Factors affecting vaccine handling and storage practices among immunization service providers in Ibadan, Oyo State, Nigeria.

PubMed

Dairo, David M; Osizimete, Oyarebu E

2016-06-01

Improper handling has been identified as one of the major reasons for the decline in vaccine potency at the time of administration. Loss of potency becomes evident when immunised individuals contract the diseases the vaccines were meant to prevent. Assessing the factors associated with vaccine handling and storage practices. This was a cross-sectional study. Three-stage sampling was used to recruit 380 vaccine handlers from 273 health facilities from 11 Local Government areas in Ibadan. Data was analysed using SPSS version 16. Seventy-three percent were aware of vaccine handling and storage guidelines with 68.4% having ever read such guidelines. Only 15.3% read a guideline less than 1 month prior to the study. About 65.0% had received training on vaccine management. Incorrect handling practices reported included storing injections with vaccines (13.7%) and maintaining vaccine temperature using ice blocks (7.6%). About 43.0% had good knowledge of vaccine management, while 66.1% had good vaccine management practices. Respondents who had good knowledge of vaccine handling and storage [OR=10.0, 95%CI (5.28 - 18.94), p < 0.001] and had received formal training on vaccine management [OR=5.3, 95%CI (2.50 - 11.14), p< 0.001] were more likely to have good vaccine handling and storage practices. Regular training is recommended to enhance vaccine handling and storage practices.

International Guidelines on Computer-Based and Internet-Delivered Testing

ERIC Educational Resources Information Center

International Journal of Testing, 2006

2006-01-01

Developed by the International Test Commission, the International Guidelines on Computer-Based and Internet-Delivered Testing are a set of guidelines specifically developed to highlight good practice issues in relation to computer/Internet tests and testing. These guidelines have been developed from an international perspective and are directed at…

British Thoracic Society Guideline for the initial outpatient management of pulmonary embolism

PubMed Central

Howard, Luke S; Barden, Steven; Condliffe, Robin; Connolly, Vincent; Davies, Chris; Donaldson, James; Everett, Bernard; Free, Catherine; Horner, Daniel; Hunter, Laura; Kaler, Jasvinder; Nelson-Piercy, Catherine; O’Dowd, Emma; Patel, Raj; Preston, Wendy; Sheares, Karen; Tait, Campbell

2018-01-01

The following is a summary of the recommendations and good practice points for the BTS Guideline for the initial outpatient management of pulmonary embolism. Please refer to the full guideline for full information about each section.

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.

Guidelines for direct radionuclide cystography in children.

PubMed

Fettich, Jure; Colarinha, Paula; Fischer, Sibylle; Frökier, Jörgen; Gordon, Isky; Hahn, Klaus; Kabasakal, Levent; Mann, Mike; Mitjavila, Mercedes; Olivier, Pierre; Piepsz, Amy; Porn, Ute; Roca, Isabel; Sixt, Rune; van Velzen, Jeannette

2003-05-01

These guidelines, which summarise the views of the Paediatric Committee of the European Association of Nuclear Medicine, provide a framework which may prove helpful to nuclear medicine teams in daily practice. They contain information on the indications, acquisition, processing and interpretation of direct radioisotope cystography in children. The guidelines should be taken in the context of "good practice" and any local/national rules which apply to nuclear medicine examinations.

How do we know if a clinical practice guideline is good? A response to Djulbegovic and colleagues' use of fast-and-frugal decision trees to improve clinical care strategies.

PubMed

Mercuri, Mathew

2018-04-17

Clinical practice guidelines (CPGs) and clinical pathways have become important tools for improving the uptake of evidence-based care. Where CPGs are good, adherence to the recommendations within is thought to result in improved patient outcomes. However, the usefulness of such tools for improving patient important outcomes depends both on adherence to the guideline and whether or not the CPG in question is good. This begs the question of what it is that makes a CPG good? In this issue of the Journal, Djulbegovic and colleagues offer a theory to help guide the development of CPGs. The "fast-and-frugal tree" (FFT) heuristic theory is purported to provide the theoretical structure needed to quantitatively assess clinical guidelines in practice, something that the lack of theory to guide CPG development has precluded. In this paper, I examine the role of FFTs in providing an adequate theoretical framework for developing CPGs. In my view, positioning guideline development within the FFT framework may help with problems related to adherence. However, I believe that FTTs fall short in providing panel members with the theoretical basis needed to justify which factors should be considered when developing a CPG, how information on those factors derived from research studies should be interpreted, and how those factors should be integrated into the recommendation. © 2018 John Wiley & Sons, Ltd.

BTS guideline for the investigation and management of malignant pleural mesothelioma.

PubMed

Woolhouse, Ian; Bishop, Lesley; Darlison, Liz; de Fonseka, Duneesha; Edey, Anthony; Edwards, John; Faivre-Finn, Corinne; Fennell, Dean A; Holmes, Steve; Kerr, Keith M; Nakas, Apostolos; Peel, Tim; Rahman, Najib M; Slade, Mark; Steele, Jeremy; Tsim, Selina; Maskell, Nick A

2018-01-01

The full guideline for the investigation and management of malignant pleural mesothelioma is published in Thorax . The following is a summary of the recommendations and good practice points. The sections referred to in the summary refer to the full guideline.

Guide to good practices for operations and administration updates through required reading

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

Not Available

1992-12-01

The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, Conduct of Operations Requirements for DOE Facilities.'' (JDB)

Guide to good practices for operations and administration updates through required reading

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

Not Available

1992-12-01

The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, ``Conduct of Operations Requirements for DOE Facilities.`` (JDB)

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

PubMed

2015-01-01

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. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - first revision.

PubMed

Van den Bergh, P Y K; Hadden, R D M; Bouche, P; Cornblath, D R; Hahn, A; Illa, I; Koski, C L; Léger, J-M; Nobile-Orazio, E; Pollard, J; Sommer, C; van Doorn, P A; van Schaik, I N

2010-03-01

Consensus guidelines on the definition, investigation, and treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) have been previously published in European Journal of Neurology and Journal of the Peripheral Nervous System. To revise these guidelines. Disease experts, including a representative of patients, considered references retrieved from MEDLINE and Cochrane Systematic Reviews published between August 2004 and July 2009 and prepared statements that were agreed in an iterative fashion. The Task Force agreed on Good Practice Points to define clinical and electrophysiological diagnostic criteria for CIDP with or without concomitant diseases and investigations to be considered. The principal treatment recommendations were: (i) intravenous immunoglobulin (IVIg) (Recommendation Level A) or corticosteroids (Recommendation Level C) should be considered in sensory and motor CIDP; (ii) IVIg should be considered as the initial treatment in pure motor CIDP (Good Practice Point); (iii) if IVIg and corticosteroids are ineffective, plasma exchange (PE) should be considered (Recommendation Level A); (iv) if the response is inadequate or the maintenance doses of the initial treatment are high, combination treatments or adding an immunosuppressant or immunomodulatory drug should be considered (Good Practice Point); (v) symptomatic treatment and multidisciplinary management should be considered (Good Practice Point).

BTS guideline for the investigation and management of malignant pleural mesothelioma

PubMed Central

Woolhouse, Ian; Bishop, Lesley; Darlison, Liz; de Fonseka, Duneesha; Edey, Anthony; Edwards, John; Faivre-Finn, Corinne; Fennell, Dean A; Holmes, Steve; Kerr, Keith M; Nakas, Apostolos; Peel, Tim; Rahman, Najib M; Slade, Mark; Steele, Jeremy; Tsim, Selina; Maskell, Nick A

2018-01-01

The full guideline for the investigation and management of malignant pleural mesothelioma is published in Thorax. The following is a summary of the recommendations and good practice points. The sections referred to in the summary refer to the full guideline. PMID:29531746

Canadian Guidelines for Controlled Pediatric Donation After Circulatory Determination of Death-Summary Report.

PubMed

Weiss, Matthew J; Hornby, Laura; Rochwerg, Bram; van Manen, Michael; Dhanani, Sonny; Sivarajan, V Ben; Appleby, Amber; Bennett, Mary; Buchman, Daniel; Farrell, Catherine; Goldberg, Aviva; Greenberg, Rebecca; Singh, Ram; Nakagawa, Thomas A; Witteman, William; Barter, Jill; Beck, Allon; Coughlin, Kevin; Conradi, Alf; Cupido, Cynthia; Dawson, Rosanne; Dipchand, Anne; Freed, Darren; Hornby, Karen; Langlois, Valerie; Mack, Cheryl; Mahoney, Meagan; Manhas, Deepak; Tomlinson, Christopher; Zavalkoff, Samara; Shemie, Sam D

2017-11-01

Create trustworthy, rigorous, national clinical practice guidelines for the practice of pediatric donation after circulatory determination of death in Canada. We followed a process of clinical practice guideline development based on World Health Organization and Canadian Medical Association methods. This included application of Grading of Recommendations Assessment, Development, and Evaluation methodology. Questions requiring recommendations were generated based on 1) 2006 Canadian donation after circulatory determination of death guidelines (not pediatric specific), 2) a multidisciplinary symposium of national and international pediatric donation after circulatory determination of death leaders, and 3) a scoping review of the pediatric donation after circulatory determination of death literature. Input from these sources drove drafting of actionable questions and Good Practice Statements, as defined by the Grading of Recommendations Assessment, Development, and Evaluation group. We performed additional literature reviews for all actionable questions. Evidence was assessed for quality using Grading of Recommendations Assessment, Development, and Evaluation and then formulated into evidence profiles that informed recommendations through the evidence-to-decision framework. Recommendations were revised through consensus among members of seven topic-specific working groups and finalized during meetings of working group leads and the planning committee. External review was provided by pediatric, critical care, and critical care nursing professional societies and patient partners. We generated 63 Good Practice Statements and seven Grading of Recommendations Assessment, Development, and Evaluation recommendations covering 1) ethics, consent, and withdrawal of life-sustaining therapy, 2) eligibility, 3) withdrawal of life-sustaining therapy practices, 4) ante and postmortem interventions, 5) death determination, 6) neonatal pediatric donation after circulatory determination of death, 7) cardiac and innovative pediatric donation after circulatory determination of death, and 8) implementation. For brevity, 48 Good Practice Statement and truncated justification are included in this summary report. The remaining recommendations, detailed methodology, full Grading of Recommendations Assessment, Development, and Evaluation tables, and expanded justifications are available in the full text report. This process showed that rigorous, transparent clinical practice guideline development is possible in the domain of pediatric deceased donation. Application of these recommendations will increase access to pediatric donation after circulatory determination of death across Canada and may serve as a model for future clinical practice guideline development in deceased donation.

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

PubMed

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

2016-12-01

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

Design guidelines for assessing and controlling spacecraft charging effects

NASA Technical Reports Server (NTRS)

Purvis, C. K.; Garrett, H. B.; Whittlesey, A. C.; Stevens, N. J.

1984-01-01

The need for uniform criteria, or guidelines, to be used in all phases of spacecraft design is discussed. Guidelines were developed for the control of absolute and differential charging of spacecraft surfaces by the lower energy space charged particle environment. Interior charging due to higher energy particles is not considered. A guide to good design practices for assessing and controlling charging effects is presented. Uniform design practices for all space vehicles are outlined.

Design guidelines for assessing and controlling spacecraft charging effects

NASA Technical Reports Server (NTRS)

Purvis, C. K.; Garrett, H. B.; Whittlesey, A.; Stevens, N. J.

1985-01-01

The need for uniform criteria, or guidelines, to be used in all phases of spacecraft design is discussed. Guidelines were developed for the control of absolute and differential charging of spacecraft surfaces by the lower energy space charged particle environment. Interior charging due to higher energy particles is not considered. A guide to good design practices for assessing and controlling charging effects is presented. Uniform design practices for all space vehicles are outlined.

A Lesson Plan for the Enhancement of Training and Research in Academia by the Adaptation and Adoption of Good Laboratory Practice Guidelines

ERIC Educational Resources Information Center

Sitaraman, Ramakrishnan

2010-01-01

The implementation of good laboratory practices (GLPs) is recognized by the biotechnology and pharmaceutical industries as being critical for ensuring the international acceptability of products. However, as universities and colleges (and research organizations) do not necessarily work under similar constraints, actual laboratory practices vary…

Clinical inertia, uncertainty and individualized guidelines.

PubMed

Reach, G

2014-09-01

Doctors often do not follow the guidelines of good practice based on evidence-based medicine, and this "clinical inertia" may represent an impediment to efficient care. The aims of this article are as follows: 1) to demonstrate that this phenomenon is often the consequence of a discrepancy between the technical rationality of evidence-based medicine and the modes of reasoning of physicians practiced in "real-life", which is marked by uncertainty and risk; 2) to investigate in this context the meaning of the recent, somewhat paradoxical, concept of "individualized guidelines"; and 3) to revisit the real, essentially pedagogical, place of guidelines in medical practice. Copyright © 2014. Published by Elsevier Masson SAS.

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.

Practice guidelines for program evaluation in community-based rehabilitation.

PubMed

Grandisson, Marie; Hébert, Michèle; Thibeault, Rachel

2017-06-01

This paper proposes practice guidelines to evaluate community-based rehabilitation (CBR) programs. These were developed through a rigorous three-phase research process including a literature review on good practices in CBR program evaluation, a field study during which a South Africa CBR program was evaluated, and a Delphi study to generate consensus among a highly credible panel of CBR experts from a wide range of backgrounds and geographical areas. The 10 guidelines developed are summarized into a practice model highlighting key features of sound CBR program evaluation. They strongly indicate that sound CBR evaluations are those that give a voice and as much control as possible to the most affected groups, embrace the challenge of diversity, and foster use of evaluation processes and findings through a rigorous, collaborative and empowering approach. The practice guidelines should facilitate CBR evaluation decisions in respect to facilitating an evaluation process, using frameworks and designing methods. Implications for rehabilitation Ten practice guidelines provide guidance to facilitate sound community-based rehabilitation (CBR) program evaluation decisions. Key indications of good practice include: • being as participatory and empowering as possible; • ensuring that all, including the most affected, have a real opportunity to share their thoughts; • highly considering mixed methods and participatory tools; • adapting to fit evaluation context, local culture and language(s); • defining evaluation questions and reporting findings using shared CBR language when possible, which the framework offered may facilitate.

European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of multifocal motor neuropathy.

PubMed

van Schaik, I N; Bouche, P; Illa, I; Léger, J-M; Van den Bergh, P; Cornblath, D R; Evers, E M A; Hadden, R D M; Hughes, R A C; Koski, C L; Nobile-Orazio, E; Pollard, J; Sommer, C; van Doorn, P A

2006-08-01

Several diagnostic criteria for multifocal motor neuropathy have been proposed in recent years and a beneficial effect of intravenous immunoglobulin (IVIg) and various other immunomodulatory drugs has been suggested in several trials and uncontrolled studies. The objectives were to prepare consensus guidelines on the definition, investigation and treatment of multifocal motor neuropathy. Disease experts and a patient representative considered references retrieved from MEDLINE and the Cochrane Library in July 2004 and prepared statements which were agreed in an iterative fashion. The Task Force agreed good practice points to define clinical and electrophysiological diagnostic criteria for multifocal motor neuropathy and investigations to be considered. The principal recommendations and good practice points were: (i) IVIg (2 g/kg given over 2-5 days) should be considered as the first line treatment (level A recommendation) when disability is sufficiently severe to warrant treatment. (ii) Corticosteroids are not recommended (good practice point). (iii) If initial treatment with IVIg is effective, repeated IVIg treatment should be considered (level C recommendation). The frequency of IVIg maintenance therapy should be guided by the individual response (good practice point). Typical treatment regimens are 1 g/kg every 2-4 weeks or 2 g/kg every 4-8 weeks (good practice point). (iv) If IVIg is not or not sufficiently effective then immunosuppressive treatment may be considered. Cyclophosphamide, ciclosporin, azathioprine, interferon beta1a, or rituximab are possible agents (good practice point). (v) Toxicity makes cyclophosphamide a less desirable option (good practice point).

Seeking an oracle: using the Delphi process to develop practice guidelines for the treatment of endometriosis with Chinese herbal medicine.

PubMed

Flower, Andrew; Lewith, George T; Little, Paul

2007-11-01

For most complementary and alternative medicine interventions, the absence of a high-quality evidence base to define good practice presents a serious problem for clinicians, educators, and researchers. The Delphi process may offer a pragmatic way to establish good practice guidelines until more rigorous forms of assessment can be undertaken. To use a modified Delphi to develop good practice guidelines for a feasibility study exploring the role of Chinese herbal medicine (CHM) in the treatment of endometriosis. To compare the outcomes from Delphi with data derived from a systematic review of the Chinese language database. An expert group was convened for a three-round Delphi that initially produced key statements relating to the CHM diagnosis and treatment of endometriosis (round 1) and then anonymously rated these on a 1-7 Likert scale (rounds 2 and 3). Statements with a median score of 5 and above were regarded as demonstrating positive group consensus. The differential diagnoses within Chinese Medicine and rating of the clinical value of individual herbs were then contrasted with comparable data from a review of Chinese language reports in the Chinese Biomedical Retrieval System (1978-2002), and China Academy of Traditional Chinese Medicine (1985-2002) databases and the Chinese TCM and magazine literature (1984-2004) databases. Consensus (good practice) guidelines for the CHM treatment of endometriosis relating to common diagnostic patterns, herb selection, dosage, and patient management were produced. The Delphi guidelines demonstrated a high degree of congruence with the information from the Chinese language databases. In the absence of rigorous evidence, Delphi offers a way to synthesize expert knowledge relating to diagnosis, patient management, and herbal selection in the treatment of endometriosis. The limitations of the expert group and the inability of Delphi to capture the subtle nuances of individualized clinical decision-making limit the usefulness of this approach.

International Continence Society guidelines on urodynamic equipment performance.

PubMed

Gammie, Andrew; Clarkson, Becky; Constantinou, Chris; Damaser, Margot; Drinnan, Michael; Geleijnse, Geert; Griffiths, Derek; Rosier, Peter; Schäfer, Werner; Van Mastrigt, Ron

2014-04-01

These guidelines provide benchmarks for the performance of urodynamic equipment, and have been developed by the International Continence Society to assist purchasing decisions, design requirements, and performance checks. The guidelines suggest ranges of specification for uroflowmetry, volume, pressure, and EMG measurement, along with recommendations for user interfaces and performance tests. Factors affecting measurement relating to the different technologies used are also described. Summary tables of essential and desirable features are included for ease of reference. It is emphasized that these guidelines can only contribute to good urodynamics if equipment is used properly, in accordance with good practice. © 2014 Wiley Periodicals, Inc.

Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

PubMed

Battisti, Wendy P; Wager, Elizabeth; Baltzer, Lise; Bridges, Dan; Cairns, Angela; Carswell, Christopher I; Citrome, Leslie; Gurr, James A; Mooney, LaVerne A; Moore, B Jane; Peña, Teresa; Sanes-Miller, Carol H; Veitch, Keith; Woolley, Karen L; Yarker, Yvonne E

2015-09-15

This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.

European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society--First Revision.

PubMed

2010-03-01

Consensus guidelines on the definition, investigation, and treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) have been published (J Peripher Nerv Syst 2005; 10: 220-228, Eur J Neurol 2006; 13: 326-332). To revise these guidelines. Disease experts, including a representative of patients, considered references retrieved from MEDLINE and Cochrane Systematic Reviews published between August 2004 and July 2009 and prepared statements that were agreed in an iterative fashion. The Task Force agreed on Good Practice Points to define clinical and electrophysiological diagnostic criteria for CIDP with or without concomitant diseases and investigations to be considered. The principal treatment recommendations were: (i) intravenous immunoglobulin (IVIg) (Recommendation Level A) or corticosteroids (Recommendation Level C) should be considered in sensory and motor CIDP; (ii) IVIg should be considered as the initial treatment in pure motor CIDP (Good Practice Point); (iii) if IVIg and corticosteroids are ineffective, plasma exchange (PE) should be considered (Recommendation Level A); (iv) if the response is inadequate or the maintenance doses of the initial treatment are high, combination treatments or adding an immunosuppressant or immunomodulatory drug should be considered (Good Practice Point); (v) symptomatic treatment and multidisciplinary management should be considered (Good Practice Point).

[French Society of Vascular Medicine good medical practice guidelines on safety and environment in vascular medicine: Treatment of varicose veins].

PubMed

Giordana, P; Miserey, G

2014-12-01

These guidelines proposed by the French Society of Vascular Medicine define the optimal environment for vascular medicine practice: outpatient clinic; equipment, layout and maintenance of the care center; infection risk prevention (hand hygiene, individual protective measures, exposure to blood, ultrasound apparatus, etc.); common interventions and techniques (liquid and foam sclerotherapy, endovenous thermal treatments). These guidelines do not include phlebectomy and use of ultrasound contrast agents. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Guidelines for radioiodinated MIBG scintigraphy in children.

PubMed

Olivier, Pierre; Colarinha, Paula; Fettich, Jure; Fischer, Sibylle; Frökier, Jörgen; Giammarile, Francesco; Gordon, Isky; Hahn, Klaus; Kabasakal, Levent; Mann, Mike; Mitjavila, Mercedes; Piepsz, Amy; Porn, Ute; Sixt, Rune; van Velzen, Jeannette

2003-05-01

These guidelines on the use of radioiodinated (99m)Tc-MIBG scintigraphy in children, which summarise the views of the Paediatric Committee of the European Association of Nuclear Medicine, provide a framework which may prove helpful to nuclear medicine teams in daily practice. They have been influenced by the conclusions of the "Consensus Guidelines for MIBG Scintigraphy" (Paris, November 6, 1997) of the European Neuroblastoma Group and by those of the Oncological Committee of the French Society of Nuclear Medicine. The guidelines should be taken in the context of "good practice" and any local/national rules which apply to nuclear medicine examinations.

[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.

Canadian Guidelines for Controlled Pediatric Donation After Circulatory Determination of Death—Summary Report*

PubMed Central

Hornby, Laura; Rochwerg, Bram; van Manen, Michael; Dhanani, ; Sonny; Sivarajan, V. Ben; Appleby, Amber; Bennett, Mary; Buchman, Daniel; Farrell, Catherine; Goldberg, Aviva; Greenberg, Rebecca; Singh, Ram; Nakagawa, Thomas A.; Witteman, William; Barter, Jill; Beck, Allon; Coughlin, Kevin; Conradi, Alf; Cupido, Cynthia; Dawson, Rosanne; Dipchand, Anne; Freed, Darren; Hornby, Karen; Langlois, Valerie; Mack, Cheryl; Mahoney, Meagan; Manhas, Deepak; Tomlinson, Christopher; Zavalkoff, Samara; Shemie, Sam D.

2017-01-01

Objectives: Create trustworthy, rigorous, national clinical practice guidelines for the practice of pediatric donation after circulatory determination of death in Canada. Methods: We followed a process of clinical practice guideline development based on World Health Organization and Canadian Medical Association methods. This included application of Grading of Recommendations Assessment, Development, and Evaluation methodology. Questions requiring recommendations were generated based on 1) 2006 Canadian donation after circulatory determination of death guidelines (not pediatric specific), 2) a multidisciplinary symposium of national and international pediatric donation after circulatory determination of death leaders, and 3) a scoping review of the pediatric donation after circulatory determination of death literature. Input from these sources drove drafting of actionable questions and Good Practice Statements, as defined by the Grading of Recommendations Assessment, Development, and Evaluation group. We performed additional literature reviews for all actionable questions. Evidence was assessed for quality using Grading of Recommendations Assessment, Development, and Evaluation and then formulated into evidence profiles that informed recommendations through the evidence-to-decision framework. Recommendations were revised through consensus among members of seven topic-specific working groups and finalized during meetings of working group leads and the planning committee. External review was provided by pediatric, critical care, and critical care nursing professional societies and patient partners. Results: We generated 63 Good Practice Statements and seven Grading of Recommendations Assessment, Development, and Evaluation recommendations covering 1) ethics, consent, and withdrawal of life-sustaining therapy, 2) eligibility, 3) withdrawal of life-sustaining therapy practices, 4) ante and postmortem interventions, 5) death determination, 6) neonatal pediatric donation after circulatory determination of death, 7) cardiac and innovative pediatric donation after circulatory determination of death, and 8) implementation. For brevity, 48 Good Practice Statement and truncated justification are included in this summary report. The remaining recommendations, detailed methodology, full Grading of Recommendations Assessment, Development, and Evaluation tables, and expanded justifications are available in the full text report. Conclusions: This process showed that rigorous, transparent clinical practice guideline development is possible in the domain of pediatric deceased donation. Application of these recommendations will increase access to pediatric donation after circulatory determination of death across Canada and may serve as a model for future clinical practice guideline development in deceased donation. PMID:28925929

[Clinical Practice Guidelines for Management of Schizophrenia: Evaluation Using AGREE II].

PubMed

de la Hoz Bradford, Ana María; Ávila, Mauricio J; Bohórquez Peñaranda, Adriana Patricia; García Valencia, Jenny; Arenas Borrero, Álvaro Enrique; Vélez Traslaviña, Ángela; Jaramillo González, Luis Eduardo; Gómez-Restrepo, Carlos

2014-01-01

Colombia is developing multiple national practice guidelines from a range of diseases. Clinical practice guidelines represent a very useful tool to be able to take decision over a patient care that is widely available for the clinician. In psychiatry there are a good number of international clinical guidelines for the treatment of schizophrenia nevertheless there is no article that evaluate them scientifically In the settings of developing a Colombian schizophrenia practice guideline, a systematic search was performed in multiple databases and the results were then evaluated by two trained persons. We present the results globally and by domains. We found 164 matches for possible guidelines. After screening 7 guidelines were evaluated with the AGREE II instrument. Globally and by the different domains, the National Institute for Health and Care Excellence (NICE) was the guideline that got the best score. From the guidelines that were reviewed, 4 were from Europe and only 2 were from Latin America. None of the guidelines used GRADE methodology for the recommendations. The diversity of the schizophrenia treatment guidelines does not allow an easy adoption of the recommendation by a psychiatrist in Colombia. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

[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.

A "good practice" approach to the quality and consistency of morphological examination of the internal head structures of the term rabbit fetus.

PubMed

French, Julian M

2014-07-01

Variation in the interpretation of the regulatory guidelines has resulted in a diversity of techniques employed to examine the internal structures of the foetal rabbit head. Examination of the foetal rabbit brain, using a single transverse section as the sole technique, is considered not to be sufficiently thorough to be regarded as an adequate examination method. It is not compliant with published EPA and OECD guidelines covering required examination of the internal head structures, nor is it considered to conform to the spirit of the safety assessment required by the ICH guideline. Fixation of approximately half of the heads in each litter to allow the examination of multiple transverse sections enables the major structures within the head to be assessed effectively. This method is compliant with current guidelines, represents "good practice" and should be consistently adopted for the examination of the internal head structures of the term rabbit foetus. Copyright © 2014 Elsevier Inc. All rights reserved.

Coordinated, Collaborative and Coherent: Developing and Implementing E-Learning Guidelines within a National Tertiary Education System

ERIC Educational Resources Information Center

Suddaby, Gordon; Milne, John

2008-01-01

Purpose: The paper aims to discusses two complementary initiatives focussed on developing and implementing e-learning guidelines to support good pedagogy in e-learning practice. Design/methodology/approach: The first initiative is the development of a coherent set of open access e-learning guidelines for the New Zealand tertiary sector. The second…

Critical appraisal of clinical practice guidelines in pediatric infectious diseases.

PubMed

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

2015-10-01

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

Updated CCPS Investigation Guidelines book.

PubMed

Philley, J; Pearson, K; Sepeda, A

2003-11-14

Incident investigation standards and performance criteria continue to improve. In recognition, the Center for Chemical Process Safety (CCPS) undertook a major project to upgrade and update the Incident Investigation Guidelines originally published in 1992. These significantly expanded guidelines provide a practical resource for effective investigation of process-related incidents, and reflect changes in good practices and expectations of regulators. This paper highlights the content of the new guidelines with special emphasis on what is new and improved. Entirely new chapters address the topics of legal considerations, the near-miss event, and continuous improvement of the investigation system. The objective of the guidelines is to allow chemical process organizations to develop and implement an incident investigation management system that is effective in identifying underlying causes.

[Clinical practice guidelines and knowledge management in healthcare].

PubMed

Ollenschläger, Günter

2013-10-01

Clinical practice guidelines are key tools for the translation of scientific evidence into everyday patient care. Therefore guidelines can act as cornerstones of evidence based knowledge management in healthcare, if they are trustworthy, and its recommendations are not biased by authors' conflict of interests. Good medical guidelines should be disseminated by means of virtual (digital/electronic) health libraries - together with implementation tools in context, such as guideline based algorithms, check lists, patient information, a.s.f. The article presents evidence based medical knowledge management using the German experiences as an example. It discusses future steps establishing evidence based health care by means of combining patient data, evidence from medical science and patient care routine, together with feedback systems for healthcare providers.

[Pharmaceutical product quality control and good manufacturing practices].

PubMed

Hiyama, Yukio

2010-01-01

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

[Implementation of good quality and safety practices. Descriptive study in a occupational mutual health centre].

PubMed

Manzanera, R; Plana, M; Moya, D; Ortner, J; Mira, J J

2016-01-01

To describe the level of implementation of quality and safety good practice elements in a Mutual Society health centre. A Cross-sectional study was conducted to assess the level of implementation of good practices using a questionnaire. Some quality dimensions were also assessed (scale 0 to 10) by a set of 87 quality coordinators of health centres and a random sample of 54 healthcare professionals working in small centres. Seventy quality coordinators and 27 professionals replied (response rates 80% and 50%, respectively. There were no differences in the assessment of quality attributes between both groups. They identified as areas for improvement: use of practice guidelines (7.6/10), scientific and technical skills (7.5/10), and patient satisfaction (7.7/10). Availability and accessibility to clinical reports, informed consent, availability of hydro-alcoholic solution, and to record allergies, were considered of high importance to be implemented, with training and research, improvements in equipment and technology plans, adherence to clinical practice guidelines and the preparation of risk maps, being of less importance. The good practices related to equipment and resources have a higher likelihood to be implemented, meanwhile those related to quality and safety attitudes have more barriers before being implemented. The mutual has a similar behaviour than other healthcare institutions. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

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

PubMed

Hyde, Tiffany D

2014-01-01

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

Evidence-based practice guidelines in OHS: are they agree-able?

PubMed

Hulshof, Carel; Hoenen, John

2007-01-01

The purpose of this study was to evaluate the acceptance, validity, reliability and feasibility of the AGREE (Appraisal of Guidelines and REsearch and Evaluation) instrument to assess the quality of evidence-based practice guidelines for occupational physicians. In total, 6 practice guidelines of the Netherlands Society of Occupational Medicine (NVAB) were appraised by 20 occupational health professionals and experts in guideline development or implementation. Although appraisers often disagreed on individual item scores, the internal consistency and interrater reliability for most domains was sufficient. The AGREE criteria were in general considered relevant and no major suggestions for additional items for use in the context of occupational health were brought up. The domain scores for the individual guidelines show a wide variety: 'applicability' had on average the lowest mean score (53%) while 'scope and purpose' had the highest one (87%). Low scores indicate where improvements are possible and necessary, e.g. by providing more information about the development. Key experts in occupational health report that AGREE is a relevant and easy to use instrument to evaluate quality aspects and the included criteria provide a good framework to develop or update evidence-based practice guidelines in the field of occupational health.

Keep These Guidelines in Mind when Reviewing Your Religious Leave Policy.

ERIC Educational Resources Information Center

Sharp, Ralph

1986-01-01

Provides five guidelines to follow in developing alternative policy for accommodating employees' religious practices. Discusses two court cases where school systems lost to teachers because the schools did not make good-faith attempts to accommodate the teachers' religious needs. Includes outline of a board's comprehensive policy for religious…

Cost Accounting, Business Education: 7709.41.

ERIC Educational Resources Information Center

Carino, Mariano G.

Cost accounting principles and procedures provide students with sufficient background to apply cost accounting factors to service and manufacturing businesses. Overhead, materials, goods in process, and finished goods are emphasized. Students complete a practice set in the course, which has guidelines, performance objectives, learning activities…

Prioritizing guideline topics: development and evaluation of a practical tool.

PubMed

Ketola, Eeva; Toropainen, Erja; Kaila, Minna; Luoto, Riitta; Mäkelä, Marjukka

2007-08-01

A clear process for selecting and adopting clinical practice guidelines in the new topic areas is needed. The aim of this study is to design and develop a practical tool to assess guideline topics that have been suggested to the organization responsible for producing guidelines. We carried out an iterative development, feasibility and validation study of a guideline topic prioritization tool. The setting included the guideline producer organization and the tax-funded health care system. In the first stage of the tool development, participants were researchers, members of the Current Care Board and experts from health care organizations. In the second stage, the evaluation was done internally within the project by three independent reviewers. The main outcome measures were responses to an evaluation questionnaire, qualitative process feedback and analysis of the performance of the instrument on a random set of guidelines. Evaluations by three independent reviewers revealed good agreement and face validity with respect to its feasibility as a planning tool at the guideline board level. Feedback from board members suggested that the instrument is useful in prioritizing guideline topics. This instrument was accepted for use by the Board. Further developments are needed to ensure feedback and acceptability of the instrument by those proposing topics.

Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

PubMed

MacQueen, Kathleen M; Eley, Natalie T; Frick, Mike; Mingote, Laia Ruiz; Chou, Alicia; Seidel, Stephanie S; Hannah, Stacey; Hamilton, Carol

2016-07-01

Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials. © The Author(s) 2016.

Managing the Risk of Occupational Allergy in the Enzyme Detergent Industry

PubMed Central

Basketter, David A.; Kruszewski, Francis H.; Mathieu, Sophie; Kirchner, Donald Bruce; Panepinto, Anthony; Fieldsend, Mark; Siegert, Volker; Barnes, Fiona; Bookstaff, Robert; Simonsen, Merete; Concoby, Beth

2015-01-01

Enzyme proteins have potential to cause occupational allergy/asthma. Consequently, as users of enzymes in formulated products, detergents manufacturers have implemented a number of control measures to ensure that the hazard does not translate into health effects in the workforce. To that end, trade associations have developed best practice guidelines which emphasize occupational hygiene and medical monitoring as part of an effective risk management strategy. The need for businesses to recognize the utility of this guidance is reinforced by reports where factories which have failed to follow good industrial hygiene practices have given rise to incidences of occupational allergy. In this article, an overview is provided of how the industry guidelines are actually implemented in practice and what experience is to be derived therefrom. Both medical surveillance and air monitoring practices associated with the implementation of industry guidelines at approximately 100 manufacturing facilities are examined. The data show that by using the approaches described for the limitation of exposure, for the provision of good occupational hygiene and for the active monitoring of health, the respiratory allergenic risk associated with enzyme proteins can be successfully managed. This therefore represents an approach that could be recommended to other industries contemplating working with enzymes. PMID:25692928

Managing the Risk of Occupational Allergy in the Enzyme Detergent Industry.

PubMed

Basketter, David A; Kruszewski, Francis H; Mathieu, Sophie; Kirchner, Donald Bruce; Panepinto, Anthony; Fieldsend, Mark; Siegert, Volker; Barnes, Fiona; Bookstaff, Robert; Simonsen, Merete; Concoby, Beth

2015-01-01

Enzyme proteins have potential to cause occupational allergy/asthma. Consequently, as users of enzymes in formulated products, detergents manufacturers have implemented a number of control measures to ensure that the hazard does not translate into health effects in the workforce. To that end, trade associations have developed best practice guidelines which emphasize occupational hygiene and medical monitoring as part of an effective risk management strategy. The need for businesses to recognize the utility of this guidance is reinforced by reports where factories which have failed to follow good industrial hygiene practices have given rise to incidences of occupational allergy. In this article, an overview is provided of how the industry guidelines are actually implemented in practice and what experience is to be derived therefrom. Both medical surveillance and air monitoring practices associated with the implementation of industry guidelines at approximately 100 manufacturing facilities are examined. The data show that by using the approaches described for the limitation of exposure, for the provision of good occupational hygiene and for the active monitoring of health, the respiratory allergenic risk associated with enzyme proteins can be successfully managed. This therefore represents an approach that could be recommended to other industries contemplating working with enzymes.

Good practice in reviewing and publishing studies on herbal medicine, with special emphasis on traditional Chinese medicine and Chinese materia medica.

PubMed

Chan, Kelvin; Shaw, Debbie; Simmonds, Monique S J; Leon, Christine J; Xu, Qihe; Lu, Aiping; Sutherland, Ian; Ignatova, Svetlana; Zhu, You-Ping; Verpoorte, Rob; Williamson, Elizabeth M; Duez, Pierre

2012-04-10

Studies on traditional Chinese medicine (TCM), like those of other systems of traditional medicine (TM), are very variable in their quality, content and focus, resulting in issues around their acceptability to the global scientific community. In an attempt to address these issues, an European Union funded FP7 consortium, composed of both Chinese and European scientists and named "Good practice in traditional Chinese medicine" (GP-TCM), has devised a series of guidelines and technical notes to facilitate good practice in collecting, assessing and publishing TCM literature as well as highlighting the scope of information that should be in future publications on TMs. This paper summarises these guidelines, together with what has been learned through GP-TCM collaborations, focusing on some common problems and proposing solutions. The recommendations also provide a template for the evaluation of other types of traditional medicine such as Ayurveda, Kampo and Unani. GP-TCM provided a means by which experts in different areas relating to TCM were able to collaborate in forming a literature review good practice panel which operated through e-mail exchanges, teleconferences and focused discussions at annual meetings. The panel involved coordinators and representatives of each GP-TCM work package (WP) with the latter managing the testing and refining of such guidelines within the context of their respective WPs and providing feedback. A Good Practice Handbook for Scientific Publications on TCM was drafted during the three years of the consortium, showing the value of such networks. A "deliverable - central questions - labour division" model had been established to guide the literature evaluation studies of each WP. The model investigated various scoring systems and their ability to provide consistent and reliable semi-quantitative assessments of the literature, notably in respect of the botanical ingredients involved and the scientific quality of the work described. This resulted in the compilation of (i) a robust scoring system and (ii) a set of minimum standards for publishing in the herbal medicines field, based on an analysis of the main problems identified in published TCM literature. Good quality, peer-reviewed literature is crucial in maintaining the integrity and the reputation of the herbal scientific community and promoting good research in TCM. These guidelines provide a clear starting point for this important endeavour. They also provide a platform for adaptation, as appropriate, to other systems of traditional medicine. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

1997-06-15

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

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.

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

PubMed

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

2017-01-18

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

An appraisal of the 2012 American College of Rheumatology Guidelines for the Management of Gout.

PubMed

Nuki, George

2014-03-01

Appraisal of the 2012 American College of Rheumatology (ACR) Guidelines for the Management of Gout. The ACRs first clinical practice guidelines for the management of gout focus on recommendations for nonpharmacologic and pharmacologic approaches to hyperuricaemia and the treatment and prophylaxis of acute gouty arthritis. The RAND/UCLA appropriateness methodology employed assessed risks and benefits of alternative treatments for efficacy, safety and quality but not for cost-effectiveness. Novel recommendations include the use of either allopurinol or febuxostat for first-line urate-lowering drug therapy (ULT), screening for HLA-B*5801 prior to initiation of allopurinol in Asians at relatively high risk for allopurinol hypersensitivity, and the use of pegloticase for patients with severe, symptomatic, tophaceous gout refractory to, or intolerant of, appropriately dosed ULTs. Appraisal and comparison with other guidelines using Guidelines International Network and Appraisal of Guidelines, Research and Evaluation (AGREE II) criteria showed good scores for scope and purpose, stakeholder involvement, rigour of development, clarity of presentation, editorial independence and, overall quality, but not for applicability. The ACR guidelines provide comprehensive, up-to-date, good-quality, evidence-based, expert consensus recommendations for the management of gout in clinical practice but score poorly for applicability. To improve the management of gout in the community a summary of key recommendations, criteria for audit and standards of care are now required.

A knowledge infrastructure for occupational safety and health.

PubMed

van Dijk, Frank J H; Verbeek, Jos H; Hoving, Jan L; Hulshof, Carel T J

2010-12-01

Occupational Safety and Health (OSH) professionals should use scientific evidence to support their decisions in policy and practice. Although examples from practice show that progress has been made in evidence-based decision making, there is a challenge to improve and extend the facilities that support knowledge translation in practice. A knowledge infrastructure that supports OSH practice should include scientific research, systematic reviews, practice guidelines, and other tools for professionals such as well accessible virtual libraries and databases providing knowledge, quality tools, and good learning materials. A good infrastructure connects facilities with each other and with practice. Training and education is needed for OSH professionals in the use of evidence to improve effectiveness and efficiency. New initiatives show that occupational health can profit from intensified international collaboration to establish a good functioning knowledge infrastructure.

What hospitals need to know about guidelines-A mixed-method analysis of guideline implementation in Dutch hospitals.

PubMed

Blume, Louise H K; van Weert, Nico J H W; Busari, Jamiu O; Stoopendaal, Annemiek M V; Delnoij, Diana M J

2017-12-01

This study provides insight into how Dutch hospitals ensure that guidelines are used in practice and identifies what key messages other hospitals can learn from existing practices. We examine current practices in handling compliance and, therefore, focus on hospitals that reported that they do not experience problems in the implementation of guidelines. A survey of Dutch hospital boards and 9 semistructured interviews were conducted with a purposive sample of 3 hospitals. Interviews were held with 3 representatives of each hospital, specifically, with a member of the board of directors, a member of the executive medical staff, and the manager of the quality and safety department. Hospitals find guidelines necessary and useful. Hospitals have the power to improve implementation if boards of directors and medical staff are committed, intrinsically motivated, cooperate with each other, and use guidelines pragmatically. Even then, they prioritize guidelines, as resources are scarce. Despite their good work, all hospitals in this study appeared to struggle to adhere to guidelines. If hospitals experience problems with guideline implementation, they tend to focus more on external expectations, leading to defensive behaviour. Hospitals that do not experience implementation problems focus more on integrating guidelines into their own policies. © 2017 John Wiley & Sons, Ltd.

