that the project or guidelines are reported on with clarity, completeness, and transparency. The primary purpose of this paper is to help nurses understand the difference between critical appraisal tools and reporting guidelines. A secondary purpose is to help nurses locate the appropriate tool for the appraisal or reporting of evidence. A systematic search was conducted to find commonly used critical appraisal tools and reporting guidelines for EBP in nursing. This article serves as a resource to help nurse navigate the often-overwhelming terrain of critical appraisal tools and reporting guidelines, and will help both novice and experienced consumers of evidence more easily select the appropriate tool(s) to use for critical appraisal and reporting of evidence. Having the skills to select the appropriate tool or guideline is an essential part of meeting EBP competencies for both practicing registered nurses and advanced practice nurses (Melnyk & Gallagher-Ford, 2015; Melnyk, Gallagher-Ford, & Fineout-Overholt, 2017). Nine commonly used critical appraisal tools and eight reporting guidelines were found and are described in this manuscript. Specific steps for selecting an appropriate tool as well as examples of each tool's use in a publication are provided. Practicing registered nurses and advance practice nurses must be able to critically appraise and disseminate evidence in order to meet EBP competencies. This article is a resource for understanding the difference between critical appraisal tools and reporting guidelines, and identifying and accessing appropriate tools or guidelines. © 2017 Sigma Theta Tau International.

Clinical exome sequencing reports: current informatics practice and future opportunities.

PubMed

Swaminathan, Rajeswari; Huang, Yungui; Astbury, Caroline; Fitzgerald-Butt, Sara; Miller, Katherine; Cole, Justin; Bartlett, Christopher; Lin, Simon

2017-11-01

The increased adoption of clinical whole exome sequencing (WES) has improved the diagnostic yield for patients with complex genetic conditions. However, the informatics practice for handling information contained in whole exome reports is still in its infancy, as evidenced by the lack of a common vocabulary within clinical sequencing reports generated across genetic laboratories. Genetic testing results are mostly transmitted using portable document format, which can make secondary analysis and data extraction challenging. This paper reviews a sample of clinical exome reports generated by Clinical Laboratory Improvement Amendments-certified genetic testing laboratories at tertiary-care facilities to assess and identify common data elements. Like structured radiology reports, which enable faster information retrieval and reuse, structuring genetic information within clinical WES reports would help facilitate integration of genetic information into electronic health records and enable retrospective research on the clinical utility of WES. We identify elements listed as mandatory according to practice guidelines but are currently missing from some of the clinical reports, which might help to organize the data when stored within structured databases. We also highlight elements, such as patient consent, that, although they do not appear within any of the current reports, may help in interpreting some of the information within the reports. Integrating genetic and clinical information would assist the adoption of personalized medicine for improved patient care and outcomes. © 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.

Potential facilitators and barriers to adopting standard treatment guidelines in clinical practice.

PubMed

Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia

2017-04-18

Purpose The purpose of this paper is to assess medicines information sources accessed by clinicians, if sources differed in theory and practice and to find out the barriers and facilitators to effective guideline adoption. Design/methodology/approach In all, 183 doctors were surveyed. Barriers and facilitators were classified as: communication; potential adopters; innovation; organization characteristics and environmental/social/economic context. Findings Most of the clinicians accessed multiple information sources including standard treatment guidelines, but also consulted seniors/colleagues in practice. The top three factors influencing clinical practice guideline adoption were innovation characteristics, environmental context and individual characteristics. The respondents differed in the following areas: concerns about flexibility offered by the guideline; denying patients' individuality; professional autonomy; insights into gaps in current practice and evidence-based practice; changing practices with little or no benefit. Barriers included negative staff attitudes/beliefs, guideline integration into organizational structures/processes, time/resource constraints. Fearing third parties (government and insurance companies) restricting medicines reimbursement and poor liability protection offered by the guidelines emerged as the barriers. Facilitators include aligning organizational structures/processes with the innovation; providing leadership support to guide diffusion; increasing awareness and enabling early innovation during pre/in-service training, with regular feedback on outcomes and use. Practical implications Guideline adoption in clinical practice is partly within doctors' control. There are other key prevailing factors in the local context such as environmental, social context, professional and organizational culture affecting its adoption. Organizational policy and accreditation standards necessitating adherence can serve as a driver. Originality/value This survey among clinicians, despite limitations, gives helpful insights. While favourable attitudes may be helpful, clinical adoption could be improved more effectively by targeting barriers.

Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement

PubMed Central

Hong, Dae Gy; Shin, So-Jin; Ju, Woong; Cho, Hanbyoul; Lee, Chulmin; Kim, Hyun-Jung; Bae, Duk-Soo

2017-01-01

Clinical practice guidelines for gynecologic cancers have been developed by many organizations. Although these guidelines have much in common in terms of the practice of standard of care for uterine corpus cancer, practice guidelines that reflect the characteristics of patients and healthcare and insurance systems are needed for each country. The Korean Society of Gynecologic Oncology (KSGO) published the first edition of practice guidelines for gynecologic cancer treatment in late 2006; the second edition was released in July 2010 as an evidence-based recommendation. The Guidelines Revision Committee was established in 2015 and decided to produce the third edition of the guidelines as an advanced form based on evidence-based medicine, considering up-to-date clinical trials and abundant qualified Korean data. These guidelines cover screening, surgery, adjuvant treatment, and advanced and recurrent disease with respect to endometrial carcinoma and uterine sarcoma. The committee members and many gynecologic oncologists derived key questions from the discussion, and a number of relevant scientific literatures were reviewed in advance. Recommendations for each specific question were developed by the consensus conference, and they are summarized here, together with other details. The objective of these practice guidelines is to establish standard policies on issues in clinical areas related to the management of uterine corpus cancer based on the findings in published papers to date and the consensus of experts as a KSGO Consensus Statement. PMID:27894165

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine].

PubMed

Liu, Yu-Qi; Liu, Meng-Yu; Li, Chun; Shi, Nan-Nan; Wang, Yue-Xi; Wang, Li-Ying; Zhao, Xue-Yao; Kou, Shuang; Han, Xue-Jie; Wang, Yan-Ping

2017-09-01

This study is to assess the Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine in clinical application and provide evidence for further guideline revision. The assessment was divided into applicability assessment and practicability assessment. The applicability assessment based on questionnaire survey and the traditional Chinese medicine (TCM) practitioners were asked to independently fill the Questionnaire for Applicability Assessment on the Guidelines for Diagnosis and Treatment in Traditional Chinese Medicine. The practicability assessment was based on prospective case investigation and analysis method and the TCM practitioners-in-charge filled the Case Investigation Questionnaire for Practicability Assessment on the Guidelines for Diagnosis and Treatment in Traditional Chinese Medicine. The data were analyzed in descriptive statistics. 151 questionnaires were investigated for applicability assessment and 1 016 patients were included for practicability assessment. The results showed that 88.74% of them were familiar with the guidelines and 45.70% used them. The guidelines quality and related items were similar in applicability assessment and practicability assessment, and scored highly as more than 85.00% except the "recuperating and prevention". The results suggested that the quality of Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine was high and could better guide the clinical practice. The "recuperating and prevention" part should be improved and the evidence data should be included in future guideline revision, so that the clinical utilization rate could be increased. Copyright© by the Chinese Pharmaceutical Association.

[Clinical Practice Guidelines for Management of Schizophrenia: Evaluation Using AGREE II].

PubMed

de la Hoz Bradford, Ana María; Ávila, Mauricio J; Bohórquez Peñaranda, Adriana Patricia; García Valencia, Jenny; Arenas Borrero, Álvaro Enrique; Vélez Traslaviña, Ángela; Jaramillo González, Luis Eduardo; Gómez-Restrepo, Carlos

2014-01-01

Colombia is developing multiple national practice guidelines from a range of diseases. Clinical practice guidelines represent a very useful tool to be able to take decision over a patient care that is widely available for the clinician. In psychiatry there are a good number of international clinical guidelines for the treatment of schizophrenia nevertheless there is no article that evaluate them scientifically In the settings of developing a Colombian schizophrenia practice guideline, a systematic search was performed in multiple databases and the results were then evaluated by two trained persons. We present the results globally and by domains. We found 164 matches for possible guidelines. After screening 7 guidelines were evaluated with the AGREE II instrument. Globally and by the different domains, the National Institute for Health and Care Excellence (NICE) was the guideline that got the best score. From the guidelines that were reviewed, 4 were from Europe and only 2 were from Latin America. None of the guidelines used GRADE methodology for the recommendations. The diversity of the schizophrenia treatment guidelines does not allow an easy adoption of the recommendation by a psychiatrist in Colombia. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Clinical practice guidelines (CPGs) reduce costs in the management of isolated splenic injuries at pediatric trauma centers.

PubMed

Gutierrez, Ivan M; Zurakowski, David; Chen, Qiaoli; Mooney, David P

2013-02-01

The American Pediatric Surgical Association Trauma Committee proposed the use of a clinical practice guideline (CPG) for the non-operative management of isolated splenic injuries in 1998. An analysis was conducted to determine the financial impact of CPGs on the management of these injuries. The Pediatric Health Information System database, which contains data from 44 children's hospitals, was used to identify children who sustained a graded isolated splenic injury between June 2005 and June 2010. Demographics, length of stay (LOS), readmission rates, and laboratory, imaging, procedural, and total cost data were determined for all hospitals verified as a pediatric trauma center by the American College of Surgeons and/or designated by their local authority. Comparisons were made between facilities self-identifying as having a splenic injury management CPG and those without a CPG. Children (1,154) with isolated splenic injuries (grades 1-4) were cared for in 26 pediatric trauma centers: 20 with a CPG and 6 without (non-CPG). Median costs were significantly lower at CPG than non-CPG centers for imaging (US $163 vs. US $641, P < .001), laboratory (US $629 vs. US $1,044, P < .001), and total hospital stay (US $9,868 vs. US $10,830, P < .001). The median LOS for CPG and non-CPG centers were similar (3 vs. 2 days, P = .38), as were readmission rates within 90 days (3.1 vs. 5.1 %, P = .21). Multiple linear regression indicated that LOS (P < .001) and utilization of a CPG (P = .007) are significant independent predictors of total cost. Utilization of a CPG to manage children with isolated splenic injuries at a pediatric trauma center results in significantly reduced imaging, laboratory, and total hospital costs independent of patient age, gender, grade, and LOS.

Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors.

PubMed

Checketts, Jake X; Sims, Matthew Thomas; Vassar, Matt

2017-12-01

It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10 000, and 18 accepted more than $50 000. Financial payments amounted to a mean of $157 177 per author. The total reimbursement among the 49 authors from 2013 to 2015 was $7 701 681. Of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. Authors received payments from companies with products directly related to the guideline topic. Violations to the Administrative Regulations were found. Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments. The American Academy of Dermatology policies may benefit from stricter enforcement or the adoption of new standards.

Canadian physicians' attitudes about and preferences regarding clinical practice guidelines

PubMed Central

Hayward, R S; Guyatt, G H; Moore, K A; McKibbon, K A; Carter, A O

1997-01-01

OBJECTIVE: To assess Canadian physicians' confidence in, attitudes about and preferences regarding clinical practice guidelines. DESIGN: Cross-sectional, self-administered mailed survey. PARTICIPANTS: Stratified random sample of 3000 Canadian physicians; 1878 (62.6%) responded. SETTING: Canada. OUTCOME MEASURES: Physicians' use of various information sources; familiarity with and confidence in guidelines; attitudes about guidelines and their effect on medical care; rating of importance of guidelines and other sources of information in clinical decision-making; rating of importance of various considerations in deciding whether to adopt a set of guidelines; and rating of usefulness of different formats for presenting guidelines. MAIN RESULTS: In all, 52% of the respondents reported using guidelines at least monthly, substantially less frequently than traditional information sources. Most of the respondents expressed confidence in guidelines issued by various physician organizations, but 51% to 77% were not confident in guidelines issued by federal or provincial health ministries or by health insurance plans. The respondents were generally positive about guidelines (e.g., over 50% strongly agreed that they are a convenient source of advice and good educational tools); however, 22% to 26% had concerns about loss of autonomy, the rigidity of guidelines and decreased satisfaction with medical practice. Endorsement by respected colleagues or major organizations was identified as very important by 78% and 62% of the respondents respectively in deciding whether to adopt a set of guidelines in their practice. User friendliness of the guidelines format was thought to be very important by 62%; short pamphlets, manuals summarizing a number of guidelines, journal articles and pocket cards summarizing guidelines were the preferred formats (identified as most useful by 50% to 62% of the respondents). CONCLUSIONS: Canadian physicians, although generally positive about guidelines and confident in those developed by clinicians, have not yet integrated the use of guidelines into their practices to a large extent. Our results suggest that respected organizations and opinion leaders should be involved in the development of guidelines and that the acceptability of any proposed format and medium for guidelines presentation should be pretested. PMID:9220923

Nonpharmacological, blood conservation techniques for preventing neonatal anemia--effective and promising strategies for reducing transfusion.

PubMed

Carroll, Patrick D; Widness, John A

2012-08-01

The development of anemia after birth in very premature, critically ill newborn infants is a universal well-described phenomenon. Although preventing anemia in this population, along with efforts to establish optimal red blood cell (RBC) transfusion and pharmacologic therapy continue to be actively investigated, the present review focuses exclusively on nonpharmacological approaches to the prevention and treatment of neonatal anemia. We begin with an overview of topics relevant to nonpharmacological techniques. These topics include neonatal and fetoplacental hemoglobin levels and blood volumes, clinical and laboratory practices applied in critically ill neonates, and current RBC transfusion practice guidelines. This is followed by a discussion of the most effective and promising nonpharmacological blood conservation strategies and techniques. Fortunately, many of these techniques are feasible in most neonatal intensive care units. When applied together, these techniques are more effective than existing pharmacotherapies in significantly decreasing neonatal RBC transfusions. They include increasing hemoglobin endowment and circulating blood volume at birth; removing less blood for laboratory testing; and optimizing nutrition. Copyright © 2012 Elsevier Inc. All rights reserved.

Ministry of Health Clinical Practice Guidelines: Prevention, Diagnosis and Management of Tuberculosis

PubMed Central

Wang, Yee Tang Sonny; Chee, Cynthia Bin Eng; Hsu, Li Yang; Jagadesan, Raghuram; Kaw, Gregory Jon Leng; Kong, Po Marn; Lew, Yii Jen; Lim, Choon Seng; Lim, Ting Ting Jayne; Lu, Kuo Fan Mark; Ooi, Peng Lim; Sng, Li-Hwei; Thoon, Koh Cheng

2016-01-01

The Ministry of Health (MOH) has developed the clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis to provide doctors and patients in Singapore with evidence-based treatment for tuberculosis. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis, for the information of SMJ readers. The chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines. PMID:26996216

Utilization of the American Telemedicine Association's Clinical Practice Guidelines

PubMed Central

Antoniotti, Nina; Bernard, Jordana

2013-01-01

Abstract Background: The American Telemedicine Association (ATA) Standards and Guidelines Committee develops practice standards and guidelines. Key to the Committee's mission is dissemination so the standards can be used in the practice of telemedicine. Over a 2-year period, when a standards document was accessed from the ATA Web site, a short survey was completed, but it did not assess how the documents were used once downloaded. A more formal survey was conducted to determine the impact ATA standards and guidelines are having on healthcare delivery via telemedicine. Materials and Methods: A survey was developed and distributed via SurveyMonkey to 13,177 ATA members and nonmembers in November 2011. Results were compiled and analyzed after a 90-day open period for responses to be submitted. Results: The majority of respondents (96%) believe the practice of telemedicine/telehealth should have standards and guidelines and that the ATA and other professional societies/associations should be responsible for developing them. The top uses of guidelines include guidance for clinical practice, training, gaining reimbursement, and research. Respondents indicating a need for standards and guidelines said the ATA (78.7%) and other professional societies/associations (74.5%) should be responsible for development. When asked to list specific practice guidelines or standards they are using for telehealth, the majority (21.5%) are using in-house (e.g., hospital, company)-developed guidelines, followed by those from professional associations/societies (20.4%) and those developed by the ATA (18.2%). Conclusions: Overall, the survey results indicate guidelines documents developed by the ATA and other professional societies and those developed in-house are being regularly accessed and used in both public and private sectors. Practitioners of telemedicine believe that standards and guidelines are needed for guidance for clinical practice, training, gaining reimbursement, and research, and they are to use those developed by professional organization such as the ATA as well as those developed by their own institutions. PMID:24050615

International Society for the Advancement of Cytometry cell sorter biosafety standards.

PubMed

Holmes, Kevin L; Fontes, Benjamin; Hogarth, Philip; Konz, Richard; Monard, Simon; Pletcher, Charles H; Wadley, Robert B; Schmid, Ingrid; Perfetto, Stephen P

2014-05-01

Flow cytometric cell sorting of biological specimens has become prevalent in basic and clinical research laboratories. These specimens may contain known or unknown infectious agents, necessitating precautions to protect instrument operators and the environment from biohazards arising from the use of sorters. To this end the International Society of Analytical Cytology (ISAC) was proactive in establishing biosafety guidelines in 1997 (Schmid et al., Cytometry 1997;28:99-117) and subsequently published revised biosafety standards for cell sorting of unfixed samples in 2007 (Schmid et al., Cytometry Part A J Int Soc Anal Cytol 2007;71A:414-437). Since their publication, these documents have become recognized worldwide as the standard of practice and safety precautions for laboratories performing cell sorting experiments. However, the field of cytometry has progressed since 2007, and the document requires an update. The new Standards provides guidance: (1) for laboratory design for cell sorter laboratories; (2) for the creation of laboratory or instrument specific Standard Operating Procedures (SOP); and (3) on procedures for the safe operation of cell sorters, including personal protective equipment (PPE) and validation of aerosol containment. Published © 2014 Wiley Periodicals Inc.

Practice parameters for the treatment of colonic diverticular disease: Italian Society of Colon and Rectal Surgery (SICCR) guidelines.

PubMed

Binda, G A; Cuomo, R; Laghi, A; Nascimbeni, R; Serventi, A; Bellini, D; Gervaz, P; Annibale, B

2015-10-01

The mission of the Italian Society of Colorectal Surgery (SICCR) is to optimize patient care. Providing evidence-based practice guidelines is therefore of key importance. About the present report it concernes the SICCR practice guidelines for the diagnosis and treatment of diverticular disease of the colon. The guidelines are not intended to define the sole standard of care but to provide evidence-based recommendations regarding the available therapeutic options.

Treatment of Tobacco Dependence, a Critical Gap in Czech Clinical Practice Guidelines.

PubMed

Zvolská, Kamila; Fraser, Keely; Zvolský, Miroslav; Králíková, Eva

2017-06-01

Tobacco related comorbidities and treatment of dependence are relevant to clinicians of all disciplines. Clinicians should provide a brief intervention about tobacco use with smokers at each clinical contact (success rate of 5-10 %). Intensive treatment (success rate >30%) should be available to those who need it. Brief intervention is not yet standard clinical practice. Our aim was to assess clinical practice guidelines (CPG) of selected medical professional societies to determine whether or not tobacco dependence treatment recommendations were included. Between October and December 2013, we conducted a keyword search of CPG for 20 medical professional societies in the Czech Republic. We searched for the keywords "smoking", "tobacco" and "nicotine addiction" in 91 CPG documents, which were freely available on the websites of selected professional societies. We focused specifically on CPG relating to cardiovascular and respiratory diseases as well as cancer. We excluded any CPG focused on acute conditions, diagnostics only, laboratory methods, or administration. There was no mention of smoking in 27.7% (26/94) of CPG documents. Only 16% (15/94) of CPG documents listed smoking as a risk factor. 42.5% (40/94) mentioned smoking related phrases (e.g. "smoking ban"). Only 13.8% (13/94) of CPG included a section on tobacco dependence, referenced tobacco dependence treatment guidelines or mentioned specialized treatment centres where smokers can be referred. Nearly one third of CPG related to cardiovascular and respiratory diseases as well as cancer made no mention of smoking. Despite the clinical significance of smoking, the majority of CPG did not adequately address tobacco dependence and its treatment. Copyright© by the National Institute of Public Health, Prague 2017

Practical guidelines for feminist research in nursing.

PubMed

Im, Eun-Ok

2013-01-01

With increasing interests in oppressed groups, the number of feminist studies in nursing has steadily increased. Despite the increasing number of feminist studies, very few articles have been written to provide practical guidelines for feminist research in nursing. In this article, guidelines for feminist research in nursing are proposed on the basis of 3 previous feminist studies. First, characteristics of feminist research are concisely described. Then, the 3 studies that are the basis for the guidelines are described. Finally, practical guidelines for feminist nursing research are proposed on the basis of 10 idea categories related to issues/concerns from the 3 studies.

Renal dietitians lack time and resources to follow the NKF KDOQI guidelines for frequency and method of diet assessment: results of a survey.

PubMed

Hand, Rosa K; Steiber, Alison; Burrowes, Jerrilynn

2013-11-01

This study was conducted to determine how often renal dietitians assess patients' diets and what methods they use to collect and analyze the data. Data were collected through an anonymous online survey. The survey was distributed to renal dietitians during the winter of 2012. Currently practicing renal dietitian members of the International Society for Renal Nutrition and Metabolism, the National Kidney Foundation Council on Renal Nutrition, the Academy of Nutrition and Dietetics Renal Practice Group, and the RenalRD listserve were invited to participate. Of 599 usable responses received, 91% worked in the United States. The main outcome measure was dietitian compliance with Kidney Disease Outcomes Quality Initiative (KDOQI) nutrition assessment guidelines. Most dietitians collect dietary intake data when certain laboratory results are abnormal (70%) whereas 6.5% biannually collect dietary intake data (recommended by KDOQI). The most common reasons for not collecting dietary intake data more frequently were lack of time (42%) and software (25%). Most dietitians determine the frequency of dietary intake assessment on their own (60%) whereas 10% follow the KDOQI guidelines. The most common method of dietary intake data collection was a typical day recall (50%), although 8% reported using a 3-day food record as recommended by KDOQI. The most common method for analyzing dietary intake data was "estimate in my head" (62%) followed by calculate by hand (24.5%). Renal dietitians do not follow the KDOQI guidelines for diet assessment because of time constraints. Research must explore which nutrition assessment tools may improve patient outcomes and can also be completed within the time allotted for nutrition care. Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Clinical Practice Guidelines for Irritable Bowel Syndrome in Korea, 2017 Revised Edition

PubMed Central

Song, Kyung Ho; Jung, Hye-Kyung; Kim, Hyun Jin; Koo, Hoon Sup; Kwon, Yong Hwan; Shin, Hyun Duk; Lim, Hyun Chul; Shin, Jeong Eun; Kim, Sung Eun; Cho, Dae Hyeon; Kim, Jeong Hwan; Kim, Hyun Jung

2018-01-01

In 2011, the Korean Society of Neurogastroenterology and Motility (KSNM) published clinical practice guidelines on the management of irritable bowel syndrome (IBS) based on a systematic review of the literature. The KSNM planned to update the clinical practice guidelines to support primary physicians, reduce the socioeconomic burden of IBS, and reflect advances in the pathophysiology and management of IBS. The present revised version of the guidelines is in continuity with the previous version and targets adults diagnosed with, or suspected to have, IBS. A librarian created a literature search query, and a systematic review was conducted to identify candidate guidelines. Feasible documents were verified based on predetermined inclusion and exclusion criteria. The candidate seed guidelines were fully evaluated by the Guidelines Development Committee using the Appraisal of Guidelines for Research and Evaluation II quality assessment tool. After selecting 7 seed guidelines, the committee prepared evidence summaries to generate data exaction tables. These summaries comprised the 4 main themes of this version of the guidelines: colonoscopy; a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols; probiotics; and rifaximin. To adopt the core recommendations of the guidelines, the Delphi technique (ie, a panel of experts on IBS) was used. To enhance dissemination of the clinical practice guidelines, a Korean version will be made available, and a food calendar for patients with IBS is produced. PMID:29605976

Model-guided fieldwork: practical guidelines for multidisciplinary research on wildlife ecological and epidemiological dynamics

PubMed Central

Restif, Olivier; Hayman, David T S; Pulliam, Juliet R C; Plowright, Raina K; George, Dylan B; Luis, Angela D; Cunningham, Andrew A; Bowen, Richard A; Fooks, Anthony R; O'Shea, Thomas J; Wood, James L N; Webb, Colleen T

2012-01-01

Infectious disease ecology has recently raised its public profile beyond the scientific community due to the major threats that wildlife infections pose to biological conservation, animal welfare, human health and food security. As we start unravelling the full extent of emerging infectious diseases, there is an urgent need to facilitate multidisciplinary research in this area. Even though research in ecology has always had a strong theoretical component, cultural and technical hurdles often hamper direct collaboration between theoreticians and empiricists. Building upon our collective experience of multidisciplinary research and teaching in this area, we propose practical guidelines to help with effective integration among mathematical modelling, fieldwork and laboratory work. Modelling tools can be used at all steps of a field-based research programme, from the formulation of working hypotheses to field study design and data analysis. We illustrate our model-guided fieldwork framework with two case studies we have been conducting on wildlife infectious diseases: plague transmission in prairie dogs and lyssavirus dynamics in American and African bats. These demonstrate that mechanistic models, if properly integrated in research programmes, can provide a framework for holistic approaches to complex biological systems. PMID:22809422

Care Model Design for E-Health: Integration of Point-of-Care Testing at Dutch General Practices

PubMed Central

Verhees, Bart; van Kuijk, Kees

2017-01-01

Point-of-care testing (POCT)—laboratory tests performed with new mobile devices and online technologies outside of the central laboratory—is rapidly outpacing the traditional laboratory test market, growing at a rate of 12 to 15% each year. POCT impacts the diagnostic process of care providers by yielding high efficiency benefits in terms of turnaround time and related quality improvements in the reduction of errors. However, the implementation of this disruptive eHealth technology requires the integration and transformation of diagnostic services across the boundaries of healthcare organizations. Research has revealed both advantages and barriers of POCT implementations, yet to date, there is no business model for the integration of POCT within general practice. The aim of this article is to contribute with a design for a care model that enables the integration of POCT in primary healthcare. In this research, we used a design modelling toolkit for data collection at five general practices. Through an iterative design process, we modelled the actors and value transactions, and designed an optimized care model for the dynamic integration of POCTs into the GP’s network of care delivery. The care model design will have a direct bearing on improving the integration of POCT through the connectivity and norm guidelines between the general practice, the POC technology, and the diagnostic centre. PMID:29267224

Ministry of Health clinical practice guidelines: Management of Rhinosinusitis and Allergic Rhinitis.

