Have CONSORT guidelines improved the quality of reporting of randomised controlled trials published in public health dentistry journals?

PubMed

Savithra, Prakash; Nagesh, Lakshminarayan Shetty

2013-01-01

To assess a) whether the quality of reporting of randomised controlled trials (RCTs) has improved since the formulation of the Consolidated Standards of Reporting Trials (CONSORT) statement and b) whether there is any difference in reporting of RCTs between the selected public health dentistry journals. A hand search of the journals of public health dentistry was performed and four journals were identified for the study. They were Community Dentistry and Oral Epidemiology (CDOE), Community Dental Health (CDH), Journal of Public Health Dentistry (JPHD) and Oral Health and Preventive Dentistry (OHPD). A total of 114 RCTs published between 1990 and 2009 were selected. CONSORT guidelines were applied to each selected article in order to assess and determine any improvement since the publication of CONSORT guidelines. The chi-square test was employed to determine any statistical significant difference in quality of reporting of RCTs before and after the publication of the CONSORT guidelines. A comparison was also done to determine any statistically significant difference in quality of reporting of RCTs between the selected journals. Title, abstract, discussion and conclusion sections of the selected articles showed adherence to the CONSORT guidelines, whereas the compliance was poor with respect to the methodology section. The quality of reporting of RCTs is generally poor in public health dentistry journals. Overall, the quality of reporting has not substantially improved since the publication of CONSORT guidelines.

The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial.

PubMed

Vickrey, Barbara G; Mittman, Brian S; Connor, Karen I; Pearson, Marjorie L; Della Penna, Richard D; Ganiats, Theodore G; Demonte, Robert W; Chodosh, Joshua; Cui, Xinping; Vassar, Stefanie; Duan, Naihua; Lee, Martin

2006-11-21

Adherence to dementia guidelines is poor despite evidence that some guideline recommendations can improve symptoms and delay institutionalization of patients. To test the effectiveness of a dementia guideline-based disease management program on quality of care and outcomes for patients with dementia. Clinic-level, cluster randomized, controlled trial. 3 health care organizations collaborating with 3 community agencies in southern California. 18 primary care clinics and 408 patients with dementia age 65 years or older paired with 408 informal caregivers. Disease management program led by care managers and provided to 238 patient-caregiver pairs at 9 intervention clinics for more than 12 months. Adherence to 23 guideline recommendations (primary outcome) and receipt of community resources and patient and caregiver health and quality-of-care measures (secondary outcomes). The mean percentage of per-patient guideline recommendations to which care was adherent was significantly higher in the intervention group than in the usual care group (63.9% vs. 32.9%, respectively; adjusted difference, 30.1% [95% CI, 25.2% to 34.9%]; P < 0.001). Participants who received the intervention had higher care quality on 21 of 23 guidelines (P < or = 0.013 for all), and higher proportions received community agency assistance (P < or = 0.03) than those who received usual care. Patient health-related quality of life, overall quality of patient care, caregiving quality, social support, and level of unmet caregiving assistance needs were better for participants in the intervention group than for those in the usual care group (P < 0.05 for all). Caregiver health-related quality of life did not differ between the 2 groups. Participants were well-educated, were predominantly white, had a usual source of care, and were not institutionalized. Generalizability to other patients and geographic regions is unknown. Also, costs of a care management program under fee-for-service reimbursement may impede adoption. A dementia guideline-based disease management program led to substantial improvements in quality of care for patients with dementia. Current Controlled Trials identifier: ISRCTN72577751.

Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China

PubMed Central

2015-01-01

Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new “interim guidelines” for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs. PMID:25471126

Cluster-Randomized Trial of Personalized Site Performance Feedback in Get With The Guidelines-Heart Failure.

PubMed

DeVore, Adam D; Cox, Margueritte; Heidenreich, Paul A; Fonarow, Gregg C; Yancy, Clyde W; Eapen, Zubin J; Peterson, Eric D; Hernandez, Adrian F

2015-07-01

There is significant variation in the delivery of evidence-based care for patients with heart failure (HF), but there is limited evidence defining the best methods to improve the quality of care. We performed a cluster-randomized trial of personalized site performance feedback at 147 hospitals participating in the Get With The Guidelines-Heart Failure quality improvement program from October 2009 to March 2011. The intervention provided sites with specific data on their heart failure achievement and quality measures in addition to the usual Get With The Guidelines-Heart Failure tools. The primary outcome for our trial was improvement in site composite quality of care score. Overall, 73 hospitals (n=33 886 patients) received the intervention, whereas 74 hospitals (n=37 943 patients) did not. One year after the intervention, both the intervention and control arms had a similar mean change in percentage points in their composite quality score (absolute change, +0.31 [SE, 1.51] versus +3.18 [SE, 1.68] in control; P=0.21). Similarly, none of the individual achievement measures or quality measures improved more at intervention versus control hospitals. Our site-based intervention, which included personalized site feedback on adherence to quality metrics, was not able to elicit more quality improvement beyond that already associated with participation in the Get With The Guidelines-Heart Failure program. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00979264. © 2015 American Heart Association, Inc.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

WHO Expert Committee on specifications for pharmaceutical preparations.

PubMed

2010-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file.

76 FR 75467 - Approval and Promulgation of Air Quality Implementation Plans; Louisiana; Revisions To Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... Guidelines in Lieu of Regulations for Miscellaneous Metal Products Coatings, Plastic Parts Coatings, Auto and... Pleasure Craft portion of the Control Techniques Guidelines (CTG) for Miscellaneous Metal and Plastic Parts... and Plastic Parts Coatings regulations based on EPA's 2008 guidance titled ``Control Techniques...

THE UNITED STATES EPA CONCEPT FOR DERIVING WATER QUALITY GUIDELINES FOR RECREATIONAL WATERS

EPA Science Inventory

The guidelines developed by the US EPA for controlling the quality of recreational waters are based on protecting the health of swimmers and other recreationists who may be exposed to waters contaminated by human and animal excreta. Risks to swimmers were determined through a se...

European Guidelines for AP/PA chest X-rays: routinely satisfiable in a paediatric radiology division?

PubMed

Tschauner, Sebastian; Marterer, Robert; Gübitz, Michael; Kalmar, Peter I; Talakic, Emina; Weissensteiner, Sabine; Sorantin, Erich

2016-02-01

Accurate collimation helps to reduce unnecessary irradiation and improves radiographic image quality, which is especially important in the radiosensitive paediatric population. For AP/PA chest radiographs in children, a minimal field size (MinFS) from "just above the lung apices" to "T12/L1" with age-dependent tolerance is suggested by the 1996 European Commission (EC) guidelines, which were examined qualitatively and quantitatively at a paediatric radiology division. Five hundred ninety-eight unprocessed chest X-rays (45% boys, 55% girls; mean age 3.9 years, range 0-18 years) were analysed with a self-developed tool. Qualitative standards were assessed based on the EC guidelines, as well as the overexposed field size and needlessly irradiated tissue compared to the MinFS. While qualitative guideline recommendations were satisfied, mean overexposure of +45.1 ± 18.9% (range +10.2% to +107.9%) and tissue overexposure of +33.3 ± 13.3% were found. Only 4% (26/598) of the examined X-rays completely fulfilled the EC guidelines. This study presents a new chest radiography quality control tool which allows assessment of field sizes, distances, overexposures and quality parameters based on the EC guidelines. Utilising this tool, we detected inadequate field sizes, inspiration depths, and patient positioning. Furthermore, some debatable EC guideline aspects were revealed. • European Guidelines on X-ray quality recommend exposed field sizes for common examinations. • The major failing in paediatric radiographic imaging techniques is inappropriate field size. • Optimal handling of radiographic units can reduce radiation exposure to paediatric patients. • Constant quality control helps ensure optimal chest radiographic image acquisition in children.

Methods for the guideline-based development of quality indicators--a systematic review

PubMed Central

2012-01-01

Background Quality indicators (QIs) are used in many healthcare settings to measure, compare, and improve quality of care. For the efficient development of high-quality QIs, rigorous, approved, and evidence-based development methods are needed. Clinical practice guidelines are a suitable source to derive QIs from, but no gold standard for guideline-based QI development exists. This review aims to identify, describe, and compare methodological approaches to guideline-based QI development. Methods We systematically searched medical literature databases (Medline, EMBASE, and CINAHL) and grey literature. Two researchers selected publications reporting methodological approaches to guideline-based QI development. In order to describe and compare methodological approaches used in these publications, we extracted detailed information on common steps of guideline-based QI development (topic selection, guideline selection, extraction of recommendations, QI selection, practice test, and implementation) to predesigned extraction tables. Results From 8,697 hits in the database search and several grey literature documents, we selected 48 relevant references. The studies were of heterogeneous type and quality. We found no randomized controlled trial or other studies comparing the ability of different methodological approaches to guideline-based development to generate high-quality QIs. The relevant publications featured a wide variety of methodological approaches to guideline-based QI development, especially regarding guideline selection and extraction of recommendations. Only a few studies reported patient involvement. Conclusions Further research is needed to determine which elements of the methodological approaches identified, described, and compared in this review are best suited to constitute a gold standard for guideline-based QI development. For this research, we provide a comprehensive groundwork. PMID:22436067

40 CFR 426.12 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Fiberglass Subcategory § 426.12 Effluent limitations guidelines representing the degree of effluent reduction... limitations establish the quantity or quality of pollutants or pollutant properties which may be discharged by... limitations establish the quantity or quality of pollutants or pollutant properties, controlled by this...

40 CFR 426.12 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2011 CFR

2011-07-01

... Fiberglass Subcategory § 426.12 Effluent limitations guidelines representing the degree of effluent reduction... limitations establish the quantity or quality of pollutants or pollutant properties which may be discharged by... limitations establish the quantity or quality of pollutants or pollutant properties, controlled by this...

78 FR 34306 - Approval and Promulgation of Air Quality Implementation Plans: North Carolina; Control Techniques...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

... Promulgation of Air Quality Implementation Plans: North Carolina; Control Techniques Guidelines and Reasonably Available Control Technology AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY... Carolina's commitment associated with the conditional approval of its reasonably available control...

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.

76 FR 52917 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-24

... Large Appliance and Metal Furniture Coatings AGENCY: Environmental Protection Agency (EPA). ACTION... Techniques Guidelines (CTG) standards for large appliance and metal furniture coatings. In the Final Rules...; Pennsylvania; Adoption of Control Techniques Guidelines for Large Appliance and Metal Furniture Coatings...

Assessing Subjectivity in Sensor Data Post Processing via a Controlled Experiment

NASA Astrophysics Data System (ADS)

Jones, A. S.; Horsburgh, J. S.; Eiriksson, D.

2017-12-01

Environmental data collected by in situ sensors must be reviewed to verify validity, and conducting quality control often requires making edits in post processing to generate approved datasets. This process involves decisions by technicians, data managers, or data users on how to handle problematic data. Options include: removing data from a series, retaining data with annotations, and altering data based on algorithms related to adjacent data points or the patterns of data at other locations or of other variables. Ideally, given the same dataset and the same quality control guidelines, multiple data quality control technicians would make the same decisions in data post processing. However, despite the development and implementation of guidelines aimed to ensure consistent quality control procedures, we have faced ambiguity when performing post processing, and we have noticed inconsistencies in the practices of individuals performing quality control post processing. Technicians with the same level of training and using the same input datasets may produce different results, affecting the overall quality and comparability of finished data products. Different results may also be produced by technicians that do not have the same level of training. In order to assess the effect of subjective decision making by the individual technician on the end data product, we designed an experiment where multiple users performed quality control post processing on the same datasets using a consistent set of guidelines, field notes, and tools. We also assessed the effect of technician experience and training by conducting the same procedures with a group of novices unfamiliar with the data and the quality control process and compared their results to those generated by a group of more experienced technicians. In this presentation, we report our observations of the degree of subjectivity in sensor data post processing, assessing and quantifying the impacts of individual technician as well as technician experience on quality controlled data products.

Success, failures and costs of implementing standards in the USA--lessons for infection control.

PubMed

McGowan, J E

1995-06-01

In the US, extensive standards for performance and 'guidelines for practice' have been instituted by a number of governmental and non-governmental agencies. New governmental plans for health care depend heavily on practice guidelines, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has been especially enthusiastic about continuous quality improvement. Monitoring the appropriateness of care and altering physician practice appeals to insurance carriers and health care management organizations. Some initial data exist to show that the quality of health care has been enhanced by these regulations. The total cost for health care administration in 1990 in the USA was 24.8% of each hospital's spending for health care. Much of this was associated with spending for new initiatives in practice guidelines, physician profiling, quality assurance, and the like. Few data exist to show that the quality of health care or hospital infection control has been enhanced by these expenditures. Regulations and guidelines also have proliferated in infection control. Guides from the JCAHO have been expanded, and recent mandates from the Occupational Health and Safety Administration (OSHA) for protecting employees from blood-borne and respiratory pathogens promise to be especially costly for health care organizations to implement. Little data exist to show that the quality of infection control has been enhanced by these regulations. Standards are difficult to develop, because the science to back them up often is lacking, interpretation of validating data is imprecise, and inherent biological variation makes exceptions common. Seven lessons are important for those developing standards today. These include focusing on objective measures of the impact of the standard, clearly indicating the degree of scientific validity, making the development process inclusive, allowing for local variation, making sure that funding is provided for mandated standards, considering non-scientific implications of standards, and remaining involved in the process after the guideline is developed. Infection control workers should make sure that standards developed take the lessons above into account before they are promulgated.

Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline Update From the American College of Physicians.

PubMed

Qaseem, Amir; Barry, Michael J; Humphrey, Linda L; Forciea, Mary Ann

2017-02-21

The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on oral pharmacologic treatment of type 2 diabetes in adults. This guideline serves as an update to the 2012 ACP guideline on the same topic. This guideline is endorsed by the American Academy of Family Physicians. This guideline is based on a systematic review of randomized, controlled trials and observational studies published through December 2015 on the comparative effectiveness of oral medications for type 2 diabetes. Evaluated interventions included metformin, thiazolidinediones, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Study quality was assessed, data were extracted, and results were summarized qualitatively on the basis of the totality of evidence identified by using several databases. Evaluated outcomes included intermediate outcomes of hemoglobin A1c, weight, systolic blood pressure, and heart rate; all-cause mortality; cardiovascular and cerebrovascular morbidity and mortality; retinopathy, nephropathy, and neuropathy; and harms. This guideline grades the recommendations by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. The target audience for this guideline includes all clinicians, and the target patient population includes adults with type 2 diabetes. ACP recommends that clinicians prescribe metformin to patients with type 2 diabetes when pharmacologic therapy is needed to improve glycemic control. (Grade: strong recommendation; moderate-quality evidence). ACP recommends that clinicians consider adding either a sulfonylurea, a thiazolidinedione, an SGLT-2 inhibitor, or a DPP-4 inhibitor to metformin to improve glycemic control when a second oral therapy is considered. (Grade: weak recommendation; moderate-quality evidence.) ACP recommends that clinicians and patients select among medications after discussing benefits, adverse effects, and costs.

ASVCP guidelines: quality assurance for point-of-care testing in veterinary medicine.

PubMed

Flatland, Bente; Freeman, Kathleen P; Vap, Linda M; Harr, Kendal E

2013-12-01

Point-of-care testing (POCT) refers to any laboratory testing performed outside the conventional reference laboratory and implies close proximity to patients. Instrumental POCT systems consist of small, handheld or benchtop analyzers. These have potential utility in many veterinary settings, including private clinics, academic veterinary medical centers, the community (eg, remote area veterinary medical teams), and for research applications in academia, government, and industry. Concern about the quality of veterinary in-clinic testing has been expressed in published veterinary literature; however, little guidance focusing on POCT is available. Recognizing this void, the ASVCP formed a subcommittee in 2009 charged with developing quality assurance (QA) guidelines for veterinary POCT. Guidelines were developed through literature review and a consensus process. Major recommendations include (1) taking a formalized approach to POCT within the facility, (2) use of written policies, standard operating procedures, forms, and logs, (3) operator training, including periodic assessment of skills, (4) assessment of instrument analytical performance and use of both statistical quality control and external quality assessment programs, (5) use of properly established or validated reference intervals, (6) and ensuring accurate patient results reporting. Where possible, given instrument analytical performance, use of a validated 13s control rule for interpretation of control data is recommended. These guidelines are aimed at veterinarians and veterinary technicians seeking to improve management of POCT in their clinical or research setting, and address QA of small chemistry and hematology instruments. These guidelines are not intended to be all-inclusive; rather, they provide a minimum standard for maintenance of POCT instruments in the veterinary setting. © 2013 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.

Proposed quality control guidelines for antimicrobial susceptibility tests using tilmicosin.

PubMed Central

Shryock, T R; White, D W; Werner, C S; Staples, J M

1995-01-01

Quality control guidelines for tilmicosin, a novel veterinary-use-only macrolide, were developed in a multi-laboratory study according to established National Committee for Clinical Laboratory Standards (NCCLS) procedures (M23-T2). Tilmicosin was incorporated into Sensititre plates for broth microdilution endpoint testing and into two lots of 15-micrograms disks for Kirby-Bauer agar disk diffusion testing. One common lot and five unique lots of Mueller-Hinton media were used. (Broth was cation adjusted, and agar was supplemented with 5% defibrinated sheep blood.) Bacteria used for reference strains included Pasteurella haemolytica 128K, Pasteurella multocida ATCC 43137, and Staphylococcus aureus ATCC 29213 (microdilution) and ATCC 25923 (disk). Replicate tests were conducted. Disk diffusion and broth microdilution quality control ranges are proposed. PMID:7714188

Do Clinical Standards for Diabetes Care Address Excess Risk for Hypoglycemia in Vulnerable Patients? A Systematic Review

PubMed Central

Berkowitz, Seth A; Aragon, Katherine; Hines, Jonas; Seligman, Hilary; Lee, Sei; Sarkar, Urmimala

2013-01-01

Objective To determine whether diabetes clinical standards consider increased hypoglycemia risk in vulnerable patients. Data Sources MEDLINE, the National Guidelines Clearinghouse, the National Quality Measures Clearinghouse, and supplemental sources. Study Design Systematic review of clinical standards (guidelines, quality metrics, or pay-for-performance programs) for glycemic control in adult diabetes patients. The primary outcome was discussion of increased risk for hypoglycemia in vulnerable populations. Data Collection/Extraction Methods Manuscripts identified were abstracted by two independent reviewers using prespecified inclusion/exclusion criteria and a standardized abstraction form. Principal Findings We screened 1,166 titles, and reviewed 220 manuscripts in full text. Forty-four guidelines, 17 quality metrics, and 8 pay-for-performance programs were included. Five (11 percent) guidelines and no quality metrics or pay-for-performance programs met the primary outcome. Conclusions Clinical standards do not substantively incorporate evidence about increased risk for hypoglycemia in vulnerable populations. PMID:23445498

PREPARE: guidelines for planning animal research and testing

PubMed Central

Smith, Adrian J; Clutton, R Eddie; Lilley, Elliot; Hansen, Kristine E Aa; Brattelid, Trond

2017-01-01

There is widespread concern about the quality, reproducibility and translatability of studies involving research animals. Although there are a number of reporting guidelines available, there is very little overarching guidance on how to plan animal experiments, despite the fact that this is the logical place to start ensuring quality. In this paper we present the PREPARE guidelines: Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. PREPARE covers the three broad areas which determine the quality of the preparation for animal studies: formulation, dialogue between scientists and the animal facility, and quality control of the various components in the study. Some topics overlap and the PREPARE checklist should be adapted to suit specific needs, for example in field research. Advice on use of the checklist is available on the Norecopa website, with links to guidelines for animal research and testing, at https://norecopa.no/PREPARE. PMID:28771074

Do clinical standards for diabetes care address excess risk for hypoglycemia in vulnerable patients? A systematic review.

PubMed

Berkowitz, Seth A; Aragon, Katherine; Hines, Jonas; Seligman, Hilary; Lee, Sei; Sarkar, Urmimala

2013-08-01

To determine whether diabetes clinical standards consider increased hypoglycemia risk in vulnerable patients. MEDLINE, the National Guidelines Clearinghouse, the National Quality Measures Clearinghouse, and supplemental sources. Systematic review of clinical standards (guidelines, quality metrics, or pay-for-performance programs) for glycemic control in adult diabetes patients. The primary outcome was discussion of increased risk for hypoglycemia in vulnerable populations. Manuscripts identified were abstracted by two independent reviewers using prespecified inclusion/exclusion criteria and a standardized abstraction form. We screened 1,166 titles, and reviewed 220 manuscripts in full text. Forty-four guidelines, 17 quality metrics, and 8 pay-for-performance programs were included. Five (11 percent) guidelines and no quality metrics or pay-for-performance programs met the primary outcome. Clinical standards do not substantively incorporate evidence about increased risk for hypoglycemia in vulnerable populations. © Health Research and Educational Trust.

PREPARE: guidelines for planning animal research and testing.

PubMed

Smith, Adrian J; Clutton, R Eddie; Lilley, Elliot; Hansen, Kristine E Aa; Brattelid, Trond

2018-04-01

There is widespread concern about the quality, reproducibility and translatability of studies involving research animals. Although there are a number of reporting guidelines available, there is very little overarching guidance on how to plan animal experiments, despite the fact that this is the logical place to start ensuring quality. In this paper we present the PREPARE guidelines: Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. PREPARE covers the three broad areas which determine the quality of the preparation for animal studies: formulation, dialogue between scientists and the animal facility, and quality control of the various components in the study. Some topics overlap and the PREPARE checklist should be adapted to suit specific needs, for example in field research. Advice on use of the checklist is available on the Norecopa website, with links to guidelines for animal research and testing, at https://norecopa.no/PREPARE .

Commercial jet fuel quality control

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

Strauss, K.H.

1995-05-01

The paper discusses the purpose of jet fuel quality control between the refinery and the aircraft. It describes fixed equipment, including various types of filters, and the usefulness and limitations of this equipment. Test equipment is reviewed as are various surveillance procedures. These include the Air Transport Association specification ATA 103, the FAA Advisory Circular 150/5230-4, the International Air Transport Association Guidance Material for Fuel Quality Control and Fuelling Service and the Guidelines for Quality Control at Jointly Operated Fuel Systems. Some past and current quality control problems are briefly mentioned.

WHO Expert Committee on Biological Standardization.

PubMed

2002-01-01

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and quality control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on issues relevant to international guidelines, recommendations and other matters related to the manufacture and quality control of biologicals. This is followed by information on the status and development of reference materials for bovine spongiform encephalopathy, various antigens, blood products, cytokines, growth factors and endocrinological substances. The second part of the report, of particular interest to manufacturers and national control authorities, contains sets of recommendations for the production and control of poliomyelitis vaccine (oral) and poliomyelitis vaccine (inactivated) and guidelines for the production and control of live attenuated Japanese encephalitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine, and other relevant documents.

Quality of the written radiology report: a review of the literature.

PubMed

Pool, Felicity; Goergen, Stacy

2010-08-01

A literature review was carried out, guided by the question, What are the important elements of a high-quality radiology written report? Two papers known to the authors were used as a basis for 5 PubMed search strategies. Exclusion criteria were applied to retrieved citations. Reference lists of retrieved citations were scanned for additional relevant papers and exclusion criteria applied to these. Web sites of professional radiology organizations were scanned for guidelines relating to the written radiology report. Retrieved guidelines were appraised using the Appraisal of Guidelines for Research & Evaluation instrument. Methodologies of retrieved papers were not suitable for conventional appraisal, and an evidence table was constructed. The search strategy identified 25 published papers and 4 guidelines. Published study methodologies included 1 randomized controlled trial; 1 before-and-after study of interventions; 10 observational studies, audits, or analyses; 12 surveys; and 1 narrative review of the literature. Existing guidelines have a number of weaknesses with regard to scope and purpose, methods of development, stakeholder consultation, and editorial independence and applicability. There is a major gap in published studies relating to testing of interventions to improve report quality using conventional randomized controlled trial methods. Published studies and guidelines generally support report content, including clinical history, examination quality, description of findings, comparison, and diagnosis. Important report attributes include accuracy, clarity, and certainty. There is wide variation in the language used to describe imaging findings and diagnostic certainty. Survey participants strongly preferred reports with structured or itemized formats, but few studies exist regarding the effect of report structure on quality. Copyright 2010 American College of Radiology. Published by Elsevier Inc. All rights reserved.

An Overview of Controls and Flying Qualities Technology on the F/A-18 High Alpha Research Vehicle

NASA Technical Reports Server (NTRS)

Pahle, Joseph W.; Wichman, Keith D.; Foster, John V.; Bundick, W. Thomas

1996-01-01

The NASA F/A-18 High Alpha Research Vehicle (HARV) has been the flight test bed of a focused technology effort to significantly increase maneuvering capability at high angles of attack. Development and flight test of control law design methodologies, handling qualities metrics, performance guidelines, and flight evaluation maneuvers are described. The HARV has been modified to include two research control effectors, thrust vectoring, and actuated forebody strakes in order to provide increased control power at high angles of attack. A research flight control system has been used to provide a flexible, easily modified capability for high-angle-of-attack research controls. Different control law design techniques have been implemented and flight-tested, including eigenstructure assignment, variable gain output feedback, pseudo controls, and model-following. Extensive piloted simulation has been used to develop nonlinear performance guide-lines and handling qualities criteria for high angles of attack. This paper reviews the development and evaluation of technologies useful for high-angle-of-attack control. Design, development, and flight test of the research flight control system, control laws, flying qualities specifications, and flight test maneuvers are described. Flight test results are used to illustrate some of the lessons learned during flight test and handling qualities evaluations.

Multifamily Quality Control Inspector Job/Task Analysis and Report: September 2013

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

Owens, C. M.

The development of job/task analyses (JTAs) is one of three components of the Guidelines for Home Energy Professionals project and will allow industry to develop training resources, quality assurance protocols, accredited training programs, and professional certifications. The Multifamily Quality Control Inspector JTA identifies and catalogs all of the tasks performed by multifamily quality control inspectors, as well as the knowledge, skills, and abilities (KSAs) needed to perform the identified tasks.

An adaptive toolkit for image quality evaluation in system performance test of digital breast tomosynthesis

NASA Astrophysics Data System (ADS)

Zhang, Guozhi; Petrov, Dimitar; Marshall, Nicholas; Bosmans, Hilde

2017-03-01

Digital breast tomosynthesis (DBT) is a relatively new diagnostic imaging modality for women. Currently, various models of DBT systems are available on the market and the number of installations is rapidly increasing. EUREF, the European Reference Organization for Quality Assured Breast Screening and Diagnostic Services, has proposed a preliminary Guideline - protocol for the quality control of the physical and technical aspects of digital breast tomosynthesis systems, with an ultimate aim of providing limiting values guaranteeing proper performance for different applications of DBT. In this work, we introduce an adaptive toolkit developed in accordance with this guideline to facilitate the process of image quality evaluation in DBT performance test. This toolkit implements robust algorithms to quantify various technical parameters of DBT images and provides a convenient user interface in practice. Each test is built into a separate module with configurations set corresponding to the European guideline, which can be easily adapted to different settings and extended with additional tests. This toolkit largely improves the efficiency for image quality evaluation of DBT. It is also going to evolve with the development of protocols in quality control of DBT systems.

Guidance for Efficient Small Animal Imaging Quality Control.

PubMed

Osborne, Dustin R; Kuntner, Claudia; Berr, Stuart; Stout, David

2017-08-01

Routine quality control is a critical aspect of properly maintaining high-performance small animal imaging instrumentation. A robust quality control program helps produce more reliable data both for academic purposes and as proof of system performance for contract imaging work. For preclinical imaging laboratories, the combination of costs and available resources often limits their ability to produce efficient and effective quality control programs. This work presents a series of simplified quality control procedures that are accessible to a wide range of preclinical imaging laboratories. Our intent is to provide minimum guidelines for routine quality control that can assist preclinical imaging specialists in setting up an appropriate quality control program for their facility.

Guidelines for the detection of Trichinella larvae at the slaughterhouse in a quality assurance system.

PubMed

Rossi, Patrizia; Pozio, Edoardo

2008-01-01

The European Community Regulation (EC) No. 2075/2005 lays down specific rules on official controls for the detection of Trichinella in fresh meat for human consumption, recommending the pooled-sample digestion method as the reference method. The aim of this document is to provide specific guidance to implement an appropriate Trichinella digestion method by a laboratory accredited according to the ISO/IEC 17025:2005 international standard, and performing microbiological testing following the EA-04/10:2002 international guideline. Technical requirements for the correct implementation of the method, such as the personnel competence, specific equipments and reagents, validation of the method, reference materials, sampling, quality assurance of results and quality control of performance are provided, pointing out the critical control points for the correct implementation of the digestion method.

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.

Stakeholder-Driven Quality Improvement: A Compelling Force for Clinical Practice Guidelines.

PubMed

Rosenfeld, Richard M; Wyer, Peter C

2018-01-01

Clinical practice guideline development should be driven by rigorous methodology, but what is less clear is where quality improvement enters the process: should it be a priority-guiding force, or should it enter only after recommendations are formulated? We argue for a stakeholder-driven approach to guideline development, with an overriding goal of quality improvement based on stakeholder perceptions of needs, uncertainties, and knowledge gaps. In contrast, the widely used topic-driven approach, which often makes recommendations based only on randomized controlled trials, is driven by epidemiologic purity and evidence rigor, with quality improvement a downstream consideration. The advantages of a stakeholder-driven versus a topic-driven approach are highlighted by comparisons of guidelines for otitis media with effusion, thyroid nodules, sepsis, and acute bacterial rhinosinusitis. These comparisons show that stakeholder-driven guidelines are more likely to address the quality improvement needs and pressing concerns of clinicians and patients, including understudied populations and patients with multiple chronic conditions. Conversely, a topic-driven approach often addresses "typical" patients, based on research that may not reflect the needs of high-risk groups excluded from studies because of ethical issues or a desire for purity of research design.

Implementing guidelines in nursing homes: a systematic review.

PubMed

Diehl, Heinz; Graverholt, Birgitte; Espehaug, Birgitte; Lund, Hans

2016-07-25

Research on guideline implementation strategies has mostly been conducted in settings which differ significantly from a nursing home setting and its transferability to the nursing home setting is therefore limited. The objective of this study was to systematically review the effects of interventions to improve the implementation of guidelines in nursing homes. A systematic literature search was conducted in the Cochrane Library, CINAHL, Embase, MEDLINE, DARE, HTA, CENTRAL, SveMed + and ISI Web of Science from their inception until August 2015. Reference screening and a citation search were performed. Studies were eligible if they evaluated any type of guideline implementation strategy in a nursing home setting. Eligible study designs were systematic reviews, randomised controlled trials, non-randomised controlled trials, controlled before-after studies and interrupted-time-series studies. The EPOC risk of bias tool was used to evaluate the risk of bias in the included studies. The overall quality of the evidence was rated using GRADE. Five cluster-randomised controlled trials met the inclusion criteria, evaluating a total of six different multifaceted implementation strategies. One study reported a small statistically significant effect on professional practice, and two studies demonstrated small to moderate statistically significant effects on patient outcome. The overall quality of the evidence for all comparisons was low or very low using GRADE. Little is known about how to improve the implementation of guidelines in nursing homes, and the evidence to support or discourage particular interventions is inconclusive. More implementation research is needed to ensure high quality of care in nursing homes. PROSPERO 2014: CRD42014007664.

Evaluating an integrated approach to clinical quality improvement: clinical guidelines, quality measurement, and supportive system design.

PubMed

Cretin, S; Farley, D O; Dolter, K J; Nicholas, W

2001-08-01

Implementing clinical practice guidelines to change patient outcomes presents a challenge. Studies of single interventions focused on changing provider behavior demonstrate modest effects, suggesting that effective guideline implementation requires a multifaceted approach. Traditional biomedical research designs are not well suited to evaluating systems interventions. RAND and the Army Medical Department collaborated to develop and evaluate a system for implementing guidelines and documenting their effects on patient care. The evaluation design blended quality improvement, case study, and epidemiologic methods. A formative evaluation of implementation process and an outcome evaluation of patient impact were combined. Guidelines were implemented in 3 successive demonstrations targeting low back pain, asthma, and diabetes. This paper reports on the first wave of 4 facilities implementing a low back pain guideline. Organizational climate and culture, motivation, leadership commitment, and resources were assessed. Selected indicators of processes and outcomes of care were compared before, during, and after guideline implementation at the demonstration facilities and at comparison facilities. Logistic regression analysis was used to test for guideline effects on patient care. Process evaluation documented varied approaches to quality improvement across sites. Outcome evaluation revealed a significant downward trend in the percentage of acute low back pain patients referred to physical therapy or chiropractic care (10.7% to 7.2%) at demonstration sites and no such trend at control sites. Preliminary results suggest the power of this design to stimulate improvements in guideline implementation while retaining the power to evaluate rigorously effects on patient care.

24 CFR 200.935 - Administrator qualifications and procedures for HUD building products certification programs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... guidelines in any quality assurance review: (1) ASQC Q9000-1-1994 Quality Management and Quality Assurance... Systems—Model for Quality Assurance in Final Inspection and Test; (5) ASQC Q9004-1-1994 Quality Management... in interpreting testing standards, test methods, evaluating test reports and quality control programs...

Quality assurance program guidelines for application to and use by manufacturers of rail/guideway vehicles, buses, automatic train control systems, and their major subsystems

NASA Technical Reports Server (NTRS)

Witkin, S. A.

1976-01-01

Guidelines are presented for a quality assurance system to be implemented by the manufacturer in support of designing, developing, fabricating, assembling, inspecting, testing, handling, and delivery of equipment being procured for use in public urban mass transit systems. The guidelines apply to this equipment when being procured for: (1) use in revenue service; (2) demonstration of systems that will be revenue producing or used by the public; (3) use as a prototype for follow-on operational/revenue producing equipment procurements; and (4) qualification tests.

BATHING BEACH MONITORING PROTOCOLS/COMMUNICATING SWIMMING ACTIVITY RISK TO THE PUBLIC

EPA Science Inventory

Current Environmental Protection Agency (EPA) recommended monitoring practices for bathing beach water quality were suggested in 1968, as a part of the fecal coliform guideline developed by the Federal Water Pollution Control Administration. The guideline stated that five water ...

Contributions of CCLM to advances in quality control.

PubMed

Kazmierczak, Steven C

2013-01-01

Abstract The discipline of laboratory medicine is relatively young when considered in the context of the history of medicine itself. The history of quality control, within the context of laboratory medicine, also enjoys a relatively brief, but rich history. Laboratory quality control continues to evolve along with advances in automation, measurement techniques and information technology. Clinical Chemistry and Laboratory Medicine (CCLM) has played a key role in helping disseminate information about the proper use and utility of quality control. Publication of important advances in quality control techniques and dissemination of guidelines concerned with laboratory quality control has undoubtedly helped readers of this journal keep up to date on the most recent developments in this field.

77 FR 58953 - Approval and Promulgation of Air Quality Implementation Plans; Delaware; Control Technique...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-25

... Promulgation of Air Quality Implementation Plans; Delaware; Control Technique Guidelines for Plastic Parts... categories: Plastic Parts, Metal Furniture, Large Appliances, and Miscellaneous Metal Parts. EPA is approving... Compounds, sections 2.0 ``Definitions,'' 12.0 ``Surface Coating of Plastic Parts,'' 19.0 ``Coating of Metal...

The NCS code of practice for the quality assurance and control for volumetric modulated arc therapy

NASA Astrophysics Data System (ADS)

Mans, Anton; Schuring, Danny; Arends, Mark P.; Vugts, Cornelia A. J. M.; Wolthaus, Jochem W. H.; Lotz, Heidi T.; Admiraal, Marjan; Louwe, Rob J. W.; Öllers, Michel C.; van de Kamer, Jeroen B.

2016-10-01

In 2010, the NCS (Netherlands Commission on Radiation Dosimetry) installed a subcommittee to develop guidelines for quality assurance and control for volumetric modulated arc therapy (VMAT) treatments. The report (published in 2015) has been written by Dutch medical physicists and has therefore, inevitably, a Dutch focus. This paper is a condensed version of these guidelines, the full report in English is freely available from the NCS website www.radiationdosimetry.org. After describing the transition from IMRT to VMAT, the paper addresses machine quality assurance (QA) and treatment planning system (TPS) commissioning for VMAT. The final section discusses patient specific QA issues such as the use of class solutions, measurement devices and dose evaluation methods.

ENVIRONMENTAL MONITORING FOR PUBLIC ACCESS AND COMMUNITY TRACKING (EMPACT) PROGRAM MICROBIOLOGICAL MONITORING OF RECREATIONAL WATER

EPA Science Inventory

Current Environmental Protection Agency (EPA) recommended microbiological monitoring practices for bathing beach water quality were suggested in 1968, as a part of the fecal coliform guideline developed by the Federal Water Pollution Control Administration. The guideline stated ...

Evaluating the Good Ontology Design Guideline (GoodOD) with the Ontology Quality Requirements and Evaluation Method and Metrics (OQuaRE)

PubMed Central

Duque-Ramos, Astrid; Boeker, Martin; Jansen, Ludger; Schulz, Stefan; Iniesta, Miguela; Fernández-Breis, Jesualdo Tomás

2014-01-01

Objective To (1) evaluate the GoodOD guideline for ontology development by applying the OQuaRE evaluation method and metrics to the ontology artefacts that were produced by students in a randomized controlled trial, and (2) informally compare the OQuaRE evaluation method with gold standard and competency questions based evaluation methods, respectively. Background In the last decades many methods for ontology construction and ontology evaluation have been proposed. However, none of them has become a standard and there is no empirical evidence of comparative evaluation of such methods. This paper brings together GoodOD and OQuaRE. GoodOD is a guideline for developing robust ontologies. It was previously evaluated in a randomized controlled trial employing metrics based on gold standard ontologies and competency questions as outcome parameters. OQuaRE is a method for ontology quality evaluation which adapts the SQuaRE standard for software product quality to ontologies and has been successfully used for evaluating the quality of ontologies. Methods In this paper, we evaluate the effect of training in ontology construction based on the GoodOD guideline within the OQuaRE quality evaluation framework and compare the results with those obtained for the previous studies based on the same data. Results Our results show a significant effect of the GoodOD training over developed ontologies by topics: (a) a highly significant effect was detected in three topics from the analysis of the ontologies of untrained and trained students; (b) both positive and negative training effects with respect to the gold standard were found for five topics. Conclusion The GoodOD guideline had a significant effect over the quality of the ontologies developed. Our results show that GoodOD ontologies can be effectively evaluated using OQuaRE and that OQuaRE is able to provide additional useful information about the quality of the GoodOD ontologies. PMID:25148262

Evaluating the Good Ontology Design Guideline (GoodOD) with the ontology quality requirements and evaluation method and metrics (OQuaRE).

PubMed

Duque-Ramos, Astrid; Boeker, Martin; Jansen, Ludger; Schulz, Stefan; Iniesta, Miguela; Fernández-Breis, Jesualdo Tomás

2014-01-01

To (1) evaluate the GoodOD guideline for ontology development by applying the OQuaRE evaluation method and metrics to the ontology artefacts that were produced by students in a randomized controlled trial, and (2) informally compare the OQuaRE evaluation method with gold standard and competency questions based evaluation methods, respectively. In the last decades many methods for ontology construction and ontology evaluation have been proposed. However, none of them has become a standard and there is no empirical evidence of comparative evaluation of such methods. This paper brings together GoodOD and OQuaRE. GoodOD is a guideline for developing robust ontologies. It was previously evaluated in a randomized controlled trial employing metrics based on gold standard ontologies and competency questions as outcome parameters. OQuaRE is a method for ontology quality evaluation which adapts the SQuaRE standard for software product quality to ontologies and has been successfully used for evaluating the quality of ontologies. In this paper, we evaluate the effect of training in ontology construction based on the GoodOD guideline within the OQuaRE quality evaluation framework and compare the results with those obtained for the previous studies based on the same data. Our results show a significant effect of the GoodOD training over developed ontologies by topics: (a) a highly significant effect was detected in three topics from the analysis of the ontologies of untrained and trained students; (b) both positive and negative training effects with respect to the gold standard were found for five topics. The GoodOD guideline had a significant effect over the quality of the ontologies developed. Our results show that GoodOD ontologies can be effectively evaluated using OQuaRE and that OQuaRE is able to provide additional useful information about the quality of the GoodOD ontologies.

Sci-Fri AM: Quality, Safety, and Professional Issues 01: CPQR Technical Quality Control Suite Development including Quality Control Workload Results

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

Malkoske, Kyle; Nielsen, Michelle; Brown, Erika

A close partnership between the Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) has resulted in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. The framework includes consolidation of existing guidelines and/or literature by expert reviewers, structured stages of public review, external field-testing and ratification by COMP. The adopted framework for the development and maintenance of themore » TQCs ensures the guidelines incorporate input from the medical physics community during development, measures the workload required to perform the QC tests outlined in each TQC, and remain relevant (i.e. “living documents”) through subsequent planned reviews and updates. This presentation will show the Multi-Leaf Linear Accelerator document as an example of how feedback and cross-national work to achieve a robust guidance document. During field-testing, each technology was tested at multiple centres in a variety of clinic environments. As part of the defined feedback, workload data was captured. This lead to average time associated with testing as defined in each TQC document. As a result, for a medium-sized centre comprising 6 linear accelerators and a comprehensive brachytherapy program, we evaluate the physics workload to 1.5 full-time equivalent physicist per year to complete all QC tests listed in this suite.« less

Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.

PubMed

Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na

2015-08-26

The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

Guidelines for software inspections

NASA Technical Reports Server (NTRS)

1983-01-01

Quality control inspections are software problem finding procedures which provide defect removal as well as improvements in software functionality, maintenance, quality, and development and testing methodology is discussed. The many side benefits include education, documentation, training, and scheduling.

Developing a Reporting Guideline for Social and Psychological Intervention Trials

PubMed Central

Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean

2013-01-01

Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/consort-study). PMID:23947317

Use of cardiocerebral resuscitation or AHA/ERC 2005 Guidelines is associated with improved survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis.

PubMed

Salmen, Marcus; Ewy, Gordon A; Sasson, Comilla

2012-01-01

To determine whether the use of cardiocerebral resuscitation (CCR) or AHA/ERC 2005 Resuscitation Guidelines improved patient outcomes from out-of-hospital cardiac arrest (OHCA) compared to older guidelines. Systematic review and meta-analysis. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases. We also hand-searched study references and consulted experts. Design: randomised controlled trials and observational studies. OHCA patients, age >17 years. 'Control' protocol versus 'Study' protocol. 'Control' protocol defined as AHA/ERC 2000 Guidelines for cardiopulmonary resuscitation (CPR). 'Study' protocol defined as AHA/ERC 2005 Guidelines for CPR, or a CCR protocol. Survival to hospital discharge. High-quality or medium-quality studies, as measured by the Newcastle Ottawa Scale using predefined categories. Twelve observational studies met inclusion criteria. All the three studies using CCR demonstrated significantly improved survival compared to use of AHA 2000 Guidelines, as did five of the nine studies using AHA/ERC 2005 Guidelines. Pooled data demonstrate that use of a CCR protocol has an unadjusted OR of 2.26 (95% CI 1.64 to 3.12) for survival to hospital discharge among all cardiac arrest patients. Among witnessed ventricular fibrillation/ventricular tachycardia (VF/VT) patients, CCR increased survival by an OR of 2.98 (95% CI 1.92 to 4.62). Studies using AHA/ERC 2005 Guidelines showed an overall trend towards increased survival, but significant heterogeneity existed among these studies. We demonstrate an association with improved survival from OHCA when CCR protocols or AHA/ERC 2005 Guidelines are compared to use of older guidelines. In the subgroup of patients with witnessed VF/VT, there was a threefold increase in OHCA survival when CCR was used. CCR appears to be a promising resuscitation protocol for Emergency Medical Services providers in increasing survival from OHCA. Future research will need to be conducted to directly compare AHA/ERC 2010 Guidelines with the CCR approach.

A Framework for a Quality Control System for Vendor/Processor Contracts.

ERIC Educational Resources Information Center

Advanced Technology, Inc., Reston, VA.

A framework for monitoring quality control (QC) of processor contracts administered by the Department of Education's Office of Student Financial Assistance (OSFA) is presented and applied to the Pell Grant program. Guidelines for establishing QC measures and standards are included, and the uses of a sampling procedure in the QC system are…

Quality of Diagnosis and Treatment Plans After Using the 'Diagnostic Guideline for Anxiety and Challenging Behaviours' in People with Intellectual Disabilities: A Comparative Multiple Case Study Design.

PubMed

Pruijssers, Addy; van Meijel, Berno; Maaskant, Marian; Keeman, Noortje; van Achterberg, Theo

2016-07-01

People with intellectual disabilities often have a multitude of concurrent problems due to the combination of cognitive impairments, psychiatric disorders (particularly anxiety) and related challenging behaviours. Diagnoses in people with intellectual disabilities are complicated. This study evaluates the quality of the diagnoses and treatment plans after using a guideline that was developed to support professionals in their diagnostic tasks. A comparative multiple case study with an experimental and control condition, applying deductive analyses of diagnoses and treatment plans. The analyses revealed that the number of diagnostic statements and planned treatment actions in the experimental group was significantly larger and more differentiated than in the control condition. In the control group, consequential harm and protective factors were hardly mentioned in diagnoses and treatment plans. Working with the 'Diagnostic Guideline for Anxiety and CB' leads to improved diagnoses and treatment plans compared with care as usual. © 2015 John Wiley & Sons Ltd.

75 FR 81555 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Allegheny County's...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

... Techniques Guidelines for Large Appliance and Metal Furniture; Flat Wood Paneling; Paper, Film, and Foil... appliance and metal furniture; flat wood paneling; and paper, film, and foil surface coating processes. In... Control Techniques Guidelines for Large Appliance and Metal Furniture; Flat Wood Paneling; Paper, Film...

40 CFR 426.123 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS GLASS MANUFACTURING POINT SOURCE CATEGORY Incandescent Lamp... quality of pollutants or pollutant properties, controlled by this section, which may be discharged by a... technology economically achievable: (a) [Reserved] (b) Any manufacturing plant which frosts incandescent lamp...

Bel Marin Keys Unit V Expansion of the Hamilton Wetland Restoration Project. Volume 3. Responses to Comments, Final Supplemental Environmental Impact Report/Environmental Impact Statement

DTIC Science & Technology

2003-04-01

include a program for implementing new development and construction site storm water quality controls. The objective of this component is to ensure...impacts (see Storm Water Quality Control, below). The Regional Board has adopted U.S. EPA’s Clean Water Act Section 404(b)(1) "Guidelines for...other Waters of the State. Storm Water Quality Control Storm water is the major source of fresh water to creeks and waterways. Storm water quality is

Measure Guideline. Steam System Balancing and Tuning for Multifamily Residential Buildings

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

Choi, Jayne; Ludwig, Peter; Brand, Larry

2013-04-01

This guideline provides building owners, professionals involved in multifamily audits, and contractors insights for improving the balance and tuning of steam systems. It provides readers an overview of one-pipe steam heating systems, guidelines for evaluating steam systems, typical costs and savings, and guidelines for ensuring quality installations. It also directs readers to additional resources for details not included here. Measures for balancing a distribution system that are covered include replacing main line vents and upgrading radiator vents. Also included is a discussion on upgrading boiler controls and the importance of tuning the settings on new or existing boiler controls. Themore » guideline focuses on one-pipe steam systems, though many of the assessment methods can be generalized to two-pipe steam systems.« less

Endorsement for improving the quality of reports on randomized controlled trials of traditional medicine journals in Korea: a systematic review.

PubMed

Choi, Jiae; Jun, Ji Hee; Kang, Byoung Kab; Kim, Kun Hyung; Lee, Myeong Soo

2014-11-05

The aim of this study was to assess the endorsement of reporting guidelines in Korean traditional medicine (TM) journals by reviewing their instructions to authors. We examined the instructions to authors in all of the TM journals published in Korea to assess the appropriate use of reporting guidelines for research studies. The randomized controlled trials (RCTs) published after 2010 in journals that endorsed reporting guidelines were obtained. The reporting quality was assessed using the following guidelines: the 38-item Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological trials (NPT); the 17-item Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) statement, instead of the 5-item CONSORT for acupuncture trials; and the 22-item CONSORT extensions for herbal medicine trials. The overall item score was calculated and expressed as a proportion.One journal that endorsed reporting guidelines was identified. Twenty-nine RCTs published in this journal after 2010 met the selection criteria. General editorial policies such as those of the International Committee of Medical Journal Editors (ICMJE) were endorsed by 15 journals. In each of the CONSORT-NPT articles, 21.6 to 56.8% of the items were reported, with an average of 11.3 items (29.7%) being reported. In the 24 RCTs (24/29, 82.8%) appraised using the STRICTA items, an average of 10.6 items (62.5%) were addressed, with a range of 41.2 to 100%. For the herbal intervention reporting, 17 items (77.27%) were reported. In the RCT studies before and after the endorsement of CONSORT and STRICTA guidelines by each journal, all of the STRICTA items had significant improvement, whereas the CONSORT-NPT items improved without statistical significance.The endorsement of reporting guidelines is limited in the TM journals in Korea. Authors should adhere to the reporting guidelines, and editorial departments should refer authors to the various reporting guidelines to improve the quality of their articles.

Adapting clinical guidelines in low‐resources countries: a study on the guideline on the management and prevention of type 2 diabetes mellitus in Indonesia

PubMed Central

Wangge, Grace; van der Graaf, Yolanda; van der Heijden, Geert J. M. G.

2016-01-01

Abstract Rationale, aims and objectives Most of the clinical guidelines in low‐resource countries are adaptations from preexisting international guidelines. This adaptation can be problematic when those international guidelines are not based on current evidence or original evidence‐based international guidelines are not followed. This study aims to evaluate the quality of an Indonesian type 2 diabetes mellitus guideline adapted from selected international guidelines. Methods The “Consensus on the Management and Prevention of type 2 Diabetes in Indonesia 2011” is a guideline by the Indonesian Society of Endocrinology (Perkeni). Four parent guidelines identified from its list of references were from the International Diabetes Federation (IDF), American Association of Clinical Endocrinologist (AACE), American Diabetes Association (ADA), and one jointly released by ADA and European Association for the Study of Diabetes (EASD). Two reviewers independently assessed its quality using the Appraisal of Guidelines, Research and Evaluation Collaboration (AGREE II) instrument. Six recommendations were compared: (1) screening for diabetes; (2) diagnosis; (3) control of hyperglycemia; (4) target blood glucose; (5) target blood pressure; and (6) treatment of dyslipidemia. Results Perkeni's guideline satisfied 55% of the AGREE II items, while its parent guidelines satisfied 59% to 74%. Perkeni's shows low score on “rigor of development” and “applicability” and the lowest score in the “scope and purpose” domain. Differences were found in 4 recommendations: the screening of diabetes, control of hyperglycemia, target blood glucose, and treatment of dyslipidemia. In 3 of 4, Perkeni followed the ADA's recommendation. Conclusion Derivation of recommendations from parent guidelines and their adaptation to the context of Indonesian health care lacks transparency. When guidelines are either derived from other guidelines or adapted for use in different context, evidence‐based practice principles should be followed and adhered to. PMID:27592587

Adapting clinical guidelines in low-resources countries: a study on the guideline on the management and prevention of type 2 diabetes mellitus in Indonesia.

PubMed

Widyahening, Indah S; Wangge, Grace; van der Graaf, Yolanda; van der Heijden, Geert J M G

2017-02-01

Most of the clinical guidelines in low-resource countries are adaptations from preexisting international guidelines. This adaptation can be problematic when those international guidelines are not based on current evidence or original evidence-based international guidelines are not followed. This study aims to evaluate the quality of an Indonesian type 2 diabetes mellitus guideline adapted from selected international guidelines. The "Consensus on the Management and Prevention of type 2 Diabetes in Indonesia 2011" is a guideline by the Indonesian Society of Endocrinology (Perkeni). Four parent guidelines identified from its list of references were from the International Diabetes Federation (IDF), American Association of Clinical Endocrinologist (AACE), American Diabetes Association (ADA), and one jointly released by ADA and European Association for the Study of Diabetes (EASD). Two reviewers independently assessed its quality using the Appraisal of Guidelines, Research and Evaluation Collaboration (AGREE II) instrument. Six recommendations were compared: (1) screening for diabetes; (2) diagnosis; (3) control of hyperglycemia; (4) target blood glucose; (5) target blood pressure; and (6) treatment of dyslipidemia. Perkeni's guideline satisfied 55% of the AGREE II items, while its parent guidelines satisfied 59% to 74%. Perkeni's shows low score on "rigor of development" and "applicability" and the lowest score in the "scope and purpose" domain. Differences were found in 4 recommendations: the screening of diabetes, control of hyperglycemia, target blood glucose, and treatment of dyslipidemia. In 3 of 4, Perkeni followed the ADA's recommendation. Derivation of recommendations from parent guidelines and their adaptation to the context of Indonesian health care lacks transparency. When guidelines are either derived from other guidelines or adapted for use in different context, evidence-based practice principles should be followed and adhered to. © 2016 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

User Interaction with the CNPC Link

NASA Technical Reports Server (NTRS)

Hobbs, Alan; Lyall, Elizabeth A.

2014-01-01

As part of NASAs UAS in the NAS project, human factor guidelines are being developed for the ground control station of unmanned aircraft systems. A critical task for the pilot of a UAS is the management and control of the terrestrial radio links used to provide control of the vehicle and relay communications with air traffic control. An analysis of the task of the UAS pilot has been conducted to identify areas where guidelines are required. This analysis has identified a set of information requirements that must be supported by the radio equipment used to provide Control and Non-payload Communication (CNPC). Key requirements include the need for an alert when the link is lost, information on the current quality and latency of the link, and information to enable the future quality of the link to be anticipated as the aircraft changes location. These identified requirements can assist in the development of minimum operational performance standards for CNPC equipment.

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

Malkoske, Kyle; Nielsen, Michelle; Brown, Erika

The Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist’s (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) have worked together in the development of a suite of Technical Quality Control (TQC) Guidelines for radiation treatment equipment and technologies, that outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. Early community engagement and uptake survey data showed 70% of Canadian centers are part of this process and that the data in the guideline documents reflect, and are influencing the way Canadian radiation treatmentmore » centres run their technical quality control programs. As the TQC development framework matured as a cross-country initiative, guidance documents have been developed in many clinical technologies. Recently, there have been new TQC documents initiated for Gamma Knife and Cyberknife technologies where the entire communities within Canada are involved in the review process. At the same time, QARSAC reviewed the suite as a whole for the first time and it was found that some tests and tolerances overlapped across multiple documents as single tests could pertain to multiple quality control areas. The work to streamline the entire suite has allowed for improved usability of the suite while keeping the integrity of single quality control areas. The suite will be published by the JACMP, in the coming year.« less

75 FR 37819 - Proposed Information Quality Guidelines Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... DEPARTMENT OF HOMELAND SECURITY Proposed Information Quality Guidelines Policy ACTION: Notice and request for public comment on Proposed Information Quality Guidelines. SUMMARY: These guidelines should be used to ensure and maximize the quality of disseminated information. The Department's guidelines are...

The development, implementation and evaluation of clinical pathways for chronic obstructive pulmonary disease (COPD) in Saskatchewan: protocol for an interrupted times series evaluation.

PubMed

Rotter, Thomas; Plishka, Christopher; Hansia, Mohammed Rashaad; Goodridge, Donna; Penz, Erika; Kinsman, Leigh; Lawal, Adegboyega; O'Quinn, Sheryl; Buchan, Nancy; Comfort, Patricia; Patel, Prakesh; Anderson, Sheila; Winkel, Tanya; Lang, Rae Lynn; Marciniuk, Darcy D

2017-11-28

Chronic obstructive pulmonary disease (COPD) has substantial economic and human costs; it is expected to be the third leading cause of death worldwide by 2030. To minimize these costs high quality guidelines have been developed. However, guidelines alone rarely result in meaningful change. One method of integrating guidelines into practice is the use of clinical pathways (CPWs). CPWs bring available evidence to a range of healthcare professionals by detailing the essential steps in care and adapting guidelines to the local context. We are working with local stakeholders to develop CPWs for COPD with the aims of improving care while reducing utilization. The CPWs will employ several steps including: standardizing diagnostic training, unifying components of chronic disease care, coordinating education and reconditioning programs, and ensuring care uses best practices. Further, we have worked to identify evidence-informed implementation strategies which will be tailored to the local context. We will conduct a three-year research project using an interrupted time series (ITS) design in the form of a multiple baseline approach with control groups. The CPW will be implemented in two health regions (experimental groups) and two health regions will act as controls (control groups). The experimental and control groups will each contain an urban and rural health region. Primary outcomes for the study will be quality of care operationalized using hospital readmission rates and emergency department (ED) presentation rates. Secondary outcomes will be healthcare utilization and guideline adherence, operationalized using hospital admission rates, hospital length of stay and general practitioner (GP) visits. Results will be analyzed using segmented regression analysis. Funding has been procured from multiple stakeholders. The project has been deemed exempt from ethics review as it is a quality improvement project. Intervention implementation is expected to begin in summer of 2017. This project is expected to improve quality of care and reduce healthcare utilization. In addition it will provide evidence on the effects of CPWs in both urban and rural settings. If the CPWs are found effective we will work with all stakeholders to implement similar CPWs in surrounding health regions. Clinicaltrials.gov ( NCT03075709 ). Registered 8 March 2017.

What is the quality of reporting on guideline, protocol or algorithm implementation in adult trauma centres? Protocol for a systematic review.

PubMed

Gotlib Conn, Lesley; Nathens, Avery B; Perrier, Laure; Haas, Barbara; Watamaniuk, Aaron; Daniel Pereira, Diego; Zwaiman, Ashley; da Luz, Luis Teodoro

2018-05-09

Quality improvement (QI) is mandatory in trauma centres but there is no prescription for doing successful QI. Considerable variation in implementation strategies and inconsistent use of evidence-based protocols therefore exist across centres. The quality of reporting on these strategies may limit the transferability of successful initiatives across centres. This systematic review will assess the quality of reporting on guideline, protocol or algorithm implementation within a trauma centre in terms of the Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0). We will search for English language articles published after 2010 in EMBASE, MEDLINE, CINAHL electronic databases and the Cochrane Central Register of Controlled Trials. The database search will be supplemented by searching trial registries and grey literature online. Included studies will evaluate the effectiveness of guideline implementation in terms of change in clinical practice or improvement in patient outcomes. The primary outcome will be a global score reporting the proportion of studies respecting at least 80% of the SQUIRE 2.0 criteria and will be obtained based on the 18-items identified in the SQUIRE 2.0 guidelines. Secondary outcome will be the risk of bias assessed with the Risk Of Bias In Non-randomised Studies- of Interventions tool for observational cohort studies and with the Cochrane Collaboration tool for randomised controlled trials. Meta-analyses will be conducted in randomised controlled trials to estimate the effectiveness of guideline implementation if studies are not heterogeneous. If meta-analyses are conducted, we will combine studies according to the risk of bias (low, moderate or high/unclear) in subgroup analyses. All study titles, abstracts and full-text screening will be completed independently and in duplicate by the review team members. Data extraction and risk of bias assessment will also be done independently and in duplicate. Results will be disseminated through scientific publication and conferences. CRD42018084273. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Guidelines for the processing and quality assurance of benthic invertebrate samples collected as part of the National Water-Quality Assessment Program

USGS Publications Warehouse

Cuffney, T.F.; Gurtz, M.E.; Meador, M.R.

1993-01-01

Benthic invertebrate samples are collected as part of the U.S. Geological Survey's National Water-Quality Assessment Program. This is a perennial, multidisciplinary program that integrates biological, physical, and chemical indicators of water quality to evaluate status and trends and to develop an understanding of the factors controlling observed water quality. The Program examines water quality in 60 study units (coupled ground- and surface-water systems) that encompass most of the conterminous United States and parts of Alaska and Hawaii. Study-unit teams collect and process qualitative and semi-quantitative invertebrate samples according to standardized procedures. These samples are processed (elutriated and subsampled) in the field to produce as many as four sample components: large-rare, main-body, elutriate, and split. Each sample component is preserved in 10-percent formalin, and two components, large-rare and main-body, are sent to contract laboratories for further processing. The large-rare component is composed of large invertebrates that are removed from the sample matrix during field processing and placed in one or more containers. The main-body sample component consists of the remaining sample materials (sediment, detritus, and invertebrates) and is subsampled in the field to achieve a volume of 750 milliliters or less. The remaining two sample components, elutriate and split, are used for quality-assurance and quality-control purposes. Contract laboratories are used to identify and quantify invertebrates from the large-rare and main-body sample components according to the procedures and guidelines specified within this document. These guidelines allow the use of subsampling techniques to reduce the volume of sample material processed and to facilitate identifications. These processing procedures and techniques may be modified if the modifications provide equal or greater levels of accuracy and precision. The intent of sample processing is to determine the quantity of each taxon present in the semi-quantitative samples or to list the taxa present in qualitative samples. The processing guidelines provide standardized laboratory forms, sample labels, detailed sample processing flow charts, standardized format for electronic data, quality-assurance procedures and checks, sample tracking standards, and target levels for taxonomic determinations. The contract laboratory (1) is responsible for identifications and quantifications, (2) constructs reference collections, (3) provides data in hard copy and electronic forms, (4) follows specified quality-assurance and quality-control procedures, and (5) returns all processed and unprocessed portions of the samples. The U.S. Geological Survey's Quality Management Group maintains a Biological Quality-Assurance Unit, located at the National Water-Quality Laboratory, Arvada, Colorado, to oversee the use of contract laboratories and ensure the quality of data obtained from these laboratories according to the guidelines established in this document. This unit establishes contract specifications, reviews contractor performance (timeliness, accuracy, and consistency), enters data into the National Water Information System-II data base, maintains in-house reference collections, deposits voucher specimens in outside museums, and interacts with taxonomic experts within and outside the U.S. Geological Survey. This unit also modifies the existing sample processing and quality-assurance guidelines, establishes criteria and testing procedures for qualifying potential contract laboratories, identifies qualified taxonomic experts, and establishes voucher collections.

Metrology: Measurement Assurance Program Guidelines

NASA Technical Reports Server (NTRS)

Eicke, W. G.; Riley, J. P.; Riley, K. J.

1995-01-01

The 5300.4 series of NASA Handbooks for Reliability and Quality Assurance Programs have provisions for the establishment and utilization of a documented metrology system to control measurement processes and to provide objective evidence of quality conformance. The intent of these provisions is to assure consistency and conformance to specifications and tolerances of equipment, systems, materials, and processes procured and/or used by NASA, its international partners, contractors, subcontractors, and suppliers. This Measurement Assurance Program (MAP) guideline has the specific objectives to: (1) ensure the quality of measurements made within NASA programs; (2) establish realistic measurement process uncertainties; (3) maintain continuous control over the measurement processes; and (4) ensure measurement compatibility among NASA facilities. The publication addresses MAP methods as applied within and among NASA installations and serves as a guide to: control measurement processes at the local level (one facility); conduct measurement assurance programs in which a number of field installations are joint participants; and conduct measurement integrity (round robin) experiments in which a number of field installations participate to assess the overall quality of particular measurement processes at a point in time.

Organizational culture affecting quality of care: guideline adherence in perioperative antibiotic use.

PubMed

Ukawa, Naoto; Tanaka, Masayuki; Morishima, Toshitaka; Imanaka, Yuichi

2015-02-01

The objective of this work was to elucidate aspects of organizational culture associated with hospital performance in perioperative antibiotic prophylaxis using quantitative data in a multicenter and multidimensional study. Cross-sectional retrospective study using a survey data and administrative data. Eighty-three acute hospitals in Japan. A total of 4856 respondents in the organizational culture study, and 23 172 patients for the quality indicator analysis. Multilevel models of various cultural dimensions were used to analyze the association between hospital organizational culture and guideline adherence. The dependent variable was adherence or non-adherence to Japanese and CDC guidelines at the patient level and main independent variable was hospital groups categorized according to organizational culture score. Other control variables included hospital characteristics such as ownership, bed capacity, region and urbanization level of location. The multilevel analysis showed that hospitals with a high score in organizational culture were more likely to adhere to the Japanese and CDC guidelines when compared with lower scoring hospitals. In particular, the hospital group with high scores in the 'collaboration' and 'professional growth' dimensions had three times the odds for Japanese guideline adherence in comparison with low-scoring hospitals. Our study revealed that various aspects of organizational culture were associated with adherence to guidelines for perioperative antibiotic use. Hospital managers aiming to improve quality of care may benefit from improving hospital organizational culture. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2005-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

Quality control in urodynamics and the role of software support in the QC procedure.