Good manufacturing practices for medicinal products for human use.

PubMed

Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.

Good manufacturing practices for medicinal products for human use

PubMed Central

Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

Teacher-Board Relations in Connecticut: A Summary of the Law Regarding Scope of Negotiations, Good Faith Bargaining, and Unfair Labor Practices. Preliminary Draft.

ERIC Educational Resources Information Center

Zirkel, Perry A.

This document is a discussion draft intended to lead to the formulation of a set of guidelines by the state board of education concerning three areas of teacher negotiations: scope, good faith bargaining, and prohibited practices. It has been prepared in the form of an organized data base that focuses on summarizing the present state of the law…

An audit of bronchoscopy practice in the United Kingdom: a survey of adherence to national guidelines

PubMed Central

Honeybourne, D.; Neumann, C. S.

1997-01-01

BACKGROUND: Both patient and staff safety are of major importance during the procedure of fibreoptic bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and accessories used as well as careful monitoring during the procedure. Adequate facilities, manpower and training are also essential. Staff safety depends partly on adequate procedures to minimise any risks of sensitisation to agents such as glutaraldehyde. An audit was carried out of bronchoscopy procedures in hospitals in the UK and the findings were compared with published guidelines on good practice and clinical consensus. METHODS: A postal questionnaire was sent to 218 bronchoscopy units in the UK. Findings were then compared with published evidence of good practice in the areas of disinfection, including the use of glutaraldehyde, patient monitoring, manpower, facilities, and training. RESULTS: A 73% response rate was obtained. Recommended minimum disinfection times before and after routine bronchoscopies were not achieved by 35% of units. No disinfection was carried out in 34% of units before emergency bronchoscopies and in 19% of units after suspected cases of tuberculosis. Adequate rinsing of the bronchoscope with sterile or filtered water was not carried out by 43% of units. Contrary to recommendations, 31% of departments were still using glutaraldehyde in the patient examination room and inadequate room ventilation was common. Protective clothing was often not worn by staff during bronchoscopy. Inadequate intravenous access and use of supplementary oxygen were found in many units. Practice standards were higher in departments where dedicated bronchoscopy/endoscopy units of the hospital were used, and also where staff had been on external training courses. CONCLUSIONS: This audit has shown that many units do not adhere to guidelines on disinfection procedures and patient monitoring. Unnecessary potential risks due to staff exposure to glutaraldehyde were apparent. National guidelines on good practice are not being followed in areas which may potentially affect patient and staff safety. 


 PMID:9337830

EFNS guidelines for the diagnosis and management of Alzheimer's disease.

PubMed

Hort, J; O'Brien, J T; Gainotti, G; Pirttila, T; Popescu, B O; Rektorova, I; Sorbi, S; Scheltens, P

2010-10-01

In 2008 a task force was set up to develop a revision of the European Federation of the Neurological Societies (EFNS) guideline for the diagnosis and management of Alzheimer's disease (AD) and other disorders associated with dementia, published in early 2007. The aim of this revised international guideline was to present a peer-reviewed evidence-based statement for the guidance of practice for clinical neurologists, geriatricians, psychiatrists, and other specialist physicians responsible for the care of patients with AD. Mild cognitive impairment and non-Alzheimer dementias are not included in this guideline. The task force working group reviewed evidence from original research articles, meta-analysis, and systematic reviews, published before May 2009. The evidence was classified and consensus recommendations graded (A, B, or C) according to the EFNS guidance. Where there was a lack of evidence, but clear consensus, good practice points were provided. The recommendations for clinical diagnosis, blood tests, neuropsychology, neuroimaging, electroencephalography, cerebrospinal fluid (CSF) analysis, genetic testing, disclosure of diagnosis, treatment of AD, behavioural and psychological symptoms in dementia, legal issues, counselling and support for caregivers were all revised as compared with the previous EFNS guideline. A number of new recommendations and good practice points are made, namely in CSF, neuropsychology, neuroimaging and reviewing non-evidence based therapies. The assessment, interpretation, and treatment of symptoms, disability, needs, and caregiver stress during the course of AD require the contribution of many different professionals. These professionals should adhere to these guideline to improve the diagnosis and management of AD. © 2010 The Author(s). European Journal of Neurology © 2010 EFNS.

40 CFR 52.2633 - Stack height regulations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Wyoming § 52.2633 Stack height... with the “Guideline for Determination of Good Engineering Practice Stack Height (Technical Support...

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

PubMed Central

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

2011-01-01

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

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…

Death knocks, professional practice, and the public good: the media experience of suicide reporting in New Zealand.

PubMed

Collings, Sunny C; Kemp, Christopher G

2010-07-01

Health, government, and media organizations around the world have responded to research demonstrating the imitative effects of suicide coverage in the news media by developing guidelines to foster responsible reporting. Implementation of these guidelines has encountered some resistance, and little is known about the media perspective on suicide coverage and its effects on guideline use. This qualitative study provides an in-depth appreciation of this perspective by investigating the experiences of journalists covering suicide in New Zealand. Fifteen newspaper, television and radio journalists were interviewed between December 2008 and March 2009 and transcripts were analyzed using a grounded hermeneutic editing approach. Five themes were identified: public responsibility, media framing of suicide, professional practice, personal experience of suicide reporting, and restricted reporting. Participants asserted the role of the media in the protection of the public good. Though this stance aligns them with the goals of health policymakers, it is derived from a set of professional mores at odds with the perceived paternalism of suicide reporting guidelines. Participants were stakeholders in the issue of suicide coverage. We conclude that policymakers must engage with the news media and acknowledge the competing imperatives that provide the context for the application of suicide reporting guidelines by individual journalists. Collaborative guideline development will be vital to effective implementation. Copyright 2010 Elsevier Ltd. All rights reserved.

[Software for illustrating a cost-quality balance carried out by clinical laboratory practice].

PubMed

Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi

2010-09-01

We have no proper reference indicating the quality of clinical laboratory practice, which should clearly illustrates that better medical tests require more expenses. Japanese Society of Laboratory Medicine was concerned about recent difficult medical economy and issued a committee report proposing a guideline to evaluate the good laboratory practice. According to the guideline, we developed software that illustrate a cost-quality balance carried out by clinical laboratory practice. We encountered a number of controversial problems, for example, how to measure and weight each quality-related factor, how to calculate costs of a laboratory test and how to consider characteristics of a clinical laboratory. Consequently we finished only prototype software within the given period and the budget. In this paper, software implementation of the guideline and the above-mentioned problems are summarized. Aiming to stimulate these discussions, the operative software will be put on the Society's homepage for trial

What Medical Writing Means To Me

PubMed Central

Wager, Elizabeth

2007-01-01

This is a personal account based on many years experience as a medical writer. It considers aspects of medical writing with particular focus on the intellectual and ethical dilemmas it can raise. What makes medical writing both so interesting and so challenging is the fact that it often takes place at the border between different disciplines. For example, it straddles both science and art. Ethical issues also arise at the boundaries between academia and commerce. Until recently there have been few guidelines to help navigate such potentially dangerous territory. I have been privileged to be involved in developing two such guidelines and I describe how I hope the Good Publication Practice guidelines for pharmaceutical companies and the European Medical Writers Association guidelines may improve the practice of this fascinating profession, Medical Writing. PMID:22058630

What medical writing means to me.

PubMed

Wager, Elizabeth

2007-01-01

This is a personal account based on many years experience as a medical writer. It considers aspects of medical writing with particular focus on the intellectual and ethical dilemmas it can raise. What makes medical writing both so interesting and so challenging is the fact that it often takes place at the border between different disciplines. For example, it straddles both science and art. Ethical issues also arise at the boundaries between academia and commerce. Until recently there have been few guidelines to help navigate such potentially dangerous territory. I have been privileged to be involved in developing two such guidelines and I describe how I hope the Good Publication Practice guidelines for pharmaceutical companies and the European Medical Writers Association guidelines may improve the practice of this fascinating profession, Medical Writing.

Guidelines for drug donations.

PubMed Central

Hogerzeil, H. V.; Couper, M. R.; Gray, R.

1997-01-01

Drug donations are usually given in response to acute emergencies, but they can also be part of development aid. Donations may be given directly by governments, by non-governmental organisations, as corporate donations (direct or through private voluntary organisations), or as private donations to single health facilities. Although there are legitimate differences between these donations, basic rules should apply to them all. This common core of "good donation practice" is the basis for new guidelines which have recently been issued by the World Health Organisation after consultation with all relevant United Nations agencies, the Red Cross, and other major international agencies active in humanitarian emergency relief. This article summarises the need for such guidelines, the development process, the core principles, and the guidelines themselves and gives practical advice to recipients and donor agencies. PMID:9116555

[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.

Canadian physicians' attitudes about and preferences regarding clinical practice guidelines

PubMed Central

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

1997-01-01

OBJECTIVE: To assess Canadian physicians' confidence in, attitudes about and preferences regarding clinical practice guidelines. DESIGN: Cross-sectional, self-administered mailed survey. PARTICIPANTS: Stratified random sample of 3000 Canadian physicians; 1878 (62.6%) responded. SETTING: Canada. OUTCOME MEASURES: Physicians' use of various information sources; familiarity with and confidence in guidelines; attitudes about guidelines and their effect on medical care; rating of importance of guidelines and other sources of information in clinical decision-making; rating of importance of various considerations in deciding whether to adopt a set of guidelines; and rating of usefulness of different formats for presenting guidelines. MAIN RESULTS: In all, 52% of the respondents reported using guidelines at least monthly, substantially less frequently than traditional information sources. Most of the respondents expressed confidence in guidelines issued by various physician organizations, but 51% to 77% were not confident in guidelines issued by federal or provincial health ministries or by health insurance plans. The respondents were generally positive about guidelines (e.g., over 50% strongly agreed that they are a convenient source of advice and good educational tools); however, 22% to 26% had concerns about loss of autonomy, the rigidity of guidelines and decreased satisfaction with medical practice. Endorsement by respected colleagues or major organizations was identified as very important by 78% and 62% of the respondents respectively in deciding whether to adopt a set of guidelines in their practice. User friendliness of the guidelines format was thought to be very important by 62%; short pamphlets, manuals summarizing a number of guidelines, journal articles and pocket cards summarizing guidelines were the preferred formats (identified as most useful by 50% to 62% of the respondents). CONCLUSIONS: Canadian physicians, although generally positive about guidelines and confident in those developed by clinicians, have not yet integrated the use of guidelines into their practices to a large extent. Our results suggest that respected organizations and opinion leaders should be involved in the development of guidelines and that the acceptability of any proposed format and medium for guidelines presentation should be pretested. PMID:9220923

Workplace etiquette for the medical practice employee.

PubMed

Hills, Laura

2010-01-01

Medical practice workplace etiquette is slowly being modified and fine-tuned. New workplace etiquette rules have become necessary because of advances in communications technology, shifting norms, and expectations of what constitutes good manners. Today's medical practice employees must concern themselves with traditional workplace manners but also the manners that come into play when they make or receive cell phone calls, text messages, and e-mails, and when they use social networking media outside of work. This article offers 25 rules for good manners in the medical practice that relate to the ways employees interact with people today, whether face-to-face or when using electronic communications technologies. It offers practical guidelines for making introductions both inside and outside the medical practice. This article also provides a self-quiz to help medical practice employees assess their workplace etiquette intelligence and 12 tips for good workplace table manners.

To adopt, to adapt, or to contextualise? The big question in clinical practice guideline development.

PubMed

Dizon, Janine Margarita; Machingaidze, Shingai; Grimmer, Karen

2016-09-13

Developing new clinical practice guidelines (CPGs) can be time-consuming and expensive. A more efficient approach could be to adopt, adapt or contextualise recommendations from existing good quality CPGs so that the resultant guidance is tailored to the local context. The first steps are to search for international CPGs that have a similar purpose, end-users and patients to your situation. The second step is to critically appraise the methodological quality of the CPGs to ensure that your guidance is based on credible evidence. Then the decisions begin. Can you simply 'adopt' this (parent) clinical practice guidelines, and implement the recommendations in their entirety, without any changes, in your setting? If so, then no further work is required. However this situation is rare. What is more likely, is that even if recommendations from the parent clinical practice guidelines can be adopted, how they are implemented needs to address local issues. Thus you may need to 'contextualise' the guidance, by addressing implementation issues such as local workforce, training, health systems, equipment and/or access to services. Generally this means that additional information is required (Practice/Context Points) to support effective implementation of the clinical practice guidelines recommendations. In some cases, you may need to 'adapt' the guidance, where you will make changes to the recommendations so that care is relevant to your local environments. This may involve additional work to search for local research, or obtain local consensus, regarding how best to adapt recommendations. For example, adaptation might reflect substituting one drug for another (drugs have similar effects, but the alternative drug to the recommended one may be cheaper, more easily obtained or more culturally acceptable). There is lack of standardisation of clinical practice guidelines terminology, leading clinical practice guideline activities often being poorly conceptualised or reported. We provide an approach that would help improve efficiency and standardisation of clinical practice guidelines activities.

Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care

PubMed Central

Scopetti, Matteo; Gatto, Vittorio

2017-01-01

The latest research achievements in the field of stem cells led in 2016 to the publication of “Guidelines for Stem Cell Research and Clinical Translation” by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered. PMID:29090010

Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care.

PubMed

Frati, Paola; Scopetti, Matteo; Santurro, Alessandro; Gatto, Vittorio; Fineschi, Vittorio

2017-01-01

The latest research achievements in the field of stem cells led in 2016 to the publication of "Guidelines for Stem Cell Research and Clinical Translation" by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.

PubMed

Ravinetto, Raffaella; De Nys, Katelijne; Boelaert, Marleen; Diro, Ermias; Meintjes, Graeme; Adoke, Yeka; Tagbor, Harry; Casteels, Minne

2015-12-30

Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other research counterparts. Non-commercial sponsors of clinical trials should surely invest in the development of adequate legal, administrative and management skills. By acknowledging their role and specificities, and by providing them with adapted guidance, the international Good Clinical Practices codes would provide valuable guidance and support to non-commercial clinical research, whose relevance for global health is increasingly evident.

Revised guidelines for good practice in IVF laboratories (2015).

PubMed

De los Santos, Maria José; Apter, Susanna; Coticchio, Giovanni; Debrock, Sophie; Lundin, Kersti; Plancha, Carlos E; Prados, Fernando; Rienzi, Laura; Verheyen, Greta; Woodward, Bryan; Vermeulen, Nathalie

2016-04-01

Which recommendations can be provided by the European Society of Human Reproduction and Embryology Special Interest Group (ESHRE SIG) Embryology to support laboratory specialists in the organization and management of IVF laboratories and the optimization of IVF patient care? Structured in 13 sections, the guideline development group formulated recommendations for good practice in the organization and management of IVF laboratories, and for good practice of the specific procedures performed within the IVF laboratory. NA. The guideline was produced by a group of 10 embryologists representing different European countries, settings and levels of expertise. The group evaluated the document of 2008, and based on this assessment, each group member rewrote one or more sections. Two 2-day meetings were organized during which each of the recommendations was discussed and rewritten until consensus within the guideline group was reached. After finalizing the draft, the members of the ESHRE SIG embryology were invited to review the guideline. NA. The guideline provides recommendations on the general organization of an IVF laboratory (staffing and direction, quality management, laboratory safety), and on the specific aspects of the procedures performed in IVF laboratories (Identification of patients and traceability of their reproductive cells, consumables, handling of biological material, oocyte retrieval, sperm preparation, insemination of oocytes, scoring for fertilization, embryo culture and transfer, and cryopreservation). A last section provides recommendations regarding an Emergency plan for IVF laboratories. Evidence on most of the issues described is scarce, and therefore it was decided not to perform a formal search for and assessment of scientific evidence. However, recommendations published in the EUTCD and relevant and recent documents, manuals and consensus papers were taken into account when formulating the recommendations. Despite the limitations, the guideline group is confident that this document will be helpful to directors and managers involved in the management and organization of IVF laboratories, but also to embryologists and laboratory technicians performing daily tasks. The guideline was developed and funded by ESHRE, covering expenses associated with the guideline meetings. The guideline group members did not receive payment. Dr Coticchio reports speaker's fees from IBSA and Cook, outside the submitted work; Dr Lundin reports grants from Vitrolife, personal fees from Merck Serono, non-financial support from Unisense, outside the submitted work; Dr. Rienzi reports personal fees from Merck Serono, personal fees from MSD, grants from GFI, outside the submitted work; the other authors had nothing to disclose. NA. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Good collaborative practice: reforming capacity building governance of international health research partnerships.

PubMed

Ward, Claire Leonie; Shaw, David; Sprumont, Dominique; Sankoh, Osman; Tanner, Marcel; Elger, Bernice

2018-01-08

In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines - the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH-GCP should reference CIOMS ethical guidelines as the established standard for collaborative partnership. Moreover, greater commitment and support should be given to co-ordinate, strengthen and enforce local laws requiring equitable research partnerships and health system strengthening.

International variations in clinical practice guidelines for palliative sedation: a systematic review.

PubMed

Abarshi, Ebun; Rietjens, Judith; Robijn, Lenzo; Caraceni, Augusto; Payne, Sheila; Deliens, Luc; Van den Block, Lieve

2017-09-01

Palliative sedation is a highly debated medical practice, particularly regarding its proper use in end-of-life care. Worldwide, guidelines are used to standardise care and regulate this practice. In this review, we identify and compare national/regional clinical practice guidelines on palliative sedation against the European Association for Palliative Care (EAPC) palliative sedation Framework and assess the developmental quality of these guidelines using the Appraisal Guideline Research and Evaluation (AGREE II) instrument. Using the PRISMA criteria, we searched multiple databases (PubMed, CancerLit, CINAHL, Cochrane Library, NHS Evidence and Google Scholar) for relevant guidelines, and selected those written in English, Dutch and Italian; published between January 2000 and March 2016. Of 264 hits, 13 guidelines-Belgium, Canada (3), Ireland, Italy, Japan, the Netherlands, Norway, Spain, Europe, and USA (2) were selected. 8 contained at least 9/10 recommendations published in the EAPC Framework; 9 recommended 'pre-emptive discussion of the potential role of sedation in end-of-life care'; 9 recommended 'nutrition/hydration while performing sedation' and 8 acknowledged the need to 'care for the medical team'. There were striking differences in terminologies used and in life expectancy preceding the practice. Selected guidelines were conceptually similar, comparing closely to the EAPC Framework recommendations, albeit with notable variations. Based on AGREE II, 3 guidelines achieved top scores and could therefore be recommended for use in this context. Also, domains 'scope and purpose' and 'editorial independence' ranked highest and lowest, respectively-underscoring the importance of good reportage at the developmental stage. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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.

[ADHD and addiction; application of the Belgian guideline with particular reference to comorbid affective disorders].

PubMed

Matthys, F; Joostens, P; Tremmery, S; Stes, S; Sabbe, B

2013-01-01

Two patients with a multi-substance use disorder and an apparent comorbid ADHD disorder were given psychiatric treatment for both illnesses. Each patient had a comorbid affective disorder. In both cases the approach was based on the Belgian guideline Good clinical practice in the recognition and treatment of young adults with addiction problems& squo. We use the case-reports to demonstrate the usefulness and relevance of the guideline in an outpatient setting compared to an inpatient setting and look particularly at the implications of other kinds of comorbidity encompassed by the guideline.

Importance of adherence to guidelines in breast cancer clinical practice. The Italian experience (AIOM).

PubMed

Barni, Sandro; Venturini, Marco; Molino, Annamaria; Donadio, Michela; Rizzoli, Sara; Maiello, Evaristo; Gori, Stefania

2011-01-01

Project RIGHT (Research for the Identification of the most effective and hIGHly accepted clinical guidelines for cancer Treatment) is promoted by the Italian Association of Medical Oncology (AIOM) to evaluate the concordance between AIOM breast cancer guidelines and clinical practice in Italy. In RIGHT-1, feasibility and the appropriateness of indicators were assessed in patients with early breast cancer. RIGHT-2 evaluated the compliance with guidelines in a nationwide program. Thirty-five Italian centers participated in the RIGHT-2 survey. Ten indicators were evaluated to verify an agreement between 2005 AIOM breast cancer guidelines and practice. Patients with clinical stage I-II invasive breast cancer, age ≤70 years, who had their first visit at the oncology center between October 2005 and November 2006 were included. In RIGHT-2, ≥90% adherence for the diagnosis indicator and three therapy indicators were observed. The lowest degree of compliance (0%) was observed for the follow-up indicator in asymptomatic patients. In RIGHT-2, compliance to the 2005 AIOM breast cancer guidelines was 64%. When the follow-up indicator was eliminated, overall adherence to AIOM guidelines was 71%. The results highlight the need to continue improving the already good standards of breast cancer care.

A Wiki Collaboration to Create National Guidelines: Tips for Professional Practice

ERIC Educational Resources Information Center

Moser, Patt

2009-01-01

In 2006, technology directors from independent schools across the country had banded together and created "Principles of Good Practice" for technology in independent schools. These principles "define high standards and ethical behavior in key areas of independent school operations" (NAIS 2006). This author decided that it was time for the National…

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2011 CFR

2011-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

40 CFR 60.1690 - What are the operating practice requirements for my municipal waste combustion unit?

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirements for my municipal waste combustion unit? 60.1690 Section 60.1690 Protection of Environment... SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operating Requirements § 60.1690 What...

Risk Management for Study Abroad Programs: Issues and Resources to Inform Program Development, Administration, and Training

ERIC Educational Resources Information Center

Rhodes, Gary

2014-01-01

This chapter provides a practical background to the health and safety risks and challenges for U.S. colleges and universities and other program providers. Potential risks, field-based guidelines, good practices, and resources to support the management of risks by study abroad offices will be covered.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2012-01-01

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: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.

The Good Clinical Practice guideline and its interpretation - perceptions of clinical trial teams in sub-Saharan Africa.

PubMed

Vischer, N; Pfeiffer, C; Joller, A; Klingmann, I; Ka, A; Kpormegbe, S K; Burri, C

2016-08-01

To explore the advantages and challenges of working with the Good Clinical Practice (GCP)-International Conference of Harmonization (ICH) E6 guideline and its interpretation from the perspective of clinical trial teams based in sub-Saharan Africa. We conducted 60 key informant interviews with clinical trial staff at different levels in clinical research centres in Kenya, Ghana, Burkina Faso and Senegal and thematically analysed the responses. Clinical trial teams perceived working with ICH-GCP as highly advantageous and regarded ICH-GCP as applicable to their setting and efficiently applied. Only for informed consent did some clinical trial staff (one-third) perceive the guideline as insufficiently applicable. Specific challenges included meeting the requirements for written and individual consent, conditions for impartial witnesses for illiterates or legally acceptable representatives for children, guaranteeing voluntary participation and ensuring full understanding of the consent given. It was deemed important to have ICH-GCP compliance monitored by relevant ethics committees and regulatory authorities, without having guidelines applied overcautiously. Clinical trial teams in sub-Saharan Africa perceived GCP as a helpful guideline, despite having been developed by northern organisations and despite the high administrative burden of implementing it. To mitigate consent challenges, we suggest adapting GCP and making use of the flexibility it offers. © 2016 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

Good governance in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

NASA Astrophysics Data System (ADS)

Wee, Seow Ta; Abas, Muhamad Azahar; Mohamed, Sulzakimin; Chen, Goh Kai; Zainal, Rozlin

2017-10-01

The National Solid Waste Management Policy (NSWMP) was introduced in 2007 under the Act 672. The execution of NSWMP involves stakeholders from various government agencies and a collaboration with the private sectors. Despite the initiatives taken by the stakeholders, the objectives of NSWMP failed to materialise. One of the major constraints is weak governance among stakeholders with regards to the NSWMP implementation. This paper will explore the good governance practices implemented by the stakeholders. Identifying the current good governance practices implemented by the stakeholders is crucial as it will serve as a guideline to improve good governance practice in the future. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires involved in the NSWMP implementation. A total of six respondents took part in this study. The findings of this study show that there are several good governance practices implemented in policy promotion, participation of stakeholders, and capacity enhancement programme for the staff. This study also proposed some points on good governance practices in the context of policy promotion and staff development. A paradigm shift by the stakeholders is imperative so as to enhance the good governance practice in NSWMP implementation towards an efficient solid waste management in Malaysia.

Defining the Path Forward: Guidance for Laboratory Medicine Guidelines

PubMed Central

Jones, Patricia M.; Chin, Alex C.; Christenson, Robert H.

2015-01-01

The National Academy of Clinical Biochemistry (NACB) has developed consensus-based guidelines for the laboratory evaluation and monitoring of patients with specified disorders for two decades. In 1997, the NACB recognized the need to standardize the process of guideline development and promulgated its first Standard Operating Procedure (SOP) for this purpose. In 2010, the American Association of Clinical Chemistry (AACC) and NACB created the Evidence-Based Laboratory Medicine Committee (EBLMC). Among other roles, this group was given responsibility to provide oversight of clinical practice guideline development in accordance with SOP guidance and using currently accepted good practices. In 2011, the U.S. Institute of Medicine (IOM) published two reports of relevance: ‘Clinical Practice Guidelines We Can Trust’ and ‘Finding What Works in Health Care – Standards for Systematic Reviews.’ These reports were created as part of a response to a legislative mandate from the U.S. Congress requesting that steps be taken to implement recommendations from lOM’s report on ‘Knowing What Works in Health Care’ (2008). The latest revision of the laboratory medicine practice guidelines (LMPG) SOP was in part driven by these reports. NACB continues to develop LMPGs at a rate of roughly one per year through standard processes detailed in its 2014 revision of the SOP. This article describes the NACB and EBLMC experience in developing LMPGs with a focus on the evolution and use of the latest SOP. AACC and NACB have established a solid track record in collaboratively working with many clinical societies and professional organizations on clinical practice guideline development. Presently, three LMPG’s are in various stages of development and all with the collaboration of other clinical/professional groups. The practices and tools being used for current LMPGs in progress are also highlighted in the context of the challenges that presently exist for effective clinical practice guideline development in the U.S. PMID:27683491

Clinical examination & record-keeping: Part 2: History taking.

PubMed

Hadden, A M

2017-12-15

This article is the second part of a BDJ series of Practice papers on the subject of clinical examination and related record keeping. The series is taken from the Faculty of General Dental Practice UK (FGDP[UK]) 2016 Good Practice Guidelines book on this topic, edited by A. M. Hadden. This particular article discusses history taking, where information may be gathered prior to the patient seeing the clinician or, in some cases, this may be carried out chairside by the individual. The information gathered can include a medical history, socio-behavioural history, and patient anxiety levels. It is important to note that throughout this article (and the BDJ series and associated FGDP[UK] book), the specific guidelines will be marked as follows: A: Aspirational, B: Basic, C: Conditional. Further information about this guideline notation system is provided in Part 1 of this series ( 2017; 223: 765-768).

The constraints of good governance practice in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

NASA Astrophysics Data System (ADS)

Wee, Seow Ta; Abas, Muhamad Azahar; Chen, Goh Kai; Mohamed, Sulzakimin

2017-10-01

Nowadays, international donors have emphasised on the adoption of good governance practices in solid waste management which include policy implementation. In Malaysia, the National Solid Waste Management Policy (NSWMP) was introduced as the main guideline for its solid waste management and the Malaysian government has adopted good governance practice in the NSMWP implementation. However, the good governance practices implemented by the Malaysian government encountered several challenges. This study was conducted to explore the good governance constraints experienced by stakeholders in the NSWMP implementation. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires that involved in the NSWMP implementation in Malaysia. A total of six respondents took part in this study. The findings revealed three main good governance constraints in the NSWMP implementation, namely inadequate fund, poor staff's competency, and ambiguity of policy implementation system. Moreover, this study also disclosed that the main constraint influenced the other constraints. Hence, it is crucial to identify the main constraint in order to minimise its impact on the other constraints.

A systematic literature review on the ethics of palliative sedation: an update (2016).

PubMed

Henry, Blair

2016-09-01

Palliative sedation has been the subject of intensive debate since its first appearance in 1990. In a 2010 review of palliative sedation, the following areas were identified as lacking in consensus: inconsistent terminology, its use in nonphysical suffering, the ongoing experience of distress, and concern that the practice of palliative sedation may hasten death. This review looks at the literature over the past 6 years and provides an update on these outstanding concerns. Good clinical guidelines and policies are still required to address issues of emotional distress and waylay concerns that palliative sedation hastens death. The empirical evidence suggests some movement toward consensus on the practice of palliative sedation. However, a continued need exists for evidence-informed practice guidelines, education, and research to support the ethical practice of palliative sedation at the end of life. Until that time, clinicians are advised to adopt a framework or guideline that has been expert driven to ensure consistent and ethical use of palliative sedation at the end of life.

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.

Evidence-based practice guidelines: a survey of subcutaneous dexamethasone administration.

PubMed

Walker, Jackie; Lane, Pauline; McKenzie, Clare

2010-10-01

Searching for good evidence to develop clinical practice guidelines can be challenging, as research may not be published or available. A simple question set the authors on a journey to find evidence related to the nursing administration of subcutaneous dexamethasone in the palliative setting. This article outlines the search for evidence and discusses the survey results to gather expert opinion about the nursing administration of dexamethasone. Survey results indicated that only 39% of community services gave dexamethasone via a bolus injection and 88% gave it via a continuous infusion, mainly for site preservation. The diluents used were water for injection or normal saline. Many procedural aspects were supported by current guidelines, with several services using the New Zealand Waitemata District Health Board's (2008) clinical guidelines. Developing and implementing procedural recommendations for nurses to administer this subcutaneous medication will form the next stage of the project.

I.S.Mu.L.T. first-time patellar dislocation guidelines

PubMed Central

Vetrano, Mario; Oliva, Francesco; Bisicchia, Salvatore; Bossa, Michela; De Carli, Angelo; Di Lorenzo, Luigi; Erroi, Davide; Forte, Alfonso; Foti, Calogero; Frizziero, Antonio; Gasparre, Giuseppe; Via, Alessio Giai; Innocenti, Bernardo; Longo, Umile Giuseppe; Mahmoud, Asmaa; Masiero, Stefano; Mazza, Daniele; Natali, Simone; Notarangelo, Christian; Osti, Leonardo; Padulo, Johnny; Pellicciari, Leonardo; Perroni, Fabrizio; Piccirilli, Eleonora; Ramponi, Carlo; Salvatore, Giuseppe; Panni, Alfredo Schiavone; Suarez, Tania; Tarantino, Umberto; Vittadini, Filippo; Vulpiani, Maria Chiara; Ferretti, Andrea; Maffulli, Nicola

2017-01-01

Summary Primary traumatic patellar dislocation is common, particularly in young active individuals. A consensus on its management is still lacking. The present work provides easily accessible guidelines to be considered as recommendations for a good clinical practice developed through a process of systematic review of the literature and expert opinion, to improve the quality of care and rationalize the use of resources. Level of evidence: Ia. PMID:28717605

Nature and Quality of Antipsychotic Prescribing Practice in UK Psychiatry of Intellectual Disability Services

ERIC Educational Resources Information Center

Paton, C.; Flynn, A.; Shingleton-Smith, A.; McIntyre, S.; Bhaumik, S.; Rasmussen, J.; Hardy, S.; Barnes, T.

2011-01-01

Background: Antipsychotics are perceived to be over-used in the management of behavioural problems in people with an intellectual disability (ID). Published guidelines have set good practice standards for the use of these drugs for behavioural indications. We sought to identify the range of indications for which antipsychotic drugs are prescribed…

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.

Ten Rules for Good Behavior.

ERIC Educational Resources Information Center

Hingsburger, Dave

1986-01-01

Ten guidelines for effective use of positive reinforcement as a parenting technique are described. Practical examples are used to illustrate such principles as consistency, immediacy, and specificity in giving praise. A distinction is made between giving reinforcement and giving love. (JW)

Evidence-based medicine. Interpreting studies and setting policy.

PubMed

Woolf, S H; George, J N

2000-08-01

The ascendancy of EBM has been accompanied by a greater awareness of its shortcomings. It is increasingly evident from the cost, length, and difficulty of performing RCTs that studies cannot be launched to address every question in medicine. Good evidence is often lacking in medicine. Epistomologists question the very notions of evidence and the suitability of current study designs and measurement tools to research the salient issues of concern to patients and others concerned with quality. Lack of evidence of effectiveness does not prove ineffectiveness, yet, in reaction to EBM, insurance companies and government often make this inference to justify decisions to withhold coverage or research support. The unbridled enthusiasm for the evidence-based practice guideline of the early 1990s has been tempered by a more mature understanding of its limitations. Not many practice guidelines are developed well, and the implementation of flawed guidelines can cause harm. The seven-step process outlined earlier is slow, laborious, and expensive (sometimes costing hundreds of thousands of dollars). Moreover, there is little evidence that either the rigor of the methods or the guidelines themselves have a meaningful effect on practice behavior or patient outcomes. To the most cynical observers, the only consistent beneficiaries of guidelines are payers, who use guidelines with considerable success in reducing costs, lengths of stay, and utilization rates. Even ardent advocates of guidelines acknowledge the evidence that disseminating reviews and recommendations, by itself, fails to motivate clinicians to increase delivery of effective interventions and to abandon ineffective ones. This absence of response has stimulated a closer look at the barriers to behavior change and the design of thoughtful implementation strategies that begin with, but reach beyond, simple guidelines. Tools such as reminder systems, standing orders, academic detailing, peer review and audit, feedback, and health system changes recognize that knowing what to do is only one piece of an increasingly complex puzzle. The competitive marketplace of managed health care has added new economic influences on clinician behavior but is also fueling private-sector interest in good research. Patients, clinicians, and policy makers will continue to seek better data concerning what works in medicine and what does not.

Symptom relief in patients with pneumonia and dementia: implementation of a practice guideline.

PubMed

van der Maaden, Tessa; van der Steen, Jenny T; Koopmans, Raymond T C M; Doncker, Sarah M M M; Anema, Johannes R; Hertogh, Cees M P M; de Vet, Henrica C W

2017-08-01

This study aimed to assess the degree of implementation and barriers encountered in the use of a practice guideline for optimal symptom relief for patients with dementia and pneumonia in Dutch nursing homes. A process evaluation included assessment of reach, fidelity, and dose delivered using researcher's observations, and dose received was addressed in a question "use of the practice guideline," which the physicians completed for each patient included in the study. Perceived barriers were assessed with a structured questionnaire (response 69%) and semi-structured interviews (n = 14), which were subject to qualitative content analysis. Of the 55 physicians involved in the intervention phase, 87% attended an implementation meeting; 20 physicians joined the study later (reach). The intervention was implemented as planned, and all intervention components were delivered by the researchers (fidelity and dose delivered). Thirty-six physicians included 109 patients. For 81% of the patients, the treating physician stated to have used the guideline (dose received). The guideline was perceived as providing a good overview of current practice, but some physicians had expected a more directive protocol or algorithm. Further, recommended regular observations of symptoms were rarely performed. Physician's often felt that "this is not different from what we usually do," and with the acute illness, there was not always enough time to (re)familiarize with the contents. The physicians used the practice guideline frequently despite important barriers. Future implementation may involve strategies such as multiple interactive meetings. Further, the greatest potential to alter usual practice should be emphasized, such as using observational instruments. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Deficits in knowledge, attitude, and practice towards blood culture sampling: results of a nationwide mixed-methods study among inpatient care physicians in Germany.

PubMed

Raupach-Rosin, Heike; Duddeck, Arne; Gehrlich, Maike; Helmke, Charlotte; Huebner, Johannes; Pletz, Mathias W; Mikolajczyk, Rafael; Karch, André

2017-08-01

Blood culture (BC) sampling rates in Germany are considerably lower than recommended. Aim of our study was to assess knowledge, attitudes, and practice of physicians in Germany regarding BC diagnostics. We conducted a cross-sectional mixed-methods study among physicians working in inpatient care in Germany. Based on the results of qualitative focus groups, a questionnaire-based quantitative study was conducted in 2015-2016. In total, 706 medical doctors and final-year medical students from 11 out of 16 federal states in Germany participated. BC sampling was considered an important diagnostic tool by 95% of the participants. However, only 23% of them would collect BCs in three scenarios for which BC ordering is recommended by present guidelines in Germany; almost one out of ten physicians would not have taken blood cultures in any of the three scenarios. The majority of participants (74%) reported not to adhere to the guideline recommendation that blood culture sampling should include at least two blood culture sets from two different injection sites. High routine in blood culture sampling, perceived importance of blood culture diagnostics, the availability of an in-house microbiological lab, and the department the physician worked in were identified as predictors for good blood culture practice. Our study suggests that there are substantial deficits in BC ordering and the application of guidelines for good BC practice in Germany. Based on these findings, multimodal interventions appear necessary for improving BC diagnostics.

[Austrian guideline for palliative sedation therapy (long version) : Results of a Delphi process of the Austrian Palliative Society (OPG)].

PubMed

Weixler, Dietmar; Roider-Schur, Sophie; Likar, Rudolf; Bozzaro, Claudia; Daniczek, Thomas; Feichtner, Angelika; Gabl, Christoph; Hammerl-Ferrari, Bernhard; Kletecka-Pulker, Maria; Körtner, Ulrich H J; Kössler, Hilde; Meran, Johannes G; Miksovsky, Aurelia; Pusswald, Bettina; Wienerroither, Thomas; Watzke, Herbert

2017-02-01

Palliative sedation therapy (PST) is an important and ethically accepted therapy in the care of selected palliative care patients with otherwise unbearable suffering from refractory distress. PST is increasingly used in end-of-life care. Austria does not have a standardized ethical guideline for this exceptional practice near end of life, but there is evidence that practice varies throughout the country. The Austrian Palliative Society (OPG) nominated a multidisciplinary working group of 16 palliative care experts and ethicists who established the national guideline on the basis of recent review work with the aim to adhere to the Europeans Association of Palliative Care's (EAPC) framework on palliative sedation therapy respecting Austrians legal, structural and cultural background. Consensus was achieved by a four-step sequential Delphi process. The Delphi-process was strictly orientated to the recently published EUROIMPACT-sedation-study-checklist and to the AGREE-2-tool. Additionally national stakeholders participated in the reflection of the results. As a result of a rigorous consensus process the long version of the Austrian National Palliative Sedation Guideline contains 112 statements within eleven domains and is supplemented by a philosophers excursus on suffering. By establishing a national guideline for palliative sedation therapy using the Delphi technique for consensus and stakeholder involvement the Austrian Palliative Society aims to ensure nationwide good practice of palliative sedation therapy. Screening for the practicability and efficacy of this guideline will be a future task.

Practical Guidelines for Evaluating Sampling Designs in Survey Studies.

ERIC Educational Resources Information Center

Fan, Xitao; Wang, Lin

The popularity of sample surveys in evaluation and research makes it necessary for consumers to tell a good survey from a poor one. Several sources were identified that gave advice on how to evaluate a sample design used in a survey study. The sources are either too limited or too extensive to be useful practically. The purpose of this paper is to…

Facing the Challenge of e-Learning: Reflections on Teaching Evidence-Based Practice through Online Discussion Groups

ERIC Educational Resources Information Center

Clegg, Phil; Heap, John

2006-01-01

The advent of e-learning in higher education has entailed extensive use of online discussion boards to promote collaborative learning among students; however, the role of instructors as online facilitators is typically ill-defined due to a lack of sufficient standards or guidelines for good practice. In their audit of online discussion forum…

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

PubMed Central

2014-01-01

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

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

PubMed

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

2014-08-26

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

[Clinical application evaluation of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine].

PubMed

Liu, Meng-Yu; Yang, Wei; Wang, Li-Ying; Zhao, Xue-Yao; Wang, Yue-Xi; Liu, Yu-Qi; Han, Xue-Jie; Lv, Ai-Ping

2017-09-01

Clinical application evaluation research of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine intends to evaluate the quality level and clinical application of the guideline. A questionnaire and prospective case survey methods were used to evaluate the applicability evaluation based on the clinician questionnaire and the application evaluation based on clinical case observation. The applicability evaluation, familiarity and utilization rate of doctors' guidelines were 85.06%, 62.76%; Sort by technical grade, intermediate grade doctors have a higher familiarity rate and utilization rate, while the junior grade doctor's is lower; Guide quality level of applicability evaluation, other items' rational percentage are better than 96% except the items of health preserving and prevention and other treatment is relatively low; Items' applicable percentage of applicability evaluation are more than 91% except the item of guide simplicity. Comprehensive applicability evaluation, The percentage of the guideline applicable to clinical practice accounted for 94.94%. The consistency rate of syndrome differentiation and clinical application is more than 96% in addition to prescription medication, other treatments and health preserving and prevention of the guidelines apply consistency of application evaluation. The percentage of good treatment effect accounted for 92.96% of application effect evaluation. The safety percentage is 99.89% and economy is 97.45%. The research shows that of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine quality level is good and is basically applicable to pediatric clinical practice which can be used as a standardized recommendation of pediatric common diseases' treatment specification. A small part of the guidelines are not applicable and need to be further consummated. Health preserving and prevention and other treatment of the guideline need to be revised. Copyright© by the Chinese Pharmaceutical Association.

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.