PubMed

Siow, J K; Alshaikh, N A; Balakrishnan, A; Chan, K O; Chao, S S; Goh, L G; Hwang, S Y; Lee, C Y; Leong, J L; Lim, L; Menon, A; Sethi, D S; Tan, H; Wang, D Y

2010-03-01

The Ministry of Health publishes national clinical practice guidelines to provide doctors and patients in Singapore with evidence-based guidance on managing important medical conditions. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the Ministry of Health clinical practice guidelines on Management of Rhinosinusitis and Allergic Rhinitis, for the information of readers of the Singapore Medical Journal. Chapters, page and figure numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website (http://www.moh.gov.sg/mohcorp/publications.aspx?id=24046). The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

[A reporting tool for practice guidelines in health care: the RIGHT statement].

PubMed

Chen, Yaolong; Yang, Kehu; Marušić, Ana; Qaseem, Amir; Meerpohl, Joerg J; Flottorp, Signe; Akl, Elie A; Schünemann, Holger J; Chan, Edwin S Y; Falck-Ytter, Yngve; Ahmed, Faruque; Barber, Sarah; Chen, Chiehfeng; Zhang, Mingming; Xu, Bin; Tian, Jinhui; Song, Fujian; Shang, Hongcai; Tang, Kun; Wang, Qi; Norris, Susan L; Labonté, Valérie C; Möhler, Ralph; Kopp, Ina; Nothacker, Monika; Meerpohl, Joerg J

2017-11-01

The quality of reporting practice guidelines is often poor, and there is no widely accepted guidance or standards for such reporting in health care. The international RIGHT (Reporting Items for practice Guidelines in HealThcare) Working Group was established to address this gap. The group followed an existing framework for developing guidelines for health research reporting and the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach. A checklist and an explanation and elaboration statement were developed. The RIGHT checklist includes 22 items that are considered essential for good reporting of practice guidelines: basic information (items 1 to 4), background (items 5 to 9), evidence (items 10 to 12), recommendations (items 13 to 15), review and quality assurance (items 16 and 17), funding and declaration and management of interests (items 18 and 19), and other information (items 20 to 22). The RIGHT checklist can assist developers in reporting guidelines, support journal editors and peer reviewers when considering guideline reports, and help health care practitioners understand and implement a guideline. Copyright © 2017. Published by Elsevier GmbH.

Development of the Champlain primary care cardiovascular disease prevention and management guideline

PubMed Central

Montoya, Lorraine; Liddy, Clare; Hogg, William; Papadakis, Sophia; Dojeiji, Laurie; Russell, Grant; Akbari, Ayub; Pipe, Andrew; Higginson, Lyall

2011-01-01

Abstract Problem addressed A well documented gap remains between evidence and practice for clinical practice guidelines in cardiovascular disease (CVD) care. Objective of program As part of the Champlain CVD Prevention Strategy, practitioners in the Champlain District of Ontario launched a large quality-improvement initiative that focused on increasing the uptake in primary care practice settings of clinical guidelines for heart disease, stroke, diabetes, and CVD risk factors. Program description The Champlain Primary Care CVD Prevention and Management Guideline is a desktop resource for primary care clinicians working in the Champlain District. The guideline was developed by more than 45 local experts to summarize the latest evidence-based strategies for CVD prevention and management, as well as to increase awareness of local community-based programs and services. Conclusion Evidence suggests that tailored strategies are important when implementing specific practice guidelines. This article describes the process of creating an integrated clinical guideline for improvement in the delivery of cardiovascular care. PMID:21673196

A review of clinical practice guidelines for lung cancer

PubMed Central

Ball, David; Silvestri, Gerard A.

2013-01-01

Clinical practice guidelines are important evidence-based resources to guide complex clinical decision making. However, it is challenging for health professionals to keep abreast available guidelines and to know how and where to access relevant guidelines. This review examines currently available guidelines for lung cancer published in the English language. Important key features are listed for each identified guideline. The methodology, approaches to dissemination and implementation, and associated resources are summarised. General challenges in the area of guideline development are highlighted. The potential to collaborate more widely across lung cancer guideline developers by sharing literature searches and assessments is discussed. PMID:24163752

Clinical practice guidelines in complementary and alternative medicine. An analysis of opportunities and obstacles. Practice and Policy Guidelines Panel, National Institutes of Health Office of Alternative Medicine.

PubMed

1997-01-01

An estimated 1 of 3 Americans uses some form of complementary and alternative medicine (CAM), such as acupuncture, homeopathy, or herbal medicine. In 1995, the National Institutes of Health Office of Alternative Medicine convened an expert panel to examine the role of clinical practice guidelines in CAM. The panel concluded that CAM practices currently are unsuitable for the development of evidence-based practice guidelines, in part because of the lack of relevant outcomes data from well-designed clinical trials. Moreover, the notions of standardization and appropriateness, inherent in guideline development, face challenging methodologic problems when applied to CAM, which considers many different treatment practices appropriate and encourages highly individualized care. Due to different belief systems and divergent theories about the nature of health and illness, CAM disciplines have fundamental differences in how they define target conditions, causes of disease, interventions, and outcome measures of effectiveness. These differences are even more striking when compared with those used by Western medicine. The panel made a series of recommendations on strategies to strengthen the evidence base for future guideline development in CAM and to meet better the current information needs of clinicians, patients, and guideline developers who seek information about CAM treatments.

Designation, diligence and drift: understanding laboratory expenditure increases in British Columbia, 1996/97 to 2005/06.

PubMed

Sivananthan, Saskia N; Peterson, Sandra; Lavergne, Ruth; Barer, Morris L; McGrail, Kimberlyn M

2012-12-21

Laboratory testing is one of the fastest growing areas of health services spending in Canada. We examine the extent to which increases in laboratory expenditures might be explained by testing that is consistent with guidelines for the management of chronic conditions, by analyzing fee-for-service physician payment data in British Columbia from 1996/97 and 2005/06. We used direct standardization to quantify the effect on laboratory expenditures from changes in: fee levels; population growth; population aging; treatment prevalence; expenditure on recommended tests for those conditions; and expenditure on other tests. The chronic conditions selected were those with guidelines containing laboratory recommendations developed by the BC Guidelines and Protocol Advisory Committee: diabetes, hypertension, congestive heart failure, renal failure, liver disease, rheumatoid arthritis, osteoarthritis and dementia. Laboratory service expenditures increased by $98 million in 2005/06 compared to 1996/97, or 3.6% per year after controlling for population growth and aging. Testing consistent with guideline-recommended care for chronic conditions explained one-third (1.2% per year) of this growth. Changes in treatment prevalence were just as important, contributing 1.5% per year. Hypertension was the most common condition, but renal failure and dementia showed the largest changes in prevalence over time. Changes in other laboratory expenditure including for those without chronic conditions accounted for the remaining 0.9% growth per year. Increases in treatment prevalence were the largest driver of laboratory cost increases between 1996/97 and 2005/06. There are several possible contributors to increasing treatment prevalence, all of which can be expected to continue to put pressure on health care expenditures.

How can clinical practice guidelines be adapted to facilitate shared decision making? A qualitative key-informant study.

PubMed

van der Weijden, Trudy; Pieterse, Arwen H; Koelewijn-van Loon, Marije S; Knaapen, Loes; Légaré, France; Boivin, Antoine; Burgers, Jako S; Stiggelbout, Anne M; Faber, Marjan; Elwyn, Glyn

2013-10-01

To explore how clinical practice guidelines can be adapted to facilitate shared decision making. This was a qualitative key-informant study with group discussions and semi-structured interviews. First, 75 experts in guideline development or shared decision making participated in group discussions at two international conferences. Next, health professionals known as experts in depression or breast cancer, experts on clinical practice guidelines and/or shared decision making, and patient representatives were interviewed (N=20). Using illustrative treatment decisions on depression or breast cancer, we asked the interviewees to indicate as specifically as they could how guidelines could be used to facilitate shared decision making. Interviewees suggested some generic strategies, namely to include a separate chapter on the importance of shared decision making, to use language that encourages patient involvement, and to develop patient versions of guidelines. Recommendation-specific strategies, related to specific decision points in the guideline, were also suggested: These include structuring the presentation of healthcare options to increase professionals' option awareness; structuring the deliberation process between professionals and patients; and providing relevant patient support tools embedded at important decision points in the guideline. This study resulted in an overview of strategies to adapt clinical practice guidelines to facilitate shared decision making. Some strategies seemed more contentious than others. Future research should assess the feasibility and impact of these strategies to make clinical practice guidelines more conducive to facilitate shared decision making.

Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.

PubMed

2003-02-01

International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. To develop and validate an international instrument for assessing the quality of the process and reporting of clinical practice guideline development. The instrument was developed through a multi-staged process of item generation, selection and scaling, field testing, and refinement procedures. 100 guidelines selected from 11 participating countries were evaluated independently by 194 appraisers with the instrument. Following refinement the instrument was further field tested on three guidelines per country by a new set of 70 appraisers. The final version of the instrument contained 23 items grouped into six quality domains with a 4 point Likert scale to score each item (scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, editorial independence). 95% of appraisers found the instrument useful for assessing guidelines. Reliability was acceptable for most domains (Cronbach's alpha 0.64-0.88). Guidelines produced as part of an established guideline programme had significantly higher scores on editorial independence and, after the publication of a national policy, had significantly higher quality scores on rigour of development (p<0.005). Guidelines with technical documentation had higher scores on that domain (p<0.0001). This is the first time an appraisal instrument for clinical practice guidelines has been developed and tested internationally. The instrument is sensitive to differences in important aspects of guidelines and can be used consistently and easily by a wide range of professionals from different backgrounds. The adoption of common standards should improve the consistency and quality of the reporting of guideline development worldwide and provide a framework to encourage international comparison of clinical practice guidelines.

A content validated questionnaire for assessment of self reported venous blood sampling practices

PubMed Central

2012-01-01

Background Venous blood sampling is a common procedure in health care. It is strictly regulated by national and international guidelines. Deviations from guidelines due to human mistakes can cause patient harm. Validated questionnaires for health care personnel can be used to assess preventable "near misses"--i.e. potential errors and nonconformities during venous blood sampling practices that could transform into adverse events. However, no validated questionnaire that assesses nonconformities in venous blood sampling has previously been presented. The aim was to test a recently developed questionnaire in self reported venous blood sampling practices for validity and reliability. Findings We developed a questionnaire to assess deviations from best practices during venous blood sampling. The questionnaire contained questions about patient identification, test request management, test tube labeling, test tube handling, information search procedures and frequencies of error reporting. For content validity, the questionnaire was confirmed by experts on questionnaires and venous blood sampling. For reliability, test-retest statistics were used on the questionnaire answered twice. The final venous blood sampling questionnaire included 19 questions out of which 9 had in total 34 underlying items. It was found to have content validity. The test-retest analysis demonstrated that the items were generally stable. In total, 82% of the items fulfilled the reliability acceptance criteria. Conclusions The questionnaire could be used for assessment of "near miss" practices that could jeopardize patient safety and gives several benefits instead of assessing rare adverse events only. The higher frequencies of "near miss" practices allows for quantitative analysis of the effect of corrective interventions and to benchmark preanalytical quality not only at the laboratory/hospital level but also at the health care unit/hospital ward. PMID:22260505

A content validated questionnaire for assessment of self reported venous blood sampling practices.

PubMed

Bölenius, Karin; Brulin, Christine; Grankvist, Kjell; Lindkvist, Marie; Söderberg, Johan

2012-01-19

Venous blood sampling is a common procedure in health care. It is strictly regulated by national and international guidelines. Deviations from guidelines due to human mistakes can cause patient harm. Validated questionnaires for health care personnel can be used to assess preventable "near misses"--i.e. potential errors and nonconformities during venous blood sampling practices that could transform into adverse events. However, no validated questionnaire that assesses nonconformities in venous blood sampling has previously been presented. The aim was to test a recently developed questionnaire in self reported venous blood sampling practices for validity and reliability. We developed a questionnaire to assess deviations from best practices during venous blood sampling. The questionnaire contained questions about patient identification, test request management, test tube labeling, test tube handling, information search procedures and frequencies of error reporting. For content validity, the questionnaire was confirmed by experts on questionnaires and venous blood sampling. For reliability, test-retest statistics were used on the questionnaire answered twice. The final venous blood sampling questionnaire included 19 questions out of which 9 had in total 34 underlying items. It was found to have content validity. The test-retest analysis demonstrated that the items were generally stable. In total, 82% of the items fulfilled the reliability acceptance criteria. The questionnaire could be used for assessment of "near miss" practices that could jeopardize patient safety and gives several benefits instead of assessing rare adverse events only. The higher frequencies of "near miss" practices allows for quantitative analysis of the effect of corrective interventions and to benchmark preanalytical quality not only at the laboratory/hospital level but also at the health care unit/hospital ward.

A Systematic Review of Clinical Practice Guidelines' Recommendations on Levothyroxine Therapy Alone versus Combination Therapy (LT4 plus LT3) for Hypothyroidism.

PubMed

Kraut, Eyal; Farahani, Pendar

2015-12-04

Patients with hypothyroidism are increasingly enquiring about the benefit of using combination therapy of levothyroxine (LT4) and liothyronine (LT3) as a potential treatment for hypothyroidism. Combination therapy, however, remains controversial. The purpose of this study was to systematically review available hypothyroidism treatment recommendations from clinical practice guidelines from around the world to identify the consensus regarding combination therapy. Clinical practice guidelines were obtained from searches of PubMed, EMBASE, and MEDLINE, using several combinations of MeSH terms. The search was limited to clinical guidelines in English-language publications, published between January 1, 1990 and May 1, 2015. A quantitative approach was utilized for data synthesis. Thirteen guidelines were identified, including three regarding pregnancy, two regarding pediatric populations and eight regarding adult populations. There were six guidelines from North America, four guidelines from Europe and three guidelines from South America. Twelve of the guidelines were published after 2010. Nine guidelines addressed combination therapy of LT4 plus LT3, and all nine concluded that LT4 therapy alone is the standard of care, with insufficient evidence to recommend widespread combination therapy. Only the 2012 ETA Guidelines and the 2015 BTA Guidelines concluded that combination therapy could be used, although only in certain circumstances and as an experimental treatment. This systematic review illustrates that clinical practice guidelines worldwide do not recommend and do not support routine use of combination LT4 and LT3 therapy to treat hypothyroidism.

Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline.

PubMed

Lenders, Jacques W M; Duh, Quan-Yang; Eisenhofer, Graeme; Gimenez-Roqueplo, Anne-Paule; Grebe, Stefan K G; Murad, Mohammad Hassan; Naruse, Mitsuhide; Pacak, Karel; Young, William F

2014-06-01

The aim was to formulate clinical practice guidelines for pheochromocytoma and paraganglioma (PPGL). The Task Force included a chair selected by the Endocrine Society Clinical Guidelines Subcommittee (CGS), seven experts in the field, and a methodologist. The authors received no corporate funding or remuneration. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. The Task Force reviewed primary evidence and commissioned two additional systematic reviews. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, European Society of Endocrinology, and Americal Association for Clinical Chemistry reviewed drafts of the guidelines. The Task Force recommends that initial biochemical testing for PPGLs should include measurements of plasma free or urinary fractionated metanephrines. Consideration should be given to preanalytical factors leading to false-positive or false-negative results. All positive results require follow-up. Computed tomography is suggested for initial imaging, but magnetic resonance is a better option in patients with metastatic disease or when radiation exposure must be limited. (123)I-metaiodobenzylguanidine scintigraphy is a useful imaging modality for metastatic PPGLs. We recommend consideration of genetic testing in all patients, with testing by accredited laboratories. Patients with paraganglioma should be tested for SDHx mutations, and those with metastatic disease for SDHB mutations. All patients with functional PPGLs should undergo preoperative blockade to prevent perioperative complications. Preparation should include a high-sodium diet and fluid intake to prevent postoperative hypotension. We recommend minimally invasive adrenalectomy for most pheochromocytomas with open resection for most paragangliomas. Partial adrenalectomy is an option for selected patients. Lifelong follow-up is suggested to detect recurrent or metastatic disease. We suggest personalized management with evaluation and treatment by multidisciplinary teams with appropriate expertise to ensure favorable outcomes.

Relating UMLS semantic types and task-based ontology to computer-interpretable clinical practice guidelines.

PubMed

Kumar, Anand; Ciccarese, Paolo; Quaglini, Silvana; Stefanelli, Mario; Caffi, Ezio; Boiocchi, Lorenzo

2003-01-01

Medical knowledge in clinical practice guideline (GL) texts is the source of task-based computer-interpretable clinical guideline models (CIGMs). We have used Unified Medical Language System (UMLS) semantic types (STs) to understand the percentage of GL text which belongs to a particular ST. We also use UMLS semantic network together with the CIGM-specific ontology to derive a semantic meaning behind the GL text. In order to achieve this objective, we took nine GL texts from the National Guideline Clearinghouse (NGC) and marked up the text dealing with a particular ST. The STs we took into consideration were restricted taking into account the requirements of a task-based CIGM. We used DARPA Agent Markup Language and Ontology Inference Layer (DAML + OIL) to create the UMLS and CIGM specific semantic network. For the latter, as a bench test, we used the 1999 WHO-International Society of Hypertension Guidelines for the Management of Hypertension. We took into consideration the UMLS STs closest to the clinical tasks. The percentage of the GL text dealing with the ST "Health Care Activity" and subtypes "Laboratory Procedure", "Diagnostic Procedure" and "Therapeutic or Preventive Procedure" were measured. The parts of text belonging to other STs or comments were separated. A mapping of terms belonging to other STs was done to the STs under "HCA" for representation in DAML + OIL. As a result, we found that the three STs under "HCA" were the predominant STs present in the GL text. In cases where the terms of related STs existed, they were mapped into one of the three STs. The DAML + OIL representation was able to describe the hierarchy in task-based CIGMs. To conclude, we understood that the three STs could be used to represent the semantic network of the task-bases CIGMs. We identified some mapping operators which could be used for the mapping of other STs into these.

Prescriber Compliance With Liver Monitoring Guidelines for Pazopanib in the Postapproval Setting: Results From a Distributed Research Network.

PubMed

Shantakumar, Sumitra; Nordstrom, Beth L; Hall, Susan A; Djousse, Luc; van Herk-Sukel, Myrthe P P; Fraeman, Kathy H; Gagnon, David R; Chagin, Karen; Nelson, Jeanenne J

2017-04-20

Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines. Over a 4-year period, a distributed network approach was used across 3 databases: US Veterans Affairs Healthcare System, a US outpatient oncology community practice database, and the Dutch PHARMO Database Network. Measures of prescriber compliance were designed using the original pazopanib label guidelines for liver monitoring. Results from the VA (n = 288) and oncology databases (n = 283) indicate that prescriber liver chemistry monitoring was less than 100%: 73% to 74% compliance with baseline testing and 37% to 39% compliance with testing every 4 weeks. Compliance was highest near drug initiation and decreased over time. Among patients who should have had weekly testing, the compliance was 56% in both databases. The more serious elevations examined, including combinations of liver enzyme elevations meeting the laboratory definition of Hy's law were infrequent but always led to appropriate discontinuation of pazopanib. Only 4 patients were identified for analysis in the Dutch database; none had recorded baseline testing. In this population-based study, prescriber compliance was reasonable near pazopanib initiation but low during subsequent weeks of treatment. This study provides information from real-world community practice settings and offers feedback to regulators on the effectiveness of label monitoring guidelines.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Communicating statin evidence to support shared decision-making.

PubMed

Barrett, Bruce; Ricco, Jason; Wallace, Margaret; Kiefer, David; Rakel, Dave

2016-04-06

The practice of clinical medicine rests on a foundation of ethical principles as well as scientific knowledge. Clinicians must artfully balance the principle of beneficence, doing what is best for patients, with autonomy, allowing patients to make their own well-informed health care decisions. The clinical communication process is complicated by varying degrees of confidence in scientific evidence regarding patient-oriented benefits, and by the fact that most medical options are associated with possible harms as well as potential benefits. Evidence-based clinical guidelines often neglect patient-oriented issues involved with the thoughtful practice of shared decision-making, where individual values, goals, and preferences should be prioritized. Guidelines on the use of statin medications for preventing cardiovascular events are a case in point. Current guidelines endorse the use of statins for people whose 10-year risk of cardiovascular events is as low as 7.5%. Previous guidelines set the 10-year risk benchmark at 20%. Meta-analysis of randomized trials suggests that statins can reduce cardiovascular event rates by about 25%, bringing 10-year risk from 7.5 to 5.6%, for example, or from 20 to 15%. Whether or not these benefits should justify the use of statins for individual patients depends on how those advantages are valued in comparison with disadvantages, such as side effect risks, and with inconveniences associated with taking a pill each day and visiting clinicians and laboratories regularly. Whether or not the overall benefit-harm balance justifies the use of a medication for an individual patient cannot be determined by a guidelines committee, a health care system, or even the attending physician. Instead, it is the individual patient who has a fundamental right to decide whether or not taking a drug is worthwhile. Researchers and professional organizations should endeavor to develop shared decision-making tools that provide up-to-date best evidence in easily understandable formats, so as to assist clinicians in helping their patients to make the decisions that are right for them.