PubMed

Hogan, S; Jarvis, P; Gammie, A; Abrams, P

2011-11-01

This article aims to identify quality control (QC) best practice, to review published QC audits in order to identify how closely good practice is followed, and to carry out a market survey of the software features that support QC offered by urodynamics machines available in the UK. All UK distributors of urodynamic systems were contacted and asked to provide information on the software features relating to data quality of the products they supply. The results of the market survey show that the features offered by manufacturers differ greatly. Automated features, which can be turned off in most cases, include: cough recognition, detrusor contraction detection, and high pressure alerts. There are currently no systems that assess data quality based on published guidelines. A literature review of current QC guidelines for urodynamics was carried out; QC audits were included in the literature review to see how closely guidelines were being followed. This review highlights the fact that basic QC is not being carried out effectively by urodynamicists. Based on the software features currently available and the results of the literature review there is both the need and capacity for a greater degree of automation in relation to urodynamic data quality and accuracy assessment. Some progress has been made in this area and certain manufacturers have already developed automated cough detection. Copyright © 2011 Wiley Periodicals, Inc.

Validation of a proposal for evaluating hospital infection control programs.

PubMed

Silva, Cristiane Pavanello Rodrigues; Lacerda, Rúbia Aparecida

2011-02-01

To validate the construct and discriminant properties of a hospital infection prevention and control program. The program consisted of four indicators: technical-operational structure; operational prevention and control guidelines; epidemiological surveillance system; and prevention and control activities. These indicators, with previously validated content, were applied to 50 healthcare institutions in the city of São Paulo, Southeastern Brazil, in 2009. Descriptive statistics were used to characterize the hospitals and indicator scores, and Cronbach's α coefficient was used to evaluate the internal consistency. The discriminant validity was analyzed by comparing indicator scores between groups of hospitals: with versus without quality certification. The construct validity analysis was based on exploratory factor analysis with a tetrachoric correlation matrix. The indicators for the technical-operational structure and epidemiological surveillance presented almost 100% conformity in the whole sample. The indicators for the operational prevention and control guidelines and the prevention and control activities presented internal consistency ranging from 0.67 to 0.80. The discriminant validity of these indicators indicated higher and statistically significant mean conformity scores among the group of institutions with healthcare certification or accreditation processes. In the construct validation, two dimensions were identified for the operational prevention and control guidelines: recommendations for preventing hospital infection and recommendations for standardizing prophylaxis procedures, with good correlation between the analysis units that formed the guidelines. The same was found for the prevention and control activities: interfaces with treatment units and support units were identified. Validation of the measurement properties of the hospital infection prevention and control program indicators made it possible to develop a tool for evaluating these programs in an ethical and scientific manner in order to obtain a quality diagnosis in this field.

Preoperative radiotherapy for rectal cancer: a comparative study of quality control adherence at two cancer hospitals in Spain and Poland

PubMed Central

Fundowicz, Magdalena; Macia, Miguel; Marin, Susanna; Bogusz-Czerniewicz, Marta; Konstanty, Ewelina; Modolel, Ignaci; Malicki, Julian; Guedea, Ferran

2014-01-01

Background We performed a clinical audit of preoperative rectal cancer treatment at two European radiotherapy centres (Poland and Spain). The aim was to independently verify adherence to a selection of indicators of treatment quality and to identify any notable inter-institutional differences. Methods A total of 162 patients, in Catalan Institute of Oncology (ICO) 68 and in Greater Poland Cancer Centre (GPCC) 94, diagnosed with locally advanced rectal cancer and treated with preoperative radiotherapy or radio-chemotherapy were included in retrospective study. A total of 7 quality control measures were evaluated: waiting time, multidisciplinary treatment approach, portal verification, in vivo dosimetry, informed consent, guidelines for diagnostics and therapy, and patient monitoring during treatment. Results Several differences were observed. Waiting time from pathomorphological diagnosis to initial consultation was 31 (ICO) vs. 8 (GPCC) days. Waiting time from the first visit to the beginning of the treatment was twice as long at the ICO. At the ICO, 82% of patient experienced treatment interruptions. The protocol for portal verification was the same at both institutions. In vivo dosimetry is not used for this treatment localization at the ICO. The ICO utilizes locally-developed guidelines for diagnostics and therapy, while the GPCC is currently developing its own guidelines. Conclusions An independent external clinical audit is an excellent approach to identifying and resolving deficiencies in quality control procedures. We identified several procedures amenable to improvement. Both institutions have since implemented changes to improve quality standards. We believe that all radiotherapy centres should perform a comprehensive clinical audit to identify and rectify deficiencies. PMID:24991212

Preoperative radiotherapy for rectal cancer: a comparative study of quality control adherence at two cancer hospitals in Spain and Poland.

PubMed

Fundowicz, Magdalena; Macia, Miguel; Marin, Susanna; Bogusz-Czerniewicz, Marta; Konstanty, Ewelina; Modolel, Ignaci; Malicki, Julian; Guedea, Ferran

2014-06-01

We performed a clinical audit of preoperative rectal cancer treatment at two European radiotherapy centres (Poland and Spain). The aim was to independently verify adherence to a selection of indicators of treatment quality and to identify any notable inter-institutional differences. A total of 162 patients, in Catalan Institute of Oncology (ICO) 68 and in Greater Poland Cancer Centre (GPCC) 94, diagnosed with locally advanced rectal cancer and treated with preoperative radiotherapy or radio-chemotherapy were included in retrospective study. A total of 7 quality control measures were evaluated: waiting time, multidisciplinary treatment approach, portal verification, in vivo dosimetry, informed consent, guidelines for diagnostics and therapy, and patient monitoring during treatment. Several differences were observed. Waiting time from pathomorphological diagnosis to initial consultation was 31 (ICO) vs. 8 (GPCC) days. Waiting time from the first visit to the beginning of the treatment was twice as long at the ICO. At the ICO, 82% of patient experienced treatment interruptions. The protocol for portal verification was the same at both institutions. In vivo dosimetry is not used for this treatment localization at the ICO. The ICO utilizes locally-developed guidelines for diagnostics and therapy, while the GPCC is currently developing its own guidelines. An independent external clinical audit is an excellent approach to identifying and resolving deficiencies in quality control procedures. We identified several procedures amenable to improvement. Both institutions have since implemented changes to improve quality standards. We believe that all radiotherapy centres should perform a comprehensive clinical audit to identify and rectify deficiencies.

The preanalytical optimization of blood cultures: a review and the clinical importance of benchmarking in 5 Belgian hospitals.

PubMed

Willems, Elise; Smismans, Annick; Cartuyvels, Reinoud; Coppens, Guy; Van Vaerenbergh, Kristien; Van den Abeele, Anne-Marie; Frans, Johan

2012-05-01

Bloodstream infections remain a major challenge in medicine. Optimal detection of pathogens is only possible if the quality of preanalytical factors is thoroughly controlled. Since the laboratory is responsible for this preanalytical phase, the quality control of critical factors should be integrated in its quality control program. The numerous recommendations regarding blood culture collection contain controversies. Only an unambiguous guideline permits standardization and interlaboratory quality control. We present an evidence-based concise guideline of critical preanalytical determinants for blood culture collection and summarize key performance indicators with their concomitant target values. In an attempt to benchmark, we compared the true-positive rate, contamination rate, and collected blood volume of blood culture bottles in 5 Belgian hospital laboratories. The true-positive blood culture rate fell within previously defined acceptation criteria by Baron et al. (2005) in all 5 hospitals, whereas the contamination rate exceeded the target value in 4 locations. Most unexpected, in each of the 5 laboratories, more than one third of the blood culture bottles were incorrectly filled, irrespective of the manufacturer of the blood culture vials. As a consequence of this shortcoming, one manufacturer recently developed an automatic blood volume monitoring system. In conclusion, clear recommendations for standardized blood culture collection combined with quality control of critical factors of the preanalytical phase are essential for diagnostic blood culture improvement. Copyright © 2012 Elsevier Inc. All rights reserved.

Association between adherence to physical activity guidelines and health-related quality of life among individuals with physician-diagnosed arthritis.

PubMed

Austin, Shamly; Qu, Haiyan; Shewchuk, Richard M

2012-10-01

To examine the association between adherence to physical activity guidelines and health-related quality of life (HRQOL) among individuals with arthritis. A cross-sectional sample with 33,071 US adults, 45 years or older with physician-diagnosed arthritis was obtained from 2007 Behavioral Risk Factor Surveillance System survey. We conducted negative binomial regression analysis to examine HRQOL as a function of adherence to physical activity guidelines controlling for physicians' recommendations for physical activity, age, sex, race, education, marital status, employment, annual income, health insurance, personal physician, emotional support, body mass index, activity limitations, health status, and co-morbidities based on Behavioral Model of Health Services Utilization. Descriptive statistics showed that 60% adults with arthritis did not adhere to physical activity guidelines, mean physically and mentally unhealthy days were 7.7 and 4.4 days, respectively. Results from negative binomial regression indicated that individuals who did not adhere to physical activity guidelines had 1.14 days more physically unhealthy days and 1.12 days more mentally unhealthy days than those who adhered controlling for covariates. Adherence to physical activity is important to improve HRQOL for individuals with arthritis. However, adherence is low among this population. Interventions are required to engage individuals with arthritis in physical activity.

Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

PubMed Central

Grant, Sean P.; Mayo-Wilson, Evan; Melendez-Torres, G. J.; Montgomery, Paul

2013-01-01

Background Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. Objective/Design We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. Data Sources (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. Eligibility (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. Results (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in “Instructions to Authors.” Conclusion Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely missing from trial publications; most leading journals in social and behavioural sciences do not ask authors to follow reporting standards. Findings demonstrate a need to develop a CONSORT extension with updated standards for social and psychological intervention trials. PMID:23734256

Quality control in gastrointestinal surgery.

PubMed

Ramírez-Barba, Ector Jaime; Arenas-Moya, Diego; Vázquez-Guerrero, Arturo

2011-01-01

We analyzed the Mexican legal framework, identifying the vectors that characterize quality and control in gastrointestinal surgery. Quality is contemplated in the health protection rights determined according to the Mexican Constitution, established in the general health law and included as a specific goal in the actual National Development Plan and Health Sector Plan. Quality control implies planning, verification and application of corrective measures. Mexico has implemented several quality strategies such as certification of hospitals and regulatory agreements by the General Salubrity Council, creation of the National Health Quality Committee, generation of Clinical Practice Guidelines and the Certification of Medical Specialties, among others. Quality control in gastrointestinal surgery must begin at the time of medical education and continue during professional activities of surgeons, encouraging multidisciplinary teamwork, knowledge, abilities, attitudes, values and skills that promote homogeneous, safe and quality health services for the Mexican population.

12 CFR 652.60 - Corporation board guidelines.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... (a) Your board of directors is responsible for ensuring that you maintain total capital at a level... developing the capital adequacy plan: (1) Capability of management; (2) Strategies and objectives in your business plan; (3) Quality of operating policies, procedures, and internal controls; (4) Quality and...

Comprehensive Testing Guidelines to Increase Efficiency in INDOT Operations : [Technical Summary

DOT National Transportation Integrated Search

2012-01-01

When the Indiana Department of Transportation designs a pavement project, a decision for QC/QA (Quality Control/ Quality Assurance) or nonQC/QA is made solely based on the quantity of pavement materials to be used in the project. Once the pavement...

Comprehensive Testing Guidelines to Increase Efficiency in INDOT Operations : [Technical Summary

DOT National Transportation Integrated Search

2012-01-01

When the Indiana Department of Transportation designs : a pavement project, a decision for QC/QA (Quality Control/ : Quality Assurance) or nonQC/QA is made solely : based on the quantity of pavement materials to be used : in the project. Once the ...

12 CFR 652.60 - Corporation board guidelines.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... (a) Your board of directors is responsible for ensuring that you maintain total capital at a level... developing the capital adequacy plan: (1) Capability of management; (2) Strategies and objectives in your business plan; (3) Quality of operating policies, procedures, and internal controls; (4) Quality and...

75 FR 16088 - Proposed Information Quality Guidelines Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-31

... ELECTION ASSISTANCE COMMISSION Proposed Information Quality Guidelines Policy AGENCY: U.S... Quality Guidelines Policy. SUMMARY: The U.S. Election Assistance Commission (EAC) seeks public comment on the Proposed Information Quality Guidelines policy. The policy outlines the EAC's directives and...

Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review.

PubMed

Péron, Julien; Pond, Gregory R; Gan, Hui K; Chen, Eric X; Almufti, Roula; Maillet, Denis; You, Benoit

2012-07-03

The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. A total of 357 RCTs were reviewed. The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. The results show that numerous items remained unreported for many trials. Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.

Considerations on the Improved Integration of Medical Guidelines into Routine Clinical Practice – a Review and Concept Proposal

PubMed Central

Beckmann, M. W.; Schlieter, H.; Richter, P.; Wesselmann, S.

2016-01-01

Medical guidelines have become established as the standard for the comprehensive synopsis of all available information (scientific trials, expert opinion) on diagnosis and treatment recommendations. The transfer of guidelines to clinical practice and subsequent monitoring has however proven difficult. In particular the potential interaction between guideline developers and guideline users has not been fully utilised. This review article analyses the status quo and existing methodological and technical information solutions supporting the guideline life cycle. It is shown that there are numerous innovative developments that in isolation do not provide comprehensive support. The vision of the “Living Guidelines 2.0” is therefore presented. This outlines the merging of guideline development and implementation on the basis of clinical pathways and guideline-based quality control, and building on this, the generation of information for guideline development and research. PMID:27134291

[Development of analysis software package for the two kinds of Japanese fluoro-d-glucose-positron emission tomography guideline].

PubMed

Matsumoto, Keiichi; Endo, Keigo

2013-06-01

Two kinds of Japanese guidelines for the data acquisition protocol of oncology fluoro-D-glucose-positron emission tomography (FDG-PET)/computed tomography (CT) scans were created by the joint task force of the Japanese Society of Nuclear Medicine Technology (JSNMT) and the Japanese Society of Nuclear Medicine (JSNM), and published in Kakuigaku-Gijutsu 27(5): 425-456, 2007 and 29(2): 195-235, 2009. These guidelines aim to standardize PET image quality among facilities and different PET/CT scanner models. The objective of this study was to develop a personal computer-based performance measurement and image quality processor for the two kinds of Japanese guidelines for oncology (18)F-FDG PET/CT scans. We call this software package the "PET quality control tool" (PETquact). Microsoft Corporation's Windows(™) is used as the operating system for PETquact, which requires 1070×720 image resolution and includes 12 different applications. The accuracy was examined for numerous applications of PETquact. For example, in the sensitivity application, the system sensitivity measurement results were equivalent when comparing two PET sinograms obtained from the PETquact and the report. PETquact is suited for analysis of the two kinds of Japanese guideline, and it shows excellent spec to performance measurements and image quality analysis. PETquact can be used at any facility if the software package is installed on a laptop computer.

Recommendations for assessing water quality and safety on board merchant ships.

PubMed

Grappasonni, Iolanda; Cocchioni, Mario; Degli Angioli, Rolando; Saturnino, Andrea; Sibilio, Fabio; Scuri, Stefania; Amenta, Francesco

2013-01-01

Health and diseases on board ships may depend on water. Interventions to improve the quality of water may bring to significant benefits to health and water stores/supply and should be controlledto protect health. This paper has reviewed the main regulations for the control of water safety and qualityon board ships and presents some practical recommendations for keeping water healthy and safe in passenger and cargo merchant ships. The main international regulations and guidelines on the topic were analysed. Guidelines forWater Quality on Board Merchant Ships Including Passenger Vessels of Health Protection Agency, World Health Organisation (WHO) Guide to Ship Sanitation, WHO Guidelines for Drinking Water Quality, WHO Water Safety Plan and the United States Center for Disease Control and Prevention Vessel Sanitation Program were examined. Recommendations for passenger and, if available, for cargo ships were collected and compared. Recommended questionnaire: A questionnaire summarising the main information to collect for assessingthe enough quality of water for the purposes it should be used on board is proposed. The need of havinga crew member with water assessment duties on board, trained for performing these activities properlyis discussed. Water quality on board ships should be monitored routinely. Monitoring should be directedto chemical and microbiological parameters for identifying possible contamination sources, using specifickits by a designed crew member. More detailed periodic assessments should be under the responsibility ofspecialised personnel/laboratories and should be based on sample collection from all tanks and sites of waterdistribution. It is important to select a properly trained crew member on board for monitoring water quality.

76 FR 8753 - Final Information Quality Guidelines Policy

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

... DEPARTMENT OF HOMELAND SECURITY Final Information Quality Guidelines Policy AGENCY: Department of Homeland Security. ACTION: Notice and request for public comment on Final Information Quality Guidelines. SUMMARY: These guidelines should be used to ensure and maximize the quality of disseminated information...

[Implementation of new guidelines for management of prelabour rupture of membranes did not have the desired effect].

PubMed

Kamper, Christina Hjørnet; Hvidman, Lone; Helmig, Rikke Bek

2014-02-03

Many resources are used in developing guidelines for the treatment and handling of different diseases and clinical situations. It is important to evaluate the effect of these guidelines; are they being followed and do they have the desired impact on patient care? This report describes a quality control evaluation of whether the implementation of a new PROM (prelabour rupture of membranes) management guideline at Department Y at the Aarhus University Hospital had the wanted effect on the length of labour, use of prophylactic antibiotics, frequency of neonatal admission and neonatal infection.

76 FR 72885 - Approval and Promulgation of Air Quality Implementation Plans: South Carolina; Negative...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... Carolina; Negative Declarations for Groups I, II, III and IV Control Techniques Guidelines; and Reasonably Available Control Technology AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY... Carolina Department of Health and Environmental Control (SC DHEC). These revisions establish reasonably...

The Digital electronic Guideline Library (DeGeL): a hybrid framework for representation and use of clinical guidelines.

PubMed

Shahar, Yuval; Young, Ohad; Shalom, Erez; Mayaffit, Alon; Moskovitch, Robert; Hessing, Alon; Galperin, Maya

2004-01-01

We propose to present a poster (and potentially also a demonstration of the implemented system) summarizing the current state of our work on a hybrid, multiple-format representation of clinical guidelines that facilitates conversion of guidelines from free text to a formal representation. We describe a distributed Web-based architecture (DeGeL) and a set of tools using the hybrid representation. The tools enable performing tasks such as guideline specification, semantic markup, search, retrieval, visualization, eligibility determination, runtime application and retrospective quality assessment. The representation includes four parallel formats: Free text (one or more original sources); semistructured text (labeled by the target guideline-ontology semantic labels); semiformal text (which includes some control specification); and a formal, machine-executable representation. The specification, indexing, search, retrieval, and browsing tools are essentially independent of the ontology chosen for guideline representation, but editing the semi-formal and formal formats requires ontology-specific tools, which we have developed in the case of the Asbru guideline-specification language. The four formats support increasingly sophisticated computational tasks. The hybrid guidelines are stored in a Web-based library. All tools, such as for runtime guideline application or retrospective quality assessment, are designed to operate on all representations. We demonstrate the hybrid framework by providing examples from the semantic markup and search tools.

[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.

78 FR 28773 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Miscellaneous Metal and Plastic Parts Which Includes Pleasure Craft Coating Operations AGENCY: Environmental... recommended by EPA's control technique guidelines (CTG) for Miscellaneous Metal Parts and Plastic Coating... air pollution control authorities information that should assist them in determining RACT for VOC from...

76 FR 71886 - Revisions to the California State Implementation Plan, Placer County Air Pollution Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

... the California State Implementation Plan, Placer County Air Pollution Control District and Sacramento... Pollution Control District (PCAPCD) and Sacramento Metropolitan Air Quality Management District (SMAQMD... Guidelines for Miscellaneous Metal and Plastic Parts Coatings,'' EPA-453/R-08-003, September 2008. 7...

Patient and public attitudes to and awareness of clinical practice guidelines: a systematic review with thematic and narrative syntheses

PubMed Central

2014-01-01

Background Clinical practice guidelines are typically written for healthcare providers but there is increasing interest in producing versions for the public, patients and carers. The main objective of this review is to identify and synthesise evidence of the public’s attitudes towards clinical practice guidelines and evidence-based recommendations written for providers or the public, together with their awareness of guidelines. Methods We included quantitative and qualitative studies of any design reporting on public, patient (and their carers) attitudes and awareness of guidelines written for providers or patients/public. We searched electronic databases including MEDLINE, PSYCHINFO, ERIC, ASSIA and the Cochrane Library from 2000 to 2012. We also searched relevant websites, reviewed citations and contacted experts in the field. At least two authors independently screened, abstracted data and assessed the quality of studies. We conducted a thematic analysis of first and second order themes and performed a separate narrative synthesis of patient and public awareness of guidelines. Results We reviewed 5415 records and included 26 studies (10 qualitative studies, 13 cross sectional and 3 randomised controlled trials) involving 24 887 individuals. Studies were mostly good to fair quality. The thematic analysis resulted in four overarching themes: Applicability of guidelines; Purpose of guidelines for patient; Purpose of guidelines for health care system and physician; and Properties of guidelines. Overall, participants had mixed attitudes towards guidelines; some participants found them empowering but many saw them as a way of rationing care. Patients were also concerned that the information may not apply to their own health care situations. Awareness of guidelines ranged from 0-79%, with greater awareness in participants surveyed on national guideline websites. Conclusion There are many factors, not only formatting, that may affect the uptake and use of guideline-derived material by the public. Producers need to make clear how the information is relevant to the reader and how it can be used to make healthcare improvements although there were problems with data quality. Awareness of guidelines is generally low and guideline producers cannot assume that the public has a more positive perception of their material than of alternative sources of health information. PMID:25064372

A Study of University Efforts to Provide Students with the Ability to Comprehend and Apply Total Quality Principles in Their Fields of Study

DTIC Science & Technology

1993-09-01

Geber , 1990:30-31). These steps are a formula to implement and measure quality in a service organization. While guidelines such as these apply to...1991. Evans, James R. and William M. Lindsay. The Management and Control of Quality. Minneapolis/St. Paul: West Publishing Company, 1993. Geber

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.

European Guidelines for Quality Assurance in Cervical Cancer Screening. Second edition--summary document.

PubMed

Arbyn, M; Anttila, A; Jordan, J; Ronco, G; Schenck, U; Segnan, N; Wiener, H; Herbert, A; von Karsa, L

2010-03-01

European Guidelines for Quality Assurance in Cervical Cancer Screening have been initiated in the Europe Against Cancer Programme. The first edition established the principles of organised population-based screening and stimulated numerous pilot projects. The second multidisciplinary edition was published in 2008 and comprises approximately 250 pages divided into seven chapters prepared by 48 authors and contributors. Considerable attention has been devoted to organised, population-based programme policies which minimise adverse effects and maximise benefits of screening. It is hoped that this expanded guidelines edition will have a greater impact on countries in which screening programmes are still lacking and in which opportunistic screening has been preferred in the past. Other methodological aspects such as future prospects of human papillomavirus testing and vaccination in cervical cancer control have also been examined in the second edition; recommendations for integration of the latter technologies into European guidelines are currently under development in a related project supported by the European Union Health Programme. An overview of the fundamental points and principles that should support any quality-assured screening programme and key performance indicators are presented here in a summary document of the second guidelines edition in order to make these principles and standards known to a wider scientific community.

Association between bibliometric parameters, reporting and methodological quality of randomised controlled trials in vascular and endovascular surgery.

PubMed

Hajibandeh, Shahab; Hajibandeh, Shahin; Antoniou, George A; Green, Patrick A; Maden, Michelle; Torella, Francesco

2017-04-01

Purpose We aimed to investigate association between bibliometric parameters, reporting and methodological quality of vascular and endovascular surgery randomised controlled trials. Methods The most recent 75 and oldest 75 randomised controlled trials published in leading journals over a 10-year period were identified. The reporting quality was analysed using the CONSORT statement, and methodological quality with the Intercollegiate Guidelines Network checklist. We used exploratory univariate and multivariable linear regression analysis to investigate associations. Findings Bibliometric parameters such as type of journal, study design reported in title, number of pages; external funding, industry sponsoring and number of citations are associated with reporting quality. Moreover, parameters such as type of journal, subject area and study design reported in title are associated with methodological quality. Conclusions The bibliometric parameters of randomised controlled trials may be independent predictors for their reporting and methodological quality. Moreover, the reporting quality of randomised controlled trials is associated with their methodological quality and vice versa.

The association between AHA CPR quality guideline compliance and clinical outcomes from out-of-hospital cardiac arrest.

PubMed

Cheskes, Sheldon; Schmicker, Robert H; Rea, Tom; Morrison, Laurie J; Grunau, Brian; Drennan, Ian R; Leroux, Brian; Vaillancourt, Christian; Schmidt, Terri A; Koller, Allison C; Kudenchuk, Peter; Aufderheide, Tom P; Herren, Heather; Flickinger, Katharyn H; Charleston, Mark; Straight, Ron; Christenson, Jim

2017-07-01

Measures of chest compression fraction (CCF), compression rate, compression depth and pre-shock pause have all been independently associated with improved outcomes from out-of-hospital (OHCA) cardiac arrest. However, it is unknown whether compliance with American Heart Association (AHA) guidelines incorporating all the aforementioned metrics, is associated with improved survival from OHCA. We performed a secondary analysis of prospectively collected data from the Resuscitation Outcomes Consortium Epistry-Cardiac Arrest database. As per the 2015 American Heart Association (AHA) guidelines, guideline compliant cardiopulmonary resuscitation (CPR) was defined as CCF >0.8, chest compression rate 100-120/minute, chest compression depth 50-60mm, and pre-shock pause <10s. Multivariable logistic regression models controlling for Utstein variables were used to assess the relationship between global guideline compliance and survival to hospital discharge and neurologically intact survival with MRS ≤3. Due to potential confounding between CPR quality metrics and cases that achieved early ROSC, we performed an a priori subgroup analysis restricted to patients who obtained ROSC after ≥10min of EMS resuscitation. After allowing for study exclusions, 19,568 defibrillator records were collected over a 4-year period ending in June 2015. For all reported models, the reference standard included all cases who did not meet all CPR quality benchmarks. For the primary model (CCF, rate, depth), there was no significant difference in survival for resuscitations that met all CPR quality benchmarks (guideline compliant) compared to the reference standard (OR 1.26; 95% CI: 0.80, 1.97). When the dataset was restricted to patients obtaining ROSC after ≥10min of EMS resuscitation (n=4,158), survival was significantly higher for those resuscitations that were guideline compliant (OR 2.17; 95% CI: 1.11, 4.27) compared to the reference standard. Similar findings were obtained for neurologically intact survival with MRS ≤3 (OR 3.03; 95% CI: 1.12, 8.20). In this observational study, compliance with AHA guidelines for CPR quality was not associated with improved outcomes from OHCA. Conversely, when restricting the cohort to those with late ROSC, compliance with guidelines was associated with improved clinical outcomes. Strategies to improve overall guideline compliance may have a significant impact on outcomes from OHCA. Copyright © 2017 Elsevier B.V. All rights reserved.

The "Diagnostic Guideline for Anxiety and Challenging Behaviour" for Persons with Intellectual Disabilities: Preliminary Outcomes on Internalizing Problems, Challenging Behaviours, Quality of Life and Clients' Satisfaction

ERIC Educational Resources Information Center

Pruijssers, Addy; Meijel, Berno; Maaskant, Marian; Teerenstra, Steven; van Achterberg, Theo

2017-01-01

Background: People with intellectual disabilities are vulnerable to develop psychopathology (in particular anxiety) and related challenging behaviour. Method: A comparative multiple case study with an experimental and a control condition. Results: The application of the guideline showed a trend of decreases of internalizing problems (P = 0.07) and…

Risk/Requirements Trade-off Guidelines for Low Cost Satellite Systems

NASA Technical Reports Server (NTRS)

Cornford, Steven L.; Man, Kin F.

1996-01-01

The accelerating trend toward faster, better, cheaper missions places increasing emphasis on the trade-offs between requirements and risk to reduce cost and development times, while still improving quality and reliability. The Risk/Requirement Trade-off Guidelines discussed in this paper are part of an integrated approach to address the main issues by focusing on the sum of prevention, analysis, control, or test (PACT) processes.

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

PubMed Central

2011-01-01

Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. Trial Registration http://www.clinicaltrials.gov NCT00302718 PMID:21967830

Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol.

PubMed

Petersen, Laura A; Urech, Tracy; Simpson, Kate; Pietz, Kenneth; Hysong, Sylvia J; Profit, Jochen; Conrad, Douglas; Dudley, R Adams; Lutschg, Meghan Z; Petzel, Robert; Woodard, Lechauncy D

2011-10-03

Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. http://www.clinicaltrials.govNCT00302718.

Instrument Quality Control.

PubMed

Jayakody, Chatura; Hull-Ryde, Emily A

2016-01-01

Well-defined quality control (QC) processes are used to determine whether a certain procedure or action conforms to a widely accepted standard and/or set of guidelines, and are important components of any laboratory quality assurance program (Popa-Burke et al., J Biomol Screen 14: 1017-1030, 2009). In this chapter, we describe QC procedures useful for monitoring the accuracy and precision of laboratory instrumentation, most notably automated liquid dispensers. Two techniques, gravimetric QC and photometric QC, are highlighted in this chapter. When used together, these simple techniques provide a robust process for evaluating liquid handler accuracy and precision, and critically underpin high-quality research programs.

Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events.

PubMed

Augestad, Knut M; Vonen, Barthold; Aspevik, Ranveig; Nestvold, Torunn; Ringberg, Unni; Johnsen, Roar; Norum, Jan; Lindsetmo, Rolv-Ole

2008-06-25

All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG). These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general practitioner (GP) without altering quality of life, cost effectiveness and/or the incidence of serious clinical events. Patients undergoing surgery for colon cancer with histological grade Dukes's Stage A, B or C and below 75 years of age are eligible for inclusion. They will be randomized after surgery to follow-up at the surgical outpatient clinic (control group) or follow-up by the district GP (intervention group). Both study arms comply with the national NGICG guidelines. The primary endpoints will be quality of life (QoL) (measured by the EORTC QLQ C-30 and the EQ-5D instruments), serious clinical events (SCEs), and costs. The follow-up period will be two years after surgery, and quality of life will be measured every three months. SCEs and costs will be estimated prospectively. The sample size was 170 patients. There is an ongoing debate on the best method of follow-up for patients with CRC. Due to a wide range of follow-up programmes and paucity of randomized trials, it is impossible to draw conclusions about the best combination and frequency of clinic (or family practice) visits, blood tests, endoscopic procedures and radiological examinations that maximize the clinical outcome, quality of life and costs. Most studies on follow-up of CRC patients have been performed in a hospital outpatient setting. We hypothesize that postoperative follow-up of colon cancer patients (according to national guidelines) by GPs will not have any impact on patients' quality of life. Furthermore, we hypothesize that there will be no increase in SCEs and that the incremental cost-effectiveness ratio will improve. This trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00572143.

Auditing the management of vaccine-preventable disease outbreaks: the need for a tool.

PubMed

Torner, Nuria; Carnicer-Pont, Dolors; Castilla, Jesus; Cayla, Joan; Godoy, Pere; Dominguez, Angela

2011-01-13

Public health activities, especially infectious disease control, depend on effective teamwork. We present the results of a pilot audit questionnaire aimed at assessing the quality of public health services in the management of VPD outbreaks. Audit questionnaire with three main areas indicators (structure, process and results) was developed. Guidelines were set and each indicator was assessed by three auditors. Differences in indicator scores according to median size of outbreaks were determined by ANOVA (significance at p≤0.05). Of 154 outbreaks; eighteen indicators had a satisfactory mean score, indicator "updated guidelines" and "timely reporting" had a poor mean score (2.84±106 and 2.44±1.67, respectively). Statistically significant differences were found according to outbreak size, in the indicators "availability of guidelines/protocol updated less than 3 years ago" (p = 0.03) and "days needed for outbreak control" (p = 0.04). Improving availability of updated guidelines, enhancing timely reporting and adequate recording of control procedures taken is needed to allow for management assessment and improvement.

A CONSORT analysis of randomised controlled trials for the treatment of invasive aspergillosis.

PubMed

Jones, Brian L; Richardson, Malcolm D; Ingram, Patricia M; Agrawal, Samir G

2017-08-01

There is no assessment of the reporting quality of antifungal randomized, controlled trials (RCT), upon which guidelines for the treatment of invasive aspergillosis (IA) in patients with hematological malignancy are based. Trial reports were identified through Trip, Cochrane, Medline, and Embase database searches. Report quality was assessed using the 25-item CONSORT checklist and a rating scale of 1 (strongly disagree) to 4 (strongly agree). The primary endpoint was quality as assessed by mean group-scores among papers published at the time of the most recent IA treatment guidelines. Seven RCTs were identified for analysis. Overall mean group-score for all seven papers was 2.44 (out of a total of four). There were significant differences between publications regarding overall reporting quality (P < .001) and specifically for the Methods and Results (P = .004 and P = .010, respectively), which best reflect data quality. The Cornely trial report achieved the highest mean group-score overall (3.15 ± 0.93; 95% CI, 2.82, 3.47), as well as for Methods (3.36) and Results (3.40). Mean group scores also showed that it was of significantly higher overall quality than the other six publications (P-value range; .012 to <.001), and of higher quality for Methods than five publications (P-value range; .013 to <.001). Incorporating this CONSORT analysis into the evidence-based grading systems in North American (IDSA), European (ECIL and ESCMID) IA guidelines could alter the value placed on these RCTs, thereby impacting on clinical recommendations. © The Author 2016. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Real-time audiovisual feedback system in a physician-staffed helicopter emergency medical service in Finland: the quality results and barriers to implementation.

PubMed

Sainio, Marko; Kämäräinen, Antti; Huhtala, Heini; Aaltonen, Petri; Tenhunen, Jyrki; Olkkola, Klaus T; Hoppu, Sanna

2013-07-01

To evaluate the quality of cardiopulmonary resuscitation (CPR) in a physician staffed helicopter emergency medical service (HEMS) using a monitor-defibrillator with a quality analysis feature. As a post hoc analysis, the potential barriers to implementation were surveyed. The quality of CPR performed by the HEMS from November 2008 to April 2010 was analysed. To evaluate the implementation rate of quality analysis, the HEMS database was screened for all cardiac arrest missions during the study period. As a consequence of the observed low implementation rate, a survey was sent to physicians working in the HEMS to evaluate the possible reasons for not utilizing the automated quality analysis feature. During the study period, the quality analysis was used for 52 out of 187 patients (28%). In these cases the mean compression depth was < 40 mm in 46% and < 50 mm in 96% of the 1-min analysis intervals, but otherwise CPR quality corresponded with the 2005 resuscitation guidelines. In particular, the no-flow fraction was remarkably low 0.10 (0.07, 0.16). The most common reasons for not using quality-controlled CPR were that the device itself was not taken to the scene, or not applied to the patient, because another EMS unit was already treating the patient with another defibrillator. When quality-controlled CPR technology was used, the indicators of good quality CPR as described in the 2005 resuscitation guidelines were mostly achieved albeit with sufficient compression depth. The use of the well-described technology in improving patient care was low. Wider implementation of the automated quality control and feedback feature in defibrillators could further improve the quality of CPR on the field. ClinicalTrials.gov (NCT00951704).

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

Is there a suitable point-of-care glucose meter for tight glycemic control? Evaluation of one home-use and four hospital-use meters in an intensive care unit.

PubMed

Gijzen, Karlijn; Moolenaar, David L J; Weusten, Jos J A M; Pluim, Hendrik J; Demir, Ayse Y

2012-11-01

Implementation of tight glycemic control (TGC) and avoidance of hypoglycemia in intensive care unit (ICU) patients require frequent analysis of blood glucose. This can be achieved by accurate point-of-care (POC) hospital-use glucose meters. In this study one home-use and four different hospital-use POC glucose meters were evaluated in critically ill ICU patients. All patients (n = 80) requiring TGC were included in this study. For each patient three to six glucose measurements (n = 390) were performed. Blood glucose was determined by four hospital-use POC glucose meters, Roche Accu-Check Inform II System, HemoCue Glu201DM, Nova StatStrip, Abbott Precision Xceed Pro, and one home-use POC glucose meter, Menarini GlucoCard Memory PC. The criteria described in ISO 15197, Dutch TNO quality guideline and in NACB/ADA-2011 were applied in the comparisons. According to the ISO 15197, the percentages of the measured values that fulfilled the criterion were 99.5% by Roche, 95.1% by HemoCue, 91.0% by Nova, 96.6% by Abbott, and 63.3% by Menarini. According to the TNO quality guideline these percentages were 96.1% , 91.0% , 81.8% , 94.2% , and 47.7% , respectively. Application of the NACB/ADA guideline resulted in percentages of 95.6%, 89.2%, 77.9%, 93.4%, and 45.4%, respectively. When ISO 15197 was applied, Roche, HemoCue and Abbott fulfilled the criterion in this patient population, whereas Nova and Menarini did not. However, when TNO quality guideline and NACB/ADA 2011 guideline were applied only Roche fulfilled the criteria.

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

PubMed Central

Bour, Robert K.; Pozniak, Myron; Ranallo, Frank N.

2015-01-01

The purpose of this paper is to describe our experience with the AAPM Medical Physics Practice Guideline 1.a: “CT Protocol Management and Review Practice Guideline”. Specifically, we will share how our institution's quality management system addresses the suggestions within the AAPM practice report. We feel this paper is needed as it was beyond the scope of the AAPM practice guideline to provide specific details on fulfilling individual guidelines. Our hope is that other institutions will be able to emulate some of our practices and that this article would encourage other types of centers (e.g., community hospitals) to share their methodology for approaching CT protocol optimization and quality control. Our institution had a functioning CT protocol optimization process, albeit informal, since we began using CT. Recently, we made our protocol development and validation process compliant with a number of the ISO 9001:2008 clauses and this required us to formalize the roles of the members of our CT protocol optimization team. We rely heavily on PACS‐based IT solutions for acquiring radiologist feedback on the performance of our CT protocols and the performance of our CT scanners in terms of dose (scanner output) and the function of the automatic tube current modulation. Specific details on our quality management system covering both quality control and ongoing optimization have been provided. The roles of each CT protocol team member have been defined, and the critical role that IT solutions provides for the management of files and the monitoring of CT protocols has been reviewed. In addition, the invaluable role management provides by being a champion for the project has been explained; lack of a project champion will mitigate the efforts of a CT protocol optimization team. Meeting the guidelines set forth in the AAPM practice guideline was not inherently difficult, but did, in our case, require the cooperation of radiologists, technologists, physicists, IT, administrative staff, and hospital management. Some of the IT solutions presented in this paper are novel and currently unique to our institution. PACS number: 87.57.Q PMID:26103176

78 FR 9648 - Approval and Promulgation of Air Quality Implementation Plans; District of Columbia; Volatile...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... Regulations (DCMR) for the Control of Volatile Organic Compounds (VOC) to meet the requirement to adopt reasonably available control technology (RACT) for sources as recommended by the Ozone Transport Commission (OTC) model rules and EPA's Control Techniques Guidelines (CTG) standards. On January 26, 2010 and...

Quality assurance in pathology in colorectal cancer screening and diagnosis—European recommendations

PubMed Central

Quirke, Phil; Risio, Mauro; Lambert, René; von Karsa, Lawrence

2010-01-01

In Europe, colorectal cancer is the most common newly diagnosed cancer and the second most common cause of cancer deaths, accounting for approximately 436,000 incident cases and 212,000 deaths in 2008. The potential of high-quality screening to improve control of the disease has been recognized by the Council of the European Union who issued a recommendation on cancer screening in 2003. Multidisciplinary, evidence-based European Guidelines for quality assurance in colorectal cancer screening and diagnosis have recently been developed by experts in a pan-European project coordinated by the International Agency for Research on Cancer. The full guideline document consists of ten chapters and an extensive evidence base. The content of the chapter dealing with pathology in colorectal cancer screening and diagnosis is presented here in order to promote international discussion and collaboration leading to improvements in colorectal cancer screening and diagnosis by making the principles and standards recommended in the new EU Guidelines known to a wider scientific community. PMID:21061133

[Phantom studies of ultrasound equipment for quality improvement in breast diagnosis].

PubMed

Madjar, H; Mundinger, A; Lattermann, U; Gufler, H; Prömpeler, H J

1996-04-01

According to the German guidelines for quality control of ultrasonic equipment, the following conditions are required for breast ultrasound: A transducer frequency between 5-7.5 MHz and a minimum field of view of 5 cm. Satisfactory images must be obtained in a depth between 0.5 and 4 cm with a wide tolerance of the focal zones. This allows the use of poor quality equipment which does not produce satisfactory image quality and it excludes a number of high frequency and high resolution transducers with a field of view below 5 cm. This study with a test phantom was performed to define image quality objectively. Sixteen ultrasound instruments in different price categories were used to perform standardized examinations on a breast phantom model 550 (ATS Laboratories, Bridgeport, USA). Contrast and spatial resolution in different penetration depths were investigated on cyst phantoms from 1-4 mm diameter and wire targets with defined distances between 0.5-3 mm 4 investigations reported the images. A positive correlation was seen between price category and image quality. This study demonstrates that transducer frequency and image geometry do not allow sufficient quality control. An improvement of ultrasound diagnosis is only possible if equipment guidelines are based on standard examinations with test phantoms.

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 and reporting of guidelines on the diagnosis and management of dystonia.

PubMed

Tamás, G; Abrantes, C; Valadas, A; Radics, P; Albanese, A; Tijssen, M A J; Ferreira, J J

2018-02-01

The quality of clinical practice guidelines on dystonia has not yet been assessed. Our aim was to appraise the methodological quality of guidelines worldwide and to analyze the consistency of their recommendations. We searched for clinical practice guidelines on dystonia diagnosis/treatment in the National Guideline Clearinghouse, PubMed, National Institute for Health and Care Excellence, Guidelines International Network and Web of Science databases. We also searched for guidelines on homepages of international neurological societies. We asked for guidelines from every Management Committee member of the BM1101 Action of the Cooperation between Science and Technology European framework and every member of the International Parkinson and Movement Disorders Society with special interest in dystonia. Fifteen guidelines were evaluated. Among guidelines on treatment, only one from the American Academy of Neurology could be considered as high quality. Among guidelines on diagnosis and therapy, the guideline from the European Federation of Neurological Societies was recommended by the appraisers. Clinical applicability and reports of editorial independence were the greatest shortcomings. The rigor of development was poor and stakeholder involvement was also incomplete in most guidelines. Discrepancies among recommendations may result from the weight given to consensus statements and expert opinions due to the lack of evidence, as well as inaccuracy of disease classification. The quality of appraised guidelines was low. It is necessary to improve the quality of guidelines on dystonia, and the applied terminology of dystonia also needs to be standardized. © 2017 EAN.

Systematic review of guidelines for management of intermediate hepatocellular carcinoma using the Appraisal of Guidelines Research and Evaluation II instrument.

PubMed

Holvoet, Tom; Raevens, Sarah; Vandewynckel, Yves-Paul; Van Biesen, Wim; Geboes, Karen; Van Vlierberghe, Hans

2015-10-01

Hepatocellular carcinoma is the second leading cause of cancer-related mortality worldwide. Multiple guidelines have been developed to assist clinicians in its management. We aimed to explore methodological quality of these guidelines focusing on treatment of intermediate hepatocellular carcinoma by transarterial chemoembolization. A systematic search was performed for Clinical Practice Guidelines and Consensus statements for hepatocellular carcinoma management. Guideline quality was appraised using the Appraisal of Guidelines Research and Evaluation II instrument, which rates guideline development processes across 6 domains: 'Scope and purpose', 'Stakeholder involvement', 'Rigour of development', 'Clarity of presentation', 'Applicability' and 'Editorial independence'. Thematic analysis of guidelines was performed to map differences in recommendations. Quality of 21 included guidelines varied widely, but was overall poor with only one guideline passing the 50% mark on all domains. Key recommendations as (contra)indications and technical aspects were inconsistent between guidelines. Aspects on side effects and health economics were mainly neglected. Methodological quality of guidelines on transarterial chemoembolization in hepatocellular carcinoma management is poor. This results in important discrepancies between guideline recommendations, creating confusion in clinical practice. Incorporation of the Appraisal of Guidelines Research and Evaluation II instrument in guideline development may improve quality of future guidelines by increasing focus on methodological aspects. Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

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.

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

A six sigma review of miniature optics alignment

NASA Astrophysics Data System (ADS)

Tesar, John

2009-08-01

The key to high quality optics is a set of guidelines. Create an understanding of the Criteria for Quality. Focus on understanding and controlling process variation. Examine verification and validation of methods. Take a view of the horizon as well as drilling down so you know when to put down the shovel.

Infection control in hemodialysis units: a quick access to essential elements.

PubMed

Karkar, Ayman; Bouhaha, Betty Mandin; Dammang, Mienalyn Lim

2014-05-01

Infection is the most common cause of hospitalization and the second most common cause of mortality among hemodialysis (HD) patients, after cardiovascular disease. HD patients as well as the dialysis staff are vulnerable to contracting health-care-associated infections (HAIs) due to frequent and prolonged exposure to many possible contaminants in the dialysis environment. The extracorporeal nature of the therapy, the associated common environmental conditions and the immune compromised status of HD patients are major predisposing factors. The evident increased potential for transmission of infections in the HD settings led to the creation and implementation of specific and stricter infection prevention and control measures in addition to the usual standard precautions. Different international organizations have generated guidelines and recommendations on infection prevention and control for implementation in the HD settings. These include the Centers for Disease Control and Prevention (CDC), the Association of Professionals in Infection Control (APIC), the Kidney Disease Outcomes Quality Initiative (K/DOQI), the European Best Practice Guidelines/European Renal Best Practice (EBPG/ERBP) and the Kidney Disease: Improving Global Outcomes (KDIGO). However, these guidelines are extensive and sometimes vary among different guideline-producing bodies. Our aim in this review is to facilitate the access, increase the awareness and encourage implementation among dialysis providers by reviewing, extracting and comparing the essential elements of guidelines and recommendations on infection prevention and control in HD units.

Quality assurance for gamma knives

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

Jones, E.D.; Banks, W.W.; Fischer, L.E.

1995-09-01

This report describes and summarizes the results of a quality assurance (QA) study of the Gamma Knife, a nuclear medical device used for the gamma irradiation of intracranial lesions. Focus was on the physical aspects of QA and did not address issues that are essentially medical, such as patient selection or prescription of dose. A risk-based QA assessment approach was used. Sample programs for quality control and assurance are included. The use of the Gamma Knife was found to conform to existing standards and guidelines concerning radiation safety and quality control of external beam therapies (shielding, safety reviews, radiation surveys,more » interlock systems, exposure monitoring, good medical physics practices, etc.) and to be compliant with NRC teletherapy regulations. There are, however, current practices for the Gamma Knife not covered by existing, formalized regulations, standards, or guidelines. These practices have been adopted by Gamma Knife users and continue to be developed with further experience. Some of these have appeared in publications or presentations and are slowly finding their way into recommendations of professional organizations.« less

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.

Methodological Quality of National Guidelines for Pediatric Inpatient Conditions

PubMed Central

Hester, Gabrielle; Nelson, Katherine; Mahant, Sanjay; Eresuma, Emily; Keren, Ron; Srivastava, Rajendu

2014-01-01

Background Guidelines help inform standardization of care for quality improvement (QI). The Pediatric Research in Inpatient Settings (PRIS) network published a prioritization list of inpatient conditions with high prevalence, cost, and variation in resource utilization across children’s hospitals. The methodological quality of guidelines for priority conditions is unknown. Objective To rate the methodological quality of national guidelines for 20 priority pediatric inpatient conditions. Design We searched sources including PubMed for national guidelines published 2002–2012. Guidelines specific to one organism, test or treatment, or institution were excluded. Guidelines were rated by two raters using a validated tool (AGREE II) with an overall rating on a 7-point scale (7–highest). Inter-rater reliability was measured with a weighted kappa coefficient. Results 17 guidelines met inclusion criteria for 13 conditions, 7 conditions yielded no relevant national guidelines. The highest methodological quality guidelines were for asthma, tonsillectomy, and bronchiolitis (mean overall rating 7, 6.5 and 6.5 respectively); the lowest were for sickle cell disease (2 guidelines) and dental caries (mean overall rating 4, 3.5, and 3 respectively). The overall weighted kappa was 0.83 (95% confidence interval 0.78–0.87). Conclusions We identified a group of moderate to high methodological quality national guidelines for priority pediatric inpatient conditions. Hospitals should consider these guidelines to inform QI initiatives. PMID:24677729

76 FR 64237 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-18

... chemical production and polytetrafluoroethylene operations; from paint, resin, and adhesive manufacturing... miscellaneous industrial adhesives control techniques guideline (CTG) category in accordance with the... to COMAR 26.11.19.30 ``Control of VOC from Chemical Production and Polytetrafluoroethylene Operations...

Evaluation of the theory-based Quality Improvement in Physical Therapy (QUIP) programme: a one-group, pre-test post-test pilot study.

PubMed

Rutten, Geert M; Harting, Janneke; Bartholomew, L Kay; Schlief, Angelique; Oostendorp, Rob A B; de Vries, Nanne K

2013-05-25

Guideline adherence in physical therapy is far from optimal, which has consequences for the effectiveness and efficiency of physical therapy care. Programmes to enhance guideline adherence have, so far, been relatively ineffective. We systematically developed a theory-based Quality Improvement in Physical Therapy (QUIP) programme aimed at the individual performance level (practicing physiotherapists; PTs) and the practice organization level (practice quality manager; PQM). The aim of the study was to pilot test the multilevel QUIP programme's effectiveness and the fidelity, acceptability and feasibility of its implementation. A one-group, pre-test, post-test pilot study (N = 8 practices; N = 32 PTs, 8 of whom were also PQMs) done between September and December 2009. Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines' main recommendations. Determinants of adherence were measured using quantitative methods (questionnaires). Delivery of the programme and management changes were assessed using qualitative methods (observations, group interviews, and document analyses). Changes in adherence and determinants were tested in the paired samples T-tests and expressed in effect sizes (Cohen's d). Overall adherence did not change (3.1%; p = .138). Adherence to three quality indicators improved (8%, 24%, 43%; .000 ≤ p ≤ .023). Adherence to one quality indicator decreased (-15.7%; p = .004). Scores on various determinants of individual performance improved and favourable changes at practice organizational level were observed. Improvements were associated with the programme's multilevel approach, collective goal setting, and the application of self-regulation; unfavourable findings with programme deficits. The one-group pre-test post-test design limits the internal validity of the study, the self-selected sample its external validity. The QUIP programme has the potential to change physical therapy practice but needs considerable revision to induce the ongoing quality improvement process that is required to optimize overall guideline adherence. To assess its value, the programme needs to be tested in a randomized controlled trial.

Danish evidence-based clinical guideline for use of nutritional support in pulmonary rehabilitation of undernourished patients with stable COPD.

PubMed

Beck, Anne Marie; Iepsen, Ulrik Winning; Tobberup, Randi; Jørgensen, Karsten Juhl

2015-02-01

Disease-related under-nutrition is a common problem in individuals with COPD. The rationale for nutritional support in pulmonary rehabilitation therefore seems obvious. However there is limited evidence regarding the patient-relevant outcomes i.e. activities of daily living (ADL) or quality of life. Therefore the topic was included in The Danish Health and Medicines Authority's development of an evidence-based clinical guideline for rehabilitation of patients with stable COPD. The methods were specified by The Danish Health and Medicines Authority as part of a standardized approach to evidence-based national clinical practice guidelines. They included formulation of a PICO with pre-defined criteria for the Population, Intervention, Control and Outcomes. Existing guidelines or systematic reviews were used after assessment using the AGREE II tool or AMSTAR, if possible. We identified primary studies by means of a systematic literature search (July to December 2013), and any identified studies were then quality assessed using the Cochrane risk of bias tool and the GRADE approach. The extracted data on our pre-defined outcomes were summarized in meta-analyses when possible, or meta-analyses from existing guidelines or systematic reviews were adapted. The results were used for labeling and wording of the recommendations. Data from 12 randomized controlled trials were included in a systematic review, which formed the basis for our recommendations as no new primary studies had been published. There were evidence of moderate quality that nutritional support for undernourished patients with COPD lead to a weight gain of 1.7kg (95% confidence interval: 1.3 to 2.2kg), but the effect was quantified as a mean change from baseline, which is less reliable. There were evidence of moderate quality that nutritional therapy does not increase in the 6 minute walking distance of 13 m (95% confidence interval: -27 to 54 m) when results in the intervention and control groups were compared at 9-16 weeks of follow-up. There was evidence of very low quality for an increase in lean body mass. The studies did not demonstrate an effect on either quality of life or ADL in patients with COPD. Some pre-defined outcomes (adverse events, hospital admissions and mortality) were not quantified. The evidence base for nutritional supplementation in rehabilitation of COPD patients is weak and any effect was limited to surrogate markers, such as increased weight and lean body mass, while an effect could not be seen on patient-relevant outcomes such as quality of life or activities of daily living. The intervention was given a weak recommendation. Copyright © 2014.

Current quality of cardiovascular prevention for Million Hearts: an analysis of 147,038 outpatients from The Guideline Advantage.

PubMed

Eapen, Zubin J; Liang, Li; Shubrook, Jay H; Bauman, Mary A; Bufalino, Vincent J; Bhatt, Deepak L; Peterson, Eric D; Hernandez, Adrian F

2014-09-01

Million Hearts is a national initiative to prevent 1 million heart attacks and strokes over 5 years. The degree to which outpatient providers are controlling risk factors has not been fully described. We examined adherence to the Million Hearts clinical quality measures using The Guideline Advantage, a nationwide quality improvement program for outpatient care. Specifically, we determined the proportion of patients with (1) ischemic vascular disease who were prescribed an antiplatelet drug; (2) hypertension whose blood pressure was controlled; (3) diabetes mellitus whose most recent low-density lipoprotein cholesterol level was <100 mg/dL; and 4) a tobacco use screening and who received a smoking cessation intervention as needed. From January 1, 2010, to March 31, 2012, there were 147,038 patients enrolled from 25 US practices. At the practice level, antiplatelet prescription ranged from 50.0% to 82.3% (median 71.9%, interquartile range [IQR] 66.7-82.1), hypertension control ranged from 48.6% to 75.3% (median 66.6%, IQR 60.1-70.9), hyperlipidemia control among patients with diabetes mellitus ranged from 53.3% to 100.0% (median 75.8%, IQR 65.8-83.0), and tobacco use screening and intervention ranged from 31.0% to 98.8% (median 79.8%, IQR 72.0-83.2). Black and people of color races were associated with a lower likelihood of blood pressure control and cholesterol control. Female gender was associated with a lower likelihood of antiplatelet prescription and cholesterol control. Compliance with quality measures for the Million Hearts initiative varies widely and is notable for racial and gender disparities. Our findings identify multiple opportunities to improve the quality of cardiovascular prevention. Copyright © 2014 Mosby, Inc. All rights reserved.

A new independent authority is needed to issue National Health Care guidelines.

PubMed

Keyhani, Salomeh; Kim, Azalea; Mann, Micah; Korenstein, Deborah

2011-02-01

Health experts emphasize that getting doctors to follow clinical guidelines can save both lives and money. Less attention has been paid to how the guidelines are developed and the variability in the recommendations they include. We examined the quality and content of screening guidelines as a proxy for guidelines in general and found that the source of the guidelines affects their quality. Guidelines with inconsistent recommendations are unlikely to serve patients or physicians well. The creation of an independent organization that would work with multiple stakeholders to develop guidelines holds the potential to improve their quality.

40 CFR 451.21 - Effluent limitations attainable by the application of the best practicable control technology...

Code of Federal Regulations, 2012 CFR

2012-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS... as video cameras, digital scanning sonar, and upweller systems; monitoring of sediment quality...

40 CFR 451.21 - Effluent limitations attainable by the application of the best practicable control technology...

Code of Federal Regulations, 2014 CFR

2014-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS... as video cameras, digital scanning sonar, and upweller systems; monitoring of sediment quality...

40 CFR 451.21 - Effluent limitations attainable by the application of the best practicable control technology...

Code of Federal Regulations, 2013 CFR

2013-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS... as video cameras, digital scanning sonar, and upweller systems; monitoring of sediment quality...

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

Medication and monitoring in palliative sedation therapy: a systematic review and quality assessment of published guidelines.

PubMed

Schildmann, Eva Katharina; Schildmann, Jan; Kiesewetter, Isabel

2015-04-01

Palliative sedation therapy (PST) is increasingly used in patients at the end of life. However, consensus about medications and monitoring is lacking. To assess published PST guidelines with regard to quality and recommendations on drugs and monitoring. We searched CINAHL, the Cochrane Library, Embase, PsycINFO, PubMed, and references of included articles until July 2014. Search terms included "palliative sedation" or "sedation" and "guideline" or "policy" or "framework." Guideline selection was based on English or German publications that included a PST guideline. Two investigators independently assessed the quality of the guidelines according to the Appraisal of Guidelines for Research and Evaluation II instrument (AGREE II) and extracted information on drug selection and monitoring. Nine guidelines were eligible. Eight guidelines received high quality scores for the domain "scope and purpose" (median 69%, range 28-83%), whereas in the other domains the guidelines' quality differed considerably. The majority of guidelines suggest midazolam as drug of first choice. Recommendations on dosage and alternatives vary. The guidelines' recommendations regarding monitoring of PST show wide variation in the number and details of outcome parameters and methods of assessment. The published guidelines on PST vary considerably regarding their quality and content on drugs and monitoring. Given the need for clear guidance regarding PST in patients at the end of life, this comparative analysis may serve as a starting point for further improvement. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

[Systematic Review of the Methodology Quality in Lung Cancer Screening Guidelines].

PubMed

Li, Jiang; Su, Kai; Li, Fang; Tang, Wei; Huang, Yao; Wang, Le; Huang, Huiyao; Shi, Jufang; Dai, Min

2016-10-20

Lung cancer is the most common malignancy and screening can decrease the mortality. High quality screening guideline is necessary and important for effective work. Our study is to review and evaluate the basic characteristics and methodology quality of the current global lung cancer screening guidelines so as to provide useful information for domestic study in the future. Electronic searches were done in English and Chinese databases including PubMed, the Cochrane Library, Web of Science, Embase, CNKI, CBM, Wanfang, and some cancer official websites. Articles were screened according to the predefined inclusion and exclusion criteria by two researchers. The quality of guidelines was assessed by AGREE II. At last, a total of 11 guidelines with methodology were included. The guidelines were issued mainly by USA (81%). Canada and China developed one, respectively. As for quality, the average score in the "Scale and objective" of all guidelines was 80, the average score in the "Participants" was 52, the average score in the "rigorism" was 50, the average score in the "clarity" was 76, the average score in the "application" was 43 and the average score in the "independence" was 59. The highest average score was found in 2013 and 2015. Canada guideline had higher quality in six domains. 7 guidelines were evaluated as A level. The number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries with heavy burden. Multi-country contribution to one guideline was another trend. Evidence-based methodology was accepted globally in the guideline development.

Forest management guidelines for controlling wild grapevines

Treesearch

H. Clay Smith

1984-01-01

Grapevines (Vitis spp.) are becoming a major problem to forest managers in the Appalachians, especially when clearcutting is done on highly productive hardwood sites. Where present, grapevines can reduce tree quality and growth, and eventually kill the tree. Silvical characteristics of grapevines are discussed as background for grapevine control....

76 FR 31856 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... Flat Wood Paneling Surface Coating Processes AGENCY: Environmental Protection Agency (EPA). ACTION... by EPA's Control Techniques Guidelines (CTG) standards for flat wood paneling surface coating processes. EPA is approving this revision concerning the adoption of the EPA CTG requirements for flat wood...

76 FR 4578 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... Wood Paneling Coatings AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY... (RACT) for sources covered by EPA's Control Techniques Guidelines (CTG) for flat wood paneling coatings. These amendments will reduce emissions of volatile organic compound (VOC) from flat wood coating...

76 FR 13567 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-14

... Flat Wood Paneling Surface Coating Processes AGENCY: Environmental Protection Agency (EPA). ACTION... sources covered by EPA's Control Techniques Guidelines (CTG) standards for flat wood paneling surface... Protection (PADEP) submitted to EPA a SIP revision concerning the adoption of the CTG for flat wood paneling...

Revisiting the Quality of Reporting Randomized Controlled Trials in Nursing Literature.

PubMed

Adams, Yenupini Joyce; Kamp, Kendra; Liu, Cheng Ching; Stommel, Manfred; Thana, Kanjana; Broome, Marion E; Smith, Barbara

2018-03-01

To examine and update the literature on the quality of randomized controlled trials (RCTs) as reported in top nursing journals, based on manuscripts' adherence to the CONsolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive review of adherence of RCT manuscript to CONSORT guidelines. Top 40 International Scientific Indexing (ISI) ranked nursing journals that published 20 or more RCTs between 2010 and 2014, were included in the study. Selected articles were randomly assigned to four reviewers who assessed the quality of the articles using the CONSORT checklist. Data were analyzed using descriptive and inferential statistics. A total of 119 articles were included in the review. The mean CONSORT score significantly differed by journal but did not differ based on year of publication. The least consistently reported items included random allocation, who randomly assigned participants and whether those administering the interventions were blinded to group assignment. Although progress has been made, there is still room for improvement in the quality of RCT reporting in nursing journals. Special attention must be paid to how adequately studies adhere to the CONSORT prior to publication in nursing journals. Evidence from (RCTs) are thought to provide the best evidence for evaluating the impact of treatments and interventions by the U.S. Preventive Services Task Force. Since the evidence may be used for the development of clinical practice guidelines, it is critical that RCTs be designed, conducted, and reported appropriately and precisely. © 2017 Sigma Theta Tau International.

Linking water quality guidelines to the natural characteristics of catchments in order to support distinct aquatic ecosystems: Water quality guidelines for suspended particulate matter

NASA Astrophysics Data System (ADS)

Bilotta, G. S.; Grove, M. K.; Harrison, C.; Joyce, C. B.; Peacock, C.

2012-12-01

The natural characteristics of a catchment provide a template that controls the background rates of geomorphological processes operating within that catchment, which in-turn determines the background physico-chemical and hydro-morphological characteristics of the catchment's surface waters. Large differences in the natural characteristics of catchments (e.g. geology, topography, climate), lead to unique physico-chemical and hydro-morphological conditions that support unique freshwater communities. However, this uniqueness is not always recognised in international water quality guidelines, which often attempt to apply blanket water-quality guidelines to 'protect' a wide range of ecosystems. In this paper we investigate the natural characteristics that control background concentrations of suspended particulate matter (SPM - including nano-scale particles to sand-sized sediments), which is a well-known cause of ecological degradation. At present, the management of SPM is hampered by a lack of understanding of the SPM conditions that water quality managers should aim to achieve in contrasting environments in order to support good ecological status. To address this, in this paper we examine the SPM preferences of contrasting biological communities that are in reference condition (minimal anthropogenic disturbance and high ecological status). We analyse historical SPM data collected on a monthly basis from a wide range of reference-condition temperate environments (638 stream/river sites comprising 42 different biological community-types). This analysis reveals that there are statistically significant differences (One-way ANOVA p < 0.001) between the background SPM concentrations observed in contrasting communities that are in reference condition. Mean background SPM concentrations for contrasting communities ranged from 1.7 to 26.2 mg L-1 (i.e. more than a 15-fold difference). We propose a model for predicting environment-specific water quality guidelines for SPM. In order to develop this model, the 638 reference-condition sites were first classified into one of five mean background SPM ranges (0.00-5.99, 6.00-11.99, 12.00-17.99, 18.00-23.99 and >24.00 mg L-1). Stepwise Multiple Discriminant Analysis (MDA) of these ranges showed that a site's SPM range can be predicted as a function of: mean annual air temperature, mean annual precipitation, mean altitude of upstream catchment, distance from source, slope to source, channel width and depth, the percentage of catchment area comprised of clay, chalk, and hard rock solid geology, and the percentage of the catchment area comprised of blown sand/landslide material as the surface (drift) material. Although the model is still being improved and developed, this research highlights the need to link water quality guidelines to the natural characteristics of catchments and the physico-chemical preferences of the biological communities that would naturally inhabit them.