The views of medical education stakeholders on guidelines for cultural diversity teaching.

PubMed

Dogra, Nisha

2007-03-01

The General Medical Council set out the framework within which it expects medical education to develop. Educational guidelines have been developed across the world but their development is less clear in the UK. There has been little work regarding views about educational guidelines. The research objective was to establish the views of medical education stakeholders towards specific guidelines for teaching in cultural diversity to medical students. Sixty-one individuals were interviewed using a semi-structured interview. Thematic analysis was undertaken after the interviews were transcribed verbatim. In total, 51 respondents felt that guidelines would be useful; 17 of these explicitly stipulated that these would only be useful if they were not prescriptive and if they were applied flexibly and were practical. Four respondents, including two policy-makers holding senior positions with medical educational bodies, felt that new guidelines would not be useful, as they already existed in some form. Five respondents were unsure if guidelines would be helpful or not. Guidelines were considered to be potentially useful for several reasons including to: help clarify what should be taught regarding cultural diversity and how it should be taught, provide justification for teaching the subject, help those unfamiliar with the subject, support those assigned with responsibility for developing such teaching, provide course and curriculum designers with reassurance, increase the credibility of the subject, set standards that serve as a benchmark against which schools can compare themselves with one another and highlight good practice. The reservations expressed suggest that the guidelines need to be developed using a range of stakeholders and have some degree of consensus to ensure that they will be used. The literature relating to attitudes towards clinical practice guidelines has much to contribute to the development of educational guidelines.

Swiss clinical practice guidelines on field cancerization of the skin.

PubMed

Hofbauer, Günther; Anliker, Mark; Boehncke, Wolf-Henning; Brand, Christoph; Braun, Ralph; Gaide, Olivier; Hafner, Jürg; Hunger, Robert; Itin, Peter; Kaeuper, Gina; Lautenschlager, Stephan; Mainetti, Carlo; Streit, Markus

2014-01-01

Actinic keratosis (AK) affects millions of people worldwide, and its prevalence continues to increase. AK lesions are caused by chronic ultraviolet radiation exposure, and the presence of two or more AK lesions along with photodamage should raise the consideration of a diagnosis of field cancerization. Effective treatment of individual lesions as well as field cancerization is essential for good long-term outcomes. The Swiss Registry of Actinic Keratosis Treatment (REAKT) Working Group has developed clinical practice guidelines for the treatment of field cancerization in patients who present with AK. These guidelines are intended to serve as a resource for physicians as to the most appropriate treatment and management of AK and field cancerization based on current evidence and the combined practical experience of the authors. Treatment of AK and field cancerization should be driven by consideration of relevant patient, disease, and treatment factors, and appropriate treatment decisions will differ from patient to patient. Prevention measures and screening recommendations are discussed, and special considerations related to management of immunocompromised patients are provided.

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

PubMed

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

2018-06-08

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

Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force.

PubMed

Husereau, Don; Drummond, Michael; Petrou, Stavros; Carswell, Chris; Moher, David; Greenberg, Dan; Augustovski, Federico; Briggs, Andrew H; Mauskopf, Josephine; Loder, Elizabeth

2013-01-01

Economic evaluations of health interventions pose a particular challenge for reporting because substantial information must be conveyed to allow scrutiny of study findings. Despite a growth in published reports, existing reporting guidelines are not widely adopted. There is also a need to consolidate and update existing guidelines and promote their use in a user-friendly manner. A checklist is one way to help authors, editors, and peer reviewers use guidelines to improve reporting. The task force's overall goal was to provide recommendations to optimize the reporting of health economic evaluations. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines into one current, useful reporting guidance. The CHEERS Elaboration and Explanation Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force facilitates the use of the CHEERS statement by providing examples and explanations for each recommendation. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. Previously published checklists or guidance documents related to reporting economic evaluations were identified from a systematic review and subsequent survey of task force members. A list of possible items from these efforts was created. A two-round, modified Delphi Panel with representatives from academia, clinical practice, industry, and government, as well as the editorial community, was used to identify a minimum set of items important for reporting from the larger list. Out of 44 candidate items, 24 items and accompanying recommendations were developed, with some specific recommendations for single study-based and model-based economic evaluations. The final recommendations are subdivided into six main categories: 1) title and abstract, 2) introduction, 3) methods, 4) results, 5) discussion, and 6) other. The recommendations are contained in the CHEERS statement, a user-friendly 24-item checklist. The task force report provides explanation and elaboration, as well as an example for each recommendation. The ISPOR CHEERS statement is available online via Value in Health or the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices - CHEERS Task Force webpage (http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope that the ISPOR CHEERS statement and the accompanying task force report guidance will lead to more consistent and transparent reporting, and ultimately, better health decisions. To facilitate wider dissemination and uptake of this guidance, we are copublishing the CHEERS statement across 10 health economics and medical journals. We encourage other journals and groups to consider endorsing the CHEERS statement. The author team plans to review the checklist for an update in 5 years. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

40 CFR 52.2633 - Stack height regulations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Stack height regulations. 52.2633 Section 52.2633 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... with the “Guideline for Determination of Good Engineering Practice Stack Height (Technical Support...

Salmon's Laws.

ERIC Educational Resources Information Center

Shannon, Thomas A.

1994-01-01

Presents Paul Salmon's old-fashioned, common-sense guidelines for success in practical school administration. The maxims advise on problem ownership; the value of selective neglect; the importance of empowerment, enthusiasm, and effective communication; and the need for positive reinforcement, cultivation of support, and good relations with media,…

Where to find information about drugs

PubMed Central

Day, Richard O; Snowden, Leone

2016-01-01

SUMMARY Good medicines information is critical to medical practice. Choose high-quality, pre-appraised sources first and make sure they are current. Select the information that is most relevant to the needs of your particular patient. Take the time to become familiar with the features of the resources you use. Australian Medicines Handbook, Therapeutic Guidelines, Australian Prescriber and NPS MedicineWise cover most routine clinical practice needs. PMID:27346917

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

PubMed

2014-10-01

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

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.

Proper management of rheumatoid arthritis in Latin America. What the guidelines say?

PubMed

Brenol, Claiton V; Nava, Jorge Ivan Gamez; Soriano, Enrique R

2015-03-01

To analyze characteristics of clinical practice guidelines (CPGs) for the management of rheumatoid arthritis (RA) developed in Latin American (LA) countries and to describe the knowledge, use, and barriers for their implementation perceived among LA rheumatologists, a comprehensive literature search including Medline, PubMed, Cochrane Library, LILACS and Scielo was performed. The Appraisal of Guidelines for Research and Evaluation (AGREE) instrument was applied for evaluation. A survey was sent to PANLAR members containing questions related to knowledge about guidelines, application of the recommendations, and difficulties in implementing CPGs. Eight guidelines were identified. Most guidelines were evidence based (62 %), but in only 37 % a systematic literature search was done. None of the guidelines included patients' views and preferences, and only few of them stated an updating procedure. Funding body independence and disclosure of conflicts of interest were rarely reported. The survey was answered by 214 rheumatologists from all Latin American countries. Most rheumatologist reported knowledge and use of clinical guidelines, mainly international ones. In general, rheumatologist felt that guidelines apply to only a minority of patients seen in daily clinical practice. Limited access expensive drugs, suggested by the guidelines, was the most frequent barrier to guidelines implementation that was reported. A good number of guidelines on the treatment of rheumatoid arthritis have been developed in Latin America. Most of them are lacking some of the components recognized for high-quality clinical guidelines development. In spite that most rheumatologist know and apply guidelines, access to drugs is still a very important barrier to their implementation in Latin America.

How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study.

PubMed

Berger, M; Kooyman, P J; Makkee, M; van der Zee, J S; Sterk, P J; van Dijk, J; Kemper, E M

2016-08-19

Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the study. However, there are no specific regulations or guidelines for non-Medicinal Investigational Products (non-MIPs) such as allergens, enriched food supplements, and air pollution components. As a consequence, investigators will avoid clinical research and prefer preclinical models or in vitro testing for e.g. toxicology studies. 1) briefly review the current guidelines and regulations for Investigational Medicinal Products; 2) present a standardised approach to ensure the quality and safety of non-MIPs in human in vivo research; and 3) discuss some lessons we have learned. We propose a practical line of approach to compose a clarifying product dossier (PD), comprising the description of the production process, the analysis of the raw and final product, toxicological studies, and a thorough risk-benefit-analysis. This is illustrated by an example from a human in vivo research model to study exposure to air pollutants, by challenging volunteers with a suspension of carbon nanoparticles (the component of ink cartridges for laser printers). With this novel risk-based approach, the members of competent authorities are provided with standardised information on the quality of the product in relation to the safety of the participants, and the scientific goal of the 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.

Collaboration, campaigns and champions for appropriate imaging: feedback from the Zagreb workshop.

PubMed

Remedios, D; Brkljacic, B; Ebdon-Jackson, S; Hierath, M; Sinitsyn, V; Vassileva, J

2018-04-01

Leading radiologists and representatives from national radiation protection regulatory authorities and health ministries from 19 countries of the European region worked together with five experts at the workshop on justification and appropriate use of imaging in Zagreb, Croatia, from 26 to 28 October 2017 jointly organised by the IAEA and the European Society of Radiology. The workshop served as a forum to exchange information on challenges and solutions for improving justification and the appropriate use of diagnostic imaging. Common barriers to improving the use of imaging referral guidelines were discussed and the need for increased collaboration identified. Examples of good practices were presented, including use of Clinical Decision Support (CDS) systems to facilitate rapid and good justification decisions. The workshop identified some of the needs of European countries for achieving more appropriate imaging proposing wider use of collaboration, campaigns and champions. • Drivers for appropriate imaging in Europe are similar to those elsewhere globally. • Implementing imaging referral guidelines is the main barrier to more appropriate imaging. • Clinical Decision Support systems (CDS) facilitates good referral practice and justification decisions. • Collaboration, campaigns and champions may improve awareness, appropriateness and audit.

Education for the unified health system: what do good professors do from the perspective of students?

PubMed

Carmo Menegaz, Jouhanna do; Schubert Backes, Vânia Marli

2015-12-01

to analyze the educational practices for the Unified Health System performed by good professors, from the perspective of nursing, medical and odontology students, based on the Shulman's concepts of knowledge of educational ends, purposes, values ​​and their historical and philosophical grounds, at a university in southern Brazil. A qualitative study with an exploratory and analytical approach in which the participants were graduating students, interviewed with the aid of vignettes, between October of 2011 and January of 2012. Data were analyzed based on thematic analysis. it was observed that good professors educate for the Unified Health System through the promotion of teamwork, interdisciplinary practices, good communication, leadership exercises, and promotion of a student's desire to be an agent of change for the sake of improvement and guaranteeing the right to health. the students attribute to professors the responsibility for the performance of these practices. Despite their consistency with the Brazilian curriculum guidelines, the professors that perform them are seen as a minority.

Review of guidelines for good practice in decision-analytic modelling in health technology assessment.

PubMed

Philips, Z; Ginnelly, L; Sculpher, M; Claxton, K; Golder, S; Riemsma, R; Woolacoot, N; Glanville, J

2004-09-01

To identify existing guidelines and develop a synthesised guideline plus accompanying checklist. In addition to provide guidance on key theoretical, methodological and practical issues and consider the implications of this research for what might be expected of future decision-analytic models. Electronic databases. A systematic review of existing good practice guidelines was undertaken to identify and summarise guidelines currently available for assessing the quality of decision-analytic models that have been undertaken for health technology assessment. A synthesised good practice guidance and accompanying checklist was developed. Two specific methods areas in decision modelling were considered. The first method's topic is the identification of parameter estimates from published literature. Parameter searches were developed and piloted using a case-study model. The second topic relates to bias in parameter estimates; that is, how to adjust estimates of treatment effect from observational studies where there are risks of selection bias. A systematic literature review was conducted to identify those studies looking at quantification of bias in parameter estimates and the implication of this bias. Fifteen studies met the inclusion criteria and were reviewed and consolidated into a single set of brief statements of good practice. From this, a checklist was developed and applied to three independent decision-analytic models. Although the checklist provided excellent guidance on some key issues for model evaluation, it was too general to pick up on the specific nuances of each model. The searches that were developed helped to identify important data for inclusion in the model. However, the quality of life searches proved to be problematic: the published search filters did not focus on those measures specific to cost-effectiveness analysis and although the strategies developed as part of this project were more successful few data were found. Of the 11 studies meeting the criteria on the effect of selection bias, five concluded that a non-randomised trial design is associated with bias and six studies found 'similar' estimates of treatment effects from observational studies or non-randomised clinical trials and randomised controlled trials (RCTs). One purpose of developing the synthesised guideline and checklist was to provide a framework for critical appraisal by the various parties involved in the health technology assessment process. First, the guideline and checklist can be used by groups that are reviewing other analysts' models and, secondly, the guideline and checklist could be used by the various analysts as they develop their models (to use it as a check on how they are developing and reporting their analyses). The Expert Advisory Group (EAG) that was convened to discuss the potential role of the guidance and checklist felt that, in general, the guidance and checklist would be a useful tool, although the checklist is not meant to be used exclusively to determine a model's quality, and so should not be used as a substitute for critical appraisal. The review of current guidelines showed that although authors may provide a consistent message regarding some aspects of modelling, in other areas conflicting attributes are presented in different guidelines. In general, the checklist appears to perform well, in terms of identifying those aspects of the model that should be of particular concern to the reader. The checklist cannot, however, provide answers to the appropriateness of the model structure and structural assumptions, as these may be seen as a general problem with generic checklists and do not reflect any shortcoming with the synthesised guidance and checklist developed here. The assessment of the checklist, as well as feedback from the EAG, indicated the importance of its use in conjunction with a more general checklist or guidelines on economic evaluation. Further methods research into the following areas would be valuable: the quantification of selection bias in non-controlled studies and in controlled observational studies; the level of bias in the different non-RCT study designs; a comparison of results from RCTs with those from other non-randomised studies; assessment of the strengths and weaknesses of alternative ways to adjust for bias in a decision model; and how to prioritise searching for parameter estimates.

How to Submit | Center for Cancer Research

Cancer.gov

be submitted by a current NIH or FDA fellow. The work does not need to have been done at the NIH/FDA. However, the submitter must be an author on the document and be in compliance with the intended journal's authorship guidelines or general good authorship practices. 

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine].

PubMed

Han, Xue-Jie; Liu, Meng-Yu; Lian, Zhi-Hua; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Jun

2017-09-01

To evaluate the applicability and clinical applications of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine, so as to provide the basis for the revision of the guidelines. This study was completed by the research and promotion base for traditional Chinese medicine(TCM) standard. The methods of applicability evaluation and application evaluation were used in the study. The questionnaires were filled out to evaluate applicability of the guideline, including doctor's familiarity with the guideline,the quality of the guideline, applicable conditions and clinical applications. The prospective case study analysis method was used to evaluate application of the guideline, including evaluation of clinical application compliance and application results(such as clinical effects, safety and economy). There were two parts in the guideline, which were TCM guideline and Western medicine guideline. The results of applicability evaluation showed that there were no obvious differences between TCM guideline and Western medicine guideline in doctor's familiarity with guideline(85.43%, 84.57%) and the use of the guideline(52.10%, 54.47%); the guidelines with good quality, and higher scores in the scope of application and the use of the term rationality(91.94%, 93.35%); the rationality scores of relevant contents in syndrome differentiation and treatment were more than 75%; the applicable conditions were better, and the safety score was the the highest. The comprehensive applicability evaluation showed that the proportion of the application of TCM guideline and Western medicine guideline were 77.73%, 75.46%, respectively. The results of application evaluation showed that there was high degree coincidence between the guideline with its clinical application; except for "other treatment" and "recuperation and prevention" in TCM, other items got high scores which were more than 90%; in the evaluation of application effects, safety of the guideline was best, economy of the guideline was better, and clincal effect was good. The comprehensive application evaluation showed that 75%~80% doctors were satisfied with the guideline. The Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine has been widely used in clinical practice, which is of high quality, high degree of clinical application,good safety and economy. But there were some disadvantages of the guideline such as lack of evidence-based medicine and innovation, which is need to be improved constantly in the guideline revision. Copyright© by the Chinese Pharmaceutical Association.

Guidelines for a palliative approach for aged care in the community setting: A suite of resources.

PubMed

Toye, Christine; Blackwell, Scott; Maher, Sean; Currow, David C; Holloway, Kristi; Tieman, Jennifer; Hegarty, Meg

2012-01-01

In Australia, many people ageing in their own homes are becoming increasingly frail and unwell, approaching the end of life. A palliative approach, which adheres to palliative care principles, is often appropriate. These principles provide a framework for proactive and holistic care in which quality of life and of dying is prioritised, as is support for families. A palliative approach can be delivered by the general practitioner working with the community aged care team, in collaboration with family carers. Support from specialist palliative care services is available if necessary.The Guidelines for a Palliative Approach for Aged Care in the Community Setting were published by the Australian Government Department of Health and Ageing to inform practice in this area. There are three resource documents. The main document provides practical evidence based guidelines, good practice points, tools, and links to resources. This document is written for general practitioners, nurses, social workers, therapists, pastoral care workers, and other health professionals and responded to needs identified during national consultation. Evidence based guidelines were underpinned by systematic reviews of the research literature. Good practice points were developed from literature reviews and expert opinion. Two 'plain English' booklets were developed in a process involving consumer consultation; one is for older people and their families, the other for care workers.The resources are intended to facilitate home care that acknowledges and plans for the client's deteriorating functional trajectory and inevitable death. At a time when hospitals and residential aged care facilities are under enormous pressure as the population ages, such a planned approach makes sense for the health system as a whole. The approach also makes sense for older people who wish to die in their own homes. Family needs are recognised and addressed. Unnecessary hospitalisations or residential placements and clinically futile interventions are also minimised.

Inter-radiologist agreement for CT scoring of pediatric splenic injuries and effect on an established clinical practice guideline.

PubMed

Leschied, Jessica R; Mazza, Michael B; Davenport, Matthew; Chong, Suzanne T; Smith, Ethan A; Hoff, Carrie N; Ladino-Torres, Maria F; Khalatbari, Shokoufeh; Ehrlich, Peter F; Dillman, Jonathan R

2016-02-01

The American Pediatric Surgical Association (APSA) advocates for the use of a clinical practice guideline to direct management of hemodynamically stable pediatric spleen injuries. The clinical practice guideline is based on the CT score of the spleen injury according to the American Association for the Surgery of Trauma (AAST) CT scoring system. To determine the potential effect of radiologist agreement for CT scoring of pediatric spleen injuries on an established APSA clinical practice guideline. We retrospectively analyzed blunt splenic injuries occurring in children from January 2007 to January 2012 at a single level 1 trauma center (n = 90). Abdominal CT exams performed at clinical presentation were reviewed by four radiologists who documented the following: (1) splenic injury grade (AAST system), (2) arterial extravasation and (3) pseudoaneurysm. Inter-rater agreement for AAST injury grade was assessed using the multi-rater Fleiss kappa and Kendall coefficient of concordance. Inter-rater agreement was assessed using weighted (AAST injury grade) or prevalence-adjusted bias-adjusted (binary measures) kappa statistics; 95% confidence intervals were calculated. We evaluated the hypothetical effect of radiologist disagreement on an established APSA clinical practice guideline. Inter-rater agreement was good for absolute AAST injury grade (kappa: 0.64 [0.59–0.69]) and excellent for relative AAST injury grade (Kendall w: 0.90). All radiologists agreed on the AAST grade in 52% of cases. Based on an established clinical practice guideline, radiologist disagreement could have changed the decision for intensive care management in 11% (10/90) of children, changed the length of hospital stay in 44% (40/90), and changed the time to return to normal activity in 44% (40/90). Radiologist agreement when assigning splenic AAST injury grades is less than perfect, and disagreements have the potential to change management in a substantial number of pediatric patients.

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

World Health Organization strong recommendations based on low-quality evidence (study quality) are frequent and often inconsistent with GRADE guidance.

PubMed

Alexander, Paul E; Brito, Juan P; Neumann, Ignacio; Gionfriddo, Michael R; Bero, Lisa; Djulbegovic, Benjamin; Stoltzfus, Rebecca; Montori, Victor M; Norris, Susan L; Schünemann, Holger J; Guyatt, Gordon H

2016-04-01

In 2007 the World Health Organization (WHO) adopted the GRADE system for development of public health guidelines. Previously we found that many strong recommendations issued by WHO are based on evidence for which there is only low or very low confidence in the estimates of effect (discordant recommendations). GRADE guidance indicates that such discordant recommendations are rarely appropriate but suggests five paradigmatic situations in which discordant recommendations may be warranted. We sought to provide insight into the many discordant recommendations in WHO guidelines. We examined all guidelines that used the GRADE method and were approved by the WHO Guideline Review Committee between 2007 and 2012. Teams of reviewers independently abstracted data from eligible guidelines and classified recommendations either into one of the five paradigms for appropriately-formulated discordant recommendations or into three additional categories in which discordant recommendations were inconsistent with GRADE guidance: 1) the evidence warranted moderate or high confidence (a misclassification of evidence) rather than low or very low confidence; 2) good practice statements; or 3) uncertainty in the estimates of effect would best lead to a conditional (weak) recommendation. The 33 eligible guidelines included 160 discordant recommendations, of which 98 (61.3%) addressed drug interventions and 132 (82.5%) provided some rationale (though not entirely explicit at times) for the strong recommendation. Of 160 discordant recommendations, 25 (15.6%) were judged consistent with one of the five paradigms for appropriate recommendations; 33 (21%) were based on evidence warranting moderate or high confidence in the estimates of effect; 29 (18%) were good practice statements; and 73 (46%) warranted a conditional, rather than a strong recommendation. WHO discordant recommendations are often inconsistent with GRADE guidance, possibly threatening the integrity of the process. Further training in GRADE methods for WHO guideline development group members may be necessary, along with further research on what motivates the formulation of such recommendations. Copyright © 2016 Elsevier Inc. All rights reserved.

Development and validation of a multiplex quantitative polymerase chain reaction assay for the detection of Mollicutes impurities in human cells, cultured under good manufacturing practice conditions, and following European Pharmacopoeia requirements and the International Conference on Harmonization guidelines.

PubMed

Vanni, Irene; Ugolotti, Elisabetta; Raso, Alessandro; Di Marco, Eddi; Melioli, Giovanni; Biassoni, Roberto

2012-07-01

The clinical applications of in vitro manipulated cultured cells and their precursors are often made use of in therapeutic trials. However, tissue cultures can be easily contaminated by the ubiquitous Mollicutes micro-organisms, which can cause various and severe alterations in cellular function. Thus methods able to detect and trace Mollicutes impurities contaminating cell cultures are required before starting any attempt to grow cells under good manufacturing practice (GMP) conditions. We developed a multiplex quantitative polymerase chain reaction (qPCR) assay specific for the 16S-23S rRNA intergenic spacer regions, for the Tuf and P1 cytoadhesin genes, able to detect contaminant Mollicutes species in a single tube reaction. The system was validated by analyzing different cell lines and the positive samples were confirmed by 16S and P1 cytoadhesin gene dideoxy sequencing. Our multiplex qPCR detection system was able to reach a sensitivity, specificity and robustness comparable with the culture and the indicator cell culture method, as required by the European Pharmacopoeia guidelines. We have developed a multiplex qPCR method, validated following International Conference on Harmonization (ICH) guidelines, as a qualitative limit test for impurities, assessing the validation characteristics of limit of detection and specificity. It also follows the European Pharmacopoeia guidelines and Food and Drug Administration (FDA) requirements.

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

EPA Science Inventory

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

Factors associated with good TB infection control practices among primary healthcare workers in the Free State Province, South Africa.

PubMed

Engelbrecht, Michelle; Janse van Rensburg, André; Kigozi, Gladys; van Rensburg, Hcj Dingie

2016-11-04

Despite the availability of TB infection control guidelines, and good levels of healthcare worker knowledge about infection control, often these measures are not well implemented. This study sought to determine the factors associated with healthcare workers' good TB infection control practices in primary health care facilities in the Free State Province, South Africa. A cross-sectional self-administered survey among nurses (n = 202) and facility-based community healthcare workers (n = 34) as well as facility observations were undertaken at all 41 primary health care facilities in a selected district of the Free State Province. The majority of respondents were female (n = 200; 87.7 %) and the average age was 44.19 years (standard deviation ±10.82). Good levels of knowledge were recorded, with 42.8 % (n = 101) having an average score (i.e. 65-79 %) and 31.8 % (n = 75) a good score (i.e. ≥ 80 %). Most respondents (n = 189; 80.4 %) had positive attitudes towards TB infection control practices (i.e. ≥ 80 %). While good TB infection control practices were reported by 72.9 % (n = 161) of the respondents (i.e. ≥75 %), observations revealed this to not necessarily be the case. For every unit increase in attitudes, good practices increased 1.090 times (CI:1.016-1.169). Respondents with high levels of knowledge (≥80 %) were 4.029 (CI: 1.550-10.469) times more likely to have good practices when compared to respondents with poor levels of knowledge (<65 %). The study did not find TB/HIV-related training to be a predictor of good practices. Positive attitudes and good levels of knowledge regarding TB infection control were the main factors associated with good infection control practices. Although many respondents reported good infection control practices - which was somewhat countered by the observations - there are areas that require attention, particularly those related to administrative controls and the use of personal protective equipment.

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.

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey

PubMed Central

Wager, Elizabeth; Woolley, Karen; Adshead, Viv; Cairns, Angela; Fullam, Josh; Gonzalez, John; Grant, Tom; Tortell, Stephanie

2014-01-01

Objective To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry. Design/setting Web-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013. Participants 469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies (‘industry’, n=144), communication agencies (‘agency’, n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ≥5 years and 62% had a PhD/MD. Results Over 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors’ Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents’ companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents’ departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results. Conclusions Within this sample, most publication professionals working in or for industry were aware of, and applying, major publication guidelines. However, the survey also identified specific areas where education and promotion of guidelines are needed to ensure ethical publication practices. PMID:24747794

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey.

PubMed

Wager, Elizabeth; Woolley, Karen; Adshead, Viv; Cairns, Angela; Fullam, Josh; Gonzalez, John; Grant, Tom; Tortell, Stephanie

2014-04-19

To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry. Web-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013. 469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies ('industry', n=144), communication agencies ('agency', n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ≥5 years and 62% had a PhD/MD. Over 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors' Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents' companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents' departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results. Within this sample, most publication professionals working in or for industry were aware of, and applying, major publication guidelines. However, the survey also identified specific areas where education and promotion of guidelines are needed to ensure ethical publication practices.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part IV - postanalytic considerations.

PubMed

Barnett, David; Louzao, Raaul; Gambell, Peter; De, Jitakshi; Oldaker, Teri; Hanson, Curtis A

2013-01-01

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

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part II - preanalytical issues.

PubMed

Davis, Bruce H; Dasgupta, Amar; Kussick, Steven; Han, Jin-Yeong; Estrellado, Annalee

2013-01-01

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

Clinical trials and the new good clinical practice guideline in Japan. An economic perspective.

PubMed

Ono, S; Kodama, Y

2000-08-01

Japanese clinical trials have been drastically changing in response to the implementation of the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guideline in 1997. The most important aim of the new guideline is to standardise the quality of clinical trials in the US, European Union and Japan, but it inevitably imposes substantial costs on investigators, sponsors and even patients in Japan. The study environment in Japan differs from that in the US in several ways: (i) historical lack of a formal requirement for informed consent; (ii) patients' attitudes to clinical trials in terms of expectation of positive outcomes; (iii) the implications of universal health insurance for trial participation; (iv) the historical absence of on-site monitoring by the sponsor, with the attendant effects on study quality; and (v) the lack of adequate financial and personnel support for the conduct of trials. Implementation of the new GCP guideline will improve the ethical and scientific quality of trials conducted in Japan. It may also lead to an improved relationship between medical professionals and patients if the requirement for explicit informed consent in clinical trials leads to the provision of a similar level of patient information in routine care and changes the traditional paternalistic attitude of physicians to patients. The initial response of the Japanese 'market' for clinical trials to the implementation of the ICH-GCP guideline has been clinical trial price increases and a decrease in the number of study contracts. These changes can be explained by applying a simple demand-supply scheme. Whether clinical trials undertaken in Japan become more or less attractive to the industry in the long term will depend on other factors such as international regulations on the acceptability of foreign clinical trials and the reform of domestic healthcare policies.

Stereotactic Radiosurgery in the Management of Limited (1-4) Brain Metasteses: Systematic Review and International Stereotactic Radiosurgery Society Practice Guideline.

PubMed

Chao, Samuel T; De Salles, Antonio; Hayashi, Motohiro; Levivier, Marc; Ma, Lijun; Martinez, Roberto; Paddick, Ian; Régis, Jean; Ryu, Samuel; Slotman, Ben J; Sahgal, Arjun

2017-11-03

Guidelines regarding stereotactic radiosurgery (SRS) for brain metastases are missing recently published evidence. To conduct a systematic review and provide an objective summary of publications regarding SRS in managing patients with 1 to 4 brain metastases. Using Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, a systematic review was conducted using PubMed and Medline up to November 2016. A separate search was conducted for SRS for larger brain metastases. Twenty-seven prospective studies, critical reviews, meta-analyses, and published consensus guidelines were reviewed. Four key points came from these studies. First, there is no detriment to survival by withholding whole brain radiation (WBRT) in the upfront management of brain metastases with SRS. Second, while SRS on its own provides a high rate of local control (LC), WBRT may provide further increase in LC. Next, WBRT does provide distant brain control with less need for salvage therapy. Finally, the addition of WBRT does affect neurocognitive function and quality of life more than SRS alone. For larger brain metastases, surgical resection should be considered, especially when factoring lower LC with single-session radiosurgery. There is emerging data showing good LC and/or decreased toxicity with multisession radiosurgery. A number of well-conducted prospective and meta-analyses studies demonstrate good LC, without compromising survival, using SRS alone for patients with a limited number of brain metastases. Some also demonstrated less impact on neurocognitive function with SRS alone. Practice guidelines were developed using these data with International Stereotactic Radiosurgery Society consensus. Copyright © 2017 by the Congress of Neurological Surgeons

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

PubMed

Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

ASVCP quality assurance guidelines: control of preanalytical and analytical factors for hematology for mammalian and nonmammalian species, hemostasis, and crossmatching in veterinary laboratories.

PubMed

Vap, Linda M; Harr, Kendal E; Arnold, Jill E; Freeman, Kathleen P; Getzy, Karen; Lester, Sally; Friedrichs, Kristen R

2012-03-01

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and provides recommendations for control of preanalytical and analytical factors related to hematology for mammalian and nonmammalian species, hemostasis testing, and crossmatching and is adapted from sections 1.1 and 2.3 (mammalian hematology), 1.2 and 2.4 (nonmammalian hematology), 1.5 and 2.7 (hemostasis testing), and 1.6 and 2.8 (crossmatching) of the complete guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation

PubMed Central

Burghaus, R; Cosson, V; Cheung, SYA; Chenel, M; DellaPasqua, O; Frey, N; Hamrén, B; Harnisch, L; Ivanow, F; Kerbusch, T; Lippert, J; Milligan, PA; Rohou, S; Staab, A; Steimer, JL; Tornøe, C; Visser, SAG

2016-01-01

This document was developed to enable greater consistency in the practice, application, and documentation of Model‐Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of “good practice” recommendations are assembled here in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of this white paper are to: i) inform company decision makers how the strategic integration of MID3 can benefit R&D efficiency; ii) provide MID3 analysts with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide regulatory authorities with substrate to develop MID3 related and/or MID3 enabled guidelines. PMID:27069774

National Dam Inspection Program. Converse Lake Dam (CT 00044). Connecticut Coastal Basin, Greenwich, Connecticut. Phase I Inspection Report.

DTIC Science & Technology

1980-02-01

Guidelines for Safety Inspection of Dams, and with good engineering judgement and practice, and is hereby submitted for approval. ’ /00s~rs H W. NT’EGAN...below the top of the dam, with water flowing over the spillway. b. Dam Crest - The top of the dam is a concrete cap and is in good condition (Photo 1...the masonry portion is not substantial the dam is not safe. Masonry on water side is a good job of cement rubble. Top width is 7’. But it is doubtful

Promoting safer blood transfusion practice in hospital.

PubMed

Parris, E; Grant-Casey, J

Results from a national comparative audit of bedside transfusion practice show that patients in the UK are at risk of misidentification and poor monitoring when undergoing a blood transfusion. A commonly identified reason for poor compliance with guidelines from the British Committee for Standards in Haematology (BCSH et al 1999) is a lack of awareness of good transfusion practice (National Blood Service (NBS) 2005). This article discusses the implications of the audit findings for the administration of blood at the bedside and examines initiatives to support hospital staff in their efforts to improve blood transfusion safety.

Influence of agricultural practices on fusarium infection of cereals and subsequent contamination of grain by trichothecene mycotoxins.

PubMed

Edwards, Simon G

2004-10-10

Fusarium head blight (FHB) of small grain cereals and ear rot in maize are significant diseases across the world. Infection can not only result in reduced yield as a result of shrunken grains but also result in reduced milling and malting quality and the contamination of grains with mycotoxins. Mycotoxins are hazardous to animal and human health. Therefore, guidelines and legislation are in place, or under consideration, in most countries to protect consumers and animal welfare. As fusarium mycotoxins are produced within the growing crop, it is important to understand how agricultural practices affect mycotoxin contamination of grain. Such information could then be used to determine guidelines on "Good Agricultural Practice" (GAP) to minimise the mycotoxin contamination of cereal products. Evidence is provided to show the importance of choice of cultivar, crop rotation, soil cultivation, fertiliser and the chemical and biological control of insects, weeds and fungi.

[EBM, guidelines, protocols: knowledge, attitudes and utilization in the era of law on professional responsibility and safety of health care.

PubMed

Minozzi, Silvia; Ruggiero, Francesca; Capobussi, Matteo; González-Lorenzo, Marien; La Regina, Micaela; Squizzato, Alessandro; Moja, Lorenzo; Orlandini, Francesco

2018-05-01

The knowledge of principles and methods of Evidence Based Medicine (EBM) and the use of Clinical Practice Guidelines to inform clinical decisions are recognised as key instruments to improve the quality of care. In Italy the Parliament has revised the legal system that rules the responsibilities of health professionals and health care safety, prescribing health professionals to adhere to guidelines and good practice recommendations. The objective of the study was to evaluate guidelines and clinical pathways developed at local level and to assess knowledge and attitudes of healthcare workers toward EBM and guidelines. At the l'ASL 5 Liguria La Spezia we performed a census of all the documents registered as "guidelines" or "clinical pathways" at the Direzione Generale by the end of May 2016. We assessed their methodological quality by the "Recognition Card for Clinical Pathways Production and Revision Activity" prepared by the Ligurian Region. We conducted semi-structured interviews to assess attitudes and knowledge of healthcare workers. We found 17 clinical pathways, 41% contained organizational/management recommendations, and 59% contained mainly clinical recommendations. 41% was produced by assimilating already existing guidelines. 29% did not describe the method of production. Only one document linked directly each recommendation with scientific evidence. 10 healthcare workers out of 32 invited actually accepted to conduct the interview. Respondents showed a positive attitude toward the EBM and guidelines but a poor knowledge of the methodology of production and the instruments and principles for critical appraising of scientific literature. Nobody knew the GRADE approach. The most relevant barriers identified were: lack of time, poor knowledge of English and statistical methods, poor applicability of the international guidelines to local setting and real patients encountered in clinical practice. Despite the initiatives of the legislator toward civil responsibility and safety of care that should increase the use of guidelines, we found an overall poor knowledge of the concepts of EBM and method of guidelines production. Though the attitudes of responders to the interview were positive, barriers to use seemed to be predominant and considered more as obstacles than as a stimulus. In peripheral settings or in hospitals of medium/small size, clinical guidelines could remain confined to a merely juridical role, with weak impact on professional practice.

ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories.

PubMed

Flatland, Bente; Freeman, Kathy P; Friedrichs, Kristen R; Vap, Linda M; Getzy, Karen M; Evans, Ellen W; Harr, Kendal E

2010-09-01

Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance Guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. ©2010 American Society for Veterinary Clinical Pathology.

Destroying the Art of Cartography: Teaching Illustrations Using ArcView.

ERIC Educational Resources Information Center

Hill, Miriam Helen

Introductory courses in Geographic Information Systems and cartography cover the fundamentals of map design. Students are given guidelines for producing a good map, but visual demonstrations are much more impressive. ArcView was used to produce illustrations of bad mapping practices and placed in a Microsoft PowerPoint presentation to demonstrate…

Manufacturing of tattoo ink products today and in future: Europe.

PubMed

Michel, Ralf

2015-01-01

The article describes the European market situation and the legal framework in Europe. It shows the state-of-the-art production under ISO 9001:2008 quality management and describes the future of tattoo ink production based on good manufacturing practice guidelines for tattoo inks. © 2015 S. Karger AG, Basel.

Collaboration in Language Testing and Assessment. Language Testing and Evaluation. Volume 26

ERIC Educational Resources Information Center

Tsagari, Dina, Ed.; Csepes, Ildiko, Ed.

2012-01-01

The Guidelines for Good Practice of the European Association for Language Testing and Assessment (EALTA) stress the importance of collaboration between all parties involved in the process of developing instruments, activities and programmes for testing and assessment. Collaboration is considered to be as important as validity and reliability,…

Psychologists as Witnesses: Background and Good Practice in the Delivery of Evidence

ERIC Educational Resources Information Center

Ireland, Jane L.

2008-01-01

An outline of the background to the provision of psychological evidence within legal settings will be provided, with attention to formal and quasi-court settings (e.g., tribunals). Key points of relevance to psychologists and to educational psychologists in particular will be illustrated, including guidelines for defendable written and oral…

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2012 CFR

2012-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2011 CFR

2011-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2013 CFR

2013-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2014 CFR

2014-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

40 CFR 60.1680 - After the required date for operator certification, who may operate the municipal waste...

Code of Federal Regulations, 2010 CFR

2010-07-01

... certification, who may operate the municipal waste combustion unit? 60.1680 Section 60.1680 Protection of... NEW STATIONARY SOURCES Emission Guidelines and Compliance Times for Small Municipal Waste Combustion Units Constructed on or Before August 30, 1999 Model Rule-Good Combustion Practices: Operator...

The Role of Measurement Quality on Practical Guidelines for Assessing Measurement and Structural Invariance

ERIC Educational Resources Information Center

Kang, Yoonjeong; McNeish, Daniel M.; Hancock, Gregory R.

2016-01-01

Although differences in goodness-of-fit indices (?GOFs) have been advocated for assessing measurement invariance, studies that advanced recommended differential cutoffs for adjudicating invariance actually utilized a very limited range of values representing the quality of indicator variables (i.e., magnitude of loadings). Because quality of…

A Media Policies Handbook for Rosholt Public Schools.

ERIC Educational Resources Information Center

Adams, Helen R.

Policies and guidelines designed to provide media program consistency and continuity in the Rosholt School District (Wisconsin) are presented together with a report on a study conducted to determine policies conducive to good media practice. Each of the ten policy statements follows a review of the literature especially pertinent to that area.…

Crossing the Threshhold: Successful Learning Provision for Homeless People.

ERIC Educational Resources Information Center

Cameron, Helen; McKaig, Wendy; Taylor, Sue

This guide tells the story of a successful collaboration between The City Literary Institute and homelessness agencies to create an arts-based learning program for homeless people in central London. It identifies guidelines and good practice to stimulate similar work in other locations with problems of homelessness and rough sleeping. The guide is…

How medical doctors and students should use Social Media: a review of the main guidelines for proposing practical recommendations.

PubMed

Mayer, Miguel Angel; Leis, Angela; Mayer, Alex; Rodriguez-Gonzalez, Alejandro

2012-01-01

Social Media has grown exponentially and in the last few years there has been an increasing use amongst medical doctors and students. There is intense debate about the complexities of ensuring medical professionalism in the digital age and especially on using open and massive online services. The objectives of this paper are: first, to gather the main recommendations on using Social Media platforms and websites by medical doctors and students, which are proposed by several international organizations, institutions and universities of reference and second, to propose a set of practical recommendations, based on the comparison of the statements and items of the guidelines, in order to find agreements and differences among them and select the most common and practical items stated. A Decalogue of good practices has been drawn up, pointing out the most important aspects that should be considered, highlighting the relevance of maintaining professional behavior in these environments, taking into account the advantages and drawbacks when using them.

“At 150 kg, you can't run” men's weight loss stories in a popular health magazine provide appropriate examples of good health practice

PubMed Central

Couch, Danielle; Han, Gil-Soo; Robinson, Priscilla; Komesaroff, Paul

2014-01-01

We explore weight loss stories from 47 men collected from the Australian edition of Men's Health magazine between January 2009 and December 2012. Our analysis uses a mixed methods approach that combines thematic analysis and descriptive statistics to examine weight loss strategies against clinical practice guidelines for the management of overweight and obesity. All the stories reported the use of physical activity for weight loss and most stories detailed dietary changes for weight loss. Our findings indicate that most of the men reportedly used some form of behavioural strategies to assist them in their behaviour change efforts. The weight loss methods used were consistent with clinical practice guidelines, with the exception of some dietary practices. As narratives may assist with behaviour change, stories like those examined in this study could prove to be very useful in promoting weight loss to men. PMID:25750780

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.

[First line management without IVF of infertility related to endometriosis: Result of medical therapy? Results of ovarian superovulation? Results of intrauterine insemination? CNGOF-HAS Endometriosis Guidelines].