Cervical cancer screening in adolescents: an evidence-based internet education program for practice improvement among advanced practice nurses.

PubMed

Choma, Kim; McKeever, Amy E

2015-02-01

The literature reports great variation in the knowledge levels and application of the recent changes of cervical cancer screening guidelines into clinical practice. Evidence-based screening guidelines for the prevention and early detection of cervical cancer offers healthcare providers the opportunity to improve practice patterns among female adolescents by decreasing psychological distress as well as reducing healthcare costs and morbidities associated with over-screening. The purpose of this pilot intervention study was to determine the effects of a Web-based continuing education unit (CEU) program on advanced practice nurses' (APNs) knowledge of current cervical cancer screening evidence-based recommendations and their application in practice. This paper presents a process improvement project as an example of a way to disseminate updated evidence-based practice guidelines among busy healthcare providers. This Web-based CEU program was developed, piloted, and evaluated specifically for APNs. The program addressed their knowledge level of cervical cancer and its relationship with high-risk human papillomavirus. It also addressed the new cervical cancer screening guidelines and the application of those guidelines into clinical practice. Results of the study indicated that knowledge gaps exist among APNs about cervical cancer screening in adolescents. However, when provided with a CEU educational intervention, APNs' knowledge levels increased and their self-reported clinical practice behaviors changed in accordance with the new cervical cancer screening guidelines. Providing convenient and readily accessible up-to-date electronic content that provides CEU enhances the adoption of clinical practice guidelines, thereby decreasing the potential of the morbidities associated with over-screening for cervical cancer in adolescents and young women. © 2014 Sigma Theta Tau International.

Child neurology practice guidelines: past, present, and future.

PubMed

Hurwitz, Benjamin A; Hurwitz, Kathleen Bretzius; Ashwal, Stephen

2015-03-01

Practice guidelines have been developed in child neurology during the last fifteen years to address important clinical questions and provide evidence-based recommendations for patient care. This review describes the guideline development process and how it has evolved to meet the needs of child neurologists. Several current child neurology guidelines are reviewed and the advantages and disadvantages of guidelines, as well as the legal consequences of using them to determine a standard of care are discussed. The future of guidelines and of their influence on integrated support systems also is considered. Child neurology practice guidelines are a helpful resource for clinicians, families and institutions as they provide evidence-based recommendations concerning the diagnosis and management of common neurological conditions affecting children. Incorporating consensus processes has allowed expansion of clinically relevant recommendations that has increased the utility of guidelines. Copyright © 2015 Elsevier Inc. All rights reserved.

Consumers' practical understanding of healthy food choices: a fake food experiment.

PubMed

Mötteli, Sonja; Keller, Carmen; Siegrist, Michael; Barbey, Jana; Bucher, Tamara

2016-08-01

Little is known about laypeople's practical understanding of a healthy diet, although this is important to successfully promote healthy eating. The present study is the first to experimentally examine how consumers define healthy and balanced food choices for an entire day compared with normal choices and compared with dietary guidelines. We used an extensive fake food buffet (FFB) with 179 foods commonly consumed in the Swiss diet. The FFB is a validated method to investigate food choice behaviour in a well-controlled laboratory setting. People from the general population in Switzerland (n 187; 51·9 % females), aged between 18 and 65 years, were randomly assigned to one of two conditions. In the control group, the participants were instructed to serve themselves foods they would eat on a normal day, whereas in the 'healthy' group they were instructed to choose foods representing a healthy diet. Participants chose significantly more healthy foods, with 4·5 g more dietary fibre, 2 % more protein and 2 % less SFA in the 'healthy' group compared with the control group. However, in both experimental conditions, participants served themselves foods containing twice as much sugar and salt than recommended by dietary guidelines. The results suggest that laypeople lack knowledge about the recommended portion sizes and the amounts of critical nutrients in processed food, which has important implications for communicating dietary guidelines. Furthermore, the energy of the food served was substantially correlated with the energy needs of the participants, demonstrating the potential of the fake food buffet method.

A guide to unclassified sensitive information protection

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

Donahue, S.C.

1996-11-14

This document is a reference guide for CIC-Division employees who lead or participate in projects that use and/or produce unclassified sensitive information. It is intended for use on a case by case basis to develop project specific sensitive information handling procedures and standards. It contains criteria for identifying sensitive information and determining levels of sensitivity, and describes cost effective measures for protecting various levels of sensitive information. The goal of this document is to help establish good business practices that benefit both the Laboratory and its customers. Division personnel are encouraged to apply these guidelines.

Value for money in changing clinical practice: should decisions about guidelines and implementation strategies be made sequentially or simultaneously?

PubMed

Hoomans, Ties; Severens, Johan L; Evers, Silvia M A A; Ament, Andre J H A

2009-01-01

Decisions about clinical practice change, that is, which guidelines to adopt and how to implement them, can be made sequentially or simultaneously. Decision makers adopting a sequential approach first compare the costs and effects of alternative guidelines to select the best set of guideline recommendations for patient management and subsequently examine the implementation costs and effects to choose the best strategy to implement the selected guideline. In an integral approach, decision makers simultaneously decide about the guideline and the implementation strategy on the basis of the overall value for money in changing clinical practice. This article demonstrates that the decision to use a sequential v. an integral approach affects the need for detailed information and the complexity of the decision analytic process. More importantly, it may lead to different choices of guidelines and implementation strategies for clinical practice change. The differences in decision making and decision analysis between the alternative approaches are comprehensively illustrated using 2 hypothetical examples. We argue that, in most cases, an integral approach to deciding about change in clinical practice is preferred, as this provides more efficient use of scarce health-care resources.

Guidelines for project-level traffic forecasting for Hawaii Department of Transportation.

DOT National Transportation Integrated Search

2015-12-01

These guidelines describe both best practice and acceptable practice for performing project-level traffic : forecasts for the State of Hawaii. The guidelines describe a number of techniques and options that are all : acceptable within their intended ...

Antimicrobial susceptibility testing by Australian veterinary diagnostic laboratories.

PubMed

Hardefeldt, L Y; Marenda, M; Crabb, H; Stevenson, M A; Gilkerson, J R; Billman-Jacobe, H; Browning, G F

2018-04-01

The national strategy for tackling antimicrobial resistance highlights the need for antimicrobial stewardship in veterinary practice and for surveillance of antimicrobial susceptibility in veterinary pathogens. Diagnostic laboratories have an important role in facilitating both of these processes, but it is unclear whether data from veterinary diagnostic laboratories are similar enough to allow for compilation and if there is consistent promotion of appropriate antimicrobial use embedded in the approaches of different laboratories to susceptibility testing. A cross-sectional study of antimicrobial susceptibility testing and reporting procedures by Australian veterinary diagnostic laboratories was conducted in 2017 using an online questionnaire. All 18 veterinary diagnostic laboratories in Australia completed the questionnaire. Kirby-Bauer disc diffusion was the method predominantly used for antimicrobial susceptibility testing and was used to evaluate 86% of all isolates, although two different protocols were used across the 18 laboratories (CLSI 15/18, CDS 3/18). Minimum inhibitory concentrations were never reported by 61% of laboratories. Common isolates were consistently reported on across all species, except for gram-negative isolates in pigs, for which there was some variation in the approach to reporting. There was considerable diversity in the panels of antimicrobials used for susceptibility testing on common isolates and no consistency was apparent between laboratories for any bacterial species. We recommend that nationally agreed and consistent antimicrobial panels for routine susceptibility testing should be developed and a uniform set of guidelines should be adopted by veterinary diagnostic laboratories in Australia. © 2018 Australian Veterinary Association.

KDIGO 2012 Clinical Practice Guideline CKD classification rules out creatinine clearance 24 hour urine collection?

PubMed

Ognibene, A; Grandi, G; Lorubbio, M; Rapi, S; Salvadori, B; Terreni, A; Veroni, F

2016-01-01

The recent guideline for the evaluation and management of Chronic Kidney Disease recommends assessing GFR employing equations based on serum creatinine; despite this, creatinine clearance 24-hour urine collection is used routinely in many settings. In this study we compared the classification assessed from CrCl (creatinine clearance 24h urine collection) and e-GFR calculated with CKD-EPI or MDRD formulas. In this retrospective study we analyze consecutive laboratory data: creatinine clearance 24h urine collection, serum creatinine and demographic data such as sex and age from 15,777 patients >18 years of age collected from 2011 to 2013 in our laboratory at Careggi Hospital. The results were then compared to the estimated GFR calculated with the equations according to the recent treatment guidelines. Consecutive and retrospective laboratory data (creatinine clearance 24h urine collection, serum creatinine and, demographic data such as sex and age) from 15,777 patients >18 years of age seen at Careggi Hospital were collected. Comparison between e-GFR calculated with CKD-EPI or MDRD formulas and GFR according CrCl determinations and bias [95% CI] were 11.34 [-47,4/70.1] and 11.4 [-50.2/73] respectively. The concordance for 18/65 years aged group when compared with e-GFR classification between MDRD vs CKDEPI, MDRD vs CrCl and CKD-EPI vs CrCl were 0.78, 0.34, and 0.41 respectively, while in the 65/110years aged group the concordance Kappas were 0.84, 0.38, and 0.36 respectively. The use of CrCl provides a different classification than the estimation of GFR using a prediction equation. The CrCl is unreliable when it is necessary to identify CKD subjects with decrease of GFR of 5ml/min/1.73m(2)/year. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Practice organisational characteristics can impact on compliance with the BTS/SIGN asthma guideline: qualitative comparative case study in primary care.

PubMed

Wiener-Ogilvie, Sharon; Huby, Guro; Pinnock, Hilary; Gillies, John; Sheikh, Aziz

2008-06-04

Although the BTS-SIGN asthma guideline is one of the most well known and widely respected guidelines in the world, implementation in UK primary care remains patchy. Building on extensive earlier descriptive work, we sought to explore the way teamwork and inter-professional relationships impact on the implementation of the BTS-SIGN guideline on asthma in general practice. Qualitative comparative case study using nine in-depth interviews and 2 focus groups with general practitioners and practice nurses, involved in delivering asthma care. Participants were purposively recruited from practices in a Scottish health board with high and low compliance with the BTS-SIGN asthma guideline. There was a marked difference in the way respondents from practices with high compliance and respondents from practices with low compliance spoke about the value of guidelines and the challenges of implementing them. On both accounts, the former were more positive than the latter and were able to be more specific about the strategies they used to overcome barriers to implementation. We explored the reason for this difference in response and identified practice organisation, centring on delegation of work to nurses, as a factor mediating the practice's level of compliance. Effective delegation was underpinned by organisation of asthma work among practice members who have the appropriate level of skills and knowledge, know and understand each others' work and responsibilities, communicate well among themselves and trust each others' skills. It was the combination of these factors which made for successful delegation and guideline implementation, not any one factor in isolation. In our sample of practices, teamwork and organisation of care within practices appeared to impact on guideline implementation and further larger studies are needed to explore this issue further. Isolated interventions such as measures to improve staff's knowledge or increased clinical resource and time, which are currently being considered, are unlikely to be effective unless practices are supported in developing their teams in a way which supports the deployment of these resources.

Influence of qualitative research on women's health screening guidelines.

PubMed

Abadir, Anna Maria; Lang, Ariella; Klein, Talia; Abenhaim, Haim Arie

2014-01-01

Considerable time and resources are allocated to carry out qualitative research. The purpose of our study was to evaluate the availability of qualitative research on women's health screening and assess its influence on screening practice guidelines in the United States, Canada, and the United Kingdom. Medline, CINHAL, and WEB of Science databases were used to identify the availability of qualitative research conducted in the past 15 years on 3 different women's health screening topics: cervical cancer screening, breast cancer screening, and prenatal first-trimester screening. Key national practice guidelines on women's health screening were selected using the National Guideline Clearinghouse web site. Bibliometric analysis was used to determine the frequency of qualitative references cited in the guidelines. A total of 272 qualitative research papers on women's health screening was identified: 109 on cervical cancer screening, 104 on breast cancer screening, and 59 on prenatal first-trimester screening. The qualitative studies focused on health care provider perspectives as well as ethical, ethnographic, psychological, and social issues surrounding screening. Fifteen national clinical practice guidelines on women's health screening were identified. A total of 943 references was cited, only 2 of which comprised of qualitative research cited by only 1 clinical practice guideline. Although there is considerable qualitative research that has been carried out on women's health screening, its incorporation into clinical practice guidelines is minimal. Further exploration of the disconnect between the two is important for enhancing knowledge translation of qualitative research within clinical practice. Copyright © 2014 Mosby, Inc. All rights reserved.

Evaluation of the novel respiratory virus surveillance program: Pediatric Early Warning Sentinel Surveillance (PEWSS).

PubMed

Armour, Patricia A; Nguyen, Linh M; Lutman, Michelle L; Middaugh, John P

2013-01-01

Infections caused by respiratory viruses are associated with recurrent epidemics and widespread morbidity and mortality. Routine surveillance of these pathogens is necessary to determine virus activity, monitor for changes in circulating strains, and plan for public health preparedness. The Southern Nevada Health District in Las Vegas, Nevada, recruited five pediatric medical practices to serve as sentinel sites for the Pediatric Early Warning Sentinel Surveillance (PEWSS) program. Sentinel staff collected specimens throughout the year from ill children who met the influenza-like illness case definition and submitted specimens to the Southern Nevada Public Health Laboratory for molecular testing for influenza and six non-influenza viruses. Laboratory results were analyzed and reported to the medical and general communities in weekly bulletins year-round. PEWSS data were also used to establish viral respiratory seasonal baselines and in influenza vaccination campaigns. The surveillance program was evaluated using the Centers for Disease Control and Prevention's (CDC's) Updated Guidelines for Evaluating Public Health Surveillance Systems. PEWSS met three of six program usefulness criteria and seven of nine surveillance system attributes, which exceeded the CDC Guidelines evaluation criteria for a useful and complete public health surveillance program. We found that PEWSS is a useful and complete public health surveillance system that is simple, flexible, accessible, and stable.

Evaluation of the Novel Respiratory Virus Surveillance Program: Pediatric Early Warning Sentinel Surveillance (PEWSS)

PubMed Central

Nguyen, Linh M.; Lutman, Michelle L.; Middaugh, John P.

2013-01-01

Objectives Infections caused by respiratory viruses are associated with recurrent epidemics and widespread morbidity and mortality. Routine surveillance of these pathogens is necessary to determine virus activity, monitor for changes in circulating strains, and plan for public health preparedness. The Southern Nevada Health District in Las Vegas, Nevada, recruited five pediatric medical practices to serve as sentinel sites for the Pediatric Early Warning Sentinel Surveillance (PEWSS) program. Methods Sentinel staff collected specimens throughout the year from ill children who met the influenza-like illness case definition and submitted specimens to the Southern Nevada Public Health Laboratory for molecular testing for influenza and six non-influenza viruses. Results Laboratory results were analyzed and reported to the medical and general communities in weekly bulletins year-round. PEWSS data were also used to establish viral respiratory seasonal baselines and in influenza vaccination campaigns. The surveillance program was evaluated using the Centers for Disease Control and Prevention's (CDC's) Updated Guidelines for Evaluating Public Health Surveillance Systems. PEWSS met three of six program usefulness criteria and seven of nine surveillance system attributes, which exceeded the CDC Guidelines evaluation criteria for a useful and complete public health surveillance program. Conclusion We found that PEWSS is a useful and complete public health surveillance system that is simple, flexible, accessible, and stable. PMID:23997308

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest

PubMed Central

2012-01-01

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development. PMID:22762776

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest.

PubMed

Eccles, Martin P; Grimshaw, Jeremy M; Shekelle, Paul; Schünemann, Holger J; Woolf, Steven

2012-07-04

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development.

Draft Test Guideline: Site-Specific Aquatic Microcosm Test, Laboratory

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Draft Test Guideline: Generic Freshwater Microcosm Test, Laboratory

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Best Practice No 177: Best practice guideline: writing a business case for service development in pathology.

PubMed

Galloway, M J

2004-04-01

This guideline reviews the introduction and development of business planning in the National Health Service. A guideline for writing a business case for service development that would form part of a pathology business plan has been developed. This guideline outlines six steps that are required in the preparation of a business case. The format of the guideline has been developed largely from other national guidelines that have been published for the development of capital projects. In view of the publication of these guidelines, the scope of this guideline excludes business cases for information, management, and technology projects and large capital projects.

Review of the International Society for Heart and Lung Transplantation Practice guidelines for management of heart failure in children.

PubMed

Colan, Steven D

2015-08-01

In 2004, practice guidelines for the management of heart failure in children by Rosenthal and colleagues were published in conjunction with the International Society for Heart and Lung Transplantation. These guidelines have not been updated or reviewed since that time. In general, there has been considerable controversy as to the utility and purpose of clinical practice guidelines, but there is general recognition that the relentless progress of medicine leads to the progressive irrelevance of clinical practice guidelines that do not undergo periodic review and updating. Paediatrics and paediatric cardiology, in particular, have had comparatively minimal participation in the clinical practice guidelines realm. As a result, most clinical practice guidelines either specifically exclude paediatrics from consideration, as has been the case for the guidelines related to cardiac failure in adults, or else involve clinical practice guidelines committees that include one or two paediatric cardiologists and produce guidelines that cannot reasonably be considered a consensus paediatric opinion. These circumstances raise a legitimate question as to whether the International Society for Heart and Lung Transplantation paediatric heart failure guidelines should be re-reviewed. The time, effort, and expense involved in producing clinical practice guidelines should be considered before recommending an update to the International Society for Heart and Lung Transplantation Paediatric Heart Failure guidelines. There are specific areas of rapid change in the evaluation and management of heart failure in children that are undoubtedly worthy of updating. These domains include areas such as use of serum and imaging biomarkers, wearable and implantable monitoring devices, and acute heart failure management and mechanical circulatory support. At the time the International Society for Heart and Lung Transplantation guidelines were published, echocardiographic tissue Doppler, 3 dimensional imaging, and strain and strain rate were either novel or non-existent and have now moved into the main stream. Cardiac magnetic resonance imaging (MRI) had very limited availability, and since that time imaging and assessment of myocardial iron content, delayed gadolinium enhancement, and extracellular volume have moved into the mainstream. The only devices discussed in the International Society for Heart and Lung Transplantation guidelines were extracorporeal membrane oxygenators, pacemakers, and defibrillators. Since that time, ventricular assist devices have become mainstream. Despite the relative lack of randomised controlled trials in paediatric heart failure, advances continue to occur. These advances warrant implementation of an update and review process, something that is best done under the auspices of the national and international cardiology societies. A joint activity that includes the International Society for Heart and Lung Transplantation, American College of Cardiology/American Heart Association, the Association for European Paediatric and Congenital Cardiology (AEPC), European Society of Cardiology, Canadian Cardiovascular Society, and others will have more credibility than independent efforts by any of these organisations.

Global perspectives on ensuring the safety of pharmaceutical products in the distribution process
.

PubMed

Jeong, Sohyun; Ji, Eunhee

2018-01-01

The distribution of counterfeit or falsified drugs is increasing worldwide. This can contribute to the high burden of disease and cost to society and is of global concern with the worldwide circulation of pharmaceuticals. The preparation and implementation of good distribution practice should be one of the most important aspects of ensuring safe drug circulation and administration. This research aimed to compare and analyze good distribution practice guidelines from advanced countries and international organizations, and to evaluate the status of the current good distribution practice guidelines in the world. Advanced pharmaceutical countries and international organizations, such as the World Health Organization, European Union, Pharmaceutical Inspection Co-operation Scheme, United States of America, Canada, and Australia, which have stable good distribution practice guidelines and public confidence, were included in the analysis. The World Health Organization and European Union guidelines are models for standardized good distribution practice for nations worldwide. The United States of America has a combination of four different series of distribution practices which have a unique structure and detailed content compared to those of other countries. The Canadian guidelines focus on temperature control during storage and transportation. The Australian guidelines apply to both classes of medicinal products and medical devices and need separate standardization. Transparent information about the Internet chain, international cooperation regarding counterfeiting, a high-standard qualification of sellers and customers, and technology to track and trace the whole life cycle of drugs should be the main focus of future good distribution practice guidelines worldwide.
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Oncology nurses' use of National Comprehensive Cancer Network clinical practice guidelines for chemotherapy-induced and febrile neutropenia.

PubMed

Nirenberg, Anita; Reame, Nancy K; Cato, Kenrick D; Larson, Elaine L

2010-11-01

To describe oncology nurses' use of National Comprehensive Cancer Network (NCCN) clinical practice guidelines for chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Cross-sectional survey design; descriptive, correlational analysis. E-mail invitation to Web-based survey. Random sample of 309 Oncology Nursing Society (ONS) members with e-mail addresses who provide care to adult patients receiving chemotherapy. The investigator-developed Neutropenia Oncology Nurses Survey was used. Descriptive tests compared respondents' personal and professional characteristics to those of general ONS members; nonparametric chi-square and Kruskal-Wallis tests were used to correlate respondents' survey subscale scores with demographic data. Significant associations were entered into multiple logistic regression models. The Neutropenia Oncology Nurses Survey's subscales measured subjective norm, attitude, perceived competence and confidence, perceived barriers, and use of NCCN clinical practice guidelines for CIN and FN. Response rate of nurses who opened the survey was 50%. Most practiced in community versus academic centers. Eighty percent reported using the NCCN clinical practice guidelines for CIN and FN. Respondents were more likely to use clinical practice guidelines when they were expected to by physician and nurse colleagues, they perceived fewer barriers, or they held advanced oncology certification. This study was the first to assess oncology nurses' reported use of NCCN clinical practice guidelines for CIN and FN. It also demonstrated the feasibility of partnering with ONS for Web-based survey research. The findings give insight into work-place barriers to evidence-based practice in various settings. Expanding dissemination and implementation of clinical practice guideline recommendations will support the development of oncology nursing standards for risk assessment, management, and patient and family education in CIN and FN.

Deficiencies in the National Institute of Health's guidelines for the care and protection of laboratory animals.

PubMed

Stephenson, W

1993-08-01

This paper is a critique of NIH guidelines for the care and protection of laboratory animals. It exposes four serious deficiencies in these guidelines: (1) failure to make it clear that the mere pursuit of knowledge does not justify using animals; (2) failure to give any guidance concerning what constitutes human benefit or well-being; (3) failure to countenance trade-offs between human benefit or well-being and animal well-being; (4) failure to clearly specify what constitutes keeping animals in an 'environment appropriate to the species and its life history.' It concludes with the suggestion that the construction and revision of these guidelines is too important to be left to the professionals.

[Current status of practice of providing dietary advice to pregnant women by members of the Japanese Midwives' Association. Knowledge and utilization of the "Dietary Guidelines for Pregnant and Lactating Women"].

PubMed

Takimoto, Hidemi; Yonezawa, Junko; Shimada, Marie; Kato, Noriko; Yokoyama, Tetsuji

2013-01-01

Midwives are actively involved in providing dietary advice to pregnant women. In order to describe the current status of prenatal dietary advice provided by midwives, we conducted a questionnaire survey inquiring about their knowledge and usage of the "Dietary Guidelines for Pregnant and Lactating Women" (Guidelines) issued by the Ministry of Health, Labour, and Welfare in 2006. In total, 2000 members of the Japanese Midwives' Association were randomly selected for administration of the questionnaire. The recovery rate was 42.1%, and 785 responses were eligible for analyses. The questionnaire collected information on the respondent's age, years of work experience, current involvement in delivery practice, number of deliveries per year in the current affiliation, provision of dietary advice to pregnant women, and knowledge and usage of the Guidelines. The proportion of respondents in their 20 s was low (1.8%). About half of the respondents were practicing delivery. Further, 66.1% (519 midwives) reported they had knowledge of the Guidelines. Among those who had knowledge of the Guidelines and were currently providing dietary advice (426 midwives), 88.0% were using the Guidelines. The most frequently used item in the Guidelines was "Diet for preventing anemia" (75.8%). The least used item was "Shoku-iku (diet and nutrition education) for pregnant and lactating women" (58.5%). Midwives who were practicing delivery showed a significantly lower usage of the Guidelines than those who were not (84.9% vs. 92.6%, P = 0.02). Among midwives practicing delivery, the most common reason for not using the Guidelines was "using original educational material produced by oneself or the facility." Providing dietary advice to pregnant women constituted a large fraction of midwives' duties as well as delivery practice. About 90% of the midwives, who had knowledge of the Guidelines and provided dietary advice, were using the Guidelines. In order to increase the usage of individual items of the Guidelines, ready-to-use brochures should be developed for midwives.