Lateral-Directional Eigenvector Flying Qualities Guidelines for High Performance Aircraft

NASA Technical Reports Server (NTRS)

Davidson, John B.; Andrisani, Dominick, II

1996-01-01

This report presents the development of lateral-directional flying qualities guidelines with application to eigenspace (eigenstructure) assignment methods. These guidelines will assist designers in choosing eigenvectors to achieve desired closed-loop flying qualities or performing trade-offs between flying qualities and other important design requirements, such as achieving realizable gain magnitudes or desired system robustness. This has been accomplished by developing relationships between the system's eigenvectors and the roll rate and sideslip transfer functions. Using these relationships, along with constraints imposed by system dynamics, key eigenvector elements are identified and guidelines for choosing values of these elements to yield desirable flying qualities have been developed. Two guidelines are developed - one for low roll-to-sideslip ratio and one for moderate-to-high roll-to-sideslip ratio. These flying qualities guidelines are based upon the Military Standard lateral-directional coupling criteria for high performance aircraft - the roll rate oscillation criteria and the sideslip excursion criteria. Example guidelines are generated for a moderate-to-large, an intermediate, and low value of roll-to-sideslip ratio.

Benchmarking of venous thromboembolism prophylaxis practice with ENT.UK guidelines.

PubMed

Al-Qahtani, Ali S

2017-05-01

The aim of this study was to benchmark our guidelines of prevention of venous thromboembolism (VTE) in ENT surgical population against ENT.UK guidelines, and also to encourage healthcare providers to utilize benchmarking as an effective method of improving performance. The study design is prospective descriptive analysis. The setting of this study is tertiary referral centre (Assir Central Hospital, Abha, Saudi Arabia). In this study, we are benchmarking our practice guidelines of the prevention of VTE in the ENT surgical population against that of ENT.UK guidelines to mitigate any gaps. ENT guidelines 2010 were downloaded from the ENT.UK Website. Our guidelines were compared with the possibilities that either our performance meets or fall short of ENT.UK guidelines. Immediate corrective actions will take place if there is quality chasm between the two guidelines. ENT.UK guidelines are evidence-based and updated which may serve as role-model for adoption and benchmarking. Our guidelines were accordingly amended to contain all factors required in providing a quality service to ENT surgical patients. While not given appropriate attention, benchmarking is a useful tool in improving quality of health care. It allows learning from others' practices and experiences, and works towards closing any quality gaps. In addition, benchmarking clinical outcomes is critical for quality improvement and informing decisions concerning service provision. It is recommended to be included on the list of quality improvement methods of healthcare services.

TECHNICAL GUIDANCE DOCUMENT: THE FABRICATION OF POLYETHYLENE FML FIELD SEAMS

EPA Science Inventory

This technical guidance document is meant to augment the numerous construction quality control and construction assurance (CQC and CQA) guidelines that are presently available for high density polyethylene (HDPE) liner installation and inspection.

78 FR 59240 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-26

... Guidelines for Miscellaneous Metal and Plastic Parts Which Includes Pleasure Craft Coating Operations AGENCY... Miscellaneous Metal Parts and Plastic Coating (MMPPC) operations and as recommended by trade associations...

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.

Framework for Small-Scale Experiments in Software Engineering: Guidance and Control Software Project: Software Engineering Case Study

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J.

1998-01-01

Software is becoming increasingly significant in today's critical avionics systems. To achieve safe, reliable software, government regulatory agencies such as the Federal Aviation Administration (FAA) and the Department of Defense mandate the use of certain software development methods. However, little scientific evidence exists to show a correlation between software development methods and product quality. Given this lack of evidence, a series of experiments has been conducted to understand why and how software fails. The Guidance and Control Software (GCS) project is the latest in this series. The GCS project is a case study of the Requirements and Technical Concepts for Aviation RTCA/DO-178B guidelines, Software Considerations in Airborne Systems and Equipment Certification. All civil transport airframe and equipment vendors are expected to comply with these guidelines in building systems to be certified by the FAA for use in commercial aircraft. For the case study, two implementations of a guidance and control application were developed to comply with the DO-178B guidelines for Level A (critical) software. The development included the requirements, design, coding, verification, configuration management, and quality assurance processes. This paper discusses the details of the GCS project and presents the results of the case study.

Recent Regulatory Trends in Pharmaceutical Manufacturing and their Impact on the Industry.

PubMed

Tabersky, Daniel; Woelfle, Michael; Ruess, Juan-Antonio; Brem, Simon; Brombacher, Stephan

2018-03-30

The pharmaceutical industry is one of the most regulated industries in Switzerland. Though the concept of good manufacturing practises (GMP) was implemented for chemical production in the early 1990s, the rules and regulations for our industry are in constant evolution. In this article we will highlight the impact of these changes to the industry using three recent guideline up-dates as examples: the implementation of ICH Q3D 'Guideline for elemental impurities', the EU-GMP Guideline Part III Chapter 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' from 01. June 2015, and the new guidelines to data integrity such as 'PIC/S 041-1 Good Practices for Data Management and Integrity in regulated GMP/GDP environments'. These examples show how scientific approaches help to modernize the control strategies for our products and increase product quality for a better patient safety. The requirements of data integrity regulations are also of interest to industries and universities not working under GxP requirements as they also support the business to improve data quality (traceability) for patent applications, and reduce risk of data falsification.

Methodological Quality of Consensus Guidelines in Implant Dentistry.

PubMed

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions.

Methodological Quality of Consensus Guidelines in Implant Dentistry

PubMed Central

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Background Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. Objective To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. Methods The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Results Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Conclusions Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions. PMID:28107405

Single-Family Quality Control Inspector Job Task Analysis

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

Head, Heather R; Kurnik, Charles W

The National Renewable Energy Laboratory (NREL) is contracted by the U.S. Department of Energy (DOE) Weatherization Assistance Program (WAP) to develop and maintain the resources under the Guidelines for Home Energy Professionals (GHEP) project. As part of the GHEP strategy to increase the quality of work conducted for single-family, residential energy-efficiency retrofits, the Home Energy Professionals Job Task Analysis are used as the foundation for quality training programs and trainers.

Use of cardiocerebral resuscitation or AHA/ERC 2005 Guidelines is associated with improved survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis

PubMed Central

Salmen, Marcus; Ewy, Gordon A; Sasson, Comilla

2012-01-01

Objective To determine whether the use of cardiocerebral resuscitation (CCR) or AHA/ERC 2005 Resuscitation Guidelines improved patient outcomes from out-of-hospital cardiac arrest (OHCA) compared to older guidelines. Design Systematic review and meta-analysis. Data sources MEDLINE, EMBASE, Web of Science and the Cochrane Library databases. We also hand-searched study references and consulted experts. Study selection Design: randomised controlled trials and observational studies. Population OHCA patients, age >17 years. Comparators ‘Control’ protocol versus ‘Study’ protocol. ‘Control’ protocol defined as AHA/ERC 2000 Guidelines for cardiopulmonary resuscitation (CPR). ‘Study’ protocol defined as AHA/ERC 2005 Guidelines for CPR, or a CCR protocol. Outcome Survival to hospital discharge. Quality High-quality or medium-quality studies, as measured by the Newcastle Ottawa Scale using predefined categories. Results Twelve observational studies met inclusion criteria. All the three studies using CCR demonstrated significantly improved survival compared to use of AHA 2000 Guidelines, as did five of the nine studies using AHA/ERC 2005 Guidelines. Pooled data demonstrate that use of a CCR protocol has an unadjusted OR of 2.26 (95% CI 1.64 to 3.12) for survival to hospital discharge among all cardiac arrest patients. Among witnessed ventricular fibrillation/ventricular tachycardia (VF/VT) patients, CCR increased survival by an OR of 2.98 (95% CI 1.92 to 4.62). Studies using AHA/ERC 2005 Guidelines showed an overall trend towards increased survival, but significant heterogeneity existed among these studies. Conclusions We demonstrate an association with improved survival from OHCA when CCR protocols or AHA/ERC 2005 Guidelines are compared to use of older guidelines. In the subgroup of patients with witnessed VF/VT, there was a threefold increase in OHCA survival when CCR was used. CCR appears to be a promising resuscitation protocol for Emergency Medical Services providers in increasing survival from OHCA. Future research will need to be conducted to directly compare AHA/ERC 2010 Guidelines with the CCR approach. PMID:23036985

Publishing web-based guidelines using interactive decision models.

PubMed

Sanders, G D; Nease, R F; Owens, D K

2001-05-01

Commonly used methods for guideline development and dissemination do not enable developers to tailor guidelines systematically to specific patient populations and update guidelines easily. We developed a web-based system, ALCHEMIST, that uses decision models and automatically creates evidence-based guidelines that can be disseminated, tailored and updated over the web. Our objective was to demonstrate the use of this system with clinical scenarios that provide challenges for guideline development. We used the ALCHEMIST system to develop guidelines for three clinical scenarios: (1) Chlamydia screening for adolescent women, (2) antiarrhythmic therapy for the prevention of sudden cardiac death; and (3) genetic testing for the BRCA breast-cancer mutation. ALCHEMIST uses information extracted directly from the decision model, combined with the additional information from the author of the decision model, to generate global guidelines. ALCHEMIST generated electronic web-based guidelines for each of the three scenarios. Using ALCHEMIST, we demonstrate that tailoring a guideline for a population at high-risk for Chlamydia changes the recommended policy for control of Chlamydia from contact tracing of reported cases to a population-based screening programme. We used ALCHEMIST to incorporate new evidence about the effectiveness of implantable cardioverter defibrillators (ICD) and demonstrate that the cost-effectiveness of use of ICDs improves from $74 400 per quality-adjusted life year (QALY) gained to $34 500 per QALY gained. Finally, we demonstrate how a clinician could use ALCHEMIST to incorporate a woman's utilities for relevant health states and thereby develop patient-specific recommendations for BRCA testing; the patient-specific recommendation improved quality-adjusted life expectancy by 37 days. The ALCHEMIST system enables guideline developers to publish both a guideline and an interactive decision model on the web. This web-based tool enables guideline developers to tailor guidelines systematically, to update guidelines easily, and to make the underlying evidence and analysis transparent for users.

Systematic analysis underlying the quality of the scientific evidence and conflicts of interest in gastroenterology practice guidelines.

PubMed

Feuerstein, Joseph D; Gifford, Anne E; Akbari, Mona; Goldman, Jonathan; Leffler, Daniel A; Sheth, Sunil G; Cheifetz, Adam S

2013-11-01

The practice guidelines published by the American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG) are used to establish standards of care and improve patient outcomes. We examined the guidelines for quality of evidence, methods of grading evidence, and conflicts of interest (COIs). All 81 (AGA and ACG) guidelines available online on 26 July 2012 were reviewed for the presence of grading of evidence and COIs. In total, 570 recommendations were evaluated for level of evidence and methods used to grade the evidence. The data were evaluated in aggregate and by society. Only 31% (n=25) of the guidelines graded the levels of evidence. A total of 12 systems were used to grade the quality of evidence in these 25 guidelines. Of the 570 recommendations reviewed, only 29% (n=165) were supported by the highest quality of evidence, level A; 37% (n=210) level B, 29% (n=165) level C, and 5% (n=30) level D. Since 2007, 87% (n=13/15) of the ACG guidelines graded the evidence compared with only 33% of the AGA guidelines (n=4/12). Furthermore, 70% (n=57/81) of the guidelines failed to disclose any information regarding COIs. Of the 24 articles commenting on COIs, 67% reported COIs. Although the majority of the gastroenterology guidelines fail to grade the quality of evidence, more recent ACG guidelines grade majority of their recommendations. When the evidence is graded, most of the supporting evidence is based on lower-quality evidence. In addition, most of the guidelines fail to comment on COIs, and when disclosed, numerous COIs were present. This study highlights the critical need to revise the guideline development process. Future guidelines should clearly state the quality of evidence for their recommendations, utilize a standard grading system, and be transparent regarding all COIs.

[Quality indicators for National Disease Management Guidelines using the example of the National Disease Management Guideline for "Chronic Heart Failure"].

PubMed

Nothacker, Monika Judith; Langer, Thomas; Weinbrenner, Susanne

2011-01-01

Together with an expert committee a structured approach to determining quality indicators for National Disease Management Guidelines has been developed. The key steps of this approach include: introducing guideline authors to the methodology at an early stage of the process of guideline development, pre-selecting recommendations of the guideline which are potentially measurable by means of quality indicators, assessing the potentially measurable quality indicators in written form using five criteria (including their importance for the health care system and clarity of definitions) and approving them in a formal consensus process. For lack of a database these quality indicators must be regarded as preliminary. For the National Disease Management Guideline "Chronic Heart Failure" nine rate-based indicators have been chosen. The indicators correspond to important strong recommendations (grade of recommendation: A) from the fields of diagnosis (two), general therapeutic strategy (two), specific treatment (three), clinical monitoring (one) and co-ordination of care (one). In a second step, the quality indicators have to be validated within a pilot project. The determination and assessment of the potential quality indicators have revealed room for improvement of guideline development. In particular, there is a need for more health care data and for specification of recommendations.

222-S Laboratory Quality Assurance Plan. Revision 1

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

Meznarich, H.K.

1995-07-31

This Quality Assurance Plan provides,quality assurance (QA) guidance, regulatory QA requirements (e.g., 10 CFR 830.120), and quality control (QC) specifications for analytical service. This document follows the U.S Department of Energy (DOE) issued Hanford Analytical Services Quality Assurance Plan (HASQAP). In addition, this document meets the objectives of the Quality Assurance Program provided in the WHC-CM-4-2, Section 2.1. Quality assurance elements required in the Guidelines and Specifications for Preparing Quality Assurance Program Plans (QAMS-004) and Interim Guidelines and Specifications for Preparing Quality Assurance Project Plans (QAMS-005) from the US Environmental Protection Agency (EPA) are covered throughout this document. A qualitymore » assurance index is provided in the Appendix A. This document also provides and/or identifies the procedural information that governs laboratory operations. The personnel of the 222-S Laboratory and the Standards Laboratory including managers, analysts, QA/QC staff, auditors, and support staff shall use this document as guidance and instructions for their operational and quality assurance activities. Other organizations that conduct activities described in this document for the 222-S Laboratory shall follow this QA/QC document.« less

An Evaluation of Web-Based Clinical Practice Guidelines for Managing Problems Associated with Cannabis Use

PubMed Central

Turner, Michael W; Rooke, Sally E; Langton, Julia M; Gates, Peter J

2012-01-01

Background Cannabis is the most widely used illicit substance, and multiple treatment options and avenues exist for managing its use. There has been an increase in the development of clinical practice guidelines (CPGs) to improve standards of care in this area, many of which are disseminated online. However, little is known about the quality and accessibility of these online CPGs. Objective The purpose of study 1 was to determine the extent to which cannabis-related CPGs disseminated online adhere to established methodological standards. The purpose of study 2 was to determine if treatment providers are familiar with these guidelines and to assess their perceived quality of these guidelines. Methods Study 1 involved a systematic search using the Google Scholar search engine and the National Drugs Sector Information Service (NDSIS) website of the Alcohol and Other Drugs Council of Australia (ADCA) to identify CPGs disseminated online. To be included in the current study, CPGs needed to be free of charge and provide guidance on psychological interventions for reducing cannabis use. Four trained reviewers independently assessed the quality of the 7 identified guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. Study 2 assessed 166 Australian cannabis-use treatment providers’ (mean age = 45.47 years, SD 12.14) familiarity with and opinions of these 7 guidelines using an online survey. Treatment providers were recruited using online advertisements that directed volunteers to a link to complete the survey, which was posted online for 6 months (January to June 2012). Primary study outcomes included quality scores and rates of guideline familiarity, guideline use, and discovery methods. Results Based on the AGREE II, the quality of CPGs varied considerably. Across different reporting domains, adherence to methodological standards ranged from 0% to 92%. Quality was lowest in the domains of rigor of development (50%), applicability (46%), and editorial independence (30%). Although examination of AGREE II domain scores demonstrated that the quality of the 7 guidelines could be divided into 3 categories (high quality, acceptable to low quality, and very low quality), review of treatment providers’ quality perceptions indicated all guidelines fell into 1 category (acceptable quality). Based on treatment providers’ familiarity with and usage rates of the CPGs, a combination of peer/colleagues, senior professionals, workshops, and Internet dissemination was deemed to be most effective for promoting cannabis use CPGs. Lack of time, guideline length, conflicts with theoretical orientation, and prior content knowledge were identified as barriers to guideline uptake. Conclusions Developers of CPGs should improve their reporting of development processes, conflicts of interest, and CPGs’ applicability to practice, while remaining cognizant that long guidelines may deter implementation. Treatment providers need to be aware that the quality of cannabis-related CPGs varies substantially. PMID:23249447

Guidelines and recommendations for household and external travel surveys.

DOT National Transportation Integrated Search

2010-03-01

The Texas Department of Transportation has a comprehensive ongoing travel survey program. Research under RMC : 0-5711 examined areas within two select travel surveys concerning quality control issues involved in data collection : and sampling error i...

Disk diffusion quality control guidelines for NVP-PDF 713: a novel peptide deformylase inhibitor.

PubMed

Anderegg, Tamara R; Jones, Ronald N

2004-01-01

NVP-PDF713 is a peptide deformylase inhibitor that has emerged as a candidate for treating Gram-positive infections and selected Gram-negative species that commonly cause community-acquired respiratory tract infections. This report summarizes the results of a multi-center (seven participants) disk diffusion quality control (QC) investigation for NVP PDF-713 using guidelines of the National Committee for Clinical Laboratory Standards and the standardized disk diffusion method. A total of 420 NVP-PDF 713 zone diameter values were generated for each QC organism. The proposed zone diameter ranges contained 97.6-99.8% of the reported participant results and were: Staphylococcus aureus ATCC 25923 (25-35 mm), Streptococcus pneumoniae ATCC 49619 (30-37 mm), and Haemophilus influenzae ATCC 49247 (24-32 mm). These QC criteria for the disk diffusion method should be applied during the NVP-PDF 713 clinical trials to maximize test accuracy.

SIMPLE: implementation of recommendations from international evidence-based guidelines on caesarean sections in the Netherlands. Protocol for a controlled before and after study.

PubMed

Melman, Sonja; Schoorel, Ellen N C; Dirksen, Carmen; Kwee, Anneke; Smits, Luc; de Boer, Froukje; Jonkers, Madelaine; Woiski, Mallory D; Mol, Ben Willem J; Doornbos, Johannes P R; Visser, Harry; Huisjes, Anjoke J M; Porath, Martina M; Delemarre, Friso M C; Kuppens, Simone M I; Aardenburg, Robert; Van Dooren, Ivo M A; Vrouenraets, Francis P J M; Lim, Frans T H; Kleiverda, Gunilla; van der Salm, Paulien C M; de Boer, Karin; Sikkema, Marko J; Nijhuis, Jan G; Hermens, Rosella P M G; Scheepers, Hubertina C J

2013-01-03

Caesarean section (CS) rates are rising worldwide. In the Netherlands, the most significant rise is observed in healthy women with a singleton in vertex position between 37 and 42 weeks gestation, whereas it is doubtful whether an improved outcome for the mother or her child was obtained. It can be hypothesized that evidence-based guidelines on CS are not implemented sufficiently. Therefore, the present study has the following objectives: to develop quality indicators on the decision to perform a CS based on key recommendations from national and international guidelines; to use the quality indicators in order to gain insight into actual adherence of Dutch gynaecologists to guideline recommendations on the performance of a CS; to explore barriers and facilitators that have a direct effect on guideline application regarding CS; and to develop, execute, and evaluate a strategy in order to reduce the CS incidence for a similar neonatal outcome (based on the information gathered in the second and third objectives). An independent expert panel of Dutch gynaecologists and midwives will develop a set of quality indicators on the decision to perform a CS. These indicators will be used to measure current care in 20 hospitals with a population of 1,000 women who delivered by CS, and a random selection of 1,000 women who delivered vaginally in the same period. Furthermore, by interviewing healthcare professionals and patients, the barriers and facilitators that may influence the decision to perform a CS will be measured. Based on the results, a tailor-made implementation strategy will be developed and tested in a controlled before-and-after study in 12 hospitals (six intervention, six control hospitals) with regard to effectiveness, experiences, and costs. This study will offer insight into the current CS care and into the hindering and facilitating factors influencing obstetrical policy on CS. Furthermore, it will allow definition of patient categories or situations in which a tailor-made implementation strategy will most likely be meaningful and cost effective, without negatively affecting the outcome for mother and child. http://www.clinicaltrials.gov: NCT01261676.

An international comparison of occupational health guidelines for the management of mental disorders and stress-related psychological symptoms.

PubMed

Joosen, Margot C W; Brouwers, Evelien P M; van Beurden, Karlijn M; Terluin, Berend; Ruotsalainen, Jani H; Woo, Jong-Min; Choi, Kyeong-Sook; Eguchi, Hisashi; Moriguchi, Jiro; van der Klink, Jac J L; van Weeghel, Jaap

2015-05-01

We compared available guidelines on the management of mental disorders and stress-related psychological symptoms in an occupational healthcare setting and determined their development and reporting quality. To identify eligible guidelines, we systematically searched National Guideline Clearinghouse, Guidelines International Network Library and PubMed. Members of the International Commission on Occupational Health (ICOH), were also consulted. Guidelines recommendations were compared and reporting quality was assessed using the AGREE II instrument. Of 2126 titles retrieved, 14 guidelines were included: 1 Japanese, 2 Finnish, 2 Korean, 2 British and 7 Dutch. Four guidelines were of high-reporting quality. Best described was the Scope and Purpose, and the poorest described were competing interests (Editorial independence) and barriers and facilitators for implementation (Applicability). Key recommendations were often difficult to identify. Most guidelines recommend employing an inventory of symptoms, diagnostic classification, performance problems and workplace factors. All guidelines recommend specific return-to-work interventions, and most agreed on psychological treatment and communication between involved stakeholders. Practice guidelines to address work disability due to mental disorders and stress-related symptoms are available in various countries around the world, however, these guidelines are difficult to find. To promote sharing, national guidelines should be accessible via established international databases. The quality of the guideline's developmental process varied considerably. To increase quality and applicability, guideline developers should adopt a common structure for the development and reporting of their guidelines, for example Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. Owing to differences in social systems, developers can learn from each other through reviews of this kind. 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.

An evaluation of the objective quality and perceived usefulness of maternity clinical practice guidelines at a tertiary maternity unit.

PubMed

Trollope, Helena; Leung, Joyce Pui Yee; Wise, Michelle; Farquhar, Cynthia; Sadler, Lynn

2018-03-05

Compliance with maternity clinical practice guidelines developed by National Women's Health has been found to be low at audit. To explore the reasons for poor compliance with maternity guidelines by evaluating the quality of a sample of National Women's Health guidelines using a validated instrument and assessing local guideline users' perceptions of and attitudes toward guidelines. Five independent reviewers evaluated the quality of 10 purposively selected guidelines for adherence to the Appraisal of Guidelines Research & Evaluation (AGREE) II instrument standards. A self-administered questionnaire for staff was undertaken regarding views of and barriers to guideline use. None of the guidelines attained a score over 50% for the following domains: stakeholder involvement, rigour of development, applicability, editorial independence. The highest scoring domain was clarity of presentation (mean 69%). All guidelines scored the minimum possible for editorial independence. Survey respondents had positive attitudes toward guidelines, believed that their use could improve quality of care within the service, and felt that encouragement from senior staff members and peers would encourage their use. Accessibility was the most commonly cited of many barriers identified. The National Women's Health guidelines evaluated in this study cannot be considered to be high quality, and could be improved by reporting on methodology of the development process. Although poor guideline development may contribute to failure of the local maternity guidelines, it appears that accessibility is a major barrier to their use and implementation. © 2018 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Guidelines for the Design, Fabrication, Testing, Installation and Operation of Srf Cavities

NASA Astrophysics Data System (ADS)

Theilacker, J.; Carter, H.; Foley, M.; Hurh, P.; Klebaner, A.; Krempetz, K.; Nicol, T.; Olis, D.; Page, T.; Peterson, T.; Pfund, P.; Pushka, D.; Schmitt, R.; Wands, R.

2010-04-01

Superconducting Radio-Frequency (SRF) cavities containing cryogens under pressure pose a potential rupture hazard to equipment and personnel. Generally, pressure vessels fall within the scope of the ASME Boiler and Pressure Vessel Code however, the use of niobium as a material for the SRF cavities is beyond the applicability of the Code. Fermilab developed a guideline to ensure sound engineering practices governing the design, fabrication, testing, installation and operation of SRF cavities. The objective of the guideline is to reduce hazards and to achieve an equivalent level of safety afforded by the ASME Code. The guideline addresses concerns specific to SRF cavities in the areas of materials, design and analysis, welding and brazing, pressure relieving requirements, pressure testing and quality control.

Long-term pavement performance compliance with Department of Transportation information dissemination quality guidelines

DOT National Transportation Integrated Search

2008-11-01

This document provides information on the compliance of the LTPP program with the guidelines the Department of Transportation (DOT) issued Information Dissemination Quality Guidelines (IDQG). These guidelines were developed in response to requirement...

[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.

Water Quality Criteria for Hexahydro-1,3,5-Trinitro-1,3,5-Triazine (RDX)

DTIC Science & Technology

1986-06-01

Guidelines ( OECD 1981) for testing of chemicals require that mortality of controls should not exceed 20 percent at the end of the test, and that the average...of the accumulated RDX, but virtually no eliminatio, occurred from either muscle or viscera in bluegill sunfish (Bentley et alk . 1977). No maximum...Organisation for Economic Co-Operation and Development ( OECD ). 1981. OECD Guidelines for Testing of Chemicals. OECD Publications and Infor- mation Center

21 CFR 104.5 - General principles.

Code of Federal Regulations, 2011 CFR

2011-04-01

... CONSUMPTION NUTRITIONAL QUALITY GUIDELINES FOR FOODS General Provisions § 104.5 General principles. (a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional... requirements of the nutritional quality guideline established for its class of food may state “This product...

21 CFR 104.5 - General principles.

Code of Federal Regulations, 2012 CFR

2012-04-01

... CONSUMPTION NUTRITIONAL QUALITY GUIDELINES FOR FOODS General Provisions § 104.5 General principles. (a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional... requirements of the nutritional quality guideline established for its class of food may state “This product...

21 CFR 104.5 - General principles.

Code of Federal Regulations, 2014 CFR

2014-04-01

... CONSUMPTION NUTRITIONAL QUALITY GUIDELINES FOR FOODS General Provisions § 104.5 General principles. (a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional... requirements of the nutritional quality guideline established for its class of food may state “This product...

21 CFR 104.5 - General principles.

Code of Federal Regulations, 2013 CFR

2013-04-01

... CONSUMPTION NUTRITIONAL QUALITY GUIDELINES FOR FOODS General Provisions § 104.5 General principles. (a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional... requirements of the nutritional quality guideline established for its class of food may state “This product...

21 CFR 104.5 - General principles.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CONSUMPTION NUTRITIONAL QUALITY GUIDELINES FOR FOODS General Provisions § 104.5 General principles. (a) A nutritional quality guideline prescribes the minimum level or range of nutrient composition (nutritional... requirements of the nutritional quality guideline established for its class of food may state “This product...

Oncology trial abstracts showed suboptimal improvement in reporting: a comparative before-and-after evaluation using CONSORT for Abstract guidelines.

PubMed

Ghimire, Saurav; Kyung, Eunjung; Lee, Heeyoung; Kim, Eunyoung

2014-06-01

The aims of this study were to evaluate the quality of randomized controlled trial (RCT) abstracts published in the field of oncology and identify characteristics associated with better reporting quality. All phase III trials published during 2005-2007 [before Consolidated Standards of Reporting Trials (CONSORT)] and 2010-2012 (after CONSORT) were searched electronically in MEDLINE/PubMed and retrieved for review using an 18-point overall quality score (OQS) for reporting based on the CONSORT for Abstract guidelines. Descriptive statistics followed by multivariate linear regression were used to identify features associated with improved reporting quality. The mean OQS was 8.2 (range: 5-13; 95% confidence interval (CI): 8.0, 8.3) and 9.9 (range: 5-18; 95% CI: 9.7, 10.2) in the pre- and post-CONSORT periods, respectively. The method for random sequence generation, allocation concealment, blinding details, and funding sources were missing in pre-CONSORT abstracts and insufficiently reported (<20%) in post-CONSORT abstracts. A high impact factor (P < 0.001) and the journal of publication (P < 0.001) were independent factors that were significantly associated with higher reporting quality on multivariate analysis. The reporting quality of RCT abstracts in oncology showed suboptimal improvement over time. Thus, stricter adherence to the CONSORT for Abstract guidelines is needed to improve the reporting quality of RCT abstracts published in oncology. Copyright © 2014 Elsevier Inc. All rights reserved.

Developing quality indicators and auditing protocols from formal guideline models: knowledge representation and transformations.

PubMed

Advani, Aneel; Goldstein, Mary; Shahar, Yuval; Musen, Mark A

2003-01-01

Automated quality assessment of clinician actions and patient outcomes is a central problem in guideline- or standards-based medical care. In this paper we describe a model representation and algorithm for deriving structured quality indicators and auditing protocols from formalized specifications of guidelines used in decision support systems. We apply the model and algorithm to the assessment of physician concordance with a guideline knowledge model for hypertension used in a decision-support system. The properties of our solution include the ability to derive automatically context-specific and case-mix-adjusted quality indicators that can model global or local levels of detail about the guideline parameterized by defining the reliability of each indicator or element of the guideline.

Quality control of colonoscopy procedures: a prospective validated method for the evaluation of professional practices applicable to all endoscopic units.

PubMed

Coriat, R; Pommaret, E; Chryssostalis, A; Viennot, S; Gaudric, M; Brezault, C; Lamarque, D; Roche, H; Verdier, D; Parlier, D; Prat, F; Chaussade, S

2009-02-01

To produce valid information, an evaluation of professional practices has to assess the quality of all practices before, during and after the procedure under study. Several auditing techniques have been proposed for colonoscopy. The purpose of this work is to describe a straightforward original validated method for the prospective evaluation of professional practices in the field of colonoscopy applicable in all endoscopy units without increasing the staff work load. Pertinent quality-control criteria (14 items) were identified by the endoscopists at the Cochin Hospital and were compatible with: findings in the available literature; guidelines proposed by the Superior Health Authority; and application in any endoscopy unit. Prospective routine data were collected and the methodology validated by evaluating 50 colonoscopies every quarter for one year. The relevance of the criteria was assessed using data collected during four separate periods. The standard checklist was complete for 57% of the colonoscopy procedures. The colonoscopy procedure was appropriate according to national guidelines in 94% of cases. These observations were particularly noteworthy: the quality of the colonic preparation was insufficient for 9% of the procedures; complete colonoscopy was achieved for 93% of patients; and 0.38 adenomas and 0.045 carcinomas were identified per colonoscopy. This simple and reproducible method can be used for valid quality-control audits in all endoscopy units. In France, unit-wide application of this method enables endoscopists to validate 100 of the 250 points required for continuous medical training. This is a quality-control tool that can be applied annually, using a random month to evaluate any changes in routine practices.

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.

Initial Investigation of Reaction Control System Design on Spacecraft Handling Qualities for Earth Orbit Docking

NASA Technical Reports Server (NTRS)

Bailey, Randall E.; Jackson, E. Bruce; Goodrich, Kenneth H.; Ragsdale, W. Al; Neuhaus, Jason; Barnes, Jim

2008-01-01

A program of research, development, test, and evaluation is planned for the development of Spacecraft Handling Qualities guidelines. In this first experiment, the effects of Reaction Control System design characteristics and rotational control laws were evaluated during simulated proximity operations and docking. Also, the influence of piloting demands resulting from varying closure rates was assessed. The pilot-in-the-loop simulation results showed that significantly different spacecraft handling qualities result from the design of the Reaction Control System. In particular, cross-coupling between translational and rotational motions significantly affected handling qualities as reflected by Cooper-Harper pilot ratings and pilot workload, as reflected by Task-Load Index ratings. This influence is masked but only slightly by the rotational control system mode. While rotational control augmentation using Rate Command Attitude Hold can reduce the workload (principally, physical workload) created by cross-coupling, the handling qualities are not significantly improved. The attitude and rate deadbands of the RCAH introduced significant mental workload and control compensation to evaluate when deadband firings would occur, assess their impact on docking performance, and apply control inputs to mitigate that impact.

Physical activity interventions for people with mental illness: a systematic review and meta-analysis.

PubMed

Rosenbaum, Simon; Tiedemann, Anne; Sherrington, Catherine; Curtis, Jackie; Ward, Philip B

2014-09-01

To determine effects of physical activity on depressive symptoms (primary objective), symptoms of schizophrenia, anthropometric measures, aerobic capacity, and quality of life (secondary objectives) in people with mental illness and explore between-study heterogeneity. MEDLINE, Cochrane Controlled Trials Register, PsycINFO, CINAHL, Embase, and the Physiotherapy Evidence Database (PEDro) were searched from earliest record to 2013. Randomized controlled trials of adults with a DSM-IV-TR, ICD-10, or clinician-confirmed diagnosis of a mental illness other than dysthymia or eating disorders were selected. Interventions included exercise programs, exercise counseling, lifestyle interventions, tai chi, or physical yoga. Study methodological quality and intervention compliance with American College of Sports Medicine (ACSM) guidelines were also assessed. Two investigators extracted data. Data were pooled using random-effects meta-analysis. Meta-regression was used to examine sources of between-study heterogeneity. Thirty-nine eligible trials were identified. The primary meta-analysis found a large effect of physical activity on depressive symptoms (n = 20; standardized mean difference (SMD) = 0.80). The effect size in trial interventions that met ACSM guidelines for aerobic exercise did not differ significantly from those that did not meet these guidelines. The effect for trials with higher methodological quality was smaller than that observed for trials with lower methodological quality (SMD = 0.39 vs 1.35); however, the difference was not statistically significant. A large effect was found for schizophrenia symptoms (SMD = 1.0), a small effect was found for anthropometry (SMD = 0.24), and moderate effects were found for aerobic capacity (SMD = 0.63) and quality of life (SMD = 0.64). Physical activity reduced depressive symptoms in people with mental illness. Larger effects were seen in studies of poorer methodological quality. Physical activity reduced symptoms of schizophrenia and improved anthropometric measures, aerobic capacity, and quality of life among people with mental illness. PROSPERO registration #CRD42012002012. © Copyright 2014 Physicians Postgraduate Press, Inc.

Report on the External Quality Control Review of the U.S. EPA's OIG

EPA Pesticide Factsheets

HHS OIG conducted this review in accordance with the Council of the Inspectors General on Integrity and Efficiency guidelines and discussed the review with you and members of your staff on April 5, 2012.

The Influence of Physical Therapy Guideline Adherence on Healthcare Utilization and Costs among Patients with Low Back Pain: A Systematic Review of the Literature

PubMed Central

Liu, Xinliang; Kolber, Morey J.

2016-01-01

Background Low back pain (LBP) is common and associated healthcare costs are significant. While clinical practice guidelines have been established in an attempt to reduce costs and healthcare utilization, it is unclear if adherence to physical therapy guidelines for those with LBP is efficacious. Therefore, the purpose of this study was to assess current evidence and evaluate the impact of physical therapy guideline adherence on subsequent healthcare costs and utilization for patients with LBP. Methods An electronic search was conducted in PubMed, CINAHL (EBSCO Host), AMED (Ovid), and PEDro. Studies included in this review were published in peer reviewed journals and the primary mode of treatment was administered by a physical therapist. Also, the definition of adherence was clearly defined based on claims data and at least one measure of cost or utilization reported. Quality assessment was evaluated via a modified Downs and Black checklist. Due to the conceptual heterogeneity in variable measurements, data were qualitatively synthesized and stratified by reported utilization and cost measures. Results A total of 256 results were identified and after omitting duplicates, 4 articles were retained, which were all retrospective in nature. Quality scores ranged between 19 and 21 points out of a possible 26 on the modified Downs and Black checklist. All identified studies used the same definition of guideline adherence, which focused on billing active codes and minimizing use of passive codes. The results demonstrated trends that, with a few exceptions, suggested those patients with LBP that were treated with an adherent guideline program demonstrated decreased healthcare utilization and an overall healthcare savings. Conclusion Preliminary evidence suggests that adherence to established clinical practice guidelines may assist with decreasing healthcare utilization and costs. Additional research based on prospective randomized controlled trials are needed to provide high quality evidence regarding the impact of guideline adherence among patients with LBP. PMID:27285608

Use of Vital Pulp Therapies in Primary Teeth with Deep Caries Lesions.

PubMed

Dhar, Vineet; Marghalani, Abdullah A; Crystal, Yasmi O; Kumar, Ashok; Ritwik, Priyanshi; Tulunoglu, Ozlem; Graham, Laurel

2017-09-15

This manuscript presents evidence-based guidance on the use of vital pulp therapies for treatment of deep caries lesions in children. A guideline panel convened by the American Academy of Pediatric Dentistry formulated evidence-based recommendations on three vital pulp therapies: indirect pulp treatment (IPT; also known as indirect pulp cap), direct pulp cap (DPC), and pulpotomy. The basis of the guideline's recommendations was evidence from "Primary Tooth Vital Pulp Therapy: A Systematic Review and Meta-Analysis." (Pediatr Dent 2017;15;39[1]:16-23.) A systematic search was conducted in PubMed®/MEDLINE, Embase®, Cochrane Central Register of Controlled Trials, and trial databases to identify randomized controlled trials and systematic reviews addressing peripheral issues of vital pulp therapies such as patient preferences of treatment and impact of cost. Quality of the evidence was assessed through the Grading of Recommendations Assessment, Development, and Evaluation approach; the evidence-to-decision framework was used to formulate a recommendation. The panel was unable to make a recommendation on superiority of any particular type of vital pulp therapy owing to lack of studies directly comparing these interventions. The panel recommends use of mineral trioxide aggregate (MTA) and formocresol in pulpotomy treatments; these are recommendations based on moderate-quality evidence at 24 months. The panel made weak recommendations regarding choice of medicament in both IPT (moderate-quality evidence [24 months], low quality evidence [48 months]) and DPC (very-low quality evidence [24 months]). Success of both treatments was independent of type of medicament used. The panel also recommends use of ferric sulfate (low-quality evidence), lasers (low-quality evidence), sodium hypochlorite (very low-quality evidence), and tricalcium silicate (very low-quality evidence) in pulpotomies; these are weak recommendations based on low-quality evidence. The panel recommended against the use of calcium hydroxide as pulpotomy medicament in primary teeth with deep caries lesions. Conclusions and practical implications: The guideline intends to inform the clinical practices with evidence-based recommendations on vital pulp therapies in primary teeth with deep caries lesions. These recommendations are based upon the best available evidence to-date.

Efficient clinical evaluation of guideline quality: development and testing of a new tool

PubMed Central

2014-01-01

Background Evaluating the methodological quality of clinical practice guidelines is essential before deciding which ones which could best inform policy or practice. One current method of evaluating clinical guideline quality is the research-focused AGREE II instrument. This uses 23 questions scored 1–7, arranged in six domains, which requires at least two independent testers, and uses a formulaic weighted domain scoring system. Following feedback from time-poor clinicians, policy-makers and managers that this instrument did not suit clinical need, we developed and tested a simpler, shorter, binary scored instrument (the iCAHE Guideline Quality Checklist) designed for single users. Methods Content and construct validity, inter-tester reliability and clinical utility were tested by comparing the new iCAHE Guideline Quality Checklist with the AGREE II instrument. Firstly the questions and domains in both instruments were compared. Six randomly-selected guidelines on a similar theme were then assessed by three independent testers with different experience in guideline quality assessment, using both instruments. Per guideline, weighted domain and total AGREE II scores were calculated, using the scoring rubric for three testers. Total iCAHE scores were calculated per guideline, per tester. The linear relationship between iCAHE and AGREE II scores was assessed using Pearson r correlation coefficients. Score differences between testers were assessed for the iCAHE Guideline Quality Checklist. Results There were congruent questions in each instrument in four domains (Scope & Purpose, Stakeholder involvement, Underlying evidence/Rigour, Clarity). The iCAHE and AGREE II scores were moderate to strongly correlated for the six guidelines. There was generally good agreement between testers for iCAHE scores, irrespective of their experience. The iCAHE instrument was preferred by all testers, and took significantly less time to administer than the AGREE II instrument. However, the use of only three testers and six guidelines compromised study power, rendering this research as pilot investigations of the psychometric properties of the iCAHE instrument. Conclusion The iCAHE Guideline Quality Checklist has promising psychometric properties and clinical utility. PMID:24885893

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.

DNA Commission of the International Society for Forensic Genetics: revised and extended guidelines for mitochondrial DNA typing.

PubMed

Parson, W; Gusmão, L; Hares, D R; Irwin, J A; Mayr, W R; Morling, N; Pokorak, E; Prinz, M; Salas, A; Schneider, P M; Parsons, T J

2014-11-01

The DNA Commission of the International Society of Forensic Genetics (ISFG) regularly publishes guidelines and recommendations concerning the application of DNA polymorphisms to the question of human identification. Previous recommendations published in 2000 addressed the analysis and interpretation of mitochondrial DNA (mtDNA) in forensic casework. While the foundations set forth in the earlier recommendations still apply, new approaches to the quality control, alignment and nomenclature of mitochondrial sequences, as well as the establishment of mtDNA reference population databases, have been developed. Here, we describe these developments and discuss their application to both mtDNA casework and mtDNA reference population databasing applications. While the generation of mtDNA for forensic casework has always been guided by specific standards, it is now well-established that data of the same quality are required for the mtDNA reference population data used to assess the statistical weight of the evidence. As a result, we introduce guidelines regarding sequence generation, as well as quality control measures based on the known worldwide mtDNA phylogeny, that can be applied to ensure the highest quality population data possible. For both casework and reference population databasing applications, the alignment and nomenclature of haplotypes is revised here and the phylogenetic alignment proffered as acceptable standard. In addition, the interpretation of heteroplasmy in the forensic context is updated, and the utility of alignment-free database searches for unbiased probability estimates is highlighted. Finally, we discuss statistical issues and define minimal standards for mtDNA database searches. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

EFFECTIVE USE OF SEDIMENT QUALITY GUIDELINES: WHICH GUIDELINE IS RIGHT FOR ME?

EPA Science Inventory

A bewildering array of sediment quality guidelines have been developed, but fortunately they mostly fall into two families: empirically-derived and theoretically-derived. The empirically-derived guidelines use large data bases of concurrent sediment chemistry and biological effe...

Guidelines and mHealth to Improve Quality of Hypertension and Type 2 Diabetes Care for Vulnerable Populations in Lebanon: Longitudinal Cohort Study

PubMed Central

Paik, Kenneth E; Hei Tam, Hok; Fahed, Zeina; Winkler, Eric; Kontunen, Kaisa; Mkanna, Abdalla; Burnham, Gilbert

2017-01-01

Background Given the protracted nature of the crisis in Syria, the large noncommunicable disease (NCD) caseload of Syrian refugees and host Lebanese, and the high costs of providing NCD care, the implications for Lebanon’s health system are vast. Objective The aim of this study was to evaluate the effectiveness of treatment guidelines and a mobile health (mHealth) app on quality of care and health outcomes in primary care settings in Lebanon. Methods A longitudinal cohort study was implemented from January 2015 to August 2016 to evaluate the effectiveness of treatment guidelines and an mHealth app on quality of care and health outcomes for Syrian and Lebanese patients in Lebanese primary health care (PHC) facilities. Results Compared with baseline record extraction, recording of blood pressure (BP) readings (−11.4%, P<.001) and blood sugar measurements (−6.9%, P=.03) significantly decreased following the implementation of treatment guidelines. Recording of BP readings also decreased after the mHealth phase as compared with baseline (−8.4%, P=.001); however, recording of body mass index (BMI) reporting increased at the end of the mHealth phase from baseline (8.1%, P<.001) and the guidelines phase (7.7%, P<.001). There were a great proportion of patients for whom blood sugar, BP, weight, height, and BMI were recorded using the tablet compared with in paper records; however, only differences in BMI were statistically significant (31.6% higher in app data as compared with paper records; P<.001). Data extracted from the mHealth app showed that a higher proportion of providers offered lifestyle counseling compared with the counseling reported in patients’ paper records (health diet counseling; 77.3% in app data vs 8.8% in paper records, P<.001 and physical activity counseling and 59.7% in app vs 7.1% in paper records, P<.001). There were statistically significant increases in all four measures of patient-provider interaction across study phases. Provider inquiry of medical history increased by 16.6% from baseline following guideline implementation and by 28.2% from baseline to mHealth implementation (P<.001). From baseline, patient report of provider inquiry regarding medication complications increased in the guidelines and mHealth phases by 12.9% and 59.6%, respectively, (P<.001). The proportion of patients reporting that providers asked other questions relevant to their illness increased from baseline through guidelines implementation by 27.8% and to mHealth implementation by 66.3% (P<.001). Follow-up scheduling increased from baseline to the guidelines phase by 20.6% and the mHealth phase by 39.8% (P<.001). Conclusions Results from this study of an mHealth app in 10 PHC facilities in Lebanon indicate that the app has potential to improve adherence to guidelines and quality of care. Further studies are necessary to determine the effects of patient-controlled health record apps on provider adherence to treatment guidelines, as well as patients’ long-term medication and treatment adherence and disease control. PMID:29046266

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.

Methodological quality of guidelines in gastroenterology.

PubMed

Malheiro, Rui; de Monteiro-Soares, Matilde; Hassan, Cesare; Dinis-Ribeiro, Mário

2014-06-01

Clinical guidelines are a common feature in modern endoscopy practice and they are being produced faster than ever. However, their methodological quality is rarely assessed. This study evaluated the methodological quality of current clinical guidelines in the field of gastroenterology, with an emphasis on endoscopy. Practice guidelines published by the American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), European Society of Gastrointestinal Endoscopy (ESGE), British Society of Gastroenterology (BSG), National Institute for Health and Care Excellence (NICE), and the Scottish Intercollegiate Guidelines Network (SIGN) were searched between September and October 2012 and evaluated using the AGREE II (Appraisal of Guidelines for Research and Evaluation) instrument (23 items, scores 1 - 7 for each item; higher scores mean better quality). A total of 100 guidelines were assessed. The mean number of items scoring 6 or 7 per guideline was 9.2 (out of 23 items). Overall, 99 % of guidelines failed to include the target population in the development process, and 96 % did not report facilitators and barriers to guideline application. In addition, 86 % did not include advice or tools, and 94 % did not present monitoring or auditing criteria. The global methodological quality of clinical guidelines in the field of gastroenterology is poor, particularly regarding involvement of the target population in the development of guidelines and in the provision of clear suggestions to practitioners. © Georg Thieme Verlag KG Stuttgart · New York.

[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.

Quality of care for patients with type 2 diabetes mellitus in the Netherlands and the United States: a comparison of two quality improvement programs.

PubMed

Valk, Gerlof D; Renders, Carry M; Kriegsman, Didi M W; Newton, Katherine M; Twisk, Jos W R; van Eijk, Jacques Th M; van der Wal, Gerrit; Wagner, Edward H

2004-08-01

To assess differences in diabetes care and patient outcomes by comparing two multifaceted quality improvement programs in two different countries, and to increase knowledge of effective elements of such programs. Primary care in the ExtraMural Clinic (EMC) of the Department of General Practice of the Vrije Universiteit in Amsterdam, the Netherlands, and the Group Health Cooperative (GHC), a group-model health maintenance organization (HMO) in western Washington State in the United States. Data were collected from 1992 to 1997. In this observational study two diabetes cohorts in which a quality improvement program was implemented were compared. Both programs included a medical record system, clinical practice guidelines, physician educational meetings, audit, and feedback. Only the Dutch program (EMC) included guidelines on the structure of diabetes care and a recall system. Only the GHC program included educational outreach visits, formation of multidisciplinary teams, and patient self-management support. Included were 379 EMC patients, and 2,119 GHC patients with type 2 diabetes mellitus. Main process outcomes were: annual number of diabetes visits, and number of HbA1c and blood lipid measurements. Main patient outcomes were HbA1c and blood lipid levels. Multilevel analysis was used to adjust for dependency between repeated observations within one patient and for clustering of patients within general practices. In the EMC process outcomes and glycemic control improved more than at GHC, however, GHC had better baseline measures. There were no differences between programs on blood lipid control. During follow-up, intensification of pharmacotherapy was noted at both sites. Differences noted between programs were in line with differences in diabetes guidelines. Following implementation of guidelines and organizational improvement efforts, change occurred primarily in the process outcomes, rather than in the patient outcomes. Although much effort was put into improving process and patient outcomes, both complex programs still showed only moderate effects.

Developing Quality Indicators and Auditing Protocols from Formal Guideline Models: Knowledge Representation and Transformations

PubMed Central

Advani, Aneel; Goldstein, Mary; Shahar, Yuval; Musen, Mark A.

2003-01-01

Automated quality assessment of clinician actions and patient outcomes is a central problem in guideline- or standards-based medical care. In this paper we describe a model representation and algorithm for deriving structured quality indicators and auditing protocols from formalized specifications of guidelines used in decision support systems. We apply the model and algorithm to the assessment of physician concordance with a guideline knowledge model for hypertension used in a decision-support system. The properties of our solution include the ability to derive automatically (1) context-specific and (2) case-mix-adjusted quality indicators that (3) can model global or local levels of detail about the guideline (4) parameterized by defining the reliability of each indicator or element of the guideline. PMID:14728124

European Fissure Sealant Guidelines: assessment using AGREE II.

PubMed

San Martin-Galindo, L; Rodríguez-Lozano, F J; Abalos-Labruzzi, C; Niederman, R

2017-02-01

Pit and fissure sealants are effective in reducing the incidence of occlusal caries, and multiple clinical practice guidelines (CPGs) have been developed for recommending their proper use. The usefulness of CPGs depends on their quality and on the rigour of the guideline development process. A study was made to assess the quality of current European CPGs based on the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument, which uses 23 key items rated on a 7-point scale to assess practice guideline development and the quality of reporting. A search was conducted for fissure sealant guidelines for preventing caries in children and adults at high and low risk published in the last 10 years. Calibration was carried out before scoring to assess agreement between the appraisers using the AGREE II instrument. The searches identified 19 relevant guidelines, and following application of the inclusion/exclusion criteria, three guidelines were retained for evaluation. The proportion of observed agreement was calculated, expressed by the agreement separately for positive and negative ratings (PA = 0.89, NA = 0-91). The results of the guideline assessments revealed the highest score for the Irish guideline, a moderate score for the French guideline and the lowest score for the European guideline. Based on the AGREE II instrument, the results obtained show significant variation in the quality assessment of the three European Fissure Sealant Guidelines. Future studies should be carried out both to develop quality dental CPGs and to investigate effective ways of adopting them. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Control Points in School Business Management, Presenting General Observations, Specific Control Points, and a Series of Checkpoints for the Practicing School Business Administrator.

ERIC Educational Resources Information Center

Association of School Business Officials, Chicago, IL.

This revised outline of a 1962 address contains general guidelines considered still useful for practicing school business administrators. Introductory "general observations" and a preamble give advice about good personal qualities, policy and planning practices, and relations with school boards, community, staff, and fellow professional…

76 FR 72844 - Approval and Promulgation of Air Quality Implementation Plans: South Carolina; Negative...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... has various NO X sources. The 4110 Paper Mill-Coating unit requires Best Available Control Technology... Carolina; Negative Declarations for Groups I, II, III and IV Control Techniques Guidelines; and Reasonably... for Groups I and I CTG. ``EPA-R04-OAR-2010-0018'' for comments regarding the negative declarations for...

Incident reviews in UK maternity units: a systematic appraisal of the quality of local guidelines.

PubMed

Shah, Anjali; Mohamed-Ahmed, Olaa; Peirsegaele, Philippe; McClymont, Charlotte; Knight, Marian

2015-03-14

Maternity care is recognised as a particularly high-risk speciality that is subject to investigation and inquiry, and improvements in risk management have been recommended. However, the quality of guidelines for local reviews of maternity incidents is unknown. The aim of the study is to appraise the quality of local guidance on conducting reviews of severe maternity incidents in the National Health Service. Guidelines for incident reviews were requested from all 211 consultant-led maternity units in the UK during 2012. The Appraisal of Guidelines for Research and Evaluation Instrument (AGREE II) was used to evaluate the quality of guidelines. The methods used for reviewing an incident, the people involved in the review and the methods for disseminating the outcomes of the reviews were also examined. Guidelines covering 148 (70%) of all NHS maternity units in the UK were received for evaluation. Most guidelines (55%) received were of good or high quality. The median score on 'scope and purpose' (86%), concerned with the aims and target population of the guideline, was higher than for other domains. Median scores were: 'stakeholder involvement' (representation of users' views) 56%, 'rigour of development' (process used to develop guideline) 34%, 'clarity of presentation' 78%, 'applicability' (organisational and cost implications of applying guideline) 56% and 'editorial independence' 0%. Most guidelines (81%) recommended a range of health professionals review serious maternity incidents using root cause analysis. Findings were most often disseminated at meetings, in reports and in newsletters. Many guidelines (69%) stated lessons learnt from incidents would be audited. Overall, local guidance for the review of maternity incidents was mostly of good or high quality. Stakeholder participation in guideline development could be widened, and editorial independence more clearly stated. It was unclear in over a quarter of guidelines whether changes in practice in response to review recommendations were audited or monitored; such auditing should be mandatory. Further research is required to examine the translation of guidance into practice by evaluating the quality of local reviews of maternity incidents.

[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.

Improving the adaptability of WHO evidence-informed guidelines for nutrition actions: results of a mixed methods evaluation.

PubMed

Dedios, Maria Cecilia; Esperato, Alexo; De-Regil, Luz Maria; Peña-Rosas, Juan Pablo; Norris, Susan L

2017-03-21

Over the past decade, the World Health Organization (WHO) has implemented a standardized, evidence-informed guideline development process to assure technically sound and policy-relevant guidelines. This study is an independent evaluation of the adaptability of the guidelines produced by the Evidence and Programme Guidance unit, at the Department of Nutrition for Health and Development (NHD). The study systematizes the lessons learned by the NHD group at WHO. We used a mixed methods approach to determine the adaptability of the nutrition guidelines. Adaptability was defined as having two components; methodological quality and implementability of guidelines. Additionally, we gathered recommendations to improve future guideline development in nutrition actions for health and development. Data sources for this evaluation were official documentation and feedback (both qualitative and quantitative) from key stakeholders involved in the development of nutrition guidelines. The qualitative data was collected through a desk review and two waves of semi-structured interviews (n = 12) and was analyzed through axial coding. Guideline adaptability was assessed quantitatively using two standardized instruments completed by key stakeholders. The Appraisal Guideline for Research and Evaluation questionnaire, version II was used to assess guideline quality (n = 6), while implementability was assessed with the electronic version of the GuideLine Implementability Appraisal (n = 7). The nutrition evidence-informed guideline development process has several strengths, among them are the appropriate management of conflicts of interest of guideline developers and the systematic use of high-quality evidence to inform the recommendations. These features contribute to increase the methodological quality of the guidelines. The key areas for improvement are the limited implementability of the recommendations, the lack of explicit and precise implementation advice in the guidelines and challenges related to collaborative work within interdisciplinary groups. Overall, our study found that the nutrition evidence-informed guidelines are of good methodological quality but that the implementability requires improvement. The recommendations to improve guideline adaptability address the guideline content, the dynamics shaping interdisciplinary work, and actions for implementation feasibility. As WHO relies heavily on a standardized procedure to develop guidelines, the lessons learned may be applicable to guideline development across the organization and to other groups developing guidelines.

Quality of reporting in infertility journals.

PubMed

Glujovsky, Demian; Boggino, Carolina; Riestra, Barbara; Coscia, Andrea; Sueldo, Carlos E; Ciapponi, Agustín

2015-01-01

To evaluate whether fertility and top gynecology journals indexed in PubMed require the use of reporting guidelines and to identify the percentage of randomized controlled trials (RCTs) published in 2013 that were written following CONSORT guidelines in the top four fertility journals (by their highest impact factor). Cross-sectional study evaluating instructions for authors and RCTs published in fertility journals. Academic institution. None. None. Proportion of instruction-for-authors documents that suggested or required the use of reporting guidelines, and proportion of RCTs published in 2013 that accomplished the CONSORT checklist. In 47% (16/34) of the journals one or more reporting guidelines were mentioned in the instructions for authors' documents. PRISMA and CONSORT were the most commonly mentioned reporting guidelines. None of the analyzed RCTs completed the 25 items of CONSORT guideline. Sequence generation or allocation concealment was not described in 69% of the studies. One-third of the journals did not publish a flowchart, 72% did not show relative and absolute size-effect measures, and 42% did not use measures of imprecision. In the summaries, 42% did not discuss the limitations of the study and 78% did not mention the generalizability of the results. Less than half of the analyzed peer-reviewed journals request the authors to use reporting guidelines. Nevertheless, among the top fertility and gynecology journals, reporting guidelines are widely mentioned. Overall, accomplishment of CONSORT items was suboptimal. Editorial boards, reviewers, and authors should join efforts to improve the quality of reporting. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Implementing self sustained quality control procedures in a clinical laboratory.

PubMed

Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

2013-01-01

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

[SmartCare: automatizing clinical guidelines].

PubMed

Mersmann, Stefan

2009-10-01

In critical care environments, important medical and economic challenges are presented by the enhancement of therapeutic quality and the reduction of therapeutic costs. For this purpose, several clinical studies have demonstrated a positive impact of the adoption of so-called clinical guidelines. Clinical guidelines represent well documented best practices in healthcare and are fundamental aspects of evidence-based medicine. However, at the bedside, such clinical guidelines remain difficult to use by clinical staff. The knowledge-based technology SmartCare allows incorporation of arbitrary computerized clinical guidelines into various medical target systems. SmartCare constitutes a clinical guideline engine because it executes one or more clinical guidelines on a specific medical device. SmartCare was initially applied for the automated control of a mechanical ventilator to assist the process of weaning from a medical device. The methodology allows further applications to be implemented effectively with other medical devices and/or with other appropriate guidelines. In this paper, we report on the methodology and the resulting versatility of such a system, as well as the clinical evaluation of SmartCare/PS and its perspectives.

Management of Acute and Recurrent Gout: A Clinical Practice Guideline From the American College of Physicians.

PubMed

Qaseem, Amir; Harris, Russell P; 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 management of gout. Using the ACP grading system, the committee based these recommendations on a systematic review of randomized, controlled trials; systematic reviews; and large observational studies published between January 2010 and March 2016. Clinical outcomes evaluated included pain, joint swelling and tenderness, activities of daily living, patient global assessment, recurrence, intermediate outcomes of serum urate levels, and harms. The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute or recurrent gout. ACP recommends that clinicians choose corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or colchicine to treat patients with acute gout. (Grade: strong recommendation, high-quality evidence). ACP recommends that clinicians use low-dose colchicine when using colchicine to treat acute gout. (Grade: strong recommendation, moderate-quality evidence). ACP recommends against initiating long-term urate-lowering therapy in most patients after a first gout attack or in patients with infrequent attacks. (Grade: strong recommendation, moderate-quality evidence). ACP recommends that clinicians discuss benefits, harms, costs, and individual preferences with patients before initiating urate-lowering therapy, including concomitant prophylaxis, in patients with recurrent gout attacks. (Grade: strong recommendation, moderate-quality evidence).

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.

Implementation of a clinical quality control program in a mammography screening service of Brazil.

PubMed

DE Souza Sabino, Silvia Maria Prioli; Silva, Thiago Buosi; Watanabe, Anapaula Hidemi Uema; Syrjänen, Kari; Carvalho, André Lopes; Mauad, Edmundo Carvalho

2014-09-01

To evaluate the effect of a clinical quality control program on the final quality of a mammography screening service. We conducted retrospective assessment of the clinical quality of 5,000 mammograms taken in a Mammography Screening Program between November 2010 and September 2011, following the implementation of a Clinical Quality Control Program based on the European Guidelines. Among the 105,000 evaluated quality items, there were 8,588 failures (8.2%) - 1.7 failures per examination. Altogether, 89% of the failures were associated with positioning. The recall rate due to a technical error reached a maximum of 0.5% in the early phase of the observation period and subsequently stabilized (0.09%). The ongoing education and monitoring combined with personalized training increased the critical thinking of the involved professionals, reducing the technical failures and unnecessary exposure of patients to radiation, with substantial improvement in the final quality of mammography. Copyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

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.

The methodological quality of guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia: A systematic review.

PubMed

Ambaras Khan, R; Aziz, Z

2018-05-02

Clinical practice guidelines serve as a framework for physicians to make decisions and to support best practice for optimizing patient care. However, if the guidelines do not address all the important components of optimal care sufficiently, the quality and validity of the guidelines can be reduced. The objectives of this study were to systematically review current guidelines for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), evaluate their methodological quality and highlight the similarities and differences in their recommendations for empirical antibiotic and antibiotic de-escalation strategies. This review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Electronic databases including MEDLINE, CINAHL, PubMed and EMBASE were searched up to September 2017 for relevant guidelines. Other databases such as NICE, Scottish Intercollegiate Guidelines Network (SIGN) and the websites of professional societies were also searched for relevant guidelines. The quality and reporting of included guidelines were assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE-II) instrument. Six guidelines were eligible for inclusion in our review. Among 6 domains of AGREE-II, "clarity of presentation" scored the highest (80.6%), whereas "applicability" scored the lowest (11.8%). All the guidelines supported the antibiotic de-escalation strategy, whereas the majority of the guidelines (5 of 6) recommended that empirical antibiotic therapy should be implemented in accordance with local microbiological data. All the guidelines suggested that for early-onset HAP/VAP, therapy should start with a narrow spectrum empirical antibiotic such as penicillin or cephalosporins, whereas for late-onset HAP/VAP, the guidelines recommended the use of a broader spectrum empirical antibiotic such as the penicillin extended spectrum carbapenems and glycopeptides. Expert guidelines promote the judicious use of antibiotics and prevent antibiotic overuse. The quality and validity of available HAP/VAP guidelines would be enhanced by improving their adherence to accepted best practice for the management of HAP and VAP. © 2018 John Wiley & Sons Ltd.

Systematic analysis of the quality of the scientific evidence and conflicts of interest in osteoarthritis of the hip and knee practice guidelines.

PubMed

Feuerstein, Joseph D; Pelsis, Jonathan R; Lloyd, Samuel; Cheifetz, Adam S; Stone, Kevin R

2016-02-01

To determine the validity of the hip and knee osteoarthritis guidelines. A systematic search of PubMed using a combination of Mesh and text terms with limitations to guidelines was performed to identify hip and knee osteoarthritis guidelines. The study was performed from April 17, 2014 to October 1, 2014. Guidelines were reviewed for graded levels of evidence, methods used to grade the evidence, and disclosures of conflicts of interest. Additionally, guidelines were also assessed for key quality measures using the AGREE II system for assessing the quality of guidelines. A total of 13 guidelines relevant to the diagnosis and/or treatment of hip/knee osteoarthritis was identified. The 180 recommendations reviewed were supported by 231 pieces of evidence. In total, 35% (n = 80; range: 0-26) were supported by level A evidence, 15% (n = 35; range: 0-10) were by level B, and 50% (n = 116; range: 0-62) were by level C. Median age of the guidelines was 4 years (±4.8; range: 0-16) with no comments on planned updates. In total, 31% of the guidelines included patients in the development process. Only one guideline incorporated cost consideration, and only 15% of the guidelines addressed the surgical management of osteoarthritis. Additionally, 46% of guidelines did not comment on conflicts of interest (COI). When present, there was an average 29.8 COI. Notably, 82% of the COI were monetary support/consulting. In total, 50% of the hip/knee osteoarthritis guideline recommendations are based on lower quality evidence. Nearly half the guidelines fail to disclose relevant COI and when disclosed, multiple potential COI are present. Future hip/knee osteoarthritis guideline development committees should strive to improve the transparency and quality of evidence used to formulate practice guidelines. Copyright © 2015 Elsevier Inc. All rights reserved.