PubMed

Boujenah, J; Santulli, P; Mathieu-d'Argent, E; Decanter, C; Chauffour, C; Poncelet, P

2018-03-01

Using the structured methodology of French guidelines (HAS-CNGOF), the aim of this chapter was to formulate good practice points (GPP), in relation to optimal non-ART management of endometriosis related to infertility, based on the best available evidence in the literature. This guideline was produced by a group of experts in the field including a thorough systematic search of the literature (from January 1980 to March 2017). Were included only women with endometriosis related to infertility. For each recommendation, a grade (A-D, where A is the highest quality) was assigned based on the strength of the supporting evidence. Management of endometriosis related to infertility should be multidisciplinary and take account into the pain, the global evaluation of infertile couple and the different phenotypes of endometriotic lesions (good practice point). Hormonal treatment for suppression of ovarian function should not prescribe to improve fertility (grade A). After laproscopy for endometriosis related to infertility, the Endometriosis Fertility Index should be used to counsel patients regarding duration of conventional treatments before undergoing ART (grade C). After laparoscopy surgery for infertile women with AFS/ASRM stage I/II endometriosis or superficial peritoneal endometriosis, controlled ovarian stimulation with or without intrauterine insemination could be used to enhance non-ART pregnancy rate (grade C). Gonadotrophins should be the first line therapy for the stimulation (grade B). The number of cycles before referring ART should not exceed up to 6 cycles (good practice point). No recommendation can be performed for non-ART management of deep infiltrating endometriosis or endometrioma, as suitable evidence is lacking. Non-ART management is a possible option for the management of endometriosis related to infertility. Endometriosis Fertilty Index could be a useful tool for subsequent postoperative fertility management. Controlled ovarian stimulation can be proposed. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Individualized cost-effectiveness analysis of patient-centered care: a case series of hospitalized patient preferences departing from practice-based guidelines.

PubMed

Padula, William V; Millis, M Andrew; Worku, Aelaf D; Pronovost, Peter J; Bridges, John F P; Meltzer, David O

2017-03-01

To develop cases of preference-sensitive care and analyze the individualized cost-effectiveness of respecting patient preference compared to guidelines. Four cases were analyzed comparing patient preference to guidelines: (a) high-risk cancer patient preferring to forgo colonoscopy; (b) decubitus patient preferring to forgo air-fluidized bed use; (c) anemic patient preferring to forgo transfusion; (d) end-of-life patient requesting all resuscitative measures. Decision trees were modeled to analyze cost-effectiveness of alternative treatments that respect preference compared to guidelines in USD per quality-adjusted life year (QALY) at a $100,000/QALY willingness-to-pay threshold from patient, provider and societal perspectives. Forgoing colonoscopy dominates colonoscopy from patient, provider, and societal perspectives. Forgoing transfusion and air-fluidized bed are cost-effective from all three perspectives. Palliative care is cost-effective from provider and societal perspectives, but not from the patient perspective. Prioritizing incorporation of patient preferences within guidelines holds good value and should be prioritized when developing new guidelines.

The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.

PubMed

De Vos, Filip J; De Decker, Mario; Dierckx, Rudi A

2005-07-01

Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.

Curriculum for education and training of medical physicists in nuclear medicine: recommendations from the EANM Physics Committee, the EANM Dosimetry Committee and EFOMP.

PubMed

Del Guerra, Alberto; Bardies, Manuel; Belcari, Nicola; Caruana, Carmel J; Christofides, Stelios; Erba, Paola; Gori, Cesare; Lassmann, Michael; Lonsdale, Markus Nowak; Sattler, Bernhard; Waddington, Wendy

2013-03-01

To provide a guideline curriculum covering theoretical and practical aspects of education and training for Medical Physicists in Nuclear Medicine within Europe. National training programmes of Medical Physics, Radiation Physics and Nuclear Medicine physics from a range of European countries and from North America were reviewed and elements of best practice identified. An independent panel of experts was used to achieve consensus regarding the content of the curriculum. Guidelines have been developed for the specialist theoretical knowledge and practical experience required to practice as a Medical Physicist in Nuclear Medicine in Europe. It is assumed that the precondition for the beginning of the training is a good initial degree in Medical Physics at master level (or equivalent). The Learning Outcomes are categorised using the Knowledge, Skill and Competence approach along the lines recommended by the European Qualifications Framework. The minimum level expected in each topic in the theoretical knowledge and practical experience sections is intended to bring trainees up to the requirements expected of a Medical Physicist entering the field of Nuclear Medicine. This new joint EANM/EFOMP European guideline curriculum is a further step to harmonise specialist training of Medical Physicists in Nuclear Medicine within Europe. It provides a common framework for national Medical Physics societies to develop or benchmark their own curricula. The responsibility for the implementation and accreditation of these standards and guidelines resides within national training and regulatory bodies. Copyright © 2012 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

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.

The quality of operative note taking: an audit using the Royal College of Surgeons Guidelines as the gold standard.

PubMed

Shayah, A; Agada, F O; Gunasekaran, S; Jassar, P; England, R J A

2007-04-01

To assess the quality of operative note keeping and compare the results with the Royal College of Surgeons (RCS) of England guidelines 'Good Surgical Practice' as the gold standard. ENT Department at Hull Royal Infirmary, University Hospital. A hundred consecutive operative notes were selected between November 2005 and January 2006. The documentation of the operative notes in each case was compared with the RCS of England guidelines. All surgeons were made aware of the results of the first cycle and the guidelines were made available in all ENT theatres in the form of a printed aide-memoir. A second audit cycle was then carried out prospectively between April and June 2006. The results demonstrated a change in practice in key areas. The 1st cycle results showed the documentation of patient identification (94%), name of surgeon (98%) and clearly written postoperative instructions (94%). However, surgeons performed suboptimally at recording the name of assistant (82%), operative diagnosis (46%), the incision type (87%) and the type of wound closure (83%). After introducing the aide-memoir, the second cycle demonstrated a change in practice with 100% documentation in most of the assessed parameters except that the time of surgery and the type of surgery (emergency or elective) were not adequately recorded. We recommend that all surgical departments should have the RCS guidelines as an aide-memoir in theatres to enhance the quality and standardise operative note recording.

An Advisory Committee for the Regulation of Innovation in Gynaecologic Practice: Development and Implementation.

PubMed

Farrell, Scott A; Van Eyk, Nancy

2016-08-01

The fundamental precepts that underpin the delivery of all medical care are safety and efficacy. Although these precepts, in theory, are accepted without challenge, in many settings where clinical care is delivered, there is a lack of formal oversight necessary to ensure their implementation in practice. Even though most medical specialties have national bodies that provide guidelines for good medical practice, and hospital accreditation makes reference to dissemination of such guidelines, there is usually not a mechanism to monitor medical uptake and adherence to good practice in the day-to-day delivery of care. Most hospitals require approval by an institutional review board before research protocols can be undertaken, but regional health authorities and hospitals do not usually have formal processes in place to regulate the adoption of new technologies into clinical practice. Recognizing the lack of a formal process at the hospital level to guide and regulate the introduction of new technologies or procedures, we set out to establish an oversight process to fill this gap. A committee was established to oversee innovation in the Gynaecology Division of our hospital. We describe here the establishment of this committee, the tools the committee used, and the processes used for the committee to do its work. We conclude that formal, local oversight of medical innovation is indispensible for ensuring the high standards of medical practice necessary to optimize patient safety. Copyright © 2016 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2013-01-01

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

Towards Reproducible Descriptions of Neuronal Network Models

PubMed Central

Nordlie, Eilen; Gewaltig, Marc-Oliver; Plesser, Hans Ekkehard

2009-01-01

Progress in science depends on the effective exchange of ideas among scientists. New ideas can be assessed and criticized in a meaningful manner only if they are formulated precisely. This applies to simulation studies as well as to experiments and theories. But after more than 50 years of neuronal network simulations, we still lack a clear and common understanding of the role of computational models in neuroscience as well as established practices for describing network models in publications. This hinders the critical evaluation of network models as well as their re-use. We analyze here 14 research papers proposing neuronal network models of different complexity and find widely varying approaches to model descriptions, with regard to both the means of description and the ordering and placement of material. We further observe great variation in the graphical representation of networks and the notation used in equations. Based on our observations, we propose a good model description practice, composed of guidelines for the organization of publications, a checklist for model descriptions, templates for tables presenting model structure, and guidelines for diagrams of networks. The main purpose of this good practice is to trigger a debate about the communication of neuronal network models in a manner comprehensible to humans, as opposed to machine-readable model description languages. We believe that the good model description practice proposed here, together with a number of other recent initiatives on data-, model-, and software-sharing, may lead to a deeper and more fruitful exchange of ideas among computational neuroscientists in years to come. We further hope that work on standardized ways of describing—and thinking about—complex neuronal networks will lead the scientific community to a clearer understanding of high-level concepts in network dynamics, and will thus lead to deeper insights into the function of the brain. PMID:19662159

Glenohumeral osteoarthritis: overview, therapy, and rehabilitation.

PubMed

Macías-Hernández, Salvador Israel; Morones-Alba, Juan Daniel; Miranda-Duarte, Antonio; Coronado-Zarco, Roberto; Soria-Bastida, María de Los Angeles; Nava-Bringas, Tania; Cruz-Medina, Eva; Olascoaga-Gómez, Andrea; Tallabs-Almazan, Laura Verónica; Palencia, Chanell

2017-08-01

Glenohumeral osteoarthritis (GHOA) is a common cause of pain and functional disability of the shoulder. Despite the limited evidence, there are several options for the treatment of this pathology. The aim of this article is to provide current information on the characteristics of the disease and the pathophysiology, evidence based on medical and surgical treatments with emphasis on the rehabilitation process. It was performed with an extensive literature review, mainly clinical practice guidelines, randomized controlled trials, reviews, focusing on the rehabilitation management. There are few clinical practice guidelines that address GHOA as a pathology with unique characteristics. Evidence based treatment recommendations are mostly supported by low-quality evidence and experts' opinions, with few high levels of evidence studies guiding treatment decisions. Despite the lack of good quality evidence, rehabilitation programs have proven to be efficient and reliable, and this revision provides information and recommendations in this field. Implication of Rehabilitation Glenohumeral osteoarthritis is a common cause of pain and functional disability of the shoulder There are few clinical practice guidelines that address Glenohumeral Osteoarthritis as a pathology with unique characteristics, and recommendations for rehabilitation and therapeutic exercise are poor The paper provides current information on the characteristics of the disease, its rehabilitation process, and could be of interest for rehabilitation professionals to direct their practices in this field.

Public nutrition in complex emergencies.

PubMed

Young, Helen; Borrel, Annalies; Holland, Diane; Salama, Peter

Public nutrition is a broad-based, problem-solving approach to addressing malnutrition in complex emergencies that combines analysis of nutritional risk and vulnerability with action-oriented strategies, including policies, programmes, and capacity development. This paper focuses on six broad areas: nutritional assessment, distribution of a general food ration, prevention and treatment of moderate malnutrition, treatment of severe malnutrition in children and adults, prevention and treatment of micronutrient deficiency diseases, and nutritional support for at-risk groups, including infants, pregnant and lactating women, elderly people, and people living with HIV. Learning and documenting good practice from previous emergencies, the promotion of good practice in current emergencies, and adherence to international standards and guidelines have contributed to establishing the field of public nutrition. However, many practical challenges reduce the effectiveness of nutritional interventions in complex emergencies, and important research and programmatic questions remain.

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.

[How practical guidelines can be applied in poor countries? Example of the introduction of a bronchoscopy unit in Cambodia].

PubMed

Couraud, S; Chan, S; Avrillon, V; Horn, K; Try, S; Gérinière, L; Perrot, É; Guichon, C; Souquet, P-J; Ny, C

2013-10-01

According to UN, Cambodia is one of the poorest countries in the World. Respiratory diseases are current public health priorities. In this context, a new bronchoscopy unit (BSU) was created in the respiratory medicine department of Preah Kossamak hospital (PKH) thanks to a tight cooperation between a French and a Cambodian team. Aim of this study was to describe conditions of introduction of this equipment. Two guidelines for practice are available. They are respectively edited by the French and British societies of pulmonology. These guidelines were reviewed and compared to the conditions in which BS was introduced in PKH. Each item from guidelines was combined to a categorical value: "applied", "adapted" or "not applied". In 2009, 54 bronchoscopies were performed in PKH, mainly for suspicion of infectious or tumour disease. In total, 52% and 46% of the French and British guideline items respectively were followed in this Cambodian unit. Patient safety items are those highly followed. By contrast "staff safety" items were those weakly applied. Implementation of EBS in developing countries seems feasible in good conditions of quality and safety for patients. However, some recommendations cannot be applied due to local conditions. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of multifocal motor neuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society--first revision.

PubMed

2010-12-01

A European Federation of Neurological Societies/Peripheral Nerve Society consensus guideline on the definition, investigation, and treatment of multifocal motor neuropathy (MMN) was published in 2006. The aim is to revise this guideline. Disease experts considered references retrieved from MEDLINE and Cochrane Systematic Reviews published between August 2004 and July 2009 and prepared statements that were agreed to in an iterative fashion. The Task Force agreed on Good Practice Points to define clinical and electrophysiological diagnostic criteria for MMN, investigations to be considered, and principal recommendations for treatment. © 2010 Peripheral Nerve Society.

Children's behaviour problems: a NICE mess.

PubMed

Timimi, S

2014-09-01

The potential harms of medicalisation are well known. A good illustration comes from the medicalisation of children's behaviour problems. National Institute for health and Clinical Excellence (NICE) guidelines on conditions such as Attention Deficit Hyperactivity Disorder (ADHD), Autistic Spectrum Disorder (ASD) and Conduct Disorder (CD) reflect how attempts to regulate medical practice in this area has spawned guidelines based more on wish fulfilment (that getting kids to behave themselves can be accomplished by simple technological interventions that exist independent of context) than scientific evidence. In this perspective piece, I explain why these NICE guidelines are more a reflection of cultural confusion about how to deal with children, than the outcome of sound scientific understanding in this area. © 2014 John Wiley & Sons Ltd.

Assessing the Impact of Higher Education on Regional Development: Using a Realist Approach for Policy Enhancement

ERIC Educational Resources Information Center

Higher Education Management and Policy, 2005

2005-01-01

Higher Education is widely seen as a crucial ingredient in the regional economic development mix, and as fundamental to the development of the knowledge economy (Barclays, 2002). Indeed the Higher Education Funding Council for England has issued broad guidelines for benchmarking good practice in assessing regional development contribution of a…

"Who Is Helsinki" Sex Workers Advise Improving Communication for Good Participatory Practice in Clinical Trials

ERIC Educational Resources Information Center

Ditmore, Melissa Hope; Allman, Dan

2011-01-01

After premature closures in 2004 of biomedical human immunodeficiency virus (HIV) prevention trials involving sex workers in Africa and Asia, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and Global Advocacy for HIV Prevention (AVAC) undertook consultations to establish better participatory guidelines for such trials in order to address…

Mastering the Diversity Challenge: Easy On-the-Job Applications for Measurable Results.

ERIC Educational Resources Information Center

Lebo, Fern

This book provides practical, step-by-step guidelines and gives important reasons why managing diversity is good for overall business. It identifies issues specific to designated groups and provides effective techniques for creating a level playing field, as well as specific on-the-job applications for running meetings, building a team, opening…

Social Media for Learning and Teaching Undergraduate Sciences: Good Practice Guidelines from Intervention

ERIC Educational Resources Information Center

Thalluri, Jyothi; Penman, Joy

2015-01-01

In 2013, Facebook was used in learning and teaching clinical problem solving in a Pathology and a Clinical Sciences course delivered at a South Australian university. It involved first- and second-year Medical Radiation students and second-year Nursing students, Of the 152 students enrolled in the Pathology course, there were 148 students who…

Gap Between Clinical Practice and Guidelines: A National Survey of the Knowledge of Recommended Heart Failure Guidelines Among Chinese Physicians.

PubMed

Gan, Tianyi; Zhang, Yuhui; Liu, Nini; Huang, Yuhui; Liang, Tuo; Zhao, Xuemei; Zhang, Jian

We investigated the current level of knowledge of Chinese heart failure (HF) guidelines among physicians, as a reference for the promotion and transformation of HF knowledge. Physicians from 88 hospitals in 27 provinces of China completed our survey between July and December 2014. The questions covered the main points included in the Chinese HF diagnosis and treatment guidelines (2014). A total of 2146 physicians, aged 20 to 62 years (35.6 ± 7.6 years), completed the survey. The correctness rate of their answers to the 15 multiple-choice questions in the HF questionnaire was generally low (mean 32.6%). The mean correctness rate for 10 blank-filling questions about the target doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, and β-blockers was 42.5%. On the basis of their responses, physicians whose knowledge of the guidelines was "excellent," "good," "medium," and "bad" accounted for 1.1%, 11.4%, 14.2%, and 73.4%, respectively. Physicians who possessed a higher level of qualifications had significantly greater awareness of HF guidelines than those with relatively low qualifications (P < .001). A statistically significant association was found between hospital level and adherence to treatment guidelines (P < .001). A significant difference was also observed among physicians in different practice scopes (P < .001). The survey found an obvious deficiency in physicians' mastery of fundamental knowledge about HF. There is a need to improve physicians' education about HF in China.

[Consumer involvement in the Disease Management Guideline for Asthma--a background report].

PubMed

Senger, Sylvia; Lelgemann, Monika; Kopp, Ina

2006-01-01

In the past clinical guidelines were mainly developed by experts and in everyday clinical practice almost exclusively used by clinical experts, while issues that were relevant from the patients' (consumers') point of view tended to be neglected. But then, the majority of patient information has not been perceptibly connected to clinical guidelines. Connecting the development of clinical guidelines with the development of patient information publications would make good sense for both products, though. On the one hand, evidence-based treatment guidelines could be made available to the actual target group of the clinical care process--i.e. the patients or consumers--and on the other hand, patient experiences and competencies (social evidence) might inform the production of guidelines. Such a procedure demands the cooperation of clinical experts and patients. So far there are no generally accepted methods in Germany for the practical implementation of consumer involvement on both the organizational and content level with the aim of involving patients in the development process of guidelines as well as the production of the respective patient information versions. Such a methodology shall be established as part of the National Program for Disease Management Guidelines. For the first time in this program, patient involvement is being exercised within the scope of the National Disease Management Guideline for Asthma (NDM Asthma). Here, patients are involved in the NDM development process by providing the opportunity to comment on the consented guideline draft and to participate in the translation of the NDM Asthma into a patient version. The present paper is a background report describing the current state of work and indicating consequences for some future developments.

Guidelines for procedural pain in the newborn

PubMed Central

Lago, Paola; Garetti, Elisabetta; Merazzi, Daniele; Pieragostini, Luisa; Ancora, Gina; Pirelli, Anna; Bellieni, Carlo Valerio

2009-01-01

Despite accumulating evidence that procedural pain experienced by newborn infants may have acute and even long-term detrimental effects on their subsequent behaviour and neurological outcome, pain control and prevention remain controversial issues. Our aim was to develop guidelines based on evidence and clinical practice for preventing and controlling neonatal procedural pain in the light of the evidence-based recommendations contained in the SIGN classification. A panel of expert neonatologists used systematic review, data synthesis and open discussion to reach a consensus on the level of evidence supported by the literature or customs in clinical practice and to describe a global analgesic management, considering pharmacological, non-pharmacological, behavioural and environmental measures for each invasive procedure. There is strong evidence to support some analgesic measures, e.g. sucrose or breast milk for minor invasive procedures, and combinations of drugs for tracheal intubation. Many other pain control measures used during chest tube placement and removal, screening and treatment for ROP, or for postoperative pain, are still based not on evidence, but on good practice or expert opinions. Conclusion: These guidelines should help improving the health care professional's awareness of the need to adequately manage procedural pain in neonates, based on the strongest evidence currently available. PMID:19484828

Managing barriers to empathy in the clinical encounter: a qualitative interview study with GPs.

PubMed

Derksen, Frans Awm; Olde Hartman, Tim C; Bensing, Jozien M; Lagro-Janssen, Antoine Lm

2016-12-01

Current daily general practice has become increasingly technical and somatically oriented (where attention to patients' feelings is decreased) due to an increase in protocol-based guidelines. Priorities in GP-patient communication have shifted from a focus on listening and empathy to task-oriented communication. To explore what barriers GPs experience when applying empathy in daily practice, and how these barriers are managed. Thirty Dutch GPs with sufficient heterogeneity in sex, age, type of practice, and rural or urban setting were interviewed. The consolidated criteria for reporting qualitative research (COREQ) were applied. The verbatim transcripts were then analysed. According to participating GPs, the current emphasis on protocol-driven care can be a significant barrier to genuineness in communication. Other potential barriers mentioned were time pressures and constraints, and dealing with patients displaying 'unruly behaviour' or those with personality disorders. GPs indicated that it can be difficult to balance emotional involvement and professional distance. Longer consulting times, smaller practice populations, and efficient practice organisation were described as practical solutions. In order to focus on a patient-as-person approach, GPs strongly suggested that deviating from guidelines should be possible when necessary as an element of good-quality care. Joining intercollegiate counselling groups was also discussed. In addition to practical solutions for barriers to behaving empathically, GPs indicated that they needed more freedom to balance working with protocols and guidelines, as well as a patient-as-person and patient-as-partner approach. This balance is necessary to remain connected with patients and to deliver care that is truly personal. © British Journal of General Practice 2016.

Realizing good care within a context of cross-cultural diversity: an ethical guideline for healthcare organizations in Flanders, Belgium.

PubMed

Denier, Yvonne; Gastmans, Chris

2013-09-01

In our globalizing world, health care professionals and organizations increasingly experience cross-cultural challenges in care relationships, which give rise to ethical questions regarding "the right thing to do" in such situations. For the time being, the international literature lacks examples of elaborated ethical guidelines for cross-cultural healthcare on the organizational level. As such, the ethical responsibility of healthcare organizations in realizing cross-cultural care remains underexposed. This paper aims to fill this gap by offering a case-study that illustrates the bioethical practice on a large-scale organizational level by presenting the ethical guideline developed in the period 2007-2011 by the Ethics Committee of Zorgnet Vlaanderen, a Christian-inspired umbrella organization for over 500 social profit healthcare organizations in Flanders, Belgium. The guideline offers an ethical framework within which fundamental ethical values are being analyzed within the context of cross-cultural care. The case study concludes with implications for healthcare practice on four different levels: (1) the level of the healthcare organization, (2) staff, (3) care receivers, and (4) the level of care supply. The study combines content-based ethics with process-based benchmarks. Copyright © 2013. Published by Elsevier Ltd.

Time to finger point or fix? An invitation to join ongoing efforts to promote ethical authorship and other good publication practices.

PubMed

Woolley, Karen L; Gertel, Art; Hamilton, Cindy W; Jacobs, Adam; Snyder, Gene P

2013-01-01

In this commentary, we present evidence that unethical authorship (eg, guest and ghost authoring) and other publication practices are not restricted to the pharmaceutical industry; they also occur in academia. Such practices are not an industry problem--they are a research problem. To enhance trust in industry-sponsored research, companies have made rapid and far-reaching changes to their publication guidelines, policies, and procedures. Professional medical writers have adopted, and continue to implement, these changes. Although evidence indicates that industry practices are improving, there is certainly more to do, both in industry and academia. We invite readers to join ongoing efforts to promote ethical publication practices.

Developing a tool to support diagnostic delivery of dementia.

PubMed

Bennett, Claire E; De Boos, Danielle; Moghaddam, Nima G

2018-01-01

It is increasingly recognised that there are challenges affecting the current delivery of dementia diagnoses. Steps are required to address this. Current good practice guidelines provide insufficient direction and interventions from other healthcare settings do not appear to fully translate to dementia care settings. This project has taken a sequential two-phase design to developing a tool specific to dementia diagnostic delivery. Interviews with 14 participants explored good diagnostic delivery. Thematic analysis produced key themes (overcoming barriers, navigation of multiple journeys and completing overt and covert tasks) that were used to inform the design of a tool for use by clinicians, patients and companions. The tool was evaluated for acceptability in focused group discussions with 13 participants, which indicated a desire to use the tool and that it could encourage good practice. Adaptations were highlighted and incorporated to improve acceptability. Future research is now required to further evaluate the tool.

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.

Pharmacoeconomic evaluations of pharmacogenetic and genomic screening programmes: a systematic review on content and adherence to guidelines.

PubMed

Vegter, Stefan; Boersma, Cornelis; Rozenbaum, Mark; Wilffert, Bob; Navis, Gerjan; Postma, Maarten J

2008-01-01

The fields of pharmacogenetics and pharmacogenomics have become important practical tools to progress goals in medical and pharmaceutical research and development. As more screening tests are being developed, with some already used in clinical practice, consideration of cost-effectiveness implications is important. A systematic review was performed on the content of and adherence to pharmacoeconomic guidelines of recent pharmacoeconomic analyses performed in the field of pharmacogenetics and pharmacogenomics. Economic analyses of screening strategies for genetic variations, which were evidence-based and assumed to be associated with drug efficacy or safety, were included in the review. The 20 papers included cover a variety of healthcare issues, including screening tests on several cytochrome P450 (CYP) enzyme genes, thiopurine S-methyltransferase (TMPT) and angiotensin-converting enzyme (ACE) insertion deletion (ACE I/D) polymorphisms. Most economic analyses reported that genetic screening was cost effective and often even clearly dominated existing non-screening strategies. However, we found a lack of standardization regarding aspects such as the perspective of the analysis, factors included in the sensitivity analysis and the applied discount rates. In particular, an important limitation of several studies related to the failure to provide a sufficient evidence-based rationale for an association between genotype and phenotype. Future economic analyses should be conducted utilizing correct methods, with adherence to guidelines and including extensive sensitivity analyses. Most importantly, genetic screening strategies should be based on good evidence-based rationales. For these goals, we provide a list of recommendations for good pharmacoeconomic practice deemed useful in the fields of pharmacogenetics and pharmacogenomics, regardless of country and origin of the economic analysis.

Reprocessing and reuse of urological armamentarium: How correct are we!

PubMed Central

Raval, Krutik Vipulbhai; Chaudhari, Rajeev; Khant, Shahil Rameshbhai; Joglekar, Omkar; Patel, Dipen

2017-01-01

Healthcare is expensive for a large proportion of the population in spite of high per capita income and good health insurance penetration. In an effort to reduce cost of the procedure, reprocessing of devices was started in the late 1970s. Reprocessing practice includes various measures such as proper cleaning, disinfection, and sterilization procedures. As reprocessing is aimed at reducing cost, there is a potential risk of compromising patient safety due to cross contamination after inadequate sterilization. There is also risk of performance alteration of urological reprocessed devices during sterilization/disinfection processing. Therefore, there is a need for formulating proper guidelines to decide methods of reprocessing for various urological equipment. There is also need to discuss the problematic areas that urologists face and to find their solutions. A PubMed search was made in September 2016, using key words “reprocessing of medical devices,” “Single Use Devices,” “methods of reprocessing of devices in clinical practice,” “use of formalin chamber,” “urological disposable sterilization,” etc., After excluding duplicates, all English articles were reviewed by title and abstract. Full texts of selected articles were obtained, and these articles were cross-referenced to find any other related articles. All the articles were reviewed. A product can be reused if it can be economically reprocessed with validated protocols with preservation of its function. There is no reason to discard it after one use. This practice is useful for controlling economics of a urological case and to reduce the financial burden. Current Food and Drug Administration guidelines are stringent. The contamination described to test the sterilization process in the suggested guidelines actually does never exist in clinical practice. Therefore, new guidelines considering the clinical practice scenario are desirable. PMID:28479760

Consensus statement on the anticipation and prevention of acute postoperative pain: multidisciplinary RADAR approach.

PubMed

Vickers, A; Bali, S; Baxter, A; Bruce, G; England, J; Heafield, R; Langford, R; Makin, R; Power, I; Trim, J

2009-10-01

There has been considerable investment in efforts to improve postoperative pain management, including the introduction of acute pain teams. There have also been a number of guidelines published on postoperative pain management and there is widespread agreement on how pain should be practically managed. Despite these advances, there is no apparent improvement in the number of patients experiencing moderately severe or extreme pain after surgery. This highlights significant scope for improvement in acute postoperative pain management. In January 2009, a multidisciplinary UK expert panel met to define and agree a practical framework to encourage implementation of the numerous guidelines and fundamentals of pain management at a local level. The panel recognised that to do this, there was a need to organise the information and guidelines into a simplified, accessible and easy-to-implement system based on their practical clinical experience. Given the volume of literature in this area, the Chair recommended that key international guidelines from professional bodies should be distributed and then reviewed during the meeting to form the basis of the framework. Consensus was reached by unanimous agreement of all ten participants. This report provides a framework for the key themes, including consensus recommendations based upon practical experience agreed during the meeting, with the aim of consolidating the key guidelines to provide a fundamental framework which is simple to teach and implement in all areas. Key priorities that emerged were: Responsibility, Anticipation, Discussion, Assessment and Response. This formed the basis of RADAR, a novel framework to help pain specialists educate the wider care team on understanding and prioritising the management of acute pain. Acute postoperative pain can be more effectively managed if it is prioritised and anticipated by a well-informed care team who are educated with regard to appropriate analgesic options and understand what the long-term benefits of pain relief are. The principles of RADAR provide structure to help with training and implementation of good practice, to achieve effective postoperative pain management.

The development of evidence-based guidelines in dentistry.

PubMed

Faggion, C M

2013-02-01

Use of guidelines is an important means of reducing the gap between research and clinical practice. Sound and unbiased information should be available to enable dental professionals to provide better clinical treatment for their patients. The development of clinical guidelines in dentistry should follow standard and transparent methodology. The purpose of this article is to propose important steps for developing evidence-based clinical recommendations in dentistry. Initially, dental guidelines should be extensively sought and assessed to answer focused clinical questions. If there is a paucity of guidelines or if existing guidelines are not of good methodological quality, systematic reviews should be searched or conducted to serve as a basis for the development of evidence-based guidelines. When systematic reviews are produced, they should be rigorous in order to provide the best evidence possible. In the last phase of the process, the overall quality of evidence should be scrutinized and assessed, together with other factors (balance between treatment effects and side effects, patients' values, and cost-effectiveness of therapy) to determine the strength of recommendations. It is expected this approach will result in the development of sound clinical guidelines and consequent improvement of dental treatment.

Evidence-based practice: attitudes, knowledge and behaviour among allied health care professionals.

PubMed

Heiwe, Susanne; Kajermo, Kerstin Nilsson; Tyni-Lenné, Raija; Guidetti, Susanne; Samuelsson, Monika; Andersson, Inga-Lena; Wengström, Yvonne

2011-04-01

To explore dieticians', occupational therapists' and physical therapists' attitudes, beliefs, knowledge and behaviour concerning evidence-based practice within a university hospital setting. Cross-sectional survey. University hospital. All dieticians, occupational therapists and physical therapists employed at a Swedish university hospital (n = 306) of whom 227 (74%) responded. Attitudes towards, perceived benefits and limitations of evidence-based practice, use and understanding of clinical practice guidelines, availability of resources to access information and skills in using these resources. Findings showed positive attitudes towards evidence-based practice and the use of evidence to support clinical decision-making. It was seen as necessary. Literature and research findings were perceived as useful in clinical practice. The majority indicated having the necessary skills to be able to interpret and understand the evidence, and that clinical practice guidelines were available and used. Evidence-based practice was not perceived as taking into account the patient preferences. Lack of time was perceived as the major barrier to evidence-based practice. The prerequisites for evidence-based practice were assessed as good, but ways to make evidence-based practice time efficient, easy to access and relevant to clinical practice need to be continuously supported at the management level, so that research evidence becomes linked to work-flow in a way that does not adversely affect productivity and the flow of patients.

Computer ergonomics: the medical practice guide to developing good computer habits.

PubMed

Hills, Laura

2011-01-01

Medical practice employees are likely to use computers for at least some of their work. Some sit several hours each day at computer workstations. Therefore, it is important that members of your medical practice team develop good computer work habits and that they know how to align equipment, furniture, and their bodies to prevent strain, stress, and computer-related injuries. This article delves into the field of computer ergonomics-the design of computer workstations and work habits to reduce user fatigue, discomfort, and injury. It describes practical strategies medical practice employees can use to improve their computer work habits. Specifically, this article describes the proper use of the computer workstation chair, the ideal placement of the computer monitor and keyboard, and the best lighting for computer work areas and tasks. Moreover, this article includes computer ergonomic guidelines especially for bifocal and progressive lens wearers and offers 10 tips for proper mousing. Ergonomically correct posture, movements, positioning, and equipment are all described in detail to enable the frequent computer user in your medical practice to remain healthy, pain-free, and productive.

Continuous palliative sedation until death: practice after introduction of the Dutch national guideline.

PubMed

Swart, Siebe J; van der Heide, Agnes; Brinkkemper, Tijn; van Zuylen, Lia; Perez, Roberto; Rietjens, Judith

2012-09-01

In 2005, a national palliative guideline was launched in The Netherlands. The authors describe the practice of continuous palliative sedation until death (CPS) after the introduction of this guideline. In 2008, a random sample of physicians (n=1580) were asked to fill out a questionnaire regarding the last patient in whom they had provided CPS until death. The response was 38%. In all, 82% of the respondents were aware of the existence of the national guideline. Dyspnoea, pain and physical exhaustion were most often mentioned as decisive indications for continuous sedation. The decision to use sedation was discussed with all competent patients, but in 18% this merely involved informing the patient. Life expectancy at the start of continuous sedation was estimated to be less than 2 weeks in 97% of the cases. In 14%, the physicians had felt pressure to start the sedation, predominantly from patients and relatives. Physicians were present at the start of the sedation in 81% of the cases. Midazolam was used to induce the sedation in 92%. Overall, 41% of the physicians estimated that continuous sedation had hastened death to some extent. Most physicians thought that patients' complaints were adequately relieved by continuous sedation, that relatives were satisfied and that a good quality of dying was achieved. Continuous palliative sedation practice in The Netherlands largely reflects the recommendations from the national guideline. Issues needing further attention are the pressure felt by physicians to start continuous sedation and the potential life-shortening effect as mentioned by the physicians.

Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline

PubMed Central

Kapur, Vishesh K.; Auckley, Dennis H.; Chowdhuri, Susmita; Kuhlmann, David C.; Mehra, Reena; Ramar, Kannan; Harrod, Christopher G.

2017-01-01

Introduction: This guideline establishes clinical practice recommendations for the diagnosis of obstructive sleep apnea (OSA) in adults and is intended for use in conjunction with other American Academy of Sleep Medicine (AASM) guidelines on the evaluation and treatment of sleep-disordered breathing in adults. Methods: The AASM commissioned a task force of experts in sleep medicine. A systematic review was conducted to identify studies, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, patient values and preferences, and resource use. In addition, the task force adopted foundational recommendations from prior guidelines as “good practice statements”, that establish the basis for appropriate and effective diagnosis of OSA. The AASM Board of Directors approved the final recommendations. Recommendations: The following recommendations are intended as a guide for clinicians diagnosing OSA in adults. Under GRADE, a STRONG recommendation is one that clinicians should follow under most circumstances. A WEAK recommendation reflects a lower degree of certainty regarding the outcome and appropriateness of the patient-care strategy for all patients. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources. Good Practice Statements: Diagnostic testing for OSA should be performed in conjunction with a comprehensive sleep evaluation and adequate follow-up. Polysomnography is the standard diagnostic test for the diagnosis of OSA in adult patients in whom there is a concern for OSA based on a comprehensive sleep evaluation. Recommendations: We recommend that clinical tools, questionnaires and prediction algorithms not be used to diagnose OSA in adults, in the absence of polysomnography or home sleep apnea testing. (STRONG)We recommend that polysomnography, or home sleep apnea testing with a technically adequate device, be used for the diagnosis of OSA in uncomplicated adult patients presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA. (STRONG)We recommend that if a single home sleep apnea test is negative, inconclusive, or technically inadequate, polysomnography be performed for the diagnosis of OSA. (STRONG)We recommend that polysomnography, rather than home sleep apnea testing, be used for the diagnosis of OSA in patients with significant cardiorespiratory disease, potential respiratory muscle weakness due to neuromuscular condition, awake hypoventilation or suspicion of sleep related hypoventilation, chronic opioid medication use, history of stroke or severe insomnia. (STRONG)We suggest that, if clinically appropriate, a split-night diagnostic protocol, rather than a full-night diagnostic protocol for polysomnography be used for the diagnosis of OSA. (WEAK)We suggest that when the initial polysomnogram is negative and clinical suspicion for OSA remains, a second polysomnogram be considered for the diagnosis of OSA. (WEAK) Citation: Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical practice guideline for diagnostic testing for adult obstructive sleep apnea: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(3):479–504. PMID:28162150

A Passion for Print: Promoting Reading and Books to Teens

ERIC Educational Resources Information Center

Mahood, Kristine

2006-01-01

Get teens excited about reading by using the readers own love of books along with a good dose of market savvy. This simple, upbeat guide is packed with practical guidelines and a wealth of exciting ideas for promoting books and reading through everything the reader does--from collection building, designing the space, and creating a Web site, to…

Developing the Effective Teacher: Hiring, Evaluation, and Retention Practices for the School Administrator.

ERIC Educational Resources Information Center

Whaley, Jamie, Ed.; Cox, Cheryl, Ed.

Educators love to say it takes a village to raise a child. This task is accomplished through the skills, talents, and support of good teachers. This manual is designed to help school administrators help their teachers and students reach their maximum potential. It contains tools, tips, and guidelines that school leaders around the nation use to…

Rheumatic diseases and pregnancy: a national survey about practice patterns among rheumatologists and obstetricians.

PubMed

Fayad, Fouad; Ziade, Nelly; Karam, Ghada Abi; Ghaname, Wadih; Khamashta, Munther

2018-05-24

Management of rheumatic diseases (RD) is often problematic in pregnant patients, hence the need for guideline implementation. This survey-based study aimed to assess beliefs among obstetricians and rheumatologists about managing RD in pregnant Lebanese patients. Questionnaires were completed by a representative sample of rheumatologists and obstetricians practicing throughout Lebanon. Collected data included physicians' information, opinion on pregnancy in RD patients, compatible drugs with fertility, pregnancy and breastfeeding, references used in their clinical management, referral to specialists, and knowledge about guidelines. Qualitative variables were analysed using Chi-square or Fisher's exact tests, and quantitative variables using Wilcoxon or Student t-tests. Results were matched against a scoring system based on the EULAR/BSR guidelines. p-value <0.05 indicated statistical significance. Analysis showed high response rates of physicians, especially among rheumatologists. Overall, physicians practice was in concordance with international guidelines and only few misconceptions were reported. Systemic lupus erythematosus (SLE) was associated with risk on fertility, foetal malformation and eclampsia while anti-phospholipid (APL) syndrome was associated with miscarriage and vasculitis with eclampsia. Spondyloarthritis was considered 'safe' in pregnancy. Most physicians think that cyclophosphamide, leflunomide, methotrexate, mycophenolate mofetil and azathioprine compromise fertility, pregnancy, and breastfeeding. Our data showed relatively good concordance of the physicians' beliefs with the current literature and recommendations. However, we identified misconceptions about anti-rheumatic drugs safety in pregnancy and discrepancy between rheumatologists and obstetricians practices; hence the need for promoting collaboration between both specialties and disseminating knowledge to physicians and patients in the Middle East region.

Establishing good collaborative research practices in the responsible conduct of research in nursing science.

PubMed

Ulrich, Connie M; Wallen, Gwenyth R; Cui, Naixue; Chittams, Jesse; Sweet, Monica; Plemmons, Dena

2015-01-01

Team science is advocated to speed the pace of scientific discovery, yet the goals of collaborative practice in nursing science and the responsibilities of nurse stakeholders are sparse and inconclusive. The purpose of this study was to examine nurse scientists' views on collaborative research as part of a larger study on standards of scientific conduct. Web-based descriptive survey of nurse scientists randomly selected from 50 doctoral graduate programs in the United States. Nearly forty percent of nurse respondents were not able to identify good collaborative practices for the discipline; more than three quarters did not know of any published guidelines available to them. Successful research collaborations were challenged by different expectations of authorship and data ownership, lack of timeliness and communication, poorly defined roles and responsibilities, language barriers, and when they involve junior and senior faculty working together on a project. Individual and organizational standards, practices, and policies for collaborative research needs clarification within the discipline. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2012-01-01

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

Assessing Clinical Microbiology Practice Guidelines: American Society for Microbiology Ad Hoc Committee on Evidence-Based Laboratory Medicine Practice Guidelines Assessment

PubMed Central

Kirn, Thomas J.; Westblade, Lars F.; Humphries, Romney

2017-01-01

ABSTRACT As part of the American Society for Microbiology (ASM) Evidence-Based Laboratory Medicine Practice Guidelines Committee of the Professional Practice Committee, an ad hoc committee was formed in 2014 to assess guidelines published by the committee using an assessment tool, Appraisal of Guidelines for Research Evaluation II (AGREE II). The AGREE II assessment helps reviewers determine whether published guidelines are robust, transparent, and clear in presenting practice recommendations in a standardized manner. Identifying strengths and weaknesses of practice guidelines by ad hoc assessments helps with improving future guidelines through the participation of key stakeholders. This minireview describes the development of the ad hoc committee and results from their review of several ASM best practices guidelines and a non-ASM practice guideline from the Emergency Nurses Association. PMID:28835476

Survey of current practice in clinical transvaginal ultrasound scanning in the UK

PubMed Central

Shaw, Adam; Lees, Christoph

2015-01-01

During transvaginal ultrasound scanning, the fetus and other sensitive tissues are placed close to the transducer. Heating of these tissues occurs by direct conduction from the transducer and by absorption of ultrasound in the tissue. The extent of any heating will depend on the equipment and settings used, the duration of the scan, imaging modes and other aspects of scanning practice. To ensure that scans are performed with minimum risk, staff should have an appropriate knowledge of safety and follow guidelines issued by professional bodies. An online survey aiming to document current practice in transvaginal ultrasound in the UK was created and distributed to individuals performing this type of scanning. The survey posed questions about the respondents, the departments where scans were performed, the equipment used, knowledge of ultrasound safety, scanning practice and the frequency, duration and mode of transvaginal ultrasound scans for gynaecology, obstetrics and fertility applications. In all, 294 responses were obtained, mostly from sonographers (94%). From the analysis of the responses, it was clear that there was a good understanding of the general meaning of thermal and mechanical index and high awareness of guidelines issued by professional bodies. However, 40% of respondents stated that they rarely or never monitor Thermal or Mechanical indices during scanning. Scanning practice was consistent in terms of the duration of scans, scan protocols followed and use of imaging modes. The results highlight the importance of continued ultrasound safety training and promotion of safety guidelines to users. PMID:27433250

Dutch practice guidelines for managing adjustment disorders in occupational and primary health care.