Society for Academic Continuing Medical Education Intervention Guideline Series: Guideline 2, Practice Facilitation.

PubMed

Van Hoof, Thomas J; Grant, Rachel E; Campbell, Craig; Colburn, Lois; Davis, David; Dorman, Todd; Fischer, Michael; Horsley, Tanya; Jacobs-Halsey, Virginia; Kane, Gabrielle; LeBlanc, Constance; Moore, Donald E; Morrow, Robert; Olson, Curtis A; Silver, Ivan; Thomas, David C; Turco, Mary; Kitto, Simon

2015-01-01

The Society for Academic Continuing Medical Education commissioned a study to clarify and, if possible, standardize the terminology for a set of important educational interventions. In the form of a guideline, this article describes one such intervention, practice facilitation, which is a common strategy in primary care to help practices develop capacity and infrastructure to support their ability to improve patient care. Based on a review of recent evidence and a facilitated discussion with US and Canadian experts, we describe practice facilitation, its terminology, and other important information about the intervention. We encourage leaders and researchers to consider and build on this guideline as they plan, implement, evaluate, and report practice facilitation efforts. Clear and consistent use of terminology is imperative, along with complete and accurate descriptions of interventions, to improve the use and study of practice facilitation.

Effect of evidence-based feeding guidelines on mortality of critically ill adults: a cluster randomized controlled trial.

PubMed

Doig, Gordon S; Simpson, Fiona; Finfer, Simon; Delaney, Anthony; Davies, Andrew R; Mitchell, Imogen; Dobb, Geoff

2008-12-17

Evidence demonstrates that providing nutritional support to intensive care unit (ICU) patients within 24 hours of ICU admission reduces mortality. However, early feeding is not universally practiced. Changing practice in complex multidisciplinary environments is difficult. Evidence supporting whether guidelines can improve ICU feeding practices and patient outcomes is contradictory. To determine whether evidence-based feeding guidelines, implemented using a multifaceted practice change strategy, improve feeding practices and reduce mortality in ICU patients. Cluster randomized trial in ICUs of 27 community and tertiary hospitals in Australia and New Zealand. Between November 2003 and May 2004, 1118 critically ill adult patients expected to remain in the ICU longer than 2 days were enrolled. All participants completed the study. Intensive care units were randomly assigned to guideline or control groups. Guideline ICUs developed an evidence-based guideline using Browman's Clinical Practice Guideline Development Cycle. A practice-change strategy composed of 18 specific interventions, leveraged by educational outreach visits, was implemented in guideline ICUs. Hospital discharge mortality. Secondary outcomes included ICU and hospital length of stay, organ dysfunction, and feeding process measures. Guideline and control ICUs enrolled 561 and 557 patients, respectively. Guideline ICUs fed patients earlier (0.75 vs 1.37 mean days to enteral nutrition start; difference, -0.62 [95% confidence interval {CI}, -0.82 to -0.36]; P < .001 and 1.04 vs 1.40 mean days to parenteral nutrition start; difference, -0.35 [95% CI, -0.61 to -0.01]; P = .04) and achieved caloric goals more often (6.10 vs 5.02 mean days per 10 fed patient-days; difference, 1.07 [95% CI, 0.12 to 2.22]; P = .03). Guideline and control ICUs did not differ with regard to hospital discharge mortality (28.9% vs 27.4%; difference, 1.4% [95% CI, -6.3% to 12.0%]; P = .75) or to hospital length of stay (24.2 vs 24.3 days; difference, -0.08 [95% CI, -3.8 to 4.4]; P = .97) or ICU length of stay (9.1 vs 9.9 days; difference, -0.86 [95% CI, -2.6 to 1.3]; P = .42). Using a multifaceted practice change strategy, ICUs successfully developed and introduced an evidence-based nutritional support guideline that promoted earlier feeding and greater nutritional adequacy. However, use of the guideline did not improve clinical outcomes. Trial Registration anzctr.org.au Identifier: ACTRN12608000407392.

To adopt, to adapt, or to contextualise? The big question in clinical practice guideline development.

PubMed

Dizon, Janine Margarita; Machingaidze, Shingai; Grimmer, Karen

2016-09-13

Developing new clinical practice guidelines (CPGs) can be time-consuming and expensive. A more efficient approach could be to adopt, adapt or contextualise recommendations from existing good quality CPGs so that the resultant guidance is tailored to the local context. The first steps are to search for international CPGs that have a similar purpose, end-users and patients to your situation. The second step is to critically appraise the methodological quality of the CPGs to ensure that your guidance is based on credible evidence. Then the decisions begin. Can you simply 'adopt' this (parent) clinical practice guidelines, and implement the recommendations in their entirety, without any changes, in your setting? If so, then no further work is required. However this situation is rare. What is more likely, is that even if recommendations from the parent clinical practice guidelines can be adopted, how they are implemented needs to address local issues. Thus you may need to 'contextualise' the guidance, by addressing implementation issues such as local workforce, training, health systems, equipment and/or access to services. Generally this means that additional information is required (Practice/Context Points) to support effective implementation of the clinical practice guidelines recommendations. In some cases, you may need to 'adapt' the guidance, where you will make changes to the recommendations so that care is relevant to your local environments. This may involve additional work to search for local research, or obtain local consensus, regarding how best to adapt recommendations. For example, adaptation might reflect substituting one drug for another (drugs have similar effects, but the alternative drug to the recommended one may be cheaper, more easily obtained or more culturally acceptable). There is lack of standardisation of clinical practice guidelines terminology, leading clinical practice guideline activities often being poorly conceptualised or reported. We provide an approach that would help improve efficiency and standardisation of clinical practice guidelines activities.

[Prospective comparison of the flow chart for laboratory investigations for anaemia from the Dutch College of General Practitioners' guideline 'Anaemia' with a self-developed, substantive and logistical alternative flow chart].

PubMed

Oosterhuis, W P; van der Horst, M; van Dongen, K; Ulenkate, H J L M; Volmer, M; Wulkan, R W

2007-10-20

To compare the flow diagram for the diagnosis of anaemia from the guideline 'Anaemia' from the Dutch College of General Practitioners (NHG) with a substantive and logistical alternative protocol. Prospective. For evaluation of anaemia, 124 patients from primary care reported to the laboratories of the St. Elisabeth Hospital in Tilburg (n = 94) and the Scheper Hospital in Emmen (n = 30), the Netherlands. Two flow charts were used: the NHG's flow chart and a self-developed chart in which not mean corpuscular volume, but ferritin concentration occupies the central position. All the laboratory tests mentioned in both flow charts were carried out in every patient with, for practical reasons, the exception of Hgb electrophoresis and bone marrow investigations. General practitioners were approached and patient dossiers were consulted to obtain further clinical data. According to the NHG protocol, on the grounds of the laboratory investigations, 64 (52%) of patients could not be put in a specific category. The majority were patients with normocytary anaemia who did not fulfil the criteria for iron deficiency anaemia or the anaemia of chronic disease. According to the alternative chart, in 36 (29%) patients no diagnosis was made. These were patients in whom no abnormal laboratory findings were observed, other than low haemoglobin values. The majority of the patients had normocytary anaemia, in some cases this was interpreted as the anaemia of chronic disease, but more often the anaemia could not be assigned to a particular category. A large number ofpatients had a raised creatinine value. This value did not appear in the NHG protocol. In 15% of patients, more than one cause for anaemia was found. The NHG protocol did not enable these multiple diagnoses to be made. Accordingly, the NHG protocol was difficult to implement in the laboratory. Using the NHG flow diagram a large percentage of patients could not be assigned to a particular category. Using the alternative flow diagram, which procedure is easier to carry out in the laboratory, it was possible to make multiple diagnoses.

Palliative Sedation: An Analysis of International Guidelines and Position Statements.

PubMed

Gurschick, Lauren; Mayer, Deborah K; Hanson, Laura C

2015-09-01

To describe the suggested clinical practice of palliative sedation as it is presented in the literature and discuss available guidelines for its use. CINAHL, PubMed, and Web of Science were searched for publications since 1997 for recommended guidelines and position statements on palliative sedation as well as data on its provision. Keywords included palliative sedation, terminal sedation, guidelines, United States, and end of life. Inclusion criteria were palliative sedation policies, frameworks, guidelines, or discussion of its practice, general or oncology patient population, performance of the intervention in an inpatient unit, for humans, and in English. Exclusion criteria were palliative sedation in children, acute illness, procedural, or burns, and predominantly ethical discussions. Guidelines were published by American College of Physicians-American Society of Internal Medicine (2000), Hospice and Palliative Nurses Association (2003), American Academy of Hospice and Palliative Medicine (2006), American Medical Association (2008), Royal Dutch Medical Association (2009), European Association for Palliative Care (2009), National Hospice and Palliative Care Organization (2010), and National Comprehensive Cancer Network (2012). Variances throughout guidelines include definitions of the practice, indications for its use, continuation of life-prolonging therapies, medications used, and timing/prognosis. The development and implementation of institutional-based guidelines with clear stance on the discussed variances is necessary for consistency in practice. Data on provision of palliative sedation after implementation of guidelines needs to be collected and disseminated for a better understanding of the current practice in the United States. © The Author(s) 2014.

Rapid Development and Distribution of Mobile Media-Rich Clinical Practice Guidelines Nationwide in Colombia.

PubMed

Flórez-Arango, José F; Sriram Iyengar, M; Caicedo, Indira T; Escobar, German

2017-01-01

Development and electronic distribution of Clinical Practice Guidelines production is costly and challenging. This poster presents a rapid method to represent existing guidelines in auditable, computer executable multimedia format. We used a technology that enables a small number of clinicians to, in a short period of time, develop a substantial amount of computer executable guidelines without programming.

Laboratory Medicine Education at U.S. Medical Schools: A 2014 Status Report.

PubMed

Smith, Brian R; Kamoun, Malek; Hickner, John

2016-01-01

To assess the current state of laboratory medicine education at U.S. medical schools. From 2013 to 2014, the authors surveyed the appropriate dean, department chair, or undergraduate education director at each U.S. medical school accredited by the Liaison Committee on Medical Education about the state of laboratory medicine education, curriculum and competency assessment, and barriers to education at his or her institution. The authors used descriptive statistics to analyze the results. The authors received 98 (75%) responses. Eighty-two schools (84%) offered course work in laboratory medicine; 76 (78%) required it. The median number of hours of required course work was 12.5, with 8.0 devoted to lectures and 4.5 to small-group, problem-based learning and/or laboratory sessions. Only 8 schools required training in a clinical setting. Fewer than half reported regular, formal review of the laboratory medicine curriculum. The assessment of students' competency in laboratory medicine was rare (8 schools), and only half of respondents were aware of published curriculum guidelines. Barriers to teaching laboratory medicine included lack of sufficient time in the preclinical curriculum (86; 88%) or clinical curriculum (84; 86%), lack of knowledge of best laboratory practices by residents (70; 72%), lack of student interest (62; 63%), and lack of knowledge by attending physicians (58; 59%). Half of respondents were likely to use a national standardized examination to assess competency in laboratory medicine, if one was available. Significant opportunities exist to improve laboratory medicine education, including in the proper use and interpretation of clinical laboratory testing.

Laboratory Medicine Education at U.S. Medical Schools: A 2014 Status Report

PubMed Central

Smith, Brian R.; Kamoun, Malek; Hickner, John

2017-01-01

Purpose To assess the current state of laboratory medicine education at U.S. medical schools. Method From 2013 to 2014, the authors surveyed the appropriate dean, department chair, or undergraduate education director at each U.S. medical school accredited by the Liaison Committee on Medical Education about the state of laboratory medicine education, curriculum and competency assessment, and barriers to education at his or her institution. The authors used descriptive statistics to analyze the results. Results The authors received 98 (75%) responses. Eighty-two schools (84%) offered course work in laboratory medicine; 76 (78%) required it. The median number of hours of required course work was 12.5, with 8.0 devoted to lectures and 4.5 to small-group, problem-based learning and/or laboratory sessions. Only 8 schools required training in a clinical setting. Fewer than half reported regular, formal review of the laboratory medicine curriculum. The assessment of students’ competency in laboratory medicine was rare (8 schools), and only half of respondents were aware of published curriculum guidelines. Barriers to teaching laboratory medicine included lack of sufficient time in the preclinical curriculum (86; 88%) or clinical curriculum (84; 86%), lack of knowledge of best laboratory practices by residents (70; 72%), lack of student interest (62; 63%), and lack of knowledge by attending physicians (58; 59%). Half of respondents were likely to use a national standardized examination to assess competency in laboratory medicine, if one was available. Conclusions Significant opportunities exist to improve laboratory medicine education, including in the proper use and interpretation of clinical laboratory testing. PMID:26200574

[Implementation of clinical practice guidelines: how can we close the evidence-practice gap?].

PubMed

Muche-Borowski, Cathleen; Nothacker, M; Kopp, I

2015-01-01

Guidelines are intended as instruments of knowledge transfer to support decision-making by physicians, other health professionals and patients in clinical practice and thereby contribute to quality improvements in healthcare. To date they are an indispensable tool for healthcare. Their benefit for patients can only be seen in application, i.e. the implementation of guideline recommendations. For successful implementation, implementability and practicability play a crucial role and these characteristics can be influenced and should be promoted by the guideline development group. In addition, a force field analysis to identify barriers against and facilitators for the implementation of specific guideline recommendations from the perspective of physicians and patients is recommended to guide the development of an individual implementation strategy and the selection of appropriate interventions. However, implementation cannot be achieved by the guideline development group alone and a universal implementation strategy does not exist. Therefore, a process using theory, analysis, experience and shared responsibility of stakeholders in healthcare is recommended, with the aim to achieve sustainable behavioral change and improve the quality of care by guideline-oriented behavior.

Clinical practice guideline development manual: a quality-driven approach for translating evidence into action.

PubMed

Rosenfeld, Richard M; Shiffman, Richard N

2009-06-01

Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing health-care variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective-or potentially harmful-interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. This manual describes the principles and practices used successfully by the American Academy of Otolaryngology-Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multidisciplinary applicability. The development process, which allows moving from conception to completion in 12 months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence. As clinical practice guidelines become more prominent as a key metric of quality health care, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are-and are not-and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals.

The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.

PubMed

Zeng, Xiantao; Zhang, Yonggang; Kwong, Joey S W; Zhang, Chao; Li, Sheng; Sun, Feng; Niu, Yuming; Du, Liang

2015-02-01

To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline. We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools. We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines. We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

Evaluation of clinical practice guidelines.

PubMed Central

Basinski, A S

1995-01-01

Compared with the current focus on the development of clinical practice guidelines the effort devoted to their evaluation is meagre. Yet the ultimate success of guidelines depends on routine evaluation. Three types of evaluation are identified: evaluation of guidelines under development and before dissemination and implementation, evaluation of health care programs in which guidelines play a central role, and scientific evaluation, through studies that provide the scientific knowledge base for further evolution of guidelines. Identification of evaluation and program goals, evaluation design and a framework for evaluation planning are discussed. PMID:7489550

Characteristics of communication guidelines that facilitate or impede guideline use: a focus group study

PubMed Central

Veldhuijzen, Wemke; Ram, Paul M; van der Weijden, Trudy; Niemantsverdriet, Susan; van der Vleuten, Cees PM

2007-01-01

Background The quality of doctor-patient communication has a major impact on the quality of medical care. Communication guidelines define best practices for doctor patient communication and are therefore an important tool for improving communication. However, adherence to communication guidelines remains low, despite doctors participating in intensive communication skill training. Implementation research shows that adherence is higher for guidelines in general that are user centred and feasible, which implies that they are consistent with users' opinions, tap into users' existing skills and fit into existing routines. Developers of communication guidelines seem to have been somewhat negligent with regard to user preferences and guideline feasibility. In order to promote the development of user centred and practicable communication guidelines, we elicited user preferences and identified which guideline characteristics facilitate or impede guideline use. Methods Seven focus group interviews were conducted with experienced GPs, communication trainers (GPs and behavioural scientists) and communication learners (GP trainees and medical students) and three focus group interviews with groups of GP trainees only. All interviews were transcribed and analysed qualitatively. Results The participants identified more impeding guideline characteristics than facilitating ones. The most important impeding characteristic was that guidelines do not easily fit into GPs' day-to-day practice. This is due to rigidity and inefficiency of communication guidelines and erroneous assumptions underpinning guideline development. The most important facilitating characteristic was guideline structure. Guidelines that were structured in distinct phases helped users to remain in control of consultations, which was especially useful in complicated consultations. Conclusion Although communication guidelines are generally considered useful, especially for structuring consultations, their usefulness is impaired by lack of flexibility and applicability to practice routines. User centred and feasible guidelines should combine the advantages of helping doctors to structure consultations with flexibility to tailor communication strategies to specific contexts and situations. PMID:17506878

Draft Test Guideline: Special Considerations for Conducting Aquatic Laboratory Studies

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Enhanced implementation of low back pain guidelines in general practice: study protocol of a cluster randomised controlled trial.

PubMed

Riis, Allan; Jensen, Cathrine Elgaard; Bro, Flemming; Maindal, Helle Terkildsen; Petersen, Karin Dam; Jensen, Martin Bach

2013-10-20

Evidence-based clinical practice guidelines may improve treatment quality, but the uptake of guideline recommendations is often incomplete and slow. Recently new low back pain guidelines are being launched in Denmark. The guidelines are considered to reduce personal and public costs. The aim of this study is to evaluate whether a complex, multifaceted implementation strategy of the low back pain guidelines will reduce secondary care referral and improve patient outcomes compared to the usual simple implementation strategy. In a two-armed cluster randomised trial, 100 general practices (clusters) and 2,700 patients aged 18 to 65 years from the North Denmark region will be included. Practices are randomly allocated 1:1 to a simple or a complex implementation strategy. Intervention practices will receive a complex implementation strategy, including guideline facilitator visits, stratification tools, and quality reports on low back pain treatment. Primary outcome is referral to secondary care. Secondary outcomes are pain, physical function, health-related quality of life, patient satisfaction with care and treatment outcome, employment status, and sick leave. Primary and secondary outcomes pertain to the patient level. Assessments of outcomes are blinded and follow the intention-to-treat principle. Additionally, a process assessment will evaluate the degree to which the intervention elements will be delivered as planned, as well as measure changes in beliefs and behaviours among general practitioners and patients. This study provides knowledge concerning the process and effect of an intervention to implement low back pain guidelines in general practice, and will provide insight on essential elements to include in future implementation strategies in general practice. Registered as NCT01699256 on ClinicalTrials.gov.

Smoking cessation treatment practices: recommendations for improved adoption on cardiology wards.

PubMed

Berndt, Nadine C; Bolman, Catherine; de Vries, Hein; Segaar, Dewi; van Boven, Irene; Lechner, Lilian

2013-01-01

Smoking cessation treatment practices described by the 5 A's (ask, advise, assess, assist, arrange) are not well applied at cardiology wards because of various reasons, such as a lack of time and appropriate skills of the nursing staff. Therefore, a simplified guideline proposing an ask-advise-refer (AAR) strategy was introduced in Dutch cardiac wards. This study aimed to identify factors that determine the intentions of cardiac ward heads in adopting the simplified AAR guideline, as ward heads are key decision makers in the adoption of new guidelines. Ward heads' perceptions of current smoking cessation practices at the cardiac ward were also investigated. A cross-sectional survey with written questionnaires was conducted among heads of cardiology wards throughout the Netherlands, of whom 117 (64%) responded. According to the heads of cardiac wards, smoking cessation practices by cardiologists and nurses were mostly limited to brief practices that are easy to conduct. Only a minority offered intensive counseling or arranged follow-up contact. Heads with strong intentions of adopting the AAR guideline differed significantly on motivational and organizational attributes and perceived more smoking cessation assistance by other health professionals than did heads with weak intentions of adopting. Positive attitudes, social support toward adoption, and perception of much assistance at the ward were significantly associated with increased intentions to adopt the AAR guideline. Brief smoking cessation practices are adequately performed at cardiac wards, but the most effective practices, offering assistance and arranging for follow-up, are less than optimal. The AAR guideline offers a more feasible approach for busy cardiology wards. To ensure successful adoption of this guideline, the heads of cardiac wards should be convinced of its advantages and be encouraged by a supportive work environment. Policies may also facilitate the adoption of the AAR guideline.

Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues

PubMed Central

Mourya, Devendra T.; Yadav, Pragya D.; Khare, Ajay; Khan, Anwar H.

2017-01-01

With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process. PMID:29434059

Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues.

PubMed

Mourya, Devendra T; Yadav, Pragya D; Khare, Ajay; Khan, Anwar H

2017-10-01

With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process.

Assessment of readiness for clinical decision support to aid laboratory monitoring of immunosuppressive care at U.S. liver transplant centers.

PubMed

Jacobs, J; Weir, C; Evans, R S; Staes, C

2014-01-01

Following liver transplantation, patients require lifelong immunosuppressive care and monitoring. Computerized clinical decision support (CDS) has been shown to improve post-transplant immunosuppressive care processes and outcomes. The readiness of transplant information systems to implement computerized CDS to support post-transplant care is unknown. a) Describe the current clinical information system functionality and manual and automated processes for laboratory monitoring of immunosuppressive care, b) describe the use of guidelines that may be used to produce computable logic and the use of computerized alerts to support guideline adherence, and c) explore barriers to implementation of CDS in U.S. liver transplant centers. We developed a web-based survey using cognitive interviewing techniques. We surveyed 119 U.S. transplant programs that performed at least five liver transplantations per year during 2010-2012. Responses were summarized using descriptive analyses; barriers were identified using qualitative methods. Respondents from 80 programs (67% response rate) completed the survey. While 98% of programs reported having an electronic health record (EHR), all programs used paper-based manual processes to receive or track immunosuppressive laboratory results. Most programs (85%) reported that 30% or more of their patients used external laboratories for routine testing. Few programs (19%) received most external laboratory results as discrete data via electronic interfaces while most (80%) manually entered laboratory results into the EHR; less than half (42%) could integrate internal and external laboratory results. Nearly all programs had guidelines regarding pre-specified target ranges (92%) or testing schedules (97%) for managing immunosuppressive care. Few programs used computerized alerting to notify transplant coordinators of out-of-range (27%) or overdue laboratory results (20%). Use of EHRs is common, yet all liver transplant programs were largely dependent on manual paper-based processes to monitor immunosuppression for post-liver transplant patients. Similar immunosuppression guidelines provide opportunities for sharing CDS once integrated laboratory data are available.

Clinical Guidelines and Implementation into Daily Dental Practice.