Measuring the quality of infection control in Dutch nursing homes using a standardized method; the Infection prevention RIsk Scan (IRIS)

PubMed Central

2014-01-01

Background We developed a standardised method to assess the quality of infection control in Dutch Nursing Home (NH), based on a cross-sectional survey that visualises the results. The method was called the Infection control RIsk Infection Scan (IRIS). We tested the applicability of this new tool in a multicentre surveillance executed June and July 2012. Methods The IRIS includes two patient outcome-variables, i.e. the prevalence of healthcare associated infections (HAI) and rectal carriage of Extended-Spectrum Beta-Lactamase (ESBL) producing Enterobacteriaceae (ESBL-E); two patient-related risk factors, i.e. use of medical devices, and antimicrobial therapy; and three ward-related risk factors, i.e. environmental contamination, availability of local guidelines, and shortcomings in infection prevention preconditions. Results were categorised as low-, intermediate- and high risk, presented in an easy-to-read graphic risk spider-plot. This plot was given as feedback to management and healthcare workers of the NH. Results Large differences were found among most the variables in the different NH. Common shortcomings were the availability of infection control guidelines and the level of environmental cleaning. Most striking differences were observed in the prevalence of ESBL carriage, ranged from zero to 20.6% (p < 0.001). Conclusions The IRIS provided a rapid and easy to understand assessment of the infection control situation of the participating NH. The results can be used to improve the quality of infection control based on the specific needs of a NH but needs further validation in future studies. Repeated measurement can determine the effectiveness of the interventions. This makes the IRIS a useful tool for quality systems. PMID:25243067

Effect of using reporting guidelines during peer review on quality of final manuscripts submitted to a biomedical journal: masked randomised trial

PubMed Central

Cortés, J; Ribera, J M; Cardellach, F; Selva-O’Callaghan, A; Kostov, B; García, L; Cirugeda, L; Altman, D G; González, J A; Sànchez, J A; Miras, F; Urrutia, A; Fonollosa, V; Rey-Joly, C; Vilardell, M

2011-01-01

Objective To investigate the effect of an additional review based on reporting guidelines such as STROBE and CONSORT on quality of manuscripts. Design Masked randomised trial. Population Original research manuscripts submitted to the Medicina Clínica journal from May 2008 to April 2009 and considered suitable for publication. Intervention Control group: conventional peer reviews alone. Intervention group: conventional review plus an additional review looking for missing items from reporting guidelines. Outcomes Manuscript quality, assessed with a 5 point Likert scale (primary: overall quality; secondary: average quality of specific items in paper). Main analysis compared groups as allocated, after adjustment for baseline factors (analysis of covariance); sensitivity analysis compared groups as reviewed. Adherence to reviewer suggestions assessed with Likert scale. Results Of 126 consecutive papers receiving conventional review, 34 were not suitable for publication. The remaining 92 papers were allocated to receive conventional reviews alone (n=41) or additional reviews (n=51). Four papers assigned to the conventional review group deviated from protocol; they received an additional review based on reporting guidelines. We saw an improvement in manuscript quality in favour of the additional review group (comparison as allocated, 0.25, 95% confidence interval –0.05 to 0.54; as reviewed, 0.33, 0.03 to 0.63). More papers with additional reviews than with conventional reviews alone improved from baseline (22 (43%) v eight (20%), difference 23.6% (3.2% to 44.0%), number needed to treat 4.2 (from 2.3 to 31.2), relative risk 2.21 (1.10 to 4.44)). Authors in the additional review group adhered more to suggestions from conventional reviews than to those from additional reviews (average increase 0.43 Likert points (0.19 to 0.67)). Conclusions Additional reviews based on reporting guidelines improve manuscript quality, although the observed effect was smaller than hypothesised and not definitively demonstrated. Authors adhere more to suggestions from conventional reviews than to those from additional reviews, showing difficulties in adhering to high methodological standards at the latest research phases. To boost paper quality and impact, authors should be aware of future requirements of reporting guidelines at the very beginning of their study. Trial registration and protocol Although registries do not include trials of peer review, the protocol design was submitted to sponsored research projects (Instituto de Salud Carlos III, PI081903). PMID:22108262

Developing a reporting guideline for social and psychological intervention trials

PubMed Central

2013-01-01

Social and psychological interventions are often complex. Understanding randomised controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this paper, we explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for RCTs: CONSORT-SPI (an Extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study). PMID:23915044

The Diabetes Surgery Summit II Guidelines: a Disease-Based Clinical Recommendation.

PubMed

Cohen, Ricardo V; Shikora, Scott; Petry, Tarissa; Caravatto, Pedro Paulo; Le Roux, Carel W

2016-08-01

There is mounting evidence, derived from mechanistic studies, RCTs, and other high-quality studies that there are weight loss independent antidiabetic effects of gastrointestinal surgery. Additionally, there appears to be no relation between the positive metabolic outcomes to baseline BMI. The outdated US National Health Institutes guidelines from 1991 were centered on BMI only criterion and often misleading. The Second Diabetes Surgery Summit held in collaboration with leading diabetes organizations and endorsed by a large group of international Professional Societies developed guidelines that defined eligibility based on the severity and degree of T2D medical control while referring to obesity as a qualifier and not the sole criterion. That is the first time that guidelines are provided to put metabolic surgery into the T2D treatment algorithms.

Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline.

PubMed

Lyman, Gary H; Greenlee, Heather; Bohlke, Kari; Bao, Ting; DeMichele, Angela M; Deng, Gary E; Fouladbakhsh, Judith M; Gil, Brigitte; Hershman, Dawn L; Mansfield, Sami; Mussallem, Dawn M; Mustian, Karen M; Price, Erin; Rafte, Susan; Cohen, Lorenzo

2018-06-11

Purpose The Society for Integrative Oncology (SIO) produced an evidence-based guideline on use of integrative therapies during and after breast cancer treatment that was determined to be relevant to the American Society of Clinical Oncology (ASCO) membership. ASCO considered the guideline for endorsement. Methods The SIO guideline addressed the use of integrative therapies for the management of symptoms and adverse effects, such as anxiety and stress, mood disorders, fatigue, quality of life, chemotherapy-induced nausea and vomiting, lymphedema, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance. Interventions of interest included mind and body practices, natural products, and lifestyle modifications. SIO systematic reviews focused on randomized controlled trials that were published from 1990 through 2015. The SIO guideline was reviewed by ASCO content experts for clinical accuracy and by ASCO methodologists for developmental rigor. On favorable review, an ASCO Expert Panel was convened to review the guideline contents and recommendations. Results The ASCO Expert Panel determined that the recommendations in the SIO guideline-published in 2017-are clear, thorough, and based on the most relevant scientific evidence. ASCO endorsed the guideline with a few added discussion points. Recommendations Key recommendations include the following: Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction. Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders. Meditation and yoga are recommended to improve quality of life. Acupressure and acupuncture are recommended for reducing chemotherapy-induced nausea and vomiting. Acetyl-l-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy because of a possibility of harm. No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatment-related adverse effects. Additional information is available at: www.asco.org/supportive-care-guidelines .

Image registration assessment in radiotherapy image guidance based on control chart monitoring.

PubMed

Xia, Wenyao; Breen, Stephen L

2018-04-01

Image guidance with cone beam computed tomography in radiotherapy can guarantee the precision and accuracy of patient positioning prior to treatment delivery. During the image guidance process, operators need to take great effort to evaluate the image guidance quality before correcting a patient's position. This work proposes an image registration assessment method based on control chart monitoring to reduce the effort taken by the operator. According to the control chart plotted by daily registration scores of each patient, the proposed method can quickly detect both alignment errors and image quality inconsistency. Therefore, the proposed method can provide a clear guideline for the operators to identify unacceptable image quality and unacceptable image registration with minimal effort. Experimental results demonstrate that by using control charts from a clinical database of 10 patients undergoing prostate radiotherapy, the proposed method can quickly identify out-of-control signals and find special cause of out-of-control registration events.

77 FR 22282 - Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

...] Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma Contamination... Detection of Mycoplasma Contamination.'' This draft guideline identifies stages of manufacture where... contamination. Because the guidelines apply to final product and master seed/cell testing in veterinary vaccines...

No. 279-Female Sexual Health Consensus Clinical Guidelines.

PubMed

Lamont, John; Bajzak, Krisztina; Bouchard, Céline; Burnett, Margaret; Byers, Sandra; Cohen, Trevor; Fisher, William; Holzapfel, Stephen; Senikas, Vyta

2018-06-01

To establish national guidelines for the assessment of women's sexual health concerns and the provision of sexual health care for women. Published literature was retrieved through searches of PubMed, CINAHL, and the Cochrane Library from May to October 2010, using appropriate controlled vocabulary (e.g., sexuality, "sexual dysfunction," "physiological," dyspareunia) and key words (e.g., sexual dysfunction, sex therapy, anorgasmia). Results were restricted, where possible, to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no language restrictions. Searches were updated on a regular basis and incorporated in the guideline to December 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Each article was screened for relevance and the full text acquired if determined to be relevant. The evidence obtained was reviewed and evaluated by the members of the Expert Workgroup established by The Society of Obstetricians and Gynaecologists of Canada. The quality of evidence was evaluated and recommendations made using the use of criteria described by the Canadian Task Force on Preventive Health Care (Table). Copyright © 2018. Published by Elsevier Inc.

Feasibility of encoding the Institute for Clinical Systems Improvement Depression Guideline using the Omaha System.

PubMed

Monsen, Karen A; Neely, Claire; Oftedahl, Gary; Kerr, Madeleine J; Pietruszewski, Pam; Farri, Oladimeji

2012-08-01

Evidence-based clinical guidelines are being developed to bridge the gap between research and practice with the goals of improving health care quality and population health. However, disseminating, implementing, and ensuring ongoing use of clinical guidelines in practice settings is challenging. The purpose of this study was to demonstrate the feasibility of encoding evidence-based clinical guidelines using the Omaha System. Clinical documentation with Omaha System-encoded guidelines generates individualized, meaningful data suitable for program evaluation and health care quality research. The use of encoded guidelines within the electronic health record has potential to reinforce use of guidelines, and thus improve health care quality and population health. Research using Omaha System data generated by clinicians has potential to discover new knowledge related to guideline use and effectiveness. Copyright © 2012 Elsevier Inc. All rights reserved.

Does the CONSORT checklist for abstracts improve the quality of reports of randomized controlled trials on clinical pathways?

PubMed

Cui, Qi; Tian, Jinhui; Song, Xuping; Yang, Kehu

2014-12-01

The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides reporting guidelines to improve the reporting quality of randomized controlled trials (RCTs). This present study was aim to assess the reporting quality of abstracts of RCTs on clinical pathway. Eight databases were searched from inception to November 2012 to identify RCTs. We extracted basic information and CONSORT items from abstracts. Each abstract was assessed independently by two reviewers. Statistical analyses were performed with SPSS 13.0. Level of significance was set at P < 0.05. 328 abstracts were included. 300 (91.5%) were published in Chinese, of which 292 were published on high impact factor journals. 28 English abstracts were all published on Science Citation Index (SCI) journals. (1) Intervention, objective and outcome were almost fully reported in all abstracts, while recruitment and funding were never reported. (2) There are nine items (P < 0.05) in Chinese that were of low quality compared with in English. There was statistically difference on total score between Chinese and English abstracts (P < 0.00001). (3) There was no difference in any items between high and low impact factor journal in China. (4) In SCI journals, there were significant changes in reporting for three items trial design (P = 0.026), harms (P = 0.039) and trial registration (P = 0.019) in different periods (pre- and post-CONSORT), but only the numbers of randomized (P = 0.003) changed in Chinese abstracts. The reporting quality of abstracts of RCTs on clinical pathway still should be improved. After the publication of CONSORT for abstracts guideline, the RCT abstracts reporting quality were improvement to some extent. The abstracts in Chinese journals showed non-adherence to the CONSORT for abstracts guidelines. © 2014 John Wiley & Sons, Ltd.

Systematic review of the methodological quality of clinical guideline development for the management of chronic disease in Europe.

PubMed

Knai, Cécile; Brusamento, Serena; Legido-Quigley, Helena; Saliba, Vanessa; Panteli, Dimitra; Turk, Eva; Car, Josip; McKee, Martin; Busse, Reinhard

2012-10-01

The use of evidence-based clinical guidelines is an essential component of chronic disease management. However, there is well-documented concern about variability in the quality of clinical guidelines, with evidence of persisting methodological shortcomings. The most widely accepted approach to assessing the quality of guidelines is the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. We have conducted a systematic review of the methodological quality (as assessed by AGREE) of clinical guidelines developed in Europe for the management of chronic diseases published since 2000. The systematic review was undertaken in accordance with the Cochrane methodology. The inclusion criteria were that studies should have appraised European clinical guidelines for certain selected chronic disorders using the AGREE instrument. We searched five databases (Cab Abstracts, EMBASE, MEDLINE, Trip and EPPI). Nine studies reported in 10 papers, analysing a total of 28 European guidelines from eight countries as well as pan-European, were included. There was considerable variation in the quality of clinical guidelines across the AGREE domains. The least well addressed domains were 'editorial independence' (with a mean domain score of 41%), 'applicability' (44%), 'stakeholder involvement' (55%), and 'rigour of development' (64%), while 'clarity of presentation' (80%) and 'scope and purpose' (84%) were less problematic. This review indicates that there is considerable scope for improvement in the methods used to develop clinical guidelines for the prevention, management and treatment of chronic diseases in Europe. Given the importance of decision support strategies such as clinical guidelines in chronic disease management, improvement measures should include the explicit and transparent involvement of key stakeholders (especially scientific experts, guideline users and methodological specialists) and consideration of the implications for guideline implementation and applicability early on in the process. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians.

PubMed

Qaseem, Amir; Forciea, Mary Ann; McLean, Robert M; Denberg, Thomas D

2017-06-06

This guideline updates the 2008 American College of Physicians (ACP) recommendations on treatment of low bone density and osteoporosis to prevent fractures in men and women. This guideline is endorsed by the American Academy of Family Physicians. The ACP Clinical Guidelines Committee based these recommendations on a systematic review of randomized controlled trials; systematic reviews; large observational studies (for adverse events); and case reports (for rare events) that were published between 2 January 2005 and 3 June 2011. The review was updated to July 2016 by using a machine-learning method, and a limited update to October 2016 was done. Clinical outcomes evaluated were fractures and adverse events. This guideline focuses on the comparative benefits and risks of short- and long-term pharmacologic treatments for low bone density, including pharmaceutical prescriptions, calcium, vitamin D, and estrogen. Evidence was graded according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. The target audience for this guideline includes all clinicians. The target patient population includes men and women with low bone density and osteoporosis. ACP recommends that clinicians offer pharmacologic treatment with alendronate, risedronate, zoledronic acid, or denosumab to reduce the risk for hip and vertebral fractures in women who have known osteoporosis. (Grade: strong recommendation; high-quality evidence). ACP recommends that clinicians treat osteoporotic women with pharmacologic therapy for 5 years. (Grade: weak recommendation; low-quality evidence). ACP recommends that clinicians offer pharmacologic treatment with bisphosphonates to reduce the risk for vertebral fracture in men who have clinically recognized osteoporosis. (Grade: weak recommendation; low-quality evidence). ACP recommends against bone density monitoring during the 5-year pharmacologic treatment period for osteoporosis in women. (Grade: weak recommendation; low-quality evidence). ACP recommends against using menopausal estrogen therapy or menopausal estrogen plus progestogen therapy or raloxifene for the treatment of osteoporosis in women. (Grade: strong recommendation; moderate-quality evidence). ACP recommends that clinicians should make the decision whether to treat osteopenic women 65 years of age or older who are at a high risk for fracture based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications. (Grade: weak recommendation; low-quality evidence).

An overview of clinical guidelines for the management of vertebral compression fracture: a systematic review.

PubMed

Parreira, Patrícia C S; Maher, Chris G; Megale, Rodrigo Z; March, Lyn; Ferreira, Manuela L

2017-12-01

Vertebral compression fractures (VCFs) are the most common type of osteoporotic fracture comprising approximately 1.4 million cases worldwide. Clinical practice guidelines can be powerful tools for promoting evidence-based practice as they integrate research findings to support decision making. However, currently available clinical guidelines and recommendations, established by different medical societies, are sometimes contradictory. The aim of this study was to appraise the recommendations and the methodological quality of international clinical guidelines for the management of VCFs. This is a systematic review of clinical guidelines for the management of VCF. Guidelines were selected by searching MEDLINE and PubMed, PEDro, CINAHL, and EMBASE electronic databases between 2010 and 2016. We also searched clinical practice guideline databases, including the National Guideline Clearinghouse and the Canadian Medical Association InfoBase. The methodological quality of the guidelines was assessed by two authors independently using the Appraisal of Guidelines, Research and Evaluation (AGREE) II Instrument. We also classified the strength of each recommendation as either strong (ie, based on high-quality studies with consistent findings for recommending for or against the intervention), weak (ie, based on a lack of compelling evidence resulting in uncertainty for benefit or potential harm), or expert consensus (ie, based on expert opinion of the working group rather than on scientific evidence). Guideline recommendations were grouped into diagnostic, conservative care, interventional care, and osteoporosis treatment and prevention of future fractures. Our study was prospectively registered on PROSPERO. Four guidelines from three countries, published in the period 2010-2013, were included. In general, the quality was not satisfactory (50% or less of the maximum possible score). The domains scoring 50% or less of the maximum possible score were rigor of development, clarity of presentation, and applicability. The use of plain radiography or dual-energy X-ray absorptiometry for diagnosis was recommended in two of the four guidelines. Vertebroplasty or kyphoplasty was recommended in three of the four guidelines. The recommendation for bed rest, trunk orthoses, electrical stimulation, and supervised or unsupervised exercise was inconsistent across the included guidelines. The comparison of clinical guidelines for the management of VCF showed that diagnostic and therapeutic recommendations were generally inconsistent. The evidence available to guideline developers was limited in quantity and quality. Greater efforts are needed to improve the quality of the majority of guidelines. Copyright © 2017 Elsevier Inc. All rights reserved.

Quality assurance and the need to evaluate interventions and audit programme outcomes.

PubMed

Zhao, Min; Vaartjes, Ilonca; Klipstein-Grobusch, Kerstin; Kotseva, Kornelia; Jennings, Catriona; Grobbee, Diederick E; Graham, Ian

2017-06-01

Evidence-based clinical guidelines provide standards for the provision of healthcare. However, these guidelines have been poorly implemented in daily practice. Clinical audit is a quality improvement tool to promote quality of care in daily practice and to improve outcomes through the systematic review of care delivery and implementation of changes. A major priority in the management of subjects with cardiovascular disease (CVD) management is secondary prevention by controlling cardiovascular risk factors and providing appropriate medical treatment. Clinical audits can be applied to monitor modifiable risk factors and evaluate quality improvements of CVD management in daily practice. Existing clinical audits have provided an overview of the burden of risk factors in subjects with CVD and reflect real-world risk factor recording and management. However, consistent and representative data from clinic audits are still insufficient to fully monitor quality improvement of CVD management. Data are lacking in particular from low- and middle-income countries, limiting the evaluation of CVD management quality by clinical audit projects in many settings. To support the development of clinical standards, monitor daily practice performance, and improve quality of care in CVD management at national and international levels, more widespread clinical audits are warranted.

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.

Flu vaccine shortage creates ethical issues, safety challenges.

PubMed

2004-12-01

Decisions may have to be made as to whether staff or patients get priority. Centers for Disease Control and Prevention guidelines help ease choices when it comes to inoculating workers. Quality professionals should be aware of the legal implications of their decisions.

Liquid and gaseous oxygen safety review

NASA Technical Reports Server (NTRS)

Lapin, A.

1973-01-01

Materials used in oxygen systems and allowable oxygen environments are specified for each material. Design criteria, cleaning procedures and quality control methods are covered. Guidelines for protection against hazards involved with production, transportation, storage and use of oxygen are presented. Study also lists extensive references.

Recommendations for acupuncture in clinical practice guidelines of the national guideline clearinghouse.

PubMed

Guo, Yao; Zhao, Hong; Wang, Fang; Li, Si-Nuo; Sun, Yu-Xiu; Han, Ming-Juan; Liu, Bao-Yan

2017-11-01

To organize the clinical practice guidelines (CPGs) related to acupuncture included in the National Guideline Clearinghouse (NGC) to systematically summarize the diseases and disorders most commonly treated with acupuncture, the strength of recommendations for acupuncture and the quality of evidence. The NGC database was systematically searched for guidelines that included acupuncture as an intervention. Two independent reviewers studied the summaries and the full texts of the guidelines and included guidelines based on the inclusion and exclusion criteria. Thirty-nine guidelines were collected with 80 recommendations. The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument was used to assess the quality of these guidelines. Of the 80 recommendations on acupuncture, 49 recommendations were clearly for acupuncture, 25 recommendations were against acupuncture and 6 recommendations did not indicate any clear recommendations, 37 recommendations were for painful diseases/disorders, and 12 recommendations were for non-painful diseases/disorders. Locomotor system disorders were the most common in the painful diseases/disorders category. Out of all the recommendations for acupuncture, most recommendations (87.76%) were weak in strength, and most of the evidence (40.84%) was of low quality. In the National Guideline Clearinghouse, the recommendations for acupuncture focus on painful diseases/disorders. The recommendations in the guidelines are not high in strength, and most of the evidence is moderate or low in quality.

The CONSORT Statement: Application within and adaptations for orthodontic trials.

PubMed

Pandis, Nikolaos; Fleming, Padhraig S; Hopewell, Sally; Altman, Douglas G

2015-06-01

High-quality randomized controlled trials (RCTs) are an integral part of evidence-based medicine. RCTs are the bricks and mortar of high-quality systematic reviews, which are important determinants of health care policy and clinical practice. For published research to be used most effectively, investigators and authors should follow the guidelines for accurate and transparent reporting of RCTs. The consolidated standards of reporting trials (CONSORT) statement and its extensions are among the most widely used reporting guidelines in biomedical research. CONSORT was adopted by the American Journal of Orthodontics and Dentofacial Orthopedics in 2004. Since 2011, this Journal has been actively implementing compliance with the CONSORT reporting guidelines. The objective of this explanatory article is to highlight the relevance and implications of the various CONSORT items to help authors to achieve CONSORT compliance in their research submissions of RCTs to this and other orthodontic journals. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Field guide for collecting samples for analysis of volatile organic compounds in stream water for the National Water-Quality Assessment Program

USGS Publications Warehouse

Shelton, Larry R.

1997-01-01

For many years, stream samples for analysis of volatile organic compounds have been collected without specific guidelines or a sampler designed to avoid analyte loss. In 1996, the U.S. Geological Survey's National Water-Quality Assessment Program began aggressively monitoring urban stream-water for volatile organic compounds. To assure representative samples and consistency in collection procedures, a specific sampler was designed to collect samples for analysis of volatile organic compounds in stream water. This sampler, and the collection procedures, were tested in the laboratory and in the field for compound loss, contamination, sample reproducibility, and functional capabilities. This report describes that sampler and its use, and outlines field procedures specifically designed to provide contaminant-free, reproducible volatile organic compound data from stream-water samples. These guidelines and the equipment described represent a significant change in U.S. Geological Survey instructions for collecting and processing stream-water samples for analysis of volatile organic compounds. They are intended to produce data that are both defensible and interpretable, particularly for concentrations below the microgram-per-liter level. The guidelines also contain detailed recommendations for quality-control samples.

Thermal pasteurization of ready-to-eat foods and vegetables: Critical factors for process design and effects on quality.

PubMed

Peng, Jing; Tang, Juming; Barrett, Diane M; Sablani, Shyam S; Anderson, Nathan; Powers, Joseph R

2017-09-22

Increasing consumer desire for high quality ready-to-eat foods makes thermal pasteurization important to both food producers and researchers. To be in compliance with the Food Safety Modernization Act (FSMA), food companies seek regulatory and scientific guidelines to ensure that their products are safe. Clearly understanding the regulations for chilled or frozen foods is of fundamental importance to the design of thermal pasteurization processes for vegetables that meet food safety requirements. This article provides an overview of the current regulations and guidelines for pasteurization in the U.S. and in Europe for control of bacterial pathogens. Poorly understood viral pathogens, in terms of their survival in thermal treatments, are an increasing concern for both food safety regulators and scientists. New data on heat resistance of viruses in different foods are summarized. Food quality attributes are sensitive to thermal degradation. A review of thermal kinetics of inactivation of quality-related enzymes in vegetables and the effects of thermal pasteurization on vegetable quality is presented. The review also discusses shelf-life of thermally pasteurized vegetables.

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.

Combining Task Execution and Background Knowledge for the Verification of Medical Guidelines

NASA Astrophysics Data System (ADS)

Hommersom, Arjen; Groot, Perry; Lucas, Peter; Balser, Michael; Schmitt, Jonathan

The use of a medical guideline can be seen as the execution of computational tasks, sequentially or in parallel, in the face of patient data. It has been shown that many of such guidelines can be represented as a 'network of tasks', i.e., as a number of steps that have a specific function or goal. To investigate the quality of such guidelines we propose a formalization of criteria for good practice medicine a guideline should comply to. We use this theory in conjunction with medical background knowledge to verify the quality of a guideline dealing with diabetes mellitus type 2 using the interactive theorem prover KIV. Verification using task execution and background knowledge is a novel approach to quality checking of medical guidelines.

Detecting Changes in Newspaper Reporting of Suicide after a Statewide Social Marketing Campaign.

PubMed

Abbott, Michele; Ramchand, Rajeev; Chamberlin, Margaret; Marcellino, William

2018-06-01

A social marketing campaign was introduced in California in 2012, promoting media adherence to consensus-based guidelines on reporting about suicide. We examine adherence to these guidelines by applying quantitative scores to articles in California and a national control group in two six-month intervals prior to and following campaign implementation. Utilizing a difference-in-difference approach, we found no significant effect of the campaign, though the type of article content was a significant indicator of the overall score. Findings also demonstrated a nation-wide downward trend in the quality of reporting. Qualitative results suggest a need for more flexible guidelines in light of a technologically driven news culture.

The new production theory for health care through clinical reengineering: a study of clinical guidelines--Part II.

PubMed

Sharp, J R

1995-01-01

In Part I of this two-part article, in the December 1994 issue of the journal, the author discussed the manufacturing theories of Peter Drucker in terms of their applicability for the health care field. He concluded that Drucker's four principles and practices of manufacturing--statistical quality control, manufacturing accounting, modular organization, and systems approach--do have application to the health care system. Clinical guidelines, a variation on the Drucker theory, are a specific example of the manufacturing process in health. The performance to date of some guidelines and their implications for the health care reform debate are discussed in Part II of the article.

Guidelines for the symptomatic management of fever in children: systematic review of the literature and quality appraisal with AGREE II.

PubMed

Chiappini, Elena; Bortone, Barbara; Galli, Luisa; de Martino, Maurizio

2017-07-31

Several societies have produced and disseminated clinical practice guidelines (CPGs) for the symptomatic management of fever in children. However, to date, the quality of such guidelines has not been appraised. To identify and evaluate guidelines for the symptomatic management of fever in children. The research was conducted using PubMed, guideline websites, and Google (January 2010 to July 2016). The quality of the CPGs was independently assessed by two assessors using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) instrument, and specific recommendations in guidelines were summarised and evaluated. Domain scores were considered of sufficient quality when >60% and of good quality when >80%. Seven guidelines were retrieved. The median score for the scope and purpose domain was 85.3% (range 66.6-100%). The median score for the stakeholder involvement domain was 57.5% (range 33.3-83.3%) and four guidelines scored >60%. The median score for the rigour of development domain was 52.0% (range 14.6-98.9%), and only three guidelines scored >60%. The median score for the clarity of presentation domain was 80.9% (range 50.0-94.4%). The median score for the applicability domain was 39.3% (8.3-100%). Only one guideline scored >60%. The median score for the editorial independence domain was 48.84% (0-91.6%); only three guidelines scored >60%. Most guidelines were recommended for use even if with modification, especially in the methodology, the applicability and the editorial independence domains. Our results could help improve reporting of future guidelines, and affect the selection and use of guidelines in clinical practice. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Tools to enhance the quality and transparency of health research reports: reporting guidelines].

PubMed

Galvão, Taís Freire; Silva, Marcus Tolentino; Garcia, Leila Posenato

2016-01-01

Scientific writing is the cornestone for publishing the results of research. Reporting guidelines are important tools for all those involved in the process of research production and report writing. These guidelines detail what is expected to be found in each section of a report for a given study design. The EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) is an international initiative that seeks to improve the reliability and the value of health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines. The use of reporting guidelines has contributed to improved reports as well as increased quality of research methods. Reporting guidelines need to be publicized in order to increase knowledge about these essential tools among health researchers. Encouraging their use by journals is key to enhancing the quality of scientific publications.

Appraisal Tools for Clinical Practice Guidelines: A Systematic Review

PubMed Central

Siering, Ulrich; Eikermann, Michaela; Hausner, Elke; Hoffmann-Eßer, Wiebke; Neugebauer, Edmund A.

2013-01-01

Introduction Clinical practice guidelines can improve healthcare processes and patient outcomes, but are often of low quality. Guideline appraisal tools aim to help potential guideline users in assessing guideline quality. We conducted a systematic review of publications describing guideline appraisal tools in order to identify and compare existing tools. Methods Among others we searched MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews from 1995 to May 2011 for relevant primary and secondary publications. We also handsearched the reference lists of relevant publications. On the basis of the available literature we firstly generated 34 items to be used in the comparison of appraisal tools and grouped them into thirteen quality dimensions. We then extracted formal characteristics as well as questions and statements of the appraisal tools and assigned them to the items. Results We identified 40 different appraisal tools. They covered between three and thirteen of the thirteen possible quality dimensions and between three and 29 of the possible 34 items. The main focus of the appraisal tools were the quality dimensions “evaluation of evidence” (mentioned in 35 tools; 88%), “presentation of guideline content” (34 tools; 85%), “transferability” (33 tools; 83%), “independence” (32 tools; 80%), “scope” (30 tools; 75%), and “information retrieval” (29 tools; 73%). The quality dimensions “consideration of different perspectives” and “dissemination, implementation and evaluation of the guideline” were covered by only twenty (50%) and eighteen tools (45%) respectively. Conclusions Most guideline appraisal tools assess whether the literature search and the evaluation, synthesis and presentation of the evidence in guidelines follow the principles of evidence-based medicine. Although conflicts of interest and norms and values of guideline developers, as well as patient involvement, affect the trustworthiness of guidelines, they are currently insufficiently considered. Greater focus should be placed on these issues in the further development of guideline appraisal tools. PMID:24349397

Quality assessment of clinical practice guidelines for eosinophilic esophagitis using the AGREE II instrument.

PubMed

Lucendo, Alfredo J; Arias, Ángel; Redondo-González, Olga; Molina-Infante, Javier

2017-04-01

High-quality evidence-based clinical practice guidelines can guide diagnosis and treatment to optimize outcomes. We aimed to systematically review the quality of international guidelines on eosinophilic esophagitis (EoE). MEDLINE and Scopus databases were searched for appropriate guidelines up to 2016. Two gastroenterologists and two methodologists independently evaluated the documents using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Amongst the 25 records initially retrieved, four guidelines developed by recognized scientific organizations met inclusion criteria. AGREE II results varied widely across domains, but none achieved an overall assessment score of over 60%. Scope and purpose (61.82 ± 19.24%), clarity of presentation (57.13 ± 40.56%) and editorial independence (93.75 ± 1.69%) showed the highest mean rating, whereas stakeholder involvement (28.82 ± 11.19%), rigor of development (32.29 ± 12.02%) and applicability (21.62 ± 7.14%) did not reach quality thresholds. Intraclass correlation coefficients for agreement was excellent among appraisers (0.903), between gastroenterologists and methodologists (0.878) and for each individual guideline (0.838 to 0.955). Clinical practice guidelines for EoE vary significantly in quality, are invariably limited and currently, none can be 'strongly recommended'.

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.

Methods used in adaptation of health-related guidelines: A systematic survey.

PubMed

Abdul-Khalek, Rima A; Darzi, Andrea J; Godah, Mohammad W; Kilzar, Lama; Lakis, Chantal; Agarwal, Arnav; Abou-Jaoude, Elias; Meerpohl, Joerg J; Wiercioch, Wojtek; Santesso, Nancy; Brax, Hneine; Schünemann, Holger; Akl, Elie A

2017-12-01

Adaptation refers to the systematic approach for considering the endorsement or modification of recommendations produced in one setting for application in another as an alternative to de novo development. To describe and assess the methods used for adapting health-related guidelines published in peer-reviewed journals, and to assess the quality of the resulting adapted guidelines. We searched Medline and Embase up to June 2015. We assessed the method of adaptation, and the quality of included guidelines. Seventy-two papers were eligible. Most adapted guidelines and their source guidelines were published by professional societies (71% and 68% respectively), and in high-income countries (83% and 85% respectively). Of the 57 adapted guidelines that reported any detail about adaptation method, 34 (60%) did not use a published adaptation method. The number (and percentage) of adapted guidelines fulfilling each of the ADAPTE steps ranged between 2 (4%) and 57 (100%). The quality of adapted guidelines was highest for the "scope and purpose" domain and lowest for the "editorial independence" domain (respective mean percentages of the maximum possible scores were 93% and 43%). The mean score for "rigor of development" was 57%. Most adapted guidelines published in peer-reviewed journals do not report using a published adaptation method, and their adaptation quality was variable.

Implementation of American Academy of Pediatrics guidelines for palivizumab prophylaxis in a pediatric hospital.

PubMed

Zembles, Tracy N; Gaertner, Katherine M; Gutzeit, Michael F; Willoughby, Rodney E

2016-03-15

One hospital's implementation of revised American Academy of Pediatrics (AAP) guidelines for palivizumab prophylaxis of respiratory syncytial virus (RSV) infection is described. Revised AAP guidelines for RSV prophylaxis in infants and young children at increased risk for RSV infection recommend that up to five doses of palivizumab be administered during the RSV season. The guidelines also recommend that inpatients not receive monthly palivizumab prophylaxis and that infants and young children eligible for prophylaxis during the RSV season receive a dose of palivizumab two or three days before discharge or promptly after discharge. To ensure compliance with the revised AAP guidelines, a 296-bed hospital implemented a quality-improvement project including (1) efforts by the antimicrobial stewardship pharmacist and the chief medical officer to notify and educate healthcare providers regarding institutional adoption of the guidelines, (2) reinforcement of guideline adherence by clinical pharmacists during daily bedside rounds and via prospective review of all palivizumab orders, and (3) a medication-use evaluation (MUE) to assess adherence to the guidelines. The MUE results showed that during the 2014-15 RSV season (after implementation of the practice changes), the number of palivizumab doses administered at the hospital declined by 56% from the previous RSV season, with 97% of doses administered for appropriate indications. Standardized, comprehensive guidelines with defined criteria for palivizumab prophylaxis of RSV infection resulted in $303,227 of cost savings without a discernible change in nosocomial transmission, or morbidity, or mortality. Hospital infection-control practices controlled nosocomial RSV transmission. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Survey of the prevalence and methodology of quality assurance for B-mode ultrasound image quality among veterinary sonographers.

PubMed

Hoscheit, Larry P; Heng, Hock Gan; Lim, Chee Kin; Weng, Hsin-Yi

2018-05-01

Image quality in B-mode ultrasound is important as it reflects the diagnostic accuracy and diagnostic information provided during clinical scanning. Quality assurance programs for B-mode ultrasound systems/components are comprised of initial quality acceptance testing and subsequent regularly scheduled quality control testing. The importance of quality assurance programs for B-mode ultrasound image quality using ultrasound phantoms is well documented in the human medical and medical physics literature. The purpose of this prospective, cross-sectional, survey study was to determine the prevalence and methodology of quality acceptance testing and quality control testing of image quality for ultrasound system/components among veterinary sonographers. An online electronic survey was sent to 1497 members of veterinary imaging organizations: the American College of Veterinary Radiology, the Veterinary Ultrasound Society, and the European Association of Veterinary Diagnostic Imaging, and a total of 167 responses were received. The results showed that the percentages of veterinary sonographers performing quality acceptance testing and quality control testing are 42% (64/151; 95% confidence interval 34-52%) and 26% (40/156: 95% confidence interval 19-33%) respectively. Of the respondents who claimed to have quality acceptance testing or quality control testing of image quality in place for their ultrasound system/components, 0% have performed quality acceptance testing or quality control testing correctly (quality acceptance testing 95% confidence interval: 0-6%, quality control testing 95% confidence interval: 0-11%). Further education and guidelines are recommended for veterinary sonographers in the area of quality acceptance testing and quality control testing for B-mode ultrasound equipment/components. © 2018 American College of Veterinary Radiology.

Synthesis, grading, and presentation of evidence in guidelines: article 7 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Guyatt, Gordon; Akl, Elie A; Oxman, Andy; Wilson, Kevin; Puhan, Milo A; Wilt, Timothy; Gutterman, David; Woodhead, Mark; Antman, Elliott M; Schünemann, Holger J

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the seventh of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on synthesizing, rating, and presenting evidence in guidelines. In this review we addressed the following questions. (1) What evidence should guideline panels use to inform their recommendations? (2) How should they rate the quality of the evidence they use? (3) How should they grade evidence regarding diagnostic tests? (4) What should they do when quality of evidence differs across outcomes? (5) How should they present the evidence in a guideline? We did not conduct systematic reviews ourselves. We relied on prior evaluations of electronic databases and systematic reviews suggesting that the Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) approach includes the desired features of a system for grading quality of evidence, including provision of models for presenting evidence for guideline panels, and for the consumers of practice guidelines. This article describes the GRADE approach to grading the quality of evidence and presenting evidence. Available evidence, the practice of leading guideline developers, and workshop discussions provide the basis for our conclusions. GRADE rates the quality of evidence for each outcome across studies rather than for each study. In the GRADE approach randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down or up. Five factors may lead to rating down the quality of evidence: study limitations or risk of bias, inconsistency of results, indirectness of evidence, imprecision, and publication bias. Three factors may lead to rating up the quality of evidence from observational studies: large magnitude of effect, dose-response gradient, and situations in which all plausible confounders would decrease an apparent treatment effect, or would create a spurious effect when results suggest no effect. GRADE suggests use of evidence profiles that provide a comprehensive way to display the key evidence relevant to a clinical question. Guideline developers who follow this structure will find the transparency of their recommendations markedly enhanced.

Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.

PubMed

Flandrin-Gresta, Pascale; Cornillet, Pascale; Hayette, Sandrine; Gachard, Nathalie; Tondeur, Sylvie; Mauté, Carole; Cayuela, Jean-Michel

2015-01-01

Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.

Advancing infection control in dental care settings: factors associated with dentists' implementation of guidelines from the Centers for Disease Control and Prevention.

PubMed

Cleveland, Jennifer L; Bonito, Arthur J; Corley, Tammy J; Foster, Misty; Barker, Laurie; Gordon Brown, G; Lenfestey, Nancy; Lux, Linda

2012-10-01

The authors set out to identify factors associated with implementation by U.S. dentists of four practices first recommended in the Centers for Disease Control and Prevention's Guidelines for Infection Control in Dental Health-Care Settings-2003. In 2008, the authors surveyed a stratified random sample of 6,825 U.S. dentists. The response rate was 49 percent. The authors gathered data regarding dentists' demographic and practice characteristics, attitudes toward infection control, sources of instruction regarding the guidelines and knowledge about the need to use sterile water for surgical procedures. Then they assessed the impact of those factors on the implementation of four recommendations: having an infection control coordinator, maintaining dental unit water quality, documenting percutaneous injuries and using safer medical devices, such as safer syringes and scalpels. The authors conducted bivariate analyses and proportional odds modeling. Responding dentists in 34 percent of practices had implemented none or one of the four recommendations, 40 percent had implemented two of the recommendations and 26 percent had implemented three or four of the recommendations. The likelihood of implementation was higher among dentists who acknowledged the importance of infection control, had practiced dentistry for less than 30 years, had received more continuing dental education credits in infection control, correctly identified more surgical procedures that require the use of sterile water, worked in larger practices and had at least three sources of instruction regarding the guidelines. Dentists with practices in the South Atlantic, Middle Atlantic or East South Central U.S. Census divisions were less likely to have complied. Implementation of the four recommendations varied among U.S. dentists. Strategies targeted at raising awareness of the importance of infection control, increasing continuing education requirements and developing multiple modes of instruction may increase implementation of current and future Centers for Disease Control and Prevention guidelines.

Summary of the effects of engine throttle response on airplane formation-flying qualities

NASA Technical Reports Server (NTRS)

Walsh, Kevin R.

1993-01-01

A flight evaluation was conducted to determine the effect of engine throttle response characteristics on precision formation-flying qualities. A variable electronic throttle control system was developed and flight-tested on a TF-104G airplane with a J79-11B engine at the NASA Dryden Flight Research Facility. This airplane was chosen because of its known, very favorable thrust response characteristics. Ten research flights were flown to evaluate the effects of throttle gain, time delay, and fuel control rate limiting on engine handling qualities during a demanding precision wing formation task. Handling quality effects of lag filters and lead compensation time delays were also evaluated. The Cooper and Harper Pilot Rating Scale was used to assign levels of handling quality. Data from pilot ratings and comments indicate that throttle control system time delays and rate limits cause significant degradations in handling qualities. Threshold values for satisfactory (level 1) and adequate (level 2) handling qualities of these key variables are presented. These results may provide engine manufacturers with guidelines to assure satisfactory handling qualities in future engine designs.

Systematic evaluation of clinical practice guidelines for pharmacogenomics.

PubMed

Beckett, Robert D; Kisor, David F; Smith, Thomas; Vonada, Brooke

2018-06-01

To systematically assess methodological quality of pharmacogenomics clinical practice guidelines. Guidelines published through 2017 were reviewed by at least three independent reviewers using the AGREE II instrument, which consists of 23 items grouped into 6 domains and 2 items representing an overall assessment. Items were assessed on a seven-point rating scale, and aggregate quality scores were calculated. 31 articles were included. All guidelines were published as peer-reviewed articles and 90% (n = 28) were endorsed by professional organizations. Mean AGREE II domain scores (maximum score 100%) ranged from 46.6 ± 11.5% ('applicability') to 78.9 ± 11.4% ('clarity of presentation'). Median overall quality score was 72.2% (IQR: 61.1-77.8%). Quality of pharmacogenomics guidelines was generally high, but variable, for most AGREE II domains.

40 CFR Appendix W to Part 51 - Guideline on Air Quality Models

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Guideline on Air Quality Models W Appendix W to Part 51 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS Pt. 51, App. W Appendix W to Part 51—Guideline on Air Quality Models...

Core components for effective infection prevention and control programmes: new WHO evidence-based recommendations.

PubMed

Storr, Julie; Twyman, Anthony; Zingg, Walter; Damani, Nizam; Kilpatrick, Claire; Reilly, Jacqui; Price, Lesley; Egger, Matthias; Grayson, M Lindsay; Kelley, Edward; Allegranzi, Benedetta

2017-01-01

Health care-associated infections (HAI) are a major public health problem with a significant impact on morbidity, mortality and quality of life. They represent also an important economic burden to health systems worldwide. However, a large proportion of HAI are preventable through effective infection prevention and control (IPC) measures. Improvements in IPC at the national and facility level are critical for the successful containment of antimicrobial resistance and the prevention of HAI, including outbreaks of highly transmissible diseases through high quality care within the context of universal health coverage. Given the limited availability of IPC evidence-based guidance and standards, the World Health Organization (WHO) decided to prioritize the development of global recommendations on the core components of effective IPC programmes both at the national and acute health care facility level, based on systematic literature reviews and expert consensus. The aim of the guideline development process was to identify the evidence and evaluate its quality, consider patient values and preferences, resource implications, and the feasibility and acceptability of the recommendations. As a result, 11 recommendations and three good practice statements are presented here, including a summary of the supporting evidence, and form the substance of a new WHO IPC guideline.

Guidelines to reach high-quality purified recombinant proteins.

PubMed

Oliveira, Carla; Domingues, Lucília

2018-01-01

The final goal in recombinant protein production is to obtain high-quality pure protein samples. Indeed, the successful downstream application of a recombinant protein depends on its quality. Besides production, which is conditioned by the host, the quality of a recombinant protein product relies mainly on the purification procedure. Thus, the purification strategy must be carefully designed from the molecular level. On the other hand, the quality control of a protein sample must be performed to ensure its purity, homogeneity and structural conformity, in order to validate the recombinant production and purification process. Therefore, this review aims at providing succinct information on the rational purification design of recombinant proteins produced in Escherichia coli, specifically the tagging purification, as well as on accessible tools for evaluating and optimizing protein quality. The classical techniques for structural protein characterization-denaturing protein gel electrophoresis (SDS-PAGE), size exclusion chromatography (SEC), dynamic light scattering (DLS) and circular dichroism (CD)-are revisited with focus on the protein and their main advantages and disadvantages. Furthermore, methods for determining protein concentration and protein storage are also presented. The guidelines compiled herein will aid preparing pure, soluble and homogeneous functional recombinant proteins from the very beginning of the molecular cloning design.

Indoor air quality and the law in Singapore.

PubMed

Chan, P

1999-12-01

With the greater use of air-conditioned offices in Singapore, achieving good indoor air quality has become an important issue. The laws that impose duties upon designers and contractors with respect to the design and construction of air-conditioning and mechanical ventilation (ACMV) systems are set out in the Building Control Regulations and the Singapore Standard Code of Practice for Mechanical Ventilation and Air-conditioning in Buildings (hereinafter "SS CP 13:1980"). ACMV maintenance is governed by the Environmental Public Health Act, the Building and Common Property (Maintenance and Management) Act, and the Land Titles (Strata) Act, as well as by lease or tenancy agreements. Designers, contractors, developers, building owners and management corporations may also be liable to the workers, occupants and other premises users for indoor air quality (IAQ)-related injuries under the general principles of contract and tort. Recently, the Guidelines for Good Indoor Air Quality in Office Premises was issued by the Ministry of Environment to complement SS CP 13:1980 toward improving the indoor air quality of air-conditioned office premises. Although the Guidelines have no statutory effect, they may be adopted as contractual requirements in construction, lease and maintenance contracts. They may also be used to determine the relevant standard of duty of care required to discharge tortious liability. This paper looks at the existing laws and rules affecting the design, construction and maintenance of air-conditioned offices in light of Part III of the Ministry's Guidelines.

A scoping review of patient discharge from intensive care: opportunities and tools to improve care.

PubMed

Stelfox, Henry T; Lane, Dan; Boyd, Jamie M; Taylor, Simon; Perrier, Laure; Straus, Sharon; Zygun, David; Zuege, Danny J

2015-02-01

We conducted a scoping review to systematically review the literature reporting patient discharge from ICUs, identify facilitators and barriers to high-quality care, and describe tools developed to improve care. We searched Medline, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials. Data were extracted on the article type, study details for research articles, patient population, phase of care during discharge, and dimensions of health-care quality. From 8,154 unique publications we included 224 articles. Of these, 131 articles (58%) were original research, predominantly case series (23%) and cohort (16%) studies; 12% were narrative reviews; and 11% were guidelines/policies. Common themes included patient and family needs/experiences (29% of articles) and the importance of complete and accurate information (26%). Facilitators of high-quality care included provider-patient communication (30%), provider-provider communication (25%), and the use of guidelines/policies (29%). Patient and family anxiety (21%) and limited availability of ICU and ward resources (26%) were reported barriers to high-quality care. A total of 47 tools to facilitate patient discharge from the ICU were identified and focused on patient evaluation for discharge (29%), discharge planning and teaching (47%), and optimized discharge summaries (23%). Common themes, facilitators and barriers related to patient and family needs/experiences, communication, and the use of guidelines/policies to standardize patient discharge from ICU transcend the literature. Candidate tools to improve care are available; comparative evaluation is needed prior to broad implementation and could be tested through local quality-improvement programs.

A systematic review and appraisal of the quality of practice guidelines for the management of Neisseria gonorrhoeae infections.

PubMed

Dickson, Catherine; Arnason, Trevor; Friedman, Dara Spatz; Metz, Gila; Grimshaw, Jeremy M

2017-11-01

Clinical guidelines help ensure consistent care informed by current evidence. As shifts in antimicrobial resistance continue to influence first-line treatment, up-to-date guidelines are important for preventing treatment failure. A guideline's development process will influence its recommendations and users' trust. To assess the quality of current gonorrhoea guidelines' development processes. Multiple databases. Original and current English-language guidelines targeting health professionals and containing treatment recommendations for uncomplicated gonorrhoea in the general adult population. Two appraisers assessed the guidelines independently using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Scores were combined as per the AGREE II users' manual. We identified 10 guidelines meeting the inclusion criteria. The quality of the gonorrhoea treatment guidelines varied. Most scored poorly on Rigour of Development ; information on the evidence review process and methods for formulating recommendations was often missing. The WHO Guidelines for the Treatment of Neisseria gonorrhoeae and UK National Guideline for the Management of Gonorrhoea in Adults scored the highest on Rigour of Development . Methods to address conflicts of interest were often not described in the materials reviewed. Implementation of recommendations was often not addressed. By limiting our study to English-language guidelines, a small number of guidelines we identified were excluded. Our analysis was limited to either published or online materials that were readily available to users. We could not differentiate between items addressed in the development process but not documented from items that were not addressed. Gonorrhoea treatment guidelines may slow antimicrobial resistance. Many current guidelines are not in line with the current guideline development best practices; this might undermine the perceived trustworthiness of guidelines. By identifying current limitations, this study can help improve the quality of future guidelines. 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/.

Using AGREE II to Evaluate the Quality of Traditional Medicine Clinical Practice Guidelines in China.

PubMed

Deng, Wei; Li, Le; Wang, Zixia; Chang, Xiaonan; Li, Rui; Fang, Ziye; Wei, Dang; Yao, Liang; Wang, Xiaoqin; Wang, Qi; An, Guanghui

2016-03-15

To evaluate/assess the quality of the Clinical Practice Guidelines (CPGs) of traditional medicine in China. We systematically searched the literature databases WanFang Data, VIP, CNKI and CBM for studies published between 1978 and 2012 to identify and select CPGs of traditional medicine. We used the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument to evaluate these guidelines. A total of 75 guidelines were included, of which 46 guidelines (62%) were on Traditional Chinese Medicine, 19 (25%) on Chinese Integrated Medicine, and 10 (13%) on Uyghur Medicine. Most traditional medicine CPGs published in domestic journals scored <20% (range: 0-63%). Eleven (14%) CPGs were developed following the methodology of evidence-based medicine. In each domain of AGREE II, traditional Medicine CPGs performed clearly better than international CPGs. The same trend was seen in guidelines of Modern Medicine. An increasing amount of CPGs are being published, but their quality is low. Referring to the key points of international guidelines development, supervision through AGREE II, cooperating with international groups and exploring the strategy of guideline development could improve the quality of CPGs on traditional medicine. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.

Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians.

PubMed

Qaseem, Amir; Wilt, Timothy J; McLean, Robert M; Forciea, Mary Ann

2017-04-04

The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on noninvasive treatment of low back pain. Using the ACP grading system, the committee based these recommendations on a systematic review of randomized, controlled trials and systematic reviews published through April 2015 on noninvasive pharmacologic and nonpharmacologic treatments for low back pain. Updated searches were performed through November 2016. Clinical outcomes evaluated included reduction or elimination of low back pain, improvement in back-specific and overall function, improvement in health-related quality of life, reduction in work disability and return to work, global improvement, number of back pain episodes or time between episodes, patient satisfaction, and adverse effects. The target audience for this guideline includes all clinicians, and the target patient population includes adults with acute, subacute, or chronic low back pain. Given that most patients with acute or subacute low back pain improve over time regardless of treatment, clinicians and patients should select nonpharmacologic treatment with superficial heat (moderate-quality evidence), massage, acupuncture, or spinal manipulation (low-quality evidence). If pharmacologic treatment is desired, clinicians and patients should select nonsteroidal anti-inflammatory drugs or skeletal muscle relaxants (moderate-quality evidence). (Grade: strong recommendation). For patients with chronic low back pain, clinicians and patients should initially select nonpharmacologic treatment with exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence). (Grade: strong recommendation). In patients with chronic low back pain who have had an inadequate response to nonpharmacologic therapy, clinicians and patients should consider pharmacologic treatment with nonsteroidal anti-inflammatory drugs as first-line therapy, or tramadol or duloxetine as second-line therapy. Clinicians should only consider opioids as an option in patients who have failed the aforementioned treatments and only if the potential benefits outweigh the risks for individual patients and after a discussion of known risks and realistic benefits with patients. (Grade: weak recommendation, moderate-quality evidence).

Specific guidelines for assessing and improving the methodological quality of economic evaluations of newborn screening

PubMed Central

2012-01-01

Background Economic evaluation of newborn screening poses specific methodological challenges. Amongst others, these challenges refer to the use of quality adjusted life years (QALYs) in newborns, and which costs and outcomes need to be considered in a full evaluation of newborn screening programmes. Because of the increasing scale and scope of such programmes, a better understanding of the methods of high-quality economic evaluations may be crucial for both producers/authors and consumers/reviewers of newborn screening-related economic evaluations. The aim of this study was therefore to develop specific guidelines designed to assess and improve the methodological quality of economic evaluations in newborn screening. Methods To develop the guidelines, existing guidelines for assessing the quality of economic evaluations were identified through a literature search, and were reviewed and consolidated using a deductive iterative approach. In a subsequent test phase, these guidelines were applied to various economic evaluations which acted as case studies. Results The guidelines for assessing and improving the methodological quality of economic evaluations in newborn screening are organized into 11 categories: “bibliographic details”, “study question and design”, “modelling”, “health outcomes”, “costs”, “discounting”, “presentation of results”, “sensitivity analyses”, “discussion”, “conclusions”, and “commentary”. Conclusions The application of the guidelines highlights important issues regarding newborn screening-related economic evaluations, and underscores the need for such issues to be afforded greater consideration in future economic evaluations. The variety in methodological quality detected by this study reveals the need for specific guidelines on the appropriate methods for conducting sound economic evaluations in newborn screening. PMID:22947299

The state of ambient air quality in Pakistan--a review.

PubMed

Colbeck, Ian; Nasir, Zaheer Ahmad; Ali, Zulfiqar

2010-01-01

Pakistan, during the last decade, has seen an extensive escalation in population growth, urbanization, and industrialization, together with a great increase in motorization and energy use. As a result, a substantial rise has taken place in the types and number of emission sources of various air pollutants. However, due to the lack of air quality management capabilities, the country is suffering from deterioration of air quality. Evidence from various governmental organizations and international bodies has indicated that air pollution is a significant risk to the environment, quality of life, and health of the population. The Government has taken positive steps toward air quality management in the form of the Pakistan Clean Air Program and has recently established a small number of continuous monitoring stations. However, ambient air quality standards have not yet been established. This paper reviews the data being available on the criteria air pollutants: particulate matter (PM), sulfur dioxide, ozone, carbon monoxide, nitrogen dioxide, and lead. Air pollution studies in Pakistan published in both scientific journals and by the Government have been reviewed and the reported concentrations of PM, SO(2), O(3), CO, NO(2), and Pb collated. A comparison of the levels of these air pollutants with the World Health Organization air quality guidelines was carried out. Particulate matter was the most serious air pollutant in the country. NO(2) has emerged as the second high-risk pollutant. The reported levels of PM, SO(2), CO, NO(2), and Pb were many times higher than the World Health Organization air quality guidelines. Only O(3) concentrations were below the guidelines. The current state of air quality calls for immediate action to tackle the poor air quality. The establishment of ambient air quality standards, an extension of the continuous monitoring sites, and the development of emission control strategies are essential.

A state of the art regarding urban air quality prediction models

NASA Astrophysics Data System (ADS)

Croitoru, Cristiana; Nastase, Ilinca

2018-02-01

Urban pollution represents an increasing risk to residents of urban regions, particularly in large, over-industrialized cities knowing that the traffic is responsible for more than 25% of air gaseous pollutants and dust particles. Air quality modelling plays an important role in addressing air pollution control and management approaches by providing guidelines for better and more efficient air quality forecasting, along with smart monitoring sensor networks. The advances in technology regarding simulations, forecasting and monitoring are part of the new smart cities which offers a healthy environment for their occupants.

40 CFR 52.1824 - Review of new sources and modifications.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Quality Models” as supplemented by the “North Dakota Guideline for Air Quality Modeling Analysis”.In a... requirements of the EPA Guideline for air quality modeling demonstrations associated with the permitting of new...

2017 American College of Rheumatology/American Association of Hip and Knee Surgeons Guideline for the Perioperative Management of Antirheumatic Medication in Patients With Rheumatic Diseases Undergoing Elective Total Hip or Total Knee Arthroplasty.

PubMed

Goodman, Susan M; Springer, Bryan; Guyatt, Gordon; Abdel, Matthew P; Dasa, Vinod; George, Michael; Gewurz-Singer, Ora; Giles, Jon T; Johnson, Beverly; Lee, Steve; Mandl, Lisa A; Mont, Michael A; Sculco, Peter; Sporer, Scott; Stryker, Louis; Turgunbaev, Marat; Brause, Barry; Chen, Antonia F; Gililland, Jeremy; Goodman, Mark; Hurley-Rosenblatt, Arlene; Kirou, Kyriakos; Losina, Elena; MacKenzie, Ronald; Michaud, Kaleb; Mikuls, Ted; Russell, Linda; Sah, Alexander; Miller, Amy S; Singh, Jasvinder A; Yates, Adolph

2017-08-01

This collaboration between the American College of Rheumatology and the American Association of Hip and Knee Surgeons developed an evidence-based guideline for the perioperative management of antirheumatic drug therapy for adults with rheumatoid arthritis (RA), spondyloarthritis (SpA) including ankylosing spondylitis and psoriatic arthritis, juvenile idiopathic arthritis (JIA), or systemic lupus erythematosus (SLE) undergoing elective total hip (THA) or total knee arthroplasty (TKA). A panel of rheumatologists, orthopedic surgeons specializing in hip and knee arthroplasty, and methodologists was convened to construct the key clinical questions to be answered in the guideline. A multi-step systematic literature review was then conducted, from which evidence was synthesized for continuing versus withholding antirheumatic drug therapy and for optimal glucocorticoid management in the perioperative period. A Patient Panel was convened to determine patient values and preferences, and the Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of evidence and the strength of recommendations, using a group consensus process through a convened Voting Panel of rheumatologists and orthopedic surgeons. The strength of the recommendation reflects the degree of certainty that benefits outweigh harms of the intervention, or vice versa, considering the quality of available evidence and the variability in patient values and preferences. The guideline addresses the perioperative use of antirheumatic drug therapy including traditional disease-modifying antirheumatic drugs, biologic agents, tofacitinib, and glucocorticoids in adults with RA, SpA, JIA, or SLE who are undergoing elective THA or TKA. It provides recommendations regarding when to continue, when to withhold, and when to restart these medications, and the optimal perioperative dosing of glucocorticoids. The guideline includes 7 recommendations, all of which are conditional and based on low- or moderate-quality evidence. This guideline should help decision-making by clinicians and patients regarding perioperative antirheumatic medication management at the time of elective THA or TKA. These conditional recommendations reflect the paucity of high-quality direct randomized controlled trial data. © 2017, American College of Rheumatology.

Quality control and improvement of cancer care: what is needed? 4th European Roundtable Meeting (ERTM) May 5th, 2017, Berlin, Germany.

PubMed

Ortmann, Olaf; Helbig, Ulrike; Torode, Julie; Schreck, Stefan; Karjalainen, Sakari; Bettio, Manola; Ringborg, Ulrik; Klinkhammer-Schalke, Monika; Bray, Freddy

2018-06-01

National Cancer Control Plans (NCCPs) often describe structural requirements for high quality cancer care. During the fourth European Roundtable Meeting (ERTM) participants shared learnings from their own national setting to formulate best practice in optimizing communication strategies between parties involved in clinical cancer registries, cancer centers and guideline groups. A decentralized model of data collection close to the patient and caregiver enhances timely completion and the quality of the data captured. Nevertheless, central coordination is necessary to define datasets, indicators, standard settings, education, training and quality control to maintain standards across the network. In particular, interaction of parties in cancer care network has to be established and maintained on a regular basis. After establishing the structural requirements of cancer care networks, communication between the different components and parties is required to analyze outcome data, provide regular reporting to all and develop strategies for continuous improvement of quality across the network.

Quality control in the diagnosis of Trichuris trichiura and Ascaris lumbricoides using the Kato-Katz technique: experience from three randomised controlled trials.

PubMed

Speich, Benjamin; Ali, Said M; Ame, Shaali M; Albonico, Marco; Utzinger, Jürg; Keiser, Jennifer

2015-02-05

An accurate diagnosis of soil-transmitted helminthiasis is important for individual patient management, for drug efficacy evaluation and for monitoring control programmes. The Kato-Katz technique is the most widely used method detecting soil-transmitted helminth eggs in faecal samples. However, detailed analyses of quality control, including false-positive and faecal egg count (FEC) estimates, have received little attention. Over a 3-year period, within the frame of a series of randomised controlled trials conducted in Pemba, United Republic of Tanzania, 10% of randomly selected Kato-Katz thick smears were re-read for Trichuris trichiura and Ascaris lumbricoides eggs. In case of discordant result (i.e. positive versus negative) the slides were re-examined a third time. A result was assumed to be false-positive or false-negative if the result from the initial reading did not agree with the quality control as well as the third reading. We also evaluated the general agreement in FECs between the first and second reading, according to internal and World Health Organization (WHO) guidelines. From the 1,445 Kato-Katz thick smears subjected to quality control, 1,181 (81.7%) were positive for T. trichiura and 290 (20.1%) were positive for A. lumbricoides. During quality control, very low rates of false-positive results were observed; 0.35% (n = 5) for T. trichiura and 0.28% (n = 4) for A. lumbricoides. False-negative readings of Kato-Katz thick smears were obtained in 28 (1.94%) and 6 (0.42%) instances for T. trichiura and A. lumbricoides, respectively. A high frequency of discordant results in FECs was observed (i.e. 10.0-23.9% for T. trichiura, and 9.0-11.4% for A. lumbricoides). Our analyses show that the rate of false-positive diagnoses of soil-transmitted helminths is low. As the probability of false-positive results increases after examination of multiple stool samples from a single individual, the potential influence of false-positive results on epidemiological studies and anthelminthic drug efficacy studies should be determined. Existing WHO guidelines for quality control might be overambitious and might have to be revised, specifically with regard to handling disagreements in FECs.

Handling qualities effects of display latency

NASA Technical Reports Server (NTRS)

King, David W.

1993-01-01

Display latency is the time delay between aircraft response and the corresponding response of the cockpit displays. Currently, there is no explicit specification for allowable display lags to ensure acceptable aircraft handling qualities in instrument flight conditions. This paper examines the handling qualities effects of display latency between 70 and 400 milliseconds for precision instrument flight tasks of the V-22 Tiltrotor aircraft. Display delay effects on the pilot control loop are analytically predicted through a second order pilot crossover model of the V-22 lateral axis, and handling qualities trends are evaluated through a series of fixed-base piloted simulation tests. The results show that the effects of display latency for flight path tracking tasks are driven by the stability characteristics of the attitude control loop. The data indicate that the loss of control damping due to latency can be simply predicted from knowledge of the aircraft's stability margins, control system lags, and required control bandwidths. Based on the relationship between attitude control damping and handling qualities ratings, latency design guidelines are presented. In addition, this paper presents a design philosophy, supported by simulation data, for using flight director display augmentation to suppress the effects of display latency for delays up to 300 milliseconds.

Air pollution management and control in Latin America and the Caribbean: implications for climate change.

PubMed

Riojas-Rodríguez, Horacio; da Silva, Agnes Soares; Texcalac-Sangrador, José Luis; Moreno-Banda, Grea Litai

2016-09-01

To assess the status of the legal framework for air quality control in all countries of Latin America and Caribbean (LAC); to determine the current distribution of air monitoring stations and mean levels of air pollutants in all capital and large cities (more than 100 000 inhabitants); and to discuss the implications for climate change and public policymaking. From January 2015-February 2016, searches were conducted of online databases for legislation, regulations, policies, and air pollution programs, as well as for the distribution of monitoring stations and the mean annual levels of air pollution in all LAC countries. Only 117 cities distributed among 17 of 33 LAC countries had official information on ground level air pollutants, covering approximately 146 million inhabitants. The annual mean of inhalable particles concentration in most of the cities were over the World Health Organization Air Quality Guidelines; notably, only Bolivia, Peru, and Guatemala have actually adopted the guidelines. Most of the cities did not have information on particulate matter of 2.5 microns or less, and only a few measured black carbon. The air quality regulatory framework should be updated to reflect current knowledge on health effects. Monitoring and control of ground level pollutants should be extended and strengthened to increase awareness and protect public health. Using the co-benefits of air pollution control for health and climate as a framework for policy and decision-making in LAC is recommended.