PubMed

van der Klink, Jac J L; van Dijk, Frank J H

2003-12-01

Stress-related disorders, especially adjustment disorders, are widespread among working populations and are responsible for high costs in terms of suffering, sick leave, disability, and economic losses. Despite their high prevalence, there has been relatively little research on the effectiveness of treatments in an occupational health care setting. Guidelines for occupational physicians and general practitioners in relation to mental health problems were recently developed in The Netherlands and are discussed in this article. The guidelines provide a classification based on terms that are already used in the profession and are consistent with the diagnosis "adjustment disorder". They give recommendations for guidance and treatment on the basis of existing evidence, experience in adjacent fields, and consensus procedures. They are based on cognitive behavioral principles, mainly stress inoculation training and graded activity, and aim to enhance the problem-solving capacity of patients in relation to the work environment. The aim of this paper is to contribute to the exchange of and a discussion on methods and good practices in primary and occupational health care.

Clostridium difficile-associated disease: impact of the updated SHEA/IDSA guidelines.

PubMed

Kincaid, Scott E

2010-12-01

Clostridium difficile-associated disease (CDAD) is an increasingly difficult condition to treat because of the emergence of antibiotic resistance and highly pathogenic strains of bacteria. These newly identified strains affect patients in every facet of health care, from individuals in the community to those in intensive care units and all points in between. Appropriate management regarding diagnosis, infection control, pharmacotherapy, and prevention is the key to good outcomes in all patient populations. Geriatric patients are particularly at risk of acquiring CDAD as a result of their gradually declining immune systems and increased exposure to health care facilities. Therefore, they merit a higher level of attention when CDAD is suspected. In an effort to identify the best practices, the Society for Healthcare Epidemiology of America in conjunction with the Infectious Diseases Society of America developed guidelines regarding the diagnosis and management of Clostridium-associated disease. By utilizing these guidelines to educate other health care practitioners and by considering the recommendations in their own practice, pharmacists can have a positive impact on every facet of CDAD prevention and management.

Quality assurance of herbal raw materials in supply chain: challenges and opportunities.

PubMed

Govindaraghavan, Suresh

2008-01-01

The herbal medicine industry is presently adopting modern scientific tools to substantiate the guarantee of efficacy that, in the past, rested only on anecdotal evidence derived from traditional knowledge systems. This is particularly true for the processes of identification of herbal raw materials adopting modern tools for phytochemical fingerprinting. The successful adaptation of available technologies and practices depends on an understanding of the phytochemical complexity and variability innate in biological material. It challenges the "mainstream medicinal mindset" that "tend(s) to reject …. therapies for which mechanisms of action do not fit within Newtonian, biochemical orientation" (Dumoff, 2003). The herbal medicinal industry is independently evolving its own rigid quality assurance and control systems using Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) guidelines, but it faces unique difficulties. These include lack of Good Agricultural and Collection Practice (GACP), lack of transparency in the raw material supply chain so as to preclude the use of unsafe practices, problems in the authentication of herbal raw materials, and a general lack of understanding of the need to reduce phytochemical variability in these materials. This paper explores these difficulties and outlines strategies to overcome them, but these strategies will require coordinated international government regulations to be fully effective.

Managing vulnerabilities and achieving compliance for Oracle databases in a modern ERP environment

NASA Astrophysics Data System (ADS)

Hölzner, Stefan; Kästle, Jan

In this paper we summarize good practices on how to achieve compliance for an Oracle database in combination with an ERP system. We use an integrated approach to cover both the management of vulnerabilities (preventive measures) and the use of logging and auditing features (detective controls). This concise overview focusses on the combination Oracle and SAP and it’s dependencies, but also outlines security issues that arise with other ERP systems. Using practical examples, we demonstrate common vulnerabilities and coutermeasures as well as guidelines for the use of auditing features.

Regulatory considerations in application of encapsulated cell therapies.

PubMed

van Zanten, J; de Vos, Paul

2010-01-01

The encapsulation of tissue in semi-permeable membranes is a technology with high potential and in due time several new therapies based on this technology will be tested in clinical trials. Recent, new legislation requires that these investigational medicinal products used in clinical trials Phase I must be produced according to Good Manufacturing Practice (GMP). Consequently, the activities of GMP are expanding to the field of research and researchers might need to change developed protocols in order to meet GMP legislation. This chapters gives an overview of the overall guidelines covering GMP and more specific guidelines dealing with cell based therapies and gene therapy.

Design and pilot evaluation of a system to develop computer-based site-specific practice guidelines from decision models.

PubMed

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

2000-01-01

Local tailoring of clinical practice guidelines (CPGs) requires experts in medicine and evidence synthesis unavailable in many practice settings. The authors' computer-based system enables developers and users to create, disseminate, and tailor CPGs, using normative decision models (DMs). ALCHEMIST, a web-based system, analyzes a DM, creates a CPG in the form of an annotated algorithm, and displays for the guideline user the optimal strategy. ALCHEMIST'S interface enables remote users to tailor the guideline by changing underlying input variables and observing the new annotated algorithm that is developed automatically. In a pilot evaluation of the system, a DM was used to evaluate strategies for staging non-small-cell lung cancer. Subjects (n = 15) compared the automatically created CPG with published guidelines for this staging and critiqued both using a previously developed instrument to rate the CPGs' usability, accountability, and accuracy on a scale of 0 (worst) to 2 (best), with higher scores reflecting higher quality. The mean overall score for the ALCHEMIST CPG was 1.502, compared with the published-CPG score of 0.987 (p = 0.002). The ALCHEMIST CPG scores for usability, accountability, and accuracy were 1.683, 1.393, and 1.430, respectively; the published CPG scores were 1.192, 0.941, and 0.830 (each comparison p < 0.05). On a scale of 1 (worst) to 5 (best), users' mean ratings of ALCHEMIST'S ease of use, usefulness of content, and presentation format were 4.76, 3.98, and 4.64, respectively. The results demonstrate the feasibility of a web-based system that automatically analyzes a DM and creates a CPG as an annotated algorithm, enabling remote users to develop site-specific CPGs. In the pilot evaluation, the ALCHEMIST guidelines met established criteria for quality and compared favorably with national CPGs. The high usability and usefulness ratings suggest that such systems can be a good tool for guideline development.

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.

Assessing Clinical Microbiology Practice Guidelines: American Society for Microbiology Ad Hoc Committee on Evidence-Based Laboratory Medicine Practice Guidelines Assessment.

PubMed

Nachamkin, Irving; Kirn, Thomas J; Westblade, Lars F; Humphries, Romney

2017-11-01

As part of the American Society for Microbiology (ASM) Evidence-Based Laboratory Medicine Practice Guidelines Committee of the Professional Practice Committee, an ad hoc committee was formed in 2014 to assess guidelines published by the committee using an assessment tool, Appraisal of Guidelines for Research Evaluation II (AGREE II). The AGREE II assessment helps reviewers determine whether published guidelines are robust, transparent, and clear in presenting practice recommendations in a standardized manner. Identifying strengths and weaknesses of practice guidelines by ad hoc assessments helps with improving future guidelines through the participation of key stakeholders. This minireview describes the development of the ad hoc committee and results from their review of several ASM best practices guidelines and a non-ASM practice guideline from the Emergency Nurses Association. Copyright © 2017 American Society for Microbiology.

Practice Paper of the Academy of Nutrition and Dietetics: Selecting Nutrient-Dense Foods for Good Health.

PubMed

Hingle, Melanie D; Kandiah, Jayanthi; Maggi, Annette

2016-09-01

The 2015 Dietary Guidelines for Americans encourage selection of nutrient-dense foods for health promotion and disease prevention and management. The purpose of this Academy of Nutrition and Dietetics practice paper is to provide an update regarding the science and practice of nutrient-dense food identification and selection. Characterization of tools used to identify nutrient density of foods is provided and recommendations for how registered dietitian nutritionists and nutrition and dietetics technicians, registered, might use available profiling tools to help consumers select nutrient-dense foods is discussed. Copyright © 2016 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

Behavioral Patterns in Special Education. Good Teaching Practices

PubMed Central

Rodríguez-Dorta, Manuela; Borges, África

2017-01-01

Providing quality education means to respond to the diversity in the classroom. The teacher is a key figure in responding to the various educational needs presented by students. Specifically, special education professionals are of great importance as they are the ones who lend their support to regular classroom teachers and offer specialized educational assistance to students who require it. Therefore, special education is different from what takes place in the regular classroom, demanding greater commitment by the teacher. There are certain behaviors, considered good teaching practices, which teachers have always been connected with to achieve good teaching and good learning. To ensure that these teachers are carrying out their educational work properly it is necessary to evaluate. This means having appropriate instruments. The Observational Protocol for Teaching Functions in Primary School and Special Education (PROFUNDO-EPE, v.3., in Spanish) allows to capture behaviors from these professionals and behavioral patterns that correspond to good teaching practices. This study evaluates the behavior of two special education teachers who work with students from different educational stages and educational needs. It reveals that the analyzed teachers adapt their behavior according the needs and characteristics of their students to the students responding more adequately to the needs presented by the students and showing good teaching practices. The patterns obtained indicate that they offer support, help and clear guidelines to perform the tasks. They motivate them toward learning by providing positive feedback and they check that students have properly assimilated the contents through questions or non-verbal supervision. Also, they provide a safe and reliable climate for learning. PMID:28512437

Behavioral Patterns in Special Education. Good Teaching Practices.

PubMed

Rodríguez-Dorta, Manuela; Borges, África

2017-01-01

Providing quality education means to respond to the diversity in the classroom. The teacher is a key figure in responding to the various educational needs presented by students. Specifically, special education professionals are of great importance as they are the ones who lend their support to regular classroom teachers and offer specialized educational assistance to students who require it. Therefore, special education is different from what takes place in the regular classroom, demanding greater commitment by the teacher. There are certain behaviors, considered good teaching practices, which teachers have always been connected with to achieve good teaching and good learning. To ensure that these teachers are carrying out their educational work properly it is necessary to evaluate. This means having appropriate instruments. The Observational Protocol for Teaching Functions in Primary School and Special Education (PROFUNDO-EPE, v.3., in Spanish) allows to capture behaviors from these professionals and behavioral patterns that correspond to good teaching practices. This study evaluates the behavior of two special education teachers who work with students from different educational stages and educational needs. It reveals that the analyzed teachers adapt their behavior according the needs and characteristics of their students to the students responding more adequately to the needs presented by the students and showing good teaching practices. The patterns obtained indicate that they offer support, help and clear guidelines to perform the tasks. They motivate them toward learning by providing positive feedback and they check that students have properly assimilated the contents through questions or non-verbal supervision. Also, they provide a safe and reliable climate for learning.

A Validation Study of the National Assessment Instruments for Young English Language Learners in Norway and Slovenia

ERIC Educational Resources Information Center

Pižorn, Karmen; Moe, Eli

2012-01-01

This article is a validation study of two national large-scale tests that measure the language proficiency of 11/12 year-old English learners in Norway and Slovenia. Following the example of Alderson and Banerjee (2008), the authors of the article have employed the EALTA guidelines for good practice to validate the tests, and to formulate major…

Pre-return-to-work medical consultation for low back pain workers. Good practice recommendations based on systematic review and expert consensus.

PubMed

Petit, A; Rozenberg, S; Fassier, J B; Rousseau, S; Mairiaux, P; Roquelaure, Y

2015-10-01

The pre-return-to-work medical consultation during sick leave for low back pain (LBP) aims at assessing the worker's ability to resume working without risk for his/her health, and anticipating any difficulties inherent to returning to work and job retention. This article summarizes the good practices guidelines proposed by the French Society of Occupational Medicine (SFMT) and the French National Health Authority (HAS), and published in October 2013. Good practices guidelines developed by a multidisciplinary and independent task force (24 experts) and peer review committee (50 experts) based on a literature review from 1990 to 2012, according to the HAS methodology. According to the labour regulations, workers can request a medical consultation with their occupational physician at any time. The pre-return-to-work consultation precedes the effective return-to-work and can be requested by the employee regardless of their sick leave duration. It must be scheduled early enough to: (i) deliver reassuring information regarding risks to the lower back and managing LBP; (ii) evaluate prognostic factors of chronicity and prolonged disability in relations to LBP and its physical, social and occupational consequences in order to implement the necessary conditions for returning to work; (iii) support and promote staying at work by taking into account all medical, social and occupational aspects of the situation and ensure proper coordination between the different actors. A better understanding of the pre-return-to-work consultation would improve collaboration and coordination of actions to facilitate resuming work and job retention for patients with LBP. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Study of antibiotic prescribing among dental practitioners in Shiraz, Islamic Republic of Iran.

PubMed

Vessal, G; Khabiri, A; Mirkhani, H; Cookson, B D; Askarian, M

2011-10-01

Inappropriate prescribing of antibiotics by health care professionals is a worldwide concern. This study evaluated the knowledge and practices of dental practitioners in the city of Shiraz, Islamic Republic of Iran regarding their therapeutic use of antibiotics for patients with dentoalveolar infections. Of 219 (48.6%) dentists responding to the questionnaire more than 40% would prescribe antibiotics for localized fluctuant swelling and for problems for which antibiotics are not required according to good practice guidelines (acute pulpitis, chronic apical infection, periodontal abscess, chronic gingivitis, chronic periodontitis, pericoronitis and dry socket). A majority correctly prescribed antibiotics for acute periapical infection (77.2%), cellulitis (75.3%) and acute ulcerated gingivitis (63.0%). Amoxicillin was the most frequently prescribed antibiotic for all clinical conditions but there was a wide variation in dosage, frequency and duration for all antibiotics used. Guidelines on rational antibiotic use are needed for dental practitioners in the Islamic Republic of Iran.

Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

PubMed Central

2014-01-01

Background Anxiety and related disorders are among the most common mental disorders, with lifetime prevalence reportedly as high as 31%. Unfortunately, anxiety disorders are under-diagnosed and under-treated. Methods These guidelines were developed by Canadian experts in anxiety and related disorders through a consensus process. Data on the epidemiology, diagnosis, and treatment (psychological and pharmacological) were obtained through MEDLINE, PsycINFO, and manual searches (1980–2012). Treatment strategies were rated on strength of evidence, and a clinical recommendation for each intervention was made, based on global impression of efficacy, effectiveness, and side effects, using a modified version of the periodic health examination guidelines. Results These guidelines are presented in 10 sections, including an introduction, principles of diagnosis and management, six sections (Sections 3 through 8) on the specific anxiety-related disorders (panic disorder, agoraphobia, specific phobia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder), and two additional sections on special populations (children/adolescents, pregnant/lactating women, and the elderly) and clinical issues in patients with comorbid conditions. Conclusions Anxiety and related disorders are very common in clinical practice, and frequently comorbid with other psychiatric and medical conditions. Optimal management requires a good understanding of the efficacy and side effect profiles of pharmacological and psychological treatments. PMID:25081580

Managing barriers to empathy in the clinical encounter: a qualitative interview study with GPs

PubMed Central

Derksen, Frans AWM; Hartman, Tim C olde; Bensing, Jozien M; Lagro-Janssen, Antoine LM

2016-01-01

Background Current daily general practice has become increasingly technical and somatically oriented (where attention to patients’ feelings is decreased) due to an increase in protocol-based guidelines. Priorities in GP–patient communication have shifted from a focus on listening and empathy to task-oriented communication. Aim To explore what barriers GPs experience when applying empathy in daily practice, and how these barriers are managed. Design and setting Thirty Dutch GPs with sufficient heterogeneity in sex, age, type of practice, and rural or urban setting were interviewed. Method The consolidated criteria for reporting qualitative research (COREQ) were applied. The verbatim transcripts were then analysed. Results According to participating GPs, the current emphasis on protocol-driven care can be a significant barrier to genuineness in communication. Other potential barriers mentioned were time pressures and constraints, and dealing with patients displaying ‘unruly behaviour’ or those with personality disorders. GPs indicated that it can be difficult to balance emotional involvement and professional distance. Longer consulting times, smaller practice populations, and efficient practice organisation were described as practical solutions. In order to focus on a patient-as-person approach, GPs strongly suggested that deviating from guidelines should be possible when necessary as an element of good-quality care. Joining intercollegiate counselling groups was also discussed. Conclusion In addition to practical solutions for barriers to behaving empathically, GPs indicated that they needed more freedom to balance working with protocols and guidelines, as well as a patient-as-person and patient-as-partner approach. This balance is necessary to remain connected with patients and to deliver care that is truly personal. PMID:27884917

Pharmacological guidelines for schizophrenia: a systematic review and comparison of recommendations for the first episode

PubMed Central

Keating, Dolores; McWilliams, Stephen; Schneider, Ian; Hynes, Caroline; Cousins, Gráinne; Strawbridge, Judith; Clarke, Mary

2017-01-01

Objectives Clinical practice guidelines (CPGs) support the translation of research evidence into clinical practice. Key health questions in CPGs ensure that recommendations will be applicable to the clinical context in which the guideline is used. The objectives of this study were to identify CPGs for the pharmacological treatment of first-episode schizophrenia; assess the quality of these guidelines using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument; and compare recommendations in relation to the key health questions that are relevant to the pharmacological treatment of first-episode schizophrenia. Methods A multidisciplinary group identified key health questions that are relevant to the pharmacological treatment of first-episode schizophrenia. The MEDLINE and EMBASE databases, websites of professional organisations and international guideline repositories, were searched for CPGs that met the inclusion criteria. The AGREE II instrument was applied by three raters and data were extracted from the guidelines in relation to the key health questions. Results In total, 3299 records were screened. 10 guidelines met the inclusion criteria. 3 guidelines scored well across all domains. Recommendations varied in specificity. Side effect concerns, rather than comparative efficacy benefits, were a key consideration in antipsychotic choice. Antipsychotic medication is recommended for maintenance of remission following a first episode of schizophrenia but there is a paucity of evidence to guide duration of treatment. Clozapine is universally regarded as the medication of choice for treatment resistance. There is less evidence to guide care for those who do not respond to clozapine. Conclusions An individual's experience of using antipsychotic medication for the initial treatment of first-episode schizophrenia may have implications for future engagement, adherence and outcome. While guidelines of good quality exist to assist in medicines optimisation, the evidence base required to answer key health questions relevant to the pharmacological treatment of first-episode schizophrenia is limited. PMID:28062471

Are pediatric Open Access journals promoting good publication practice? An analysis of author instructions.

PubMed

Meerpohl, Joerg J; Wolff, Robert F; Antes, Gerd; von Elm, Erik

2011-04-09

Several studies analyzed whether conventional journals in general medicine or specialties such as pediatrics endorse recommendations aiming to improve publication practice. Despite evidence showing benefits of these recommendations, the proportion of endorsing journals has been moderate to low and varied considerably for different recommendations. About half of pediatric journals indexed in the Journal Citation Report referred to the Uniform Requirements for Manuscripts of the International Committee of Medical Journal Editors (ICMJE) but only about a quarter recommended registration of trials. We aimed to investigate to what extent pediatric open-access (OA) journals endorse these recommendations. We hypothesized that a high proportion of these journals have adopted recommendations on good publication practice since OA electronic publishing has been associated with a number of editorial innovations aiming at improved access and transparency. We identified 41 journals publishing original research in the subject category "Health Sciences, Medicine (General), Pediatrics" of the Directory of Open Access Journals http://www.doaj.org. From the journals' online author instructions we extracted information regarding endorsement of four domains of editorial policy: the Uniform Requirements for Manuscripts, trial registration, disclosure of conflicts of interest and five major reporting guidelines such as the CONSORT (Consolidated Standards of Reporting Trials) statement. Two investigators collected data independently. The Uniform Requirements were mentioned by 27 (66%) pediatric OA journals. Thirteen (32%) required or recommended trial registration prior to publication of a trial report. Conflict of interest policies were stated by 25 journals (61%). Advice about reporting guidelines was less frequent: CONSORT was referred to by 12 journals (29%) followed by other reporting guidelines (MOOSE, PRISMA or STARD) (8 journals, 20%) and STROBE (3 journals, 7%). The EQUATOR network, a platform of several guideline initiatives, was acknowledged by 4 journals (10%). Journals published by OA publishing houses gave more guidance than journals published by professional societies or other publishers. Pediatric OA journals mentioned certain recommendations such as the Uniform Requirements or trial registration more frequently than conventional journals; however, endorsement is still only moderate. Further research should confirm these exploratory findings in other medical fields and should clarify what the motivations and barriers are in implementing such policies.

Are pediatric Open Access journals promoting good publication practice? An analysis of author instructions

PubMed Central

2011-01-01

Background Several studies analyzed whether conventional journals in general medicine or specialties such as pediatrics endorse recommendations aiming to improve publication practice. Despite evidence showing benefits of these recommendations, the proportion of endorsing journals has been moderate to low and varied considerably for different recommendations. About half of pediatric journals indexed in the Journal Citation Report referred to the Uniform Requirements for Manuscripts of the International Committee of Medical Journal Editors (ICMJE) but only about a quarter recommended registration of trials. We aimed to investigate to what extent pediatric open-access (OA) journals endorse these recommendations. We hypothesized that a high proportion of these journals have adopted recommendations on good publication practice since OA electronic publishing has been associated with a number of editorial innovations aiming at improved access and transparency. Methods We identified 41 journals publishing original research in the subject category "Health Sciences, Medicine (General), Pediatrics" of the Directory of Open Access Journals http://www.doaj.org. From the journals' online author instructions we extracted information regarding endorsement of four domains of editorial policy: the Uniform Requirements for Manuscripts, trial registration, disclosure of conflicts of interest and five major reporting guidelines such as the CONSORT (Consolidated Standards of Reporting Trials) statement. Two investigators collected data independently. Results The Uniform Requirements were mentioned by 27 (66%) pediatric OA journals. Thirteen (32%) required or recommended trial registration prior to publication of a trial report. Conflict of interest policies were stated by 25 journals (61%). Advice about reporting guidelines was less frequent: CONSORT was referred to by 12 journals (29%) followed by other reporting guidelines (MOOSE, PRISMA or STARD) (8 journals, 20%) and STROBE (3 journals, 7%). The EQUATOR network, a platform of several guideline initiatives, was acknowledged by 4 journals (10%). Journals published by OA publishing houses gave more guidance than journals published by professional societies or other publishers. Conclusions Pediatric OA journals mentioned certain recommendations such as the Uniform Requirements or trial registration more frequently than conventional journals; however, endorsement is still only moderate. Further research should confirm these exploratory findings in other medical fields and should clarify what the motivations and barriers are in implementing such policies. PMID:21477335

Cross-sectional survey on the use and impact of the Danish national antibiotic use guidelines for companion animal practice.

PubMed

Jessen, Lisbeth Rem; Sørensen, Tina Møller; Lilja, Zenia Littau; Kristensen, Maja; Hald, Tine; Damborg, Peter

2017-12-11

The Danish antibiotic use guidelines for companion animal practice were published by the Danish Veterinary Association in 2012. Since then, national surveillance data indicate a 10% reduction in the total use of antibiotics for companion animals, particularly a marked reduction in the use of third generation cephalosporins. The aim of the study was to assess if and how the guidelines have impacted diagnostic and antibiotic prescription habits of the users, and to identify user perceived barriers to implementation. An online questionnaire was sent to all 882 members of the Danish Small Animal Veterinary Association in October 2015. The survey was completed by 151 veterinarians. Respondents most frequently consulted the recommendations on skin and urinary tract infections (UTI), and users generally reported a high degree of adherence to the recommendations. Sixty-five per cent indicated that the guidelines had influenced their habits in one or more of the areas being investigated, i.e. perioperative use of antibiotics, use of first line antibiotics for the treatment of pyoderma or UTI, and/or use of microbiological diagnostics. Perioperative use of antibiotics for clean surgeries was uncommon, irrespective of whether respondents had consulted the relevant recommendations or not. On the contrary, significant differences in the prescribing habits between guideline users and non-users were observed for pyoderma and UTI, suggesting an impact of the guidelines towards more prudent antimicrobial use. The diagnostic habits were examined in a subgroup of 63 guideline users. Of those, 19 and 39% reported frequent use of culture and susceptibility (C&S) testing prior to treating pyoderma and UTI respectively, whereas 68-84% reported C&S testing in the event of poor response to treatment or recurrence of infections. The main barriers for implementation of therapeutic recommendations were confidence in old prescribing practices and unavailability of recommended drugs. The main barriers for C&S testing were good experience with empiric treatment, and the owners' financial situation. The findings suggest a positive influence of the national antibiotic guidelines on prescription patterns among companion animal practitioners in Denmark. Sustained campaign activity is encouraged and should include promotion of bacteriological testing.

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

A comparison of the outcome of CPR according to AHA 2005 ACLS and AHA 2010 ACLS guidelines in cardiac arrest: multicenter study.

PubMed

Ocal, Oktay; Ozucelik, Dogac Niyazi; Avci, Akkan; Yazicioglu, Mustafa; Aydin, Yilmaz; Ayvaci, Baris Murat; Dogan, Halil; Aciksari, Kurtulus; Cukurova, Zafer

2015-01-01

The aim of this study was to evaluate whether there is a difference in the return of spontaneous circulation (ROSC) and survival with sequel-free recovery rates between the patients who underwent cardiopulmonary resuscitation (CPR) according to 2005 and 2010 guidelines. This study was conducted in the Bakırköy Dr. Sadi Konuk and Kartal Lütfi Kırdar Training and Research Hospital between dates of October 2010 and 28 February 2011 after approval of Ethics Committee. In the first months of the study, CPR was performed according to AHA 2005 ACLS guidelines (Group-1), while CPR was performed according to AHA 2010 ACLS guidelines after November 2010 (Group-2). Patients were assessed for neurological deficit with Cerebral Performance Categories Scale. Mean age was found as 69.01±13.05 (minimum: 21, maximum: 92) in 86 patients included. Of the 33 patients underwent CPR in the Group 1, ROSC was achieved in 51.5%; and 6.1% of these patients were discharged. Of the 53 patients underwent CPR in the Group 2, ROSC was achieved in 37.7%; and 9.4% of these patients were discharged. Although the number of living patients in Group 2 was higher than Group 1, the difference was not found statistically significant (5 versus 2), (P>0.05). But, neurological outcomes were found better with 2010 compared to 2005 guidelines (3/7 versus 0/2 good cerebral performance). It was found that the 2005 CPR guidelines practices in ED were more successful than the 2010 CPR guidelines practices in ROSC, but less successful in the rate of discharge from hospital and neurological sequel-free discharge rate.

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.

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

PubMed

Kageura, Mitsuyoshi

2002-09-01

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

The Surgical Care Improvement Project Antibiotic Guidelines: Should We Expect More Than Good Intentions?

PubMed

Schonberger, Robert B; Barash, Paul G; Lagasse, Robert S

2015-08-01

Since 2006, the Surgical Care Improvement Project (SCIP) has promoted 3 perioperative antibiotic recommendations designed to reduce the incidence of surgical site infections. Despite good evidence for the efficacy of these recommendations, the efforts of SCIP have not measurably improved the rates of surgical site infections. We offer 3 arguments as to why SCIP has fallen short of expectations. We then suggest a reorientation of quality improvement efforts to focus less on reporting, and incentivizing adherence to imperfect metrics, and more on creating local and regional quality collaboratives to educate clinicians about how to improve practice. Ultimately, successful quality improvement projects are behavioral interventions that will only succeed to the degree that they motivate individual clinicians, practicing within a particular context, to do the difficult work of identifying failures and iteratively working toward excellence.

The Surgical Care Improvement Project Antibiotic Guidelines: Should We Expect More than Good Intentions?

PubMed Central

Schonberger, Robert B.; Barash, Paul G.; Lagasse, Robert S.

2015-01-01

Since 2006, the Surgical Care Improvement Project (SCIP) has promoted three perioperative antibiotic recommendations designed to reduce the incidence of surgical-site infections. Despite good evidence for the efficacy of these recommendations, SCIP's efforts have not measurably improved rates of surgical site-infections. We offer three arguments as to why SCIP has fallen-short of expectations. We then suggest a reorientation of quality improvement efforts to focus less on reporting, and incentivizing adherence to imperfect metrics, and more on creating local and regional quality collaboratives to educate clinicians about how to improve practice. Ultimately, successful quality improvement projects are behavioral interventions that will only succeed to the degree that they motivate individual clinicians, practicing within a particular context, to do the difficult work of identifying failures and iteratively working toward excellence. PMID:26197373

The effect of dietary guidelines on cancer risk and mortality.

PubMed

Bälter, Katarina; Möller, Elisabeth; Fondell, Elinor

2012-01-01

Dietary guidelines are important tools for educating the general public and helping health professionals promote good health and prevent chronic diet-related diseases. However, it is of major public health relevance that the effect of the guidelines per se is evaluated to make sure that they serve their purpose. The aim of this article is to review the current research on dietary guidelines and their effect on cancer risk and mortality. Since the last 30-40 years, most industrialized countries have had dietary guidelines. The guidelines are based on thorough reviews of the current scientific evidence regarding dietary intake and health. Potential health benefits associated with good adherence to the guidelines have been evaluated in observational studies during the last 15 years, with an increase in the number of studies during the most recent years. Available data on the potential association between dietary guidelines and cancer are limited and inconclusive. A meta-analysis of studies on overall cancer risk shows no protective effect for good adherence to the dietary guidelines as compared with poor adherence. However, good adherence was associated with a 21% reduced risk of colorectal cancer, and 22% reduced cancer-specific mortality.

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.

Feeding and Nutrition of Infants and Young Children: Guidelines for the WHO European Region, with Emphasis on the Former Soviet Countries. WHO Regional Publications, European Series, No. 87.

ERIC Educational Resources Information Center

Michaelsen, Kim Fleischer; Weaver, Lawrence; Branca, Francesco; Robertson, Aileen

Noting that good feeding practices will prevent malnutrition and early growth retardation, which are still common in some parts of the World Health Organization (WHO) European Region, this report provides a scientific rationale for the development of national nutrition and feeding recommendations for children from birth to 3 years and presents…

A tool for assessment of heart failure prescribing quality: A systematic review and meta-analysis.

PubMed

El Hadidi, Seif; Darweesh, Ebtissam; Byrne, Stephen; Bermingham, Margaret

2018-04-16

Heart failure (HF) guidelines aim to standardise patient care. Internationally, prescribing practice in HF may deviate from guidelines and so a standardised tool is required to assess prescribing quality. A systematic review and meta-analysis were performed to identify a quantitative tool for measuring adherence to HF guidelines and its clinical implications. Eleven electronic databases were searched to include studies reporting a comprehensive tool for measuring adherence to prescribing guidelines in HF patients aged ≥18 years. Qualitative studies or studies measuring prescription rates alone were excluded. Study quality was assessed using the Good ReseArch for Comparative Effectiveness Checklist. In total, 2455 studies were identified. Sixteen eligible full-text articles were included (n = 14 354 patients, mean age 69 ± 8 y). The Guideline Adherence Index (GAI), and its modified versions, was the most frequently cited tool (n = 13). Other tools identified were the Individualised Reconciled Evidence Recommendations, the Composite Heart Failure Performance, and the Heart Failure Scale. The meta-analysis included the GAI studies of good to high quality. The average GAI-3 was 62%. Compared to low GAI, high GAI patients had lower mortality rate (7.6% vs 33.9%) and lower rehospitalisation rates (23.5% vs 24.5%); both P ≤ .05. High GAI was associated with reduced risk of mortality (hazard ratio = 0.29, 95% confidence interval, 0.06-0.51) and rehospitalisation (hazard ratio = 0.64, 95% confidence interval, 0.41-1.00). No tool was used to improve prescribing quality. The GAI is the most frequently used tool to assess guideline adherence in HF. High GAI is associated with improved HF outcomes. Copyright © 2018 John Wiley & Sons, Ltd.

I.S.Mu.L.T - Rotator Cuff Tears Guidelines

PubMed Central

Oliva, Francesco; Piccirilli, Eleonora; Bossa, Michela; Via, Alessio Giai; Colombo, Alessandra; Chillemi, Claudio; Gasparre, Giuseppe; Pellicciari, Leonardo; Franceschetti, Edoardo; Rugiero, Clelia; Scialdoni, Alessandro; Vittadini, Filippo; Brancaccio, Paola; Creta, Domenico; Buono, Angelo Del; Garofalo, Raffaele; Franceschi, Francesco; Frizziero, Antonio; Mahmoud, Asmaa; Merolla, Giovanni; Nicoletti, Simone; Spoliti, Marco; Osti, Leonardo; Padulo, Johnny; Portinaro, Nicola; Tajana, Gianfranco; Castagna, Alex; Foti, Calogero; Masiero, Stefano; Porcellini, Giuseppe; Tarantino, Umberto; Maffulli, Nicola

2015-01-01

Despite the high level achieved in the field of shoulder surgery, a global consensus on rotator cuff tears management is lacking. This work is divided into two main sessions: in the first, we set questions about hot topics involved in the rotator cuff tears, from the etiopathogenesis to the surgical treatment. In the second, we answered these questions by mentioning Evidence Based Medicine. The aim of the present work is to provide easily accessible guidelines: they could be considered as recommendations for a good clinical practice developed through a process of systematic review of the literature and expert opinion, in order to improve the quality of care and rationalize the use of resources. PMID:26958532

42 CFR 438.236 - Practice guidelines.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

Invited Article: Threats to physician autonomy in a performance-based reimbursement system.

PubMed

Larriviere, Daniel G; Bernat, James L

2008-06-10

Physician autonomy is currently threatened by the external application of pay for performance standards and required conformity to practice guidelines. This phenomenon is being driven by concerns over the economic viability of increasing per capita health care expenditures without a concomitant rise in favorable health outcomes and by the unjustified marked variations among physicians' practice patterns. Proponents contend that altering the reimbursement system to encourage physicians to make choices based upon the best available evidence would be one way to ensure better outcomes per health care dollar spent. Although physician autonomy is most easily justified when decisions are made by appealing to the best available evidence, incentivizing decision-making risks sacrificing physician autonomy to political and social forces if the limitations of evidence-based medicine are not respected. Any reimbursement system designed to encourage physicians to utilize the best available evidence by providing financial incentives must recognize physicians who try to play to the numbers as well as physicians who refuse to follow the best available evidence if doing so would conflict with good medicine or patient preferences. By designing, promulgating, and updating evidence-based clinical practice guidelines, medical specialty societies can limit threats to physician autonomy while improving medical practice.

[Biosafety in laboratories concerning exposure to biological agents].

PubMed

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

2006-01-01

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

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

Guidance on validation and qualification of processes and operations involving radiopharmaceuticals.

PubMed

Todde, S; Peitl, P Kolenc; Elsinga, P; Koziorowski, J; Ferrari, V; Ocak, E M; Hjelstuen, O; Patt, M; Mindt, T L; Behe, M

2017-01-01

Validation and qualification activities are nowadays an integral part of the day by day routine work in a radiopharmacy. This document is meant as an Appendix of Part B of the EANM "Guidelines on Good Radiopharmacy Practice (GRPP)" issued by the Radiopharmacy Committee of the EANM, covering the qualification and validation aspects related to the small-scale "in house" preparation of radiopharmaceuticals. The aim is to provide more detailed and practice-oriented guidance to those who are involved in the small-scale preparation of radiopharmaceuticals which are not intended for commercial purposes or distribution. The present guideline covers the validation and qualification activities following the well-known "validation chain", that begins with editing the general Validation Master Plan document, includes all the required documentation (e.g. User Requirement Specification, Qualification protocols, etc.), and leads to the qualification of the equipment used in the preparation and quality control of radiopharmaceuticals, until the final step of Process Validation. A specific guidance to the qualification and validation activities specifically addressed to small-scale hospital/academia radiopharmacies is here provided. Additional information, including practical examples, are also available.

[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.

Creating a multidisciplinary low back pain guideline: anatomy of a guideline adaptation process.

PubMed

Harstall, Christa; Taenzer, Paul; Angus, Donna K; Moga, Carmen; Schuller, Tara; Scott, N Ann

2011-08-01

A collaborative, multidisciplinary guideline adaptation process was developed to construct a single overarching, evidence-based clinical practice guideline (CPG) for all primary care practitioners responsible for the management of low back pain (LBP) to curb the use of ineffective treatments and improve patient outcomes. The adaptation strategy, which involved multiple committees and partnerships, leveraged existing knowledge transfer connections to recruit guideline development group (GDG) members and ensure that all stakeholders had a voice in the guideline development process. Videoconferencing was used to coordinate the large, geographically dispersed GDG. Information services and health technology assessment experts were used throughout the process to lighten the GDG's workload. The GDG reviewed seven seed guidelines and drafted an Alberta-specific guideline during 10 half-day meetings over a 12-month period. The use of ad hoc subcommittees to resolve uncertainties or disagreements regarding evidence interpretation expedited the process. Challenges were encountered in dealing with subjectivity, guideline appraisal tools, evidence source limitations and inconsistencies, and the lack of sophisticated evidence analysis inherent in guideline adaptation. Strategies for overcoming these difficulties are discussed. Guideline adaptation is useful when resources are limited and good-quality seed CPGs exist. The Ambassador Program successfully utilized existing stakeholder interest to create an overarching guideline that aligned guidance for LBP management across multiple primary care disciplines. Unforeseen challenges in guideline adaptation can be overcome with credible seed guidelines, a consistently applied and transparent methodology, and clear documentation of the subjective contextualization process. Multidisciplinary stakeholder input and an open, trusting relationship among all contributors will ensure that the end product is clinically meaningful. © 2010 Blackwell Publishing Ltd.

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

PubMed

Chung, Kevin C; Shauver, Melissa J

2009-10-01

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

Quality in the pharmaceutical industry – A literature review

PubMed Central

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

2013-01-01

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

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

PubMed

Wood, Sylvia K; Payne, Judith K

2012-06-01

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

[Impact of low-molecular-weight heparin practice guidelines in a geriatric hospital].

PubMed

d'Arailh, Lydie; Gaubert-Dahan, Marie-Line; Muller, Florence; Lechowski, Laurent; Teillet, Laurent

2011-06-01

The purpose of this study was to assess the impact of good use of anticoagulants guidelines implementation on low molecular weight heparin (LMWH) prescription in a french geriatric hospital. This interventional "before and after" study was conduced by the same geriatrician on a d-day in 2006 and 2009. Guidelines for anticoagulant's prescription based on selected references in the literature was established by an expert's consensus and implemented in 2008. Data were collected in all departments at the Sainte-Perine geriatric hospital for each patient with an LMWH prescription. Assessment was based on quality judgment criteria (indication, dosage, treatment duration, biological monitoring of LMWH). Data were collected for 72 prescriptions prior to the guidelines implementation and for 54 after. Sex-ratio, mean age and percentage of LMWH prescription did not differ significantly between the two periods. There was a better conformity for LMWH dosage prescription (p = 0.002) and biological monitoring prescription (p = 0.036) after the guidelines implementation. Conformity of LMWH indication and treatment duration were improved but the difference remained not significant (respectively p = 0.49 and p = 0.80). Implementing guidelines for LMWH use in geriatrics can improve quality of prescription. The impact was effective but limited. These guidelines are now in general use in the Sainte-Perine hospital.

Delivery room management of extremely low birth weight infants in Italy: comparison between academic and non-academic birth centres.

PubMed

Mardegan, Veronica; Satariano, Irene; Doglioni, Nicoletta; Criscoli, Giulio; Cavallin, Francesco; Gizzi, Camilla; Martano, Claudio; Ciralli, Fabrizio; Torielli, Flaminia; Villani, Paolo Ernesto; Di Fabio, Sandra; Quartulli, Lorenzo; Giannini, Luigi; Trevisanuto, Daniele

2016-01-01

International Guidelines provide a standardised approach to newborn resuscitation in the DR and, in their most recent versions, recommendations dedicated to management of ELBWI were progressively increased. It is expected that introduction in clinical practice and dissemination of the most recent evidence should be more consistent in academic than in non-academic hospitals. The aim of the study was to compare adherence to the International Guidelines and consistency of practice in delivery room management of extremely low birth weight infants between academic and non-academic institutions. A questionnaire was sent to the directors of all Italian level III centres between April and August 2012. There was a 92% (n = 98/107) response rate. Apart from polyethylene wrapping to optimise thermal control, perinatal management approach was comparable between academic and non-academic centres. There were minor differences in management of extremely low birth weight infants between Italian academic and non-academic institutions, apart from thermal management. Although there was a good, overall adherence to the International Guidelines for Neonatal Resuscitation, temperature management was not in accordance with official recommendations and every effort has to be done to improve this aspect.