PubMed

Guncu, Guliz Nigar; Nemli, Secil Karakoca; Carrilho, Eunice; Yamalık, Nermin; Volodina, Elena; Melo, Paulo; Margvelashvili, Vladimer; Rossi, Alessandra

2018-01-31

The purpose of this study is to assess the extent of the familiarity, attitude and perceptions of dental professionals regarding clinical dental guidelines and their implementation into daily dental practice. For this purpose, a questionnaire which was developed by the members of the World Dental Federation, European Regional Organization Working Group - 'Relation Between Dental Practitioner and Universities', was implemented by the National Dental Associations of six European Regional Organization-zone countries (Georgian Stomatological Association - Georgia, Associazione Nazionale Dentisti Italiani - Italy, Portuguese Dental Association - Portugal, Russian Dental Association - Russia, Swiss Dental Association - Switzerland, and Turkish Dental Association - Turkey. The questionnaire was filled by a total of 910 dental professionals who are members of one of these national dental associations and who voluntarily wanted to participate to this survey. Most of the survey participants were familiar with clinical dental guidelines (68%), claimed that they implemented them into daily practice (61.7%), and generally acknowledged their benefits (81.8%). Many participants believed that clinical dental guidelines could help to improve the clinical treatment plan (50.6 %) and the accuracy of diagnosis (39.4%); which increased with age and years of practice (p < 0.05). The most frequently perceived barrier to the effective implementation of clinical dental guidelines was expressed as 'lack of awareness', while participants suggested a role for national dental associations in spreading clinical dental guidelines. A better understanding of the perceptions and attitudes of dentists towards clinical dental guidelines and the potential impact of factors affecting such perceptions and attitudes may be of particular importance for attempts aiming at overcoming the barriers for effective implementation of clinical dental guidelines into daily practice. Despite a significant familiarity and a common positive attitude, dental professionals are likely to have different perceptions towards clinical dental guidelines, especially regarding their effective implementation into daily practice, benefits and barriers.

Singapore Armed Forces Medical Corps-Ministry of Health clinical practice guidelines: management of heat injury.

PubMed

Lee, L; Fock, K M; Lim, C L F; Ong, E H M; Poon, B H; Pwee, K H; O'Muircheartaigh, C R; Seet, B; Tan, C L B; Teoh, C S

2010-10-01

The Singapore Armed Forces (SAF) Medical Corps and the Ministry of Health (MOH) have published clinical practice guidelines on Management of Heat Injury to provide doctors and patients in Singapore with evidence-based guidance on the prevention and clinical management of exertional heat injuries. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the SAF Medical Corps-MOH clinical practice guidelines on Management of Heat Injury, for the information of readers of the Singapore Medical Journal. Chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/mohcorp/publications.aspx?id=25178. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

Health Promotion Board-Ministry of Health clinical practice guidelines: functional screening for older adults in the community.

PubMed

Thilagaratnam, S; Ding, Y Y; Au Eong, K G; Chiam, P C; Chow, Y L; Khoo, G; Lim, H B; Lim, H Y L; Lim, W S; Lim, W Y; Peh, K C; Phua, K T; Sitoh, Y Y; Tan, B Y; Wong, S F; Wong, W P; Yee, R

2010-06-01

The Health Promotion Board (HPB) and the Ministry of Health (MOH) publish clinical practice guidelines to provide doctors and patients in Singapore with evidence-based guidance on managing important medical conditions. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the HPB-MOH clinical practice guidelines on Functional Screening for Older Adults in the Community, for the information of readers of the Singapore Medical Journal. Chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Health Promotion Board website (http://www.hpb.gov.sg/uploadedFiles/HPB_Online/Publications/CPGFunctionalscreening.pdf). The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

Current challenges in adherence to clinical guidelines for antibiotic prophylaxis in surgery.

PubMed

Khan, Sohail Ahmad; Rodrigues, Gabrial; Kumar, Pramod; Rao, Padma G M

2006-06-01

To study the impact of guidelines on surgical antibiotic prophylaxis in clinical practice, barriers involved in adherence to guidelines and how to overcome the same. Literature pertaining to prophylactic antibiotic usage was searched. Medscape, Medline, Cochrane, Surgical Infection Prevention (SIP) project databases were reviewed. Recent articles from relevant journals, texts, and standard guidelines were also studied. Local guidelines seem more likely to be accepted and followed than those developed nationally. Major barriers involved in adherence to guidelines include lack of awareness about the guidelines, general perception of guideline as a bureaucratic rather than educational tool. Some practitioners perceive guidelines as "cookbook medicine" that does not permit them to make their own medical decisions. Other barriers are complex, multi-step systems that create confusion, decrease accountability. Methods for guideline adherence include surveillance and data analysis, new systems to facilitate documentation and improving workflow, education regarding current evidence-based guidelines and promoting the development of local guidelines or protocol, development and implementation of reminders to facilitate adherence to the local guidelines. A multidisciplinary steering team of surgeons, infectious disease specialists, pharmacists, anesthesiologists, microbiologists and nurses should develop local guidelines suitable to their institution and methods for adherence to prevent the surgical site infections. The gap between evidence-based guidelines and practice must be addressed in order to achieve optimal practice in this domain.

Closing the clinical gap: translating best practice knowledge to performance with guidelines implementation.

PubMed

Ishii, Lisa E

2013-06-01

Unsustainable health care costs coupled with opportunity for improvement in health care outcomes in the United States are stimulating meaningful transformation in the way we deliver care. One approach in this transformation focuses on minimizing unnecessary variation in physician practices, instead focusing on evidence-based medicine in a more uniform manner. Clinical practice guidelines contain evidence-based recommendations, articulate goals of care, and can help to reduce unnecessary variation. While thousands of clinical practice guidelines are in existence, a clinical gap exists between knowledge and clinical performance. With thoughtful guidelines implementation strategies in place, organizations can begin to close the gap and translate best practice knowledge into care. Health systems that have done this effectively have seen improved clinical outcomes, improved patient satisfaction, and lower cost per patient.

[Experience of the Mexican National Health System in the development of clinical practice guidelines].

PubMed

Sosa-García, Jesús Ojino; Nieves-Hernández, Pedro; Puentes-Rosas, Esteban; Pineda-Pérez, Dayana; Viniegra-Osorio, Arturo; Torres-Arreola, Laura del Pilar; Valenzuela-Flores, Adriana Abigail; Barragán-Padilla, Sergio Baltazar; Díaz-González, Ruth; Chávez-Valdez, Lizbeth; Ramírez-López, Juan Carlos

2016-01-01

Clinical practice guidelines are tools that have been able to streamline decisions made in health issues and to decrease the gap between clinical action and scientific evidence. The objective of the study is to share the experience in the development and to update the guidelines by the National Health System of Mexico. The methodology in the development of the guidelines consists of 5 phases: prioritisation, establishment of work groups, development by adoption of international guidelines of de novo, validation and integration in the Master catalogue of clinical practice guidelines for its dissemination. The Master catalogue of clinical practice guidelines contains 664 guidelines, distributed in 42% Internal Medicine, 22% Surgery, 24% Pediatrics and 12% Gynecology. From the total of guidelines coverage is granted at an 85% of the Universal catalogue of health services, an 84% of the Catastrophic expenses protection fund and a 61% of the XXI Century Medical Insurance of the National Commission of Social Protection in Health. The result is the sum of a great effort of coordination and cooperation between the institutions of the National Health System, political wills and a commitment of 3,477 health professionals that participate in guidelines' development and update. Master catalogue guidelines' integration, diffusion and implantation improve quality of attention and security of the users of the National Health System. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

Fifteen hundred guidelines and growing: the UK database of clinical guidelines.

PubMed

van Loo, John; Leonard, Niamh

2006-06-01

The National Library for Health offers a comprehensive searchable database of nationally approved clinical guidelines, called the Guidelines Finder. This resource, commissioned in 2002, is managed and developed by the University of Sheffield Health Sciences Library. The authors introduce the historical and political dimension of guidelines and the nature of guidelines as a mechanism to ensure clinical effectiveness in practice. The article then outlines the maintenance and organisation of the Guidelines Finder database itself, the criteria for selection, who publishes guidelines and guideline formats, usage of the Guidelines Finder service and finally looks at some lessons learnt from a local library offering a national service. Clinical guidelines are central to effective clinical practice at the national, organisational and individual level. The Guidelines Finder is one of the most visited resources within the National Library for Health and is successful in answering information needs related to specific patient care, clinical research, guideline development and education.

[Clinical practice guidelines: juridical and medico legal issues in health care malpractice liability].

PubMed

Moreschi, Carlo; Broi, Ugo Da

2014-01-01

Clinical Practice Guidelines are clinical tools addressed to medical and health professionals and are normally employed to improve quality and safety of diagnostic and therapeutical procedures but may sometimes limit the autonomy of medical and other health care professionals. The adherence to Clinical Practice Guidelines should not be an exclusive step to evaluate the liability and respect of standards of care in case of medico-legal investigations being each clinical case very specific. Medical liability and respect of standards of care should be evaluated with the support of Clinical Practice Guidelines and the extensive examination of all specific features, professional background and experience requested to treat each single patient.

Safety in the Chemical Laboratory: Procedures for Laboratory Destruction of Chemicals.

ERIC Educational Resources Information Center

McKusick, Blaine C.

1984-01-01

Discusses a National Research Council report which summarizes what laboratories need to know about Environmental Protection Agency and Department of Transportation regulations that apply to laboratory waste. The report provides guidelines for establishing and operating waste management systems for laboratories and gives specific advice on waste…

Embryo transfer practices in the United States: a survey of clinics registered with the Society for Assisted Reproductive Technology.

PubMed

Jungheim, Emily S; Ryan, Ginny L; Levens, Eric D; Cunningham, Alexandra F; Macones, George A; Carson, Kenneth R; Beltsos, Angeline N; Odem, Randall R

2010-09-01

To gain a better understanding of factors influencing clinicians' embryo transfer practices. Cross-sectional survey. Web-based survey conducted in December 2008 of individuals practicing IVF in centers registered with the Society for Assisted Reproductive Technology (SART). None. None. Prevalence of clinicians reporting following embryo transfer guidelines recommended by the American Society for Reproductive Medicine (ASRM), prevalence among these clinicians to deviate from ASRM guidelines in commonly encountered clinical scenarios, and practice patterns related to single embryo transfer. Six percent of respondents reported following their own, independent guidelines for the number of embryos to transfer after IVF. Of the 94% of respondents who reported routinely following ASRM embryo transfer guidelines, 52% would deviate from these guidelines for patient request, 51% for cycles involving the transfer of frozen embryos, and 70% for patients with previously failed IVF cycles. All respondents reported routinely discussing the risks of multiple gestations associated with standard embryo transfer practices, whereas only 34% reported routinely discussing single embryo transfer with all patients. Although the majority of clinicians responding to our survey reported following ASRM embryo transfer guidelines, at least half would deviate from these guidelines in a number of different situations. Copyright (c) 2010 American Society for Reproductive Medicine. All rights reserved.

Semantic Clinical Guideline Documents

PubMed Central

Eriksson, Henrik; Tu, Samson W.; Musen, Mark

2005-01-01

Decision-support systems based on clinical practice guidelines can support physicians and other health-care personnel in the process of following best practice consistently. A knowledge-based approach to represent guidelines makes it possible to encode computer-interpretable guidelines in a formal manner, perform consistency checks, and use the guidelines directly in decision-support systems. Decision-support authors and guideline users require guidelines in human-readable formats in addition to computer-interpretable ones (e.g., for guideline review and quality assurance). We propose a new document-oriented information architecture that combines knowledge-representation models with electronic and paper documents. The approach integrates decision-support modes with standard document formats to create a combined clinical-guideline model that supports on-line viewing, printing, and decision support. PMID:16779037

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY PROTOCOL FOR STANDARDIZED PRODUCTION OF CLINICAL PRACTICE GUIDELINES, ALGORITHMS, AND CHECKLISTS - 2017 UPDATE.

PubMed

Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Camacho, Pauline; Correa, Ricardo; Figaro, M Kathleen; Garber, Jeffrey R; Jasim, Sina; Pantalone, Kevin M; Trence, Dace; Upala, Sikarin

2017-08-01

Clinical practice guideline (CPG), clinical practice algorithm (CPA), and clinical checklist (CC, collectively CPGAC) development is a high priority of the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE). This 2017 update in CPG development consists of (1) a paradigm change wherein first, environmental scans identify important clinical issues and needs, second, CPA construction focuses on these clinical issues and needs, and third, CPG provide CPA node/edge-specific scientific substantiation and appended CC; (2) inclusion of new technical semantic and numerical descriptors for evidence types, subjective factors, and qualifiers; and (3) incorporation of patient-centered care components such as economics and transcultural adaptations, as well as implementation, validation, and evaluation strategies. This third point highlights the dominating factors of personal finances, governmental influences, and third-party payer dictates on CPGAC implementation, which ultimately impact CPGAC development. The AACE/ACE guidelines for the CPGAC program is a successful and ongoing iterative exercise to optimize endocrine care in a changing and challenging healthcare environment. AACE = American Association of Clinical Endocrinologists ACC = American College of Cardiology ACE = American College of Endocrinology ASeRT = ACE Scientific Referencing Team BEL = best evidence level CC = clinical checklist CPA = clinical practice algorithm CPG = clinical practice guideline CPGAC = clinical practice guideline, algorithm, and checklist EBM = evidence-based medicine EHR = electronic health record EL = evidence level G4GAC = Guidelines for Guidelines, Algorithms, and Checklists GAC = guidelines, algorithms, and checklists HCP = healthcare professional(s) POEMS = patient-oriented evidence that matters PRCT = prospective randomized controlled trial.

A practice guideline from the American College of Medical Genetics and Genomics and the National Society of Genetic Counselors: referral indications for cancer predisposition assessment.

PubMed

Hampel, Heather; Bennett, Robin L; Buchanan, Adam; Pearlman, Rachel; Wiesner, Georgia L

2015-01-01

The practice guidelines of the American College of Medical Genetics and Genomics (ACMG) and the National Society of Genetic Counselors (NSGC) are developed by members of the ACMG and NSGC to assist medical geneticists, genetic counselors, and other health-care providers in making decisions about appropriate management of genetic concerns, including access to and/or delivery of services. Each practice guideline focuses on a clinical or practice-based issue and is the result of a review and analysis of current professional literature believed to be reliable. As such, information and recommendations within the ACMG and NSGC joint practice guidelines reflect the current scientific and clinical knowledge at the time of publication, are current only as of their publication date, and are subject to change without notice as advances emerge. In addition, variations in practice, which take into account the needs of the individual patient and the resources and limitations unique to the institution or type of practice, may warrant approaches, treatments, and/or procedures that differ from the recommendations outlined in this guideline. Therefore, these recommendations should not be construed as dictating an exclusive course of management, nor does the use of such recommendations guarantee a particular outcome. Genetic counseling practice guidelines are never intended to displace a health-care provider's best medical judgment based on the clinical circumstances of a particular patient or patient population. Practice guidelines are published by the ACMG or the NSGC for educational and informational purposes only, and neither the ACMG nor the NSGC "approve" or "endorse" any specific methods, practices, or sources of information.Cancer genetic consultation is an important aspect of the care of individuals at increased risk of a hereditary cancer syndrome. Yet several patient, clinician, and system-level barriers hinder identification of individuals appropriate for cancer genetics referral. Thus, the purpose of this practice guideline is to present a single set of comprehensive personal and family history criteria to facilitate identification and maximize appropriate referral of at-risk individuals for cancer genetic consultation. To develop this guideline, a literature search for hereditary cancer susceptibility syndromes was conducted using PubMed. In addition, GeneReviews and the National Comprehensive Cancer Network guidelines were reviewed when applicable. When conflicting guidelines were identified, the evidence was ranked as follows: position papers from national and professional organizations ranked highest, followed by consortium guidelines, and then peer-reviewed publications from single institutions. The criteria for cancer genetic consultation referral are provided in two formats: (i) tables that list the tumor type along with the criteria that, if met, would warrant a referral for a cancer genetic consultation and (ii) an alphabetical list of the syndromes, including a brief summary of each and the rationale for the referral criteria that were selected. Consider referral for a cancer genetic consultation if your patient or any of their first-degree relatives meet any of these referral criteria.

Guidelines for computer security in general practice.

PubMed

Schattner, Peter; Pleteshner, Catherine; Bhend, Heinz; Brouns, Johan

2007-01-01

As general practice becomes increasingly computerised, data security becomes increasingly important for both patient health and the efficient operation of the practice. To develop guidelines for computer security in general practice based on a literature review, an analysis of available information on current practice and a series of key stakeholder interviews. While the guideline was produced in the context of Australian general practice, we have developed a template that is also relevant for other countries. Current data on computer security measures was sought from Australian divisions of general practice. Semi-structured interviews were conducted with general practitioners (GPs), the medical software industry, senior managers within government responsible for health IT (information technology) initiatives, technical IT experts, divisions of general practice and a member of a health information consumer group. The respondents were asked to assess both the likelihood and the consequences of potential risks in computer security being breached. The study suggested that the most important computer security issues in general practice were: the need for a nominated IT security coordinator; having written IT policies, including a practice disaster recovery plan; controlling access to different levels of electronic data; doing and testing backups; protecting against viruses and other malicious codes; installing firewalls; undertaking routine maintenance of hardware and software; and securing electronic communication, for example via encryption. This information led to the production of computer security guidelines, including a one-page summary checklist, which were subsequently distributed to all GPs in Australia. This paper maps out a process for developing computer security guidelines for general practice. The specific content will vary in different countries according to their levels of adoption of IT, and cultural, technical and other health service factors. Making these guidelines relevant to local contexts should help maximise their uptake.

Current Cytology Practices in Korea: A Nationwide Survey by the Korean Society for Cytopathology

PubMed Central

Oh, Eun Ji; Jung, Chan Kwon; Kim, Dong-Hoon; Kim, Han Kyeom; Kim, Wan Seop; Jin, So-Young; Yoon, Hye Kyoung

2017-01-01

Background Limited data are available on the current status of cytology practices in Korea. This nationwide study presents Korean cytology statistics from 2015. Methods A nationwide survey was conducted in 2016 as a part of the mandatory quality-control program by the Korean Society for Cytopathology. The questionnaire was sent to 208 medical institutions performing cytopathologic examinations in Korea. Individual institutions were asked to submit their annual cytology statistical reports and gynecologic cytology-histology correlation data for 2015. Results Responses were obtained from 206 medical institutions including 83 university hospitals, 87 general hospitals, and 36 commercial laboratories. A total of 8,284,952 cytologic examinations were performed in 2015, primarily in commercial laboratories (74.9%). The most common cytology specimens were gynecologic samples (81.3%). Conventional smears and liquid-based cytology were performed in 6,190,526 (74.7%) and 2,094,426 (25.3%) cases, respectively. The overall diagnostic concordance rate between cytologic and histologic diagnoses of uterine cervical samples was 70.5%. Discordant cases were classified into three categories: category A (minimal clinical impact, 17.4%), category B (moderate clinical impact, 10.2%), and category C (major clinical impact, 1.9%). The ratio of atypical squamous cells of undetermined significance to squamous intraepithelial lesion was 1.6 in university hospitals, 2.9 in general hospitals, and 4.9 in commercial laboratories. Conclusions This survey reveals the current status and trend of cytology practices in Korea. The results of this study can serve as basic data for the establishment of nationwide cytopathology policies and quality improvement guidelines in Korean medical institutions. PMID:28950443

Developing clinical practice guidelines: reviewing, reporting, and publishing guidelines; updating guidelines; and the emerging issues of enhancing guideline implementability and accounting for comorbid conditions in guideline development

PubMed Central

2012-01-01

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this third paper we discuss the issues of: reviewing, reporting, and publishing guidelines; updating guidelines; and the two emerging issues of enhancing guideline implementability and how guideline developers should approach dealing with the issue of patients who will be the subject of guidelines having co-morbid conditions. PMID:22762242

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.

Antidepressants during pregnancy: Guideline adherence and current practice amongst Dutch gynaecologists and midwives.

PubMed

Molenaar, Nina M; Brouwer, Marlies E; Duvekot, Johannes J; Burger, Huibert; Knijff, Esther M; Hoogendijk, Witte J; Bockting, Claudi L H; de Wolf, G S; Lambregtse-van den Berg, Mijke P

2018-06-01

prescription rates of antidepressants during pregnancy range from 2-3% in The Netherlands to 6.2% in the USA. Inconclusive evidence about harms and benefits of antidepressants during pregnancy leads to variation in advice given by gynaecologists and midwives. The objective was to investigate familiarity with, and adherence to the Dutch multidisciplinary guideline on Selective Serotonin Reuptake Inhibitor (SSRI) use during pregnancy by gynaecologists and midwives in the Netherlands. an online survey was developed and send to Dutch gynaecologists and midwives. The survey consisted mainly of multiple-choice questions addressing guideline familiarity and current practice of the respondent. Also, caregiver characteristics associated with guideline adherence were investigated. a total of 178 gynaecologists and 139 midwives responded. Overall familiarity with the Dutch guideline was 92.7%. However, current practice and advice given to patients by caregivers differed substantially, both between gynaecologists and midwives as well as within both professions. Overall guideline adherence was 13.9%. Multivariable logistic regression showed that solely caregiver profession was associated with guideline adherence, with gynaecologists having a higher adherence rate (OR 2.10, 95%CI 1.02-4.33) than midwives. although reported familiarity with the guideline is high, adherence to the guideline is low, possibly resulting in advice to patients that is inconsistent with guidelines and unwanted variation in current practice. further implementation of the recommendations as given in the guideline should be stimulated. Additional research is needed to examine how gynaecologists and midwives can be facilitated to follow the recommendations of the clinical guideline on SSRI use during pregnancy. Copyright © 2018 Elsevier Ltd. All rights reserved.

Evaluation Guidelines for the Clinical and Translational Science Awards (CTSAs)

PubMed Central

Rubio, Doris M.; Thomas, Veronica G.

2013-01-01

Abstract The National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health, currently funds the Clinical and Translational Science Awards (CTSAs), a national consortium of 61 medical research institutions in 30 states and the District of Columbia. The program seeks to transform the way biomedical research is conducted, speed the translation of laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train a new generation of clinical and translational researchers. An endeavor as ambitious and complex as the CTSA program requires high‐quality evaluations in order to show that the program is well implemented, efficiently managed, and demonstrably effective. In this paper, the Evaluation Key Function Committee of the CTSA Consortium presents an overall framework for evaluating the CTSA program and offers policies to guide the evaluation work. The guidelines set forth are designed to serve as a tool for education within the CTSA community by illuminating key issues and practices that should be considered during evaluation planning, implementation, and utilization. Additionally, these guidelines can provide a basis for ongoing discussions about how the principles articulated in this paper can most effectively be translated into operational reality. PMID:23919366

Fortuitously discovered liver lesions.

PubMed

Dietrich, Christoph F; Sharma, Malay; Gibson, Robert N; Schreiber-Dietrich, Dagmar; Jenssen, Christian

2013-06-07

The fortuitously discovered liver lesion is a common problem. Consensus might be expected in terms of its work-up, and yet there is none. This stems in part from the fact that there is no preventive campaign involving the early detection of liver tumors other than for patients with known liver cirrhosis and oncological patients. The work-up (detection and differential diagnosis) of liver tumors comprises theoretical considerations, history, physical examination, laboratory tests, standard ultrasound, Doppler ultrasound techniques, contrast-enhanced ultrasound (CEUS), computed tomography and magnetic resonance imaging, as well as image-guided biopsy. CEUS techniques have proved to be the most pertinent method; these techniques became part of the clinical routine about 10 years ago in Europe and Asia and are used for a variety of indications in daily clinical practice. CEUS is in many cases the first and also decisive technical intervention for detecting and characterizing liver tumors. This development is reflected in many CEUS guidelines, e.g., in the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) guidelines 2004, 2008 and 2012 as well as the recently published World Federation for Ultrasound in Medicine and Biology-EFSUMB guidelines 2012. This article sets out considerations for making a structured work-up of incidental liver tumors feasible.

Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research. The Chemical Manufacturers Association's Epidemiology Task Group.