Guidelines for the care of pregnant women living with HIV and interventions to reduce perinatal transmission: executive summary.

PubMed

Money, Deborah; Tulloch, Karen; Boucoiran, Isabelle; Caddy, Sheila

2014-08-01

This guideline reviews the evidence relating to the care of pregnant women living with HIV and the prevention of perinatal HIV transmission. Prenatal care of pregnancies complicated by HIV infection should include monitoring by a multidisciplinary team with experts in this area. OUTCOMES evaluated include the impact of HIV on pregnancy outcome and the efficacy and safety of antiretroviral therapy and other measures to decrease the risk of vertical transmission. Published literature was retrieved through searches of PubMed and The Cochrane Library in 2012 and 2013 using appropriate controlled vocabulary (HIV, anti-retroviral agents, pregnancy, delivery) and key words (HIV, pregnancy, antiretroviral agents, vertical transmission, perinatal transmission). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English or French. There were no date restrictions. Searches were updated on a regular basis and incorporated in the guideline to June 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1).

Revised version of quality guidelines for presurgical epilepsy evaluation and surgical epilepsy therapy issued by the Austrian, German, and Swiss working group on presurgical epilepsy diagnosis and operative epilepsy treatment.

PubMed

Rosenow, Felix; Bast, Thomas; Czech, Thomas; Feucht, Martha; Hans, Volkmar H; Helmstaedter, Christoph; Huppertz, Hans-Jürgen; Noachtar, Soheyl; Oltmanns, Frank; Polster, Tilman; Seeck, Margitta; Trinka, Eugen; Wagner, Kathrin; Strzelczyk, Adam

2016-08-01

The definition of minimal standards remains pivotal as a basis for a high standard of care and as a basis for staff allocation or reimbursement. Only limited publications are available regarding the required staffing or methodologic expertise in epilepsy centers. The executive board of the working group (WG) on presurgical epilepsy diagnosis and operative epilepsy treatment published the first guidelines in 2000 for Austria, Germany, and Switzerland. In 2014, revised guidelines were published and the WG decided to publish an unaltered English translation in this report. Because epilepsy surgery is an elective procedure, quality standards are particularly high. As detailed in the first edition of these guidelines, quality control relates to seven different domains: (1) establishing centers with a sufficient number of sufficiently and specifically trained personnel, (2) minimum technical standards and equipment, (3) continuous medical education of employees, (4) surveillance by trained personnel during video electroencephalography (EEG) monitoring (VEM), (5) systematic acquisition of clinical and outcome data, (6) the minimum number of preoperative evaluations and epilepsy surgery procedures, and (7) the cooperation of epilepsy centers. These standards required the certification of the different professions involved and minimum numbers of procedures. In the subsequent decade, quite a number of colleagues were certified by the trinational WG; therefore, the executive board of the WG decided in 2013 to make these standards obligatory. This revised version is particularly relevant given that the German procedure classification explicitly refers to the guidelines of the WG with regard to noninvasive/invasive preoperative video-EEG monitoring and invasive intraoperative diagnostics in epilepsy. Wiley Periodicals, Inc. © 2016 International League Against Epilepsy.

Update of the Mexican College of Rheumatology guidelines for the pharmacologic treatment of rheumatoid arthritis.

PubMed

Cardiel, Mario H; Díaz-Borjón, Alejandro; Vázquez del Mercado Espinosa, Mónica; Gámez-Nava, Jorge Iván; Barile Fabris, Leonor A; Pacheco Tena, César; Silveira Torre, Luis H; Pascual Ramos, Virginia; Goycochea Robles, María Victoria; Aguilar Arreola, Jorge Enrique; González Díaz, Verónica; Alvarez Nemegyei, José; González-López, Laura del Carmen; Salazar Páramo, Mario; Portela Hernández, Margarita; Castro Colín, Zully; Xibillé Friedman, Daniel Xavier; Alvarez Hernández, Everardo; Casasola Vargas, Julio; Cortés Hernández, Miguel; Flores-Alvarado, Diana E; Martínez Martínez, Laura A; Vega-Morales, David; Flores-Suárez, Luis Felipe; Medrano Ramírez, Gabriel; Barrera Cruz, Antonio; García González, Adolfo; López López, Susana Marisela; Rosete Reyes, Alejandra; Espinosa Morales, Rolando

2014-01-01

The pharmacologic management of rheumatoid arthritis has progressed substantially over the past years. It is therefore desirable that existing information be periodically updated. There are several published international guidelines for the treatment of rheumatoid arthritis that hardly adapt to the Mexican health system because of its limited healthcare resources. Hence, it is imperative to unify the existing recommendations and to incorporate them to a set of clinical, updated recommendations; the Mexican College of Rheumatology developed these recommendations in order to offer an integral management approach of rheumatoid arthritis according to the resources of the Mexican health system. To review, update and improve the available evidence within clinical practice guidelines on the pharmacological management of rheumatoid arthritis and produce a set of recommendations adapted to the Mexican health system, according to evidence available through December 2012. The working group was composed of 30 trained and experienced rheumatologists with a high quality of clinical knowledge and judgment. Recommendations were based on the highest quality evidence from the previously established treatment guidelines, meta-analysis and controlled clinical trials for the adult population with rheumatoid arthritis. During the conformation of this document, each working group settled the existing evidence from the different topics according to their experience. Finally, all the evidence and decisions were unified into a single document, treatment algorithm and drug standardization tables. This update of the Mexican Guidelines for the Pharmacologic Treatment of Rheumatoid Arthritis provides the highest quality information available at the time the working group undertook this review and contextualizes its use for the complex Mexican health system. Copyright © 2013 Elsevier España, S.L. All rights reserved.

[Guideline compliance in hip fracture: results of an external quality-assurance program in North Rhine Westphalia: 2003-2005].

PubMed

Schulze Raestrup, U; Grams, A; Smektala, R

2008-02-01

Whereas the Scottish guidelines are audited annually, nobody evaluates guideline compliance in Germany. Thus, can external quality assurance data pursuant to section 137 of the German Social Code Book V be suitable for auditing guideline compliance? From North Rhine Westphalia, a total of 48,831 cases of femoral fractures near the hip joint were evaluated. Compliance with the guidelines was determined based on preoperative hospital stay, thrombosis, and antibiotic prophylaxis. Guideline rationale was reviewed in terms of mortality and thromboembolism rate. Sixty-four percent of the interventions were performed in a timely manner. Thrombosis prophylaxis was given in 99% of cases. Antibiotics were given as a single shot. There was no connection between mortality and thromboembolism rates or time to surgery. Guideline compliance is similar in German and Scotland. The external quality assurance data are suitable for evaluating guideline compliance. The literature recommends a short time to surgery. Given the short observation period, it was not possible to demonstrate any improvement in outcomes.

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.

Clinical practice guidelines within the Southern African development community: a descriptive study of the quality of guideline development and concordance with best evidence for five priority diseases

PubMed Central

2012-01-01

Background Reducing the burden of disease relies on availability of evidence-based clinical practice guidelines (CPGs). There is limited data on availability, quality and content of guidelines within the Southern African Development Community (SADC). This evaluation aims to address this gap in knowledge and provide recommendations for regional guideline development. Methods We prioritised five diseases: HIV in adults, malaria in children and adults, pre-eclampsia, diarrhoea in children and hypertension in primary care. A comprehensive electronic search to locate guidelines was conducted between June and October 2010 and augmented with email contact with SADC Ministries of Health. Independent reviewers used the AGREE II tool to score six quality domains reporting the guideline development process. Alignment of the evidence-base of the guidelines was evaluated by comparing their content with key recommendations from accepted reference guidelines, identified with a content expert, and percentage scores were calculated. Findings We identified 30 guidelines from 13 countries, publication dates ranging from 2003-2010. Overall the 'scope and purpose' and 'clarity and presentation' domains of the AGREE II instrument scored highest, median 58%(range 19-92) and 83%(range 17-100) respectively. 'Stakeholder involvement' followed with median 39%(range 6-75). 'Applicability', 'rigour of development' and 'editorial independence' scored poorly, all below 25%. Alignment with evidence was variable across member states, the lowest scores occurring in older guidelines or where the guideline being evaluated was part of broader primary healthcare CPG rather than a disease-specific guideline. Conclusion This review identified quality gaps and variable alignment with best evidence in available guidelines within SADC for five priority diseases. Future guideline development processes within SADC should better adhere to global reporting norms requiring broader consultation of stakeholders and transparency of process. A regional guideline support committee could harness local capacity to support context appropriate guideline development. PMID:22221856

[Colonoscopy quality control as a requirement of colorectal cancer screening].

PubMed

Quintero, Enrique; Alarcón-Fernández, Onofre; Jover, Rodrigo

2013-11-01

The strategies used in population-based colorectal screening strategies culminate in colonoscopy and consequently the success of these programs largely depends on the quality of this diagnostic test. The main factors to consider when evaluating quality are scientific-technical quality, safety, patient satisfaction, and accessibility. Quality indicators allow variability among hospitals, endoscopy units and endoscopists to be determined and can identify those not achieving recommended standards. In Spain, the working group for colonoscopy quality of the Spanish Society of Gastroenterology and the Spanish Society of Gastrointestinal Endoscopy have recently drawn up a Clinical Practice Guideline that contains the available evidence on the quality of screening colonoscopy, as well as the basic requirements that must be met by endoscopy units and endoscopists carrying out this procedure. The implementation of training programs and screening colonoscopy quality controls are strongly recommended to guarantee the success of population-based colorectal cancer screening. Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.

Toward improved guideline quality: using the COGS statement with GEM.

PubMed

Shiffman, Richard N; Michel, Georges

2004-01-01

The Conference on Guideline Standardization (COGS) was convened to create a standardized documentation checklist for clinical practice guidelines in an effort to promote guideline quality and facilitate implementation. The statement was created by a multidisciplinary panel using a rigorous consensus development methodology. The Guideline Elements Model (GEM) provides a standardized approach to representing guideline documents using XML. In this work, we demonstrate the sufficiency of GEM for describing COGS components. Using the mapping between COGS and GEM elements we built an XSLT application to examine a guideline's adherence (or non-adherence) to the COGS checklist. Once a guideline has been marked up according to the GEM hierarchy, its knowledge content can be reused in multiple ways.

Interventional Radiology Clinical Practice Guideline Recommendations for Neurovascular Disorders Are Not Based on High-Quality Systematic Reviews.

PubMed

Chong, A B; Taylor, M; Schubert, G; Vassar, M

2017-04-01

In recent years, clinical practice guidelines have been criticized for biased interpretations of research evidence, and interventional radiology is no exception. Our aim was to evaluate the methodologic quality and transparency of reporting in systematic reviews used as evidence in interventional radiology clinical practice guidelines for neurovascular disorders from the Society of Interventional Radiology. Our sources were 9 neurovascular disorder clinical practice guidelines from the Society of Interventional Radiology. We selected 65 systematic reviews and meta-analyses. A Measurement Tool to Assess Systematic Reviews (AMSTAR) and Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) tools were used to assess the methodologic quality and reporting transparency of systematic reviews. Radial plots were created on the basis of average scores for PRISMA and AMSTAR items. On the basis of AMSTAR scores, 3 (4.62%) reviews were high-quality, 28 reviews (43.08%) were moderate-quality, and 34 reviews (52.31%) were low-quality, with an average quality score of 3.66 (34.32%; minimum, 0%; maximum, 81.82%). The average PRISMA score was 18.18 (69.41%). We were unable to obtain previous versions for 8 reviews, 7 of which were from the Cochrane Database of Systematic Reviews. The methodologic quality of systematic reviews needs to be improved. Although reporting clarity was much better than the methodologic quality, it still has room for improvement. The methodologic quality and transparency of reporting did not vary much among clinical practice guidelines. This study can also be applied to other medical specialties to examine the quality of studies used as evidence in their own clinical practice guidelines. © 2017 by American Journal of Neuroradiology.

Systematic Review of International Colposcopy Quality Improvement Guidelines.

PubMed

Mayeaux, Edward J; Novetsky, Akiva P; Chelmow, David; Choma, Kim; Garcia, Francisco; Liu, Angela H; Papasozomenos, Theognosia; Einstein, Mark H

2017-10-01

The American Society for Colposcopy and Cervical Pathology Colposcopy Standards Committee organized multiple working groups to draft colposcopy standards for the United States. As part of this project, international quality assurance and improvement measures were examined. The quality improvement working group performed a systematic review of the literature to collate international guidelines related to quality improvement. Source guidelines were collected using searches in Medline, Google Scholar, the International Federation of Cervical Pathology and Colposcopy Web site, other regional colposcopy group's Web sites, and communications with International Federation of Cervical Pathology and Colposcopy board of directors' members and other expert members of various national groups. Once identified, the sources were reviewed by multiple workgroup members for potential guideline materials. Fifty-six unique documents were identified, of which 18 met inclusion criteria and contributed data to the analysis. Information was abstracted and grouped by related subject. Wide variation exists in colposcopy guidance and quality indicators from regional and national colposcopy societies. Abstracted international guidelines are presented.

77 FR 28336 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Offset Lithographic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

... Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those... Technology (RACT) for sources covered by EPA's Control Techniques Guidelines (CTG) for offset lithographic..., unless the comment includes information claimed to be Confidential Business Information (CBI) or other...

40 CFR 52.1520 - Identification of plan.

Code of Federal Regulations, 2012 CFR

2012-07-01

... plan. (a) Purpose and scope. This section sets forth the applicable State Implementation Plan for New... provisions for retention and availability of air quality data Statewide 3/23/1972 7/27/1972, 37 FR 15080 See..., 1998 stating a negative declaration for the aerospace coating operations Control Techniques Guideline...

40 CFR 52.1520 - Identification of plan.

Code of Federal Regulations, 2011 CFR

2011-07-01

... plan. (a) Purpose and scope. This section sets forth the applicable State Implementation Plan for New... provisions for retention and availability of air quality data Statewide 3/23/1972 7/27/1972, 37 FR 15080 See..., 1998 stating a negative declaration for the aerospace coating operations Control Techniques Guideline...

National Functional Guidelines for Inorganic Superfund Methods Data Review (ISM02.4)

EPA Pesticide Factsheets

This document is designed to assist the reviewer in evaluating (a) whether the analytical data meet the technical and Quality Control (QC) criteria specified in the SOW, and (b) the usability and extent of bias of any data that do not meet these criteria.

Microfilm Standards. Counties, Municipalities, School Districts.

ERIC Educational Resources Information Center

New Jersey State Dept. of Education, Trenton.

This pamphlet contains the standards and requirements approved by the New Jersey State Records Committee on May 13, 1981, which bring the microfilm quality-control standards into conformity with national standards. Standards and guidelines are established for the selection of records to be microfilmed, the selection of equipment and vendors, the…

76 FR 64020 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... Plastic Parts and Business Machines Coatings AGENCY: Environmental Protection Agency (EPA). ACTION: Final....19.07-2, Plastic Parts and Business Machines Coating. Maryland's SIP revision meets the requirement... Techniques Guidelines (CTG) standards for plastic parts and business machines coatings and will help Maryland...

77 FR 43000 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Offset Lithographic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-23

... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2012-0042; FRL-9702-2] Approval and... Printing Regulations AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is... Technology (RACT) for sources covered by EPA's Control Techniques Guidelines (CTG) for offset lithographic...

Bibliographic Control of Large Quantities of Research Material.

ERIC Educational Resources Information Center

Evans, Martha M.

1983-01-01

Guidelines for individual researcher describe bibliographic methods for achieving high standards of quality while maintaining maximum efficiency in each step of all necessary procedures involved in the construction of a bibliography ranging from several hundred to several thousand items. Ways to minimize waste motion and duplication of effort are…

Quality of Care for Patients with Type 2 Diabetes Mellitus in the Netherlands and the United States: A Comparison of Two Quality Improvement Programs

PubMed Central

Valk, Gerlof D; Renders, Carry M; Kriegsman, Didi MW; Newton, Katherine M; Twisk, Jos WR; van Eijk, Jacques ThM; van der Wal, Gerrit; Wagner, Edward H

2004-01-01

Objective To assess differences in diabetes care and patient outcomes by comparing two multifaceted quality improvement programs in two different countries, and to increase knowledge of effective elements of such programs. Study Setting Primary care in the ExtraMural Clinic (EMC) of the Department of General Practice of the Vrije Universiteit in Amsterdam, the Netherlands, and the Group Health Cooperative (GHC), a group-model health maintenance organization (HMO) in western Washington State in the United States. Data were collected from 1992 to 1997. Study Design In this observational study two diabetes cohorts in which a quality improvement program was implemented were compared. Both programs included a medical record system, clinical practice guidelines, physician educational meetings, audit, and feedback. Only the Dutch program (EMC) included guidelines on the structure of diabetes care and a recall system. Only the GHC program included educational outreach visits, formation of multidisciplinary teams, and patient self-management support. Data Collection Included were 379 EMC patients, and 2,119 GHC patients with type 2 diabetes mellitus. Main process outcomes were: annual number of diabetes visits, and number of HbA1c and blood lipid measurements. Main patient outcomes were HbA1c and blood lipid levels. Multilevel analysis was used to adjust for dependency between repeated observations within one patient and for clustering of patients within general practices. Principal Findings In the EMC process outcomes and glycemic control improved more than at GHC, however, GHC had better baseline measures. There were no differences between programs on blood lipid control. During follow-up, intensification of pharmacotherapy was noted at both sites. Differences noted between programs were in line with differences in diabetes guidelines. Conclusions Following implementation of guidelines and organizational improvement efforts, change occurred primarily in the process outcomes, rather than in the patient outcomes. Although much effort was put into improving process and patient outcomes, both complex programs still showed only moderate effects. PMID:15230924

DEVELOPMENT OF MARINE WATER QUALITY CRITERIA

EPA Science Inventory

The U.S. Environmental Protectional Agency has developed guidelines for deriving numerical national water quality criteria for the protection of aquatic organisms and their uses. These guidelines provide the method for deriving water quality criteria, including minimum data base...

Traffic Data Quality Measurement : Final Report

DOT National Transportation Integrated Search

2004-09-15

One of the foremost recommendations from the FHWA sponsored workshops on Traffic Data Quality (TDQ) in 2003 was a call for "guidelines and standards for calculating data quality measures." These guidelines and standards are expected to contain method...

An intelligent case-adjustment algorithm for the automated design of population-based quality auditing protocols.

PubMed

Advani, Aneel; Jones, Neil; Shahar, Yuval; Goldstein, Mary K; Musen, Mark A

2004-01-01

We develop a method and algorithm for deciding the optimal approach to creating quality-auditing protocols for guideline-based clinical performance measures. An important element of the audit protocol design problem is deciding which guide-line elements to audit. Specifically, the problem is how and when to aggregate individual patient case-specific guideline elements into population-based quality measures. The key statistical issue involved is the trade-off between increased reliability with more general population-based quality measures versus increased validity from individually case-adjusted but more restricted measures done at a greater audit cost. Our intelligent algorithm for auditing protocol design is based on hierarchically modeling incrementally case-adjusted quality constraints. We select quality constraints to measure using an optimization criterion based on statistical generalizability coefficients. We present results of the approach from a deployed decision support system for a hypertension guideline.

Influence of stroke subtype on quality of care in the Get With The Guidelines-Stroke Program.

PubMed

Smith, E E; Liang, L; Hernandez, A; Reeves, M J; Cannon, C P; Fonarow, G C; Schwamm, L H

2009-09-01

Little is known about in-hospital care for hemorrhagic stroke. We examined quality of care in intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH) admissions in the national Get With The Guidelines-Stroke (GWTG-Stroke) database, and compared them to ischemic stroke (IS) or TIA admissions. Between April 1, 2003, and December 30, 2007, 905 hospitals contributed 479,284 consecutive stroke and TIA admissions. The proportions receiving each quality of care measure were calculated by dividing the total number of patients receiving the intervention by the total number of patients eligible for the intervention, excluding ineligible patients or those with contraindications to treatment. Logistic regression models were used to determine associations between measure compliance and stroke subtype, controlling for patient and hospital characteristics. Stroke subtypes were 61.7% IS, 23.8% TIA, 11.1% ICH, and 3.5% SAH. Performance on care measures was generally lower in ICH and SAH compared to IS/TIA, including guideline-recommended measures for deep venous thrombosis (DVT) prevention (for ICH) and smoking cessation (for SAH) (multivariable-adjusted p < 0.001 for all comparisons). Exceptions were that ICH patients were more likely than IS/TIA to have door-to-CT times <25 minutes (multivariable-adjusted p < 0.001) and to undergo dysphagia screening (multivariable-adjusted p < 0.001). Time spent in the GWTG-Stroke program was associated with improvements in many measures of care for ICH and SAH patients, including DVT prevention and smoking cessation therapy (multivariable-adjusted p < 0.001). Many hospital-based acute care and prevention measures are underutilized in intracerebral hemorrhage and subarachnoid hemorrhage compared to ischemic stroke /TIA. Duration of Get With The Guidelines-Stroke participation is associated with improving quality of care for hemorrhagic stroke.

Clinical Practice Guideline: Hoarseness (Dysphonia) (Update) Executive Summary.

PubMed

Stachler, Robert J; Francis, David O; Schwartz, Seth R; Damask, Cecelia C; Digoy, German P; Krouse, Helene J; McCoy, Scott J; Ouellette, Daniel R; Patel, Rita R; Reavis, Charles Charlie W; Smith, Libby J; Smith, Marshall; Strode, Steven W; Woo, Peak; Nnacheta, Lorraine C

2018-03-01

Objective This guideline provides evidence-based recommendations on treating patients presenting with dysphonia, which is characterized by altered vocal quality, pitch, loudness, or vocal effort that impairs communication and/or quality of life. Dysphonia affects nearly one-third of the population at some point in its life. This guideline applies to all age groups evaluated in a setting where dysphonia would be identified or managed. It is intended for all clinicians who are likely to diagnose and treat patients with dysphonia. Purpose The primary purpose of this guideline is to improve the quality of care for patients with dysphonia, based on current best evidence. Expert consensus to fill evidence gaps, when used, is explicitly stated and supported with a detailed evidence profile for transparency. Specific objectives of the guideline are to reduce inappropriate variations in care, produce optimal health outcomes, and minimize harm. For this guideline update, the American Academy of Otolaryngology-Head and Neck Surgery Foundation selected a panel representing the fields of advanced practice nursing, bronchoesophagology, consumer advocacy, family medicine, geriatric medicine, internal medicine, laryngology, neurology, otolaryngology-head and neck surgery, pediatrics, professional voice, pulmonology, and speech-language pathology. Action Statements The guideline update group made strong recommendations for the following key action statements (KASs): (1) Clinicians should assess the patient with dysphonia by history and physical examination to identify factors where expedited laryngeal evaluation is indicated. These include but are not limited to recent surgical procedures involving the head, neck, or chest; recent endotracheal intubation; presence of concomitant neck mass; respiratory distress or stridor; history of tobacco abuse; and whether the patient is a professional voice user. (2) Clinicians should advocate voice therapy for patients with dysphonia from a cause amenable to voice therapy. The guideline update group made recommendations for the following KASs: (1) Clinicians should identify dysphonia in a patient with altered voice quality, pitch, loudness, or vocal effort that impairs communication or reduces quality of life (QOL). (2) Clinicians should assess the patient with dysphonia by history and physical examination for underlying causes of dysphonia and factors that modify management. (3) Clinicians should perform laryngoscopy, or refer to a clinician who can perform laryngoscopy, when dysphonia fails to resolve or improve within 4 weeks or irrespective of duration if a serious underlying cause is suspected. (4) Clinicians should perform diagnostic laryngoscopy, or refer to a clinician who can perform diagnostic laryngoscopy, before prescribing voice therapy and document/communicate the results to the speech-language pathologist (SLP). (5) Clinicians should advocate for surgery as a therapeutic option for patients with dysphonia with conditions amenable to surgical intervention, such as suspected malignancy, symptomatic benign vocal fold lesions that do not respond to conservative management, or glottic insufficiency. (6) Clinicians should offer, or refer to a clinician who can offer, botulinum toxin injections for the treatment of dysphonia caused by spasmodic dysphonia and other types of laryngeal dystonia. (7) Clinicians should inform patients with dysphonia about control/preventive measures. (8) Clinicians should document resolution, improvement or worsened symptoms of dysphonia, or change in QOL of patients with dysphonia after treatment or observation. The guideline update group made a strong recommendation against 1 action: (1) Clinicians should not routinely prescribe antibiotics to treat dysphonia. The guideline update group made recommendations against other actions: (1) Clinicians should not obtain computed tomography (CT) or magnetic resonance imaging (MRI) for patients with a primary voice complaint prior to visualization of the larynx. (2) Clinicians should not prescribe antireflux medications to treat isolated dysphonia, based on symptoms alone attributed to suspected gastroesophageal reflux disease (GERD) or laryngopharyngeal reflux (LPR), without visualization of the larynx. (3) Clinicians should not routinely prescribe corticosteroids in patients with dysphonia prior to visualization of the larynx. The policy level for the following recommendation about laryngoscopy at any time was an option: (1) Clinicians may perform diagnostic laryngoscopy at any time in a patient with dysphonia. Differences from Prior Guideline (1) Incorporating new evidence profiles to include the role of patient preferences, confidence in the evidence, differences of opinion, quality improvement opportunities, and any exclusion to which the action statement does not apply (2) Inclusion of 3 new guidelines, 16 new systematic reviews, and 4 new randomized controlled trials (3) Inclusion of a consumer advocate on the guideline update group (4) Changes to 9 KASs from the original guideline (5) New KAS 3 (escalation of care) and KAS 13 (outcomes) (6) Addition of an algorithm outlining KASs for patients with dysphonia.

Evaluation of all African clinical practice guidelines for hypertension: Quality and opportunities for improvement.

PubMed

Okwen, Patrick Mbah; Maweu, Irene; Grimmer, Karen; Margarita Dizon, Janine

2018-06-14

Good-quality clinical practice guidelines (CPGs) provide recommendations based on current best-evidence summaries. Hypertension is a prevalent noncommunicable disease in Africa, with disastrous sequelae (stroke, heart, and kidney disease). Its effective management relies on good quality, current, locally relevant evidence. This paper reports on an all African review of the guidance documents currently informing hypertension management. Attempts were made to contact 62 African countries for formal guidance documents used nationally to inform diagnosis and management of hypertension. Their quality was assessed by using Appraisal of Guidelines for Research & Evaluation (AGREE) II, scored by 2 independent reviewers. Differences in domain scores were compared between documents written prior to 2011 and 2011 onward. Findings were compared with earlier African CPG reviews. Guidelines and protocols were provided by 26 countries. Six used country-specific stand-alone hypertension guidelines, and 10 used protocols embedded in Standard Treatment Guidelines for multiple conditions. Six used guidelines developed by the World Health Organization, and 4 indicated ad hoc use of international guidance (US, Portugal, and Brazil). Only 1 guidance document met CPG construction criteria, and none scored well on all AGREE domain scores. The lowest-scoring domain was rigour of development. There was no significant quality difference between pre-2011 and post-2011 guidance documents, and there were variable AGREE II scores for the same CPGs when comparing the African reviews. The quality of hypertension guidance used by African nations could be improved. The need for so many guidance documents is questioned. Adopting a common evidence base from international good-quality CPGs and layering it with local contexts offer 1 way to efficiently improve African hypertension CPG quality and implementation. © 2018 John Wiley & Sons, Ltd.

Electronic Reliability Design Handbook. Volume 1

DTIC Science & Technology

1988-10-12

greater use of proven designs , more design attention to non -random failures, design sim- plicity, improved quality control , more effective development and...RELIABILITY ENGINEERING DESIGN GUIDELINES 7-1 7.1 INTRODUCTION 7-1 7.2 PART SELECTION AND CONTROL 7-1 7.3 DERATING 7-4 7.3.1 DERATING OF MECHANICAL STRUCTURAL...11-58 11.3.1 INTRODUCTION 11-58 11.3.2 MAINTAINABILITY DESIGN ATTRIBUTES 11-59 11.3.3 MAINTAINABILITY CONTROL PARAMETERS 11-59 11.3.4 MAINTAINABILITY

Infection prevention and control of Clostridium difficile: a global review of guidelines, strategies, and recommendations

PubMed Central

Balsells, Evelyn; Filipescu, Teodora; Kyaw, Moe H.; Wiuff, Camilla; Campbell, Harry; Nair, Harish

2016-01-01

Background Clostridium difficile is the leading cause of health care–associated infections. Given the high incidence of C. difficile infection (CDI) and the lack of primary prevention through immunization, health care professionals should be aware of the most current guidance, as well as strengths and limitations of the evidence base underpinning this guidance. Methods We identified publicly available national or organizational guidelines related to CDI infection and prevention control (IPC) published between 2000 and 2015 and for any health care setting through an internet search using the Google search engine. We reviewed CDI–targeted IPC recommendations and describe the assessment of evidence in available guidelines. Results We identified documents from 28 countries/territories, mainly from acute care hospitals in North America, the Western Pacific, and Europe (18 countries). We identified only a few specific recommendations for long–term care facilities (LTCFs) and from countries in South America (Uruguay and Chile), South East Asia (Thailand), and none for Africa or Eastern Mediterranean. Of 10 IPC areas, antimicrobial stewardship was universally recognized as essential and supported by high quality evidence. Five other widely reported “strong” recommendations were: effective environment cleaning (including medical equipment), case isolation, use of personal protective equipment, surveillance, and education. Several unresolved and emerging issues were documented and currently available evidence was classified mainly as of mixed quality. Conclusion Our review underlines the need for targeted CDI IPC guidelines in several countries and for LTCFs. International harmonisation on the assessment of the evidence for best practices is needed as well as more robust evidence to support targeted recommendations. PMID:28028434

Infection prevention and control of Clostridium difficile: a global review of guidelines, strategies, and recommendations.

PubMed

Balsells, Evelyn; Filipescu, Teodora; Kyaw, Moe H; Wiuff, Camilla; Campbell, Harry; Nair, Harish

2016-12-01

Clostridium difficile is the leading cause of health care-associated infections. Given the high incidence of C. difficile infection (CDI) and the lack of primary prevention through immunization, health care professionals should be aware of the most current guidance, as well as strengths and limitations of the evidence base underpinning this guidance. We identified publicly available national or organizational guidelines related to CDI infection and prevention control (IPC) published between 2000 and 2015 and for any health care setting through an internet search using the Google search engine. We reviewed CDI-targeted IPC recommendations and describe the assessment of evidence in available guidelines. We identified documents from 28 countries/territories, mainly from acute care hospitals in North America, the Western Pacific, and Europe (18 countries). We identified only a few specific recommendations for long-term care facilities (LTCFs) and from countries in South America (Uruguay and Chile), South East Asia (Thailand), and none for Africa or Eastern Mediterranean. Of 10 IPC areas, antimicrobial stewardship was universally recognized as essential and supported by high quality evidence. Five other widely reported "strong" recommendations were: effective environment cleaning (including medical equipment), case isolation, use of personal protective equipment, surveillance, and education. Several unresolved and emerging issues were documented and currently available evidence was classified mainly as of mixed quality. Our review underlines the need for targeted CDI IPC guidelines in several countries and for LTCFs. International harmonisation on the assessment of the evidence for best practices is needed as well as more robust evidence to support targeted recommendations.

Interventions to Modify Health Care Provider Adherence to Asthma Guidelines: A Systematic Review

PubMed Central

Okelo, Sande O.; Butz, Arlene M.; Sharma, Ritu; Diette, Gregory B.; Pitts, Samantha I.; King, Tracy M.; Linn, Shauna T.; Reuben, Manisha; Chelladurai, Yohalakshmi

2013-01-01

BACKGROUND AND OBJECTIVE: Health care provider adherence to asthma guidelines is poor. The objective of this study was to assess the effect of interventions to improve health care providers’ adherence to asthma guidelines on health care process and clinical outcomes. METHODS: Data sources included Medline, Embase, Cochrane CENTRAL Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, PsycINFO, and Research and Development Resource Base in Continuing Medical Education up to July 2012. Paired investigators independently assessed study eligibility. Investigators abstracted data sequentially and independently graded the evidence. RESULTS: Sixty-eight eligible studies were classified by intervention: decision support, organizational change, feedback and audit, clinical pharmacy support, education only, quality improvement/pay-for-performance, multicomponent, and information only. Half were randomized trials (n = 35). There was moderate evidence for increased prescriptions of controller medications for decision support, feedback and audit, and clinical pharmacy support and low-grade evidence for organizational change and multicomponent interventions. Moderate evidence supports the use of decision support and clinical pharmacy interventions to increase provision of patient self-education/asthma action plans. Moderate evidence supports use of decision support tools to reduce emergency department visits, and low-grade evidence suggests there is no benefit for this outcome with organizational change, education only, and quality improvement/pay-for-performance. CONCLUSIONS: Decision support tools, feedback and audit, and clinical pharmacy support were most likely to improve provider adherence to asthma guidelines, as measured through health care process outcomes. There is a need to evaluate health care provider-targeted interventions with standardized outcomes. PMID:23979092

Economic evaluation of a web-based tailored lifestyle intervention for adults: findings regarding cost-effectiveness and cost-utility from a randomized controlled trial.

PubMed

Schulz, Daniela N; Smit, Eline S; Stanczyk, Nicola E; Kremers, Stef P J; de Vries, Hein; Evers, Silvia M A A

2014-03-20

Different studies have reported the effectiveness of Web-based computer-tailored lifestyle interventions, but economic evaluations of these interventions are scarce. The objective was to assess the cost-effectiveness and cost-utility of a sequential and a simultaneous Web-based computer-tailored lifestyle intervention for adults compared to a control group. The economic evaluation, conducted from a societal perspective, was part of a 2-year randomized controlled trial including 3 study groups. All groups received personalized health risk appraisals based on the guidelines for physical activity, fruit intake, vegetable intake, alcohol consumption, and smoking. Additionally, respondents in the sequential condition received personal advice about one lifestyle behavior in the first year and a second behavior in the second year; respondents in the simultaneous condition received personal advice about all unhealthy behaviors in both years. During a period of 24 months, health care use, medication use, absenteeism from work, and quality of life (EQ-5D-3L) were assessed every 3 months using Web-based questionnaires. Demographics were assessed at baseline, and lifestyle behaviors were assessed at both baseline and after 24 months. Cost-effectiveness and cost-utility analyses were performed based on the outcome measures lifestyle factor (the number of guidelines respondents adhered to) and quality of life, respectively. We accounted for uncertainty by using bootstrapping techniques and sensitivity analyses. A total of 1733 respondents were included in the analyses. From a willingness to pay of €4594 per additional guideline met, the sequential intervention (n=552) was likely to be the most cost-effective, whereas from a willingness to pay of €10,850, the simultaneous intervention (n=517) was likely to be most cost-effective. The control condition (n=664) appeared to be preferred with regard to quality of life. Both the sequential and the simultaneous lifestyle interventions were likely to be cost-effective when it concerned the lifestyle factor, whereas the control condition was when it concerned quality of life. However, there is no accepted cutoff point for the willingness to pay per gain in lifestyle behaviors, making it impossible to draw firm conclusions. Further economic evaluations of lifestyle interventions are needed. Dutch Trial Register NTR2168; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2168 (Archived by WebCite at http://www.webcitation.org/6MbUqttYB).

Guideline Implementation: Surgical Smoke Safety.

PubMed

Fencl, Jennifer L

2017-05-01

Research conducted during the past four decades has demonstrated that surgical smoke generated from the use of energy-generating devices in surgery contains toxic and biohazardous substances that present risks to perioperative team members and patients. Despite the increase in information available, however, perioperative personnel continue to demonstrate a lack of knowledge of these hazards and lack of compliance with recommendations for evacuating smoke during surgical procedures. The new AORN "Guideline for surgical smoke safety" provides guidance on surgical smoke management. This article focuses on key points of the guideline to help perioperative personnel promote smoke-free work environments; evacuate surgical smoke; and develop education programs and competency verification tools, policies and procedures, and quality improvement initiatives related to controlling surgical smoke. Perioperative RNs should review the complete guideline for additional information and for guidance when writing and updating policies and procedures. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Treatment of Malignant Pleural Mesothelioma: American Society of Clinical Oncology Clinical Practice Guideline.

PubMed

Kindler, Hedy L; Ismaila, Nofisat; Armato, Samuel G; Bueno, Raphael; Hesdorffer, Mary; Jahan, Thierry; Jones, Clyde Michael; Miettinen, Markku; Pass, Harvey; Rimner, Andreas; Rusch, Valerie; Sterman, Daniel; Thomas, Anish; Hassan, Raffit

2018-05-01

Purpose To provide evidence-based recommendations to practicing physicians and others on the management of malignant pleural mesothelioma. Methods ASCO convened an Expert Panel of medical oncology, thoracic surgery, radiation oncology, pulmonary, pathology, imaging, and advocacy experts to conduct a literature search, which included systematic reviews, meta-analyses, randomized controlled trials, and prospective and retrospective comparative observational studies published from 1990 through 2017. Outcomes of interest included survival, disease-free or recurrence-free survival, and quality of life. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. Results The literature search identified 222 relevant studies to inform the evidence base for this guideline. Recommendations Evidence-based recommendations were developed for diagnosis, staging, chemotherapy, surgical cytoreduction, radiation therapy, and multimodality therapy in patients with malignant pleural mesothelioma. Additional information is available at www.asco.org/thoracic-cancer-guidelines and www.asco.org/guidelineswiki .

Systematic analysis underlying the quality of the scientific evidence and conflicts of interest in interventional medicine subspecialty guidelines.

PubMed

Feuerstein, Joseph D; Akbari, Mona; Gifford, Anne E; Hurley, Christine M; Leffler, Daniel A; Sheth, Sunil G; Cheifetz, Adam S

2014-01-01

To determine the validity of guidelines published by interventional medical societies. We reviewed the interventional medicine subspecialty society websites of the American Association for Bronchology and Interventional Pulmonology (AABIP), American Society of Diagnostic and Interventional Nephrology (ASDIN), American Society for Gastrointestinal Endoscopy (ASGE), and Society for Cardiovascular Angiography and Interventions (SCAI) as of November 15, 2012, for published interventional guidelines. The study was performed between November 15, 2012, and January 1, 2013. The AABIP did not publish guidelines, so American Thoracic Society and American College of Chest Physicians guidelines were reviewed. All the guidelines were reviewed for graded levels of evidence, methods used to grade the evidence, and disclosures of conflicts of interest (COIs). Of 153 interventional guidelines evaluated, 4 were duplicates. Forty-six percent of guidelines (69 of 149) graded the quality of evidence using 7 different methods. The ASGE graded 71% of guidelines (46 of 65) compared with 29% (23 of 78) by the SCAI and 0 by the ASDIN (n=4) and the pulmonary societies (n=2). Of the 3425 recommendations reviewed, 11% (n=364) were supported by level A, 42% (n=1432) by level B, and 48% (n=1629) by level C. The mean age of the guidelines was 5.2 years. Additionally, 62% of the guidelines (92 of 149) failed to comment on COIs; when disclosed, 91% of guidelines (52 of 57) reported COIs. In total, 1827 COIs were reported by 45% of the authors (317 of 697), averaging 5.8 COIs per author. Most of the interventional guidelines failed to grade the evidence. When present, most guidelines used lower-quality evidence. Furthermore, most guidelines failed to disclose COIs. When commented on, numerous COIs were present. Future guidelines should clearly state the quality of evidence, use a standard grading system, be transparent regarding potential biases, and provide frequent updates. Copyright © 2014 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

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.

Quality assessment of clinical practice guidelines for integrative medicine in China: A systematic review.

PubMed

Yao, Sha; Wei, Dang; Chen, Yao-Long; Wang, Qi; Wang, Xiao-Qin; Zeng, Zhao; Li, Hui

2017-05-01

To assess the quality of integrative medicine clinical practice guidelines (CPGs) published before 2014. A systematic search of the scientific literature published before 2014 was conducted to select integrative medicine CPGs. Four major Chinese integrated databases and one guideline database were searched: the Chinese Biomedical Literature Database (CBM), the China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang Data, and the China Guideline Clearinghouse (CGC). Four reviewers independently assessed the quality of the included guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE) II Instrument. Overall consensus among the reviewers was assessed using the intra-class correlation coefficient (ICC). A total of 41 guidelines published from 2003 to 2014 were included. The overall consensus among the reviewers was good [ICC: 0.928; 95% confifi dence interval (CI): 0.920 to 0.935]. The scores on the 6 AGREE domains were: 17% for scope and purpose (range: 6% to 32%), 11% for stakeholder involvement (range: 0 to 24%), 10% for rigor of development (range: 3% to 22%), 39% for clarity and presentation (range: 25% to 64%), 11% for applicability (range: 4% to 24%), and 1% for editorial independence (range: 0 to 15%). The quality of integrative medicine CPGs was low, the development of integrative medicine CPGs should be guided by systematic methodology. More emphasis should be placed on multi-disciplinary guideline development groups, quality of evidence, management of funding and conflfl icts of interest, and guideline updates in the process of developing integrative medicine CPGs in China.

A critical appraisal of guidelines for the management of knee osteoarthritis using Appraisal of Guidelines Research and Evaluation criteria

PubMed Central

Poitras, Stéphane; Avouac, Jérôme; Rossignol, Michel; Avouac, Bernard; Cedraschi, Christine; Nordin, Margareta; Rousseaux, Chantal; Rozenberg, Sylvie; Savarieau, Bernard; Thoumie, Philippe; Valat, Jean-Pierre; Vignon, Éric; Hilliquin, Pascal

2007-01-01

Clinical practice guidelines have been elaborated to summarize evidence related to the management of knee osteoarthritis and to facilitate uptake of evidence-based knowledge by clinicians. The objectives of the present review were summarizing the recommendations of existing guidelines on knee osteoarthritis, and assessing the quality of the guidelines using a standardized and validated instrument – the Appraisal of Guidelines Research and Evaluation (AGREE) tool. Internet medical literature databases from 2001 to 2006 were searched for guidelines, with six guidelines being identified. Thirteen clinician researchers participated in the review. Each reviewer was trained in the AGREE instrument. The guidelines were distributed to four groups of three or four reviewers, each group reviewing one guideline with the exception of one group that reviewed two guidelines. One independent evaluator reviewed all guidelines. All guidelines effectively addressed only a minority of AGREE domains. Clarity/presentation was effectively addressed in three out of six guidelines, scope/purpose and rigour of development in two guidelines, editorial independence in one guideline, and stakeholder involvement and applicability in none. The clinical management recommendation tended to be similar among guidelines, although interventions addressed varied. Acetaminophen was recommended for initial pain treatment, combined with exercise and education. Nonsteroidal anti-inflammatory drugs were recommended if acetaminophen failed to control pain, but cautiously because of gastrointestinal risks. Surgery was recommended in the presence of persistent pain and disability. Education and activity management interventions were superficially addressed in most guidelines. Guideline creators should use the AGREE criteria when developing guidelines. Innovative and effective methods of knowledge translation to health professionals are needed. PMID:18062805

DRAFT METHODOLOGY FOR DERIVATION OF WATER ...

EPA Pesticide Factsheets

Development and body functions of many organisms are directed by the endocrine system. Endocrine Disrupting Chemicals (EDCs), are those exogenous (and endogenous) compounds that may interfere with this regulatory function because they may either mimic or suppress the action of the body’s natural hormones. Because these chemicals are increasingly present in the environment as a result of human activities and they only require tiny amounts to disrupt endocrine functions, EDCs may have major impacts on ecology and particularly aquatic life as evidenced by the abundance of field observations verified by both laboratory and controlled in situ experiments. The Clean Water Act § 304(a)(1) authorizes the Administrator to develop and publish criteria for water quality that are protective of aquatic life. Traditionally, ambient water quality criteria for the protection of aquatic life have been derived using the 1985 Guidelines (Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Life and Their Uses). These guidelines have comprehensive data requirements for toxicity tests using a variety of aquatic taxa, thus ensuring protection of the existing aquatic assemblage, and helping to ensure a goal of protecting and restoring “ecological integrity”. Some “Pharmaceuticals and Personal Care Products” (PPCPs), particularly those exhibiting endocrine disrupting activity, have two unique features, which distinguish them from

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.

Guidelines for preparation of the 1996 state water quality assessments (305(b) reports)

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

NONE

1995-05-01

The Federal Water Polluton Control Act (PL92-500, commonly known as the Clean Water Act), establishes a process for States to use to develop information on the quality of the Nation`s water resources and to report this information to the U.S. Environmental Protection Agency (EPA), the U.S. Congress, and the citizens of this country. Each State must develop a program to monitor the quality of its surface and ground waters and prepare a report every 2 years describing the status of its water quality. EPA compiles the data from the State reports, summarizes them, and transmits the summaries to Congress alongmore » with an analysis of the status of water quality nationwide. This process, referred to as the 305(b) process, is an essential aspect of the Nation`s water pollution control effort.« less

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…

A Survey of the Prevalence and Impact of Reporting Guideline Endorsement in Pathology Journals.

PubMed

Caron, Justin E; March, Jordon K; Cohen, Michael B; Schmidt, Robert L

2017-10-01

To determine the prevalence of reporting guideline endorsement in pathology journals and to estimate the impact of guideline endorsement. We compared the quality of reporting in two sets of studies: (1) studies published in journals that explicitly mentioned a guideline vs studies published in journals that did not and (2) studies that cited a guideline vs studies that did not. The quality of reporting in prognostic biomarker studies was assessed using the REporting recommendations for tumor MARKer prognostic studies (REMARK) guideline. We found that six (10%) of the 59 leading pathology journals explicitly mention reporting guidelines in the instructions to authors. Only one journal required authors to submit a checklist. There was significant variation in the rate at which various REMARK items were reported (P < .001). Journal endorsement was associated with more complete reporting (P = .04). Studies that cited REMARK had greater adherence to the REMARK reporting guidelines than studies that did not (P = .02). The prevalence of guideline endorsement is relatively low in pathology journals, but guideline endorsement may improve the quality of reporting. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Guidelines for quality assurance and quality control of fish taxonomic data collected as part of the National Water-Quality Assessment Program

USGS Publications Warehouse

Walsh, Stephen Joseph; Meador, Michael R.

1998-01-01

Fish community structure is characterized by the U.S. Geological Survey's National Water-Quality Assessment (NAWQA) Program as part of a perennial, multidisciplinary approach to evaluating the physical, chemical, and biological conditions of the Nation's water resources. The objective of quality assurance and quality control of fish taxonomic data that are collected as part of the NAWQA Program is to establish uniform guidelines and protocols for the identification, processing, and archiving of fish specimens to ensure that accurate and reliable data are collected. Study unit biologists, collaborating with regional biologists and fish taxonomic specialists, prepare a pre-sampling study plan that includes a preliminary faunal list and identification of an ichthyological curation center for receiving preserved fish specimens. Problematic taxonomic issues and protected taxa also are identified in the study plan, and collecting permits are obtained in advance of sampling activities. Taxonomic specialists are selected to identify fish specimens in the field and to assist in determining what fish specimens should be sacrificed, fixed, and preserved for laboratory identification, independent taxonomic verification, and long-term storage in reference or voucher collections. Quantitative and qualitative sampling of fishes follows standard methods previously established for the NAWQA Program. Common ichthyological techniques are used to process samples in the field and prepare fish specimens to be returned to the laboratory or sent to an institutional repository. Taxonomic identifications are reported by using a standardized list of scientific names that provides nomenclatural consistency and uniformity across study units.

Evaluation of the theory-based Quality Improvement in Physical Therapy (QUIP) programme: a one-group, pre-test post-test pilot study

PubMed Central

2013-01-01

Background Guideline adherence in physical therapy is far from optimal, which has consequences for the effectiveness and efficiency of physical therapy care. Programmes to enhance guideline adherence have, so far, been relatively ineffective. We systematically developed a theory-based Quality Improvement in Physical Therapy (QUIP) programme aimed at the individual performance level (practicing physiotherapists; PTs) and the practice organization level (practice quality manager; PQM). The aim of the study was to pilot test the multilevel QUIP programme’s effectiveness and the fidelity, acceptability and feasibility of its implementation. Methods A one-group, pre-test, post-test pilot study (N = 8 practices; N = 32 PTs, 8 of whom were also PQMs) done between September and December 2009. Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines’ main recommendations. Determinants of adherence were measured using quantitative methods (questionnaires). Delivery of the programme and management changes were assessed using qualitative methods (observations, group interviews, and document analyses). Changes in adherence and determinants were tested in the paired samples T-tests and expressed in effect sizes (Cohen’s d). Results Overall adherence did not change (3.1%; p = .138). Adherence to three quality indicators improved (8%, 24%, 43%; .000 ≤ p ≤ .023). Adherence to one quality indicator decreased (−15.7%; p = .004). Scores on various determinants of individual performance improved and favourable changes at practice organizational level were observed. Improvements were associated with the programme’s multilevel approach, collective goal setting, and the application of self-regulation; unfavourable findings with programme deficits. The one-group pre-test post-test design limits the internal validity of the study, the self-selected sample its external validity. Conclusions The QUIP programme has the potential to change physical therapy practice but needs considerable revision to induce the ongoing quality improvement process that is required to optimize overall guideline adherence. To assess its value, the programme needs to be tested in a randomized controlled trial. PMID:23705912

Guidelines for environmental infection control in health-care facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC).

PubMed

Sehulster, Lynne; Chinn, Raymond Y W

2003-06-06

The health-care facility environment is rarely implicated in disease transmission, except among patients who are immunocompromised. Nonetheless, inadvertent exposures to environmental pathogens (e.g., Aspergillus spp. and Legionella spp.) or airborne pathogens (e.g., Mycobacterium tuberculosis and varicella-zoster virus) can result in adverse patient outcomes and cause illness among health-care workers. Environmental infection-control strategies and engineering controls can effectively prevent these infections. The incidence of health-care--associated infections and pseudo-outbreaks can be minimized by 1) appropriate use of cleaners and disinfectants; 2) appropriate maintenance of medical equipment (e.g., automated endoscope reprocessors or hydrotherapy equipment); 3) adherence to water-quality standards for hemodialysis, and to ventilation standards for specialized care environments (e.g., airborne infection isolation rooms, protective environments, or operating rooms); and 4) prompt management of water intrusion into the facility. Routine environmental sampling is not usually advised, except for water quality determinations in hemodialysis settings and other situations where sampling is directed by epidemiologic principles, and results can be applied directly to infection-control decisions. This report reviews previous guidelines and strategies for preventing environment-associated infections in health-care facilities and offers recommendations. These include 1) evidence-based recommendations supported by studies; 2) requirements of federal agencies (e.g., Food and Drug Administration, U.S. Environmental Protection Agency, U.S. Department of Labor, Occupational Safety and Health Administration, and U.S. Department of Justice); 3) guidelines and standards from building and equipment professional organizations (e.g., American Institute of Architects, Association for the Advancement of Medical Instrumentation, and American Society of Heating, Refrigeration, and Air-Conditioning Engineers); 4) recommendations derived from scientific theory or rationale; and 5) experienced opinions based upon infection-control and engineering practices. The report also suggests a series of performance measurements as a means to evaluate infection-control efforts.

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

Intervention mapping for the development of a strategy to implement the insurance medicine guidelines for depression

PubMed Central

2011-01-01

Background This article describes the development of a strategy to implement the insurance medicine guidelines for depression. Use of the guidelines is intended to result in more transparent and uniform assessment of claimants with depressive symptoms. Methods The implementation strategy was developed using the Intervention Mapping (IM) method for alignment with insurance-medical practice. The ASE behavioural explanation model (Attitude, Social Influence and Self-Efficacy) was used as theoretical basis for the development work. A literature study of implementation strategies and interviews with insurance physicians were performed to develop instruments for use with the guideline. These instruments were designed to match the needs and the working circumstances of insurance physicians. Performance indicators to measure the quality of the assessment and the adherence to the guidelines were defined with input from insurance physicians. Results This study resulted in the development of a training course to teach insurance physicians how to apply the guidelines for depression, using the aforementioned instruments. The efficacy of this training course will be evaluated in a Randomized Controlled Trial. Conclusions The use of IM made it possible to develop guideline support instruments tailored to insurance medical practice. PMID:21208413

Summary of the 2008 BTS/SIGN British Guideline on the management of asthma.

PubMed

Levy, Mark L; Thomas, Mike; Small, Iain; Pearce, Linda; Pinnock, Hilary; Stephenson, Paul

2009-01-01

The 2008 BTS/SIGN British Guideline on the management of asthma provides comprehensive updated evidence-based guidance on asthma management for healthcare professionals. This primary care-focussed summary has been produced to aid dissemination and implementation of the key guideline messages into primary care. The section on diagnosis emphasises the new integrated symptom-based approach with clinicians using their deductive skills to determine the probability that the patient has asthma. The various tools used for monitoring asthma are discussed. There are sections on both non-pharmacological and pharmacological management of chronic asthma in adults and children. Treatment options for children are subdivided into the under-5s and children aged 5-12 years. Poor asthma control is manifested by exacerbations and acute asthma. Personalised asthma action plans for guided self management should be provided and used when levels of asthma control change. There are sections on difficult asthma and the treatment of exacerbations and acute severe asthma. Various outcome measures for auditing the quality of asthma care are discussed.

Recurrent vulvovaginal candidiasis: A review of guideline recommendations.

PubMed

Matheson, Alexia; Mazza, Danielle

2017-04-01

Recurrent vulvovaginal candidiasis (VVC) is a difficult-to-manage condition that affects 5-8% of women of reproductive age. Current treatment regimes have high relapse rates, resulting in poor quality of life for the women affected. To compare the quality and content of current guidelines concerned with recurrent VVC and to develop a summary of recommendations to assist in the management of women with this condition. Relevant clinical guidelines were identified through a search of several databases (MEDLINE, SCOPUS and The Cochrane Library) and relevant websites. Five guidelines were identified. Each guideline was assessed for quality using the AGREE II instrument. Guideline recommendations were extracted, compared and contrasted. The identified guidelines were of mixed quality. This is not related to the level of evidence supporting them but is because of poor stakeholder involvement, applicability and lack of clarity concerning editorial independence. Current international guidelines for recurrent VVC are consistent in terms of their definition of the condition, diagnostic techniques and utilising induction and maintenance therapy as the treatment of choice. However, the regimen suggested by most guidelines (fluconazole weekly for six months) is not particularly effective; only 42.9% of patients are disease free after 12 months. An alternative regimen put forward by one of the guidelines cites a 77% cure rate after 12 months. Most guidelines lacked specific recommendations for the induction part of induction and maintenance treatment. The current most recommended treatment of recurrent VVC is sub-optimal. Studies performed on a larger scale are required to identify more effective treatments. © 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

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...

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

Food science and food ingredients: the need for reliable scientific approaches and correct communication, Florence, 24 March 2015.

PubMed

Ruxton, Carrie Helen

2016-01-01

This report summarises the proceedings of a conference organised by the Italian Association of Hospital Cardiologists. The aim was to consider the process by which dietary guidelines (DG) are developed and the quality of evidence underpinning these guidelines, as well as debating whether or not this has resulted in DG that are effective in terms of health improvement. Key points were a caution about false positives in research, the importance of holistic DG rather than single nutrient targets, the need for appropriate disease endpoints in studies and control of confounders, a plea for less reliance on observational studies which cannot address cause-and-effect relationships and a need to bear in mind unintended consequences. Options for improving the system and the quality of evidence were discussed.

A systematic scoping review of adherence to reporting guidelines in health care literature

PubMed Central

Samaan, Zainab; Mbuagbaw, Lawrence; Kosa, Daisy; Debono, Victoria Borg; Dillenburg, Rejane; Zhang, Shiyuan; Fruci, Vincent; Dennis, Brittany; Bawor, Monica; Thabane, Lehana

2013-01-01

Background Reporting guidelines have been available for the past 17 years since the inception of the Consolidated Standards of Reporting Trials statement in 1996. These guidelines were developed to improve the quality of reporting of studies in medical literature. Despite the widespread availability of these guidelines, the quality of reporting of medical literature remained suboptimal. In this study, we assess the current adherence practice to reporting guidelines; determine key factors associated with better adherence to these guidelines; and provide recommendations to enhance adherence to reporting guidelines for future studies. Methods We undertook a systematic scoping review of systematic reviews of adherence to reporting guidelines across different clinical areas and study designs. We searched four electronic databases (Cumulative Index to Nursing and Allied Health Literature, Web of Science, Embase, and Medline) from January 1996 to September 2012. Studies were included if they addressed adherence to one of the following guidelines: Consolidated Standards of Reporting Trials (CONSORT), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Quality of Reporting of Meta-analysis (QUOROM), Transparent Reporting of Evaluations with Nonrandomized Designs (TREND), Meta-analysis Of Observational Studies in Epidemiology (MOOSE) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). A protocol for this study was devised. A literature search, data extraction, and quality assessment were performed independently by two authors in duplicate. This study reporting follows the PRISMA guidelines. Results Our search retrieved 5159 titles, of which 50 were eligible. Overall, 86.0% of studies reported suboptimal levels of adherence to reporting guidelines. Factors associated with better adherence included journal impact factor and endorsement of guidelines, publication date, funding source, multisite studies, pharmacological interventions and larger studies. Conclusion Reporting guidelines in the clinical literature are important to improve the standards of reporting of clinical studies; however, adherence to these guidelines remains suboptimal. Action is therefore needed to enhance the adherence to these standards. Strategies to enhance adherence include journal editorial policies endorsing these guidelines. PMID:23671390

Uniform data collection in routine clinical practice in cardiovascular patients for optimal care, quality control and research: The Utrecht Cardiovascular Cohort.

PubMed

Asselbergs, Folkert W; Visseren, Frank Lj; Bots, Michiel L; de Borst, Gert J; Buijsrogge, Marc P; Dieleman, Jan M; van Dinther, Baukje Gf; Doevendans, Pieter A; Hoefer, Imo E; Hollander, Monika; de Jong, Pim A; Koenen, Steven V; Pasterkamp, Gerard; Ruigrok, Ynte M; van der Schouw, Yvonne T; Verhaar, Marianne C; Grobbee, Diederick E

2017-05-01

Background Cardiovascular disease remains the major contributor to morbidity and mortality. In routine care for patients with an elevated cardiovascular risk or with symptomatic cardiovascular disease information is mostly collected in an unstructured manner, making the data of limited use for structural feedback, quality control, learning and scientific research. Objective The Utrecht Cardiovascular Cohort (UCC) initiative aims to create an infrastructure for uniform registration of cardiovascular information in routine clinical practice for patients referred for cardiovascular care at the University Medical Center Utrecht, the Netherlands. This infrastructure will promote optimal care according to guidelines, continuous quality control in a learning healthcare system and creation of a research database. Methods The UCC comprises three parts. UCC-1 comprises enrolment of all eligible cardiovascular patients in whom the same information will be collected, based on the Dutch cardiovascular management guideline. A sample of UCC-1 will be invited for UCC-2. UCC-2 involves an enrichment through extensive clinical measurements with emphasis on heart failure, cerebral ischaemia, arterial aneurysms, diabetes mellitus and elevated blood pressure. UCC-3 comprises on-top studies, with in-depth measurements in smaller groups of participants typically based on dedicated project grants. All participants are followed up for morbidity and mortality through linkage with national registries. Conclusion In a multidisciplinary effort with physicians, patients and researchers the UCC sets a benchmark for a learning cardiovascular healthcare system. UCC offers an invaluable resource for future high quality care as well as for first-class research for investigators.

Application of a risk management system to improve drinking water safety.

PubMed

Jayaratne, Asoka

2008-12-01

The use of a comprehensive risk management framework is considered a very effective means of managing water quality risks. There are many risk-based systems available to water utilities such as ISO 9001 and Hazard Analysis and Critical Control Point (HACCP). In 2004, the World Health Organization's (WHO) Guidelines for Drinking Water Quality recommended the use of preventive risk management approaches to manage water quality risks. This paper describes the framework adopted by Yarra Valley Water for the development of its Drinking Water Quality Risk Management Plan incorporating HACCP and ISO 9001 systems and demonstrates benefits of Water Safety Plans such as HACCP. Copyright IWA Publishing 2008.

RAPADAPTE for rapid guideline development: high-quality clinical guidelines can be rapidly developed with limited resources.

PubMed

Alper, Brian S; Tristan, Mario; Ramirez-Morera, Anggie; Vreugdenhil, Maria M T; Van Zuuren, Esther J; Fedorowicz, Zbys

2016-06-01

Guideline development is challenging, expensive and labor-intensive. A high-quality guideline with 90 recommendations for breast cancer treatment was developed within 6 months with limited resources in Costa Rica. We describe the experience and propose a process others can use and adapt.The ADAPTE method (using existing guidelines to minimize repeating work that has been done) was used but existing guidelines were not current. The method was extended to use databases that systematically identify, appraise and synthesize evidence for clinical application (DynaMed, EBM Guidelines) to provide current evidence searches and critical appraisal of evidence. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the quality of evidence and the strength of recommendations. Draft recommendations with supporting evidence were provided to panel members for facilitated voting to target panel discussion to areas necessary for reaching consensus.Training panelists in guideline development methodology facilitated rapid consensus development. Extending 'guideline adaptation' to 'evidence database adaptation' was highly effective and efficient. Methods were created to simplify mapping DynaMed evidence ratings to GRADE ratings. Twelve steps are presented to facilitate rapid guideline development and enable further adaptation by others.This is a case report and the RAPADAPTE method was retrospectively derived. Prospective replication and validation will support advances for the guideline development community. If guideline development can be accelerated without compromising validity and relevance of the resulting recommendations this would greatly improve our ability to impact clinical care. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

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.

[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.

[Certification of an ambulatory gastroenterologic service fulfilling ISO Law 9001--criteria and national guidelines of the Gastroenterologic Association].

PubMed

Birkner, B

2000-09-01

The objectives of certification and accreditation are the deployment and examination of quality improvement measures in health care services. The quality management system of the ISO 9001 is created to install measures and tools leading to assured and improved quality in health care. Only some experiences with certification fulfilling ISO 9001 criteria exist in the German health care system. Evidence-based clinical guidelines can serve as references for the development of standards in quality measurement. Only little data exists on the implementation strategy of guidelines and evaluation, respectively. A pilot quality management system in consistence with ISO 9001 criteria was developed for ambulatory, gastroenterological services. National guidelines of the German Society of Gastroenterology and Metabolism and the recommendations of the German Association of Physicians for quality assurance of gastrointestinal endoscopy were included in the documentation and internal auditing. This pilot quality management system is suitable for the first steps in the introduction of quality management in ambulatory health care. This system shows validity for accreditation and certification of gastrointestinal health care units as well.

Deciding what type of evidence and outcomes to include in guidelines: article 5 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Wilt, Timothy J; Guyatt, Gordon; Kunz, Regina; Macnee, William; Puhan, Milo A; Viegi, Giovanni; Woodhead, Mark; Akl, Elie A; Schünemann, Holger J

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fifth of a series of 14 articles that were prepared by an international panel to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on what type of evidence and outcomes to include in guidelines. In this review we addressed the following topics and questions. (1) What methods should be used to select important outcomes? (2) What types of outcomes should be considered? (3) What sources of evidence should be considered? (4) How should the importance of outcomes be ranked? (5) How to deal with surrogate outcomes. (6) What issues related to outcomes should be considered in the evidence review? (7) What quality of evidence should be used? (8) How to interpret the effect on outcomes. (9) How to incorporate outcomes related to harm. We based our responses on a PubMed literature review, prior reviews, relevant methodological research, and workshop discussions. Guideline panels should use transparent and systematic methods to select both the evidence and important outcomes, with input from groups that represent a wide range of expertise and constituencies. Outcomes should address both benefits and downsides, with consideration of the definitions, severity, and time course of the outcomes. Guideline panels should use a transparent approach to rank outcome importance recognizing that stakeholder and patient values and preferences may vary. Intermediate and surrogate outcomes are frequently reported, but their correlation with patient important outcomes may be low. A guideline panel should determine a priori the magnitude of effect judged clinically significant, factors that may influence outcome reporting, and whether different ways of measuring the outcomes permit the outcomes to be combined. Comprehensive identification of the evidence includes the use of multiple data sources. While randomized controlled trials (RCTs) provide the highest quality evidence, reviewers of evidence also need to consider nonrandomized studies such as case series, registries, and case-control studies if randomized trials are not available. This is particularly true for harms. The outcomes reported from RCTs may not always directly apply to clinical practice settings (i.e., they may not be generalizable).