[SERV clinical practice guidelines: management of retinal vein occlusion. Sociedad Española de Retina y Vitreo].

PubMed

Gómez-Ulla, F; Abraldes, M J; Basauri, E; Fernández, M; García-Layana, A; Gili, P; Montero, J; Nadal, J; Morales, V; Saravia, M; Cabrera, F; Cervera, E

2010-09-01

A guidelines for the management of retinal vein occlusion is presented. This is necessary because at this moment several therapeutic alternatives have been developed although their role is not yet sufficiently defined. Review of the literature for evidence published up to date. Relevant literature was identified and the level of evidence graded. Evidence was then assessed for consistency, applicability and clinical impact. The information was contrasted with those guides published in other countries. Taking into account the different options of treatment that are currently used, several modes of action are suggested. The role of the various complementary examinations are discussed and it is recommended that criteria for the treatment are based on clinical, angiographic, and tomographic findings. Although there is no overall consensus, these guidelines promote a good standard of clinical practise and provide an update of the management of retinal vein occlusion. Copyright © 2010. Published by Elsevier Espana.

Legal and ethical issues in research.

PubMed

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-09-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

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

PubMed

Hsiao, Ju-Ling; Chen, Rai-Fu

2016-01-16

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

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

PubMed Central

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

2013-01-01

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

'A world of difference': a qualitative study of medical students' views on professionalism and the 'good doctor'.

PubMed

Cuesta-Briand, Beatriz; Auret, Kirsten; Johnson, Paula; Playford, Denese

2014-04-12

The importance of professional behaviour has been emphasized in medical school curricula. However, the lack of consensus on what constitutes professionalism poses a challenge to medical educators, who often resort to a negative model of assessment based on the identification of unacceptable behaviour. This paper presents results from a study exploring medical students' views on professionalism, and reports on students' constructs of the 'good' and the 'professional' doctor. Data for this qualitative study were collected through focus groups conducted with medical students from one Western Australian university over a period of four years. Students were recruited through unit coordinators and invited to participate in a focus group. De-identified socio-demographic data were obtained through a brief questionnaire. Focus groups were audio-recorded, transcribed and subjected to inductive thematic analysis. A total of 49 medical students took part in 13 focus groups. Differences between students' understandings of the 'good' and 'professional' doctor were observed. Being competent, a good communicator and a good teacher were the main characteristics of the 'good' doctor. Professionalism was strongly associated with the adoption of a professional persona; following a code of practice and professional guidelines, and treating others with respect were also associated with the 'professional' doctor. Students felt more connected to the notion of the 'good' doctor, and perceived professionalism as an external and imposed construct. When both constructs were seen as acting in opposition, students tended to forgo professionalism in favour of becoming a 'good' doctor.Results suggest that the teaching of professionalism should incorporate more formal reflection on the complexities of medical practice, allowing students and educators to openly explore and articulate any perceived tensions between what is formally taught and what is being observed in clinical practice.

Emergency management training program: Guide to good practice

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

Not Available

1991-07-01

The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate componentsmore » of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager's point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.« less

Emergency management training program: Guide to good practice

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

Not Available

1991-07-01

The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate componentsmore » of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager`s point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.« less

Ischaemic stroke management at Al-Shifa Hospital in the Gaza Strip: a clinical audit.

PubMed

Abukaresh, Amir; Al-Abadlah, Rami; Böttcher, Bettina; El-Essi, Khamis

2018-02-21

In the 2014 Palestinian annual health report, cerebrovascular accident was ranked as the third leading cause of death in the occupied Palestinian territory. Cerebrovascular accident is also one the most common causes of disability worldwide. Good management decreases mortality and morbidity. The aim of this study was to assess the current management of patients with ischaemic stroke at the Al-Shifa Hospital and to compare this with international guidelines. For this clinical audit, we used simple random sampling to select files of patients admitted with the diagnosis of ischaemic stroke to the Al-Shifa Hospital. Data collection sheets were completed, and clinical practice was compared with the 2013 American Stroke Association guidelines. Between January and June, 2016, 254 patients were admitted with ischaemic stroke, haemorrhagic stroke, or transient ischaemic attack. We selected 55 patient files. The International Classification of Diseases coding for cerebral infarction in patient files was relatively good, with 92% of files correctly coded. However, we found a substantial weakness in the documentation of duration, progression of symptoms (documented in 20% of files only), and physiotherapy assessment. Most essential acute investigations were done on time (for all [100%] patients needing blood count, renal function tests, and CT scan and for 42 [76%] patients needing ECG). However, thrombolytic drugs were not used because they were not available. Long-term antiplatelet therapy was provided properly to 51 (92%) patients discharged from hospital. However, the initial doses of antiplatelet therapy were generally lower than the international recommendations. Findings also showed a marked inconformity of blood pressure management, especially with respect to the treatment decision and the choice of antihypertensive drug. No local guidelines exist. Furthermore, the lack of availability of thrombolysis medication and the poor deviation in blood pressure management show a lack of evidence-based practice. These findings point to the urgent need for the development of local, evidence-based guidelines. None. Copyright © 2018 Elsevier Ltd. All rights reserved.

Quality of care for anxiety and depression in different ethnic groups by family practitioners in urban areas in the Netherlands.

PubMed

Fassaert, Thijs; Nielen, Mark; Verheij, Robert; Verhoeff, Arnoud; Dekker, Jack; Beekman, Aartjan; de Wit, Matty

2010-01-01

There is widespread concern about access to good quality health care for ethnic minority groups. This study investigates differences between ethnic groups regarding prevalence of anxiety and depression, and adherence to treatment guidelines by family practitioners in urban areas in the Netherlands. Data from electronic medical records, collected for the Netherlands Information Network of General Practice. Diagnoses were based on the International Classification of Primary Care. Adherence to guidelines included at least five consultations, prescription of psychotropics for 6 weeks at most (indicative of cessation in case of nonresponse) or 5 months at least (suggesting continuation in case of response), and/or a referral to a mental health care specialist. Data were analyzed using multilevel logistic regression analyses. A total of 6413 patients (4.4% of practice population) were diagnosed with anxiety and/or depression. Prevalence was highest in Turkish patients (5.2%). Of diagnosed patients, 42.9% received guideline-concordant treatment. Only Surinamese/Antillean patients were less likely than ethnic Dutch to receive treatments according to guidelines. Prevalence of and quality of care for anxiety and depression were comparable between ethnic minority clients, but some differences suggest that efforts to educate primary care providers in management of anxiety/depression should be continued and tailored to specific ethnic groups. Copyright 2010 Elsevier Inc. All rights reserved.

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

ERIC Educational Resources Information Center

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

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

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

PubMed

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

2014-01-01

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

Assessment of current practice and barriers to antimicrobial prophylaxis in peritoneal dialysis patients.

PubMed

Campbell, Denise J; Brown, Fiona G; Craig, Jonathan C; Gallagher, Martin P; Johnson, David W; Kirkland, Geoffrey S; Kumar, Subramanian K; Lim, Wai H; Ranganathan, Dwarakanathan; Saweirs, Walaa; Sud, Kamal; Toussaint, Nigel D; Walker, Rowan G; Williams, Lesley A; Yehia, Maha; Mudge, David W

2016-04-01

Existing Australasian and international guidelines outline antibiotic and antifungal measures to prevent the development of treatment-related infection in peritoneal dialysis (PD) patients. Practice patterns and rates of PD-related infection vary widely across renal units in Australia and New Zealand and are known to vary significantly from guideline recommendations, resulting in PD technique survival rates that are lower than those achieved in many other countries. The aim of this study was to determine if there is an association between current practice and PD-related infection outcomes and to identify the barriers and enablers to good clinical practice. This is a multicentre network study involving eight PD units in Australia and New Zealand, with a focus on adherence to guideline recommendations on antimicrobial prophylaxis in PD patients. Current practice was established by asking the PD unit heads to respond to a short survey about practice/protocols/policies and a 'process map' was constructed following a face-to-face interview with the primary PD nurse at each unit. The perceived barriers/enablers to adherence to the relevant guideline recommendations were obtained from the completion of 'cause and effect' diagrams by the nephrologist and PD nurse at each unit. Data on PD-related infections were obtained for the period 1 January 2011 to 31 December 2011. Perceived barriers that may result in reduced adherence to guideline recommendations included lack of knowledge, procedural lapses, lack of a centralized patient database, patients with non-English speaking background, professional concern about antibiotic resistance, medication cost and the inability of nephrologists and infectious diseases staff to reach consensus on unit protocols. The definitions of PD-related infections used by some units varied from those recommended by the International Society for Peritoneal Dialysis, particularly with exit-site infection (ESI). Wide variations were observed in the rates of ESI (0.06-0.53 episodes per patient-year) and peritonitis (0.31-0.86 episodes per patient-year). Despite the existence of strongly evidence-based guideline recommendations, there was wide variation in adherence to these recommendations between PD units which might contribute to PD-related infection rates, which varied widely between units. Although individual patient characteristics may account for some of this variability, inconsistencies in the processes of care to prevent infection in PD patients also play a role. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Justification of CT scans using referral guidelines for imaging.

PubMed

Stanescu, G; Rosca-Fartat, G; Stanescu, D

2015-07-01

This study analyses the efficiency of the justification of individual computed tomography (CT) procedures using the good practice guide. The conformity of the CT scans with guide's recommendations was retrospectively analysed in a paediatric emergency hospital in Romania. The involved patient doses were estimated. The results show that around one-third of the examinations were not prescribed in conformity with the guide's recommendations, but these results are affected by unclear guide provisions, discussed here. The implications of the provisions of the revised International Atomic Energy Agency's Basic Safety Standards and of the Council Directive 2013/59/EURATOM were analysed. The education and training courses for medical doctors disseminating the provisions of the good practice guide should be considered as the main support for the justification of the CT scans at the individual level. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Good modeling practice guidelines for applying multimedia models in chemical assessments.

PubMed

Buser, Andreas M; MacLeod, Matthew; Scheringer, Martin; Mackay, Don; Bonnell, Mark; Russell, Mark H; DePinto, Joseph V; Hungerbühler, Konrad

2012-10-01

Multimedia mass balance models of chemical fate in the environment have been used for over 3 decades in a regulatory context to assist decision making. As these models become more comprehensive, reliable, and accepted, there is a need to recognize and adopt principles of Good Modeling Practice (GMP) to ensure that multimedia models are applied with transparency and adherence to accepted scientific principles. We propose and discuss 6 principles of GMP for applying existing multimedia models in a decision-making context, namely 1) specification of the goals of the model assessment, 2) specification of the model used, 3) specification of the input data, 4) specification of the output data, 5) conduct of a sensitivity and possibly also uncertainty analysis, and finally 6) specification of the limitations and limits of applicability of the analysis. These principles are justified and discussed with a view to enhancing the transparency and quality of model-based assessments. Copyright © 2012 SETAC.

The demise of primary care: a diatribe from the trenches.

PubMed

Norenberg, David D

2009-05-19

Medical school graduates are avoiding primary care. The very aspects that once attracted students have been subverted. The breadth of practice that was once appealing has become the breadth of heavy-handed scrutiny, as politicians and business leaders have demanded quality--simplistically defined as dogmatic adherence to a standard. Individualized clinical judgment has been devalued; thinking has been replaced by algorithms. Practice guidelines have been usurped by pay-for-performance police, on patrol for deviations--not understanding that knowing and allowing for exceptions is the heart and soul of primary care. The coercive surveillance of "Quality Improvement" has become oppressive, making single organ-system specialties increasingly attractive (or at least more tolerable). Generalists are spending so much time proving they are good doctors, they don't have time to be good doctors. A remedy is suggested: a pilot project of volunteer salaried internists (more trusted, less audited) commissioned to our expandable national health care program, Medicare.

Guidelines on Good Clinical Laboratory Practice

PubMed Central

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

2008-01-01

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

Multifaceted implementation of stroke prevention guidelines in primary care: cluster‐randomised evaluation of clinical and cost effectiveness

PubMed Central

Wright, John; Bibby, John; Eastham, Joe; Harrison, Stephen; McGeorge, Maureen; Patterson, Chris; Price, Nick; Russell, Daphne; Russell, Ian; Small, Neil; Walsh, Matt; Young, John

2007-01-01

Objective To evaluate clinical and cost effectiveness of implementing evidence‐based guidelines for the prevention of stroke. Design Cluster‐randomised trial Setting Three primary care organisations in the North of England covering a population of 400 000. Participants Seventy six primary care teams in four clusters: North, South & West, City I and City II. Intervention Guidelines for the management of patients with atrial fibrillation and transient ischaemic attack (TIA) were developed and implemented using a multifaceted approach including evidence‐based recommendations, audit and feedback, interactive educational sessions, patient prompts and outreach visits. Outcomes Identification and appropriate treatment of patients with atrial fibrillation or TIA, and cost effectiveness. Results Implementation led to 36% increase (95% CI 4% to 78%) in diagnosis of atrial fibrillation, and improved treatment of TIA (odds ratio of complying with guidelines 1.8; 95% CI 1.1 to 2.8). Combined analysis of atrial fibrillation and TIA estimates that compliance was significantly greater (OR 1.46 95% CI 1.10 to 1.94) in the condition for which practices had received the implementation programme. The development and implementation of guidelines cost less than £1500 per practice. The estimated costs per quality‐adjusted life year gained by patients with atrial fibrillation or TIA were both less than £2000, very much less than the usual criterion for cost effectiveness. Conclusions Implementation of evidence‐based guidelines improved the quality of primary care for atrial fibrillation and TIA. The intervention was feasible and very cost effective. Key components of the model include contextual analysis, strong professional support, clear recommendations based on robust evidence, simplicity of adoption, good communication and use of established networks and opinion leaders. PMID:17301206

Multifaceted implementation of stroke prevention guidelines in primary care: cluster-randomised evaluation of clinical and cost effectiveness.

PubMed

Wright, John; Bibby, John; Eastham, Joe; Harrison, Stephen; McGeorge, Maureen; Patterson, Chris; Price, Nick; Russell, Daphne; Russell, Ian; Small, Neil; Walsh, Matt; Young, John

2007-02-01

To evaluate clinical and cost effectiveness of implementing evidence-based guidelines for the prevention of stroke. Cluster-randomised trial Three primary care organisations in the North of England covering a population of 400,000. Seventy six primary care teams in four clusters: North, South & West, City I and City II. Guidelines for the management of patients with atrial fibrillation and transient ischaemic attack (TIA) were developed and implemented using a multifaceted approach including evidence-based recommendations, audit and feedback, interactive educational sessions, patient prompts and outreach visits. Identification and appropriate treatment of patients with atrial fibrillation or TIA, and cost effectiveness. Implementation led to 36% increase (95% CI 4% to 78%) in diagnosis of atrial fibrillation, and improved treatment of TIA (odds ratio of complying with guidelines 1.8; 95% CI 1.1 to 2.8). Combined analysis of atrial fibrillation and TIA estimates that compliance was significantly greater (OR 1.46 95% CI 1.10 to 1.94) in the condition for which practices had received the implementation programme. The development and implementation of guidelines cost less than 1500 pounds per practice. The estimated costs per quality-adjusted life year gained by patients with atrial fibrillation or TIA were both less than 2000 pounds, very much less than the usual criterion for cost effectiveness. Implementation of evidence-based guidelines improved the quality of primary care for atrial fibrillation and TIA. The intervention was feasible and very cost effective. Key components of the model include contextual analysis, strong professional support, clear recommendations based on robust evidence, simplicity of adoption, good communication and use of established networks and opinion leaders.

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

PubMed

Saunders, Hannele

2015-07-01

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

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

PubMed

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

2017-02-01

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

[Evaluation of dairy production in the alpine regions of Valcamonica and Sondrio, and the adherence to hygienic practice guidelines].

PubMed

Astuti, M; Brega; Casali, L; Dal Vecchio, A; Domenichini, M; Pontello, M

2005-01-01

The Regional Veterinary Service of Lombardy (northern Italian region) developed guideline on good hygienic practices to improve the safety of milk production and transformation in the mountain pastures and to grant the European acknowledgment (EU seal). Therefore we carried out 26 inspections in Valcamonica (Province of Brescia) and 30 in the Sondrio's province (26% and 16% respectively) in mountain pastures that had required the acknowledgment. The data analysis has shown that in Valcamonica 26.9% of the mountains pastures was conform to the regulations, in Sondrio's province instead 6.6% was conform; the frequency of acceptable conformity level increases respectively to 46% and to 33%, if we also consider the mountains pastures in restructuring phase and with very low level of non conformity. Our study emphasizes the need of structural adjustments of these traditional setting and of education of workers in order to improve the food safety and operator's life quality, and also to promote the maintenance of mountain pastures in the Alpine region.

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

PubMed

McKillop, Ann; Crisp, Jackie; Walsh, Kenneth

2012-01-01

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

Clinical practice guidelines in hypertension: a review.

PubMed

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

2015-10-23

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

Tissue banking in australia.

PubMed

Ireland, Lynette; McKelvie, Helen

2003-01-01

The legal structure for the regulation of tissue banking has existed for many years. In Australia, the donation of human tissue is regulated by legislation in each of the eight States and Territories. These substantially uniform Acts were passed in the late 1970's and early 1980's, based on model legislation and underpinned by the concept of consensual giving. However, it was not until the early 1990's that tissue banking came under the notice of regulatory authorities. Since then the Australian Government has moved quickly to oversee the tissue banking sector in Australia. Banked human tissue has been deemed to be a therapeutic good under the Therapeutic Goods Act 1989, and tissue banks are required to be licensed by the Therapeutic Goods Administration and are audited for compliance with the Code of Good Manufacturing Practice- Human Blood and Tissues. In addition, tissue banks must comply with a myriad of other standards, guidelines and recommendations.

Primary care clinicians' experiences with treatment decision making for older persons with multiple conditions.

PubMed

Fried, Terri R; Tinetti, Mary E; Iannone, Lynne

2011-01-10

Clinicians are caring for an increasing number of older patients with multiple diseases in the face of uncertainty concerning the benefits and harms associated with guideline-directed interventions. Understanding how primary care clinicians approach treatment decision making for these patients is critical to the design of interventions to improve the decision-making process. Focus groups were conducted with 40 primary care clinicians (physicians, nurse practitioners, and physician assistants) in academic, community, and Veterans Affairs-affiliated primary care practices. Participants were given open-ended questions about their approach to treatment decision making for older persons with multiple medical conditions. Responses were organized into themes using qualitative content analysis. The participants were concerned about their patients' ability to adhere to complex regimens derived from guideline-directed care. There was variability in beliefs regarding, and approaches to balancing, the benefits and harms of guideline-directed care. There was also variability regarding how the participants involved patients in the process of decision making, with clinicians describing conflicts between their own and their patients' goals. The participants listed a number of barriers to making good treatment decisions, including the lack of outcome data, the role of specialists, patient and family expectations, and insufficient time and reimbursement. The experiences of practicing clinicians suggest that they struggle with the uncertainties of applying disease-specific guidelines to their older patients with multiple conditions. To improve decision making, they need more data, alternative guidelines, approaches to reconciling their own and their patients' priorities, the support of their subspecialist colleagues, and an altered reimbursement system.

Using scenarios to test the appropriateness of pharmacist prescribing in asthma management.

PubMed

Hanna, Tamer; Bajorek, Beata; Lemay, Kate; Armour, Carol L

2014-01-01

To explore the potential for community pharmacist prescribing in terms of usefulness, pharmacists' confidence, and appropriateness, in the context of asthma management. Twenty community pharmacists were recruited using convenience sampling from a group of trained practitioners who had already delivered asthma services. These pharmacists were asked to complete a scenario-based questionnaire (9 scenarios) modelled on information from real patients. Pharmacist interventions were independently reviewed and rated on their appropriateness according to the Respiratory Therapeutic Guidelines (TG) by three expert researchers. In seven of nine scenarios (78%), the most common prescribing intervention made by pharmacists agreed with TG recommendations. Although the prescribing intervention was appropriate in the majority of cases, the execution of such interventions was not in line with guidelines (i.e. dosage or frequency) in the majority of scenarios. Due to this, only 47% (76/162) of the interventions overall were considered appropriate. However, pharmacists were deemed to be often following common clinical practice for asthma prescribing. Therefore 81% (132/162) of prescribing interventions were consistent with clinical practice, which is often not guideline driven, indicating a need for specific training in prescribing according to guidelines. Pharmacists reported that they were confident in making prescribing interventions and that this would be very useful in their management of the patients in the scenarios. Community pharmacists may be able to prescribe asthma medications appropriately to help achieve good outcomes for their patients. However, further training in the guidelines for prescribing are required if pharmacists are to support asthma management in this way.

Using scenarios to test the appropriateness of pharmacist prescribing in asthma management

PubMed Central

Hanna, Tamer; Bajorek, Beata; LeMay, Kate; Armour, Carol L.

Objective To explore the potential for community pharmacist prescribing in terms of usefulness, pharmacists’ confidence, and appropriateness, in the context of asthma management. Methods Twenty community pharmacists were recruited using convenience sampling from a group of trained practitioners who had already delivered asthma services. These pharmacists were asked to complete a scenario-based questionnaire (9 scenarios) modelled on information from real patients. Pharmacist interventions were independently reviewed and rated on their appropriateness according to the Respiratory Therapeutic Guidelines (TG) by three expert researchers. Results In seven of nine scenarios (78%), the most common prescribing intervention made by pharmacists agreed with TG recommendations. Although the prescribing intervention was appropriate in the majority of cases, the execution of such interventions was not in line with guidelines (i.e. dosage or frequency) in the majority of scenarios. Due to this, only 47% (76/162) of the interventions overall were considered appropriate. However, pharmacists were deemed to be often following common clinical practice for asthma prescribing. Therefore 81% (132/162) of prescribing interventions were consistent with clinical practice, which is often not guideline driven, indicating a need for specific training in prescribing according to guidelines. Pharmacists reported that they were confident in making prescribing interventions and that this would be very useful in their management of the patients in the scenarios. Conclusions Community pharmacists may be able to prescribe asthma medications appropriately to help achieve good outcomes for their patients. However, further training in the guidelines for prescribing are required if pharmacists are to support asthma management in this way. PMID:24644524

Ireland and medical research with minors: some medico-legal aspects.

PubMed

Sheikh, Asim A

2008-07-01

The practice of medical research with minors in Ireland consist of practices pertaining to therapeutic and non-therapeutic medical research. Clinical trials (a category of therapeutic research), is governed by legislation. However, any other therapeutic research (non-clinical trials research) and non-therapeutic research, e.g. observational medical research such as a longitudinal study of children or non-therapeutic research such as blood sample collection for analysis of cause of disease, are unregulated by legislation. This, article will outline and describe some of the medico-legal issues involved in both types of research and will comment on matters such as what national law exists, how the directive on good clinical practice has been implemented, what guidelines, if any, exist.

[Performance of family practitioners according to the guideline otitis media acuta of the Dutch College of Family Practitioners].

PubMed

Dalhuijsen, J; Zwaard, A M; Grol, R P; Mokkink, H M

1993-10-16

To establish to which degree the guidelines of the Otitis media acuta standard of the Netherlands college of general practitioners (NHG) are followed in practice and what is GPs' opinion of them. Survey. 65 general practitioners settled throughout the Netherlands. The GPs were recruited for the study by means of an advertisement and a personal approach. Opinions and performances were inventoried using a questionnaire and self-completion forms for successive doctor-patient contacts, respectively. Virtually all participants were familiar with the NHG standard and most were familiar with three central guidelines. Of these three, the recommendation of an active follow-up policy for children up to the age of 2 was known to the fewest GPs, and this recommendation also received the least support. In the 327 consultations recorded there was good agreement between actual performance and the guidelines, especially as regards history-taking, physical examination and diagnosing. Regarding management and patient information the agreement was less. Concerning the follow-up policy for young children and the prescribing of antibiotics, actual performance clearly differed from the NHG standard, possibly because the relevant guidelines were less well known. The results of this study are relevant to the planning of GP education and the evaluation of the guidelines themselves.

Medical negligence--prevention and management.

PubMed

Chao, T C

1987-04-01

The rising spate of malpractice cases against doctors appearing in the press and annual reports of medical insurance companies causes concern. Are our doctors more careless or is the public more conscious of litigation? A well publicized malpractice case can ruin the doctor's career and practice. It is well worth a doctor's while to know the pitfalls and learn how to prevent them, and if a mistake happens, how to manage it. Not all mistakes amount to negligence. How will the court view these cases? Some local cases are cited to illustrate the difference between misadventure and negligence. They will serve as guidelines for good medical practice.

Individualised patient care: a framework for guidelines.

PubMed

Redfern, S

It is assumed that individualised patient care (IPC) benefits both patients and nurses. This study set out to clarify what IPC means to nurses and how they practise it, as well as how it is experienced by patients. With some exceptions, IPC was not practised widely in the seven wards used as case studies. Even in the wards where it was more common, there were some examples of bad practice. Factors that facilitated IPC were: the personal qualities of the nurses; a shared understanding among the ward team of the goals of nursing care and what constitutes good practice; levels of staffing and skill mix; effective leadership and management of nursing work.

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

PubMed

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

2014-01-01

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

Practices in security and confidentiality of HIV/AIDS patients' information: A national survey among staff at HIV outpatient clinics in Vietnam.

PubMed

Khac Hai, Nguyen; Lawpoolsri, Saranath; Jittamala, Podjanee; Thi Thu Huong, Phan; Kaewkungwal, Jaranit

2017-01-01

Breach of confidentiality or invasion of privacy from the collection and use of medical records, particularly those of patients with HIV/AIDS or other diseases sensitive to stigmatization, should be prevented by all related stakeholders in healthcare settings. The main focus of this study was to assess practices regarding security and confidentiality of HIV-related information among staff at HIV outpatient clinics (HIV-OPCs) in Vietnam. A descriptive cross-sectional study was conducted at all 312 HIV-OPCs across the country using an online survey technique. In general, the staff practices for securing and protecting patient information were at acceptable levels. Most staff had proper measures and practices for maintaining data security; however, the protection of patient confidentiality, particularly for data access, sharing, and transfer still required improvement. Most HIV-OPC staff had good or moderate knowledge and positive perceptions towards security and confidentiality issues. Staff who were not trained in the practice of security measures differed significantly from those who were trained (OR: 3.74; 95%CI: 1.44-9.67); staff needing improved knowledge levels differed significantly from those with good (OR: 5.20; 95%CI: 2.39-11.32) and moderate knowledge levels (OR: 5.10; 95%CI: 2.36-11.00); and staff needing improved perception levels differed significantly from those with good (i.e., with 100% proper practices) and moderate perception levels (OR: 5.67; 95%CI: 2.93-10.95). Staff who were not trained in the protection of data confidentiality differed significantly from those who were trained (OR: 2.18; 95%CI: 1.29-3.65). Training is an important factor to help raise the levels of proper practices regarding confidentiality and security, to improve knowledge and raise awareness about change among staff. The operation and management of HIV treatment and care in Vietnam are currently transitioning from separate healthcare clinics (HIV-OPC) into units integrated into general hospitals/healthcare facilities. The findings of this study highlight topics that could be used for improving management and operation of information system and revising guidelines and regulations on protection measures/strategies for data security and confidentiality of HIV/AIDS patients by Vietnam health authorities or other countries facing similar situations. Secure infrastructure and secure measures for data access and use are very important, worthwhile investments. The provision of continuous training and active enforcement and monitoring of the practices of healthcare personnel might lead to an improved understanding and acknowledegement of the importance of national policies/guidelines regarding HIV-related patient information.

Interdisciplinary Studies on the Combat Readiness and Health Issues Faced by Military Personnel

DTIC Science & Technology

2009-09-01

related activity in single subjects, and this facilitates clinical diagnosis in which single subjects are the focus of investigation. Methods...Good Clinical Practice Guidelines, the Declaration of Helsinki, and the U.S. Code of Federal Regulations. Written and informed consent was obtained from...S, and a temporal loading T. For two triplets: (Fa, Sa, Ta) and (Fb, Sb, Tb), we define the triplet similarity metric Cab = FTa Fb STaSb TTa

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

PubMed

Alonso, P; Bonfill, X

2007-01-01

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

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

PubMed Central

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

2017-01-01

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

Delivery room management of very low birth weight infants in Germany, Austria and Switzerland - a comparison of protocols

PubMed Central

2010-01-01

Background Surveys from the USA, Australia and Spain have shown significant inter-institutional variation in delivery room (DR) management of very low birth weight infants (VLBWI, < 1500 g) at birth, despite regularly updated international guidelines. Objective To investigate protocols for DR management of VLBWI in Germany, Austria and Switzerland and to compare these with the 2005 ILCOR guidelines. Methods DR management protocols were surveyed in a prospective, questionnaire-based survey in 2008. Results were compared between countries and between academic and non-academic units. Protocols were compared to the 2005 ILCOR guidelines. Results In total, 190/249 units (76%) replied. Protocols for DR management existed in 94% of units. Statistically significant differences between countries were found regarding provision of 24 hr in house neonatal service; presence of a designated resuscitation area; devices for respiratory support; use of pressure-controlled manual ventilation devices; volume control by respirator; and dosage of Surfactant. There were no statistically significant differences regarding application and monitoring of supplementary oxygen, or targeted saturation levels, or for the use of sustained inflations. Comparison of academic and non-academic hospitals showed no significant differences, apart from the targeted saturation levels (SpO2) at 10 min. of life. Comparison with ILCOR guidelines showed good adherence to the 2005 recommendations. Summary Delivery room management in German, Austrian and Swiss neonatal units was commonly based on written protocols. Only minor differences were found regarding the DR setup, devices used and the targeted ranges for SpO2 and FiO2. DR management was in good accordance with 2005 ILCOR guidelines, some units already incorporated evidence beyond the ILCOR statement into their routine practice. PMID:21159574

[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.

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

PubMed Central

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

2017-01-01

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

Guidelines to the Practice of Anesthesia - Revised Edition 2018.

PubMed

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

2018-01-01

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

Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

PubMed

Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F

2015-12-01

The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by institutional structures for the clinical practice of EEG NF. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

From actors to authors: a first account about the involvement of patients in the informed consent governance of a major Italian translational research hospital.

PubMed

Casati, Sara; Monti, Paolo; Bonino, Ferruccio

2010-01-01

From 2007 to 2009 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, one of the major public research hospitals in Italy, has invested on a participatory action to promote a good practice of informed consent. The project focused on the improvement and innovation of informed consent considered as a participated act through the involvement of all the actors at stake. The main purpose was to improve the informative practices through the participatory innovation of institutional and organizational elements as conditions of possibility. Therefore the project has pursued the involvement of managers, healthcare professionals, patients and their associations in the institutional governance of informed consent. The involvement of citizens and patients within the whole process meant to put them in charge not just as actors or final evaluators of a good practice, but as co-authors in defining standards, tools and conditions for a good practice. Several actions were taken, including a phase of analysis which involved 20 patients from 8 Associations, a phase of innovation and education where 113 patients and citizens worked together with clinicians from 53 Units in deliberative laboratories, the institution of a multidisciplinary committee inclusive of representatives from 6 associations of patients.The project has produced different outcomes: new institutional guidelines adopted by the hospital; the renewal of consent forms and procedures as part of an explicit shared informative process; an increased implementation of institutional standards of good informative practice; the measure and communication of the outcomes of care and their bench-marking; bottom-up building of paths of validation; the creation of participatory electronic tools; an innovative education on the field for patients and clinicians.

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.

GPs' knowledge, use, and confidence in national physical activity and health guidelines and tools: a questionnaire-based survey of general practice in England.

PubMed

Chatterjee, Robin; Chapman, Tim; Brannan, Mike Gt; Varney, Justin

2017-10-01

Physical activity (PA) brief advice in health care is effective at getting individuals active. It has been suggested that one in four people would be more active if advised by a GP or nurse, but as many as 72% of GPs do not discuss the benefits of physical activity with patients. To assess the knowledge, use, and confidence in national PA and Chief Medical Officer (CMO) health guidelines and tools among GPs in England. Online questionnaire-based survey of self-selecting GPs in England that took place over a 10-day period in March 2016. The questionnaire consisted of six multiple-choice questions and was available on the Doctors.net.uk (DNUK) homepage. Quotas were used to ensure good regional representation. The final analysis included 1013 responses. Only 20% of responders were broadly or very familiar with the national PA guidelines. In all, 70% of GPs were aware of the General Practice Physical Activity Questionnaire (GPPAQ), but 26% were not familiar with any PA assessment tools, and 55% reported that they had not undertaken any training with respect to encouraging PA. The majority of GPs in England (80%) are unfamiliar with the national PA guidelines. Awareness of the recommended tool for assessment, GPPAQ, is higher than use by GPs. This may be because it is used by other clinical staff, for example, as part of the NHS Health Check programme. Although brief advice in isolation by GPs on PA will only be a part of the behaviour change journey, it is an important prompt, especially if repeated as part of routine practice. This study highlights the need for significant improvement in knowledge, skills, and confidence to maximise the potential for PA advice in GP consultations. © British Journal of General Practice 2017.

Multiple Criteria Decision Analysis for Health Care Decision Making--An Introduction: Report 1 of the ISPOR MCDA Emerging Good Practices Task Force.

PubMed

Thokala, Praveen; Devlin, Nancy; Marsh, Kevin; Baltussen, Rob; Boysen, Meindert; Kalo, Zoltan; Longrenn, Thomas; Mussen, Filip; Peacock, Stuart; Watkins, John; Ijzerman, Maarten

2016-01-01

Health care decisions are complex and involve confronting trade-offs between multiple, often conflicting, objectives. Using structured, explicit approaches to decisions involving multiple criteria can improve the quality of decision making and a set of techniques, known under the collective heading multiple criteria decision analysis (MCDA), are useful for this purpose. MCDA methods are widely used in other sectors, and recently there has been an increase in health care applications. In 2014, ISPOR established an MCDA Emerging Good Practices Task Force. It was charged with establishing a common definition for MCDA in health care decision making and developing good practice guidelines for conducting MCDA to aid health care decision making. This initial ISPOR MCDA task force report provides an introduction to MCDA - it defines MCDA; provides examples of its use in different kinds of decision making in health care (including benefit risk analysis, health technology assessment, resource allocation, portfolio decision analysis, shared patient clinician decision making and prioritizing patients' access to services); provides an overview of the principal methods of MCDA; and describes the key steps involved. Upon reviewing this report, readers should have a solid overview of MCDA methods and their potential for supporting health care decision making. Copyright © 2016. Published by Elsevier Inc.

Improving the management and referral of patients with transient ischaemic attacks: a change strategy for a health community

PubMed Central

Wright, J; Harrison, S; McGeorge, M; Patterson, C; Russell, I; Russell, D; Small, N; Taylor, M; Walsh, M; Warren, E; Young, J

2006-01-01

Problem Rapid referral and management of patients with transient ischaemic attacks is a key component in the national strategy for stroke prevention. However, patients with transient ischaemic attacks are poorly identified and undertreated. Design and setting Before and after evaluation of quality improvement programme with controlled comparison in three primary care trusts reflecting diverse populations and organisational structures in an urban district in the North of England. Key measures for improvement The proportion of patients receiving antiplatelet drugs and safe driving advice on referral to a speciality clinic, and the numbers of referrals, adjusted for age, to the specialist clinic before and after the improvement programme. Strategies for change Interviews with patient and professionals to identify gaps and barriers to good practice; development of evidence based guidelines for the management of patients with transient ischaemic attacks; interactive multidisciplinary workshops for each primary care trust with feedback of individual audit results of referral practice; outreach visits to teams who were unable to attend the workshops; referral templates and desktop summaries to provide reminders of the guidelines to clinicians; incorporation of standards into professional contracts. Effects of change A significant improvement occurred in identification and referral of patients with transient ischaemic attacks to specialist clinics, with a 41% increase in referrals from trained practices compared with control practices. There were also significant improvements in the early treatment and safety advice provided to patients before referral. Lessons learnt A strategic approach to effective quality improvement across a diverse health community is feasible and achievable. Careful planning with patient and professional involvement to develop a tailored and multifaceted quality improvement programme to implement evidence based practice can work in very different primary care settings. Key components of the effectiveness of the model include contextual analysis, strong professional support, clear recommendations based on robust evidence, simplicity of adoption, good communication, and use of established networks and opinion leaders. PMID:16456203

Improving the management and referral of patients with transient ischaemic attacks: a change strategy for a health community.

PubMed

Wright, J; Harrison, S; McGeorge, M; Patterson, C; Russell, I; Russell, D; Small, N; Taylor, M; Walsh, M; Warren, E; Young, J

2006-02-01

Rapid referral and management of patients with transient ischaemic attacks is a key component in the national strategy for stroke prevention. However, patients with transient ischaemic attacks are poorly identified and undertreated. Before and after evaluation of quality improvement programme with controlled comparison in three primary care trusts reflecting diverse populations and organisational structures in an urban district in the North of England. The proportion of patients receiving antiplatelet drugs and safe driving advice on referral to a specialty clinic, and the numbers of referrals, adjusted for age, to the specialist clinic before and after the improvement programme. Interviews with patient and professionals to identify gaps and barriers to good practice; development of evidence based guidelines for the management of patients with transient ischaemic attacks; interactive multidisciplinary workshops for each primary care trust with feedback of individual audit results of referral practice; outreach visits to teams who were unable to attend the workshops; referral templates and desktop summaries to provide reminders of the guidelines to clinicians; incorporation of standards into professional contracts. A significant improvement occurred in identification and referral of patients with transient ischaemic attacks to specialist clinics, with a 41% increase in referrals from trained practices compared with control practices. There were also significant improvements in the early treatment and safety advice provided to patients before referral. A strategic approach to effective quality improvement across a diverse health community is feasible and achievable. Careful planning with patient and professional involvement to develop a tailored and multifaceted quality improvement programme to implement evidence based practice can work in very different primary care settings. Key components of the effectiveness of the model include contextual analysis, strong professional support, clear recommendations based on robust evidence, simplicity of adoption, good communication, and use of established networks and opinion leaders.

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

PubMed

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

2016-05-01

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

Ecological restoration of farmland: progress and prospects.

PubMed

Wade, Mark R; Gurr, Geoff M; Wratten, Steve D

2008-02-27

Sustainable agricultural practices in conjunction with ecological restoration methods can reduce the detrimental effects of agriculture. The Society for Ecological Restoration International has produced generic guidelines for conceiving, organizing, conducting and assessing ecological restoration projects. Additionally, there are now good conceptual frameworks, guidelines and practical methods for developing ecological restoration programmes that are based on sound ecological principles and supported by empirical evidence and modelling approaches. Restoration methods must also be technically achievable and socially acceptable and spread over a range of locations. It is important to reconcile differences between methods that favour conservation and those that favour economic returns, to ensure that conservation efforts are beneficial for both landowners and biodiversity. One option for this type of mutual benefit is the use of agri-environmental schemes to provide financial incentives to landholders in exchange for providing conservation services and other benefits. However, further work is required to define and measure the effectiveness of agri-environmental schemes. The broader potential for ecological restoration to improve the sustainability of agricultural production while conserving biodiversity in farmscapes and reducing external costs is high, but there is still much to learn, particularly for the most efficient use of agri-environmental schemes to change land use practice.

Ethical dilemmas in scientific publication: pitfalls and solutions for editors.

PubMed

Gollogly, Laragh; Momen, Hooman

2006-08-01

Editors of scientific journals need to be conversant with the mechanisms by which scientific misconduct is amplified by publication practices. This paper provides definitions, ways to document the extent of the problem, and examples of editorial attempts to counter fraud. Fabrication, falsification, duplication, ghost authorship, gift authorship, lack of ethics approval, non-disclosure, 'salami' publication, conflicts of interest, auto-citation, duplicate submission, duplicate publications, and plagiarism are common problems. Editorial misconduct includes failure to observe due process, undue delay in reaching decisions and communicating these to authors, inappropriate review procedures, and confounding a journal's content with its advertising or promotional potential. Editors also can be admonished by their peers for failure to investigate suspected misconduct, failure to retract when indicated, and failure to abide voluntarily by the six main sources of relevant international guidelines on research, its reporting and editorial practice. Editors are in a good position to promulgate reasonable standards of practice, and can start by using consensus guidelines on publication ethics to state explicitly how their journals function. Reviewers, editors, authors and readers all then have a better chance to understand, and abide by, the rules of publishing.

Off-label use of medicines: The need for good practice guidelines.

PubMed

Dooms, Marc; Killick, James

2017-01-01

'Off-label use' is the term used for the prescription and dispensing of a medicinal product for any indication, patient group, route of administration, dosage or treatment regimen other than that listed in the Summary of Product Characteristics. In this article the authors present a brief overview of current practices of off-label use in Europe and the applicable European law and jurisprudence. They then go on to present a set of guidelines for best practice in off-label use which underlines the need for guidance on prescription to be firmly rooted in the need to ensure patient safety above all other concerns. The article was written from desk research and expert engagement, including a presentation and Q&A in the European Parliament. This article intends to demonstrate that off-label use entails increased risks for patients, especially when it is not underpinned by rigorous clinical studies or the reporting routes for use are not well defined. Europe is seeing a growing trend the promotion of off-label prescription of medicinal products for reasons other than pure medical need, including motives such as cost-containment. This poses a numer of questions for the ethical and legal framework for medicine prescription and dispensing in Europe.

Psychiatrists' follow-up of identified metabolic risk: a mixed-method analysis of outcomes and influences on practice.