PubMed

1991-12-01

The Guidelines for Good Epidemiology Practices (GEPs) for Occupational and Environmental Epidemiologic Research address the conduct of studies generally undertaken to answer questions about human health in relationship to the work place or the environment. The GEPs propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epidemiologic studies and do not prescribe specific research methods. The Guidelines for Good Epidemiology Practices propose minimum practices and procedures in the following areas: I. Organization and Personnel II. Facilities, Resource Commitment, and Contractors III. Protocol IV. Review and Approval V. Study Conduct VI. Communication VII. Archiving VIII. Quality Assurance Although the Guidelines for Good Epidemiology Practices will not guarantee good epidemiology, they do provide a useful framework for ensuring that all research issues are adequately addressed. This framework is proposed as a first step in improving epidemiologic research practices through adherence to sound scientific research principles. Appendices provide an overview of standard operating procedures, a glossary of terms used in the Guidelines, and suggested references on occupational epidemiology methods.

Development and evaluation of online evidence based guideline bank system.

PubMed

Park, Myonghwa

2006-01-01

The purpose of this study was to develop and evaluate the online evidence-based nursing practice guideline bank system to support the best evidence-based decision in the clinical and community practice settings. The main homepage consisted of seven modules for introduction of site, EBN, guideline bank, guideline development, guideline review, related sites, and community. The major contents in the guidelines were purpose, developer, intended audience, method of development, target population, testing, knowledge components, and evaluation. Electronic versions of the guidelines were displayed by XML, PDF, and PDA versions. The system usability were evaluated by general users, guideline developers, and guideline reviewers on the web and the results showed high scores of satisfaction. This online evidence-based guideline bank system could support nurses' best and cost-effective clinical decision using the sharable standardized guidelines with education module of evidence based nursing.

Prevalence of urinary tract infection in acutely unwell children in general practice: a prospective study with systematic urine sampling.

PubMed

O'Brien, Kathryn; Edwards, Adrian; Hood, Kerenza; Butler, Christopher C

2013-02-01

Urinary tract infection (UTI) in children may be associated with long-term complications that could be prevented by prompt treatment. To determine the prevalence of UTI in acutely ill children ≤ 5 years presenting in general practice and to explore patterns of presenting symptoms and urine sampling strategies. Prospective observational study with systematic urine sampling, in general practices in Wales, UK. In total, 1003 children were recruited from 13 general practices between March 2008 and July 2010. The prevalence of UTI was determined and multivariable analysis performed to determine the probability of UTI. Out of 597 (60.0%) children who provided urine samples within 2 days, the prevalence of UTI was 5.9% (95% confidence interval [CI] = 4.3% to 8.0%) overall, 7.3% in those < 3 years and 3.2% in 3-5 year olds. Neither a history of fever nor the absence of an alternative source of infection was associated with UTI (P = 0.64; P = 0.69, respectively). The probability of UTI in children aged ≥3 years without increased urinary frequency or dysuria was 2%. The probability of UTI was ≥5% in all other groups. Urine sampling based purely on GP suspicion would have missed 80% of UTIs, while a sampling strategy based on current guidelines would have missed 50%. Approximately 6% of acutely unwell children presenting to UK general practice met the criteria for a laboratory diagnosis of UTI. This higher than previously recognised prior probability of UTI warrants raised awareness of the condition and suggests clinicians should lower their threshold for urine sampling in young children. The absence of fever or presence of an alternative source of infection, as emphasised in current guidelines, may not rule out UTI in young children with adequate certainty.

The ARIA guidelines in specialist practice: a nationwide survey.

PubMed

Van Hoecke, H; Van Cauwenberge, P; Thas, O; Watelet, J B

2010-03-01

In 2001, the ARIA guidelines were published to assist healthcare practitioners in managing allergic rhinitis (AR) according to the best evidence. Very limited information, however, is avail-able on the impact of these guidelines on clinical practice. All Belgian Otorhinolaryngologists were invited to complete a questionnaire, covering demographic and professional characteristics, knowledge, use and perception of the ARIA guidelines and 4 clinical case scenarios of AR. Of the 258 (44%) Belgian Otorhinolaryngologists who participated, almost 90% had ever heard about ARIA and 64% had followed a lecture specifically dedicated to the ARIA guidelines. Furthermore, 62% stated to always or mostly follow the ARIA treatment algorithms in the daily management of AR patients. In the clinical case section, adherence to the ARIA guidelines raised with increased self-reported knowledge and use of the ARIA guidelines and among participants that considered the guidelines more userfriendly. Of the respondents, 51% were considered as good com-pliers. Younger age was a significant predictor for good compliance. More efforts are required to improve the translation of scientific knowledge into clinical practice and to further identify which factors may influence guideline compliance.

Impact of implementing electronic clinical practice guidelines for the diagnosis, control and treatment of cardiovascular risk factors: A pre-post controlled study.

PubMed

Comin, Eva; Catalan-Ramos, Arantxa; Iglesias-Rodal, Manuel; Grau, Maria; Del Val, Jose Luis; Consola, Alicia; Amado, Ester; Pons, Angels; Mata-Cases, Manel; Franzi, Alicia; Ciurana, Ramon; Frigola, Eva; Cos, Xavier; Davins, Josep; Verdu-Rotellar, Jose M

To evaluate the impact of computerized clinical practice guidelines on the management, diagnosis, treatment, control, and follow-up of the main cardiovascular risk factors: hypertension, hypercholesterolaemia, and type 2 diabetes mellitus. Pre-post controlled study. Catalonia, autonomous community located in north-eastern Spain. Individuals aged 35-74 years assigned to general practitioners of the Catalan Health Institute. The intervention group consisted of individuals whose general practitioners had accessed the computerized clinical practice guidelines at least twice a day, while the control group consisted of individuals whose general practitioner had never accessed the computerized clinical practice guidelines platform. The Chi-squared test was used to detect significant differences in the follow-up, control, and treatment variables for all three disorders (hypertension, hypercholesterolaemia, and type 2 diabetes mellitus) between individuals assigned to users and non-users of the computerized clinical practice guidelines, respectively. A total of 189,067 patients were included in this study, with a mean age of 56 years (standard deviation 12), and 55.5% of whom were women. Significant differences were observed in hypertension management, treatment and control; type 2 diabetes mellitus management, treatment and diagnoses, and the management and control of hypercholesterolaemia in both sexes. Computerized clinical practice guidelines are an effective tool for the control and follow-up of patients diagnosed with hypertension, type 2 diabetes mellitus, and hypercholesterolaemia. The usefulness of computerized clinical practice guidelines to diagnose and adequately treat individuals with these disorders remains unclear. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Economic cost for implementation of the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 in an egg donor program.

PubMed

Baker, Valerie L; Gvakharia, Marina O; Rone, Heather M; Manalad, James R; Adamson, G David

2008-09-01

To assess the economic cost of implementing the U.S. Food and Drug Administration's Code of Federal Regulations Title 21, Part 1271 for infectious screening of egg donors in our practice during the first year. Physicians and employees of our practice were surveyed to ascertain the scope of duties and the number of hours spent to implement the regulations. The economic cost to the practice and the cost of additional laboratories were calculated. Private practice. Egg donors and recipient couples who underwent treatment in our center from May 25, 2005 (the day regulations became effective) to May 25, 2006; and physicians, administrators, and staff who were employed by the practice during this time frame. Using a questionnaire, structured interviews were conducted for all physicians and employees of our practice. The information regarding number of hours was provided to our chief financial officer, who calculated the cost to the practice. The cost that recipient couples paid for laboratory tests that would not otherwise be required to meet American Society for Reproductive Medicine guidelines and the cost of an external audit were also added to the overall practice costs to determine a total cost associated with the regulations in the first year. List of activities associated with implementation of the regulations, personnel hours involved to implement the regulations, and economic cost to the practice and to recipient couples. The total number of personnel hours spent by our practice in preparation for implementation of the regulations was 623.3 hours. In the first year, 675.2 additional hours were required to implement the regulations for 40 donors who cycled during this time. The economic cost to the practice for both preparation and implementation of the regulations was $219, 838, and the cost of additional laboratory work borne by the recipient couples was $15,880. Thus, the total cost was calculated to be $235,718 at 1 year after implementation of the regulations. Implementation of the FDA 21 CFR, Part 1271 was associated with a very high economic cost, even if the costs incurred by the government to develop and implement the regulation are excluded.

Utilizing a Collaborative Learning Model to Promote Early Extubation Following Infant Heart Surgery.

PubMed

Mahle, William T; Nicolson, Susan C; Hollenbeck-Pringle, Danielle; Gaies, Michael G; Witte, Madolin K; Lee, Eva K; Goldsworthy, Michelle; Stark, Paul C; Burns, Kristin M; Scheurer, Mark A; Cooper, David S; Thiagarajan, Ravi; Sivarajan, V Ben; Colan, Steven D; Schamberger, Marcus S; Shekerdemian, Lara S

2016-10-01

To determine whether a collaborative learning strategy-derived clinical practice guideline can reduce the duration of endotracheal intubation following infant heart surgery. Prospective and retrospective data collected from the Pediatric Heart Network in the 12 months pre- and post-clinical practice guideline implementation at the four sites participating in the collaborative (active sites) compared with data from five Pediatric Heart Network centers not participating in collaborative learning (control sites). Ten children's hospitals. Data were collected for infants following two-index operations: 1) repair of isolated coarctation of the aorta (birth to 365 d) and 2) repair of tetralogy of Fallot (29-365 d). There were 240 subjects eligible for the clinical practice guideline at active sites and 259 subjects at control sites. Development and application of early extubation clinical practice guideline. After clinical practice guideline implementation, the rate of early extubation at active sites increased significantly from 11.7% to 66.9% (p < 0.001) with no increase in reintubation rate. The median duration of postoperative intubation among active sites decreased from 21.2 to 4.5 hours (p < 0.001). No statistically significant change in early extubation rates was found in the control sites 11.7% to 13.7% (p = 0.63). At active sites, clinical practice guideline implementation had no statistically significant impact on median ICU length of stay (71.9 hr pre- vs 69.2 hr postimplementation; p = 0.29) for the entire cohort. There was a trend toward shorter ICU length of stay in the tetralogy of Fallot subgroup (71.6 hr pre- vs 54.2 hr postimplementation, p = 0.068). A collaborative learning strategy designed clinical practice guideline significantly increased the rate of early extubation with no change in the rate of reintubation. The early extubation clinical practice guideline did not significantly change postoperative ICU length of stay.

OVERSEER: An Expert System Monitor for the Psychiatric Hospital

PubMed Central

Bronzino, Joseph D.; Morelli, Ralph A.; Goethe, John W.

1988-01-01

In order to improve patient care, comply with regulatory guidelines and decrease potential liability, psychiatric hospitals and clinics have been searching for computer systems to monitor the management and treatment of patients. This paper describes OVERSEER: a knowledge based system that monitors the treatment of psychiatric patients in real time. Based on procedures and protocols developed in the psychiatric setting, OVERSEER monitors the clinical database and issues alerts when standard clinical practices are not followed or when laboratory results or other clinical indicators are abnormal. Written in PROLOG, OVERSEER is designed to interface directly with the hospital's database, and, thereby utilizes all available pharmacy and laboratory data. Moreover, unlike the interactive expert systems developed for the psychiatric clinic, OVERSEER does not require extensive data entry by the clinician. Consequently, the chief benefit of OVERSEER's monitoring approach is the unobtrusive manner in which it evaluates treatment and patient responses and provides information regarding patient management.

[Practice guidelines in rehabilitation: infringement upon physicians' autonomy or foundation for better outcomes?].

PubMed

Brüggemann, S; Korsukéwitz, C

2004-10-01

Clinical practice guidelines - seen as an aggregation of scientific evidence - and evidence based medicine are of relevance and importance for everybody involved in health care. Nevertheless, the discussion of their pros and cons is controversial. Major criticisms concern methodological aspects, a disregard of the patients' perspective, potentially increasing costs and the limitation of doctors' autonomy possibly caused by streamlining therapy. Supporters emphasize the improvement of care that comes with using proven therapies, patients' empowerment, cost reduction and equity in the distribution of resources. Following medical practice guidelines the liability for medical malpractice may be limited, but non-adherence to guidelines does not entail liability per se. Clinical practice guidelines in the rehabilitative sector differ from those in curative medicine by being required to achieve more complex goals than maintenance, recovery and improvement of health. Activities in the rehabilitation sector address two main topics: The integration of rehabilitation into curative guidelines, e. g. by participating in the German clearing process for guidelines, and the development of guidelines specific to rehabilitation. There are a number of guideline initiatives, e. g. with the Association of the Scientific Medical Societies (AWMF), the Federation of German Pension Insurance Institutes (VDR) and the Federal Insurance Institute for Salaried Employees (BfA). The BfA project is the first to allow integration of evidence based medicine into the quality assurance programme of the German Pension Insurance complementing it with differentiated criteria for the assessment of therapeutic processes. Taking evidence based medicine increasingly into consideration and the continuous process of introducing rehabilitative clinical practice guidelines are going to improve health care for people with chronic diseases.

Quality-assurance plan and field methods for quality-of-water activities, U.S. Geological Survey, Idaho National Engineering Laboratory, Idaho

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

Mann, L.J.

1996-10-01

Water-quality activities at the Idaho National Engineering Laboratory (INEL) Project Office are part of the US Geological Survey`s (USGS) Water Resources Division (WRD) mission of appraising the quantity and quality of the Nation`s water resources. The purpose of the Quality Assurance Plan (QAP) for water-quality activities performed by the INEL Project Office is to maintain and improve the quality of technical products, and to provide a formal standardization, documentation, and review of the activities that lead to these products. The principles of this plan are as follows: (1) water-quality programs will be planned in a competent manner and activities willmore » be monitored for compliance with stated objectives and approaches; (2) field, laboratory, and office activities will be performed in a conscientious and professional manner in accordance with specified WRD practices and procedures by qualified and experienced employees who are well trained and supervised, if or when, WRD practices and procedures are inadequate, data will be collected in a manner that its quality will be documented; (3) all water-quality activities will be reviewed for completeness, reliability, credibility, and conformance to specified standards and guidelines; (4) a record of actions will be kept to document the activity and the assigned responsibility; (5) remedial action will be taken to correct activities that are deficient.« less

[Systemic validation of clinical practice guidelines: the AGREE network].

PubMed

Hannes, K; Van Royen, P; Aertgeerts, B; Buntinx, F; Ramaekers, D; Chevalier, P

2005-12-01

Over recent decades, the number of available clinical practice guidelines has enormously grown. Guidelines should meet specific quality criteria to ensure good quality. There is a growing need for the developement of a set of criteria to ensure that potential biases inherent in guideline development have been properly addressed and that the recommendations for practice are valid and reliable. The AGREE-collaboration is an international network that developed an instrument to critically appraise the methodological quality of guidelines. AGREE promotes a clear strategy to produce, disseminate and evaluate guidelines of high quality. In the first phase of the international project the AGREE-instrument was tested in 11 different countries. Based on this experience the instrument was refined and optimised. In the second phase it was disseminated, promoted and evaluated in 18 participating countries. Belgium was one of them. The Belgian partner in the AGREE-project developed 3 workshops and established 13 validation committees to validate guidelines from Belgian developer groups. We collected 33 questionnaires from participants of the workshops and the validation committees, in which we asked for primary experiences and information on the usefulness and applicability of the instrument. We were also interested in the shortcomings of the instrument and potential strategies to bridge them. More efforts should be made to train methodological experts to gain certain skills for a critical appraisal of clinical practice guidelines. Promoting the AGREE-instrument will lead to a broader knowledge and use of quality criteria in guideline development and appraisal. The development and dissemination of an international list of criteria to appraise the quality of guidelines will stimulate the development of methodologically sound guidelines. International comparisons between existing guidelines will lead to a better collaboration between guideline developers throughout the world.

Teleworking: Guidelines for Good Practice. IES Report 329.

ERIC Educational Resources Information Center

Huws, Ursula; And Others

Because teleworking presents major new challenges to human resource managers, trade unions, and others involved in the development of good employment practices, this book provides practical guidelines for good practice in regard to teleworkers that recognize that teleworking is not a single category, but covers at least five distinct groups with…

Appraising the methodological quality of the clinical practice guideline for diabetes mellitus using the AGREE II instrument: a methodological evaluation.

PubMed

Radwan, Mahmoud; Akbari Sari, Ali; Rashidian, Arash; Takian, Amirhossein; Abou-Dagga, Sanaa; Elsous, Aymen

2017-02-01

To evaluate the methodological quality of the Palestinian Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological evaluation. A cross-cultural adaptation framework was followed to translate and develop a standardised Translated Arabic Version of the AGREE II. Palestinian Primary Healthcare Centres. Sixteen appraisers independently evaluated the Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological quality of diabetic guideline. The Translated Arabic Version of the AGREE II showed an acceptable reliability and validity. Internal consistency ranged between 0.67 and 0.88 (Cronbach's α). Intra-class coefficient among appraisers ranged between 0.56 and 0.88. The quality of this guideline is low. Both domains 'Scope and Purpose' and 'Clarity of Presentation' had the highest quality scores (66.7% and 61.5%, respectively), whereas the scores for 'Applicability', 'Stakeholder Involvement', 'Rigour of Development' and 'Editorial Independence' were the lowest (27%, 35%, 36.5%, and 40%, respectively). The findings suggest that the quality of this Clinical Practice Guideline is disappointingly low. To improve the quality of current and future guidelines, the AGREE II instrument is extremely recommended to be incorporated as a gold standard for developing, evaluating or updating the Palestinian Clinical Practice Guidelines. Future guidelines can be improved by setting specific strategies to overcome implementation barriers with respect to economic considerations, engaging of all relevant end-users and patients, ensuring a rigorous methodology for searching, selecting and synthesising the evidences and recommendations, and addressing potential conflict of interests within the development group.

A critical appraisal of guidelines for electronic communication between patients and clinicians: the need to modernize current recommendations.

PubMed

Lee, Joy L; Matthias, Marianne S; Menachemi, Nir; Frankel, Richard M; Weiner, Michael

2018-04-01

Patient-provider electronic communication has proliferated in recent years, yet there is a dearth of published research either leading to, or including, recommendations that improve clinical care and prevent unintended negative consequences. We critically appraise published guidelines and suggest an agenda for future work in this area. To understand how existing guidelines align with current practice, evidence, and technology. We performed a narrative review of provider-targeted guidelines for electronic communication between patients and providers, searching Ovid MEDLINE, Embase, and PubMed databases using relevant terms. We limited the search to articles published in English, and manually searched the citations of relevant articles. For each article, we identified and evaluated the suggested practices. Across 11 identified guidelines, the primary focus was on technical and administrative concerns, rather than on relational communication. Some of the security practices recommended by the guidelines are no longer needed because of shifts in technology. It is unclear the extent to which the recommendations that are still relevant are being followed. Moreover, there is no guideline-cited evidence of the effectiveness of the practices that have been proposed. Our analysis revealed major weaknesses in current guidelines for electronic communication between patients and providers: the guidelines appear to be based on minimal evidence and offer little guidance on how best to use electronic tools to communicate effectively. Further work is needed to systematically evaluate and identify effective practices, create a framework to evaluate quality of communication, and assess the relationship between electronic communication and quality of care.

A Handbook for Inservice Education: Guidelines for Training, Multicultural Education and Desegregation.

ERIC Educational Resources Information Center

King, Al

This handbook presents guidelines for developing and implementing inservice teacher training programs on multicultural education and school desegregation. Developed by the Ways to Improve Education in Desegegated Schools (WIEDS) project of the Southwest Educational Development Laboratory (Austin, Texas), the guidelines are based on data from the…

Undergraduate Professional Education in Chemistry: Guidelines and Evaluation Procedures.

ERIC Educational Resources Information Center

American Chemical Society, Washington, DC.

Provided are guidelines for evaluating undergraduate professional education in chemistry. The guidelines summarize an approved program as including: 400 hours of classroom work; 500 hours of laboratory work; a core curriculum covering principles of analytical, inorganic, organic, and physical chemistry; 1 year of advanced work in chemistry or…

[Cancer pain management: Systematic review and critical appraisal of clinical practice guidelines].

PubMed

Martínez-Nicolás, I; Ángel-García, D; Saturno, P J; López-Soriano, F

2016-01-01

Although several clinical practice guidelines have been developed in the last decades, cancer pain management is still deficient. The purpose of this work was to carry out a comprehensive and systematic literature review of current clinical practice guidelines on cancer pain management, and critically appraise their methodology and content in order to evaluate their quality and validity to cope with this public health issue. A systematic review was performed in the main databases, using English, French and Spanish as languages, from 2008 to 2013. Reporting and methodological quality was rated with the Appraisal of Guidelines, Research and Evaluation II (AGREE-II) tool, including an inter-rater reliability analysis. Guideline recommendations were extracted and classified into several categories and levels of evidence, aiming to analyse guidelines variability and evidence-based content comprehensiveness. Six guidelines were included. A wide variability was found in both reporting and methodological quality of guidelines, as well as in the content and the level of evidence of their recommendations. The Scottish Intercollegiate Guidelines Network guideline was the best rated using AGREE-II, while the Sociedad Española de Oncología Médica guideline was the worst rated. The Ministry of Health Malaysia guideline was the most comprehensive, and the Scottish Intercollegiate Guidelines Network guideline was the second one. The current guidelines on cancer pain management have limited quality and content. We recommend Ministry of Health Malaysia and Scottish Intercollegiate Guidelines Network guidelines, whilst Sociedad Española de Oncología Médica guideline still needs to improve. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Indoor Air Quality Guidelines for Pennsylvania Schools.

ERIC Educational Resources Information Center

Zimmerman, Robert S., Jr.

This report provides information and practical guidance on how to prevent indoor air quality (IAQ) problems in schools, and it describes how to implement a practical plan of action using a minimal amount of resources. It includes general guidelines to prevent or help resolve IAQ problems, guidelines on specific indoor contaminants, recommendations…

Optimal Pain Assessment in Pediatric Rehabilitation: Implementation of a Nursing Guideline.

PubMed

Kingsnorth, Shauna; Joachimides, Nick; Krog, Kim; Davies, Barbara; Higuchi, Kathryn Smith

2015-12-01

In Ontario, Canada, the Registered Nurses' Association promotes a Best Practice Spotlight Organization initiative to enhance evidence-based practice. Qualifying organizations are required to implement strategies, evaluate outcomes, and sustain practices aligned with nursing clinical practice guidelines. This study reports on the development and evaluation of a multifaceted implementation strategy to support adoption of a nursing clinical practice guideline on the assessment and management of acute pain in a pediatric rehabilitation and complex continuing care hospital. Multiple approaches were employed to influence behavior, attitudes, and awareness around optimal pain practice (e.g., instructional resources, electronic reminders, audits, and feedback). Four measures were introduced to assess pain in communicating and noncommunicating children as part of a campaign to treat pain as the fifth vital sign. A prospective repeated measures design examined survey and audit data to assess practice aligned with the guideline. The Knowledge and Attitudes Survey (KNAS) was adapted to ensure relevance to the local practice setting and was assessed before and after nurses' participation in three education modules. Audit data included client demographics and pain scores assessed annually over a 3-year window. A final sample of 69 nurses (78% response rate) provided pre-/post-survey data. A total of 108 pediatric surgical clients (younger than 19 years) contributed audit data across the three collection cycles. Significant improvements in nurses' knowledge, attitudes, and behaviors related to optimal pain care for children with disabilities were noted following adoption of the pain clinical practice guideline. Targeted guideline implementation strategies are central to supporting optimal pain practice. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Adherence to best practice consensus guidelines for implant-based breast reconstruction: Results from the iBRA national practice questionnaire survey.