Clinical Practice Guideline: Hoarseness (Dysphonia) (Update).

PubMed

Stachler, Robert J; Francis, David O; Schwartz, Seth R; Damask, Cecelia C; Digoy, German P; Krouse, Helene J; McCoy, Scott J; Ouellette, Daniel R; Patel, Rita R; Reavis, Charles Charlie W; Smith, Libby J; Smith, Marshall; Strode, Steven W; Woo, Peak; Nnacheta, Lorraine C

2018-03-01

Objective This guideline provides evidence-based recommendations on treating patients who present with dysphonia, which is characterized by altered vocal quality, pitch, loudness, or vocal effort that impairs communication and/or quality of life. Dysphonia affects nearly one-third of the population at some point in its life. This guideline applies to all age groups evaluated in a setting where dysphonia would be identified or managed. It is intended for all clinicians who are likely to diagnose and treat patients with dysphonia. Purpose The primary purpose of this guideline is to improve the quality of care for patients with dysphonia, based on current best evidence. Expert consensus to fill evidence gaps, when used, is explicitly stated and supported with a detailed evidence profile for transparency. Specific objectives of the guideline are to reduce inappropriate variations in care, produce optimal health outcomes, and minimize harm. For this guideline update, the American Academy of Otolaryngology-Head and Neck Surgery Foundation selected a panel representing the fields of advanced practice nursing, bronchoesophagology, consumer advocacy, family medicine, geriatric medicine, internal medicine, laryngology, neurology, otolaryngology-head and neck surgery, pediatrics, professional voice, pulmonology, and speech-language pathology. Action Statements The guideline update group made strong recommendations for the following key action statements (KASs): (1) Clinicians should assess the patient with dysphonia by history and physical examination to identify factors where expedited laryngeal evaluation is indicated. These include, but are not limited to, recent surgical procedures involving the head, neck, or chest; recent endotracheal intubation; presence of concomitant neck mass; respiratory distress or stridor; history of tobacco abuse; and whether the patient is a professional voice user. (2) Clinicians should advocate voice therapy for patients with dysphonia from a cause amenable to voice therapy. The guideline update group made recommendations for the following KASs: (1) Clinicians should identify dysphonia in a patient with altered voice quality, pitch, loudness, or vocal effort that impairs communication or reduces quality of life (QOL). (2) Clinicians should assess the patient with dysphonia by history and physical examination for underlying causes of dysphonia and factors that modify management. (3) Clinicians should perform laryngoscopy, or refer to a clinician who can perform laryngoscopy, when dysphonia fails to resolve or improve within 4 weeks or irrespective of duration if a serious underlying cause is suspected. (4) Clinicians should perform diagnostic laryngoscopy, or refer to a clinician who can perform diagnostic laryngoscopy, before prescribing voice therapy and document/communicate the results to the speech-language pathologist (SLP). (5) Clinicians should advocate for surgery as a therapeutic option for patients with dysphonia with conditions amenable to surgical intervention, such as suspected malignancy, symptomatic benign vocal fold lesions that do not respond to conservative management, or glottic insufficiency. (6) Clinicians should offer, or refer to a clinician who can offer, botulinum toxin injections for the treatment of dysphonia caused by spasmodic dysphonia and other types of laryngeal dystonia. (7) Clinicians should inform patients with dysphonia about control/preventive measures. (8) Clinicians should document resolution, improvement or worsened symptoms of dysphonia, or change in QOL of patients with dysphonia after treatment or observation. The guideline update group made a strong recommendation against 1 action: (1) Clinicians should not routinely prescribe antibiotics to treat dysphonia. The guideline update group made recommendations against other actions: (1) Clinicians should not obtain computed tomography (CT) or magnetic resonance imaging (MRI) for patients with a primary voice complaint prior to visualization of the larynx. (2) Clinicians should not prescribe antireflux medications to treat isolated dysphonia, based on symptoms alone attributed to suspected gastroesophageal reflux disease (GERD) or laryngopharyngeal reflux (LPR), without visualization of the larynx. (3) Clinicians should not routinely prescribe corticosteroids for patients with dysphonia prior to visualization of the larynx. The policy level for the following recommendation about laryngoscopy at any time was an option: (1) Clinicians may perform diagnostic laryngoscopy at any time in a patient with dysphonia. Disclaimer This clinical practice guideline is not intended as an exhaustive source of guidance for managing dysphonia (hoarseness). Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. The guideline is not intended to replace clinical judgment or establish a protocol for all individuals with this condition, and it may not provide the only appropriate approach to diagnosing and managing this problem. Differences from Prior Guideline (1) Incorporation of new evidence profiles to include the role of patient preferences, confidence in the evidence, differences of opinion, quality improvement opportunities, and any exclusion to which the action statement does not apply (2) Inclusion of 3 new guidelines, 16 new systematic reviews, and 4 new randomized controlled trials (3) Inclusion of a consumer advocate on the guideline update group (4) Changes to 9 KASs from the original guideline (5) New KAS 3 (escalation of care) and KAS 13 (outcomes) (6) Addition of an algorithm outlining KASs for patients with dysphonia.

The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD) in primary care

PubMed Central

de Lusignan, Simon; Gallagher, Hugh; Chan, Tom; Thomas, Nicki; van Vlymen, Jeremy; Nation, Michael; Jain, Neerja; Tahir, Aumran; du Bois, Elizabeth; Crinson, Iain; Hague, Nigel; Reid, Fiona; Harris, Kevin

2009-01-01

Background Chronic kidney disease (CKD) is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP) control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression Design Cluster randomised controlled trial (CRT) Methods This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education. The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices) powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD. A small group of practices (n = 4) will take part in an in-depth process evaluation. We will use time series data to examine the natural history of CKD in the community. Finally, we will conduct an economic evaluation based on a comparison of the cost effectiveness of each intervention. Clinical Trials Registration ISRCTN56023731. ClinicalTrials.gov identifier. PMID:19602233

Guidelines for preparing a quality assurance plan for district offices of the U.S. Geological Survey

USGS Publications Warehouse

Schroder, L.J.; Shampine, W.J.

1992-01-01

The U.S. Geological Survey has a policy that requires each District office to prepare a Quality Assurance Plan. This plan is a combination of a District's management principles and quality assurance processes. The guidelines presented in this report provide a framework or expanded outline that a District can use to prepare a plan. Parti- cular emphasis is given to a District's: (1) quality assurance policies; (2) organization and staff responsibilities; and (3) program and project planning. The guidelines address the 'how', 'what', and 'who' questions that need to be answered when a District Quality Assurance Plan is prepared.

[Experiences with synopses of clinical guidelines using the example of synopses for Disease Management Programmes (DMP)].

PubMed

Siering, Ulrich; Rüther, Alric

2014-01-01

Guideline synopses, i.e. the systematic synthesis of clinical practice guidelines, are used as a basis for Disease Management Programmes (DMPs) in Germany. One of the responsibilities of the German Institute for Quality and Efficiency in Health Care (IQWiG) is the preparation of guideline synopses for DMPs. The article describes the experiences with this methodology. For the preparation of guideline synopses, a systematic search for evidence-based guidelines is conducted, and their recommendations are extracted and synthesised. In parallel, the quality of the guidelines is assessed using the AGREE instrument. The need for updating or supplementing a DMP is justified by means of the Grade of Recommendation (GoR) or, alternatively, the Level of Evidence (LoE). Since 2006 IQWiG has synthesised recommendations from 256 evidence-based guidelines in 12 guideline synopses for DMPs. The results are then used by the Federal Joint Committee (G-BA) to update DMPs. Using the example of the 12 synopses, several analyses were conducted. It was determined that a search for guidelines in guideline databases is sufficient and that a search in bibliographic databases can be dispensed with. Furthermore, the analyses showed that a large proportion of recommendations in evidence-based guidelines are not clearly linked to a GoR or LoE. If GoR and LoE are provided, only about 42% of recommendations with a strong GoR also refer to a strong LoE. It was also shown that only 21 % of the analysed guideline providers supplied information on the handling of unpublished data. With consistent average to high values, the assessment of the methodological quality across all of the prepared synopses allows for the conclusion of a basically acceptable guideline quality, but with a need for improvement. A guideline synopsis is an established tool for identifying health care standards as a basis for developing and updating DMPs. Further methodological development, particularly in collaboration with guideline providers, appears to be reasonable. It should be examined whether guideline synopses are suitable not only for guideline and DMP development, but also for other health care issues. Copyright © 2014. Published by Elsevier GmbH.

Effectiveness of guideline dissemination and implementation strategies on health care professionals' behaviour and patient outcomes in the cancer care context: a systematic review protocol.

PubMed

Tomasone, Jennifer R; Chaudhary, Rushil; Brouwers, Melissa C

2015-08-25

Health care professionals (HCPs) are able to make effective decisions regarding patient care through the use of systematically developed clinical practice guidelines (CPGs). These recommendations are especially important in a cancer health care context as patients are exposed to a multitude of interdisciplinary HCPs offering high-quality care throughout diagnosis, treatment, survivorship and palliative care. Although a large number of CPGs targeted towards cancer are widely disseminated, it is unknown whether implementation strategies targeting the use of these guidelines are effective in effecting HCP behaviour and patient outcomes in the cancer care context. The purpose of this systematic review will be to determine the effectiveness of different CPG dissemination and implementation interventions on HCPs' behaviour and patient outcomes in the cancer health care context. Five electronic databases (CINAHL, the Cochrane Controlled Trials Register, MEDLINE via Ovid, EMBASE via Ovid and PsycINFO via Ovid) will be searched to include all studies examining the dissemination and/or implementation of CPGs in a cancer care setting targeting all HCPs. CPG implementation strategies will be included if the CPGs were systematically developed (e.g. literature review/evidence-informed, expert panel, evidence appraisal). The studies will be limited to randomized controlled trials, controlled clinical trials and quasi-experimental (interrupted time series, controlled before-and-after designs) studies. Two independent reviewers will assess articles for eligibility, data extraction and quality appraisal. The aim of this review is to inform cancer care health care professionals and policymakers about evidence-based implementation strategies that will allow for effective use of CPGs. PROSPERO CRD42015019331.

Critical Appraisal of Microbiology Guidelines Endorsed by two Professional Organisations: Société Française De Microbiologie (SFM) and American Society of Microbiology (ASM).

PubMed

Fonfrède, Michèle; Couaillac, Jean Paul; Augereau, Christine; Lepargneur, Jean Pierre; Watine, Joseph

2012-07-01

Medical practice guidelines (GLs) being tools that are mainly designed to evaluate medical professionals, it sounds logical, and fair, that professionals should in turn evaluate GLs. Microbiology being a medical discipline, we used the AGREE instrument, i.e. an established evaluation tool for GLs, in order to evaluate the quality of two major microbiology guidelines, i.e. the SFM GLs and the ASM GLs). Both guidelines remain sub-optimal in their levels of quality, and obtain scores that are not very different from the average scores obtained by many other guidelines in various medical disciplines. We therefore believe that both guidelines need to be modified before they can be recommended without provisos. A higher degree of multi-disciplinary work, including a more formal implication of methodologists, as well as of infectious disease clinicians, and of economists, might perhaps enable future editions of these guidelines to reach higher levels of quality.

Quality Assessment of Clinical Practice Guidelines Developed by Professional Societies in Turkey.

PubMed

Yaşar, Ilknur; Kahveci, Rabia; Baydar Artantaş, Aylin; Ayhan Başer, Duygu; Gökşin Cihan, Fatma; Şencan, Irfan; Koç, Esra Meltem; Özkara, Adem

2016-01-01

Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. There is a limited number of studies on guidelines in Turkey. The quality of Ministry of Health guidelines have formerly been assessed whereas there is no information on the other guidelines developed in the country. This study aims to assess the quality of CPGs that are developed by professional societies that work for the health sector in Turkey, and compare the findings with international guidelines. Professional societies that work for the health sector were determined by using the data obtained from the Ministry of Internal Affairs. Inclusion and exclusion criteria were defined for selecting the CPGs. Guidelines containing recommendations about disease management to the doctors, accessible online, developed within the past 5 years, citing references for recommendations, about the diseases over 1% prevalence according to the "Statistical Yearbook of Turkey 2012" were included in the study. The quality of CPGs were assessed with the AGREE II instrument, which is an internationally recognized tool for this purpose. Four independent reviewers, who did not participate in the development of the selected guidelines and were trained in CPG appraisal, used the AGREE instrument for assessment of the selected guidelines. 47 professional societies were defined which provided access to CPGs in their websites; 3 of them were only open to members so these could not be reached. 8 CPGs from 7 societies were selected from a total of 401 CPGs from 44 societies. The mean scores of the domains of the guidelines which were assessed by the AGREE II tool were; 64%, stakeholder involvement: 37.9%, rigour of development: 35.3%, clarity and presentation: 77.9%, applicability: 49.0% and editorial independence: 46.0%. This is the first study in Turkey regarding quality appraisal of guidelines developed by the local professional societies. It adds to the limited amount of information in the literature that comes from Turkey as well as other developing countries.

The confusion in complying with good manufacturing practice requirements in Malaysia

NASA Astrophysics Data System (ADS)

Jali, Mohd Bakri; Ghani, Maaruf Abdul; Nor, Norazmir Md

2016-11-01

Food manufacturing operations need to fulfil regulatory requirements related to hygiene and good manufacturing practices (GMP) to successfully market their products as safe and quality products. GMP based on its ten elements used as guidelines to ensure control over biological, chemical and physical hazards. This study aims to investigate the confusion for design and facilities elements among food industries. Both qualitative and quantitative techniques are used as systematic tools. Design and facilities elements lay a firm foundation for good manufacturing practice to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines.

"Assessing the methodological quality of systematic reviews in radiation oncology: A systematic review".

PubMed

Hasan, Haroon; Muhammed, Taaha; Yu, Jennifer; Taguchi, Kelsi; Samargandi, Osama A; Howard, A Fuchsia; Lo, Andrea C; Olson, Robert; Goddard, Karen

2017-10-01

The objective of our study was to evaluate the methodological quality of systematic reviews and meta-analyses in Radiation Oncology. A systematic literature search was conducted for all eligible systematic reviews and meta-analyses in Radiation Oncology from 1966 to 2015. Methodological characteristics were abstracted from all works that satisfied the inclusion criteria and quality was assessed using the critical appraisal tool, AMSTAR. Regression analyses were performed to determine factors associated with a higher score of quality. Following exclusion based on a priori criteria, 410 studies (157 systematic reviews and 253 meta-analyses) satisfied the inclusion criteria. Meta-analyses were found to be of fair to good quality while systematic reviews were found to be of less than fair quality. Factors associated with higher scores of quality in the multivariable analysis were including primary studies consisting of randomized control trials, performing a meta-analysis, and applying a recommended guideline related to establishing a systematic review protocol and/or reporting. Systematic reviews and meta-analyses may introduce a high risk of bias if applied to inform decision-making based on AMSTAR. We recommend that decision-makers in Radiation Oncology scrutinize the methodological quality of systematic reviews and meta-analyses prior to assessing their utility to inform evidence-based medicine and researchers adhere to methodological standards outlined in validated guidelines when embarking on a systematic review. Copyright © 2017 Elsevier Ltd. All rights reserved.

Demand controlled ventilating systems: Sensor market survey. Energy conservation in buildings and community systems programme, annex 18, December 1991

NASA Astrophysics Data System (ADS)

Raatschen, W.; Sjoegren, M.

The subject of indoor and outdoor air quality has generated a great deal of attention in many countries. Areas of concern include outgassing of building materials as well as occupant-generated pollutants such as carbon dioxide, moisture, and odors. Progress has also been made towards addressing issues relating to the air tightness of the building envelope. Indoor air quality studies indicate that better control of supply flow rates as well as the air distribution pattern within buildings are necessary. One method of maintaining good indoor air quality without extensive energy consumption is to control the ventilation rate according to the needs and demands of the occupants, or to preserve the building envelope. This is accomplished through the use of demand controlled ventilating (DCV) systems. The specific objective of Annex 18 is to develop guidelines for demand controlled ventilating systems based on state of the art analyses, case studies on ventilation effectiveness, and proposed ventilation rates for different users in domestic, office, and school buildings.

A Critical Review of the Quality of Cough Clinical Practice Guidelines.

PubMed

Jiang, Mei; Guan, Wei-Jie; Fang, Zhang-Fu; Xie, Yan-Qing; Xie, Jia-Xing; Chen, Hao; Wei, Dang; Lai, Ke-Fang; Zhong, Nan-Shan

2016-10-01

Clinical practice guidelines (CPGs) have been developed to provide health-care practitioners with the best possible evidence, but the quality of these CPGs varies greatly. The goal of this study was to systematically evaluate the quality of cough CPGs and identify gaps limiting evidence-based practice. Systematic searches were conducted to identify cough CPGs in guideline databases, developers' Websites, and Medline. Four reviewers independently evaluated eligible guidelines by using the Appraisal of Guidelines for Research and Evaluation II assessment tool. Agreement among reviewers was measured by using the intraclass correlation coefficient. The number of recommendations, strength of recommendation, and levels of evidence were determined. Fifteen cough CPGs were identified. An overall high degree of agreement among reviewers was observed (intraclass correlation coefficient, 0.82 [95% CI, 0.79-0.85]). The quality ranged from good to acceptable in the scope and purpose (mean, 72%; range, 54%-93%) and clarity and presentation (mean, 68%; range, 50%-90%) domains but not in stakeholder involvement (mean, 36%; range, 18%-90%), rigor of development (mean, 36%; range, 9%-93%), applicability (mean, 23%; range, 9%-83%), and editorial independence domains (mean, 24%; range, 0-96%). Seven guidelines (46.7%) were considered "strongly recommended" or "recommended with modifications" for clinical practice. More than 70% of recommendations were based on nonrandomized studies (Level C, 30.4%) and expert opinion (Level D, 41.3%). The quality of cough CPGs is variable, and recommendations are largely based on low-quality evidence. There is significant room for improvement to develop high-quality guidelines, which urgently warrants first-class research to minimize the vital gaps in the evidence for formulation of cough CPGs. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

[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.

Updating contextualized clinical practice guidelines on stroke rehabilitation and low back pain management using a novel assessment framework that standardizes decisions.

PubMed

Gambito, Ephraim D V; Gonzalez-Suarez, Consuelo B; Grimmer, Karen A; Valdecañas, Carolina M; Dizon, Janine Margarita R; Beredo, Ma Eulalia J; Zamora, Marcelle Theresa G

2015-11-04

Clinical practice guidelines need to be regularly updated with current literature in order to remain relevant. This paper reports on the approach taken by the Philippine Academy of Rehabilitation Medicine (PARM). This dovetails with its writing guide, which underpinned its foundational work in contextualizing guidelines for stroke and low back pain (LBP) in 2011. Working groups of Filipino rehabilitation physicians and allied health practitioners met to reconsider and modify, where indicated, the 'typical' Filipino patient care pathways established in the foundation guidelines. New clinical guidelines on stroke and low back pain which had been published internationally in the last 3 years were identified using a search of electronic databases. The methodological quality of each guideline was assessed using the iCAHE Guideline Quality Checklist, and only those guidelines which provided full text references, evidence hierarchy and quality appraisal of the included literature, were included in the PARM update. Each of the PARM-endorsed recommendations was then reviewed, in light of new literature presented in the included clinical guidelines. A novel standard updating approach was developed based on the criteria reported by Johnston et al. (Int J Technol Assess Health Care 19(4):646-655, 2003) and then modified to incorporate wording from the foundational PARM writing guide. The new updating tool was debated, pilot-tested and agreed upon by the PARM working groups, before being applied to the guideline updating process. Ten new guidelines on stroke and eleven for low back pain were identified. Guideline quality scores were moderate to good, however not all guidelines comprehensively linked the evidence body underpinning recommendations with the literature. Consequently only five stroke and four low back pain guidelines were included. The modified PARM updating guide was applied by all working groups to ensure standardization of the wording of updated recommendations and the underpinning evidence bases. The updating tool provides a simple, standard and novel approach that incorporates evidence hierarchy and quality, and wordings of recommendations. It could be used efficiently by other guideline updaters particularly in developing countries, where resources for guideline development and updates are limited. When many people are involved in guideline writing, there is always the possibility of 'slippage' in use of wording and interpretation of evidence. The PARM updating tool provides a mechanism for maintaining a standard process for guideline updating processes that can be followed by clinicians with basic training in evidence-based practice principles.

Water quality guidelines for the Great Barrier Reef World Heritage Area: a basis for development and preliminary values.

PubMed

Moss, Andrew; Brodie, Jon; Furnas, Miles

2005-01-01

The Australian and New Zealand Guidelines for Fresh and Marine Water Quality (ANZECC Guidelines) provide default national guideline values for a wide range of indicators of relevance to the protection of the ecological condition of natural waters. However, the ANZECC Guidelines also place a strong emphasis on the need to develop more locally relevant guidelines. Using a structured framework, this paper explores indicators and regional data sets that can be used to develop more locally relevant guidelines for the Great Barrier Reef World Heritage Area (GBRWHA). The paper focuses on the water quality impacts of adjacent catchments on the GBRWHA with the key stressors addressed being nutrients, sediments and agricultural chemicals. Indicators relevant to these stressors are discussed including both physico-chemical pressure indicators and biological condition indicators. Where adequate data sets are available, guideline values are proposed. Generally, data were much more readily available for physico-chemical pressure indicators than for biological condition indicators. Specifically, guideline values are proposed for the major nutrients nitrogen (N) and phosphorus (P) and for chlorophyll-a. More limited guidelines are proposed for sediment related indicators. For most agricultural chemicals, the ANZECC Guidelines are likely to remain the default of choice for some time but it is noted that there is data in the literature that could be used to develop more locally relevant guidelines.

Can Telemedicine Improve Adherence to Resuscitation Guidelines for Critically Ill Children at Community Hospitals? A Randomized Controlled Trial Using High-Fidelity Simulation.

PubMed

Yang, Chris P; Hunt, Elizabeth A; Shilkofski, Nicole; Dudas, Robert; Egbuta, Chinyere; Schwartz, Jamie M

2017-07-01

Children transferred from community hospitals lacking specialized pediatric care are more seriously ill than those presenting to pediatric centers. Pediatric consultation and adherence to management guidelines improve outcomes. The aims of the study were (1) to assess whether telemedicine consultation in critical situations is feasible and (2) to compare the impact of pediatric critical care medicine (PCCM) consultation via telemedicine versus telephone on community hospital adherence to resuscitation guidelines through a randomized controlled telemedicine trial. In situ, high-fidelity simulation scenarios of critically ill children presenting to a community hospital and progressing to cardiopulmonary arrest were performed. Scenarios were randomized to PCCM consultation via telephone (control) or telemedicine (intervention). Primary outcome measure was proportion of teams who successfully defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia. The following 30 scenarios were completed: 15 control and 15 intervention. Only 11 (37%) of 30 teams, defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia; control: 6 (40%) of 15 versus intervention: 5 (33%) of 15, P = 0.7. Request for or use of backboard during cardiopulmonary resuscitation occurred in 24 (80%) of 30 scenarios; control: 9 (60%) of 15 versus intervention: 15 (100%) of 15, P = 0.006. Request for or use of stepstool during cardiopulmonary resuscitation occurred in 6 (20%) of 30 scenarios; control: 1 (7%) of 15 versus intervention: 5 (33%) of 15, P = 0.07. This study demonstrates the feasibility of using telemedicine to support acute management of children who present to community hospitals. Neither study arm adhered to current resuscitation guidelines and telemedicine consultation with PCCM experts was not associated with improvement. However, further research on optimizing telemedicine impact on the quality of pediatric care at community hospitals is warranted.

Cost-Effectiveness of Evaluating the New Technologies.

ERIC Educational Resources Information Center

Kastner, Theodore A.

1997-01-01

This commentary on a study comparing use of the brand name drug Depakene with generic valproic acid to control seizures in people with mental retardation focuses on issues of cost-effectiveness. It notes existing guidelines for pharmacoeconomic evaluation and suggests a possible model to include a threshold price (per quality-adjusted life year)…

40 CFR Appendix W to Part 51 - Guideline on Air Quality Models

Code of Federal Regulations, 2011 CFR

2011-07-01

... sufficient spatial and temporal coverage are available. c. It would be advantageous to categorize the various... control strategies. These are referred to as refined models. c. The use of screening techniques followed... location of the source in question and its expected impacts. c. In all regulatory analyses, especially if...

40 CFR 419.34 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... limitations for contaminated runoff. The following effluent limitations constitute the quantity and quality of pollutants or pollutant properties controlled by this paragraph and attributable to contaminated runoff which... point source subject to this subpart. (1) If wastewater consists solely of contaminated runoff and is...

Delphi-Discrepancy Evaluation: A Model for the Quality Control of Federal, State, and Locally Mandated Programs.

ERIC Educational Resources Information Center

Sirois, Herman A.; Iwanick, Edward F.

Legally mandated educational programs often lack specificity and guidelines for such programs are often vague and subject to considerable variability in interpretation. This situation presents perennial problems for evaluators. Few evaluation models have the flexibility for dealing with this ambiguity and variability while at the same time…

[Goals, possibilities and limits of quality evaluation of guidelines. A background report on the user manual of the "Methodological Quality of Guidelines" check list].

PubMed

Helou, A; Ollenschläger, G

1998-06-01

Recently a German appraisal instrument for clinical guidelines was published that could be used by various parties in formal evaluation of guidelines. An user's guide to the appraisal instrument was designed that contains a detailed explanation for each question to ensure that the instrument is interpreted consistently. This paper describes the purposes, format and contents of the user's guide, and reviews the key factors influencing the validity of guidelines. Taking into account international experiences, the purposes, chances and methodological limitations of a prospective assessment of clinical practice guidelines are discussed.

Adaptation of evidence-based guideline recommendations to address urinary incontinence in nursing home residents according to the ADAPTE-process.

PubMed

Hoedl, Manuela; Schoberer, Daniela; Halfens, Ruud J G; Lohrmann, Christa

2018-04-27

To adapt international guideline recommendations for the conservative management of urinary incontinence (UI), defined as any involuntary loss of urine, in Austrian nursing home residents following the ADAPTE-process. Many international guidelines for managing UI are available. Nevertheless, the international recommendations have not yet been adapted to address the Austrian nursing home context. This crucial adaptation process will enhance the acceptance and applicability of the recommendations as well as encourage adherence among Austrian nurses and nursing home residents. This study is a methodological study based on the ADAPTE-process, including a systematic search, quality appraisal of the guidelines using the Appraisal of Clinical Guidelines for REsearch & Evaluation II (AGREE II) instrument as well as an external review by means of a Delphi technique. The guidelines had to be topic-relevant, published within the last 3 years and achieve a rigor of development score of 80% using the AGREE II instrument. We searched international guideline databases to identify adequate guidelines. Two raters assessed the quality of each guideline, ascertaining that it fulfilled the inclusion criteria using the AGREE II instrument. We translated the identified recommendations into German and externally reviewed for their applicability in the Austrian context. We identified 1,612 hits in 10 databases. After applying inclusion and exclusion criteria, we assessed five international clinical guidelines for quality using the AGREE II instrument. One clinical guideline fulfilled the inclusion criteria. This clinical guideline contains 116 recommendations, of which 29 were applicable in the Austrian nursing home setting. We identified only one suitable guideline, possibly due to the stringent nature of the inclusion criteria. However, following low-quality guidelines may result in the use of recommendations that are not based on evidence and, therefore, may lead to suboptimal nursing care and outcomes. © 2018 John Wiley & Sons Ltd.

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

Guideline for primary care management of headache in adults

PubMed Central

Becker, Werner J.; Findlay, Ted; Moga, Carmen; Scott, N. Ann; Harstall, Christa; Taenzer, Paul

2015-01-01

Abstract Objective To increase the use of evidence-informed approaches to diagnosis, investigation, and treatment of headache for patients in primary care. Quality of evidence A comprehensive search was conducted for relevant guidelines and systematic reviews published between January 2000 and May 2011. The guidelines were critically appraised using the AGREE (Appraisal of Guidelines for Research and Evaluation) tool, and the 6 highest-quality guidelines were used as seed guidelines for the guideline adaptation process. Main message A multidisciplinary guideline development group of primary care providers and other specialists crafted 91 specific recommendations using a consensus process. The recommendations cover diagnosis, investigation, and management of migraine, tension-type, medication-overuse, and cluster headache. Conclusion A clinical practice guideline for the Canadian health care context was created using a guideline adaptation process to assist multidisciplinary primary care practitioners in providing evidence-informed care for patients with headache. PMID:26273080

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.

Electronic health records in four community physician practices: impact on quality and cost of care.

PubMed

Welch, W Pete; Bazarko, Dawn; Ritten, Kimberly; Burgess, Yo; Harmon, Robert; Sandy, Lewis G

2007-01-01

To assess the impact of the electronic health record (EHR) on cost (i.e., payments to providers) and process measures of quality of care. Retrospective before-after-study-control. From the database of a large managed care organization (MCO), we obtained the claims of patients from four community physician practices that implemented the EHR and from about 50 comparison practices without the EHR in the same counties. The diverse patient and practice populations were chosen to be a sample more representative of typical private practices than has previously been studied. For four chronic conditions, we used commercially-available software to analyze cost per episode over a year and the rate of adherence to clinical guidelines as a measure of quality. The implementation of the EHR had a modest positive impact on the quality measure of guideline adherence for hypertension and hyperlipidemia, but no significant impact for diabetes and coronary artery disease. No measurable impact on the short-term cost per episode was found. Discussions with the study practices revealed that the timing and comprehensiveness of EHR implementation varied across practices, creating an intervention variable that was heterogeneous. Guideline adherence increased across practices without EHRs and slightly faster in practices with EHRs. Measuring the impact of EHRs on cost per episode was challenging, because of the difficulty of completely capturing the long-term episodic costs of a chronic condition. Few practices associated with the study MCO had implemented EHRs in any form, much less utilizing standardized protocols.

Economic evaluations and their use in infection prevention and control: a narrative review.

PubMed

Rennert-May, Elissa; Conly, John; Leal, Jenine; Smith, Stephanie; Manns, Braden

2018-01-01

The objective of this review is to provide a comprehensive overview of the different types of economic evaluations that can be utilized by Infection Prevention and Control practitioners with a particular focus on the use of the quality adjusted life year, and its associated challenges. We also highlight existing economic evaluations published within Infection Prevention and Control, research gaps and future directions. Narrative Review. To date the majority of economic evaluations within Infection Prevention and Control are considered partial economic evaluations. Acknowledging the challenges, which include variable utilities within infection prevention and control, a lack of randomized controlled trials, and difficulty in modelling infectious diseases in general, future economic evaluation studies should strive to be consistent with published guidelines for economic evaluations. This includes the use of quality adjusted life years. Further research is required to estimate utility scores of relevance within Infection Prevention and Control.

A Proposed Roadmap for Inpatient Neurology Quality Indicators

PubMed Central

Douglas, Vanja C.; Josephson, S. Andrew

2011-01-01

Background/Purpose: In recent years, there has been increasing pressure to measure and report quality in health care. However, there has been little focus on quality measurement in the field of neurology for conditions other than stroke and transient ischemic attack. As the number of evidence-based treatments for neurological conditions grows, so will the demand to measure the quality of care delivered. The purpose of this study was to review essential components of hospital performance measures for neurological disease and propose potential quality indicators for commonly encountered inpatient neurological diagnoses. Methods: We determined the most common inpatient neurological diagnoses at a major tertiary care medical center by reviewing the billing database. We then searched PubMed and the National Guidelines Clearinghouse to identify treatment guidelines for these conditions. Guideline recommendations with class I/level A evidence were evaluated as possible quality indicators. Results: We found 94 guidelines for 14 inpatient neurological conditions other than stroke and transient ischemic attack. Of these, 36 guidelines contained at least 1 recommendation with class I evidence. Based on these, potential quality indicators for intracerebral hemorrhage, subarachnoid hemorrhage, pneumococcal meningitis, coma following cardiac arrest, encephalitis, Guillain-Barre syndrome, multiple sclerosis, and benign paroxysmal positional vertigo are proposed. Conclusions: There are several inpatient neurological conditions with treatments or diagnostic test routines supported by high levels of evidence that could be used in the future as quality indicators. PMID:23983832

Acupuncture/Moxibustion RCT for Distal Sensory Peripheral Neuropathy in HIV/AIDS

PubMed Central

Anastasi, Joyce K.; Capili, Bernadette; Chung, Ann M.; Hammerschlag, Richard

2017-01-01

Distal sensory peripheral neuropathy is a common neurological complication experienced by people living with the human immunodeficiency virus (HIV). Traditional Chinese medicine (TCM) may offer effective interventions in the management of its symptoms. To improve the quality and transparency of reporting acupuncture clinical trials, the Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in 1996 and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) recommendations were introduced in 2001. Incorporating international guidelines, this paper describes the development of a RCT including rationale, design, methods, procedures and logistics for a pilot study aimed at evaluating acupuncture and moxibustion for neuropathy associated with HIV. Using STRICTA guidelines as a template, aspects of clinical research design are explored to further optimise future studies of TCM. PMID:29756126

Reliability and quality assurance on the MOD 2 wind system

NASA Technical Reports Server (NTRS)

Mason, W. E. B.; Jones, B. G.

1981-01-01

The Safety, Reliability, and Quality Assurance (R&QA) approach developed for the largest wind turbine generator, the Mod 2, is described. The R&QA approach assures that the machine is not hazardous to the public or to the operating personnel, is operated unattended on a utility grid, demonstrates reliable operation, and helps establish the quality assurance and maintainability requirements for future wind turbine projects. The significant guideline consisted of a failure modes and effects analysis (FMEA) during the design phase, hardware inspections during parts fabrication, and three simple documents to control activities during machine construction and operation.

FRAMEWORK FOR DEVELOPING AMBIENT WATER ...

EPA Pesticide Factsheets

Currently, Ambient Water Quality Criteria (AWQC) for aquatic life protection are derived according to the Guidelines for Derivation of Ambient Water Quality Criteria for the Protection of Aquatic Life and Their Uses, published in 1985. To ensure that AWQC are derived from the best available science, Office of Water assessed the need to update the Guidelines and identified issues that should be addressed in the revisions. In December 2002, EPA's Science Advisory Board concurred with EPA's assessment of the need to update the Guidelines as well as with the issues EPA identified to address. Updating the Guidelines is a Priority Strategic Action included in OST's Strategy for Water Quality Standards and Criteria (Next Priority Strategic Action #1). To revise existing methodology for deriving ambient water quality criteria for the protection of aquatic life.

The Treatment of cardiovascular Risk in Primary care using Electronic Decision supOrt (TORPEDO) study-intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare.

PubMed

Peiris, David; Usherwood, Tim; Panaretto, Katie; Harris, Mark; Hunt, Jenny; Patel, Bindu; Zwar, Nicholas; Redfern, Julie; Macmahon, Stephen; Colagiuri, Stephen; Hayman, Noel; Patel, Anushka

2012-01-01

Large gaps exist in the implementation of guideline recommendations for cardiovascular disease (CVD) risk management. Electronic decision support (EDS) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia. We have developed HealthTracker, a multifaceted EDS and quality improvement intervention to improve the management of CVD risk. It is hypothesised that the use of HealthTracker over a 12-month period will result in: (1) an increased proportion of patients receiving guideline-indicated measurements of CVD risk factors and (2) an increased proportion of patients at high risk will receive guideline-indicated prescriptions for lowering their CVD risk. Sixty health services (40 general practices and 20 Aboriginal Community Controlled Health Services (ACCHSs) will be randomised in a 1:1 allocation to receive either the intervention package or continue with usual care, stratified by service type, size and participation in existing quality improvement initiatives. The intervention consists of point-of-care decision support; a risk communication interface; a clinical audit tool to assess performance on CVD-related indicators; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance. The control arm will continue with usual care without access to these intervention components. Quantitative data will be derived from cross-sectional samples at baseline and end of study via automated data extraction. Detailed process and economic evaluations will also be conducted. The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee (HREC) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC. Formal agreements with each of the participating sites have been signed. In addition to the usual scientific forums, results will be disseminated via newsletters, study websites, face-to-face feedback forums and workshops. The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910.

Summary of development and recommendations for a quality assurance program for the procurement and manufacture of urban mass transit operating equipment and systems

NASA Technical Reports Server (NTRS)

Witkin, S. A.

1976-01-01

A viable quality program for the urban mass transit industry, and a management approach to ensure compliance with the program are outlined. Included are: (1) a set of guidelines for quality assurance to be imposed on transit authorities, and a management approach to ensure compliance with them; (2) a management approach to be used by the transit authorities (properties) for assuring compliance with the QA guidelines; and (3) quality assurance guidelines to be imposed by properties and umta for procurement of hardware and systems.

Clinical practice guidelines in breast cancer

PubMed Central

Tyagi, N. Kumar; Dhesy-Thind, S.

2018-01-01

Background A number of clinical practice guidelines (cpgs) concerning breast cancer (bca) screening and management are available. Here, we review the strengths and weaknesses of cpgs from various professional organizations and consensus groups with respect to their methodologic quality, recommendations, and implementability. Methods Guidelines from four groups were reviewed with respect to two clinical scenarios: adjuvant ovarian function suppression (ofs) in premenopausal women with early-stage estrogen receptor–positive bca, and use of sentinel lymph node biopsy (slnb) after neoadjuvant chemotherapy (nac) for locally advanced bca. Guidelines from the American Society of Clinical Oncology (asco); Cancer Care Ontario’s Program in Evidence Based Care (cco’s pebc); the U.S. National Comprehensive Cancer Network (nccn); and the St. Gallen International Breast Cancer Consensus Conference were reviewed by two independent assessors. Guideline methodology and applicability were evaluated using the agree ii tool. Results The quality of the cpgs was greatest for the guidelines developed by asco and cco’s pebc. The nccn and St. Gallen guidelines were found to have lower scores for methodologic rigour. All guidelines scored poorly for applicability. The recommendations for ofs were similar in three guidelines. Recommendations by the various organizations for the use of slnb after nac were contradictory. Conclusions Our review demonstrated that cpgs can be heterogeneous in methodologic quality. Low-quality cpg implementation strategies contribute to low uptake of, and adherence to, bca cpgs. Further research examining the barriers to recommendations—such as intrinsic guideline characteristics and the needs of end users—is required. The use of bca cpgs can improve the knowledge-to-practice gap and patient outcomes.

An assessment of resuscitation quality in the television drama Emergency Room: guideline non-compliance and low-quality cardiopulmonary resuscitation lead to a favorable outcome?

PubMed

Hinkelbein, Jochen; Spelten, Oliver; Marks, Jörg; Hellmich, Martin; Böttiger, Bernd W; Wetsch, Wolfgang A

2014-08-01

Two earlier studies found that outcome after cardiopulmonary resuscitation (CPR) in the television medical drama Emergency Room (ER) is not realistic. No study has yet evaluated CPR quality in ER. Retrospective analysis of CPR quality in episodes of ER. Three independent board-certified emergency physicians trained in CPR and the American Heart Association (AHA) guidelines reviewed ER episodes in two 5-year time-frames (2001-2005 and 2005-2009). Congruency with the corresponding 2000 and 2005 AHA guidelines was determined for each CPR scene. None. None. To evaluate whether CPR is in agreement with the specific algorithms of the AHA guidelines. Fisher's exact test and Mann-Whitney-U-test were used to evaluate statistical significance (P<0.05). A total of 136 on-screen cardiac arrests occurred in 174 episodes. Trauma was the leading cause of cardiac arrest (56.6%), which was witnessed in 80.1%. Return of spontaneous circulation occurred in 38.2%. Altogether, 19.1% of patients survived until ICU admission, and 5.1% were discharged alive. Only one CPR scene was in agreement with the published AHA guidelines. However, low-quality CPR and non-compliance with the guidelines resulted in favorable outcomes. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Guidelines in the Register of the Association of Scientific Medical Societies in Germany – A Quality Improvement Campaign

PubMed Central

Nothacker, M. J.; Muche-Borowski, C.; Kopp, I. B.

2014-01-01

The Association of Scientific Medical Societies in Germany (AWMF) is the umbrella organization of medical scientific societies in Germany. The development of guidelines goes back to an initiative of the medical scientific societies and is coordinated by the AWMF. Rules for the inclusion of guidelines in the AWMF Guideline Register have been defined including how guidelines are classified. S1 guidelines are based only on recommendations by experts, whereas S2 guidelines require a structured consensus process or a systematic literature review. S3 guidelines include both elements. In addition to compulsory disclosure of any potential conflict of interest, transparent handling of potential conflicts of interest is an important confidence-building measure. For years, the trend has been to develop higher order (S2/S3) guidelines, and the German Society for Gynecology and Obstetrics (DGGG) has been no exception to the trend. In addition to its responsibility for specific S2 and S3 guidelines, the DGGG is also involved in numerous other interdisciplinary guidelines. When developing a guideline, it is essential to define the guidelineʼs scope, identify aspects which require improvement and agree on the goals. Target groups affected by the guidelines should be involved if they are interested. Different formats (long and short versions, practical instructions, conventional or electronic decision aids, patient versions) are useful to disseminate the guideline. The guideline can be adapted to local circumstances to encourage implementation of its recommendations. Implementation can be measured using quality indicators. Feedback from practitioners is important as this highlights areas which require improvement. The medical scientific societies in Germany can look back on almost two decades of work spent on developing guidelines, most of it done by unpaid voluntary contributors, making this a very successful quality initiative. PMID:25061235

A multi-model assessment of the co-benefits of climate mitigation for global air quality

NASA Astrophysics Data System (ADS)

Rao, Shilpa; Klimont, Zbigniew; Leitao, Joana; Riahi, Keywan; van Dingenen, Rita; Aleluia Reis, Lara; Calvin, Katherine; Dentener, Frank; Drouet, Laurent; Fujimori, Shinichiro; Harmsen, Mathijs; Luderer, Gunnar; Heyes, Chris; Strefler, Jessica; Tavoni, Massimo; van Vuuren, Detlef P.

2016-12-01

We present a model comparison study that combines multiple integrated assessment models with a reduced-form global air quality model to assess the potential co-benefits of global climate mitigation policies in relation to the World Health Organization (WHO) goals on air quality and health. We include in our assessment, a range of alternative assumptions on the implementation of current and planned pollution control policies. The resulting air pollution emission ranges significantly extend those in the Representative Concentration Pathways. Climate mitigation policies complement current efforts on air pollution control through technology and fuel transformations in the energy system. A combination of stringent policies on air pollution control and climate change mitigation results in 40% of the global population exposed to PM levels below the WHO air quality guideline; with the largest improvements estimated for India, China, and Middle East. Our results stress the importance of integrated multisector policy approaches to achieve the Sustainable Development Goals.

Clinical Practice Guideline Development Manual, Third Edition: a quality-driven approach for translating evidence into action.

PubMed

Rosenfeld, Richard M; Shiffman, Richard N; Robertson, Peter

2013-01-01

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. The third edition of this manual describes the principles and practices used successfully by the American Academy of Otolaryngology--Head and Neck Surgery Foundation to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for actionable recommendations with multidisciplinary applicability. The development process emphasizes a logical sequence of key action statements supported by amplifying text, action statement profiles, and recommendation grades linking action to evidence. New material in this edition includes standards for trustworthy guidelines, updated classification of evidence levels, increased patient and public involvement, assessing confidence in the evidence, documenting differences of opinion, expanded discussion of conflict of interest, and use of computerized decision support for crafting actionable recommendations. 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 used to improve care. The information in this manual should help clinicians and organizations achieve these goals.

Yogurt, diet quality and lifestyle factors.

PubMed

Panahi, S; Fernandez, M A; Marette, A; Tremblay, A

2017-05-01

Yogurt consumption has been associated with healthy dietary patterns and lifestyles, better diet quality and healthier metabolic profiles. Studies have shown that frequent yogurt consumers do not only have higher nutrient intakes, but also an improved diet quality, which includes higher consumption of fruits and vegetables, whole grains, and dairy compared with low or non-consumers indicating better compliance with dietary guidelines. Recent epidemiological and clinical evidence suggests that yogurt contributes to better metabolic health because of its effects on the control of body weight, energy homeostasis and glycemic control. Furthermore, yogurt consumers have been shown to be more physically active (⩾ 2 h/week), smoke less, have higher education and knowledge of nutrition compared with non-consumers. Thus, yogurt consumption may be considered a signature of a healthy diet through its nutritional content, impact on metabolic health including the control of energy balance, body weight and glycemia and its relationships with healthier behaviors and lifestyle factors.

[Evaluation of quality of HIV diagnostic procedures in Poland].

PubMed

Parczewski, Miłosz; Madaliński, Kazimierz; Leszczyszyn-Pynka, Magdalena; Boroń-Kaczmarska, Anna

2010-01-01

The aim of this work was quality assessment of HIV diagnostic procedures in Poland, including human and technical resources as well as laboratory practice. Sixty questionnaires were distributed among diagnostic centers to obtain qualitative data. Basing on the survey data serological control using coded panels of HIV-1/2 samples was performed. Thirty-one filled questionnaires were received (50.8%). Surveyed laboratories perform from 350 to 5500 serological screening tests per year. In most of laboratories fourth generation assays are available, while Blood Donation Centers screen the blood both with serological assays and by HIV-RNA detection. Sanitary and Epidemiological Stations and academic laboratories hold the ISO/IEC 17025 or IS0 9001:2001 accreditation, five of the surveyed centers participate in Labquality assurance and two in Quality Control in Molecular Diagnostics programs. Data of control serological testing were received from 21 centers. In the quality control assessment 194 analyses were performed with 91 true negative, 2 false negative, 96 true positive and 5 false positive results. False negative rate of % and false positive rate of 5.2% was noted for this study. Currently, virtually no guidelines related to the HIV-diagnostics quality assurance and control in Poland are in delineated. Development of the national unified quality control system, basing on the central institution is highly desirable. National certification within the frames of the quality control and assurance program should be mandatory for all the diagnostic labs, and aim at improvement of reliability of the result distributed among clinicians and patients.

Effluent quality from 200 on-site sewage systems: design values for guidelines.

PubMed

Charles, K J; Ashbolt, N J; Roser, D J; McGuinness, R; Deere, D A

2005-01-01

The quality of effluent from an on-site sewage treatment system is a critical factor in designing the disposal area and, hence, ensuring the sustained performance of the system. Contaminant concentrations in effluent are typically specified in regulatory guidelines or standards; however, the accuracy of these guideline values are brought into question due to the poor performance of septic tanks and the high failure rates of disposal systems reported here and elsewhere. Results from studies of septic tank effluent quality indicated that the effluent is of poorer quality than currently suggested by guidelines. Aerated wastewater treatment systems were found to perform to accreditation guidelines; however, insufficient nutrient data is presently available to assess nutrient loads. It is proposed that the 80th percentile of system performance be adopted as the design value for sizing effluent disposal areas to minimise failure associated with overloading. For septic tanks this equates to 660 mg L(-1) SS, 330 mg L(-1) BOD, 250 mg L(-1) TN and 36 mg L(-1) TP.

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

Sailer, S.J.

This Quality Assurance Project Plan (QAPJP) specifies the quality of data necessary and the characterization techniques employed at the Idaho National Engineering Laboratory (INEL) to meet the objectives of the Department of Energy (DOE) Waste Isolation Pilot Plant (WIPP) Transuranic Waste Characterization Quality Assurance Program Plan (QAPP) requirements. This QAPJP is written to conform with the requirements and guidelines specified in the QAPP and the associated documents referenced in the QAPP. This QAPJP is one of a set of five interrelated QAPjPs that describe the INEL Transuranic Waste Characterization Program (TWCP). Each of the five facilities participating in the TWCPmore » has a QAPJP that describes the activities applicable to that particular facility. This QAPJP describes the roles and responsibilities of the Idaho Chemical Processing Plant (ICPP) Analytical Chemistry Laboratory (ACL) in the TWCP. Data quality objectives and quality assurance objectives are explained. Sample analysis procedures and associated quality assurance measures are also addressed; these include: sample chain of custody; data validation; usability and reporting; documentation and records; audits and 0385 assessments; laboratory QC samples; and instrument testing, inspection, maintenance and calibration. Finally, administrative quality control measures, such as document control, control of nonconformances, variances and QA status reporting are described.« less

Design and implementation of the GLIF3 guideline execution engine.

PubMed

Wang, Dongwen; Peleg, Mor; Tu, Samson W; Boxwala, Aziz A; Ogunyemi, Omolola; Zeng, Qing; Greenes, Robert A; Patel, Vimla L; Shortliffe, Edward H

2004-10-01

We have developed the GLIF3 Guideline Execution Engine (GLEE) as a tool for executing guidelines encoded in the GLIF3 format. In addition to serving as an interface to the GLIF3 guideline representation model to support the specified functions, GLEE provides defined interfaces to electronic medical records (EMRs) and other clinical applications to facilitate its integration with the clinical information system at a local institution. The execution model of GLEE takes the "system suggests, user controls" approach. A tracing system is used to record an individual patient's state when a guideline is applied to that patient. GLEE can also support an event-driven execution model once it is linked to the clinical event monitor in a local environment. Evaluation has shown that GLEE can be used effectively for proper execution of guidelines encoded in the GLIF3 format. When using it to execute each guideline in the evaluation, GLEE's performance duplicated that of the reference systems implementing the same guideline but taking different approaches. The execution flexibility and generality provided by GLEE, and its integration with a local environment, need to be further evaluated in clinical settings. Integration of GLEE with a specific event-monitoring and order-entry environment is the next step of our work to demonstrate its use for clinical decision support. Potential uses of GLEE also include quality assurance, guideline development, and medical education.

Quality assurance in forensic odontology

PubMed

Solheim, T

2018-05-30

Quality assurance or quality control is a term and concept coming from the industry. Here it is most important. All products must have a minimum quality and variation in size, for example, must be kept within certain strict limits. There must be a system to control this. May be not every single product is controlled, but spot tests must be taken. Measures must be taken to improve the quality if it is not good enough. This concept has been transferred to medicine, odontology, and consequently also to forensic odontology. These areas have in common with industry the production of that certain products. However, they are usually handmade and not produced in an industrial process. In addition, dentistry is a great deal of art and judgement and quality control of these factors may be difficult. In this paper, I will focus on forensic odontology. What are the problems? What can we do and cannot do? In addition, how can we assure the quality of the work, the assessment and conclusion, and the report? I have some personal opinions on that and I will give some suggestions. Quality assurance on an international level is difficult. Conditions and juridical systems are different in different countries. Especially forensic odontologists are different and have different opinions. This presentation will be relevant to the ongoing discussion and attempts at revising the IOFOS' guidelines for quality assurance.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

PubMed

Kroes, Burt H

2014-12-02

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply to herbal products based on clinical evidence and traditional herbal medicinal products. The basic principle is that the quality of herbal medicinal products is intrinsically associated with the quality standard of the herbal substances and/or herbal preparations. Furthermore, the herbal substance or herbal preparation in its entirety is regarded as the active substance. Consequently, a mere determination of the content of marker(s) or constituents with known therapeutic activity is not sufficient for the quality control of herbal medicinal products. Specific quality requirements include thorough product characterisation, adherence to the Good Agricultural and Collection Practices, good manufacturing practices and validated manufacturing process, e.g., raw material testing, in-process testing, fingerprint characterisation etc. Quality control of herbal medicinal products is primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Design and evaluation of a Stochastic Optimal Feed-forward and Feedback Technology (SOFFT) flight control architecture

NASA Technical Reports Server (NTRS)

Ostroff, Aaron J.; Proffitt, Melissa S.

1994-01-01

This paper describes the design and evaluation of a stochastic optimal feed-forward and feedback technology (SOFFT) control architecture with emphasis on the feed-forward controller design. The SOFFT approach allows the designer to independently design the feed-forward and feedback controllers to meet separate objectives and then integrate the two controllers. The feed-forward controller has been integrated with an existing high-angle-of-attack (high-alpha) feedback controller. The feed-forward controller includes a variable command model with parameters selected to satisfy level 1 flying qualities with a high-alpha adjustment to achieve desired agility guidelines, a nonlinear interpolation approach that scales entire matrices for approximation of the plant model, and equations for calculating feed-forward gains developed for perfect plant-model tracking. The SOFFT design was applied to a nonlinear batch simulation model of an F/A-18 aircraft modified for thrust vectoring. Simulation results show that agility guidelines are met and that the SOFFT controller filters undesired pilot-induced frequencies more effectively during a tracking task than a flight controller that has the same feedback control law but does not have the SOFFT feed-forward control.

A Systematic Review and Appraisal of Clinical Practice Guidelines for Musculoskeletal Soft Tissue Injuries and Conditions.

PubMed

Pincus, Daniel; Kuhn, John E; Sheth, Ujash; Rizzone, Katie; Colbenson, Kristi; Dwyer, Tim; Karpinos, Ashley; Marks, Paul H; Wasserstein, David

2017-05-01

Clinical practice guidelines (CPGs) are published by several sports medicine institutions. A systematic evaluation can help identify the highest quality CPGs for clinical use and identify any deficiencies that remain. To identify and appraise CPGs relevant to clinical sports medicine professionals. Systematic review. Predetermined selection criteria were utilized by 2 reviewers who independently identified published CPGs before January 1, 2014. CPGs were excluded if they focused on injured workers, radiological criteria, medical pathology, or the axial skeleton (back/neck). The remaining guidelines were scored by 6 reviewers with different clinical backgrounds using the Appraisal of Guidelines for Research and Evaluation II (AGREE II). Scores lower than 50% indicated deficiency. Scores were also stratified by the publishing institution and anatomic location and compared using Kruskal-Wallis tests. The Spearman correlation coefficient was used to assess the range of interobserver agreement between the evaluators. Seventeen CPGs met the inclusion criteria. The majority of guidelines pertained to the knee, ankle, or shoulder. Interobserver agreement was strong ( r = 0.548-0.740), and mean total scores between nonsurgical (107.8) and surgical evaluators (109.3) were not statistically different. Overall guideline quality was variable but not deficient for 16 of 17 guidelines (>50%), except regarding clinical "applicability" and "editorial independence." No difference was found between CPGs of the knee, shoulder, foot/ankle, or chronic conditions. However, CPG publishing institutions had significantly different scores; the American Academy of Orthopaedic Surgeons (AAOS) guidelines scored significantly higher (141.4) than the total mean score (108.0). The overall quality of sports medicine CPGs was variable but generally not deficient, except regarding applicability and editorial independence. Bias through poor editorial independence is a concern. To improve future guideline quality, authors should pay particular attention to these areas and use existing highest quality guidelines, or the AGREE II instrument, as templates. CPGs dedicated to anatomic areas other than the knee, ankle, and shoulder are needed.

Financial incentives linked to self-assessment of prescribing patterns: a new approach for quality improvement of drug prescribing in primary care.

PubMed

Wettermark, Björn; Pehrsson, Ake; Juhasz-Haverinen, Maria; Veg, Aniko; Edlert, Maria; Törnwall-Bergendahl, Gunilla; Almkvist, Henrik; Godman, Brian; Granath, Fredrik; Bergman, Ulf

2009-01-01

Financial incentives have been suggested to be effective in increasing the quality and efficiency of drug prescribing. Concern has been raised in relation to potential negative consequences on the quality of care. To describe and analyse the impact of an incentives model linking payment with adherence to drug and therapeutics committee (DTC) guidelines and self-reflection of prescribing pattern in a 'prescribing quality report'. The study was performed in the county of Stockholm, Sweden, with 139 (out of 154) primary healthcare centres (PHCs) participating in the project and 15 PHCs not participating. The study consisted of two parts: a quantitative observational study of prescribing patterns and a qualitative analysis of the submitted prescribing quality reports. All prescriptions issued from PHCs and dispensed at pharmacies during October to December 2005 and October to December 2006 were analysed, using adherence to the regional DTC guidelines as the main outcome measure. Adherence was assessed using the drug utilisation 90% methodology, i.e. focusing on drugs constituting 90% of the prescribed volume and the proportion of drugs included in the guidelines. The qualitative analysis focused on reports on the quality of drug prescribing submitted by each PHC in early 2007. The 139 PHCs participating in the programme accounted for 85% of all prescriptions issued in primary care during October to December 2006. Mean adherence to guidelines increased among participating practices by 3.3 percentage units (95% confidence interval (CI) 2.9-3.7%) to 83% (82.6-83.7%) during the year. The adherence among practices not participating increased by 3.1 percentage units (95% CI 1.7-4.4%) to 78.8% (95% CI 76.7-80.9%). The higher adherence achieved during the year corresponded to savings estimated at five times greater than the cost of running the programme including the financial incentives. In addition, many areas for improving prescribing were identified, such as limiting the prescribing of drugs with uncertain safety profiles and documentation as well as reporting adverse drug reactions. Although no causal effect can be attributed without a control group, we have shown the feasibility of a model linking payment to DTC adherence. This approach with its own quality assessment and goal setting offers an example to other regions and countries of how to increase the quality and efficiency of drug prescribing within limited resources.

Adherence of hip and knee arthroplasty studies to RSA standardization guidelines. A systematic review.

PubMed

Madanat, Rami; Mäkinen, Tatu J; Aro, Hannu T; Bragdon, Charles; Malchau, Henrik

2014-09-01

Guidelines for standardization of radiostereometry (RSA) of implants were published in 2005 to facilitate comparison of outcomes between various research groups. In this systematic review, we determined how well studies have adhered to these guidelines. We carried out a literature search to identify all articles published between January 2000 and December 2011 that used RSA in the evaluation of hip or knee prosthesis migration. 2 investigators independently evaluated each of the studies for adherence to the 13 individual guideline items. Since some of the 13 points included more than 1 criterion, studies were assessed on whether each point was fully met, partially met, or not met. 153 studies that met our inclusion criteria were identified. 61 of these were published before the guidelines were introduced (2000-2005) and 92 after the guidelines were introduced (2006-2011). The methodological quality of RSA studies clearly improved from 2000 to 2011. None of the studies fully met all 13 guidelines. Nearly half (43) of the studies published after the guidelines demonstrated a high methodological quality and adhered at least partially to 10 of the 13 guidelines, whereas less than one-fifth (11) of the studies published before the guidelines had the same methodological quality. Commonly unaddressed guideline items were related to imaging methodology, determination of precision from double examinations, and also mean error of rigid-body fitting and condition number cutoff levels. The guidelines have improved methodological reporting in RSA studies, but adherence to these guidelines is still relatively low. There is a need to update and clarify the guidelines for clinical hip and knee arthroplasty RSA studies.

Ambient air quality programmes for health impact assessment in the WHO European region.

PubMed

Mücke, H G

2000-06-01

An important aim of air quality assessment is to provide information about population exposure and health impact assessment. Numerous epidemiological studies have already shown that exposure to excessive levels of ambient air pollutants are associated with either acute or chronic health effects. Until recently, the adequacy of monitoring population exposure in relation to quantitative assessment of health effects of air pollution was rarely considered in ambient air monitoring strategies. This made the formulation of health-related recommendations to risk management difficult and weakens preventive and other measures to reduce adverse health effects of air pollution. To improve local and national capacities for health impact assessment, the European Centre for Environment and Health of the World Health Organization has prepared methodology guidelines concerning selected aspects of air monitoring. The WHO Collaborating Centre for Air Quality Management and Air Pollution Control support efforts in line with international programmes on quality assurance and control for Europe.

A Flying Qualities Study of Longitudinal Long-Term Dynamics of Hypersonic Planes

NASA Technical Reports Server (NTRS)

Cox, Timothy H.; Sachs, G.; Knoll, A.; Stich, R.

1995-01-01

The NASA Dryden Flight Research Center and the Technical University of Munich are cooperating in a research program to assess the impact of unstable long-term dynamics on the flying qualities of planes in hypersonic flight. These flying qualities issues are being investigated with a dedicated flight simulator for hypersonic vehicles located at NASA Dryden. Several NASA research pilots have flown the simulator through well defined steady-level turns with varying phugoid and height mode instabilities. The data collected include Pilot ratings and comments, performance measurements, and Pilot workload measurements. The results presented in this paper include design guidelines for height and Phugoid mode instabilities, an evaluation of the tapping method used to measure pilot workload, a discussion of techniques developed by the pilots to control large instabilities, and a discussion of how flying qualities of unstable long-term dynamics influence control Power design requirements.

A flying qualities study of longitudinal long-term dynamics of hypersonic planes

NASA Technical Reports Server (NTRS)

Cox, T.; Sachs, G.; Knoll, A.; Stich, R.

1995-01-01

The NASA Dryden Flight Research Center and the Technical University of Munich are cooperating in a research program to assess the impact of unstable long-term dynamics on the flying qualities of planes in hypersonic flight. These flying qualities issues are being investigated with a dedicated flight simulator for hypersonic vehicles located at NASA Dryden. Several NASA research pilots have flown the simulator through well-defined steady-level turns with varying phugoid and height mode instabilities. Th data collected include pilot ratings and comments, performance measurements, and pilot workload measurements. The results presented in this paper include design guidelines for height and phugoid mode instabilities, an evaluation of the tapping method used to measure pilot workload, a discussion of techniques developed by the pilots to control large instabilities, and a discussion of how flying qualities of unstable long-term dynamics influence control power design requirements.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2014-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

Standards and guidelines for observational studies: quality is in the eye of the beholder.

PubMed

Morton, Sally C; Costlow, Monica R; Graff, Jennifer S; Dubois, Robert W

2016-03-01

Patient care decisions demand high-quality research. To assist those decisions, numerous observational studies are being performed. Are the standards and guidelines to assess observational studies consistent and actionable? What policy considerations should be considered to ensure decision makers can determine if an observational study is of high-quality and valid to inform treatment decisions? Based on a literature review and input from six experts, we compared and contrasted nine standards/guidelines using 23 methodological elements involved in observational studies (e.g., study protocol, data analysis, and so forth). Fourteen elements (61%) were addressed by at least seven standards/guidelines; 12 of these elements disagreed in the approach. Nine elements (39%) were addressed by six or fewer standards/guidelines. Ten elements (43%) were not actionable in at least one standard/guideline that addressed the element. The lack of observational study standard/guideline agreement may contribute to variation in study conduct; disparities in what is considered credible research; and ultimately, what evidence is adopted. A common set of agreed on standards/guidelines for conducting observational studies will benefit funders, researchers, journal editors, and decision makers. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Publication guidelines for quality improvement in health care: evolution of the SQUIRE project

PubMed Central

Davidoff, F; Batalden, P; Stevens, D; Ogrinc, G; Mooney, S

2008-01-01

In 2005, draft guidelines were published for reporting studies of quality improvement interventions as the initial step in a consensus process for development of a more definitive version. This article contains the full revised version of the guidelines, which the authors refer to as SQUIRE (Standards for QUality Improvement Reporting Excellence). This paper also describes the consensus process, which included informal feedback from authors, editors and peer reviewers who used the guidelines; formal written commentaries; input from a group of publication guideline developers; ongoing review of the literature on the epistemology of improvement and methods for evaluating complex social programmes; a two-day meeting of stakeholders for critical discussion and debate of the guidelines’ content and wording; and commentary on sequential versions of the guidelines from an expert consultant group. Finally, the authors consider the major differences between SQUIRE and the initial draft guidelines; limitations of and unresolved questions about SQUIRE; ancillary supporting documents and alternative versions that are under development; and plans for dissemination, testing and further development of SQUIRE. PMID:18836063

Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders.