PubMed

Patterson, Sue; Freshwater, Kathleen; Goulter, Nicole; Ewing, Julie; Leamon, Boyd; Choudhary, Anand; Moudgil, Vikas; Emmerson, Brett

2016-10-01

Aims and method To describe and explain psychiatrists' responses to metabolic abnormalities identified during screening. We carried out an audit of clinical records to assess rates of monitoring and follow-up practice. Semi-structured interviews with 36 psychiatrists followed by descriptive and thematic analyses were conducted. Results Metabolic abnormalities were identified in 76% of eligible patients screened. Follow-up, recorded for 59%, was variable but more likely with four or more abnormalities. Psychiatrists endorse guidelines but ambivalence about responsibility, professional norms, resource constraints and skills deficits as well as patient factors influences practice. Therapeutic optimism and desire to be a 'good doctor' supported comprehensive follow-up. Clinical implications Psychiatrists are willing to attend to physical healthcare, and obstacles to recommended practice are surmountable. Psychiatrists seek consensus among stakeholders about responsibilities and a systemic approach addressing the social determinants of health inequities. Understanding patients' expectations is critical to promoting best practice.

Clinical guidelines as a tool for legal liability. An international perspective.

PubMed

Davies, Jonathan

2009-12-01

Clinical guidelines are statements that have been systematically developed and which aim to assist clinicians in making decisions about treatment for specific conditions. They are linked to evidence and are meant to facilitate good medical practice. A key issue that follows is how lawyers and the courts might use such guidelinesin medical litigation. The multiplicity of opinions and scientific professions requiring expertise might influence the expert submitting an opinion to base his opinion on scientific theses which have not been recognized scientifically, are not based on facts and are not supported by professional literature. Medical evidence has to be methodically based and reliable. In recent years the medical community has developed a new field called "Evidence Based Medicine", meaning, use of medical information based on the best information in the medical literature relevant to the condition being treated. Evidence Based Medicine distinguishes between recognized scientific theories and what is called "Junk Science". Clinical Guidelines are of value in systematizing medical procedures, mainly those which may have legal implications. In other procedures Guidelines may serve the Court as a source of sound information, provided they are the product of a recognized professional body, and proven to bear no relation to a body which may have interests in the delivery of healthcare. Clinical guidelines are set as normative standards and used as a tool to indicate the standard of care at the time. They can be used as a tool for assessment of the questionable conduct. Guidelines are consulted by courts because they provide evidence of standards justified in relation to evidence rather than custom, this helps the courts test the expert evidence that radically strengthen the normative dynamic of the law in actions alleging medical negligence. As clinical practice guidelines become more and more prevalent, some authors believe they will define the requisite "standard of care" for medical treatment and impact medical malpractice litigation. They may even replace expert testimony.

Clinical usefulness of adherence to gastro-esophageal reflux disease guideline by Spanish gastroenterologists.

PubMed

Mearin, Fermín; Ponce, Julio; Ponce, Marta; Balboa, Agustín; González, Miguel A; Zapardiel, Javier

2012-09-21

To investigate usefulness of adherence to gastro-esophageal reflux disease (GERD) guideline established by the Spanish Association of Gastroenterology. Prospective, observational and multicentre study of 301 patients with typical symptoms of GERD who should be managed in accordance with guidelines and were attended by gastroenterologists in daily practice. Patients (aged > 18 years) were eligible for inclusion if they had typical symptoms of GERD (heartburn and/or acid regurgitation) as the major complaint in the presence or absence of accompanying atypical symptoms, such as dyspeptic symptoms and/or supraesophageal symptoms. Diagnostic and therapeutic decisions should be made based on specific recommendations of the Spanish clinical practice guideline for GERD which is a widely disseminated and well known instrument among Spanish in digestive disease specialists. Endoscopy was indicated in 123 (41%) patients: 50 with alarm symptoms, 32 with age > 50 years without alarm symptom. Seventy-two patients (58.5%) had esophagitis (grade A, 23, grade B, 28, grade C, 18, grade D, 3). In the presence of alarm symptoms, endoscopy was indicated consistently with recommendations in 98% of cases. However, in the absence of alarm symptoms, endoscopy was indicated in 33% of patients > 50 years (not recommended by the guideline). Adherence for proton pump inhibitors (PPIs) therapy was 80%, but doses prescribed were lower (half) in 5% of cases and higher (double) in 15%. Adherence regarding duration of PPI therapy was 69%; duration was shorter than recommended in 1% (4 wk in esophagitis grades C-D) or longer in 30% (8 wk in esophagitis grades A-B or in patients without endoscopy). Treatment response was higher when PPI doses were consistent with guidelines, although differences were not significant (95% vs 85%). GERD guideline compliance was quite good although endoscopy was over indicated in patients > 50 years without alarm symptoms; PPIs were prescribed at higher doses and longer duration.

Clinical usefulness of adherence to gastro-esophageal reflux disease guideline by Spanish gastroenterologists

PubMed Central

Mearin, Fermín; Ponce, Julio; Ponce, Marta; Balboa, Agustín; González, Miguel A; Zapardiel, Javier

2012-01-01

AIM: To investigate usefulness of adherence to gastro-esophageal reflux disease (GERD) guideline established by the Spanish Association of Gastroenterology. METHODS: Prospective, observational and multicentre study of 301 patients with typical symptoms of GERD who should be managed in accordance with guidelines and were attended by gastroenterologists in daily practice. Patients (aged > 18 years) were eligible for inclusion if they had typical symptoms of GERD (heartburn and/or acid regurgitation) as the major complaint in the presence or absence of accompanying atypical symptoms, such as dyspeptic symptoms and/or supraesophageal symptoms. Diagnostic and therapeutic decisions should be made based on specific recommendations of the Spanish clinical practice guideline for GERD which is a widely disseminated and well known instrument among Spanish in digestive disease specialists. RESULTS: Endoscopy was indicated in 123 (41%) patients: 50 with alarm symptoms, 32 with age > 50 years without alarm symptom. Seventy-two patients (58.5%) had esophagitis (grade A, 23, grade B, 28, grade C, 18, grade D, 3). In the presence of alarm symptoms, endoscopy was indicated consistently with recommendations in 98% of cases. However, in the absence of alarm symptoms, endoscopy was indicated in 33% of patients > 50 years (not recommended by the guideline). Adherence for proton pump inhibitors (PPIs) therapy was 80%, but doses prescribed were lower (half) in 5% of cases and higher (double) in 15%. Adherence regarding duration of PPI therapy was 69%; duration was shorter than recommended in 1% (4 wk in esophagitis grades C-D) or longer in 30% (8 wk in esophagitis grades A-B or in patients without endoscopy). Treatment response was higher when PPI doses were consistent with guidelines, although differences were not significant (95% vs 85%). CONCLUSION: GERD guideline compliance was quite good although endoscopy was over indicated in patients > 50 years without alarm symptoms; PPIs were prescribed at higher doses and longer duration. PMID:23002360

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

PubMed

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

2017-08-01

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

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

PubMed

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

2018-04-01

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

Audit of sweat testing: a first report from Italian Cystic Fibrosis Centres.

PubMed

Cirilli, Natalia; Padoan, Rita; Raia, Valeria

2008-09-01

Cystic Fibrosis diagnosis is confirmed using sweat test. The aim of our study was to evaluate current techniques and methodologies in use at Italian CF Care Centres. A series of questions related to the performance of the sweat test was collected by all CF Care Centres in Italy. Answers were compared with UK and NCCLS guidelines. 39/41 Centres replied to the questionnaire. A good adherence to guidelines was registered for storing samples before analysis in 90.9%, while performing CF diagnosis by at least two sweat tests, and chloride analysis were reported respectively in 100% and 75.7% of Centres. Some inconsistencies were registered for minimum acceptable sweat quantity and time to collect sweat inadequate in respectively 42.5% and 24.2% of Centres, while performing quality control procedures and referring to an external quality assessment scheme were found inadequate in respectively 54.6% and 100%. 57.6% didn't provide any appropriate analytical ranges and only 15.1% of Centres offered proper information to patients/parents. A report form, including sweat quantity, reference ranges and interpretation, was adequate only for 9.4 up to 41.4% of CF Centres. Our study showed areas of inconsistencies in sweat testing current practices in Italy and highlights the need for evidence based national guidelines to improve practice and management strategies.

The guideline "consultation psychiatry" of the Netherlands Psychiatric Association.

PubMed

Leentjens, Albert F G; Boenink, Annette D; Sno, Herman N; Strack van Schijndel, Rob J M; van Croonenborg, Joyce J; van Everdingen, Jannes J E; van der Feltz-Cornelis, Christina M; van der Laan, Niels C; van Marwijk, Harm; van Os, Titus W D P

2009-06-01

In 2008, the Netherlands Psychiatric Association authorized a guideline "consultation psychiatry." To set a standard for psychiatric consultations in nonpsychiatric settings. The main objective of the guideline is to answer three questions: Is psychiatric consultation effective and, if so, which forms are most effective? How should a psychiatric consultations be performed? What increases adherence to recommendations given by the consulting psychiatrist? Systematic literature review. Both in general practice and in hospital settings psychiatric consultation is effective. In primary care, the effectiveness of psychiatric consultation is almost exclusively studied in the setting of "collaborative care." Procedural guidance is given on how to perform a psychiatric consultation. In this guidance, psychiatric consultation is explicitly looked upon as a complex activity that requires a broad frame of reference and adequate medical and pharmacological expertise and experience and one that should be performed by doctors. Investing in a good relation with the general practitioner, and the use of a "consultation letter" increased efficacy in general practice. In the hospital setting, investing in liaison activities and an active psychiatric follow-up of consultations increased adherence to advice. Psychiatric consultations are effective and constitute a useful contribution to the patients' treatment. With setting a standard consultations will become more transparent and checkable. It is hoped that this will increase the quality of consultation psychiatry.

Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications.

PubMed

Stocks, Angela; Simcoe, Donna; Toroser, Dikran; DeTora, Lisa

2018-06-01

To provide clarity on the professional medical writer as author or contributor by examining what "a substantial contribution" and "accountability" mean with respect to authorship in a biomedical publication. These terms relate to criteria 1 and 4 of the International Committee of Medical Journal Editors (ICMJE) authorship guidelines. We reviewed the ICMJE and Good Publication Practice authorship guidelines, which recommend that individuals not meeting all four authorship criteria should be acknowledged as contributors. We also surveyed and assessed selected journals for published guidance on authorship versus contributorship. We found that journals often vary in their authorship guidelines for medical writers. Notwithstanding, and to assist in determining the contribution made by the medical writer, we have expanded on current guidelines to develop recommendations for important intellectual contribution to the design of the work (developing the protocol, choosing endpoints) or the interpretation of data for the work (developing the discussion, interpreting new statistical output), which should result in inclusion of the medical writer as an author, as well as when accountability is relevant. If the medical writer does not qualify as an author, then their inclusion in the acknowledgements section is appropriate. Authors and contributors have a responsibility to create a publication that is accurate and true to the study results, but only authors must provide a substantial contribution and are accountable for that contribution. Contributions made by authors and non-author contributors should be fully described in the publication, to enable the reader to assess credit and responsibility.

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

PubMed Central

Tyl, Rochelle W.

2009-01-01

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

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

PubMed

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

2010-08-03

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

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

PubMed Central

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

2015-01-01

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

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

PubMed

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

2015-05-08

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

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

PubMed Central

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

2015-01-01

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

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

PubMed

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

2015-09-08

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

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

PubMed

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

2015-05-08

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

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

ERIC Educational Resources Information Center

Crall, James J.

1990-01-01

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

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

PubMed

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

2017-02-15

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

Librarian contributions to clinical practice guidelines.

PubMed

Cruse, Peggy; Protzko, Shandra

2014-01-01

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

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

PubMed Central

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

2014-01-01

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

Promoting good health research practice in low- and middle-income countries

PubMed Central

Mahendradhata, Yodi; Nabieva, Jamila; Ahmad, Riris Andono; Henley, Patricia; Launois, Pascal; Merle, Corinne; Maure, Christine; Horstick, Olaf; Elango, Varalakshmi

2016-01-01

Background Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative. Objective To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs). Design The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014–2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation. Results Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. Conclusions There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling up GHRP training and further development of GHRP principles into international standards. PMID:27498965

A 2011 Updated Systematic Review and Clinical Practice Guideline for the Management of Malignant Extradural Spinal Cord Compression

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

Loblaw, D. Andrew, E-mail: andrew.loblaw@sunnybrook.ca; Mitera, Gunita; Ford, Michael

2012-10-01

Purpose: To update the 2005 Cancer Care Ontario practice guidelines for the diagnosis and treatment of adult patients with a suspected or confirmed diagnosis of extradural malignant spinal cord compression (MESCC). Methods: A review and analysis of data published from January 2004 to May 2011. The systematic literature review included published randomized control trials (RCTs), systematic reviews, meta-analyses, and prospective/retrospective studies. Results: An RCT of radiation therapy (RT) with or without decompressive surgery showed improvements in pain, ambulatory ability, urinary continence, duration of continence, functional status, and overall survival. Two RCTs of RT (30 Gy in eight fractions vs. 16more » Gy in two fractions; 16 Gy in two fractions vs. 8 Gy in one fraction) in patients with a poor prognosis showed no difference in ambulation, duration of ambulation, bladder function, pain response, in-field failure, and overall survival. Retrospective multicenter studies reported that protracted RT schedules in nonsurgical patients with a good prognosis improved local control but had no effect on functional or survival outcomes. Conclusions: If not medically contraindicated, steroids are recommended for any patient with neurologic deficits suspected or confirmed to have MESCC. Surgery should be considered for patients with a good prognosis who are medically and surgically operable. RT should be given to nonsurgical patients. For those with a poor prognosis, a single fraction of 8 Gy should be given; for those with a good prognosis, 30 Gy in 10 fractions could be considered. Patients should be followed up clinically and/or radiographically to determine whether a local relapse develops. Salvage therapies should be introduced before significant neurologic deficits occur.« less

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

PubMed

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

2016-10-01

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

Developing guidelines for postgraduate dental educators in the UK.

PubMed

Bullock, A D; Firmstone, V R; Falcon, H C

2010-01-09

Commissioned by the UK Committee of Postgraduate Dental Deans and Directors (COPDEND), the purpose of this work was to establish UK guidelines for dental educators. The final document comprises 79 statements, in eight domains. Each domain has four zones related to what dental educators (1) know, (2) do with members of the dental team as learners, (3) do with other dental educators as learners and (4) lead on. Launched in November 2008, the document provides a framework of good practice for use in the employment, development and management of dental educators in the UK. The guidelines are readily available from the COPDEND website. A key purpose of this paper is to report on the process of development and a central part of that was the integration of feedback and consultation on early drafts. These processes elicited a total of 102 responses. Issues raised in consultation included: (1) how the zones interrelate; (2) differentiation between domains; (3) measurability; and (4) implementation challenges. This paper includes our responses to these issues.

An evaluation of the guidelines of the Society of Obstetricians and Gynaecologists of Canada.

PubMed

Ghui, Roslyn; Bansal, Jassimran Kaur; McLaughlin, Catarina; Kotaska, Andrew; Lokugamage, Amali

2016-07-01

Clinical practice guidelines hope to offer unbiased, evidence-based guidance for clinicians. This paper examines levels of evidence contained within the guidelines of the Society of Obstetricians and Gynaecologists of Canada and compares classification of the recommendation (CoR) A/B/C/D/E/L (derived from evidence and consensus) versus quality of evidence assessment (QoEA) I-III. 1250 recommendations were analysed and 43% of recommendations were graded as "good" evidence, the highest grade of CoR, while just 24.6% of recommendations were based on the highest level of QoEA (level I). The paper discusses possible reasons for this discrepancy. The authors hope that this analysis promotes greater transparency in evidence-based medicine ultimately leading to using the best quality of evidence available yet taking into account any areas of scientific uncertainty. This will enhance respectful care of patients, while taking into account their autonomy and furthering the cause of patient centre care.

Legal and ethical issues in research

PubMed Central

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-01-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees. PMID:27729698

The importance of guidelines in the development and application of probiotics.

PubMed

Reid, Gregor

2005-01-01

Probiotics, defined as "Live microorganisms which when administered in adequate amounts confer a health benefit on the host" have many attributes including the lack of adverse side effects associated with their use. While probiotics have proven benefits, the optimism associated with their use is counterbalanced by the fact that many so-called "probiotic" products are unreliable in content and unproven clinically. Therefore much remains to be done to gain the acceptance of the broader medical community. Recognition of the obvious product inequality and the lack of any regulatory guidelines lead to the development of Operating Standards in 2002 (FAO/WHO), that would ensure product safety, reliability and a level playing field for all companies producing probiotic products. The guidelines constitute a set of parameters required for a product/strain to be termed "probiotic" and also the clinically relevant steps to be followed to move probiotics closer to being embraced by the medical community. These include i) implementation of Guidelines for use of probiotics; ii) phase I, II and III clinical trials to prove health benefits that are as good as or better than standard prevention or treatments for a particular condition or disease; iii) Good Manufacturing Practice and production of high quality products; iv) studies to identify mechanism of action in vivo; v) informative/ precise labelling; vi) development of probiotic organisms that can carry vaccines to hosts and/or anti- viral probiotics; vii) expansion of proven strains to benefit the oral cavity, nasopharynx, respiratory tract, stomach, vagina, bladder and skin as well as for cancer, allergies and recovery from surgery/ injury.

Precautionary Practices of Respiratory Therapists and Other Health-Care Practitioners Who Administer Aerosolized Medications

PubMed Central

Tsai, Rebecca J; Boiano, James M; Steege, Andrea L; Sweeney, Marie H

2015-01-01

BACKGROUND: Respiratory therapists (RTs) and other health-care workers are potentially exposed to a variety of aerosolized medications. The National Institute for Occupational Safety and Health (NIOSH) Health and Safety Practices Survey of Healthcare Workers describes current exposure control practices and barriers to using personal protective equipment during administration of selected aerosolized medications. METHODS: An anonymous, multi-module, web-based survey was conducted among members of health-care professional practice organizations representing RTs, nurses, and other health-care practitioners. A module on aerosolized medications included submodules for antibiotics (amikacin, colistin, and tobramycin), pentamidine, and ribavirin. RESULTS: The submodules on antibiotics, pentamidine, and ribavirin were completed by 321, 227, and 50 respondents, respectively, most of whom were RTs. The relatively low number of ribavirin respondents precluded meaningful interpretation of these data and may reflect the rare use of this drug. Consequently, analysis focused on pentamidine, classified by NIOSH as a hazardous drug, and the antibiotics amikacin, colistin, and tobramycin, which currently lack authoritative safe handling guidelines. Respondents who administered pentamidine were more likely to adhere to good work practices compared with those who administered the antibiotics. Examples included training received on safe handling procedures (75% vs 52%), availability of employer standard procedures (82% vs 55%), use of aerosol delivery devices equipped with an expiratory filter (96% vs 53%) or negative-pressure rooms (61% vs 20%), and always using respiratory protection (51% vs 13%). CONCLUSIONS: Despite the availability of safe handling guidelines for pentamidine, implementation was not universal, placing workers, co-workers, and even family members at risk of exposure. Although the antibiotics included in this study lack authoritative safe handling guidelines, prudence dictates that appropriate exposure controls be used to minimize exposure to the antibiotics and other aerosolized medications. Employers and employees share responsibility for ensuring that precautionary measures are taken to keep exposures to all aerosolized medications as low as practicable. PMID:26152473

Precautionary Practices of Respiratory Therapists and Other Health-Care Practitioners Who Administer Aerosolized Medications.

PubMed

Tsai, Rebecca J; Boiano, James M; Steege, Andrea L; Sweeney, Marie H

2015-10-01

Respiratory therapists (RTs) and other health-care workers are potentially exposed to a variety of aerosolized medications. The National Institute for Occupational Safety and Health (NIOSH) Health and Safety Practices Survey of Healthcare Workers describes current exposure control practices and barriers to using personal protective equipment during administration of selected aerosolized medications. An anonymous, multi-module, web-based survey was conducted among members of health-care professional practice organizations representing RTs, nurses, and other health-care practitioners. A module on aerosolized medications included submodules for antibiotics (amikacin, colistin, and tobramycin), pentamidine, and ribavirin. The submodules on antibiotics, pentamidine, and ribavirin were completed by 321, 227, and 50 respondents, respectively, most of whom were RTs. The relatively low number of ribavirin respondents precluded meaningful interpretation of these data and may reflect the rare use of this drug. Consequently, analysis focused on pentamidine, classified by NIOSH as a hazardous drug, and the antibiotics amikacin, colistin, and tobramycin, which currently lack authoritative safe handling guidelines. Respondents who administered pentamidine were more likely to adhere to good work practices compared with those who administered the antibiotics. Examples included training received on safe handling procedures (75% vs 52%), availability of employer standard procedures (82% vs 55%), use of aerosol delivery devices equipped with an expiratory filter (96% vs 53%) or negative-pressure rooms (61% vs 20%), and always using respiratory protection (51% vs 13%). Despite the availability of safe handling guidelines for pentamidine, implementation was not universal, placing workers, co-workers, and even family members at risk of exposure. Although the antibiotics included in this study lack authoritative safe handling guidelines, prudence dictates that appropriate exposure controls be used to minimize exposure to the antibiotics and other aerosolized medications. Employers and employees share responsibility for ensuring that precautionary measures are taken to keep exposures to all aerosolized medications as low as practicable. Copyright © 2015 by Daedalus Enterprises.

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

PubMed Central

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

2016-01-01

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

Stakeholder Buy-In and Physician Education Improve Adherence to Guidelines for Down Syndrome.

PubMed

Santoro, Stephanie L; Martin, Lisa J; Pleatman, Stephen I; Hopkin, Robert J

2016-04-01

To assess adherence to the 2011 American Academy of Pediatrics (AAP) health supervision guidelines for Down syndrome, to determine whether pediatrician education improves adherence, and to evaluate stakeholder attitudes toward these guidelines. Twenty-two pediatric care sites participated in chart review of adherence to the components of the AAP guidelines for Down syndrome in this longitudinal cohort study. We analyzed universal recommendations which apply to all children with Down syndrome. Thirteen pediatric practices caring for 82 patients with Down syndrome received educational information. Frequency calculations with Bonferroni adjustment of the P value threshold (P = .05/9 = .0056) were performed. Adherence rates were compared between cohorts and within the individual before and after intervention using 2 × 2 contingency tables and goodness-of-fit tests. Pediatricians and parents of children with Down syndrome completed an anonymous survey regarding their attitudes toward the guidelines. Statistically significant increases in adherence were seen in 5 of the 8 universal recommendations following pediatrician education (P ≤ .002), including cardiology and genetics visits, rates of echocardiography, annual audiology testing, and sleep studies by age 4 years. Both physicians and parents reported generally positive views of the guidelines, yet baseline adherence rates were suboptimal. Pediatrician education preferences include directly integrating the guidelines into an electronic medical record system. Stakeholder attitudes reflect a willingness to follow the AAP guidelines for Down syndrome. Providing rapid access to simple, clear reminders of recommended assessments successfully improved adherence to the AAP guidelines for Down syndrome. Copyright © 2016 Elsevier Inc. All rights reserved.

Managing conflicts of interest in the UK National Institute for Health and Care Excellence (NICE) clinical guidelines programme: qualitative study.

PubMed

Graham, Tanya; Alderson, Phil; Stokes, Tim

2015-01-01

There is international concern that conflicts of interest (COI) may bias clinical guideline development and render it untrustworthy. Guideline COI policies exist with the aim of reducing this bias but it is not known how such policies are interpreted and used by guideline producing organisations. This study sought to determine how conflicts of interest (COIs) are disclosed and managed by a national clinical guideline developer (NICE: the UK National Institute for Health and Care Excellence). Qualitative study using semi-structured telephone interviews with 14 key informants: 8 senior staff of NICE's guideline development centres and 6 chairs of guideline development groups (GDGs). We conducted a thematic analysis. Participants regard the NICE COI policy as comprehensive leading to transparent and independent guidance. The application of the NICE COI policy is, however, not straightforward and clarity could be improved. Disclosure of COI relies on self reporting and guideline developers have to take "on trust" the information they receive, certain types of COI (non-financial) are difficult to categorise and manage and disclosed COI can impact on the ability to recruit clinical experts to GDGs. Participants considered it both disruptive and stressful to exclude members from GDG meetings when required by the COI policy. Nonetheless the impact of this disruption can be minimised with good group chairing skills. We consider that the successful implementation of a COI policy in clinical guideline development requires clear policies and procedures, appropriate training of GDG chairs and an evaluation of how the policy is used in practice.

Adherence to surviving sepsis guidelines among pediatric intensivists

PubMed Central

Thabet, Farah C.; Zahraa, Jihad N.; Chehab, May S.

2017-01-01

Objectives: To assess the compliance with the 2006 American College of Critical Care-Pediatric Advanced Life Support (ACCM-PALS) guidelines for sepsis management, and the 2012 surviving sepsis campaign (SSC), for the management of pediatric patients with sepsis and to identify the main barriers to adherence to these guidelines. Methods: In November 2015, a prospective cohort study in which a web based electronic survey using a case scenario to explore the usual management of a child with severe sepsis was designed and sent to all consultant pediatric intensivists practicing in Kingdom of Saudi Arabia (KSA). Adherences to 2012 SSC guidelines and to 4 algorithmic time-specific goals outlined in the ACCM-PALS guidelines were measured. Results: Sixty-one (76%) of 80 consultant pediatric intensivists working in KSA responded to the survey. Of the 61 respondents, 94% reported administering antibiotics within one hour of the child presentation, 98% reported starting resuscitation by giving fluid boluses, 93% reported starting vasopressor if the patient remained hypotensive despite fluid resuscitation, and 86% reported they would start hydrocortisone in case of catecholamine refractory shock. In total, 80% of the intensivists reported full adherence to all of the 4 components in the ACCM-PALS bundle; 50% reported that the absence of a locally written protocol was the main barrier to adherence to the SSC guidelines. Conclusion: Pediatric intensivists reported good adherence to the 2006 ACCM-PALS guidelines and 2012 SSC guidelines with some variability in interpretation of the recommendations. The absence of a written protocol was the main reported barrier to adherence to these guidelines. PMID:28578440

Adherence to surviving sepsis guidelines among pediatric intensivists. A national survey.

PubMed

Thabet, Farah C; Zahraa, Jihad N; Chehab, May S

2017-06-01

To assess the compliance with the 2006 American College of Critical Care-Pediatric Advanced Life Support (ACCM-PALS) guidelines for sepsis management, and the 2012 surviving sepsis campaign (SSC), for the management of pediatric patients with sepsis and to identify the main barriers to adherence to these guidelines. Methods: In November 2015, a prospective cohort study in which a web based electronic survey using a case scenario to explore the usual management of a child with severe sepsis was designed and sent to all consultant pediatric intensivists practicing in Kingdom of Saudi Arabia (KSA). Adherences to 2012 SSC guidelines and to 4 algorithmic time-specific goals outlined in the ACCM-PALS guidelines were measured. Results: Sixty-one (76%) of 80 consultant pediatric intensivists working in KSA responded to the survey. Of the 61 respondents, 94% reported administering antibiotics within one hour of the child presentation, 98% reported starting resuscitation by giving fluid boluses, 93% reported starting vasopressor if the patient remained hypotensive despite fluid resuscitation, and 86% reported they would start hydrocortisone in case of catecholamine refractory shock. In total, 80% of the intensivists reported full adherence to all of the 4 components in the ACCM-PALS bundle; 50% reported that the absence of a locally written protocol was the main barrier to adherence to the SSC guidelines. Conclusion: Pediatric intensivists reported good adherence to the 2006 ACCM-PALS guidelines and 2012 SSC guidelines with some variability in interpretation of the recommendations. The absence of a written protocol was the main reported barrier to adherence to these guidelines.

Evidence-based medicine knowledge, attitudes, and practices among doctors in Sri Lanka.

PubMed

Abeysena, Chrishantha; Jayawardana, Pushpa; Wickremasinghe, Rajitha; Wickramasinghe, Uthpala

2010-05-01

To assess knowledge, attitudes, and practices on evidence-based medicine (EBM) among doctors in selected hospitals in Sri Lanka. A cross-sectional descriptive study was conducted among 315 doctors in five government hospitals in Sri Lanka between December 2007 and January 2008. A pre-tested self-administered questionnaire was used to gather information on knowledge, attitudes, and practices. Of the 407 invited, 315 doctors participated, among whom, 87% (271) had heard the term EBM, 30% (n= 94) were aware of the Cochrane Library, and 8.5% (n= 27) were current users of it. Forty-seven per cent (n= 148) claimed to understand the terms systematic review and 37% (n= 115) meta-analysis. Twenty-four per cent (n= 77) had been exposed to some form of EBM training. All three components of EBM were known by 18% (n= 56) of participants. Attitudes toward EBM were positive among 76% (n= 239), 80% (n= 251) believed the practice of EBM would lead to improved patient care, and 77% (n= 243) considered EBM to be fundamental to professional practice. Just 3% (n= 13) considered it unimportant. EBM was used in clinical practice by 54% (n= 169) of participants. Thirty-six per cent (n= 114) referred to EBM sources when relevant. Available clinical guidelines were referred to by 56% (n= 176), and 34% (n= 107) thought that available guidelines provide sufficient support for the practice of EBM. The main barriers to practicing EBM were insufficient resources, overwork, lack of exposure to EBM, and lack of time and lack of endorsement of the need to practice EBM. Knowledge and practices of EBM among Sri Lanka doctors were poor. However, attitudes toward EBM were relatively good. © 2010 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

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.

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

PubMed

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

2015-12-01

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

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

PubMed

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

2018-04-01

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

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

PubMed Central

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

2018-01-01

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

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

PubMed Central

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

2007-01-01

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

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

PubMed Central

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

2017-01-01

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

Standards and Guidelines in Telemedicine and Telehealth

PubMed Central

Krupinski, Elizabeth A.; Bernard, Jordana

2014-01-01

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

The rural health care workforce implications of practice guideline implementation.

PubMed

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

1999-03-01

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

[Guidelines for the management of diabetes mellitus type 2].

PubMed

Mediavilla Bravo, José Javier

2014-09-01

In the last few years, the publication of new studies in diabetes, together with the development of new classes of blood glucose-lowering medications, have led to updates of the most prestigious clinical practice guidelines for the treatment of diabetes. Thus, a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes on the management of hyperglycemia in type 2 diabetes was published in April 2012. An update of one of the evidence-based guidelines issued by the Canadian Diabetes Association appeared in 2013 and this year, 2014, saw the publication of the consensus document of the redGDPS, whose guidelines are those most closely followed by primary care physicians in Spain. The three guidelines highlight the need for an individualized approach to type 2 diabetes mellitus, outlining both target glycemic goals and distinct treatment regimens based on patient characteristics, disease stage and the presence of comorbidities or complications. In the treatment of the disease, the three guidelines also stress the importance of considering patients' opinions and of recommending lifestyle modifications to achieve good disease control. Metformin is identified as the first-line drug, with the addition of other glucose-lowering agents if necessary. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Medicina Rural y Generalista (SEMERGEN). All rights reserved.

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

PubMed

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

2018-05-16

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

Exploration and practice of the cultivation of optoelectronic innovative talents based on the Students Innovation Training Program

NASA Astrophysics Data System (ADS)

Lei, Bing; Liu, Wei; Shi, Jianhua; Yao, Tianfu; Wang, Wei; Hu, Haojun

2017-08-01

The Students Innovation Training Program (SITP) has become an effective method to impel the teaching reform and improve undergraduate's innovative practical ability in Chinese colleges and universities, which is quite helpful for students to understand the social requirement, to grasp the basic means of scientific research and to improve their innovative practical ability and team work spirit. In this paper, three problems have been analyzed and discussed based on our organizing and instructing experience of SITP in recent years. Firstly, the SITP is a synthetically training project, and it is quite suitable to cultivate the students' innovative practical ability. Because SITP is similar to the real scientific research activity, and both of them include the steps of project application, solution design, research implementation and project summary etc. By making great efforts to these basic training steps, the undergraduates' innovative practical ability has been improved systemically. Secondly, a new talents cultivation system has been constructed based on SITP by integrating the subject competitions, graduation design and other conventional training activities, which is quite good to improve the training quality and decrease the total training class hours. Thirdly, a series of long-term effective operation and management guidelines have been established to ensure the SITP work normally, including doing a good job of project evaluation, setting up a reward and punishment system and creating a good atmosphere for innovation. In conclusion, great efforts have been made to enhance undergraduates' innovative ability, and the research results will provide useful reference for improving the training effects and reforming talents cultivating mode further.

Publishing 13C metabolic flux analysis studies: A review and future perspectives

PubMed Central

Crown, Scott B.; Antoniewicz, Maciek R.

2018-01-01

13C-Metabolic flux analysis (13C-MFA) is a powerful model-based analysis technique for determining intracellular metabolic fluxes in living cells. It has become a standard tool in many labs for quantifying cell physiology, e.g. in metabolic engineering, systems biology, biotechnology, and biomedical research. With the increasing number of 13C-MFA studies published each year, it is now ever more important to provide practical guidelines for performing and publishing 13C-MFA studies so that quality is not sacrificed as the number of publications increases. The main purpose of this paper is to provide an overview of good practices in 13C-MFA, which can eventually be used as minimum data standards for publishing 13C-MFA studies. The motivation for this work is two-fold: (1) currently, there is no general consensus among researchers and journal editors as to what minimum data standards should be required for publishing 13C-MFA studies; as a result, there are great discrepancies in terms of quality and consistency; and (2) there is a growing number of studies that cannot be reproduced or verified independently due to incomplete information provided in these publications. This creates confusion, e.g. when trying to reconcile conflicting results, and hinders progress in the field. Here, we review current status in the 13C-MFA field and highlight some of the shortcomings with regards to 13C-MFA publications. We then propose a checklist that encompasses good practices in 13C-MFA. We hope that these guidelines will be a valuable resource for the community and allow 13C-flux studies to be more easily reproduced and accessed by others in the future. PMID:24025367

[Internet presence of psychiatrists in private practice. Status, chances and legal framework].

PubMed

Kuhnigk, O; Ramuschkat, M; Schreiner, J; Schäfer, I; Reimer, J

2013-05-01

Physicians increasingly use home pages to call attention to their practice. Based on predefined criteria, this study examines the web presence of psychiatrists and medical psychotherapists in private practice. All registered psychiatrists and psychotherapists of six northern German states were examined in May 2010 with regards to existence and quality of their web presence. Homepages were evaluated by means of a standardized criteria catalogue with 42 items. Statistical analysis comprised descriptive and analytic approaches (ANOVA, linear models). The analysis included 956 physicians, 168 of whom (17.6%) had a web presence. More physicians in city states had a web presence as compared to those in states with larger territories. However, there was no difference between eastern and western states. Male as compared to female physicians more often possessed an Internet presence. The average score was 19 (± 5.2) out of 42 items, with practices with more than one physician scoring higher than single physician practices. Websites often contained general information about the practice, medical services and diseases, and rarely online services, professional information about the physician, access for disabled, emergency services and holiday substitution. Legal requirements were not sufficiently considered by more than half of the physicians. Only a smaller number of psychiatrists and psychotherapists in private practice make use of their own web presence. The quality of information varies. The criteria catalogue used in this study may offer a guideline for development of a good quality Internet presence. A consensus Internet guideline with participation of physician chambers and medical societies would be of use to establish quality standards.

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

PubMed Central

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

2018-01-01

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

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

PubMed

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

2018-04-01

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

Diabetes and hypertension guidelines and the primary health care practitioner in Barbados: knowledge, attitudes, practices and barriers--a focus group study.

PubMed

Adams, O Peter; Carter, Anne O

2010-12-03

Audits have shown numerous deficiencies in the quality of hypertension and diabetes primary care in Barbados, despite distribution of regional guidelines. This study aimed to evaluate the knowledge, attitudes and practices, and the barriers faced by primary care practitioners in Barbados concerning the recommendations of available diabetes and hypertension guidelines. Focus groups using a moderator's manual were conducted at all 8 public sector polyclinics, and 5 sessions were held for private practitioners. Polyclinic sessions were attended by 63 persons (17 physicians, 34 nurses, 3 dieticians, 3 podiatrists, 5 pharmacists, and 1 other), and private sector sessions by 20 persons (12 physicians, 1 nurse, 3 dieticians, 2 podiatrists and 2 pharmacists). Practitioners generally thought they gave a good quality of care. Commonwealth Caribbean Medical Research Council 1995 diabetes and 1998 hypertension guidelines, and the Ministry of Health 2001 diabetes protocol had been seen by 38%, 32% and 78% respectively of polyclinic practitioners, 67%, 83%, and 33% of private physicians, and 25%, 0% and 38% of non-physician private practitioners. Current guidelines were considered by some to be outdated, unavailable, difficult to remember and lacking in advice to tackle barriers. Practitioners thought that guidelines should be circulated widely, promoted with repeated educational sessions, and kept short. Patient oriented versions of the guidelines were welcomed. Patient factors causing barriers to ideal outcome included denial and fear of stigma; financial resources to access an appropriate diet, exercise and monitoring equipment; confusion over medication regimens, not valuing free medication, belief in alternative medicines, and being unable to change habits. System barriers included lack of access to blood investigations, clinic equipment and medication; the lack of human resources in polyclinics; and an uncoordinated team approach. Patients faced cultural barriers with regards to meals, exercise, appropriate body size, footwear, medication taking, and taking responsibility for one's health; and difficulty getting time off work to attend clinic. Guidelines need to be promoted repeatedly, and implemented with strategies to overcome barriers. Their development and implementation must be guided by input from all providers on the primary health care team.

National Utilization of Partial Nephrectomy Pre- and Post- AUA Guidelines: Is This as Good as It Gets?

PubMed

Sorokin, Igor; Feustel, Paul J; O'Malley, Rebecca L

2017-10-01

The purpose of the study was to compare utilization and predictors of partial nephrectomy (PN) in the pre- and post-guideline eras. American Board of Urology certification/recertification operative logs were reviewed from 2003 to 2014. Nephrectomy cases were extracted using Current Procedural Terminology codes. The cases were then stratified according to pre-guidelines (2003-October 2009) and post-guidelines (November 2009-2014). Multivariable logistic regression was used to evaluate patient, surgeon, and practice characteristics as predictors of PN. A general linear model with regression analysis was used to evaluate the change in PN over time relative to the incidence of renal cell carcinoma (RCC). We identified 20,402 and 20,729 nephrectomies in the pre- and post-guidelines eras, respectively. In multivariable analysis, the post-guidelines group was more likely to undergo PN (odds ratio, 1.87; P < .001). The pre- as well as post-guidelines groups had a higher likelihood of undergoing PN with an open approach, higher-volume surgeons, and younger patient age (P < .05). Surgeon subspecialty and US region were no longer significant factors after guidelines publication. Number of PN normalized to the incidence of RCC continued to increase over time (0.14%/y; R 2  = 0.77; P < .001). Partial nephrectomy in the post-guidelines era is no longer confined to urological subspecialists or certain densely populated US regions. Although rates of PN continue to increase relative to the recently decreasing overall incidence of RCC, the slope has leveled off somewhat. This is likely related to clinical intricacies of the best treatment modality and technologic advances rather than changes related to guidelines publication. Published by Elsevier Inc.

Safety and quality of food contact materials. Part 1: evaluation of analytical strategies to introduce migration testing into good manufacturing practice.

PubMed

Feigenbaum, A; Scholler, D; Bouquant, J; Brigot, G; Ferrier, D; Franzl, R; Lillemarktt, L; Riquet, A M; Petersen, J H; van Lierop, B; Yagoubi, N

2002-02-01

The results of a research project (EU AIR Research Programme CT94-1025) aimed to introduce control of migration into good manufacturing practice and into enforcement work are reported. Representative polymer classes were defined on the basis of chemical structure, technological function, migration behaviour and market share. These classes were characterized by analytical methods. Analytical techniques were investigated for identification of potential migrants. High-temperature gas chromatography was shown to be a powerful method and 1H-magnetic resonance provided a convenient fingerprint of plastic materials. Volatile compounds were characterized by headspace techniques, where it was shown to be essential to differentiate volatile compounds desorbed from those generated during the thermal desorption itself. For metal trace analysis, microwave mineralization followed by atomic absorption was employed. These different techniques were introduced into a systematic testing scheme that is envisaged as being suitable both for industrial control and for enforcement laboratories. Guidelines will be proposed in the second part of this paper.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2003-01-01

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, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by United Nations agencies.

[Integrated Management Area of Vascular Risk: A new organisational model for global control of risk factors].

PubMed

Armario, P; Jericó, C; Vila, L; Freixa, R; Martin-Castillejos, C; Rotllan, M

Cardiovascular disease (CVD), is a major cause of morbidity and mortality that increases the cost of care. Currently there is a low degree of control of the main cardiovascular risk factors, although we have a good therapeutic arsenal. To achieve the improvement of this reality, a good coordination and multidisciplinary participation are essential. The development of new organizational models such as the Integrated Management Area of Vascular Risk can facilitate the therapeutic harmonization and unification of the health messages offered by different levels of care, based on clinical practice guidelines, in order to provide patient-centred integrated care. Copyright © 2016 SEH-LELHA. Publicado por Elsevier España, S.L.U. All rights reserved.

Guidelines for maintaining and managing the vaccine cold chain.