PubMed

Mylvaganam, Senthurun; Conroy, Elizabeth J; Williamson, Paula R; Barnes, Nicola L P; Cutress, Ramsey I; Gardiner, Matthew D; Jain, Abhilash; Skillman, Joanna M; Thrush, Steven; Whisker, Lisa J; Blazeby, Jane M; Potter, Shelley; Holcombe, Christopher

2018-05-01

The 2008 National Mastectomy and Breast Reconstruction Audit demonstrated marked variation in the practice and outcomes of breast reconstruction in the UK. To standardise practice and improve outcomes for patients, the British professional associations developed best-practice guidelines with specific guidance for newer mesh-assisted implant-based techniques. We explored the degree of uptake of best-practice guidelines within units performing implant-based reconstruction (IBBR) as the first phase of the implant Breast Reconstruction Evaluation (iBRA) study. A questionnaire developed by the iBRA Steering Group was completed by trainee and consultant leads at breast and plastic surgical units across the UK. Simple summary statistics were calculated for each survey item to assess compliance with current best-practice guidelines. 81 units from 79 NHS Trusts completed the questionnaire. Marked variation was observed in adherence to guidelines, especially those relating to clinical governance and infection prevention strategies. Less than half (n = 28, 47%) of units obtained local clinical governance board approval prior to offering new mesh-based techniques and prospective audit of the clinical, cosmetic and patient-reported outcomes of surgery was infrequent. Most units screened for methicillin-resistant staphylococcus aureus prior to surgery but fewer than 1 in 3 screened for methicillin-sensitive strains. Laminar-flow theatres (recommended for IBBR) were not widely-available with less than 1 in 5 units having regular access. Peri-operative antibiotics were widely-used, but the type and duration were highly-variable. The iBRA national practice questionnaire has demonstrated variation in reported practice and adherence to IBBR guidelines. High-quality evidence is urgently required to inform best practice. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

NASA preferred reliability-practices for design and test

NASA Technical Reports Server (NTRS)

Lisk, Ronald C.

1992-01-01

NASA HQ established the NASA R&M Steering Committee (R&MSC) comprised of membership from each NASA field center. The primary charter of the R&MSC is to obtain, record, and share the best design practices that NASA has applied to successful space flight programs and current design considerations (guidelines) that should enhance flight reliability on emerging programs. The practices and guidelines are being assembled in a living document for distribution to NASA centers and the aerospace community. The document will be updated annually with additional practices and guidelines as contributions from the centers are reviewed and approved by the R&MSC. Practices and guidelines are not requirements, but rather a means of sharing procedures and techniques that a given center and the R&MSC together feel have strong technical merit and application to the design of space-related equipment.

Antimicrobial Susceptibility Testing, Drug Resistance Mechanisms, and Therapy of Infections with Nontuberculous Mycobacteria

PubMed Central

Nash, Kevin A.; Wallace, Richard J.

2012-01-01

Summary: Within the past 10 years, treatment and diagnostic guidelines for nontuberculous mycobacteria have been recommended by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA). Moreover, the Clinical and Laboratory Standards Institute (CLSI) has published and recently (in 2011) updated recommendations including suggested antimicrobial and susceptibility breakpoints. The CLSI has also recommended the broth microdilution method as the gold standard for laboratories performing antimicrobial susceptibility testing of nontuberculous mycobacteria. This article reviews the laboratory, diagnostic, and treatment guidelines together with established and probable drug resistance mechanisms of the nontuberculous mycobacteria. PMID:22763637

Bone Marrow Synoptic Reporting for Hematologic Neoplasms: Guideline From the College of American Pathologists Pathology and Laboratory Quality Center.

PubMed

Sever, Cordelia; Abbott, Charles L; de Baca, Monica E; Khoury, Joseph D; Perkins, Sherrie L; Reichard, Kaaren Kemp; Taylor, Ann; Terebelo, Howard R; Colasacco, Carol; Rumble, R Bryan; Thomas, Nicole E

2016-09-01

-There is ample evidence from the solid tumor literature that synoptic reporting improves accuracy and completeness of relevant data. No evidence-based guidelines currently exist for synoptic reporting for bone marrow samples. -To develop evidence-based recommendations to standardize the basic components of a synoptic report template for bone marrow samples. -The College of American Pathologists Pathology and Laboratory Quality Center convened a panel of experts in hematopathology to develop recommendations. A systematic evidence review was conducted to address 5 key questions. Recommendations were derived from strength of evidence, open comment feedback, and expert panel consensus. -Nine guideline statements were established to provide pathology laboratories with a framework by which to develop synoptic reporting templates for bone marrow samples. The guideline calls for specific data groups in the synoptic section of the pathology report; provides a list of evidence-based parameters for key, pertinent elements; and addresses ancillary testing. -A framework for bone marrow synoptic reporting will improve completeness of the final report in a manner that is clear, succinct, and consistent among institutions.

Implementation of clinical guidelines on diabetes and hypertension in urban Mongolia: a qualitative study of primary care providers' perspectives and experiences.

PubMed

Chimeddamba, Oyun; Peeters, Anna; Ayton, Darshini; Tumenjargal, Enkhjargal; Sodov, Sonin; Joyce, Catherine

2015-08-11

Hypertension and diabetes, key risk factors for cardiovascular disease, are significant health problems globally. As cardiovascular disease is one of the leading causes of mortality in Mongolia since 2000, clinical guidelines on arterial hypertension and diabetes were developed and implemented in 2011. This paper explores the barriers and enablers influencing the implementation of these guidelines in the primary care setting. A phenomenological qualitative study with semi-structured interviews was conducted to explore the implementation of the diabetes and hypertension guidelines at the primary care level, as well as to gain insight into how practitioners view the usability and practicality of the guidelines. Ten family health centres were randomly chosen from a list of all the family health centres (n = 136) located in Ulaanbaatar City. In each centre, a focus group discussion with nurses (n = 20) and individual interviews with practice doctors (n = 10) and practice managers (n = 10) were conducted. Data was analysed using a thematic approach utilising the Theoretical Domains Framework. The majority of the study participants reported being aware of the guidelines and that they had incorporated them into their daily practice. They also reported having attended guideline training sessions which were focused on practice skill development. The majority of participants expressed satisfaction with the wide range of resources that had been supplied to them by the Mongolian Government to assist with the implementation of the guidelines. The resources, supplied from 2011 onwards, included screening devices, equipment for blood tests, medications and educational materials. Other enablers were the participants' commitment and passion for guideline implementation and their belief in the simplicity and practicality of the guidelines. Primary care providers reported a number of challenges in implementing the guidelines, including frustration caused by increased workload and long waiting times, time constraints, difficulties with conflicting tasks and low patient health literacy. This study provides evidence that comprehensive and rigorous dissemination and implementation strategies increase the likelihood of successful implementation of new guidelines in low resource primary care settings. It also offers some key lessons that might be carefully considered when other evidence-based clinical guidelines are to be put into effect in low resource settings and elsewhere.

Barriers to Primary Care Clinician Adherence to Clinical Guidelines for the Management of Low Back Pain: A Systematic Review and Metasynthesis of Qualitative Studies.

PubMed

Slade, Susan C; Kent, Peter; Patel, Shilpa; Bucknall, Tracey; Buchbinder, Rachelle

2016-09-01

Despite the availability of evidence-based guidelines for the management of low back pain (LBP) that contain consistent messages, large evidence-practice gaps in primary care remain. To perform a systematic review and metasynthesis of qualitative studies that have explored primary care clinicians' perceptions and beliefs about guidelines for LBP, including perceived enablers and barriers to guideline adherence. Studies investigating perceptions and beliefs about LBP guidelines were included if participants were primary care clinicians and qualitative methods had been used for both data collection and analysis. We searched major databases up to July 2014. Pairs of reviewers independently screened titles and abstracts, extracted data, appraised method quality using the CASP checklist, conducted thematic analysis, and synthesized the results in narrative format. Seventeen studies, with a total of 705 participants, were included. We identified 3 key emergent themes and 8 subthemes: (1) guideline implementation and adherence beliefs and perceptions; (2) maintaining the patient-clinician relationship with imaging referrals; and (3) barriers to guideline implementation. Clinicians believed that guidelines were categorical, prescriptive, and constrained professional practice; however, popular clinical practices superseded the guidelines. Imaging referrals were used to manage consultations and to obtain definitive diagnoses. Clinicians' perceptions reflected a lack of content knowledge and understanding of how guidelines are developed. Addressing misconceptions and other barriers to uptake of evidence-based guidelines for managing LBP is needed to improve knowledge transfer and close the evidence-practice gap in the treatment of this common condition.

[Guidelines for the management of knee and hip osteoarthritis: For whom? Why? To do what?].

PubMed

Henrotin, Yves; Chevalier, Xavier

2010-11-01

This paper summarizes the guidelines published by the Osteoarthritis research society International (OARSI) and compares these guidelines with others. The OARSI guidelines are based on a systematic review of the literature, a meta-analysis and an expert consensus. The OARSI has developed 25 guidelines including 8 for pharmacology modalities, 12 for non-pharmacology modalities and 5 for surgery modalities. The usefulness of the guidelines in the daily practice is very low. The barriers for the guidelines implementation are the lack of interest of the practitioners, the lack of scientific advances in the OA diagnosis and treatments and the low applicability of these guidelines in the daily practice. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Clinical practice guideline development manual: A quality-driven approach for translating evidence into action

PubMed Central

Rosenfeld, Richard M.; Shiffman, Richard N.

2010-01-01

Background Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing healthcare variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective – or potentially harmful – interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. Purpose This manual describes the principles and practices used successfully by the American Academy of Otolaryngology – Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multi-disciplinary applicability. The development process, which allows moving from conception to completion in twelve months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence. Conclusions As clinical practice guidelines become more prominent as a key metric of quality healthcare, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are – and are not – and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals. PMID:19464525

Evidence-based practice guidelines in OHS: are they agree-able?

PubMed

Hulshof, Carel; Hoenen, John

2007-01-01

The purpose of this study was to evaluate the acceptance, validity, reliability and feasibility of the AGREE (Appraisal of Guidelines and REsearch and Evaluation) instrument to assess the quality of evidence-based practice guidelines for occupational physicians. In total, 6 practice guidelines of the Netherlands Society of Occupational Medicine (NVAB) were appraised by 20 occupational health professionals and experts in guideline development or implementation. Although appraisers often disagreed on individual item scores, the internal consistency and interrater reliability for most domains was sufficient. The AGREE criteria were in general considered relevant and no major suggestions for additional items for use in the context of occupational health were brought up. The domain scores for the individual guidelines show a wide variety: 'applicability' had on average the lowest mean score (53%) while 'scope and purpose' had the highest one (87%). Low scores indicate where improvements are possible and necessary, e.g. by providing more information about the development. Key experts in occupational health report that AGREE is a relevant and easy to use instrument to evaluate quality aspects and the included criteria provide a good framework to develop or update evidence-based practice guidelines in the field of occupational health.

Developing best practice for fungal specimen management: audit of UK microbiology laboratories.

PubMed

Lasseter, G; Palmer, M; Morgan, J; Watts, J; Yoxall, H; Kibbler, C; McNulty, C

2011-01-01

This study represents an audit of microbiology laboratories in the UK to ascertain whether they are aware of, or follow, the Health Protection Agency (HPA) National Standard Methods Standard Operating Procedure (NSM SOP) for the investigation of dermatological specimens for superficial mycoses, or use a locally adapted version. A questionnaire audit was distributed to 179 NHS microbiology laboratories throughout England, Wales, Scotland and Northern Ireland. The NSM SOP was followed by 92% of laboratories for the microscopy of dermatological samples; light microscopy/ KOH digestion was used by 63% and fluorescence microscopy/KOH digestion by 29% of laboratories. Preliminary reports post-microscopy were issued by 98% of laboratories, with 93% issuing reports within 48 hours. Adherence to the NSM SOP guidelines for culture was low; only 34% of laboratories incubated microscopy-negative specimens for the recommended 14 days, while approximately 60% incubated microscopy-positive specimens for 21 days. The culture medium recommended by the NSM SOP was used in 82% of laboratories. Comments were added to culture reports by 51% of laboratories; most were added manually and comments varied between laboratories. Nail samples were the most common sample received from primary care, followed by skin and hair. These results show no significant difference in the rate of microscopy positives versus culture positives. Microscopy and culture are the easiest and cheapest methods available to UK laboratories for the investigation of suspected superficial fungal infections. Although most laboratories included in this audit claimed to follow the NSM SOP for microscopy and culture, these results show that the techniques used vary throughout the UK. To maximise the service provided to primary care, UK laboratories should use standardise methods based on the NSM SOP.

Conducting remote bioanalytical data monitoring and review based on scientific quality objectives.

PubMed

He, Ling

2011-07-01

For bioanalytical laboratories that follow GLP regulations and generate data for new drug filing, ensuring quality standards set by regulatory guidance is a fundamental expectation. Numerous guidelines and White Papers have been published by regulatory agencies, professional working groups and field experts in the past two decades, and have significantly improved the standards of good practices for bioanalysis. From a sponsor's perspective, continuous quality monitoring of the data generated by CRO laboratories, identifying adverse trends and taking corrective and preventative actions against issues encountered, are critical aspects of effective bioanalytical outsourcing management. This is especially important for clinical bioanalysis, where one validated assay is applied for analyzing a large number of samples of diverse demographics and disease states. This perspective article presents thoughts toward remote data monitoring and its merits for scientific quality oversight, and introduces a novel Bioanalytical Data Review software that was custom-developed and platform-neural, to conduct remote data monitoring on raw or processed LC-MS/MS data from CROs. Flexible, adaptive and user-customizable queries are applied for conducting project-, batch- and sample-level data review based on scientific quality performance factors commonly assessed for good bioanalytical practice.

Guidelines on Chemotherapy in Advanced Stage Gynecological Malignancies: An Evaluation of 224 Professional Societies and Organizations

PubMed Central

Polyzos, Nikolaos P.; Mauri, Davide; Ioannidis, John P. A.

2011-01-01

Background Clinical practice guidelines are important for guiding practice, but it is unclear if they are commensurate with the available evidence. Methods We examined guidelines produced by cancer and gynecological societies and organizations and evaluated their coverage of and stance towards chemotherapy for advanced stage disease among 4 gynecological malignancies (breast, ovarian, cervical, endometrial cancer) where the evidence for the use of chemotherapy is very different (substantial and conclusive for breast and ovarian cancer, limited and suggesting no major benefit for cervical and endometrial cancer). Eligible societies and organizations were identified through systematic internet searches (last update June 2009). Pertinent websites were scrutinized for presence of clinical practice guidelines, and relative guidelines were analyzed. Results Among 224 identified eligible societies and organizations, 69 (31%) provided any sort of guidelines, while recommendations for chemotherapy on advanced stage gynecological malignancies were available in 20 of them. Only 14 had developed their own guideline, and only 5 had developed guidelines for all 4 malignancies. Use of levels of evidence and grades of recommendations, and aspects of the production, implementation, and timeliness of the guidelines did not differ significantly across malignancies. Guidelines on breast and ovarian cancer utilized significantly more randomized trials and meta-analyses. Guidelines differed across malignancies on their coverage of disease-free survival (p = 0.033), response rates (p = 0.024), symptoms relief (p = 0.005), quality of life (p = 0.001) and toxicity (p = 0.039), with breast and ovarian cancer guidelines typically covering more frequently these outcomes. All guidelines explicitly or implicitly endorsed the use of chemotherapy. Conclusions Clinical practice guidelines are provided by the minority of professional societies and organizations. Available guidelines tend to recommend chemotherapy even for diseases where the effect of chemotherapy is controversial and recommendations are based on scant evidence. PMID:21611154

Guideline harmonization and implementation plan for the BETTER trial: Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Family Practice

PubMed Central

Rogers, Jess; Manca, Donna; Lang-Robertson, Kelly; Bell, Stephanie; Salvalaggio, Ginetta; Greiver, Michelle; Korownyk, Christina; Klein, Doug; Carroll, June C.; Kahan, Mel; Meuser, Jamie; Buchman, Sandy; Barrett, Rebekah M.; Grunfeld, Eva

2014-01-01

Background The aim of the Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Family Practice (BETTER) randomized controlled trial is to improve the primary prevention of and screening for multiple conditions (diabetes, cardiovascular disease, cancer) and some of the associated lifestyle factors (tobacco use, alcohol overuse, poor nutrition, physical inactivity). In this article, we describe how we harmonized the evidence-based clinical practice guideline recommendations and patient tools to determine the content for the BETTER trial. Methods We identified clinical practice guidelines and tools through a structured literature search; we included both indexed and grey literature. From these guidelines, recommendations were extracted and integrated into knowledge products and outcome measures for use in the BETTER trial. End-users (family physicians, nurse practitioners, nurses and dieticians) were engaged in reviewing the recommendations and tools, as well as tailoring the content to the needs of the BETTER trial and family practice. Results In total, 3–5 high-quality guidelines were identified for each condition; from these, we identified high-grade recommendations for the prevention of and screening for chronic disease. The guideline recommendations were limited by conflicting recommendations, vague wording and different taxonomies for strength of recommendation. There was a lack of quality evidence for manoeuvres to improve the uptake of guidelines among patients with depression. We developed the BETTER clinical algorithms for the implementation plan. Although it was difficult to identify high-quality tools, 180 tools of interest were identified. Interpretation The intervention for the BETTER trial was built by integrating existing guidelines and tools, and working with end-users throughout the process to increase the intervention’s utility for practice. Trial registration: ISRCTN07170460 PMID:25077119

Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial.

PubMed

Bernhardsson, Susanne; Larsson, Maria E H; Eggertsen, Robert; Olsén, Monika Fagevik; Johansson, Kajsa; Nilsen, Per; Nordeman, Lena; van Tulder, Maurits; Öberg, Birgitta

2014-03-04

Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson's χ2 test and approximative z-test. 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the proportion in the control group. A higher proportion considered EBP helpful in decision making (p = 0.018). There were no other significant differences in secondary outcomes. A tailored, theory- and evidence-informed, multi-component intervention for the implementation of clinical practice guidelines had a modest, positive effect on awareness of, knowledge of, access to, and use of guidelines, among PTs in primary care in western Sweden. In general, attitudes to EBP and guidelines were not affected.

The local lymph node assay in practice: a current regulatory perspective.

PubMed

Cockshott, A; Evans, P; Ryan, C A; Gerberick, G F; Betts, C J; Dearman, R J; Kimber, I; Basketter, D A

2006-07-01

Following the formal acceptance of the local lymph node assay (LLNA) as an Organization for Economic Cooperation and Development (OECD) guideline in April 2002, the UK Health and Safety Executive (HSE) informed notifiers that this was now the method of choice for the assessment of skin sensitization potential under the EU notification scheme for new industrial chemicals (NONS). This paper summarizes the experience of the HSE for the 2-year period immediately following the issuing of this statement, during which 48 LLNA study reports were assessed for notification purposes. The issues discussed here include adherence to the OECD guideline, interpretation of results, and classification outcomes. Generally, notifying laboratories followed the OECD guideline successfully, with regard to the sex/ strain/numbers of mice used, the precise process used for measurement of cell proliferation, and the use of recommended vehicles and positive controls. Initially, use of the individual animal approach (measuring the cell proliferation in each animal rather than for a pooled dose group) highlighted problems caused by technical inexperience, but these were overcome by practice. Toxicity or irritation were found to be minor factors in dose selection; more important was the choice of vehicle to correctly maximize the test substance concentration, while maintaining appropriate application properties. Contrary to concerns that the LLNA would prove to be less sensitive or more sensitive than the traditionally used Guinea Pig Maximization Test (GPMT), the proportion of new substances classified as skin sensitizers was within the range observed in previous years. Although the sample size is relatively small, the experience of the HSE indicates that the LLNA is satisfactory for routine regulatory use.

Factors affecting speech pathologists' implementation of stroke management guidelines: a thematic analysis.

PubMed

Miao, Melissa; Power, Emma; O'Halloran, Robyn

2015-01-01

Although clinical practice guidelines can facilitate evidence-based practice and improve the health outcomes of stroke patients, they continue to be underutilised. There is limited research into the reasons for this, especially in speech pathology. This study provides the first in-depth, qualitative examination of the barriers and facilitators that speech pathologists perceive and experience when implementing guidelines. A maximum variation sample of eight speech pathologists participated in a semi-structured interview concerning the implementation of the National Stroke Foundation's Clinical Guidelines for Stroke Management 2010. Interviews were transcribed, thematically analysed and member checked before overall themes were identified. Three main themes and ten subthemes were identified. The first main theme, making implementation explicit, reflected the necessity of accessing and understanding guideline recommendations, and focussing specifically on implementation in context. In the second theme, demand versus ability to change, the size of changes required was compared with available resources and collaboration. The final theme, Speech pathologist motivation to implement guidelines, demonstrated the influence of individual perception of the guidelines and personal commitment to improved practice. Factors affecting implementation are complex, and are not exclusively barriers or facilitators. Some potential implementation strategies are suggested. Further research is recommended. In most Western nations, stroke remains the single greatest cause of disability, including communication and swallowing disabilities. Although adherence to stroke clinical practice guidelines improves stroke patient outcomes, guidelines continue to be underutilised, and the reasons for this are not well understood. This is the first in-depth qualitative study identifying the complex barriers and facilitators to guideline implementation as experienced by speech pathologists in stroke care. Suggested implementation strategies include local monitoring of guideline implementation (e.g. team meetings, audits), increasing collaboration on implementation projects (e.g. managerial involvement, networking), and seeking speech pathologist input into guideline development.

[How to screen for pheochromocytoma, primary aldosteronism and Cushing's syndrome].

PubMed

Meyer, Patrick

2009-01-07

Pheochromocytoma, primary aldosteronism and Cushing's syndrome are uncommon disorders and are difficult to diagnose because laboratory tests lack validation and specificity. Despite these limitations, practice guidelines are proposed to standardize the screening procedure. The most reliable method to diagnose pheochromocytoma is the measurement of plasmatic and/or urinary metanephrines and normetanephrines depending on the pre-test probability of the disease. The approach for detection of primary aldosteronism is based on the aldosterone-renin ratio under standard conditions. Finally, three tests are available to establish the diagnosis of Cushing's syndrome: 24-h urinary free cortisol excretion, low-dose dexamethasone suppression test and the recent and promising late evening salivary cortisol.

Principles and Guidelines for Equitable Mathematics Teaching Practices and Materials for English Language Learners

ERIC Educational Resources Information Center

Moschkovich, Judit

2013-01-01

In this essay, the author describes principles for equitable mathematics teaching practices for English Language Learners (ELLs) and outlines guidelines for materials to support such practices. Although research cannot provide a recipe for equitable teaching practices for ELLs, teachers, educators, and administrators can use this set of…

Research papers and publications (1981-1987): Workload research program

NASA Technical Reports Server (NTRS)

Hart, Sandra G. (Compiler)

1987-01-01

An annotated bibliography of the research reports written by participants in NASA's Workload Research Program since 1981 is presented, representing the results of theoretical and applied research conducted at Ames Research Center and at universities and industrial laboratories funded by the program. The major program elements included: 1) developing an understanding of the workload concept; 2) providing valid, reliable, and practical measures of workload; and 3) creating a computer model to predict workload. The goal is to provide workload-related design principles, measures, guidelines, and computational models. The research results are transferred to user groups by establishing close ties with manufacturers, civil and military operators of aerospace systems, and regulatory agencies; publishing scientific articles; participating in and sponsoring workshops and symposia; providing information, guidelines, and computer models; and contributing to the formulation of standards. In addition, the methods and theories developed have been applied to specific operational and design problems at the request of a number of industry and government agencies.

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.

PubMed

De Vos, Filip J; De Decker, Mario; Dierckx, Rudi A

2005-07-01

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.