PubMed

Cassis, Linda; Cortès-Saladelafont, Elisenda; Molero-Luis, Marta; Yubero, Delia; González, Maria Julieta; Ormazábal, Aida; Fons, Carme; Jou, Cristina; Sierra, Cristina; Castejon Ponce, Esperanza; Ramos, Federico; Armstrong, Judith; O'Callaghan, M Mar; Casado, Mercedes; Montero, Raquel; Meavilla-Olivas, Silvia; Artuch, Rafael; Barić, Ivo; Bartoloni, Franco; Bellettato, Cinzia Maria; Bonifazi, Fedele; Ceci, Adriana; Cvitanović-Šojat, Ljerka; Dali, Christine I; D'Avanzo, Francesca; Fumic, Ksenija; Giannuzzi, Viviana; Lampe, Christina; Scarpa, Maurizio; Garcia-Cazorla, Ángels

2015-12-30

Inherited neurometabolic disorders (iNMDs) represent a group of almost seven hundred rare diseases whose common manifestations are clinical neurologic or cognitive symptoms that can appear at any time, in the first months/years of age or even later in adulthood. Early diagnosis and timely treatments are often pivotal for the favorable course of the disease. Thus, the elaboration of new evidence-based recommendations for iNMD diagnosis and management is increasingly requested by health care professionals and patients, even though the methodological quality of existing guidelines is largely unclear. InNerMeD-I-Network is the first European network on iNMDs that was created with the aim of sharing and increasing validated information about diagnosis and management of neurometabolic disorders. One of the goals of the project was to determine the number and the methodological quality of existing guidelines and recommendations for iNMDs. We performed a systematic search on PubMed, the National Guideline Clearinghouse (NGC), the Guidelines International Network (G-I-N), the Scottish Intercollegiate Guideline Network (SIGN) and the National Institute for Health and Care Excellence (NICE) to identify all the published guidelines and recommendations for iNMDs from January 2000 to June 2015. The methodological quality of the selected documents was determined using the AGREE II instrument, an appraisal tool composed of 6 domains covering 23 key items. A total of 55 records met the inclusion criteria, 11 % were about groups of disorders, whereas the majority encompassed only one disorder. Lysosomal disorders, and in particular Fabry, Gaucher disease and mucopolysaccharidoses where the most studied. The overall methodological quality of the recommendation was acceptable and increased over time, with 25 % of the identified guidelines strongly recommended by the appraisers, 64 % recommended, and 11 % not recommended. However, heterogeneity in the obtained scores for each domain was observed among documents covering different groups of disorders and some domains like 'stakeholder involvement' and 'applicability' were generally scarcely addressed. Greater efforts should be devoted to improve the methodological quality of guidelines and recommendations for iNMDs and AGREE II instrument seems advisable for new guideline development. The elaboration of new guidelines encompassing still uncovered disorders is badly needed.

Guidelines: Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly.

PubMed

Tamber, Mandeep S; Nikas, Dimitrios; Beier, Alexandra; Baird, Lissa C; Bauer, David F; Durham, Susan; Klimo, Paul; Lin, Alexander Y; Mazzola, Catherine; McClung-Smith, Catherine; Mitchell, Laura; Tyagi, Rachana; Flannery, Ann Marie

2016-11-01

No evidence-based guidelines exist on the role of cranial-molding orthosis (helmet) therapy for patients with positional plagiocephaly. To address the clinical question: "Does helmet therapy provide effective treatment for positional plagiocephaly?" and to make treatment recommendations based on the available evidence. The US National Library of Medicine Medline database and the Cochrane Library were queried by using MeSH headings and key words relevant to the objective of this systematic review. Abstracts were reviewed, after which studies meeting the inclusion criteria were selected and graded according to their quality of evidence (Classes I-III). Evidentiary tables were constructed that summarized pertinent study results, and, based on the quality of the literature, recommendations were made (Levels I-III). Fifteen articles met criteria for inclusion into the evidence tables. There was 1 prospective randomized controlled trial (Class II), 5 prospective comparative studies (Class II), and 9 retrospective comparative studies (Class II). There is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy. Specific criteria regarding the measurement and quantification of deformity and the most appropriate time window in infancy for treatment of positional plagiocephaly with a helmet remains elusive. In general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_5.

Royal College of Physicians Intercollegiate Stroke Working Party evidence-based guidelines for the secondary prevention of stroke through nutritional or dietary modification.

PubMed

Hookway, C; Gomes, F; Weekes, C E

2015-04-01

Each year, 15 million people worldwide and 110,000 people in England have a stroke. Having a stroke increases the risk of having another. There are a number of additional known risk factors that can be modified by diet. The present study aimed to systematically review key nutrients and diets and their role in secondary prevention, as well as provide evidence-based guidelines for use in clinical practice. The work was conducted as part of the process to develop the 4th edition of the Royal College of Physicians' (RCP) National Clinical Guideline (NCG) for Stroke. Questions were generated by the research team, in consultation with the Virtual Stroke Group, an online professional interest group, and the RCP Intercollegiate Stroke Working Party Guideline Development Group. Nine questions covering several individual nutrients and diet combinations were defined and searches conducted up until 31 October 2011 using five electronic databases (Embase, Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library and Web of Science). All included studies were assessed for quality and risk of bias using van Tulder criteria for randomised controlled trials (RCTs) and Quality of Reporting of Meta-analyses (QUORUM) criteria for systematic reviews. Of 4287 abstracts were identified, 79 papers were reviewed and 29 systematic reviews and RCTs were included to provide evidence for the secondary prevention components of the guidelines. For each question, evidence statements, recommendations and practical considerations were developed. This systematic review process has resulted in the development of evidence-based guidelines for use in clinical practice and has identified areas for further research. © 2014 The British Dietetic Association Ltd.

Detection of human enteric viruses in stream water with RT-PCR and cell culture.

USGS Publications Warehouse

Denis-Mize, K.; Fout, G.S.; Dahling, D.R.; Francy, D.S.

2004-01-01

A multiplex RT-PCR method was used to measure virus occurrence at five stream water sites that span a range of hydroclimatic, water-quality, and land-use characteristics. The performance of the molecular method was evaluated in comparison with traditional cell culture and Escherichia coli membrane filtration assays. The study incorporated multiple quality controls and included a control for virus recovery during the sampling procedure as well as controls to detect potentially false-negative and false-positive data. Poliovirus recovery ranged from 16 to 65% and was variable, even in samples collected within the same stream. All five sites were positive for viruses by both molecular and cell culture-based virus assays. Enteroviruses, reoviruses, rotaviruses, and hepatitis A viruses were detected, but the use of the quality controls proved critical for interpretation of the molecular data. All sites showed evidence of faecal contamination, and culturable viruses were detected in four samples that would have met the US Environmental Protection Agency's recommended E. coli guideline for safe recreational water.

Assessment of quality guidelines implementation using a continuous quality improvement programme.

PubMed

Richards, Nick; Ayala, Juan Antonio; Cesare, Salvatore; Chazot, Charles; Di Benedetto, Attilio; Gassia, Jean-Paul; Merello, Jose-Ignacio; Rentero, Ramon; Scatizzi, Laura; Marcelli, Daniele

2007-01-01

Data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) study suggest that the level of implementation of the European Best Practice Guidelines (EBPG) is at best partial. The main aim of this study is to describe the level of implementation of the EBPG in the European Fresenius Medical Care (FME) clinic network. Data presented in this investigation were gained through the FME database EuCliD (European Clinical Database). Patient data from 4 countries (Great Britain, France, Italy, Spain) were selected from the EuCliD database. The parameters chosen were haemodialysis adequacy, biocompatibility, anaemia control and serum phosphate control, which are surrogate indicators for quality of care. They were compared, by country, between the first quarter (Q1) 2002 and the fourth quarter (Q4) 2005. During Q1 2002 and Q4 2005, respectively, a total of 7,067 and 9,232 patients were treated in FME clinics located in France, Italy, Spain and the UK. This study confirms variations in haemodialysis practices between countries as already described by the DOPPS study. A large proportion of patients in each country achieved the targets recommended by the EBPG in Q4 2005 and this represented a significant improvement over the results achieved in Q1 2002. Differences in practices between countries still exist. The FME CQI programme allows some of these differences to be overcome leading to an improvement in the quality of the treatment delivered. Copyright 2007 S. Karger AG, Basel.

Is the National Guideline Clearinghouse a Trustworthy Source of Practice Guidelines for Child and Youth Anxiety and Depression?

PubMed

Duda, Stephanie; Fahim, Christine; Szatmari, Peter; Bennett, Kathryn

2017-07-01

Innovative strategies that facilitate the use of high quality practice guidelines (PG) are needed. Accordingly, repositories designed to simplify access to PGs have been proposed as a critical component of the network of linked interventions needed to drive increased PG implementation. The National Guideline Clearinghouse (NGC) is a free, international online repository. We investigated whether it is a trustworthy source of child and youth anxiety and depression PGs. English language PGs published between January 2009 and February 2016 relevant to anxiety or depression in children and adolescents (≤ 18 years of age) were eligible. Two trained raters assessed PG quality using Appraisal of Guidelines for Research and Evaluation (AGREE II). Scores on at least three AGREE II domains (stakeholder involvement, rigor of development, and editorial independence) were used to designate PGs as: i) minimum quality (≥ 50%); and ii) high quality (≥ 70%). Eight eligible PGs were identified (depression, n=6; anxiety and depression, n=1; social anxiety disorder, n=1). Four of eight PGs met minimum quality criteria; three of four met high quality criteria. At present, NGC users without the time and special skills required to evaluate PG quality may unknowingly choose flawed PGs to guide decisions about child and youth anxiety and depression. The recent NGC decision to explore the inclusion of PG quality profiles based on Institute of Medicine standards provides needed leadership that can strengthen PG repositories, prevent harm and wasted resources, and build PG developer capacity.

Manufacturing of biodrugs: need for harmonization in regulatory standards.

PubMed

Sahoo, Niharika; Choudhury, Koel; Manchikanti, Padmavati

2009-01-01

Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs. Regulatory compliance in manufacturing and commercialization of biodrugs involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.

The quest to standardize hemodialysis care.

PubMed

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

2011-01-01

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

Quality Assessment of Clinical Practice Guidelines for Respiratory Diseases in China: A Systematic Appraisal.

PubMed

Jiang, Mei; Liao, Li-Yue; Liu, Xiao-Qing; He, Wei-Qun; Guan, Wei-Jie; Chen, Hao; Li, Yi-Min

2015-09-01

There has been a significant increase in the publication of clinical practice guidelines (CPGs) for respiratory diseases in China. However, little is known about the quality and potential impacts of these CPGs. Our objective was to critically evaluate the quality of Chinese CPGs for respiratory diseases that were published in peer-reviewed medical journals. A systematic search of scientific literature published between 1979 and 2013 was undertaken to identify and select CPGs that were related to respiratory diseases. Four Chinese databases (the Chinese Biomedical Literature database [CBM], the China National Knowledge Infrastructure [CNKI], the VIP database, and the WANFANG database) were used. The quality of eligible guidelines was assessed independently by four reviewers using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. The overall agreement among reviewers was evaluated using an intraclass correlation coefficient. A total of 109 guidelines published in 27 medical journals from 1979 to 2013 were evaluated. The overall agreement among reviewers was considered good (intraclass correlation coefficient, 0.838; 95% CI, 0.812-0.862). The scores of the six AGREE domains were low: 57.3% for scope and purpose (range, 4.2%-80.5%), 23.8% for stakeholder involvement (range, 2.8%-54.2%), 7.7% for rigor of development (range, 0%-27.1%), 59.8% for clarity and presentation (range, 22.2%-80.6%), 10.9% for applicability (range, 0%-22.9%), and 0.6% for editorial independence (range, 0%-16.7%). Scores for all guidelines were below 60%, and only three guidelines (2.8%) were recommended for clinical practice with modifications. The quality of the guidelines was low, and stakeholder involvement, rigor of development, applicability, and editorial independence should be considered in the future development of CPGs for respiratory diseases in China.

Monitoring and evaluation of patient involvement in clinical practice guideline development: lessons from the Multidisciplinary Guideline for Employment and Severe Mental Illness, the Netherlands.

PubMed

van der Ham, Alida J; van Erp, Nicole; Broerse, Jacqueline E W

2016-04-01

The aim of this study was to gain better insight into the quality of patient participation in the development of clinical practice guidelines and to contribute to approaches for the monitoring and evaluation of such initiatives. In addition, we explore the potential of a dialogue-based approach for reconciliation of preferences of patients and professionals in the guideline development processes. The development of the Multidisciplinary Guideline for Employment and Severe Mental Illness in the Netherlands served as a case study. Methods for patient involvement in guideline development included the following: four patient representatives in the development group and advisory committee, two focus group discussions with patients, a dialogue session and eight case studies. To evaluate the quality of patient involvement, we developed a monitoring and evaluation framework including both process and outcome criteria. Data collection included observations, document analysis and semi-structured interviews (n = 26). The quality of patient involvement was enhanced using different methods, reflection of patient input in the guideline text, a supportive attitude among professionals and attention to patient involvement throughout the process. The quality was lower with respect to representing the diversity of the target group, articulation of the patient perspective in the GDG, and clarity and transparency concerning methods of involvement. The monitoring and evaluation framework was useful in providing detailed insights into patient involvement in guideline development. Patient involvement was evaluated as being of good quality. The dialogue-based approach appears to be a promising method for obtaining integrated stakeholder input in a multidisciplinary setting. © 2015 John Wiley & Sons Ltd.

Promoting transparent and accurate reporting of research studies in rheumatology: endorsement of reporting guidelines in rheumatology journals.

PubMed

Marušić, Ana; Gasparyan, Armen Yuri; Kitas, George D

2013-10-01

To adequately translate research into practice, research results should be reported in a way that is useful to practicing clinicians and policymakers. Based on evidence from systematic reviews, the implementation of reporting guidelines, such as CONSORT for randomized controlled trials, may improve the quality of research reporting. We assessed the endorsement of reporting guidelines in rheumatology journals. We analyzed guidelines for authors of all (n = 28) journals indexed in the "Rheumatology" Subject Category of the Journal Citation Reports published in 2012. Journal websites were reviewed for information relevant to reporting guidelines. Out of 28 indexed journals, only about a third (n = 10) endorsed 1 or more reporting guidelines, most commonly CONSORT. General editorial policies, such as those from the International Committee of Medical Journal editors (ICMJE), were endorsed by 19 journals (all 10 journals with and 9 out of 18 without reporting guidelines). Two rheumatology journals introduced specific reporting guidelines about economic studies and genetic association studies. The endorsement of reporting guidelines is low in rheumatology journals. To continue to serve their research community, rheumatology journals should provide the platform for the discussion on most relevant reporting guidelines and adopt them as a group, especially those specific for rheumatology research. Coordinated action of journals and other stakeholders in rheumatology research in the promotion of accurate and transparent reporting of health research studies would be an important part of knowledge translation into practice and well-being of rheumatology patients. Copyright © 2013 Elsevier Inc. All rights reserved.

Timber marking guidelines to minimize chainsaw felling accidents

Treesearch

Penn A. Peters; Michael D. Erickson; Curt D. Hassler

1995-01-01

Trees are marked by foresters for retention or harvest to satisfy landowner objectives for timber sale revenues, stand improvement, wildlife habitat, water quality, and aesthetics. Another consideration when marking trees is the safety of the chainsaw feller. Can the tree that has been marked for harvest be felled safely? Will the feller be able to select and control a...

The Need for Careful Data Collection for Pattern Recognition in Digital Pathology.

PubMed

Marée, Raphaël

2017-01-01

Effective pattern recognition requires carefully designed ground-truth datasets. In this technical note, we first summarize potential data collection issues in digital pathology and then propose guidelines to build more realistic ground-truth datasets and to control their quality. We hope our comments will foster the effective application of pattern recognition approaches in digital pathology.

77 FR 42833 - Approval, Disapproval and Promulgation of Air Quality Implementation Plans; Arizona; Regional...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... the problem of visibility impairment in Class I areas, states, or the EPA when implementing a FIP... explanation and rationale for its determinations. While we find these problems in all of ADEQ's BART analyses... problems resulted in control determinations that are inconsistent with the RHR and the BART Guidelines. We...

The Relationship between the Training Function and ISO-9000 Registration.

ERIC Educational Resources Information Center

Maxwell, Randy C.; Jost, Karen L.

ISO 9000 is one of a series of international standards providing guidelines and governing quality of products and services. The ISO 9000 certification demonstrates the capability of a supplier to control the processes that determine the acceptability of the product or service being supplied. This paper focuses on the training aspects of ISO 9000…

Development and Exchange of Instructional Resources in Water Quality Control Programs, II: Instructional Materials Available.

ERIC Educational Resources Information Center

Austin, John H.

This document is one in a series of reports which reviews instructional materials and equipment for water and wastewater treatment plant personnel. Approximately 900 items are listed in this document along with guidelines for the production of instructional materials. Information is provided regarding the source, type of material, intended…

FASTQ quality control dashboard

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

2016-07-25

FQCDB builds up existing open source software, FastQC, implementing a modern web interface for across parsed output of FastQC. In addition, FQCDB is extensible as a web service to include additional plots of type line, boxplot, or heatmap, across data formatted according to guidelines. The interface is also configurable via more readable JSON format, enabling customization by non-web programmers.

77 FR 3681 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Regional Haze

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

... approach in the BART Guidelines in making a BART determination for a fossil fuel-fired EGU with total... ammonia (NH 3 ), and volatile organic compound (VOCs). Fine particle precursors react in the atmosphere to... standards, low sulfur fuel, and non-road mobile source control programs. The fourth step is to determine...

Review of Research Reporting Guidelines for Radiology Researchers.

PubMed

Cronin, Paul; Rawson, James V

2016-05-01

Prior articles have reviewed reporting guidelines and study evaluation tools for clinical research. However, only some of the many available accepted reporting guidelines at the Enhancing the QUAlity and Transparency Of health Research Network have been discussed in previous reports. In this paper, we review the key Enhancing the QUAlity and Transparency Of health Research reporting guidelines that have not been previously discussed. The study types include diagnostic and prognostic studies, reliability and agreement studies, observational studies, analytical and descriptive, experimental studies, quality improvement studies, qualitative research, health informatics, systematic reviews and meta-analyses, economic evaluations, and mixed methods studies. There are also sections on study protocols, and statistical analyses and methods. In each section, there is a brief overview of the study type, and then the reporting guideline(s) that are most applicable to radiology researchers including radiologists involved in health services research are discussed. Copyright © 2016 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Quality of clinical practice guidelines in delirium: a systematic appraisal

PubMed Central

Marchington, Katie L; Agar, Meera; Davis, Daniel H J; Sikora, Lindsey; Tsang, Tammy W Y

2017-01-01

Objective To determine the accessibility and currency of delirium guidelines, guideline summary papers and evaluation studies, and critically appraise guideline quality. Design Systematic literature search for formal guidelines (in English or French) with focus on delirium assessment and/or management in adults (≥18 years), guideline summary papers and evaluation studies. Full appraisal of delirium guidelines published between 2008 and 2013 and obtaining a ‘Rigour of Development’ domain screening score cut-off of >40% using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Data sources Multiple bibliographic databases, guideline organisation databases, complemented by a grey literature search. Results 3327 database citations and 83 grey literature links were identified. A total of 118 retrieved delirium guidelines and related documents underwent full-text screening. A final 21 delirium guidelines (with 10 being >5 years old), 12 guideline summary papers and 3 evaluation studies were included. For 11 delirium guidelines published between 2008 and 2013, the screening AGREE II ‘Rigour’ scores ranged from 3% to 91%, with seven meeting the cut-off score of >40%. Overall, the highest rating AGREE II domains were ‘Scope and Purpose’ (mean 80.1%, range 64–100%) and ‘Clarity and Presentation’ (mean 76.7%, range 38–97%). The lowest rating domains were ‘Applicability’ (mean 48.7%, range 8–81%) and ‘Editorial Independence’ (mean 53%, range 2–90%). The three highest rating guidelines in the ‘Applicability’ domain incorporated monitoring criteria or audit and costing templates, and/or implementation strategies. Conclusions Delirium guidelines are best sourced by a systematic grey literature search. Delirium guideline quality varied across all six AGREE II domains, demonstrating the importance of using a formal appraisal tool prior to guideline adaptation and implementation into clinical settings. Adding more knowledge translation resources to guidelines may improve their practical application and effective monitoring. More delirium guideline evaluation studies are needed to determine their effect on clinical practice. PMID:28283488

Practice Guideline Recommendations on Perioperative Fasting: A Systematic Review.

PubMed

Lambert, Eva; Carey, Sharon

2016-11-01

Traditionally, perioperative fasting consisted of being nil by mouth (NBM) from midnight before surgery and fasting postoperatively until recovery of bowel function. These outdated practices persist despite emerging evidence revealing that excessive fasting results in negative outcomes and delayed recovery. Various evidence-based, multimodal, enhanced recovery protocols incorporating minimized perioperative fasting have arisen to improve patient outcomes and streamline recovery, but implementation remains limited. This article aims to review current fasting guidelines, assess their quality, summarize relevant recommendations, and identify gaps in evidence. A systematic literature search of Medline and CINAHL and a manual search of relevant websites identified guidelines containing suitable grading systems and fasting recommendations. Guideline quality was assessed using the Appraisal of Guidelines Research and Evaluation (AGREE) tool. Grading systems were standardized to the American Society for Parenteral and Enteral Nutrition format and recommendations summarized based on grading and guideline quality. Nineteen guidelines were included. Rigor of development scores ranged from 29%-95%, with only 8 guidelines explicitly declaring the use of systematic methodology. Applicability scores were lowest, averaging 32%. Ten recommendation types were extracted and summarized. Strong and consistent evidence exists for the minimization of perioperative fasting, for a 2-hour preoperative fast after clear fluids, and for early recommencement of oral food and fluid intake postoperatively. This article presents several high-level recommendations ready for immediate implementation, while poorly graded and inconsistent recommendations reveal key areas for future research. Meanwhile, guideline quality requires improvement, especially regarding rigor of development and applicability, through systematic methodology, reporting transparency, and implementation strategies. © 2015 American Society for Parenteral and Enteral Nutrition.

Quality of Evidence-Based Guidelines for Transfusion of Red Blood Cells and Plasma: A Systematic Review.

PubMed

Pavenski, Katerina; Stanworth, Simon; Fung, Mark; Wood, Erica M; Pink, Joanne; Murphy, Michael F; Hume, Heather; Nahirniak, Susan; Webert, Kathryn E; Tanael, Susano; Landry, Denise; Shehata, Nadine

2018-06-01

Many transfusion guidelines are available, but little appraisal of their quality has been undertaken. The quality of guidelines may potentially influence adoption. Our aim was to determine the quality of evidence-based transfusion guidelines (EBG) for red cells and plasma, using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument, and assess duplication and consistency of recommendations. MEDLINE and EMBASE were systematically searched for EBG from 2005 to June 3, 2016. Citations were reviewed for inclusion in duplicate. A guideline was included if it had a specified clinical question, described a systematic search strategy, included critical appraisal of the literature and a description of how recommendations were developed. Four to six physicians used AGREE II to appraise each guideline. Median and scaled scores were calculated, with each item scored on a scale of one to seven, seven representing the highest score. Of 6174 citations, 30 guidelines met inclusion criteria. Twenty six guidelines had recommendations for red cells and 18 included recommendations for plasma use. The median score, the scaled score and the interquartile range of the scaled score were: scope and purpose: median score 5, scaled score 60%, IQR (49-74%); stakeholder involvement 4, 43%, (33-49%); rigor of development 4, 41%, (19-59%); clarity of presentation 5, 69%, (52-81%); applicability 1, 16%, (9-23%); editorial independence 3, 43%, (20-58%). Sixteen guidelines were evaluated to have a scaled domain score of 50% or less. Variations in recommendations were found for the use of hemoglobin triggers for red cell transfusion in patients with acute coronary syndromes and for plasma use for patients with bleeding. Our findings document, limited rigor in guideline development and duplication and inconsistencies in recommendations for the same topic. The process of developing guidelines for red cells and plasma transfusion can be enhanced to improve implementation. Copyright © 2018 Elsevier Inc. All rights reserved.

DOT report for implementing OMB's information dissemination quality guidelines

DOT National Transportation Integrated Search

2002-08-01

Consistent with The Office of : Management and Budgets (OMB) Guidelines (for Ensuring and Maximizing the Quality, : Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies) : implementing Section 515 of the Treasury and...

No. 292-Abnormal Uterine Bleeding in Pre-Menopausal Women.

PubMed

Singh, Sukhbir; Best, Carolyn; Dunn, Sheila; Leyland, Nicholas; Wolfman, Wendy Lynn

2018-05-01

Abnormal uterine bleeding is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for this problem during their reproductive years. This guideline replaces previous clinical guidelines on the topic and is aimed to enable health care providers with the tools to provide the latest evidence-based care in the diagnosis and the medical and surgical management of this common problem. To provide current evidence-based guidelines for the diagnosis and management of abnormal uterine bleeding (AUB) among women of reproductive age. Outcomes evaluated include the impact of AUB on quality of life and the results of interventions including medical and surgical management of AUB. Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of location in Canada, type of practice, subspecialty expertise, and general gynaecology background. The committee reviewed relevant evidence in the English medical literature including published guidelines. Recommendations were established as consensus statements. The final document was reviewed and approved by the Executive and Council of the SOGC. This document provides a summary of up-to-date evidence regarding diagnosis, investigations, and medical and surgical management of AUB. The resulting recommendations may be adapted by individual health care workers when serving women with this condition. Abnormal uterine bleeding is a common and sometimes debilitating condition in women of reproductive age. Standardization of related terminology, a systematic approach to diagnosis and investigation, and a step-wise approach to intervention is necessary. Treatment commencing with medical therapeutic modalities followed by the least invasive surgical modalities achieving results satisfactory to the patient is the ultimate goal of all therapeutic interventions. Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e. g., uterine hemorrhage, menorrhagia) and key words (e. g., menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology- related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered. RECOMMENDATIONS. Copyright © 2018. Published by Elsevier Inc.

Abnormal uterine bleeding in pre-menopausal women.

PubMed

Singh, Sukhbir; Best, Carolyn; Dunn, Sheila; Leyland, Nicholas; Wolfman, Wendy Lynn

2013-05-01

Abnormal uterine bleeding is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for this problem during their reproductive years. This guideline replaces previous clinical guidelines on the topic and is aimed to enable health care providers with the tools to provide the latest evidence-based care in the diagnosis and the medical and surgical management of this common problem. To provide current evidence-based guidelines for the diagnosis and management of abnormal uterine bleeding (AUB) among women of reproductive age. Outcomes evaluated include the impact of AUB on quality of life and the results of interventions including medical and surgical management of AUB. Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of location in Canada, type of practice, subspecialty expertise, and general gynaecology background. The committee reviewed relevant evidence in the English medical literature including published guidelines. Recommendations were established as consensus statements. The final document was reviewed and approved by the Executive and Council of the SOGC. This document provides a summary of up-to-date evidence regarding diagnosis, investigations, and medical and surgical management of AUB. The resulting recommendations may be adapted by individual health care workers when serving women with this condition. Abnormal uterine bleeding is a common and sometimes debilitating condition in women of reproductive age. Standardization of related terminology, a systematic approach to diagnosis and investigation, and a step-wise approach to intervention is necessary. Treatment commencing with medical therapeutic modalities followed by the least invasive surgical modalities achieving results satisfactory to the patient is the ultimate goal of all therapeutic interventions. Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e.g. uterine hemorrhage, menorrhagia) and key words (e.g. menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table). Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered.

Ottawa Panel Evidence-Based Clinical Practice Guidelines for Structured Physical Activity in the Management of Juvenile Idiopathic Arthritis.

PubMed

Cavallo, Sabrina; Brosseau, Lucie; Toupin-April, Karine; Wells, George A; Smith, Christine A; Pugh, Arlanna G; Stinson, Jennifer; Thomas, Roanne; Ahmed, Sara; Duffy, Ciarán M; Rahman, Prinon; Àlvarez-Gallardo, Inmaculada C; Loew, Laurianne; De Angelis, Gino; Feldman, Debbie Ehrmann; Majnemer, Annette; Gagnon, Isabelle J; Maltais, Désirée; Mathieu, Marie-Ève; Kenny, Glen P; Tupper, Susan; Whitney-Mahoney, Kristi; Bigford, Sarah

2017-05-01

To create guidelines focused on the use of structured physical activity (PA) in the management of juvenile idiopathic arthritis (JIA). A systematic literature search was conducted using the electronic databases Cochrane Central Register of Controlled Trials, MEDLINE (Ovid), EMBASE (Ovid), and Physiotherapy Evidence Database for all studies related to PA programs for JIA from January 1966 until December 2014, and was updated in May 2015. Study selection was completed independently by 2 reviewers. Studies were included if they involved individuals aged ≤21 years diagnosed with JIA who were taking part in therapeutic exercise or other PA interventions for which effects of various disease-related outcomes were compared with a control group (eg, no PA program or activity of lower intensity). Two reviewers independently extracted information on interventions, comparators, outcomes, time period, and study design. The statistical analysis was reported using the Cochrane Collaboration methods. The quality of the included studies was assessed according to the Physiotherapy Evidence Database Scale. Five randomized controlled trials (RCTs) fit the selection criteria; of these, 4 were high-quality RCTs. The following recommendations were developed: (1) Pilates for improving quality of life, pain, functional ability, and range of motion (ROM) (grade A); (2) home exercise program for improving quality of life and functional ability (grade A); (3) aquatic aerobic fitness for decreasing the number of active joints (grade A); and (4) and cardio-karate aerobic exercise for improving ROM and number of active joints (grade C+). The Ottawa Panel recommends the following structured exercises and physical activities for the management of JIA: Pilates, cardio-karate, home and aquatic exercises. Pilates showed improvement in a higher number of outcomes. Copyright © 2017. Published by Elsevier Inc.

Quality Assessment of Clinical Practice Guidelines Developed by Professional Societies in Turkey

PubMed Central

Yaşar, Ilknur; Kahveci, Rabia; Baydar Artantaş, Aylin; Ayhan Başer, Duygu; Gökşin Cihan, Fatma; Şencan, Irfan; Koç, Esra Meltem; Özkara, Adem

2016-01-01

Background Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. There is a limited number of studies on guidelines in Turkey. The quality of Ministry of Health guidelines have formerly been assessed whereas there is no information on the other guidelines developed in the country. Aim This study aims to assess the quality of CPGs that are developed by professional societies that work for the health sector in Turkey, and compare the findings with international guidelines. Methodology Professional societies that work for the health sector were determined by using the data obtained from the Ministry of Internal Affairs. Inclusion and exclusion criteria were defined for selecting the CPGs. Guidelines containing recommendations about disease management to the doctors, accessible online, developed within the past 5 years, citing references for recommendations, about the diseases over 1% prevalence according to the “Statistical Yearbook of Turkey 2012” were included in the study. The quality of CPGs were assessed with the AGREE II instrument, which is an internationally recognized tool for this purpose. Four independent reviewers, who did not participate in the development of the selected guidelines and were trained in CPG appraisal, used the AGREE instrument for assessment of the selected guidelines. Findings 47 professional societies were defined which provided access to CPGs in their websites; 3 of them were only open to members so these could not be reached. 8 CPGs from 7 societies were selected from a total of 401 CPGs from 44 societies. The mean scores of the domains of the guidelines which were assessed by the AGREE II tool were; Scope and purpose: 64%, stakeholder involvement: 37.9%, rigour of development: 35.3%, clarity and presentation: 77.9%, applicability: 49.0% and editorial independence: 46.0%. Conclusion This is the first study in Turkey regarding quality appraisal of guidelines developed by the local professional societies. It adds to the limited amount of information in the literature that comes from Turkey as well as other developing countries. PMID:27295303

Air quality management in China: issues, challenges, and options.

PubMed

Wang, Shuxiao; Hao, Jiming

2012-01-01

This article analyzed the control progress and current status of air quality, identified the major air pollution issues and challenges in future, proposed the long-term air pollution control targets, and suggested the options for better air quality in China. With the continuing growth of economy in the next 10-15 years, China will face a more severe situation of energy consumption, electricity generation and vehicle population leading to increase in multiple pollutant emissions. Controlling regional air pollution especially fine particles and ozone, as well as lowering carbon emissions from fossil fuel consumption will be a big challenge for the country. To protect public health and the eco-system, the ambient air quality in all Chinese cities shall attain the national ambient air quality standards (NAAQS) and ambient air quality guideline values set by the World Health Organization (WHO). To achieve the air quality targets, the emissions of SO2, NOx, PM10, and volatile organic compounds (VOC) should decrease by 60%, 40%, 50%, and 40%, respectively, on the basis of that in 2005. A comprehensive control policy focusing on multiple pollutants and emission sources at both the local and regional levels was proposed to mitigate the regional air pollution issue in China. The options include development of clean energy resources, promotion of clean and efficient coal use, enhancement of vehicle pollution control, implementation of synchronous control of multiple pollutants including SO2, NOx, VOC, and PM emissions, joint prevention and control of regional air pollution, and application of climate friendly air pollution control measures.

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.

A multifaceted feedback strategy alone does not improve the adherence to organizational guideline-based standards: a cluster randomized trial in intensive care.

PubMed

de Vos, Maartje L G; van der Veer, Sabine N; Wouterse, Bram; Graafmans, Wilco C; Peek, Niels; de Keizer, Nicolette F; Jager, Kitty J; Westert, Gert P; van der Voort, Peter H J

2015-07-08

Organizational data such as bed occupancy rate and nurse-to-patient ratio are related to clinical outcomes and to the efficient use of intensive care unit (ICU) resources. Standards for these performance indicators are provided in guidelines. We studied the effects of a multifaceted feedback strategy to improve the adherence to these standards. In a cluster randomized controlled study design the intervention ICUs received extensive monthly feedback reports, they received outreach visits and initiated a quality improvement team. The control ICUs received limited quarterly feedback reports only. We collected primary data prospectively within the setting of a Dutch national ICU registry over a 14-month study period. The target indicators were bed occupancy rate (aiming at 80 % or below) and nurse-to-patient ratio (aiming at 0.5 or higher). Data were collected per 8-h nursing shift. Logistic regression analysis was performed. For both study end points, the odds ratios (OR) for improvements at follow-up versus at baseline were calculated separately for control and intervention ICUs. We analyzed data on 67,237 nursing shifts. The bed occupancy rate did not improve in the intervention group compared to baseline (adjusted OR 0.88; 95 % confidence interval (CI), 0.62-1.27) or compared to control group (OR 0.67; 95 % CI 0.39-1.15). The nurse-to-patient ratio did not improve (OR 0.72; 95 % CI 0.41-1.26 compared to baseline and OR 0.65; 95 % CI 0.35-1.19 compared to control group). A multifaceted feedback intervention did not improve the adherence to guideline-based standards on the organizational issues bed occupancy rate and nurse-to-patient ratio in the ICU. The reasons may be a limited confidence in data quality, the lack of practical tools for improvement, and the relatively short follow-up. ISRCTN50542146.

A Critical Analysis of the INQAAHE Guidelines of Good Practice for Higher Education Quality Assurance Agencies

ERIC Educational Resources Information Center

Blackmur, Douglas

2008-01-01

The International Network of Quality Assurance Agencies in Higher Education's Guidelines of Good Practice by higher education quality assurance agencies need substantial revision before they can be considered adequate by stakeholders in any national higher education system. Various revisions are proposed in this article. But the International…

Development of Techniques and Data for Evaluating Ride Quality, Volume III : Guidelines for Development of Ride-Quality Models and Their Applications

DOT National Transportation Integrated Search

1978-02-01

Ride-quality models for city buses and intercity trains are presented and discussed in terms of their ability to predict passenger comfort and ride acceptability. The report, the last of three volumes, contains procedural guidelines to be employed by...

The governance of quality management in dutch health care: new developments and strategic challenges.

PubMed

Maarse, J A M; Ruwaard, D; Spreeuwenberg, C

2013-01-01

This article gives a brief sketch of quality management in Dutch health care. Our focus is upon the governance of guideline development and quality measurement. Governance is conceptualized as the structure and process of steering of quality management. The governance structure of guideline development in the Netherlands can be conceptualized as a network without central coordination. Much depends upon the self-initiative of stakeholders. A similar picture can be found in quality measurement. Special attention is given to the development of care standards for chronic disease. Care standards have a broader scope than guidelines and take an explicit patient perspective. They not only contain evidence-based and up-to-date guidelines for the care pathway but also contain standards for self-management. Furthermore, they comprise a set of indicators for measuring the quality of care of the entire pathway covered by the standard. The final part of the article discusses the mission, tasks and strategic challenges of the newly established National Health Care Institute (Zorginstituut Nederland), which is scheduled to be operative in 2013.

The Quality of Teaching Staff: Higher Education Institutions' Compliance with the European Standards and Guidelines for Quality Assurance--The Case of Portugal

ERIC Educational Resources Information Center

Cardoso, Sónia; Tavares, Orlanda; Sin, Cristina

2015-01-01

In recent years, initiatives for the improvement of teaching quality have been pursued both at European and national levels. Such is the case of the European Standards and Guidelines for Quality Assurance (ESG) and of legislation passed by several European countries, including Portugal, in response to European policy developments driven by the…

Impact of quality of evidence on the strength of recommendations: an empirical study

PubMed Central

Djulbegovic, Benjamin; Trikalinos, Thomas A; Roback, John; Chen, Ren; Guyatt, Gordon

2009-01-01

Background Evidence is necessary but not sufficient for decision-making, such as making recommendations by clinical practice guideline panels. However, the fundamental premise of evidence-based medicine (EBM) rests on the assumed link between the quality of evidence and "truth" and/or correctness in making guideline recommendations. If this assumption is accurate, then the quality of evidence ought to play a key role in making guideline recommendations. Surprisingly, and despite the widespread penetration of EBM in health care, there has been no empirical research to date investigating the impact of quality of evidence on the strength of recommendations made by guidelines panels. Methods The American Association of Blood Banking (AABB) has recently convened a 12 member panel to develop clinical practice guidelines (CPG) for the use of fresh-frozen plasma (FFP) for 6 different clinical indications. The panel was instructed that 4 factors should play a role in making recommendation: quality of evidence, uncertainty about the balance between desirable (benefits) and undesirable effects (harms), uncertainty or variability in values and preferences, and uncertainty about whether the intervention represents a wise use of resources (costs). Each member of the panel was asked to make his/her final judgments on the strength of recommendation and the overall quality of the body of evidence. "Voting" was anonymous and was based on the use of GRADE (Grading quality of evidence and strength of recommendations) system, which clearly distinguishes between quality of evidence and strength of recommendations. Results Despite the fact that many factors play role in formulating CPG recommendations, we show that when the quality of evidence is higher, the probability of making a strong recommendation for or against an intervention dramatically increases. Probability of making strong recommendation was 62% when evidence is "moderate", while it was only 23% and 13% when evidence was "low" or "very low", respectively. Conclusion We report the first empirical evaluation of the relationship between quality of evidence pertinent to a clinical question and strength of the corresponding guideline recommendations. Understanding the relationship between quality of evidence and probability of making (strong) recommendation has profound implications for the science of quality measurement in health care. PMID:19622148

Advanced lighting guidelines: 1993. Final report

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

Eley, C.; Tolen, T.M.; Benya, J.R.

1993-12-31

The 1993 Advanced Lighting Guidelines document consists of twelve guidelines that provide an overview of specific lighting technologies and design application techniques utilizing energy-efficient lighting practice. Lighting Design Practice assesses energy-efficient lighting strategies, discusses lighting issues, and explains how to obtain quality lighting design and consulting services. Luminaires and Lighting Systems surveys luminaire equipment designed to take advantage of advanced technology lamp products and includes performance tables that allow for accurate estimation of luminaire light output and power input. The additional ten guidelines -- Computer-Aided Lighting Design, Energy-Efficient Fluorescent Ballasts, Full-Size Fluorescent Lamps, Compact Fluorescent Lamps, Tungsten-Halogen Lamps, Metal Halidemore » and HPS Lamps, Daylighting and Lumen Maintenance, Occupant Sensors, Time Scheduling Systems, and Retrofit Control Technologies -- each provide a product technology overview, discuss current products on the lighting equipment market, and provide application techniques. This document is intended for use by electric utility personnel involved in lighting programs, lighting designers, electrical engineers, architects, lighting manufacturers` representatives, and other lighting professionals.« less

Application of industry-standard guidelines for the validation of avionics software

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J.; Shagnea, Anita M.

1990-01-01

The application of industry standards to the development of avionics software is discussed, focusing on verification and validation activities. It is pointed out that the procedures that guide the avionics software development and testing process are under increased scrutiny. The DO-178A guidelines, Software Considerations in Airborne Systems and Equipment Certification, are used by the FAA for certifying avionics software. To investigate the effectiveness of the DO-178A guidelines for improving the quality of avionics software, guidance and control software (GCS) is being developed according to the DO-178A development method. It is noted that, due to the extent of the data collection and configuration management procedures, any phase in the life cycle of a GCS implementation can be reconstructed. Hence, a fundamental development and testing platform has been established that is suitable for investigating the adequacy of various software development processes. In particular, the overall effectiveness and efficiency of the development method recommended by the DO-178A guidelines are being closely examined.

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

PubMed Central

Huang, Hongyun; Young, Wise; Chen, Lin; Feng, Shiqing; Zoubi, Ziad M. Al; Sharma, Hari Shanker; Saberi, Hooshang; Moviglia, Gustavo A.; He, Xijing; Muresanu, Dafin F.; Sharma, Alok; Otom, Ali; Andrews, Russell J.; Al-Zoubi, Adeeb; Bryukhovetskiy, Andrey S.; Chernykh, Elena R.; Domańska-Janik, Krystyna; Jafar, Emad; Johnson, W. Eustace; Li, Ying; Li, Daqing; Luan, Zuo; Mao, Gengsheng; Shetty, Ashok K.; Siniscalco, Dario; Skaper, Stephen; Sun, Tiansheng; Wang, Yunliang; Wiklund, Lars; Xue, Qun; You, Si-Wei; Zheng, Zuncheng; Dimitrijevic, Milan R.; Masri, W. S. El; Sanberg, Paul R.; Xu, Qunyuan; Luan, Guoming; Chopp, Michael; Cho, Kyoung-Suok; Zhou, Xin-Fu; Wu, Ping; Liu, Kai; Mobasheri, Hamid; Ohtori, Seiji; Tanaka, Hiroyuki; Han, Fabin; Feng, Yaping; Zhang, Shaocheng; Lu, Yingjie; Zhang, Zhicheng; Rao, Yaojian; Tang, Zhouping; Xi, Haitao; Wu, Liang; Shen, Shunji; Xue, Mengzhou; Xiang, Guanghong; Guo, Xiaoling; Yang, Xiaofeng; Hao, Yujun; Hu, Yong; Li, Jinfeng; AO, Qiang; Wang, Bin; Zhang, Zhiwen; Lu, Ming; Li, Tong

2018-01-01

Cell therapy has been shown to be a key clinical therapeutic option for central nervous system diseases or damage. Standardization of clinical cell therapy procedures is an important task for professional associations devoted to cell therapy. The Chinese Branch of the International Association of Neurorestoratology (IANR) completed the first set of guidelines governing the clinical application of neurorestoration in 2011. The IANR and the Chinese Association of Neurorestoratology (CANR) collaborated to propose the current version “Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)”. The IANR council board members and CANR committee members approved this proposal on September 1, 2016, and recommend it to clinical practitioners of cellular therapy. These guidelines include items of cell type nomenclature, cell quality control, minimal suggested cell doses, patient-informed consent, indications for undergoing cell therapy, contraindications for undergoing cell therapy, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, do not charge patients for unproven therapies, basic principles of cell therapy, and publishing responsibility. PMID:29637817

[The NHG guidelines 'Adult asthma' and 'COPD'].

PubMed

Geijer, Roeland M M; Tuut, Mariska K; in't Veen, Johannes C C M; Broekhuizen, Berna D L; Chavannes, Niels H; Smeele, Ivo J M

2015-01-01

The Dutch College of General Practitioners (NHG) guidelines 'Adult asthma' and 'COPD' have been revised. New spirometry reference values from the Global Lung Function Initiative are recommended. Airway obstruction is defined as a FEV1/FVC ratio below the 5th percentile for the reference population. Spirometry for diagnosis takes place without use of patients' inhaled medication and consists of measurements before and after standardized bronchodilation. In monitoring spirometry, patients continue using inhaled medication and standardized bronchodilation is not indicated. The goal of asthma management is optimal asthma control, tailored to individual goals. The most important non-drug intervention in asthma and COPD is to recommend stopping smoking. The goal of COPD management is to limit symptoms, improve exercise capacity and quality of life, and reduce the burden of disease. Inhaled corticosteroids are usually not indicated in COPD treatment. Patients with comorbid asthma and COPD are treated with non-drug interventions according to the COPD guideline and with medication according to the asthma guideline.

[General Strategies for Implementation of Clinical Practice Guidelines].

PubMed

Valenzuela-Flores, Adriana Abigail; Viniegra-Osorio, Arturo; Torres-Arreola, Laura Laura

2015-01-01

The need to use clinical practice guidelines (CPG) arises from the health conditions and problems that public health institutions in the country face. CPG are informative documents that help improve the quality of care processes and patient safety; having among its objectives, to reduce the variability of medical practice. The Instituto Mexicano del Seguro Social designed a strategic plan for the dissemination, implementation, monitoring and control of CPG to establish an applicable model in the medical units in the three levels of care at the Instituto. This paper summarizes some of the strategies of the plan that were made with the knowledge and experience of clinicians and managers, with which they intend to promote the adoption of the key recommendations of the guidelines, to promote a sense of belonging for health personnel, and to encourage changes in organizational culture.

Quality Primary Care and Family Planning Services for LGBT Clients: A Comprehensive Review of Clinical Guidelines.

PubMed

Klein, David A; Malcolm, Nikita M; Berry-Bibee, Erin N; Paradise, Scott L; Coulter, Jessica S; Keglovitz Baker, Kristin; Schvey, Natasha A; Rollison, Julia M; Frederiksen, Brittni N

2018-04-01

LGBT clients have unique healthcare needs but experience a wide range of quality in the care that they receive. This study provides a summary of clinical guideline recommendations related to the provision of primary care and family planning services for LGBT clients. In addition, we identify gaps in current guidelines, and inform future recommendations and guidance for clinical practice and research. PubMed, Cochrane, and Agency for Healthcare Research and Quality electronic bibliographic databases, and relevant professional organizations' websites, were searched to identify clinical guidelines related to the provision of primary care and family planning services for LGBT clients. Information obtained from a technical expert panel was used to inform the review. Clinical guidelines meeting the inclusion criteria were assessed to determine their alignment with Institute of Medicine (IOM) standards for the development of clinical practice guidelines and content relevant to the identified themes. The search parameters identified 2,006 clinical practice guidelines. Seventeen clinical guidelines met the inclusion criteria. Two of the guidelines met all eight IOM criteria. However, many recommendations were consistent regarding provision of services to LGBT clients within the following themes: clinic environment, provider cultural sensitivity and awareness, communication, confidentiality, coordination of care, general clinical principles, mental health considerations, and reproductive health. Guidelines for the primary and family planning care of LGBT clients are evolving. The themes identified in this review may guide professional organizations during guideline development, clinicians when providing care, and researchers conducting LGBT-related studies.

Choosing Wisely: assessment of current US top five list recommendations’ trustworthiness using a pragmatic approach

PubMed Central

Horvath, Karl; Semlitsch, Thomas; Jeitler, Klaus; Abuzahra, Muna E; Posch, Nicole; Domke, Andreas; Siebenhofer, Andrea

2016-01-01

Objectives Identification of sufficiently trustworthy top 5 list recommendations from the US Choosing Wisely campaign. Setting Not applicable. Participants All top 5 list recommendations available from the American Board of Internal Medicine Foundation website. Main outcome measures/interventions Compilation of US top 5 lists and search for current German highly trustworthy (S3) guidelines. Extraction of guideline recommendations, including grade of recommendation (GoR), for suggestions comparable to top 5 list recommendations. For recommendations without guideline equivalents, the methodological quality of the top 5 list development process was assessed using criteria similar to that used to judge guidelines, and relevant meta-literature was identified in cited references. Judgement of sufficient trustworthiness of top 5 list recommendations was based either on an ‘A’ GoR of guideline equivalents or on high methodological quality and citation of relevant meta-literature. Results 412 top 5 list recommendations were identified. For 75 (18%), equivalents were found in current German S3 guidelines. 44 of these recommendations were associated with an ‘A’ GoR, or a strong recommendation based on strong evidence, and 26 had a ‘B’ or a ‘C’ GoR. No GoR was provided for 5 recommendations. 337 recommendations had no equivalent in the German S3 guidelines. The methodological quality of the development process was high and relevant meta-literature was cited for 87 top 5 list recommendations. For a further 36, either the methodological quality was high without any meta-literature citations or meta-literature citations existed but the methodological quality was lacking. For the remaining 214 recommendations, either the methodological quality was lacking and no literature was cited or the methodological quality was generally unsatisfactory. Conclusions 131 of current US top 5 list recommendations were found to be sufficiently trustworthy. For a substantial number of current US top 5 list recommendations, their trustworthiness remains unclear. Methodological requirements for developing top 5 lists are recommended. PMID:27855098

Adherence of hip and knee arthroplasty studies to RSA standardization guidelines

PubMed Central

Mäkinen, Tatu J; Aro, Hannu T; Bragdon, Charles; Malchau, Henrik

2014-01-01

Background and purpose Guidelines for standardization of radiostereometry (RSA) of implants were published in 2005 to facilitate comparison of outcomes between various research groups. In this systematic review, we determined how well studies have adhered to these guidelines. Methods We carried out a literature search to identify all articles published between January 2000 and December 2011 that used RSA in the evaluation of hip or knee prosthesis migration. 2 investigators independently evaluated each of the studies for adherence to the 13 individual guideline items. Since some of the 13 points included more than 1 criterion, studies were assessed on whether each point was fully met, partially met, or not met. Results 153 studies that met our inclusion criteria were identified. 61 of these were published before the guidelines were introduced (2000–2005) and 92 after the guidelines were introduced (2006–2011). The methodological quality of RSA studies clearly improved from 2000 to 2011. None of the studies fully met all 13 guidelines. Nearly half (43) of the studies published after the guidelines demonstrated a high methodological quality and adhered at least partially to 10 of the 13 guidelines, whereas less than one-fifth (11) of the studies published before the guidelines had the same methodological quality. Commonly unaddressed guideline items were related to imaging methodology, determination of precision from double examinations, and also mean error of rigid-body fitting and condition number cutoff levels. Interpretation The guidelines have improved methodological reporting in RSA studies, but adherence to these guidelines is still relatively low. There is a need to update and clarify the guidelines for clinical hip and knee arthroplasty RSA studies. PMID:24954489

A new impetus for guideline development and implementation: construction and evaluation of a toolbox.

PubMed

Hilbink, Mirrian A H W; Ouwens, Marielle M T J; Burgers, Jako S; Kool, Rudolf B

2014-03-19

In the last decade, guideline organizations faced a number of problems, including a lack of standardization in guideline development methods and suboptimal guideline implementation. To contribute to the solution of these problems, we produced a toolbox for guideline development, implementation, revision, and evaluation. All relevant guideline organizations in the Netherlands were approached to prioritize the topics. We sent out a questionnaire and discussed the results at an invitational conference. Based on consensus, twelve topics were selected for the development of new tools. Subsequently, working groups were composed for the development of the tools. After development of the tools, their draft versions were pilot tested in 40 guideline projects. Based on the results of the pilot tests, the tools were refined and their final versions were presented. The vast majority of organizations involved in pilot testing of the tools reported satisfaction with using the tools. Guideline experts involved in pilot testing of the tools proposed a variety of suggestions for the implementation of the tools. The tools are available in Dutch and in English at a web-based platform on guideline development and implementation (http://www.ha-ring.nl). A collaborative approach was used for the development and evaluation of a toolbox for development, implementation, revision, and evaluation of guidelines. This approach yielded a potentially powerful toolbox for improving the quality and implementation of Dutch clinical guidelines. Collaboration between guideline organizations within this project led to stronger linkages, which is useful for enhancing coordination of guideline development and implementation and preventing duplication of efforts. Use of the toolbox could improve quality standards in the Netherlands, and might facilitate the development of high-quality guidelines in other countries as well.

Advancing infection control in dental care settings

PubMed Central

Cleveland, Jennifer L.; Bonito, Arthur J.; Corley, Tammy J.; Foster, Misty; Barker, Laurie; Brown, G. Gordon; Lenfestey, Nancy; Lux, Linda

2015-01-01

Background and Overview The authors set out to identify factors associated with implementation by U.S. dentists of four practices first recommended in the Centers for Disease Control and Prevention’s Guidelines for Infection Control in Dental Health-Care Settings—2003. Methods In 2008, the authors surveyed a stratified random sample of 6,825 U.S. dentists. The response rate was 49 percent. The authors gathered data regarding dentists’ demographic and practice characteristics, attitudes toward infection control, sources of instruction regarding the guidelines and knowledge about the need to use sterile water for surgical procedures. Then they assessed the impact of those factors on the implementation of four recommendations: having an infection control coordinator, maintaining dental unit water quality, documenting percutaneous injuries and using safer medical devices, such as safer syringes and scalpels. The authors conducted bivariate analyses and proportional odds modeling. Results Responding dentists in 34 percent of practices had implemented none or one of the four recommendations, 40 percent had implemented two of the recommendations and 26 percent had implemented three or four of the recommendations. The likelihood of implementation was higher among dentists who acknowledged the importance of infection control, had practiced dentistry for less than 30 years, had received more continuing dental education credits in infection control, correctly identified more surgical procedures that require the use of sterile water, worked in larger practices and had at least three sources of instruction regarding the guidelines. Dentists with practices in the South Atlantic, Middle Atlantic or East South Central U.S. Census divisions were less likely to have complied. Conclusions Implementation of the four recommendations varied among U.S. dentists. Strategies targeted at raising awareness of the importance of infection control, increasing continuing education requirements and developing multiple modes of instruction may increase implementation of current and future Centers for Disease Control and Prevention guidelines. PMID:23024311

[Blood transfusion audit methodology: the auditors, reference systems and audit guidelines].

PubMed

Chevrolle, F; Hadzlik, E; Arnold, J; Hergon, E

2000-12-01

The audit has become an essential aspect of the blood transfusion sector, and is a management tool that should be used judiciously. The main types of audit that can be envisaged in blood transfusion are the following: operational audit concerning a predetermined activity; systems quality audit; competence audit, combining the operational audit on a specific activity with quality management, e.g., laboratory accreditation; audit of the environmental management system; and social audit involving the organization of an activity and the management of human resources. However, the main type of audit considered in this article is the conformity audit, which in this context does not refer to internal control but to conformity with an internal guideline issued by the French National Blood Service. All audits are carried out on the basis of a predescribed method (contained in ISO 10 011). The audit is a system of investigation, evaluation and measurement, and also a means of continuous assessment and therefore improvement. The audit is based on set guidelines, but in fact consists of determining the difference between the directions given and what has actually been done. Auditing requires operational rigor and integrity, and has now become a profession in its own right.

Guidelines for reporting quantitative mass spectrometry based experiments in proteomics.

PubMed

Martínez-Bartolomé, Salvador; Deutsch, Eric W; Binz, Pierre-Alain; Jones, Andrew R; Eisenacher, Martin; Mayer, Gerhard; Campos, Alex; Canals, Francesc; Bech-Serra, Joan-Josep; Carrascal, Montserrat; Gay, Marina; Paradela, Alberto; Navajas, Rosana; Marcilla, Miguel; Hernáez, María Luisa; Gutiérrez-Blázquez, María Dolores; Velarde, Luis Felipe Clemente; Aloria, Kerman; Beaskoetxea, Jabier; Medina-Aunon, J Alberto; Albar, Juan P

2013-12-16

Mass spectrometry is already a well-established protein identification tool and recent methodological and technological developments have also made possible the extraction of quantitative data of protein abundance in large-scale studies. Several strategies for absolute and relative quantitative proteomics and the statistical assessment of quantifications are possible, each having specific measurements and therefore, different data analysis workflows. The guidelines for Mass Spectrometry Quantification allow the description of a wide range of quantitative approaches, including labeled and label-free techniques and also targeted approaches such as Selected Reaction Monitoring (SRM). The HUPO Proteomics Standards Initiative (HUPO-PSI) has invested considerable efforts to improve the standardization of proteomics data handling, representation and sharing through the development of data standards, reporting guidelines, controlled vocabularies and tooling. In this manuscript, we describe a key output from the HUPO-PSI-namely the MIAPE Quant guidelines, which have developed in parallel with the corresponding data exchange format mzQuantML [1]. The MIAPE Quant guidelines describe the HUPO-PSI proposal concerning the minimum information to be reported when a quantitative data set, derived from mass spectrometry (MS), is submitted to a database or as supplementary information to a journal. The guidelines have been developed with input from a broad spectrum of stakeholders in the proteomics field to represent a true consensus view of the most important data types and metadata, required for a quantitative experiment to be analyzed critically or a data analysis pipeline to be reproduced. It is anticipated that they will influence or be directly adopted as part of journal guidelines for publication and by public proteomics databases and thus may have an impact on proteomics laboratories across the world. This article is part of a Special Issue entitled: Standardization and Quality Control. Copyright © 2013 Elsevier B.V. All rights reserved.

Volume and methodological quality of randomized controlled trials in laparoscopic surgery: assessment over a 10-year period.

PubMed

Antoniou, Stavros A; Andreou, Alexandros; Antoniou, George A; Koch, Oliver O; Köhler, Gernot; Luketina, Ruzica-R; Bertsias, Antonios; Pointner, Rudolph; Granderath, Frank-Alexander

2015-11-01

Measures have been taken to improve methodological quality of randomized controlled trials (RCTs). This review systematically assessed the trends in volume and methodological quality of RCTs on minimally invasive surgery within a 10-year period. RCTs on minimally invasive surgery were searched in the 10 most cited general surgical journals and the 5 most cited journals of laparoscopic interest for the years 2002 and 2012. Bibliometric and methodological quality components were abstracted using the Scottish Intercollegiate Guidelines Network. The pooled number of RCTs from low-contribution regions demonstrated an increasing proportion of the total published RCTs, compensating for a concomitant decrease of the respective contributions from Europe and North America. International collaborations were more frequent in 2012. Acceptable or high quality RCTs accounted for 37.9% and 54.4% of RCTs published in 2002 and 2012, respectively. Components of external validity were poorly reported. Both the volume and the reporting quality of laparoscopic RCTs have increased from 2002 to 2012, but there seems to be ample room for improvement of methodological quality. Copyright © 2015 Elsevier Inc. All rights reserved.

EAACI Food Allergy and Anaphylaxis Guidelines. Food allergy health-related quality of life measures.

PubMed

Muraro, A; Dubois, A E J; DunnGalvin, A; Hourihane, J O'B; de Jong, N W; Meyer, R; Panesar, S S; Roberts, G; Salvilla, S; Sheikh, A; Worth, A; Flokstra-de Blok, B M J

2014-07-01

Instruments have been developed and validated for the measurement of health-related quality of life in patients with food allergy. This guideline has been prepared by the European Academy of Allergy and Clinical Immunology's (EAACI) Guidelines for Food Allergy and Anaphylaxis Group. It draws on a systematic review of the literature on quality of life instruments for food allergy and the Appraisal of Guidelines for Research & Evaluation (AGREE II) guideline development process. Guidance is provided on the use of such instruments in research, and the current limitations of their use in clinical practice are described. Gaps in current knowledge as well as areas of future interest are also discussed. This document is relevant to healthcare workers dealing with food-allergic patients, scientists engaging in food allergy research and policy makers involved in regulatory aspects concerning food allergy and safety. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Guidelines for establishing and maintaining construction quality databases.

DOT National Transportation Integrated Search

2006-11-01

The main objective of this study was to develop and present guidelines for State highway agencies (SHAs) in establishing and maintaining database systems geared towards construction quality issues for asphalt and concrete paving projects. To accompli...

Design of the Balance@Work project: systematic development, evaluation and implementation of an occupational health guideline aimed at the prevention of weight gain among employees.

PubMed

Verweij, Lisanne M; Proper, Karin I; Weel, Andre N H; Hulshof, Carel T J; van Mechelen, Willem

2009-12-14

Occupational health professionals may play an important role in preventive health promotion activities for employees. However, due to a lack of knowledge and evidence- and practice based methods and strategies, interventions are hardly being implemented by occupational physicians to date. The aim of the Balance@Work project is to develop, evaluate, and implement an occupational health guideline aimed at the prevention of weight gain among employees. Following the guideline development protocol of the Netherlands Society of Occupational Medicine and the Intervention Mapping protocol, the guideline was developed based on literature, interviews with relevant stakeholders, and consensus among an expert group. The guideline consists of an individual and an environmental component. The individual component includes recommendations for occupational physicians on how to promote physical activity and healthy dietary behavior based on principles of motivational interviewing. The environmental component contains an obesogenic environment assessment tool. The guideline is evaluated in a randomised controlled trial among 20 occupational physicians. Occupational physicians in the intervention group apply the guideline to eligible workers during 6 months. Occupational physicians in the control group provide care as usual. Measurements take place at baseline and 6, 12, and 18 months thereafter. Primary outcome measures include waist circumference, daily physical activity and dietary behavior. Secondary outcome measures include sedentary behavior, determinants of behavior change, body weight and body mass index, cardiovascular disease risk profile, and quality of life. Additionally, productivity, absenteeism, and cost-effectiveness are assessed. Improving workers' daily physical activity and dietary behavior may prevent weight gain and subsequently improve workers' health, increase productivity, and reduce absenteeism. After an effect- and process evaluation the guideline will be adjusted and, after authorisation, published. Together with several implementation aids, the published guideline will be disseminated broadly by the Netherlands Society of Occupational Medicine. ISRCTN73545254/NTR1190.

Design of the Balance@Work project: systematic development, evaluation and implementation of an occupational health guideline aimed at the prevention of weight gain among employees

PubMed Central

2009-01-01

Background Occupational health professionals may play an important role in preventive health promotion activities for employees. However, due to a lack of knowledge and evidence- and practice based methods and strategies, interventions are hardly being implemented by occupational physicians to date. The aim of the Balance@Work project is to develop, evaluate, and implement an occupational health guideline aimed at the prevention of weight gain among employees. Methods Following the guideline development protocol of the Netherlands Society of Occupational Medicine and the Intervention Mapping protocol, the guideline was developed based on literature, interviews with relevant stakeholders, and consensus among an expert group. The guideline consists of an individual and an environmental component. The individual component includes recommendations for occupational physicians on how to promote physical activity and healthy dietary behavior based on principles of motivational interviewing. The environmental component contains an obesogenic environment assessment tool. The guideline is evaluated in a randomised controlled trial among 20 occupational physicians. Occupational physicians in the intervention group apply the guideline to eligible workers during 6 months. Occupational physicians in the control group provide care as usual. Measurements take place at baseline and 6, 12, and 18 months thereafter. Primary outcome measures include waist circumference, daily physical activity and dietary behavior. Secondary outcome measures include sedentary behavior, determinants of behavior change, body weight and body mass index, cardiovascular disease risk profile, and quality of life. Additionally, productivity, absenteeism, and cost-effectiveness are assessed. Discussion Improving workers' daily physical activity and dietary behavior may prevent weight gain and subsequently improve workers' health, increase productivity, and reduce absenteeism. After an effect- and process evaluation the guideline will be adjusted and, after authorisation, published. Together with several implementation aids, the published guideline will be disseminated broadly by the Netherlands Society of Occupational Medicine. Trial Registration ISRCTN73545254/NTR1190 PMID:20003405

Guideline for dialysate quality of Spanish Society of Nephrology (second edition, 2015).

PubMed

Pérez-García, Rafael; García Maset, Rafael; Gonzalez Parra, Emilio; Solozábal Campos, Carlos; Ramírez Chamond, Rafael; Martín-Rabadán, Pablo; Sobrino Pérez, Pedro Enrique; Gallego Pereira, Ovidio; Dominguez, Jon; de la Cueva Matute, Enrique; Ferllen, Ricardo

2016-01-01

A Best Practice Guideline about Dialysis fluid purity was developed under the leadership of the Spanish Society of Nephrology in 2004. The second edition revised Guideline considered new evidences and International Standard. The Guideline has established recommendations for standards for preparing dialysate: water, concentrates and hemodialysis proportioning systems. This Guideline is based on the ISO13959, European Pharmacopoeia, the Real Farmacopea Española, the AAMI Standards and Recommended Practices, European Best Practice Guidelines for Haemodialysis, literature reviews, according to their level of evidence, and the opinion of the expert Spanish group. Two levels of quality of water were defined: purified water and high purified water (ultra pure) and for dialysate: ultra pure dialysate. Regular use of ultra pure dialysate is recommended for all type of hemodialysis to prevent and delay the occurrence of complications: inflammation, malnutrition, anaemia and amiloidosis. Water, concentrates and dialysate quality requirements are defined as maximum allowable contaminant levels: chemicals (4.1.2), conductivity, microbial and endotoxins (4.1.1): Monitoring frequency, maintenance and corrective actions were specified. Methods of sampling and analysis were described in appendix (anexos). For microbiological monitoring, R2A medium is recommended, incubated during 7-14 days at a temperature of 17-23°C. The dialysate quality assurance process involves all dialysis staff members and requires strict protocols. The physician in charge of hemodialysis has the ultimate responsibility for dialysate quality. All suggestions and questions about this Guideline are wellcome to www.senefro.org. Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

Adherence to National Dietary Guidelines in Association with Oral Health Impact on Quality of Life.

PubMed

Andreeva, Valentina A; Kesse-Guyot, Emmanuelle; Galan, Pilar; Feron, Gilles; Hercberg, Serge; Hennequin, Martine; Sulmont-Rossé, Claire

2018-04-24

We aimed to assess the association between oral health, in terms of its impact on quality of life, and diet quality expressed as adherence to dietary guidelines. We analyzed cross-sectional data from the French NutriNet-Santé general population-based e-cohort (N = 18,263 adults; mean age = 56.5 ± 13.8 years). The main independent variable, oral health-related quality of life, was assessed in 2016 with the GOHAI instrument (maximum score = 60). The main dependent variable, diet’s nutritional quality, was assessed with the mPNNS-GS score (maximum score = 13.5) measuring adherence to French dietary guidelines and computed on the basis of repeated 24-h dietary records. Multivariable linear regression models were fit. Mean GOHAI score was 54.5 ± 4.3 and mean mPNNS-GS score was 7.7 ± 1.6. Among participants aged 18⁻64 years, those scoring ≤50 on GOHAI (poor oral health with a detrimental impact on quality of life) were less likely to adhere to dietary guidelines than participants scoring 57⁻60 points (good oral health) (beta = −0.18, 95% CI: −0.26, −0.09; p < 0.0001). Among participants aged 65+ years, those scoring 51⁻56 points on GOHAI (average oral health with some negative impact on quality of life) were less likely to adhere to dietary guidelines than were participants scoring in the range 57⁻60 (beta = −0.23, 95% CI: −0.33, −0.13; p < 0.0001). The findings suggested modest age-dependent associations between oral health-related quality of life and diet quality. Confirmation is needed longitudinally with representative samples and accounting for diet quality evolution.

Production and quality of clinical practice guidelines in Argentina (1994–2004): a cross-sectional study

PubMed Central

Esandi, María Eugenia; Ortiz, Zulma; Chapman, Evelina; Dieguez, Marcelo García; Mejía, Raúl; Bernztein, Ricardo

2008-01-01

Background In the last decades, a sustained increment of Clinical Practice Guidelines (CPG) production in the world has been accompanied by a growing concern about their quality. Many studies related to quality assessment of guidelines produced in High Income Countries were published; however, evidence on this topic is scarce in Low and Middle Income Countries (LMIC). The objectives of this research were: a) to describe guideline production in Argentina at different levels of the health system (macro, meso and micro) from 1994 to 2004; and b) to assess their quality by using the AGREE instrument. Methods A cross-sectional study was undertaken to describe guidelines production in Argentina between 1994 and 2004. CPG were identified through Internet and electronic databases (MEDLINE and LILACS). Explicit inclusion and exclusion criteria were used to select guidelines. Each CPG was independently assessed by two reviewers using the AGREE instrument. Domain scores were calculated as recommended by the AGREE Collaboration. The internal consistency of each domain was evaluated using Cronbach's alpha and inter-observer agreement by the Intraclass Correlation Coefficient (ICC). Results A total amount of 431 potential CPG were identified, but only 144 were considered CPG. At the end, 101 CPG were included for further assessment. Median standardized score for each domain were: scope = 39%; stakeholder involvement = 13%; rigour of development = 10%; clarity = 42%; applicability = 6%; editorial independence = 0%. Only 22 CPG were recommended with modifications by both appraisers. ICC and Cronbach's alpha for each domain were in all cases moderate or high (greater than 0.40), except for editorial independence. Conclusion This study has systematically employed the AGREE instrument for the critical assessment of guidelines produced in a LMIC. Guideline development and diffusion in Argentina from 1994 to 2004 shows a constant increment, although quality of reporting did not improve; moreover, in some aspects it seemed to decline. Much room for improvement of the guideline development process was found at all levels of the health system. PMID:18851739

Impact of imaging guidelines on X-ray use among American provider network chiropractors: interrupted time series analysis.

PubMed

Bussières, André E; Sales, Anne E; Ramsay, Timothy; Hilles, Steven M; Grimshaw, Jeremy M

2014-08-01

Overuse and misuse of spine X-ray imaging for nonspecific back and neck pain persists among chiropractors. Distribution of educational materials among physicians results in small-to-modest improvements in appropriate care, such as ordering spine X-ray studies, but little is known about its impact among North American chiropractors. To evaluate the impact of web-based dissemination of a diagnostic imaging guideline on the use of spine X-ray images among chiropractors. Quasi-experimental design that used interrupted time series to evaluate the effect of guidelines dissemination on spine X-ray imaging claims by chiropractors enlisted in managed care network in the United States. Consecutive adult patients consulting for complaints of spine disorders. A change in level (the mean number of spine X-ray imaging claims per month immediately after the introduction of the guidelines), change in trend (any differences between preintervention and postintervention slopes), estimation of monthly average intervention effect after the intervention. The imaging guideline was disseminated online in April 2008. Administrative claims data were extracted between January 2006 and December 2010. Segmented regression analysis with autoregressive error was used to estimate the impact of guideline recommendations on the rate of spine X-ray studies. Sensitivity analysis considered the effect of two additional quality improvement strategies, a policy change and an education intervention. Time series analysis revealed a significant change in the level of spine X-ray study ordering weeks after introduction of the guidelines (-0.01; 95% confidence interval=-0.01, -0.002; p=.01), but no change in trend of the regression lines. The monthly mean rate of spine X-ray studies within 5 days of initial visit per new patient exams decreased by 10 per 1000, a 5.26% relative decrease after guideline dissemination. Controlling for two quality improvement strategies did not change the results. Web-based guideline dissemination was associated with an immediate reduction in spine X-ray imaging claims. Sensitivity analysis suggests our results are robust. This passive strategy is likely cost-effective in a chiropractic network setting. Copyright © 2014 Elsevier Inc. All rights reserved.

Ethical issues of cost effectiveness analysis and guideline setting in mental health care.

PubMed

Berghmans, R; Berg, M; van den Burg, M; ter Meulen, R

2004-04-01

This article discusses ethical issues which are raised as a result of the introduction of economic evidence in mental health care in order to rationalise clinical practice. Cost effectiveness studies and guidelines based on such studies are often seen as impartial, neutral instruments which try to reduce the influence of non-scientific factors. However, such rationalising instruments often hide normative assumptions about the goals of treatment, the selection of treatments, the role of the patient, and the just distribution of scarce resources. These issues are dealt with in the context of increased control over clinical practice by third parties. In particular, health insurers have a great interest in economic evidence in clinical care settings in order to control access to and quality of (mental) health care. The authors conclude that guideline setting and cost effectiveness analysis may be seen as important instruments for making choices in health care, including mental health care, but that such an approach should always go hand in hand with a social and political debate about the goals of medicine and (mental) health care. This article is partly based on the results of a research project on the normative aspects of guideline setting in psychiatry and cardiology which was conducted under the guidance of the Royal Dutch Medical Association.

Critical attitudes and beliefs towards guidelines amongst palliative care professionals - results from a national survey.

PubMed

Kalies, Helen; Schöttmer, Rieke; Simon, Steffen T; Voltz, Raymond; Crispin, Alexander; Bausewein, Claudia

2017-03-21

Little is known about palliative care professionals' attitudes towards guidelines. In 2015, the German Association for Palliative Medicine (DGP) published an evidence based guideline for palliative care in adults with incurable cancer. Before publication we conducted a national survey among members of the DGP to detect possible barriers and facilitators for its implementation. The aim of the present publication was to evaluate critical attitudes and beliefs which could hinder the effective implementation of the new guideline and to evaluate differences within professional groups and medical specialisations. This web-based online survey was addressed to all members of the DGP in summer 2014. Twenty-one questions concerning attitudes and beliefs towards guidelines were a priori developed to represent the following topics: scepticism regarding the quality of guidelines, doubts about the implementation of guidelines, restrictions in treatment options through guidelines, discrepancy between palliative care values and guidelines. Differences within professions and specialisations were tested using Kruskal-Wallis tests. All 4.786 members with known email address were invited, 1.181 followed the link, 1.138 began to answer the questionnaire and 1.031 completed the questionnaire. More than half of participating members were physicians and one third nurses. Scepticism regarding the quality of existing guidelines was high (range 12.8-73.2%). Doubts regarding practical aspects of guidelines were less prevalent but still high (range 21.8-57.6%). About one third (range 5.4-31.4%) think that guidelines restrict their treatment options. In addition, 38.8% believed that guidelines are a kind of cookbook and restrict the flexibility of individual patient care. The majority saw no or little discrepancy between palliative care values and guidelines (range 68.4-82.6%). There were relatively small but significant differences between professions and specialisations. The person-centred and individual approach of palliative care does not seem to contradict the acceptance of guidelines. Main barriers were related to scepticism regarding the quality of guidelines and the implementation of guidelines in general.

Development of the AGREE II, part 2: assessment of validity of items and tools to support application

PubMed Central

Brouwers, Melissa C.; Kho, Michelle E.; Browman, George P.; Burgers, Jako S.; Cluzeau, Françoise; Feder, Gene; Fervers, Béatrice; Graham, Ian D.; Hanna, Steven E.; Makarski, Julie

2010-01-01

Background We established a program of research to improve the development, reporting and evaluation of practice guidelines. We assessed the construct validity of the items and user’s manual in the β version of the AGREE II. Methods We designed guideline excerpts reflecting high-and low-quality guideline content for 21 of the 23 items in the tool. We designed two study packages so that one low-quality and one high-quality version of each item were randomly assigned to each package. We randomly assigned 30 participants to one of the two packages. Participants reviewed and rated the guideline content according to the instructions of the user’s manual and completed a survey assessing the manual. Results In all cases, content designed to be of high quality was rated higher than low-quality content; in 18 of 21 cases, the differences were significant (p < 0.05). The manual was rated by participants as appropriate, easy to use, and helpful in differentiating guidelines of varying quality, with all scores above the mid-point of the seven-point scale. Considerable feedback was offered on how the items and manual of the β-AGREE II could be improved. Interpretation The validity of the items was established and the user’s manual was rated as highly useful by users. We used these results and those of our study presented in part 1 to modify the items and user’s manual. We recommend AGREE II (available at www.agreetrust.org) as the revised standard for guideline development, reporting and evaluation. PMID:20513779

Quality indicators for hip fracture care, a systematic review.

PubMed

Voeten, S C; Krijnen, P; Voeten, D M; Hegeman, J H; Wouters, M W J M; Schipper, I B

2018-05-17

Quality indicators are used to measure quality of care and enable benchmarking. An overview of all existing hip fracture quality indicators is lacking. The primary aim was to identify quality indicators for hip fracture care reported in literature, hip fracture audits, and guidelines. The secondary aim was to compose a set of methodologically sound quality indicators for the evaluation of hip fracture care in clinical practice. A literature search according to the PRISMA guidelines and an internet search were performed to identify hip fracture quality indicators. The indicators were subdivided into process, structure, and outcome indicators. The methodological quality of the indicators was judged using the Appraisal of Indicators through Research and Evaluation (AIRE) instrument. For structure and process indicators, the construct validity was assessed. Sixteen publications, nine audits and five guidelines were included. In total, 97 unique quality indicators were found: 9 structure, 63 process, and 25 outcome indicators. Since detailed methodological information about the indicators was lacking, the AIRE instrument could not be applied. Seven indicators correlated with an outcome measure. A set of nine quality indicators was extracted from the literature, audits, and guidelines. Many quality indicators are described and used. Not all of them correlate with outcomes of care and have been assessed methodologically. As methodological evidence is lacking, we recommend the extracted set of nine indicators to be used as the starting point for further clinical research. Future research should focus on assessing the clinimetric properties of the existing quality indicators.

Protocol-developing meta-ethnography reporting guidelines (eMERGe).

PubMed

France, E F; Ring, N; Noyes, J; Maxwell, M; Jepson, R; Duncan, E; Turley, R; Jones, D; Uny, I

2015-11-25

Designing and implementing high-quality health care services and interventions requires robustly synthesised evidence. Syntheses of qualitative research studies can provide evidence of patients' experiences of health conditions; intervention feasibility, appropriateness and acceptability to patients; and advance understanding of health care issues. The unique, interpretive, theory-based meta-ethnography synthesis approach is suited to conveying patients' views and developing theory to inform service design and delivery. However, meta-ethnography reporting is often poor quality, which discourages trust in, and use of, meta-ethnography findings. Users of evidence syntheses require reports that clearly articulate analytical processes and findings. Tailored research reporting guidelines can raise reporting standards but none exists for meta-ethnography. This study aims to create an evidence-based meta-ethnography reporting guideline articulating the methodological standards and depth of reporting required to improve reporting quality. The mixed-methods design of this National Institute of Health Research-funded study (http://www.stir.ac.uk/emerge/) follows good practice in research reporting guideline development comprising: (1) a methodological systematic review (PROSPERO registration: CRD42015024709) to identify recommendations and guidance in conducting/reporting meta-ethnography; (2) a review and audit of published meta-ethnographies to identify good practice principles and develop standards in conduct/reporting; (3) an online workshop and Delphi studies to agree guideline content with 45 international qualitative synthesis experts and 45 other stakeholders including patients; (4) development and wide dissemination of the guideline and its accompanying detailed explanatory document, a report template for National Institute of Health Research commissioned meta-ethnographies, and training materials on guideline use. Meta-ethnography, devised in the field of education, is now used widely in other disciplines. Methodological advances relevant to meta-ethnography conduct exist. The extent of discipline-specific adaptations of meta-ethnography and the fit of any adaptions with the underpinning philosophy of meta-ethnography require investigation. Well-reported meta-ethnography findings could inform clinical decision-making. A bespoke meta-ethnography reporting guideline is needed to improve reporting quality, but to be effective potential users must know it exists, trust it and use it. Therefore, a rigorous study has been designed to develop and promote a guideline. By raising reporting quality, the guideline will maximise the likelihood that high-quality meta-ethnographies will contribute robust evidence to improve health care and patient outcomes.

The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration

PubMed Central

Ogrinc, G; Mooney, S E; Estrada, C; Foster, T; Goldmann, D; Hall, L W; Huizinga, M M; Liu, S K; Mills, P; Neily, J; Nelson, W; Pronovost, P J; Provost, L; Rubenstein, L V; Speroff, T; Splaine, M; Thomson, R; Tomolo, A M; Watts, B

2008-01-01

As the science of quality improvement in health care advances, the importance of sharing its accomplishments through the published literature increases. Current reporting of improvement work in health care varies widely in both content and quality. It is against this backdrop that a group of stakeholders from a variety of disciplines has created the Standards for QUality Improvement Reporting Excellence, which we refer to as the SQUIRE publication guidelines or SQUIRE statement. The SQUIRE statement consists of a checklist of 19 items that authors need to consider when writing articles that describe formal studies of quality improvement. Most of the items in the checklist are common to all scientific reporting, but virtually all of them have been modified to reflect the unique nature of medical improvement work. This “Explanation and Elaboration” document (E & E) is a companion to the SQUIRE statement. For each item in the SQUIRE guidelines the E & E document provides one or two examples from the published improvement literature, followed by an analysis of the ways in which the example expresses the intent of the guideline item. As with the E & E documents created to accompany other biomedical publication guidelines, the purpose of the SQUIRE E & E document is to assist authors along the path from completion of a quality improvement project to its publication. The SQUIRE statement itself, this E & E document, and additional information about reporting improvement work can be found at http://www.squire-statement.org. PMID:18836062

40 CFR 436.42 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Industrial Sand Subcategory § 436.42 Effluent limitations guidelines representing the degree of effluent... 6.0 and water quality criteria in water quality standards approved under the Act authorize such lower pH, the pH limitation for such discharge may be adjusted downward to the pH water quality...

A case study: application of statistical process control tool for determining process capability and sigma level.

PubMed

Chopra, Vikram; Bairagi, Mukesh; Trivedi, P; Nagar, Mona

2012-01-01

Statistical process control is the application of statistical methods to the measurement and analysis of variation process. Various regulatory authorities such as Validation Guidance for Industry (2011), International Conference on Harmonisation ICH Q10 (2009), the Health Canada guidelines (2009), Health Science Authority, Singapore: Guidance for Product Quality Review (2008), and International Organization for Standardization ISO-9000:2005 provide regulatory support for the application of statistical process control for better process control and understanding. In this study risk assessments, normal probability distributions, control charts, and capability charts are employed for selection of critical quality attributes, determination of normal probability distribution, statistical stability, and capability of production processes, respectively. The objective of this study is to determine tablet production process quality in the form of sigma process capability. By interpreting data and graph trends, forecasting of critical quality attributes, sigma process capability, and stability of process were studied. The overall study contributes to an assessment of process at the sigma level with respect to out-of-specification attributes produced. Finally, the study will point to an area where the application of quality improvement and quality risk assessment principles for achievement of six sigma-capable processes is possible. Statistical process control is the most advantageous tool for determination of the quality of any production process. This tool is new for the pharmaceutical tablet production process. In the case of pharmaceutical tablet production processes, the quality control parameters act as quality assessment parameters. Application of risk assessment provides selection of critical quality attributes among quality control parameters. Sequential application of normality distributions, control charts, and capability analyses provides a valid statistical process control study on process. Interpretation of such a study provides information about stability, process variability, changing of trends, and quantification of process ability against defective production. Comparative evaluation of critical quality attributes by Pareto charts provides the least capable and most variable process that is liable for improvement. Statistical process control thus proves to be an important tool for six sigma-capable process development and continuous quality improvement.

Lack of existing guidelines for a large group of patients in Sweden: a national survey across the acute surgical care delivery chain.

PubMed

Muntlin Athlin, Åsa; Juhlin, Claes; Jangland, Eva

2017-02-01

Evidence-informed healthcare is the fundament for practice, whereby guidelines based on the best available evidence should assist health professionals in managing patients. Patients seeking care for acute abdominal pain form a common group in acute care settings worldwide, for whom decision-making and timely treatment are of paramount importance. There is ambiguity about the existence, use and content of guidelines for patients with acute abdomen. The objective was to describe and compare guidelines and management of patients with acute abdomen in different settings across the acute care delivery chain in Sweden. A national cross-sectional design was used. Twenty-nine ambulance stations, 17 emergency departments and 33 surgical wards covering all six Swedish health regions were included, and 23 guidelines were quality appraised using the validated Appraisal of Guidelines for Research & Evaluation II tool. There is a lack of guidelines in use for the management of this large group of patients between and within different healthcare areas across the acute care delivery chain. The quality appraisal identified that several guidelines were of poor quality, especially the in-hospital ones. Further, range orders for analgesics are common in the ambulance services and the surgical wards, but are seldom present in the emergency departments. Also, education in pain management is more common in the ambulance services. These findings are noteworthy as, hypothetically, the same patient could be treated in three different ways during the same care episode. There is an urgent need to develop high-quality evidence-based clinical guidelines for this patient group, with the entire care process in focus. © 2016 John Wiley & Sons, Ltd.

Adapting clinical practice guidelines for diabetic retinopathy in Kenya: process and outputs.

PubMed

Mwangi, Nyawira; Gachago, Muchai; Gichangi, Michael; Gichuhi, Stephen; Githeko, Kibata; Jalango, Atieno; Karimurio, Jefitha; Kibachio, Joseph; Muthami, Lawrence; Ngugi, Nancy; Nduri, Carmichael; Nyaga, Patrick; Nyamori, Joseph; Zindamoyen, Alain Nazaire Mbongo; Bascaran, Covadonga; Foster, Allen

2018-06-15

The use of clinical practice guidelines envisages augmenting quality and best practice in clinical outcomes. Generic guidelines that are not adapted for local use often fail to produce these outcomes. Adaptation is a systematic and rigorous process that should maintain the quality and validity of the guideline, while making it more usable by the targeted users. Diverse skills are required for the task of adaptation. Although adapting a guideline is not a guarantee that it will be implemented, adaptation may improve acceptance and adherence to its recommendations. We describe the process used to adapt clinical guidelines for diabetic retinopathy in Kenya, using validated tools and manuals. A technical working group consisting of volunteers provided leadership. The process was intensive and required more time than anticipated. Flexibility in the process and concurrent health system activities contributed to the success of the adaptation. The outputs from the adaptation include the guidelines in different formats, point of care instruments, as well as tools for training, monitoring, quality assurance and patient education. Guideline adaptation is applicable and feasible at the national level in Kenya. However, it is labor- and time -intensive. It presents a valuable opportunity to develop several additional outputs that are useful at the point of care.

Hypertension and hyperlipidemia management in patients treated at community health centers.

PubMed

Kirchhoff, Anne C; Drum, Melinda L; Zhang, James X; Schlichting, Jennifer; Levie, Jessica; Harrison, James F; Lippold, Susan A; Schaefer, Cynthia T; Chin, Marshall H

2008-01-01

OBJECTIVE: Community health centers (HCs) provide care for millions of medically underserved Americans with disproportionate burdens of hypertension and hyperlipidemia. For both conditions, treatment guidelines recently became more stringent and quality improvement (QI) efforts have intensified. We assessed hypertension and hyperlipidemia management in HCs during this time of guideline revision and increased QI efforts. DESIGN: Cross-sectional chart review. SETTING AND PARTICIPANTS: Eleven Midwestern HCs for 2000 and 9 for 2002 provided audit data from 2,976 randomly chosen patients with hypertension and/or hyperlipidemia. MEASUREMENT: Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC VI/VII) and National Cholesterol Education Program Adult Treatment Panel (NCEP-ATP III) guidelines were used to assess management of these conditions. RESULTS: Hypertension (2000, N=808; 2002, N=692) and hyperlipidemia (2000, N=774; 2002, N=702) outcomes improved for specific clinical subgroups. Hypertensive patients with 1 or more cardiovascular risk factors demonstrated significant improvement (34% vs. 45% controlled at <140/90 mm Hg, p=0.02). Hypertension control for persons with diabetes, renal failure and heart failure increased (16% vs. 28% controlled at <130/85 mm Hg, p=0.006). LDL control increased significantly for patients with 2 or more risk factors (39% vs. 58% controlled at <130 mg/dl, p=0.008). Other clinical subgroups showed trends toward better control, although there was insufficient power to detect significant differences for these groups. CONCLUSION: Hypertension and hyperlipidemia outcomes improved for some risk groups; however, ongoing QI is necessary.

Paleolithic nutrition for metabolic syndrome: systematic review and meta-analysis.

PubMed

Manheimer, Eric W; van Zuuren, Esther J; Fedorowicz, Zbys; Pijl, Hanno

2015-10-01

Paleolithic nutrition, which has attracted substantial public attention lately because of its putative health benefits, differs radically from dietary patterns currently recommended in guidelines, particularly in terms of its recommendation to exclude grains, dairy, and nutritional products of industry. We evaluated whether a Paleolithic nutritional pattern improves risk factors for chronic disease more than do other dietary interventions. We conducted a systematic review of randomized controlled trials (RCTs) that compared the Paleolithic nutritional pattern with any other dietary pattern in participants with one or more of the 5 components of metabolic syndrome. Two reviewers independently extracted study data and assessed risk of bias. Outcome data were extracted from the first measurement time point (≤6 mo). A random-effects model was used to estimate the average intervention effect. The quality of the evidence was rated with the use of the Grading of Recommendations Assessment, Development and Evaluation approach. Four RCTs that involved 159 participants were included. The 4 control diets were based on distinct national nutrition guidelines but were broadly similar. Paleolithic nutrition resulted in greater short-term improvements than did the control diets (random-effects model) for waist circumference (mean difference: -2.38 cm; 95% CI: -4.73, -0.04 cm), triglycerides (-0.40 mmol/L; 95% CI: -0.76, -0.04 mmol/L), systolic blood pressure (-3.64 mm Hg; 95% CI: -7.36, 0.08 mm Hg), diastolic blood pressure (-2.48 mm Hg; 95% CI: -4.98, 0.02 mm Hg), HDL cholesterol (0.12 mmol/L; 95% CI: -0.03, 0.28 mmol/L), and fasting blood sugar (-0.16 mmol/L; 95% CI: -0.44, 0.11 mmol/L). The quality of the evidence for each of the 5 metabolic components was moderate. The home-delivery (n = 1) and dietary recommendation (n = 3) RCTs showed similar effects with the exception of greater improvements in triglycerides relative to the control with the home delivery. None of the RCTs evaluated an improvement in quality of life. The Paleolithic diet resulted in greater short-term improvements in metabolic syndrome components than did guideline-based control diets. The available data warrant additional evaluations of the health benefits of Paleolithic nutrition. This systematic review was registered at PROSPERO (www.crd.york.ac.uk/PROSPERO) as CRD42014015119. © 2015 American Society for Nutrition.

Methodological quality of systematic reviews referenced in clinical practice guidelines for the treatment of opioid use disorder.

PubMed

Ross, Andrew; Rankin, Justin; Beaman, Jason; Murray, Kelly; Sinnett, Philip; Riddle, Ross; Haskins, Jordan; Vassar, Matt

2017-01-01

With efforts to combat opioid use disorder, there is an increased interest in clinical practice guidelines (CPGs) for opioid use disorder treatments. No literature exists examining the quality of systematic reviews used in opioid use disorder CPGs. This study aims to describe the methodological quality and reporting clarity of systematic reviews (SRs) used to create CPGs for opioid use disorder. From June to July 2016 guideline clearinghouses and medical literature databases were searched for relevant CPGs used in the treatment of opioid use disorder. Included CPGs must have been recognized by a national organization. SRs from the reference section of each CPG was scored by using AMSTAR (a measurement tool to assess the methodological quality of systematic reviews) tool and PRISMA (preferred reporting items for systematic reviews and meta-analyses) checklist. Seventeen CPGs from 2006-2016 were included in the review. From these, 57 unique SRs were extracted. SRS comprised 0.28% to 17.92% of all references found in the CPGs. All SRs obtained moderate or high methodological quality score on the AMSTAR tool. All reviews met at least 70% of PRISMA criteria. In PRISMA, underperforming areas included accurate title labeling, protocol registration, and risk of bias. Underperforming areas in AMSTAR included conflicts of interest, funding, and publication bias. A positive correlation was found between AMSTAR and PRISMA scores (r = .79). Although the SRs in the CPGs were of good quality, there are still areas for improvement. Systematic reviewers should consult PRISMA and AMSTAR when conducting and reporting reviews. It is important for CPG developers to consider methodological quality as a factor when developing CPG recommendations, recognizing that the quality of systematic reviews underpinning guidelines does not necessarily correspond to the quality of the guideline itself.

Implementation of the Diabetes Practice Guideline in the Army Medical Department: Final Evaluation

DTIC Science & Technology

2005-01-01

Diabetes Quality Improvement Project DRG Diagnosis-Related Group ER Emergency room FMP Family Member Prefix HBA1c Hemoglobin A1c HCSR Health-Care Service...glycemic control by assessing and managing glycosylated hemoglobin, reported as hemoglobin A1c ( HbA1c ) lev- els. Assess HbA1c levels relative to target...frequency involved in adjusting insulin dosages Increase in the percentage of noninsulin patients who fill prescribed medications to control HbA1c

Regional Evaluation and Research Center for Head Start. Southern University, Annual Report, November 28, 1969. Final Report.

ERIC Educational Resources Information Center

Southern Univ. and Agricultural and Mechanical Coll., Baton Rouge, LA.

This final report of the third year of the Southern University-Tulane University Regional Head Start Evaluation and Research Center is a statement of activities engaged in since September 1968. Chapter I includes an introduction and description of the centers; Chapter II, evaluation guidelines, test battery, quality control, evaluation design and…

Urgent need to reevaluate the latest World Health Organization guidelines for toxic inorganic substances in drinking water.

PubMed

Frisbie, Seth H; Mitchell, Erika J; Sarkar, Bibudhendra

2015-08-13

The World Health Organization (WHO) has established guidelines for drinking-water quality that cover biological and chemical hazards from both natural and anthropogenic sources. In the most recent edition of Guidelines for Drinking-water Quality (2011), the WHO withdrew, suspended, did not establish, or raised guidelines for the inorganic toxic substances manganese, molybdenum, nitrite, aluminum, boron, nickel, uranium, mercury, and selenium. In this paper, we review these changes to the WHO drinking-water guidelines, examining in detail the material presented in the WHO background documents for each of these toxic substances. In some cases, these WHO background documents use literature reviews that do not take into account scientific research published within the last 10 or more years. In addition, there are instances in which standard WHO practices for deriving guidelines are not used; for example, rounding and other mathematical errors are made. According to published meeting reports from the WHO Chemical Aspects Working Group, the WHO has a timetable for revising some of its guidelines for drinking-water quality, but for many of these toxic substances the planned changes are minimal or will be delayed for as long as 5 years. Given the limited nature of the planned WHO revisions to the inorganic toxic substances and the extended timetable for these revisions, we suggest that governments, researchers, and other stakeholders might establish independent recommendations for inorganic toxic substances and possibly other chemicals to proactively protect public health, or at the very least, revert to previous editions of the Guidelines for Drinking-water Quality, which were more protective of public health.

Do Clinical Practice Guidelines Improve Quality?

PubMed

Baldassari, Cristina M

2017-07-01

Controversy exists surrounding how to best define and assess quality in the health care setting. Clinical practice guidelines (CPGs) have been developed to improve the quality of medical care by highlighting key clinical recommendations based on recent evidence. However, data linking CPGs to improvements in outcomes in otolaryngology are lacking. Numerous barriers contribute to difficulties in translating CPGs to improvements in quality. Future initiatives are needed to improve CPG adherence and define the impact of CPG recommendations on the quality of otolaryngologic care provided to our patients.

Adherence to diagnostic guidelines and quality indicators in asthma and COPD in Swedish primary care.

PubMed

Weidinger, Paolina; Nilsson, J Lars G; Lindblad, Ulf

2009-05-01

To study the clinical evaluation and treatment of patients with asthma and COPD in primary care in Sweden, with a focus on adherence to recommended guidelines and quality indicators. All visits at health care centres in Skaraborg, Sweden, are documented in computerized medical records constituting the Skaraborg Primary Care Database (SPCD). In a register-based retrospective observational study, all patients diagnosed with asthma or COPD during 2000-2005 (n = 12,328) were identified. In a 5% random sample (n = 623), information on performed investigations at initial visits and at follow-up during 2004-2005 was collected. Compliance with procedures as recommended by national guidelines was used for quality assessment. Among 499 patients with asthma, 167 (33%) were investigated with spirometry or Peak Expiratory Flow (PEF) during initial visits in agreement with guidelines. Correspondingly, 40 out of 124 patients with COPD (32%) were investigated with spirometry. During follow-up, evaluation in agreement with guidelines was performed in 130 (60%) of patients with asthma and in 35 patients out of 77 (45%) with COPD. Prescribing of ICS reached quality target, still every second patient made an acute visit during follow-up. Adherence to recommended guidelines in asthma/COPD was low. Acute visits were common and despite the prescribing of ICS according to recommendations, patients still seem uncontrolled in their disease. There is a need for quality improvement in the clinical evaluation and treatment of patients with asthma and COPD.

Using a knowledge translation framework to implement asthma clinical practice guidelines in primary care.

PubMed

Licskai, Christopher; Sands, Todd; Ong, Michael; Paolatto, Lisa; Nicoletti, Ivan

2012-10-01

Quality problem International guidelines establish evidence-based standards for asthma care; however, recommendations are often not implemented and many patients do not meet control targets. Initial assessment Regional pilot data demonstrated a knowledge-to-practice gap. Choice of solutions We engineered health system change in a multi-step approach described by the Canadian Institutes of Health Research knowledge translation framework. Implementation Knowledge translation occurred at multiple levels: patient, practice and local health system. A regional administrative infrastructure and inter-disciplinary care teams were developed. The key project deliverable was a guideline-based interdisciplinary asthma management program. Six community organizations, 33 primary care physicians and 519 patients participated. The program operating cost was $290/patient. Evaluation Six guideline-based care elements were implemented, including spirometry measurement, asthma controller therapy, a written self-management action plan and general asthma education, including the inhaler device technique, role of medications and environmental control strategies in 93, 95, 86, 100, 97 and 87% of patients, respectively. Of the total patients 66% were adults, 61% were female, the mean age was 35.7 (SD = ± 24.2) years. At baseline 42% had two or more symptoms beyond acceptable limits vs. 17% (P< 0.001) post-intervention; 71% reported urgent/emergent healthcare visits at baseline (2.94 visits/year) vs. 45% (1.45 visits/year) (P< 0.001); 39% reported absenteeism (5.0 days/year) vs. 19% (3.0 days/year) (P< 0.001). The mean follow-up interval was 22 (SD = ± 7) months. Lessons learned A knowledge-translation framework can guide multi-level organizational change, facilitate asthma guideline implementation, and improve health outcomes in community primary care practices. Program costs are similar to those of diabetes programs. Program savings offset costs in a ratio of 2.1:1.

Using a knowledge translation framework to implement asthma clinical practice guidelines in primary care

PubMed Central

Licskai, Christopher; Sands, Todd; Ong, Michael; Paolatto, Lisa; Nicoletti, Ivan

2012-01-01

Quality problem International guidelines establish evidence-based standards for asthma care; however, recommendations are often not implemented and many patients do not meet control targets. Initial assessment Regional pilot data demonstrated a knowledge-to-practice gap. Choice of solutions We engineered health system change in a multi-step approach described by the Canadian Institutes of Health Research knowledge translation framework. Implementation Knowledge translation occurred at multiple levels: patient, practice and local health system. A regional administrative infrastructure and inter-disciplinary care teams were developed. The key project deliverable was a guideline-based interdisciplinary asthma management program. Six community organizations, 33 primary care physicians and 519 patients participated. The program operating cost was $290/patient. Evaluation Six guideline-based care elements were implemented, including spirometry measurement, asthma controller therapy, a written self-management action plan and general asthma education, including the inhaler device technique, role of medications and environmental control strategies in 93, 95, 86, 100, 97 and 87% of patients, respectively. Of the total patients 66% were adults, 61% were female, the mean age was 35.7 (SD = ±24.2) years. At baseline 42% had two or more symptoms beyond acceptable limits vs. 17% (P< 0.001) post-intervention; 71% reported urgent/emergent healthcare visits at baseline (2.94 visits/year) vs. 45% (1.45 visits/year) (P< 0.001); 39% reported absenteeism (5.0 days/year) vs. 19% (3.0 days/year) (P< 0.001). The mean follow-up interval was 22 (SD = ±7) months. Lessons learned A knowledge-translation framework can guide multi-level organizational change, facilitate asthma guideline implementation, and improve health outcomes in community primary care practices. Program costs are similar to those of diabetes programs. Program savings offset costs in a ratio of 2.1:1 PMID:22893665

Improving the quality of hospital care for children by supportive supervision: a cluster randomized trial, Kyrgyzstan

PubMed Central

Shukurova, Venera; Davletbaeva, Marina; Monolbaev, Kubanychbek; Kulichenko, Tatiana; Akoev, Yuri; Bakradze, Maya; Margieva, Tea; Mityushino, Ilya; Namazova-Baranova, Leyla; Boronbayeva, Elnura; Kuttumuratova, Aigul; Weber, Martin Willy; Tamburlini, Giorgio

2017-01-01

Abstract Objective To determine whether periodic supportive supervision after a training course improved the quality of paediatric hospital care in Kyrgyzstan, where inappropriate care was common but in-hospital postnatal mortality was low. Methods In a cluster, randomized, parallel-group trial, 10 public hospitals were allocated to a 4-day World Health Organization (WHO) course on hospital care for children followed by periodic supportive supervision by paediatricians for 1 year, while 10 hospitals had no intervention. We assessed prospectively 10 key indicators of inappropriate paediatric case management, as indicated by WHO guidelines. The primary indicator was the combination of the three indicators: unnecessary hospitalization, increased iatrogenic risk and unnecessary painful procedures. An independent team evaluated the overall quality of care. Findings We prospectively reviewed the medical records of 4626 hospitalized children aged 2 to 60 months. In the intervention hospitals, the mean proportion of the primary indicator decreased from 46.9% (95% confidence interval, CI: 24.2 to 68.9) at baseline to 6.8% (95% CI: 1.1 to 12.1) at 1 year, but was unchanged in the control group (45.5%, 95% CI: 25.2 to 67.9, to 64.7%, 95% CI: 43.3 to 86.1). At 1 year, the risk ratio for the primary indicator in the intervention versus the control group was 0.09 (95% CI: 0.06 to 0.13). The proportions of the other nine indicators also decreased in the intervention group (P < 0.0001 for all). Overall quality of care improved significantly in intervention hospitals. Conclusion Periodic supportive supervision for 1 year after a training course improved both adherence to WHO guidelines on hospital care for children and the overall quality of paediatric care. PMID:28603306

Development of Quality Management Systems for Clinical Practice Guidelines in Korea.

PubMed

Jo, Heui-Sug; Kim, Dong Ik; Chang, Sung-Goo; Shin, Ein-Soon; Oh, Moo-Kyung

2015-11-01

This study introduces the Clinical practice guidelines (CPGs) appraisal system by the Korean Academy of Medical Sciences (KAMS). Quality management policies for CPGs vary among different countries, which have their own cultures and health care systems. However, supporting developers in guideline development and appraisals using standardized tools are common practices. KAMS, an organization representing the various medical societies of Korea, has been striving to establish a quality management system for CPGs, and has established a CPGs quality management system that reflects the characteristics of the Korean healthcare environment and the needs of its users. KAMS created a foundation for the development of CPGs, set up an independent appraisal organization, enacted regulations related to the appraisals, and trained appraisers. These efforts could enhance the ability of each individual medical society to develop CPGs, to increase the quality of the CPGs, and to ultimately improve the quality of the information available to decision-makers.

Educational Intervention Improves Compliance With AAN Guidelines for Return Epilepsy Visits: A Quality Improvement Project.

PubMed

Nelson, Gary R; Filloux, Francis M; Kerr, Lynne M

2016-10-01

In 2011, the American Academy of Neurology (AAN) released guidelines for return seizure visits detailing 8 points that should be addressed during such visits. These guidelines are designed to improve routine follow-up care for epilepsy patients. The authors performed a quality improvement project aimed at increasing compliance with these guidelines after educating providers about them. The authors performed a chart review before and after an intervention which included: education regarding the guidelines, providing materials to remind providers of the guidelines, and templates to facilitate compliance. The authors reviewed charts at 2 and 6 months after the intervention. Significant improvement in documentation of 4 of the 8 measures was observed after this educational intervention. This suggests that simple educational interventions may help providers change practice and can improve compliance with new guidelines while requiring minimal time and resources to implement. © The Author(s) 2016.

Quality of clinical practice guidelines in delirium: a systematic appraisal.

PubMed

Bush, Shirley H; Marchington, Katie L; Agar, Meera; Davis, Daniel H J; Sikora, Lindsey; Tsang, Tammy W Y

2017-03-10

To determine the accessibility and currency of delirium guidelines, guideline summary papers and evaluation studies, and critically appraise guideline quality. Systematic literature search for formal guidelines (in English or French) with focus on delirium assessment and/or management in adults (≥18 years), guideline summary papers and evaluation studies.Full appraisal of delirium guidelines published between 2008 and 2013 and obtaining a 'Rigour of Development' domain screening score cut-off of >40% using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Multiple bibliographic databases, guideline organisation databases, complemented by a grey literature search. 3327 database citations and 83 grey literature links were identified. A total of 118 retrieved delirium guidelines and related documents underwent full-text screening. A final 21 delirium guidelines (with 10 being >5 years old), 12 guideline summary papers and 3 evaluation studies were included. For 11 delirium guidelines published between 2008 and 2013, the screening AGREE II 'Rigour' scores ranged from 3% to 91%, with seven meeting the cut-off score of >40%. Overall, the highest rating AGREE II domains were 'Scope and Purpose' (mean 80.1%, range 64-100%) and 'Clarity and Presentation' (mean 76.7%, range 38-97%). The lowest rating domains were 'Applicability' (mean 48.7%, range 8-81%) and 'Editorial Independence' (mean 53%, range 2-90%). The three highest rating guidelines in the 'Applicability' domain incorporated monitoring criteria or audit and costing templates, and/or implementation strategies. Delirium guidelines are best sourced by a systematic grey literature search. Delirium guideline quality varied across all six AGREE II domains, demonstrating the importance of using a formal appraisal tool prior to guideline adaptation and implementation into clinical settings. Adding more knowledge translation resources to guidelines may improve their practical application and effective monitoring. More delirium guideline evaluation studies are needed to determine their effect on clinical practice. 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/.

Guidelines for External Reviews of Quality Assurance Agencies in the European Higher Education Area. ENQA Occasional Papers 19

ERIC Educational Resources Information Center

ENQA (European Association for Quality Assurance in Higher Education), 2012

2012-01-01

In accordance with the ENQA (European Association for Quality Assurance in Higher Education) membership criteria laid down in the Statutes of ENQA, member agencies are required to undergo external reviews against the membership criteria, and thereby the Standards and Guidelines for Quality Assurance in the European Higher Education Area (ESG) as…

40 CFR 436.32 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Construction Sand and Gravel Subcategory § 436.32 Effluent limitations guidelines representing the degree of... unaltered by man's activities, is or would be less than 6.0 and water quality criteria in water quality... adjusted downward to the pH water quality criterion for the receiving waters. In no case shall a pH...

European Standards for Quality Assurance and Institutional Practices of Student Assessment in the UK, the Netherlands and the Czech Republic

ERIC Educational Resources Information Center

Kohoutek, Jan

2014-01-01

This article analyses the student assessment procedures of 12 universities in the UK, the Netherlands and the Czech Republic with respect to their alignment with the European standards and guidelines on the quality of assessing higher education students (European Standards and Guidelines for Quality Assurance [ESG] 1.3). Based on qualitative…

RFC: EPA's Action Plan for Bisphenol A Pursuant to EPA's Data Quality Guidelines

EPA Pesticide Factsheets

The American Chemistry Council (ACC) submits this Request for Correction to the U.S. Environmental Protection Agency under the Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency

USING SEDIMENT QUALITY GUIDELINES IN DREDGED MATERIAL ASSESSMENTS

EPA Science Inventory

Sediment quality guidelines (SQGs) are not formally included in the frameworks described in the Inland Testing manual and the Green Book because these frameworks are biologically based. The SQGs are often used informally, however, to help put the results of biological testing in ...

Application of Agree II Instrument for Appraisal of Postpartum Hemorrhage Clinical Practice Guidelines in Bosnia and Herzegovina

PubMed Central

Novo, Ahmed; Subotic-popovic, Andreja; Strbac, Savka; Kandic, Alma; Horga, Mihai

2016-01-01

Introduction: Federal Minister of Health and Minister of Health and Social Welfare of the Republika Srpska as a Governmental health authorities in Federation of Bosnia and Herzegovina (FBiH) and the Republika Srpska nominated/appointed health professionals as their representatives to a multidisciplinary Guidelines Adaptation Group (GAG). This group started with its work in September 2015. The main purpose of the guidelines development exercise is to develop guidelines with worldwide recognized methodology for clinical guidelines development and adaptation. At the end of this consultancy, GAG would have develop a clinical practice guideline on Postpartum hemorrhage (PPH) through the adaptation method, starting from published international clinical guidelines and adapting it according to the country specific requirements. Methodology: During the process of identifying the best guideline for adaptation, the GAG had to pass several steps. One of the crucial steps was to identify the questions related to clinical practice and health policy for which answers are needed to be addressed by the guideline. These questions included relevant issues regarding the topic area such as diagnosis, prognosis, intervention, service delivery, and training. After that, six guidelines have been researched by the six members of the GAG to see if they answered the identified questions. Evaluating the methodological quality of the selected clinical guidelines was a second essential step before deciding which ones could best fit the needs and interests. AGREE II instrument has been chosen as methods for evaluating clinical guideline quality and appropriateness. Four appraisers conducted the assessment of each of the selected guidelines for PPH. All appraisers passed the training for the AGREE II instrument before conducting appraisals, as recommended by the AGREE collaboration. Each of the four guidelines was rated independently with the AGREE II tool by each appraiser. Results: The highest score was obtained by the WHO recommendations for postpartum hemorrhage guidelines and each of four assessors recommended it to be adapted and further implemented. Discussion: In spite of several serous attempts and two Agencies for quality improvement in BiH the whole process of guideline adaptation is still in the beginning and therefore the establishment of a strong connection with similar institutions and organizations from our region and the rest of the world is very important. Cooperation and collaboration across institutions and countries and key stakeholders have potential to significantly improve the validity and quality of the adapted guidelines and to positively influence implementation. PMID:27482138

Guidelines for planting along Virginia's roadways.

DOT National Transportation Integrated Search

1986-01-01

This Guideline for Planting along Virginia Roadways provides broad policy : statements for highway landscaping. The guideline's purpose is to ensure quality : and consistency that conform with accepted landscape architectural principles : and practic...

WHO expert committee on specifications for pharmaceutical preparations.

PubMed

2013-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine].

PubMed

Wang, Yue-Xi; Liu, Meng-Yu; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Xue-Yao; Liu, Yu-Qi; Wang, Yan-Ping; Han, Xue-Jie

2017-09-01

To assess the quality and application effect of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine(Guidelines) through the applicability and applicability evaluation respectively. The questionnaire survey was adopted to evaluate the applicability of the Guidelines, including the utilization, quality, and clinical application conditions. The results showed that the familiarity rate and utilization rate of the Guidelines were 85.37%, 48.78%, respectively. The data showed that the familiarity and the utilization rates were different in the working staff with different professional titles. The evaluation level was the lowest given by the staff with junior professional title (70.97%, 29.03%) in comparison. The assessment showed the overall quality of the Guideline was good and slightly low level for the rationality scores of the other therapeutic methods as well as for the recuperation and prevention (80.49%, 85.37%), which was in line with the clinical compliance of the Guideline. The perspective observation of clinical cases was used for the applicability evaluation, including clinical compliance of the Guideline, effect evaluation, and comprehensive assessment, et al. The results showed that the safety score was the highest, followed by the economic issue and efficacy. For the comprehensive evaluation of the applicability, complete applicability accounted for 29.27%, and the general applicability accounted for 87.80%. It was showed in the three index scores of the applicability evaluation that the accumulative score 7-9 scores were 75.65%, 73.89%, 71.12%. Through the applicability and applicability evaluation, the Guideline was satisfactory in the overall quality, high in the safety of clinical application and good in efficacy and economic issues. There are some limits on the development method and technical issues in the Guideline, which is required to be supplemented in the revision. Additionally, the strategy study on the promotion of the Guideline should be enhanced so as to expedite the recognition and utilization of the Guideline. Copyright© by the Chinese Pharmaceutical Association.

Raising the quality of rheumatology management recommendations: lessons from the EULAR process 10 years after provision of standard operating procedures.

PubMed

Colebatch-Bourn, Alexandra N; Conaghan, Philip G; Arden, Nigel K; Cooper, Cyrus; Dougados, Maxime; Edwards, Christopher J

2015-08-01

To increase understanding of how to raise the quality of rheumatology guidelines by reviewing European League Against Rheumatism (EULAR) management recommendations, using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, 10 years after publication of the EULAR standardized operating procedures (SOP) for the production of recommendations. It was hoped that this work could help inform improvements in guideline development by other societies and organizations. The SOP were published in 2004 to ensure the quality of EULAR-endorsed recommendations. We reviewed 27 published EULAR recommendations for management using the AGREE II tool. This provides a framework to assess the quality of guidelines across six broad domains using 23 specific questions. Overall the EULAR recommendations reviewed have been performed to a high standard. There are particular strengths in the methodology and presentation of the guidelines; however, the results indicate areas for development in future recommendations: in particular, stakeholder involvement and applicability of the recommendations. Improvements in quality were evident in recent years, with patient representation in 9 of 15 (60.0%) recommendations published 2010-14 compared with 4 of 12 (33.3%) published 2000-09. In the last 10 years the overall quality of recommendations was good, with standards improving over the decade following publication of the SOP. However, this review process has identified potential areas for improvement, especially in patient representation and provision of implementation tools. The lessons from this work can be applied to the development of rheumatology guidelines by other societies and organizations. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Guideline appraisal with AGREE II: Systematic review of the current evidence on how users handle the 2 overall assessments.

PubMed

Hoffmann-Eßer, Wiebke; Siering, Ulrich; Neugebauer, Edmund A M; Brockhaus, Anne Catharina; Lampert, Ulrike; Eikermann, Michaela

2017-01-01

The Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument is the most commonly used guideline appraisal tool. It includes 23 appraisal criteria (items) organized within 6 domains and 2 overall assessments (1. overall guideline quality; 2. recommendation for use). The aim of this systematic review was twofold. Firstly, to investigate how often AGREE II users conduct the 2 overall assessments. Secondly, to investigate the influence of the 6 domain scores on each of the 2 overall assessments. A systematic bibliographic search was conducted for publications reporting guideline appraisals with AGREE II. The impact of the 6 domain scores on the overall assessment of guideline quality was examined using a multiple linear regression model. Their impact on the recommendation for use (possible answers: "yes", "yes, with modifications", "no") was examined using a multinomial regression model. 118 relevant publications including 1453 guidelines were identified. 77.1% of the publications reported results for at least one overall assessment, but only 32.2% reported results for both overall assessments. The results of the regression analyses showed a statistically significant influence of all domains on overall guideline quality, with Domain 3 (rigour of development) having the strongest influence. For the recommendation for use, the results showed a significant influence of Domains 3 to 5 ("yes" vs. "no") and Domains 3 and 5 ("yes, with modifications" vs. "no"). The 2 overall assessments of AGREE II are underreported by guideline assessors. Domains 3 and 5 have the strongest influence on the results of the 2 overall assessments, while the other domains have a varying influence. Within a normative approach, our findings could be used as guidance for weighting individual domains in AGREE II to make the overall assessments more objective. Alternatively, a stronger content analysis of the individual domains could clarify their importance in terms of guideline quality. Moreover, AGREE II should require users to transparently present how they conducted the assessments.

Quality assessment of osteoporosis clinical practice guidelines for physical activity and safe movement: an AGREE II appraisal.

PubMed

Armstrong, James Jacob; Rodrigues, Isabel Braganca; Wasiuta, Tom; MacDermid, Joy C

2016-01-01

Many osteoporosis clinical practice guidelines are published, and the extent to which physical activity and safe movement is addressed varies. To better inform clinical decision-making, a quality assessment and structured analysis of recommendations was undertaken. Guideline quality varied substantially, and improvement is necessary in physical activity and safe movement recommendations. The purpose of the present study is to survey available osteoporosis clinical practice guidelines (CPGs) containing physical activity and safe movement recommendations in order to assess the methodological quality with which they were developed. An analysis of the various physical activity and safe movement recommendations was conducted to determine variability between CPGs. An online literature search revealed 19 CPGs meeting our inclusion criteria. Three independent scorers evaluated CPG quality using the Appraisal of Guidelines for Research and Evaluation version II (AGREE II) instrument. Two separate individuals used a standard table to extract relevant recommendations. Intra-reviewer AGREE II score agreement ranged from fair to good (intra-class correlation coefficient (ICC) = 0.34 to 0.65). The quality of the 19 included CPGs was variable (AGREE sub-scores: 14 to 100%). CPGs scored higher in the "scope and purpose" and "clarity of presentation" domains. They scored the lowest in "applicability" and "editorial independence." Four CPGs were classified as high quality, ten average quality, and five low quality. Most CPGs recommended weight-bearing, muscle-strengthening, and resistance exercises. Information on exercise dosage, progression, and contraindications was often absent. Immobility and movements involving spinal flexion and/or torsion were discouraged. There were several high-quality CPGs; however, variability in quality and lack of specific parameters for implementation necessitates caution and critical examination by readers. CPG development groups should pay special attention to the clinical applicability of their CPGs as well as fully disclosing conflicts of interest. CPGs were in general an agreement regarding safe physical activity and safe movement recommendations. However, recommendations were often vague and the more specific recommendations were inconsistent between CPGs.

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.

Failure to comply with NCCN guidelines for the management of pancreatic cancer compromises outcomes

PubMed Central

Visser, Brendan C; Ma, Yifei; Zak, Yulia; Poultsides, George A; Norton, Jeffrey A; Rhoads, Kim F

2012-01-01

Introduction There are little data available regarding compliance with the National Comprehensive Cancer Network (NCCN) guidelines. We investigated variation in the management of pancreatic cancer (PC) among large hospitals in California, USA, specifically to evaluate whether compliance with NCCN guidelines correlates with patient outcomes. Methods The California Cancer Registry was used to identify patients treated for PC from 2001 to 2006. Only hospitals with ≥ 400 beds were included to limit evaluation to centres possessing resources to provide multimodality care (n= 50). Risk-adjusted multivariable models evaluated predictors of adherence to stage-specific NCCN guidelines for PC and mortality. Results In all, 3706 patients were treated for PC in large hospitals during the study period. Compliance with NCCN guidelines was only 34.5%. Patients were less likely to get recommended therapy with advanced age and low socioeconomic status (SES). Using multilevel analysis, controlling for patient factors (including demographics and comorbidities), hospital factors (e.g. size, academic affiliation and case volume), compliance with NCCN guidelines was associated with a reduced risk of mortality [odds ratio (OR) for death 0.64 (0.53–0.77, P < 0.0001)]. Conclusions There is relatively poor overall compliance with the NCCN PC guidelines in California's large hospitals. Higher compliance rates are correlated with improved survival. Compliance is an important potential measure of the quality of care. PMID:22762402

Failure to comply with NCCN guidelines for the management of pancreatic cancer compromises outcomes.

PubMed

Visser, Brendan C; Ma, Yifei; Zak, Yulia; Poultsides, George A; Norton, Jeffrey A; Rhoads, Kim F

2012-08-01

There are little data available regarding compliance with the National Comprehensive Cancer Network (NCCN) guidelines. We investigated variation in the management of pancreatic cancer (PC) among large hospitals in California, USA, specifically to evaluate whether compliance with NCCN guidelines correlates with patient outcomes. The California Cancer Registry was used to identify patients treated for PC from 2001 to 2006. Only hospitals with ≥ 400 beds were included to limit evaluation to centres possessing resources to provide multimodality care (n= 50). Risk-adjusted multivariable models evaluated predictors of adherence to stage-specific NCCN guidelines for PC and mortality. In all, 3706 patients were treated for PC in large hospitals during the study period. Compliance with NCCN guidelines was only 34.5%. Patients were less likely to get recommended therapy with advanced age and low socioeconomic status (SES). Using multilevel analysis, controlling for patient factors (including demographics and comorbidities), hospital factors (e.g. size, academic affiliation and case volume), compliance with NCCN guidelines was associated with a reduced risk of mortality [odds ratio (OR) for death 0.64 (0.53-0.77, P < 0.0001)]. There is relatively poor overall compliance with the NCCN PC guidelines in California's large hospitals. Higher compliance rates are correlated with improved survival. Compliance is an important potential measure of the quality of care. © 2012 International Hepato-Pancreato-Biliary Association.

EBMPracticeNet: A Bilingual National Electronic Point-Of-Care Project for Retrieval of Evidence-Based Clinical Guideline Information and Decision Support

PubMed Central

2013-01-01

Background In Belgium, the construction of a national electronic point-of-care information service, EBMPracticeNet, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The collaboration of the government, health care providers, evidence-based medicine (EBM) partners, and vendors of electronic health records (EHR) is unique to this project. All Belgian health care professionals get free access to an up-to-date database of validated Belgian and nearly 1000 international guidelines, incorporated in a portal that also provides EBM information from other sources than guidelines, including computerized clinical decision support that is integrated in the EHRs. Objective The objective of this paper was to describe the development strategy, the overall content, and the management of EBMPracticeNet which may be of relevance to other health organizations creating national or regional electronic point-of-care information services. Methods Several candidate providers of comprehensive guideline solutions were evaluated and one database was selected. Translation of the guidelines to Dutch and French was done with translation software, post-editing by translators and medical proofreading. A strategy is determined to adapt the guideline content to the Belgian context. Acceptance of the computerized clinical decision support tool has been tested and a randomized controlled trial is planned to evaluate the effect on process and patient outcomes. Results Currently, EBMPracticeNet is in "work in progress" state. Reference is made to the results of a pilot study and to further planned research including a randomized controlled trial. Conclusions The collaboration of government, health care providers, EBM partners, and vendors of EHRs is unique. The potential value of the project is great. The link between all the EHRs from different vendors and a national database held on a single platform that is controlled by all EBM organizations in Belgium are the strengths of EBMPracticeNet. PMID:23842038

Quality assurance and quality control in mammography: a review of available guidance worldwide.

PubMed

Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos

2013-10-01

Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.

[Evaluation of the "initiative pain-free clinic" for quality improvement in postoperative pain management. A prospective controlled study].

PubMed

Lehmkuhl, D; Meissner, W; Neugebauer, E A M

2011-09-01

Demonstration of improved postoperative pain management by implementation of the S3 guidelines on treatment of acute perioperative and posttraumatic pain, by the integrated quality management concept "quality management acute pain" of the TÜV Rheinland or by participation in the benchmark project "Quality improvement in postoperative pain management" (QUIPS). A prospective controlled study (pre-post design) was carried out in hospitals with various levels of care comparing three hospital groups (n = 17/7/3, respectively). Group 1: participation in the QUIPS project (intraclinic and interclinic comparison of outcome data of postoperative pain treatment), group 2: participation in the quality management acute pain program (certified by TÜV Rheinland), group 3: control group with no involvement in either of the two concepts. In all three groups, an anonymous data collection was performed consisting of patient-reported pain intensity, side effects, pain disability and patient satisfaction. Pain therapy intervention was carried out only in group 2 by an integrated quality management concept (certification project: Quality management acute pain) with a package of measures to improve structure, process and outcome quality. The TÜV Rheinland certified clinics (group 2) showed a significant improvement in the pre-post comparison (before versus after certification) in the areas maximum pain (from visual analogue scale VAS 4.6 to 3.7), stress pain (5.3 to 3.9), pain-related impairment (proportion of patients with pain-linked decreased mobility and movement 26% to 16.1%, coughing and breathing 23.1% to 14.3%) and patient satisfaction (from 13.2 to 13.7; scale 0 completely unsatisfied, 15 very satisfied). The clinics with participation in QUIPS for 2 years also showed a significant improvement in stress pain (numeric rating scale NRS for pain 4.5 to 4.2), pain-linked-limitation of coughing and breathing (28% to 23.6%), and patient satisfaction (from 11.9 to 12.4). There were no differences in postoperative nausea and vomiting between any of the groups. The main objective of the certification concept quality management acute pain as a tool for the successful implementation of the S3 guidelines on treatment of acute perioperative and posttraumatic pain, led to a significant improvement in patient outcome. Participation in QUIPS is an ideal supplement to TÜV Rheinland certification and can be recommended as a benchmarking tool to evaluate outcome.

Impact of surgical care improvement project inf-9 on postoperative urinary tract infections: do exemptions interfere with quality patient care?

PubMed

Owen, Rachel M; Perez, Sebastian D; Bornstein, William A; Sweeney, John F

2012-10-01

The Surgical Care Improvement Project (SCIP) Inf-9 guideline promotes removal of indwelling urinary catheters (IUCs) within 48 hours of surgery. To determine whether a correlation exists between SCIP Inf-9 compliance and postoperative urinary tract infection (UTI) rates and whether an association exists between UTI rates and SCIP Inf-9 exemption status. DESIGN Retrospective case control study. Southeastern academic medical center. American College of Surgeons National Surgical Quality Improvement Program (NSQIP) and SCIP Inf-9 compliance data were collected prospectively on randomly selected general and vascular surgery inpatients. Monthly UTI rates and SCIP Inf-9 compliance scores were tested for correlation. Complete NSQIP data for all the inpatients with postoperative UTIs were compared with a group of 100 random controls to determine whether an association exists between UTI rates and SCIP Inf-9 exemption status. Postoperative UTI. In 2459 patients reviewed, SCIP Inf-9 compliance increased over time, but this was not correlated with improved monthly UTI rates. Sixty-one of the 69 UTIs (88.4%) were compliant with SCIP Inf-9; however, 49 (71.0%) of these were considered exempt from the guideline and, therefore, the IUC was not removed within 48 hours of surgery. Retrospective review of 100 random controls showed a similar compliance rate (84.0%, P = .43) but a lower rate of exemption (23.5%, P < .001). The odds of developing a postoperative UTI were 8 times higher in patients deemed exempt from SCIP Inf-9 (odds ratio [OR], 7.99; 95% CI, 3.85-16.61). After controlling for differences between the 2 groups, the adjusted ORs slightly increased (OR, 8.34; 95% CI, 3.70-18.76). Most UTIs occurred in patients deemed exempt from SCIP Inf-9. Although compliance rates remain high, practices are not actually improving. Surgical Care Improvement Project Inf-9 guidelines should be modified with fewer exemptions to facilitate earlier removal of IUCs.

Guidelines for evaluating the efficacy and safety of live anticoccidial vaccines, and obtaining approval for their use in chickens and turkeys.

PubMed

Chapman, H D; Roberts, B; Shirley, M W; Williams, R B

2005-08-01

These guidelines are intended to aid those engaged in poultry research in the design, implementation and interpretation of laboratory, floor-pen and field studies for the assessment of the efficacy and safety of live anticoccidial vaccines for immunization of chickens and turkeys against Eimeria species. In addition to efficacy and safety requirements, manufacture, quality control and licensing considerations are discussed. The guidelines do not address subunit vaccines comprising non-viable material, but many of the principles described will be relevant to such vaccines if they are developed in the future. Guidelines are available in some countries for avian vaccines of bacterial or viral origin but specific standards for anticoccidial vaccines in poultry have not, as far as we know, been produced. Information is provided on general requirements of registration authorities (based upon regulations applicable in the European Union and the USA) for obtaining marketing authorizations for vaccines. These guidelines may assist poultry specialists in providing specific information for administrators involved in the decision-making process leading to registration of new vaccines, and are intended to facilitate the worldwide adoption of consistent, standard procedures.

Quality of care in patients with atrial fibrillation in primary care: a cross-sectional study comparing clinical and claims data.

PubMed

Preuss, Rebekka; Chenot, Jean-François; Angelow, Aniela

2016-01-01

Objectives: Atrial fibrillation (AF) is a common cardiac arrhythmia with increased risk of thromboembolic stroke. Oral anticoagulation (OAC) reduces stroke risk by up to 68%. The aim of our study was to evaluate quality of care in patients with AF in a primary health care setting with a focus on physician guideline adherence for OAC prescription and heart rate- and rhythm management. In a second step we aimed to compare OAC rates based on primary care data with rates based on claims data. Methods: We included all GP practices in the region Vorpommern-Greifswald, Germany, which were willing to participate (N=29/182, response rate 16%). Claims data was derived from the regional association of statutory health insurance physicians. Patients with a documented AF diagnosis (ICD-10-GM-Code ICD I48.-) from 07/2011-06/2012 were identified using electronic medical records (EMR) and claims data. Stroke and bleeding risk were calculated using the CHA 2 DS 2 -VASc and HAS-BLED scores. We calculated crude treatment rates for OAC, rate and rhythm control medications and adjusted OAC treatment rates based on practice and claims data. Adjusted rates were calculated including the CHA 2 DS 2 -VASc and HAS-BLED scores and individual factors affecting guideline based treatment. Results: We identified 927 patients based on EMR and 1,247 patients based on claims data. The crude total OAC treatment rate was 69% based on EMR and 61% based on claims data. The adjusted OAC treatment rates were 90% for patients based on EMR and 63% based on claims data. 82% of the AF patients received a treatment for rate control and 12% a treatment for rhythm control. The most common reasons for non-prescription of OAC were an increased risk of falling, dementia and increased bleeding risk. Conclusion: Our results suggest that a high rate of AF patients receive a drug therapy according to guidelines. There is a large difference between crude and adjusted OAC treatment rates. This is due to individual contraindications and comorbidities which cannot be documented using ICD coding. Therefore, quality indicators based on crude EMR data or claims data would lead to a systematic underestimation of the quality of care. A possible overtreatment of low-risk patients cannot be ruled out.