Statin Utilization and Recommendations Among HIV- and HCV-infected Veterans: A Cohort Study

PubMed Central

Clement, Meredith E.; Park, Lawrence P.; Navar, Ann Marie; Okeke, Nwora Lance; Pencina, Michael J.; Douglas, Pamela S.; Naggie, Susanna

2016-01-01

Background. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections are associated with increased risk of cardiovascular disease (CVD). The potential impact of recently updated cholesterol guidelines on treatment of HIV- and HCV-infected veterans is unknown. Methods. We performed a retrospective cohort study to assess statin use and recommendations among 13 579 HIV-infected, 169 767 HCV-infected, and 6628 HIV/HCV-coinfected male veterans aged 40–75 years. Prior 2004 Adult Treatment Panel (ATP-III) guidelines were compared with current 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines and 2014 US Department of Veterans Affairs (VA)/US Department of Defense (DoD) joint clinical practice guidelines using laboratory, medication, and comorbidity data from the VA Clinical Case Registry from 2008 through 2010. Results. Using risk criteria delineated by the ATP-III guidelines, 50.6% of HIV-infected, 45.9% of HCV-infected, and 33.8% of HIV/HCV-coinfected veterans had an indication for statin therapy. However, among those eligible, 22.7%, 30.5%, and 31.5%, respectively, were not receiving ATP-III recommended statin therapy. When current cholesterol guidelines were applied by VA/DoD and ACC/AHA criteria, increases in recommendations for statins were found in all groups (57.3% and 66.1% of HIV-infected, 64.4% and 73.7% of HCV-infected, 49.1% and 58.5% of HIV/HCV-coinfected veterans recommended). Conclusions. Statins were underutilized among veterans infected with HIV, HCV, and HIV/HCV according to previous ATP-III guidelines. Current VA/DoD and ACC/AHA guidelines substantially expand statin recommendations and widen the gap of statin underutilization in all groups. These gaps in care present an opportunity to improve CVD prevention efforts in these at-risk populations. PMID:27143663

Statin Utilization and Recommendations Among HIV- and HCV-infected Veterans: A Cohort Study.

PubMed

Clement, Meredith E; Park, Lawrence P; Navar, Ann Marie; Okeke, Nwora Lance; Pencina, Michael J; Douglas, Pamela S; Naggie, Susanna

2016-08-01

Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections are associated with increased risk of cardiovascular disease (CVD). The potential impact of recently updated cholesterol guidelines on treatment of HIV- and HCV-infected veterans is unknown. We performed a retrospective cohort study to assess statin use and recommendations among 13 579 HIV-infected, 169 767 HCV-infected, and 6628 HIV/HCV-coinfected male veterans aged 40-75 years. Prior 2004 Adult Treatment Panel (ATP-III) guidelines were compared with current 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guidelines and 2014 US Department of Veterans Affairs (VA)/US Department of Defense (DoD) joint clinical practice guidelines using laboratory, medication, and comorbidity data from the VA Clinical Case Registry from 2008 through 2010. Using risk criteria delineated by the ATP-III guidelines, 50.6% of HIV-infected, 45.9% of HCV-infected, and 33.8% of HIV/HCV-coinfected veterans had an indication for statin therapy. However, among those eligible, 22.7%, 30.5%, and 31.5%, respectively, were not receiving ATP-III recommended statin therapy. When current cholesterol guidelines were applied by VA/DoD and ACC/AHA criteria, increases in recommendations for statins were found in all groups (57.3% and 66.1% of HIV-infected, 64.4% and 73.7% of HCV-infected, 49.1% and 58.5% of HIV/HCV-coinfected veterans recommended). Statins were underutilized among veterans infected with HIV, HCV, and HIV/HCV according to previous ATP-III guidelines. Current VA/DoD and ACC/AHA guidelines substantially expand statin recommendations and widen the gap of statin underutilization in all groups. These gaps in care present an opportunity to improve CVD prevention efforts in these at-risk populations. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Implementing guidelines: Proposed definitions of neuropsychology services in pediatric oncology.

PubMed

Baum, Katherine T; Powell, Stephanie K; Jacobson, Lisa A; Gragert, Marsha N; Janzen, Laura A; Paltin, Iris; Rey-Casserly, Celiane M; Wilkening, Greta N

2017-08-01

Several organizations have published guidelines for the neuropsychological care of survivors of childhood cancer. However, there is limited consensus in how these guidelines are applied. The model of neuropsychology service delivery is further complicated by the variable terminology used to describe recommended services. In an important first step to translate published guidelines into clinical practice, this paper proposes definitions for specific neuropsychological processes and services, with the goal of facilitating consistency across sites to foster future clinical program development and to clarify clinical practice guidelines. © 2017 Wiley Periodicals, Inc.

International Society for Analytical Cytology biosafety standard for sorting of unfixed cells.

PubMed

Schmid, Ingrid; Lambert, Claude; Ambrozak, David; Marti, Gerald E; Moss, Delynn M; Perfetto, Stephen P

2007-06-01

Cell sorting of viable biological specimens has become very prevalent in laboratories involved in basic and clinical research. As these samples can contain infectious agents, precautions to protect instrument operators and the environment from hazards arising from the use of sorters are paramount. To this end the International Society of Analytical Cytology (ISAC) took a lead in establishing biosafety guidelines for sorting of unfixed cells (Schmid et al., Cytometry 1997;28:99-117). During the time period these recommendations have been available, they have become recognized worldwide as the standard practices and safety precautions for laboratories performing viable cell sorting experiments. However, the field of cytometry has progressed since 1997, and the document requires an update. Initially, suggestions about the document format and content were discussed among members of the ISAC Biosafety Committee and were incorporated into a draft version that was sent to all committee members for review. Comments were collected, carefully considered, and incorporated as appropriate into a draft document that was posted on the ISAC web site to invite comments from the flow cytometry community at large. The revised document was then submitted to ISAC Council for review. Simultaneously, further comments were sought from newly-appointed ISAC Biosafety committee members. This safety standard for performing viable cell sorting experiments was recently generated. The document contains background information on the biohazard potential of sorting and the hazard classification of infectious agents as well as recommendations on (1) sample handling, (2) operator training and personal protection, (3) laboratory design, (4) cell sorter set-up, maintenance, and decontamination, and (5) testing the instrument for the efficiency of aerosol containment. This standard constitutes an updated and expanded revision of the 1997 biosafety guideline document. It is intended to provide laboratories involved in cell sorting with safety practices that take into account the enhanced hazard potential of high-speed sorting. Most importantly, it states that droplet-based sorting of infectious or hazardous biological material requires a higher level of containment than the one recommended for the risk group classification of the pathogen. The document also provides information on safety features of novel instrumentation, new options for personal protective equipment, and recently developed methods for testing the efficiency of aerosol containment.

Quality Improvement Intervention for Reduction of Redundant Testing.

PubMed

Ducatman, Alan M; Tacker, Danyel H; Ducatman, Barbara S; Long, Dustin; Perrotta, Peter L; Lawther, Hannah; Pennington, Kelly; Lander, Owen; Warden, Mary; Failinger, Conard; Halbritter, Kevin; Pellegrino, Ronald; Treese, Marney; Stead, Jeffrey A; Glass, Eric; Cianciaruso, Lauren; Nau, Konrad C

2017-01-01

Laboratory data are critical to analyzing and improving clinical quality. In the setting of residual use of creatine kinase M and B isoenzyme testing for myocardial infarction, we assessed disease outcomes of discordant creatine kinase M and B isoenzyme +/troponin I (-) test pairs in order to address anticipated clinician concerns about potential loss of case-finding sensitivity following proposed discontinuation of routine creatine kinase and creatine kinase M and B isoenzyme testing. Time-sequenced interventions were introduced. The main outcome was the percentage of cardiac marker studies performed within guidelines. Nonguideline orders dominated at baseline. Creatine kinase M and B isoenzyme testing in 7496 order sets failed to detect additional myocardial infarctions but was associated with 42 potentially preventable admissions/quarter. Interruptive computerized soft stops improved guideline compliance from 32.3% to 58% ( P < .001) in services not receiving peer leader intervention and to >80% ( P < .001) with peer leadership that featured dashboard feedback about test order performance. This successful experience was recapitulated in interrupted time series within 2 additional services within facility 1 and then in 2 external hospitals (including a critical access facility). Improvements have been sustained postintervention. Laboratory cost savings at the academic facility were estimated to be ≥US$635 000 per year. National collaborative data indicated that facility 1 improved its order patterns from fourth to first quartile compared to peer norms and imply that nonguideline orders persist elsewhere. This example illustrates how pathologists can provide leadership in assisting clinicians in changing laboratory ordering practices. We found that clinicians respond to local laboratory data about their own test performance and that evidence suggesting harm is more compelling to clinicians than evidence of cost savings. Our experience indicates that interventions done at an academic facility can be readily instituted by private practitioners at external facilities. The intervention data also supplement existing literature that electronic order interruptions are more successful when combined with modalities that rely on peer education combined with dashboard feedback about laboratory order performance. The findings may have implications for the role of the pathology laboratory in the ongoing pivot from quantity-based to value-based health care.

A UML approach to process modelling of clinical practice guidelines for enactment.

PubMed

Knape, T; Hederman, L; Wade, V P; Gargan, M; Harris, C; Rahman, Y

2003-01-01

Although clinical practice guidelines (CPGs) have been suggested as a means of encapsulating best practice in evidence-based medical treatment, their usage in clinical environments has been disappointing. Criticisms of guideline representations have been that they are predominantly narrative and are difficult to incorporate into clinical information systems. This paper analyses the use of UML process modelling techniques for guideline representation and proposes the automated generation of executable guidelines using XMI. This hybrid UML-XMI approach provides flexible authoring of guideline decision and control structures whilst integrating appropriate data flow. It also uses an open XMI standard interface to allow the use of authoring tools and process control systems from multiple vendors. The paper first surveys CPG modelling formalisms followed by a brief introduction to process modelling in UMI. Furthermore, the modelling of CPGs in UML is presented leading to a case study of encoding a diabetes mellitus CPG using UML.

[Unambiguous practice guidelines on urinary tract infections in primary and secondary care].

PubMed

van Asselt, Kristel M; Prins, Jan M; van der Weele, Gerda M; Knottnerus, Bart J; van Pinxteren, Bart; Geerlings, Suzanne E

2013-01-01

The Dutch College of General Practitioners (NHG) practice guideline 'Urinary tract infections' intended for primary health care and the Dutch Working Party on Antibiotic Policy (SWAB) practice guideline 'Antimicrobial therapy in complicated urinary tract infections' intended for specialists in secondary care, were reviewed together. - In the NHG guideline the differentiation between 'complicated' and 'uncomplicated' urinary tract infections has been replaced by categorisation into age, sex, risk group and the presence of fever, or invasion of tissues.- If urinary tract infection has been diagnosed, a dip slide test can be used to determine resistance.- The guidelines recommend the most narrow-spectrum antibiotic to reduce further increase in antimicrobial resistance.- A chapter about women with recurrent urinary tract infections has been added to the SWAB guideline. Amongst other things, the chapter provides information on the prescription of prophylactic lactobacillus in secondary care.

Guidelines for prevention in psychology.

PubMed

2014-04-01

The effectiveness of prevention to enhance human functioning and reduce psychological distress has been demonstrated. From infancy through adulthood, access to preventive services and interventions is important to improve the quality of life and human functioning and reduce illness and premature death. The importance of prevention is consistent with the Patient Protection and Affordable Care Act of 2010. Even with the increased focus on prevention, psychology training programs rarely require specific courses on prevention. In particular, conceptualizations about best practices in prevention, particularly at the environmental level, are lacking. Therefore, psychologists engaged in prevention can benefit from a set of guidelines that address and inform prevention practices. Accordingly, the Guidelines for Prevention in Psychology are intended to "inform psychologists, the public, and other interested parties regarding desirable professional practices" in prevention. The Prevention Guidelines are recommended based on their potential benefits to the public and the professional practice of psychology. They support prevention as an important area of practice, research, and training for psychologists. The Guidelines give increased attention to prevention within APA, encouraging psychologists to become involved with preventive activities relevant to their area of practice. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

American Burn Association Practice Guidelines: Burn Shock Resuscitation

DTIC Science & Technology

2008-02-01

Ann Surg 1979;189: 546–52. 39. Jelenko C III, Williams JB, Wheeler ML, et al. Studies in shock and resuscitation, I: use of a hypertonic, albumin...SUMMARY ARTICLE American Burn Association Practice Guidelines Burn Shock Resuscitation Tam N. Pham, MD,* Leopoldo C . Cancio, MD,† Nicole S. Gibran...practice guidelines burn shock resuscitation 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Pham T. N., Cancio L. C

Video-assisted feedback in general practice internships using German general practitioner's guidelines

PubMed Central

Bölter, Regine; Freund, Tobias; Ledig, Thomas; Boll, Bernhard; Szecsenyi, Joachim; Roos, Marco

2012-01-01

Introduction: The planned modification of the Medical Licenses Act in Germany will strengthen the specialty of general practice. Therefore, medical students should get to know the daily routine of general practitioners during their academic studies. At least 10% of students should get the possibility to spend one quarter of the internship, in the last year of their academic studies, in a practice of family medicine. The demonstrated teaching method aims at giving feedback to the student based on video recordings of patient consultations (student-patient) with the help of a checklist. Video-feedback is already successful used in medical teaching in Germany and abroad. This feasibility study aims at assessing the practicability of video-assisted feedback as a teaching method during internship in general practice. Teaching method: First of all, the general practice chooses a guideline as the learning objective. Secondly, a subsequent patient – student – consultation is recorded on video. Afterwards, a video-assisted formative feedback is given by the physician. A checklist with learning objectives (communication, medical examination, a structured case report according to the guideline) is used to structure the feedback content. Feasibility: The feasibility was assessed by a semi structured interview in order to gain insight into barriers and challenges for future implementation. The teaching method was performed in one general practice. Afterwards the teaching physician and the trainee intern were interviewed. The following four main categories were identified: feasibility, performance, implementation in daily routine, challenges of the teaching concept. The results of the feasibility study show general practicability of this approach. Installing a video camera in one examination room may solve technical problems. The trainee intern mentioned theoretical and practical benefits using the guideline. The teaching physician noted the challenge to reflect on his daily routines in the light of evidence-based guidelines. Conclusion: This teaching method supports quality control and standardizing of learning objectives during the internship in general practice by using general practice guidelines. The use of a checklist enhances this method in general practice. We consider the presented teaching method in the context of the planned modification of the Medical Licenses Act is part of quality control and standardisation of medical teaching during general practice internships. In order to validate these presumptions, further, evaluation of this method concerning the learning objectives using the guidelines of general practice need to be carried out. PMID:23255963

Video-assisted feedback in general practice internships using German general practitioner's guidelines.

PubMed

Bölter, Regine; Freund, Tobias; Ledig, Thomas; Boll, Bernhard; Szecsenyi, Joachim; Roos, Marco

2012-01-01

The planned modification of the Medical Licenses Act in Germany will strengthen the specialty of general practice. Therefore, medical students should get to know the daily routine of general practitioners during their academic studies. At least 10% of students should get the possibility to spend one quarter of the internship, in the last year of their academic studies, in a practice of family medicine. The demonstrated teaching method aims at giving feedback to the student based on video recordings of patient consultations (student-patient) with the help of a checklist. Video-feedback is already successful used in medical teaching in Germany and abroad. This feasibility study aims at assessing the practicability of video-assisted feedback as a teaching method during internship in general practice. First of all, the general practice chooses a guideline as the learning objective. Secondly, a subsequent patient - student - consultation is recorded on video. Afterwards, a video-assisted formative feedback is given by the physician. A checklist with learning objectives (communication, medical examination, a structured case report according to the guideline) is used to structure the feedback content. The feasibility was assessed by a semi structured interview in order to gain insight into barriers and challenges for future implementation. The teaching method was performed in one general practice. Afterwards the teaching physician and the trainee intern were interviewed. The Following four main categories were identified: feasibility, performance, implementation in daily routine, challenges of the teaching concept.The results of the feasibility study show general practicability of this approach. Installing a video camera in one examination room may solve technical problems. The trainee intern mentioned theoretical and practical benefits using the guideline. The teaching physician noted the challenge to reflect on his daily routines in the light of evidence-based guidelines. This teaching method supports quality control and standardizing of learning objectives during the internship in general practice by using general practice guidelines. The use of a checklist enhances this method in general practice. We consider the presented teaching method in the context of the planned modification of the Medical Licenses Act is part of quality control and standardisation of medical teaching during general practice internships. In order to validate these presumptions, further, evaluation of this method concerning the learning objectives using the guidelines of general practice need to be carried out.

Molecular testing for cystic fibrosis carrier status practice guidelines: recommendations of the National Society of Genetic Counselors.

PubMed

Langfelder-Schwind, Elinor; Karczeski, Barbara; Strecker, Michelle N; Redman, Joy; Sugarman, Elaine A; Zaleski, Christina; Brown, Trisha; Keiles, Steven; Powers, Amy; Ghate, Sumheda; Darrah, Rebecca

2014-02-01

To provide practice recommendations for genetic counselors whose clients are considering cystic fibrosis (CF) carrier testing or seeking information regarding CF molecular test results. The goals of these recommendations are to: 1) Provide updated information about the natural history, diagnosis, and treatment of CF and related conditions. 2) Supplement genetic counselors' knowledge and understanding of the available carrier screening and diagnostic testing options. 3) Describe the current state of genotype/phenotype correlations for CFTR mutations and an approach to interpreting both novel and previously described variants. 4) Provide a framework for genetic counselors to assist clients' decision-making regarding CF carrier testing, prenatal diagnosis, and pregnancy management. Disclaimer The practice guidelines of the National Society of Genetic Counselors (NSGC) are developed by members of the NSGC to assist genetic counselors and other health care providers in making decisions about appropriate management of genetic concerns; including access to and/or delivery of services. Each practice guideline focuses on a clinical or practice-based issue, and is the result of a review and analysis of current professional literature believed to be reliable. As such, information and recommendations within the NSGC practice guidelines reflect the current scientific and clinical knowledge at the time of publication, are only current as of their publication date, and are subject to change without notice as advances emerge.In addition, variations in practice, which take into account the needs of the individual patient and the resources and limitations unique to the institution or type of practice, may warrant approaches, treatments and/or procedures that differ from the recommendations outlined in this guideline. Therefore, these recommendations should not be construed as dictating an exclusive course of management, nor does the use of such recommendations guarantee a particular outcome. Genetic counseling practice guidelines are never intended to displace a health care provider's best medical judgment based on the clinical circumstances of a particular patient or patient population.Practice guidelines are published by NSGC for educational and informational purposes only, and NSGC does not "approve" or "endorse" any specific methods, practices, or sources of information.

Quality of Acute Care for Patients With Urinary Stones in the United States.

PubMed

Scales, Charles D; Bergman, Jonathan; Carter, Stacey; Jack, Gregory; Saigal, Christopher S; Litwin, Mark S

2015-11-01

To describe guideline adherence for patients with suspected upper tract stones. We performed a cross-sectional analysis of visits recorded by the National Hospital Ambulatory Medical Care Survey (emergency department [ED] component) in 2007-2010 (most recent data). We assessed adherence to clinical guidelines for diagnostic laboratory testing, imaging, and pharmacologic therapy. Multivariable regression models controlled for important covariates. An estimated 4,956,444 ED visits for patients with suspected kidney stones occurred during the study period. Guideline adherence was highest for diagnostic imaging, with 3,122,229 (63%) visits providing optimal imaging. Complete guideline-based laboratory testing occurred in only 2 of every 5 visits. Pharmacologic therapy to facilitate stone passage was prescribed during only 17% of eligible visits. In multivariable analysis of guideline adherence, we found little variation by patient, provider, or facility characteristics. Guideline-recommended care was absent from a substantial proportion of acute care visits for patients with suspected kidney stones. These failures of care delivery likely increase costs and temporary disability. Targeted interventions to improve guideline adherence should be designed and evaluated to improve care for patients with symptomatic kidney stones. Published by Elsevier Inc.

Quality of Acute Care for Patients with Urinary Stones in the United States

PubMed Central

Scales, Charles D.; Bergman, Jonathan; Carter, Stacey; Jack, Gregory; Saigal, Christopher S.; Litwin, Mark S.

2015-01-01

Objective To describe guideline adherence for patients with suspected upper tract stones. Methods We performed a cross-sectional analysis of visits recorded by the National Hospital Ambulatory Medical Care Survey (ED component) in 2007–2010 (most recent data). We assessed adherence to clinical guidelines for diagnostic laboratory testing, imaging, and pharmacologic therapy. Multivariable regression models controlled for important covariates. Results An estimated 4,956,444 ED visits for patients with suspected kidney stones occurred during the study period. Guideline adherence was highest for diagnostic imaging, with 3,122,229 (63%) visits providing optimal imaging. Complete guideline-based laboratory testing occurred in only 2 of every 5 visits. Pharmacologic therapy to facilitate stone passage was prescribed during only 17% of eligible visits. In multivariable analysis of guideline adherence, we found little variation by patient, provider or facility characteristics. Conclusions Guideline-recommended care was absent from a substantial proportion of acute care visits for patients with suspected kidney stones. These failures of care delivery likely increase costs and temporary disability. Targeted interventions to improve guideline adherence should be designed and evaluated to improve care for patients with symptomatic kidney stones. PMID:26335495

OHD/HL - National Weather Hydrology Laboratory

Science.gov Websites

resources and services. Design and Programming Standards and Guidelines General Programming C C++ FORTRAN Java v 2.0 updated 3/28/2008 Java v 1.9 Korn and Bash Shell Software Design Phase Guidelines OHD Design Specification Template OHD Design Specification Example Software Peer Review Guidelines and Checklists Software

International variations in clinical practice guidelines for palliative sedation: a systematic review.

PubMed

Abarshi, Ebun; Rietjens, Judith; Robijn, Lenzo; Caraceni, Augusto; Payne, Sheila; Deliens, Luc; Van den Block, Lieve

2017-09-01

Palliative sedation is a highly debated medical practice, particularly regarding its proper use in end-of-life care. Worldwide, guidelines are used to standardise care and regulate this practice. In this review, we identify and compare national/regional clinical practice guidelines on palliative sedation against the European Association for Palliative Care (EAPC) palliative sedation Framework and assess the developmental quality of these guidelines using the Appraisal Guideline Research and Evaluation (AGREE II) instrument. Using the PRISMA criteria, we searched multiple databases (PubMed, CancerLit, CINAHL, Cochrane Library, NHS Evidence and Google Scholar) for relevant guidelines, and selected those written in English, Dutch and Italian; published between January 2000 and March 2016. Of 264 hits, 13 guidelines-Belgium, Canada (3), Ireland, Italy, Japan, the Netherlands, Norway, Spain, Europe, and USA (2) were selected. 8 contained at least 9/10 recommendations published in the EAPC Framework; 9 recommended 'pre-emptive discussion of the potential role of sedation in end-of-life care'; 9 recommended 'nutrition/hydration while performing sedation' and 8 acknowledged the need to 'care for the medical team'. There were striking differences in terminologies used and in life expectancy preceding the practice. Selected guidelines were conceptually similar, comparing closely to the EAPC Framework recommendations, albeit with notable variations. Based on AGREE II, 3 guidelines achieved top scores and could therefore be recommended for use in this context. Also, domains 'scope and purpose' and 'editorial independence' ranked highest and lowest, respectively-underscoring the importance of good reportage at the developmental stage. 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/.

Development of clinical practice guidelines.

PubMed

Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard

2014-01-01

Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.

Clinical inertia, uncertainty and individualized guidelines.

PubMed

Reach, G

2014-09-01

Doctors often do not follow the guidelines of good practice based on evidence-based medicine, and this "clinical inertia" may represent an impediment to efficient care. The aims of this article are as follows: 1) to demonstrate that this phenomenon is often the consequence of a discrepancy between the technical rationality of evidence-based medicine and the modes of reasoning of physicians practiced in "real-life", which is marked by uncertainty and risk; 2) to investigate in this context the meaning of the recent, somewhat paradoxical, concept of "individualized guidelines"; and 3) to revisit the real, essentially pedagogical, place of guidelines in medical practice. Copyright © 2014. Published by Elsevier Masson SAS.