PubMed

2003-10-24

In February 2002, the Advisory Committee on Immunization Practices (ACIP) and American Academy of Family Physicians (AAFP) released their revised General Recommendations on Immunization, which included recommendations on the storage and handling of immunobiologics. Because of increased concern over the potential for errors with the vaccine cold chain (i.e., maintaining proper vaccine temperatures during storage and handling to preserve potency), this notice advises vaccine providers of the importance of proper cold chain management practices. This report describes proper storage units and storage temperatures, outlines appropriate temperature-monitoring practices, and recommends steps for evaluating a temperature-monitoring program. The success of efforts against vaccine-preventable diseases is attributable in part to proper storage and handling of vaccines. Exposure of vaccines to temperatures outside the recommended ranges can affect potency adversely, thereby reducing protection from vaccine-preventable diseases. Good practices to maintain proper vaccine storage and handling can ensure that the full benefit of immunization is realized.

Lessons on corporate "sustainability" disclosure from Deepwater Horizon.

PubMed

Lewis, Sanford

2011-01-01

The BP oil spill highlighted shortcomings of current financial and sustainability reporting standards and practice. "Integrated reporting" aims to combine financial and social/environmental information into a single annual corporate report. But without more stringent standards, integrated reports would neglect substantial risks and, as BP's sustainability reports demonstrate, create false impressions of good practice.To be of value, integration must: 1. Require timely disclosure of enforcement notices, orders and allegations issued by regulators. 2. Require disclosure of credible scientific reports and concerns indicative of potentially catastrophic risks of a company's products and activities, regardless of scientific uncertainty. 3. Require review and disclosures of a firm's safety culture. 4. Require disclosure of any facts or circumstances needed to ensure that the management's self-portrait of its sustainability strategies, goals and progress is not materially misleading.In conducting its misleading reporting, BP largely followed Global Reporting Initiative (GRI) guidelines. GRI is soliciting input, beginning in summer 2011, on how to revise those guidelines. Since GRI may prove a leading source for sustainability disclosure rules in integrating reporting, lessons learned from the BP experience must be applied to the next GRI revisions.

Specialty Guidelines for Forensic Psychology

ERIC Educational Resources Information Center

American Psychologist, 2013

2013-01-01

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

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

PubMed

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

2016-07-22

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

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

PubMed

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

2004-04-01

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

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

PubMed

Yamamoto, Mitsutoshi

2013-01-01

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

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

PubMed Central

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

2014-01-01

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

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

PubMed

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

2017-09-01

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

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

PubMed

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

2017-07-01

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

Supportive Care Treatment Guidelines: Value, Limitations, and Opportunities

PubMed Central

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

2013-01-01

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

[Quality improvement in workers health surveillance: the spirometry training courses experience].

PubMed

Innocenti, A; Quercia, A; Roscelli, F

2012-01-01

The spirometry execution during workers health surveillance requires accurate and reproducible spirometric measurements, which should comply with the ATS/ERS guidelines. Low acceptability of spirometric manoeuvres has been reported in health surveillance. This may hamper the validity of the results and affect clinical decision making. Training and refresher courses may produce and maintain good-quality testing, promote the use of spirometric results in clinical practice and enhance the quality of interpretation. We evaluated (with PLATINO score) 239 spirometries from 23 occupational physicians recorded before and after a spirometry refresher course (16 hours) and we verified that only 4 physicians showed a very good improvement and others 4 a good improvement of score, while 9 showed a very slight improvement and 6 instead no improvement. It is worthy of note that in 2012 some spirometers not suitable to UNI EN 26782/2009 were still in use.

Attitudes of US neurologists concerning the ethical dimensions of managed care.

PubMed

Bernat, J L; Ringel, S P; Vickrey, B G; Keran, C

1997-07-01

We surveyed attitudes of US neurologists about the ethical dimensions of managed care by administering a written instrument containing paradigmatic cases portraying conflicts of physicians, patients, and managed care organizations (MCOs). After each case, we assessed neurologists' attitudes by asking them their degree of agreement with a series of statements. We found that neurologists (1) generally were willing to follow clinical practice guidelines if they were created by medical societies; (2) experienced frequent conflicts of interest or conflicts of obligation in the care of their MCO patients; (3) feared legal ramifications of their clinical decisions on MCO patients; (4) were unwilling to employ deception or gaming to achieve what they perceived to be good patient care; (5) believed that their professional prerogatives and autonomy were under attack by MCOs; and (6) felt that the good of their patients should not be sacrificed for the good of society.

Quality evaluation of rice bran protein isolate-based weaning food for preschoolers.

PubMed

Khan, Saima H; Butt, Masood S; Anjum, Faqir M; Sameen, Ayesha

2011-05-01

Agro-industrial waste 'rice bran' was stabilized and the extracted protein isolates were used as ingredients to make nutritive complimentary food for the growing infants. The formulation processed through drum drying and the starchy ingredients were pregelatinized to reduce bulk in the prepared meal and facilitate spoon-feeding. The formulations had uniform texture, light golden color and good paste consistency. Nutrient composition was good enough to meet standards for supplementary infant foods. Caloric value remained up to 416 kcal/100 g with spoonable viscosity and 80.90-84.45% in vitro digestibility. A single meal could substantially contribute to the daily essential amino acid requirement. The formulation had good acceptability during a short-term infant-feeding trial. The present study can provide practical guideline for manufacturers as well as the nutritionist for the use of an economical and nutritive formulation for young children.

[Health Council of the Netherlands follows the ecological trail: a new venture].

PubMed

Reijnders, Lucas

2011-01-01

The Health Council of the Netherlands' report 'Guidelines for a healthy diet: the ecological perspective' only partially succeeds in its objectives. The main conclusions are correct: less calories for the obese and replacement of animal protein by plant-based foods are good for both health and the environment, and consumption of fish twice a week is good for health, but not for the environment. However, the Health Council's report does not discuss regulatory measures such as internalization of external costs and the introduction of good manufacturing practices, which can be conducive to implementing a more environmentally friendly healthy diet. Also more could have been done with existing scientific literature, which provides support for eating fresh seasonal produce and lowering the average Dutch protein intake by about one third as contributions to an environmentally friendly healthy diet, and for further research in the field of algae-based fish substitutes.

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

PubMed

Kiyoshi-Teo, Hiroko; Blegen, Mary

2015-07-01

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

Mobile PHRs compliance with Android and iOS usability guidelines.

PubMed

Cruz Zapata, Belén; Hernández Niñirola, Antonio; Idri, Ali; Fernández-Alemán, José Luis; Toval, Ambrosio

2014-08-01

Mobile Personal Health Records (PHRs) have achieved a particularly strong market share since the appearance of more powerful mobile devices and popular worldwide mobile application markets such as Apple's App Store and Android's Google Play. However, Android and Apple have a set of recommendations on design and usability targeted towards developers who wish to publish apps in their stores: Android Design Guidelines and iOS Human Interface Guidelines. This paper aims to evaluate compliance with these guidelines by assessing the usability recommendations of a set of 24 selected mobile PHR applications. An analysis process based on a well-known Systematic Literature Review (SLR) protocol was used. The results show that the 24 mobile PHR applications studied are not suitably structured. 46 % of these applications do not use any of the recommended patterns, using instead lists or springboards, which are deprecated patterns for top-level menus. 70 % of the PHRs require a registration to be able to test the application when these interactions should be delayed. Our study will help both PHR users to select user-friendly mobile PHRs and PHR providers and developers to identify the good usability practices implemented by the applications with the highest scores.

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

PubMed

2012-04-06

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

Developing Practice Guidelines for Psychoanalysis

PubMed Central

GRAY, SHEILA HAFTER

1996-01-01

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

A Review of Best Practices for Intravenous Push Medication Administration.

PubMed

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

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

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

PubMed

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

2003-01-01

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

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

PubMed

Hashmi, Noreen Rahat; Khan, Shahzad Ali

2016-01-01

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

Patients' preferences shed light on the murky world of guideline-based medicine.

PubMed

Penston, James

2007-02-01

Concordance--that is, shared decision-making between doctors and patients--is nowadays accepted as an integral part of good clinical practice. It is of particular importance in the case of treatments with only marginal benefits such as those recommended in guidelines for the management of common, chronic diseases. However, the implementation of guideline-based medicine conflicts with that of concordance. Studies indicate that patients are not adequately informed about their treatment. Clinical guidelines for conditions such as cardiovascular disease are based on large-scale randomized trials and the complex nature of the data limits effective communication especially in an environment characterized by time constraints. But other factors may be more relevant, notably pressures to comply with guidelines and financial rewards for meeting targets: it is simply not in the interests of doctors to disclose accurate information. Studies show that patients are far from impressed by the small benefits derived from large scale trials. Indeed, faced with absolute risk reductions, patients decline treatment promoted by guidelines. To participate in clinical decisions, patients require unbiased information concerning outcomes with and without treatment, and the absolute risk reduction; they should be told that most patients receiving long-term medication obtain no benefit despite being exposed to adverse drug reactions; furthermore, they should be made aware of the questionable validity of large-scale trials and that these studies may be influenced by those with a vested interest. Genuine concordance will inevitably lead to many patients rejecting the recommendations of guidelines and encourage a more critical approach to clinical research and guideline-based medicine.

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

PubMed Central

2012-01-01

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422

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.

Practices in security and confidentiality of HIV/AIDS patients’ information: A national survey among staff at HIV outpatient clinics in Vietnam

PubMed Central

Khac Hai, Nguyen; Lawpoolsri, Saranath; Jittamala, Podjanee; Thi Thu Huong, Phan

2017-01-01

Introduction Breach of confidentiality or invasion of privacy from the collection and use of medical records, particularly those of patients with HIV/AIDS or other diseases sensitive to stigmatization, should be prevented by all related stakeholders in healthcare settings. The main focus of this study was to assess practices regarding security and confidentiality of HIV-related information among staff at HIV outpatient clinics (HIV-OPCs) in Vietnam. Methods A descriptive cross-sectional study was conducted at all 312 HIV-OPCs across the country using an online survey technique. Results In general, the staff practices for securing and protecting patient information were at acceptable levels. Most staff had proper measures and practices for maintaining data security; however, the protection of patient confidentiality, particularly for data access, sharing, and transfer still required improvement. Most HIV-OPC staff had good or moderate knowledge and positive perceptions towards security and confidentiality issues. Staff who were not trained in the practice of security measures differed significantly from those who were trained (OR: 3.74; 95%CI: 1.44–9.67); staff needing improved knowledge levels differed significantly from those with good (OR: 5.20; 95%CI: 2.39–11.32) and moderate knowledge levels (OR: 5.10; 95%CI: 2.36–11.00); and staff needing improved perception levels differed significantly from those with good (i.e., with 100% proper practices) and moderate perception levels (OR: 5.67; 95%CI: 2.93–10.95). Staff who were not trained in the protection of data confidentiality differed significantly from those who were trained (OR: 2.18; 95%CI: 1.29–3.65). Conclusions Training is an important factor to help raise the levels of proper practices regarding confidentiality and security, to improve knowledge and raise awareness about change among staff. The operation and management of HIV treatment and care in Vietnam are currently transitioning from separate healthcare clinics (HIV-OPC) into units integrated into general hospitals/healthcare facilities. The findings of this study highlight topics that could be used for improving management and operation of information system and revising guidelines and regulations on protection measures/strategies for data security and confidentiality of HIV/AIDS patients by Vietnam health authorities or other countries facing similar situations. Secure infrastructure and secure measures for data access and use are very important, worthwhile investments. The provision of continuous training and active enforcement and monitoring of the practices of healthcare personnel might lead to an improved understanding and acknowledegement of the importance of national policies/guidelines regarding HIV-related patient information. PMID:29136017

Traditional Chinese medicine research in the post-genomic era: good practice, priorities, challenges and opportunities.

PubMed

Uzuner, Halil; Bauer, Rudolf; Fan, Tai-Ping; Guo, De-An; Dias, Alberto; El-Nezami, Hani; Efferth, Thomas; Williamson, Elizabeth M; Heinrich, Michael; Robinson, Nicola; Hylands, Peter J; Hendry, Bruce M; Cheng, Yung-Chi; Xu, Qihe

2012-04-10

GP-TCM is the 1st EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. This paper aims to summarise the objectives, structure and activities of the consortium and introduces the position of the consortium regarding good practice, priorities, challenges and opportunities in TCM research. Serving as the introductory paper for the GP-TCM Journal of Ethnopharmacology special issue, this paper describes the roadmap of this special issue and reports how the main outputs of the ten GP-TCM work packages are integrated, and have led to consortium-wide conclusions. Literature studies, opinion polls and discussions among consortium members and stakeholders. By January 2012, through 3 years of team building, the GP-TCM consortium had grown into a large collaborative network involving ∼200 scientists from 24 countries and 107 institutions. Consortium members had worked closely to address good practice issues related to various aspects of Chinese herbal medicine (CHM) and acupuncture research, the focus of this Journal of Ethnopharmacology special issue, leading to state-of-the-art reports, guidelines and consensus on the application of omics technologies in TCM research. In addition, through an online survey open to GP-TCM members and non-members, we polled opinions on grand priorities, challenges and opportunities in TCM research. Based on the poll, although consortium members and non-members had diverse opinions on the major challenges in the field, both groups agreed that high-quality efficacy/effectiveness and mechanistic studies are grand priorities and that the TCM legacy in general and its management of chronic diseases in particular represent grand opportunities. Consortium members cast their votes of confidence in omics and systems biology approaches to TCM research and believed that quality and pharmacovigilance of TCM products are not only grand priorities, but also grand challenges. Non-members, however, gave priority to integrative medicine, concerned on the impact of regulation of TCM practitioners and emphasised intersectoral collaborations in funding TCM research, especially clinical trials. The GP-TCM consortium made great efforts to address some fundamental issues in TCM research, including developing guidelines, as well as identifying priorities, challenges and opportunities. These consortium guidelines and consensus will need dissemination, validation and further development through continued interregional, interdisciplinary and intersectoral collaborations. To promote this, a new consortium, known as the GP-TCM Research Association, is being established to succeed the 3-year fixed term FP7 GP-TCM consortium and will be officially launched at the Final GP-TCM Congress in Leiden, the Netherlands, in April 2012. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

The impact of qualitative research on gynaecologic oncology guidelines.

PubMed

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

2015-02-01

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

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

PubMed

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

2012-08-01

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

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

PubMed

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

2017-10-01

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

Systematic review of recent dementia practice guidelines.

PubMed

Ngo, Jennifer; Holroyd-Leduc, Jayna M

2015-01-01

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

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

PubMed Central

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

2007-01-01

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

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

PubMed

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

2007-12-01

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

Cancer related fatigue: implementing guidelines for optimal management.

PubMed

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

2017-07-18

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

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.

General practitioner diagnosis and management of acute knee injuries: summary of an evidence-based guideline.

PubMed

Robb, Gillian; Reid, Duncan; Arroll, Bruce; Jackson, Rod T; Goodyear-Smith, Felicity

2007-02-16

To summarise evidence and key recommendations for general practitioner diagnosis and management of acute soft-tissue knee injuries, based on the New Zealand guideline. A multidisciplinary team developed the guideline by critically appraising and grading retrieved literature using the Graphic Appraisal Tools for Epidemiology, Clinical decision rules and the Scottish Intercollegiate Guideline Network. Recommendations were derived from resulting evidence tables. For both diagnosis and management there is a paucity of good evidence to support diagnosis and treatment of internal derangements of the knee, hence some aspects of the guideline are guideline team consensus. Good evidence supports the use of the Ottawa Knee rules to guide decisions about the use of X-ray, and the Lachman test in diagnosing anterior cruciate ligament (ACL) tears. Evidence supports inclusion of proprioceptive training in rehabilitation programmes following ACL reconstruction and in people with ACL-deficient knees. There is good evidence that ultrasound is of little benefit, and there is no evidence that physiotherapy be routinely advocated following meniscectomy. This guideline provides an evidence-based framework for diagnosis and management of internal derangements of the knee following acute injury. Moreover, its development highlights significant gaps in the evidence base and identifies priorities for new research.

Drug regulators and ethics: which GCP issues are also ethical issues?

PubMed

Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; Breekveldt, Nancy S; van Delden, Johannes J M

2016-02-01

Within the European Union (EU), good clinical practice (GCP) provides an ethical mandate to regulators; however, it is unclear what the content of that mandate is. By looking at the correspondence between GCP and ethical imperatives, we identify that the mandate is within the following: principles; benefit-risk ratio; scientific validity; results publication; informed consent; respect for participants; and special populations. There are also cases when regulations were ethical but were not pairable to an imperative, and when the former were stricter than the latter. Hence, we suggest closer cooperation between ethics committees and regulators to ensure that future versions of ethics guidelines cover the ethically relevant regulations that were not directly pairable to any imperative, and cooperation between GCP legislative bodies and ethics guideline-making bodies to resolve the discordant areas. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Criminal liability in case of medical acts considered to be incompetent: article 6 of the new Italian Law 8 March 2017, n.24].

PubMed

Renzulli, Lorenzo

2017-01-01

In Italy, Law n. 24 of 8 March 2017, Article 6, introduces in the current criminal code, Article 590 sexies entitled "Medical liability in case of death and personal lesions", which follows article 590 quinquies. The new article states that a healthcare professional who has acted in accordance with guidelines approved by the National Health Institute or, if no such guidelines exist, in accordance with good clinical practices, is not criminally liable in case of death or personal lesions due to actions that could be considered to be incompetent. We discuss criminal liability of health professionals in Italy in light of this new law, and decriminalization in case of adverse event due to incompetence, also in the context of medical care provided by different health professionals.

Contemporary understanding and management of reflux and constipation in the general population and pregnancy: a consensus meeting.

PubMed

Tytgat, G N; Heading, R C; Müller-Lissner, S; Kamm, M A; Schölmerich, J; Berstad, A; Fried, M; Chaussade, S; Jewell, D; Briggs, A

2003-08-01

Gastro-oesophageal reflux disease (GERD) and constipation have a major impact on public health; however, the wide variety of treatment options presents difficulties for recommending therapy. Lack of definitive guidelines in pharmacy and general practice medicine further exacerbates the decision dilemma. To address these issues, a panel of experts discussed the principles and practice of treating GERD and constipation in the general population and in pregnancy, with the aim of developing respective treatment guidelines. The panel recommended antacids 'on-demand' as the first-line over-the-counter treatment in reflux, and as rescue medication for immediate relief when reflux breaks through with proton pump inhibitors. Calcium/magnesium-based antacids were recommended as the treatment of choice for pregnant women because of their good safety profile. In constipation, current data do not distinguish a hierarchy between polyethylene glycol (PEG)-based laxatives and other first-line treatments, although limitations are associated with stimulant- and bulk-forming laxatives. Where data are available, PEG is superior to lactulose in terms of efficacy. In pregnancy, PEG-based laxatives meet the criteria for the ideal treatment. The experts developed algorithms that present healthcare professionals with clear treatment options and management strategies for GERD and constipation in pharmacy and general practice medicine.

National Practice Patterns for Prenatal Monitoring in Gastroschisis: Gastroschisis Outcomes of Delivery (GOOD) Provider Survey.

PubMed

Amin, Ruchi; Domack, Aaron; Bartoletti, Joseph; Peterson, Erika; Rink, Britton; Bruggink, Jennifer; Christensen, Melissa; Johnson, Anthony; Polzin, William; Wagner, Amy J

2018-05-23

Gastroschisis is an abdominal wall defect with increasing incidence. Given the lack of surveillance guidelines among maternal-fetal medicine (MFM) specialists, this study describes current practices in gastroschisis management. An online survey was administered to MFM specialists from institutions affiliated with the North American Fetal Therapy Network (NAFTNet). Questions focused on surveillance timing, testing, findings that changed clinical management, and delivery plan. Responses were obtained from 29/29 (100%) NAFTNet centers, comprising 143/371 (39%) providers. The majority had a regimen for antenatal surveillance in patients with stable gastroschisis (94%; 134/141). Antenatal testing began at 32 weeks for 68% (89/131) of MFM specialists. The nonstress test (55%; 72/129), biophysical profile (50%; 63/126), and amniotic fluid index (64%; 84/131) were used weekly. Estimated fetal weight (EFW) was performed monthly by 79% (103/131) of providers. At 28 weeks, abnormal EFW (77%; 97/126) and Doppler ultrasound (78%; 99/127) most frequently altered management. In stable gastroschisis, 43% (60/140) of providers delivered at 37 weeks, and 29% (40/ 140) at 39 weeks. Gastroschisis management differs among NAFTNet centers, although the majority initiate surveillance at 32 weeks. Timing of delivery still requires consensus. Prospective studies are necessary to further optimize practice guidelines and patient care. © 2018 S. Karger AG, Basel.

A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research.

PubMed

Koo, Terry K; Li, Mae Y

2016-06-01

Intraclass correlation coefficient (ICC) is a widely used reliability index in test-retest, intrarater, and interrater reliability analyses. This article introduces the basic concept of ICC in the content of reliability analysis. There are 10 forms of ICCs. Because each form involves distinct assumptions in their calculation and will lead to different interpretations, researchers should explicitly specify the ICC form they used in their calculation. A thorough review of the research design is needed in selecting the appropriate form of ICC to evaluate reliability. The best practice of reporting ICC should include software information, "model," "type," and "definition" selections. When coming across an article that includes ICC, readers should first check whether information about the ICC form has been reported and if an appropriate ICC form was used. Based on the 95% confident interval of the ICC estimate, values less than 0.5, between 0.5 and 0.75, between 0.75 and 0.9, and greater than 0.90 are indicative of poor, moderate, good, and excellent reliability, respectively. This article provides a practical guideline for clinical researchers to choose the correct form of ICC and suggests the best practice of reporting ICC parameters in scientific publications. This article also gives readers an appreciation for what to look for when coming across ICC while reading an article.

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.

[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.

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

PubMed

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

2015-10-01

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

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

PubMed

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

2013-05-01

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

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

PubMed

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

2018-05-01

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

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

PubMed

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

2015-06-01

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

Psychiatrists' follow-up of identified metabolic risk: a mixed-method analysis of outcomes and influences on practice

PubMed Central

Patterson, Sue; Freshwater, Kathleen; Goulter, Nicole; Ewing, Julie; Leamon, Boyd; Choudhary, Anand; Moudgil, Vikas; Emmerson, Brett

2016-01-01

Aims and method To describe and explain psychiatrists' responses to metabolic abnormalities identified during screening. We carried out an audit of clinical records to assess rates of monitoring and follow-up practice. Semi-structured interviews with 36 psychiatrists followed by descriptive and thematic analyses were conducted. Results Metabolic abnormalities were identified in 76% of eligible patients screened. Follow-up, recorded for 59%, was variable but more likely with four or more abnormalities. Psychiatrists endorse guidelines but ambivalence about responsibility, professional norms, resource constraints and skills deficits as well as patient factors influences practice. Therapeutic optimism and desire to be a ‘good doctor’ supported comprehensive follow-up. Clinical implications Psychiatrists are willing to attend to physical healthcare, and obstacles to recommended practice are surmountable. Psychiatrists seek consensus among stakeholders about responsibilities and a systemic approach addressing the social determinants of health inequities. Understanding patients' expectations is critical to promoting best practice. PMID:27752343

Chiropractic quality assurance: standards and guidelines

PubMed Central

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

2001-01-01

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

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

PubMed

Waldfahrer, Frank

2016-01-01

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

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

PubMed Central

Waldfahrer, Frank

2016-01-01

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

Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

PubMed

Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

2015-03-01

This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

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

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

Wallace, Christine

2001-05-29

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

A Summary of Important Documents in the Field of Research Ethics

PubMed Central

Fischer, Bernard A

2006-01-01

Today's researchers are obligated to conduct their studies ethically. However, it often seems a daunting task to become familiar with the important ethical codes required to do so. The purpose of this article is to examine the content of those ethical documents most relevant to the biomedical researcher. Documents examined include the Nuremberg Code, the Declaration of Helsinki, Henry Beecher's landmark paper, the Belmont Report, the U.S. Common Rule, the Guideline for Good Clinical Practice, and the National Bioethics Advisory Commission's report on research protections for the mentally ill. PMID:16192409

An Evidence-Based Multidisciplinary Practice Guideline to Reduce the Workload due to Lifting for Preventing Work-Related Low Back Pain

PubMed Central

2014-01-01

We developed an evidence-based practice guideline to support occupational safety and health (OSH) professionals in assessing the risk due to lifting and in selecting effective preventive measures for low back pain (LBP) in the Netherlands. The guideline was developed at the request of the Dutch government by a project team of experts and OSH professionals in lifting and work-related LBP. The recommendations for risk assessment were based on the quality of instruments to assess the risk on LBP due to lifting. Recommendations for interventions were based on a systematic review of the effects of worker- and work directed interventions to reduce back load due to lifting. The quality of the evidence was rated as strong (A), moderate (B), limited (C) or based on consensus (D). Finally, eight experts and twenty-four OSH professionals commented on and evaluated the content and the feasibility of the preliminary guideline. For risk assessment we recommend loads heavier than 25 kg always to be considered a risk for LBP while loads less than 3 kg do not pose a risk. For loads between 3–25 kg, risk assessment shall be performed using the Manual handling Assessment Charts (MAC)-Tool or National Institute for Occupational Safety and Health (NIOSH) lifting equation. Effective work oriented interventions are patient lifting devices (Level A) and lifting devices for goods (Level C), optimizing working height (Level A) and reducing load mass (Level C). Ineffective work oriented preventive measures are regulations to ban lifting without proper alternatives (Level D). We do not recommend worker-oriented interventions but consider personal lift assist devices as promising (Level C). Ineffective worker-oriented preventive measures are training in lifting technique (Level A), use of back-belts (Level A) and pre-employment medical examinations (Level A). This multidisciplinary evidence-based practice guideline gives clear criteria whether an employee is at risk for LBP while lifting and provides an easy-reference for (in)effective risk reduction measures based on scientific evidence, experience, and consensus among OSH experts and practitioners. PMID:24999432

An Evidence-Based Multidisciplinary Practice Guideline to Reduce the Workload due to Lifting for Preventing Work-Related Low Back Pain.

PubMed

Kuijer, P Paul Fm; Verbeek, Jos Ham; Visser, Bart; Elders, Leo Am; Van Roden, Nico; Van den Wittenboer, Marion Er; Lebbink, Marian; Burdorf, Alex; Hulshof, Carel Tj

2014-01-01

We developed an evidence-based practice guideline to support occupational safety and health (OSH) professionals in assessing the risk due to lifting and in selecting effective preventive measures for low back pain (LBP) in the Netherlands. The guideline was developed at the request of the Dutch government by a project team of experts and OSH professionals in lifting and work-related LBP. The recommendations for risk assessment were based on the quality of instruments to assess the risk on LBP due to lifting. Recommendations for interventions were based on a systematic review of the effects of worker- and work directed interventions to reduce back load due to lifting. The quality of the evidence was rated as strong (A), moderate (B), limited (C) or based on consensus (D). Finally, eight experts and twenty-four OSH professionals commented on and evaluated the content and the feasibility of the preliminary guideline. For risk assessment we recommend loads heavier than 25 kg always to be considered a risk for LBP while loads less than 3 kg do not pose a risk. For loads between 3-25 kg, risk assessment shall be performed using the Manual handling Assessment Charts (MAC)-Tool or National Institute for Occupational Safety and Health (NIOSH) lifting equation. Effective work oriented interventions are patient lifting devices (Level A) and lifting devices for goods (Level C), optimizing working height (Level A) and reducing load mass (Level C). Ineffective work oriented preventive measures are regulations to ban lifting without proper alternatives (Level D). We do not recommend worker-oriented interventions but consider personal lift assist devices as promising (Level C). Ineffective worker-oriented preventive measures are training in lifting technique (Level A), use of back-belts (Level A) and pre-employment medical examinations (Level A). This multidisciplinary evidence-based practice guideline gives clear criteria whether an employee is at risk for LBP while lifting and provides an easy-reference for (in)effective risk reduction measures based on scientific evidence, experience, and consensus among OSH experts and practitioners.

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

PubMed

Cooper, Megan; McCutcheon, Helen; Warland, Jane

2017-10-01

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

Practice Guidelines for Operative Performance Assessments.

PubMed

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

2016-12-01

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

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

PubMed Central

López, Andrea; Black, Karen; Schillinger, Dean

2011-01-01

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

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

PubMed

Buccheri, Robin K; Sharifi, Claire

2017-12-01

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

Potential facilitators and barriers to adopting standard treatment guidelines in clinical practice.

PubMed

Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia

2017-04-18

Purpose The purpose of this paper is to assess medicines information sources accessed by clinicians, if sources differed in theory and practice and to find out the barriers and facilitators to effective guideline adoption. Design/methodology/approach In all, 183 doctors were surveyed. Barriers and facilitators were classified as: communication; potential adopters; innovation; organization characteristics and environmental/social/economic context. Findings Most of the clinicians accessed multiple information sources including standard treatment guidelines, but also consulted seniors/colleagues in practice. The top three factors influencing clinical practice guideline adoption were innovation characteristics, environmental context and individual characteristics. The respondents differed in the following areas: concerns about flexibility offered by the guideline; denying patients' individuality; professional autonomy; insights into gaps in current practice and evidence-based practice; changing practices with little or no benefit. Barriers included negative staff attitudes/beliefs, guideline integration into organizational structures/processes, time/resource constraints. Fearing third parties (government and insurance companies) restricting medicines reimbursement and poor liability protection offered by the guidelines emerged as the barriers. Facilitators include aligning organizational structures/processes with the innovation; providing leadership support to guide diffusion; increasing awareness and enabling early innovation during pre/in-service training, with regular feedback on outcomes and use. Practical implications Guideline adoption in clinical practice is partly within doctors' control. There are other key prevailing factors in the local context such as environmental, social context, professional and organizational culture affecting its adoption. Organizational policy and accreditation standards necessitating adherence can serve as a driver. Originality/value This survey among clinicians, despite limitations, gives helpful insights. While favourable attitudes may be helpful, clinical adoption could be improved more effectively by targeting barriers.

Care management of the agitation or aggressiveness crisis in patients with TBI. Systematic review of the literature and practice recommendations.

PubMed

Luauté, Jacques; Plantier, David; Wiart, Laurent; Tell, Laurence

2016-02-01

The agitation crisis in the awakening phase after traumatic brain injury (TBI) is one of the most difficult behavioral disorders to alleviate. Current treatment options are heterogeneous and may involve excessive sedation. Practice guidelines are required by professionals in charge of TBI patients. Few reviews were published but those are old and based on expert opinions. The purpose of this work is to propose evidence-based guidelines to treat the agitation crisis. The elaboration of these guidelines followed the procedure validated by the French health authority for good practice recommendations, close to the Prisma statement. Guidelines were elaborated on the basis of a systematic and critical review of the literature. Twenty-eight articles concerning 376 patients were analyzed. Recommendations are: when faced with an agitation crisis, the management strategy implies to search for an underlying factor that should be treated such as pain, acute sepsis, and drug adverse effect (expert opinion). Physical restraints should be discarded when possible (expert opinion). Neuroleptic agent with a marketing authorization can be used in order to obtain a quick sedation so as to protect the patient from himself, closed ones or the healthcare team but the duration should be as short as possible (expert opinion). The efficacy of beta-blockers and antiepileptics with mood regulation effects like carbamazepine and valproate yield the most compelling evidence and should be preferably used when a background regimen is envisioned (grade B for beta-blocker and C for antiepileptics). Neuroleptics, antidepressants, benzodiazepines, buspirone may be prescribed but are considered second-line treatments (expert opinion). This study provides a strategy for treating the agitation crisis based on scientific data and expert opinion. The level of evidence remains low and published data are often old. New studies are essential to validate results from previous studies and test new drugs and non-pharmaceutical therapies. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement

PubMed Central

Hong, Dae Gy; Shin, So-Jin; Ju, Woong; Cho, Hanbyoul; Lee, Chulmin; Kim, Hyun-Jung; Bae, Duk-Soo

2017-01-01

Clinical practice guidelines for gynecologic cancers have been developed by many organizations. Although these guidelines have much in common in terms of the practice of standard of care for uterine corpus cancer, practice guidelines that reflect the characteristics of patients and healthcare and insurance systems are needed for each country. The Korean Society of Gynecologic Oncology (KSGO) published the first edition of practice guidelines for gynecologic cancer treatment in late 2006; the second edition was released in July 2010 as an evidence-based recommendation. The Guidelines Revision Committee was established in 2015 and decided to produce the third edition of the guidelines as an advanced form based on evidence-based medicine, considering up-to-date clinical trials and abundant qualified Korean data. These guidelines cover screening, surgery, adjuvant treatment, and advanced and recurrent disease with respect to endometrial carcinoma and uterine sarcoma. The committee members and many gynecologic oncologists derived key questions from the discussion, and a number of relevant scientific literatures were reviewed in advance. Recommendations for each specific question were developed by the consensus conference, and they are summarized here, together with other details. The objective of these practice guidelines is to establish standard policies on issues in clinical areas related to the management of uterine corpus cancer based on the findings in published papers to date and the consensus of experts as a KSGO Consensus Statement. PMID:27894165

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine].

PubMed

Liu, Yu-Qi; Liu, Meng-Yu; Li, Chun; Shi, Nan-Nan; Wang, Yue-Xi; Wang, Li-Ying; Zhao, Xue-Yao; Kou, Shuang; Han, Xue-Jie; Wang, Yan-Ping

2017-09-01

This study is to assess the Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine in clinical application and provide evidence for further guideline revision. The assessment was divided into applicability assessment and practicability assessment. The applicability assessment based on questionnaire survey and the traditional Chinese medicine (TCM) practitioners were asked to independently fill the Questionnaire for Applicability Assessment on the Guidelines for Diagnosis and Treatment in Traditional Chinese Medicine. The practicability assessment was based on prospective case investigation and analysis method and the TCM practitioners-in-charge filled the Case Investigation Questionnaire for Practicability Assessment on the Guidelines for Diagnosis and Treatment in Traditional Chinese Medicine. The data were analyzed in descriptive statistics. 151 questionnaires were investigated for applicability assessment and 1 016 patients were included for practicability assessment. The results showed that 88.74% of them were familiar with the guidelines and 45.70% used them. The guidelines quality and related items were similar in applicability assessment and practicability assessment, and scored highly as more than 85.00% except the "recuperating and prevention". The results suggested that the quality of Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine was high and could better guide the clinical practice. The "recuperating and prevention" part should be improved and the evidence data should be included in future guideline revision, so that the clinical utilization rate could be increased. Copyright© by the Chinese Pharmaceutical Association.

Prevention of occupational injuries: Evidence for effective good practices in foundries.

PubMed

Porru, Stefano; Calza, Stefano; Arici, Cecilia

2017-02-01

Occupational injuries are a relevant research and practical issue. However, intervention studies evaluating the effectiveness of workplace injury prevention programs are seldom performed. The effectiveness of a multifaceted intervention aimed at reducing occupational injury rates (incidence/employment-based=IR, frequency/hours-based=FR, severity=SR) was evaluated between 2008 and 2013 in 29 Italian foundries (22 ferrous; 7 non-ferrous; 3,460 male blue collar workers/year) of varying sizes. Each foundry established an internal multidisciplinary prevention team for risk assessment, monitoring and prevention of occupational injuries, involving employers, occupational physicians, safety personnel, workers' representatives, supervisors. Targets of intervention were workers, equipment, organization, workplace, job tasks. An interrupted time series (ITS) design was applied. 4,604 occupational injuries and 83,156 lost workdays were registered between 2003 and 2013. Statistical analysis showed, after intervention, a reduction of all injury rates (-26% IR, -15% FR, -18% SR) in ferrous foundries and of SR (-4%) in non-ferrous foundries. A significant (p=0.021) 'step-effect' was shown for IR in ferrous foundries, independent of secular trends (p<0.001). Sector-specific benchmarks for all injury rates were developed separately for ferrous and non-ferrous foundries. Strengths of the study were: ITS design, according to standardized quality criteria (i.e., at least three data points before and three data points after intervention; clearly defined intervention point); pragmatic approach, with good external validity; promotion of effective good practices. Main limitations were the non-randomized nature and a medium length post-intervention period. In conclusion, a multifaceted, pragmatic and accountable intervention is effective in reducing the burden of occupational injuries in small-, medium- and large-sized foundries. Practical Applications: The study poses the basis for feasible good practice guidelines to be implemented to prevent occupational injuries, by means of sector-specific numerical benchmarks, with potentially relevant impacts on workers, companies, occupational health professionals and society at large. Copyright © 2016 National Safety Council and Elsevier Ltd. All rights reserved.

Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors.

PubMed

Checketts, Jake X; Sims, Matthew Thomas; Vassar, Matt

2017-12-01

It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10 000, and 18 accepted more than $50 000. Financial payments amounted to a mean of $157 177 per author. The total reimbursement among the 49 authors from 2013 to 2015 was $7 701 681. Of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. Authors received payments from companies with products directly related to the guideline topic. Violations to the Administrative Regulations were found. Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments. The American Academy of Dermatology policies may benefit from stricter enforcement or the adoption of new standards.

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.

Ministry of Health Clinical Practice Guidelines: Prevention, Diagnosis and Management of Tuberculosis

PubMed Central

Wang, Yee Tang Sonny; Chee, Cynthia Bin Eng; Hsu, Li Yang; Jagadesan, Raghuram; Kaw, Gregory Jon Leng; Kong, Po Marn; Lew, Yii Jen; Lim, Choon Seng; Lim, Ting Ting Jayne; Lu, Kuo Fan Mark; Ooi, Peng Lim; Sng, Li-Hwei; Thoon, Koh Cheng

2016-01-01

The Ministry of Health (MOH) has developed the clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis to provide doctors and patients in Singapore with evidence-based treatment for tuberculosis. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis, for the information of SMJ readers. The chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines. PMID:26996216

Utilization of the American Telemedicine Association's Clinical Practice Guidelines

PubMed Central

Antoniotti, Nina; Bernard, Jordana

2013-01-01

Abstract Background: The American Telemedicine Association (ATA) Standards and Guidelines Committee develops practice standards and guidelines. Key to the Committee's mission is dissemination so the standards can be used in the practice of telemedicine. Over a 2-year period, when a standards document was accessed from the ATA Web site, a short survey was completed, but it did not assess how the documents were used once downloaded. A more formal survey was conducted to determine the impact ATA standards and guidelines are having on healthcare delivery via telemedicine. Materials and Methods: A survey was developed and distributed via SurveyMonkey to 13,177 ATA members and nonmembers in November 2011. Results were compiled and analyzed after a 90-day open period for responses to be submitted. Results: The majority of respondents (96%) believe the practice of telemedicine/telehealth should have standards and guidelines and that the ATA and other professional societies/associations should be responsible for developing them. The top uses of guidelines include guidance for clinical practice, training, gaining reimbursement, and research. Respondents indicating a need for standards and guidelines said the ATA (78.7%) and other professional societies/associations (74.5%) should be responsible for development. When asked to list specific practice guidelines or standards they are using for telehealth, the majority (21.5%) are using in-house (e.g., hospital, company)-developed guidelines, followed by those from professional associations/societies (20.4%) and those developed by the ATA (18.2%). Conclusions: Overall, the survey results indicate guidelines documents developed by the ATA and other professional societies and those developed in-house are being regularly accessed and used in both public and private sectors. Practitioners of telemedicine believe that standards and guidelines are needed for guidance for clinical practice, training, gaining reimbursement, and research, and they are to use those developed by professional organization such as the ATA as well as those developed by their own institutions. PMID:24050615

Practice parameters for the treatment of colonic diverticular disease: Italian Society of Colon and Rectal Surgery (SICCR) guidelines.

PubMed

Binda, G A; Cuomo, R; Laghi, A; Nascimbeni, R; Serventi, A; Bellini, D; Gervaz, P; Annibale, B

2015-10-01

The mission of the Italian Society of Colorectal Surgery (SICCR) is to optimize patient care. Providing evidence-based practice guidelines is therefore of key importance. About the present report it concernes the SICCR practice guidelines for the diagnosis and treatment of diverticular disease of the colon. The guidelines are not intended to define the sole standard of care but to provide evidence-based recommendations regarding the available therapeutic options.

The Room Where It Happens: A Skeptic's Analysis of the New Heart Failure Guidelines.

PubMed

Packer, Milton

2016-09-01

New heart failure guidelines have been issued during the past several months, both in the United States and in Europe, in response to recent advances in and the approval of new drugs for the treatment of heart failure. Although guidelines documents are often viewed as authoritative and purely evidence-based, there are replete with meaningful (and inexplicable) inconsistencies, which derive from a review of the same body of scientific data by different groups. This satirical review highlights several examples of the entertaining foolishness of recent guideline documents in the good-natured hope that physicians will understand what the guidelines are, and more importantly, what they are not. Specifically, this paper describes the emergence of a new nonexistent disease; the strange battle between 2 bradycardic drugs (digoxin and ivabradine); the confusion that reigns over the positioning and dosing of inhibitors of the renin-angiotensin system; and the special recommendations that have been issued for certain special populations. As Otto von Bismarck remarked, guideline deliberations are like sausages; it is better not to see them being made. Yet, even after they are ready for public view, we should be cautious. Practitioners who rely on them for clinical decision-making engage in an unnecessary form of self-deception; those who read them literally and adhere to them strictly do not practice evidence-based medicine; and those who delve into them in a search for the truth are destined to be disappointed. Copyright © 2016 Elsevier Inc. All rights reserved.

Practical guidelines for feminist research in nursing.

PubMed

Im, Eun-Ok

2013-01-01

With increasing interests in oppressed groups, the number of feminist studies in nursing has steadily increased. Despite the increasing number of feminist studies, very few articles have been written to provide practical guidelines for feminist research in nursing. In this article, guidelines for feminist research in nursing are proposed on the basis of 3 previous feminist studies. First, characteristics of feminist research are concisely described. Then, the 3 studies that are the basis for the guidelines are described. Finally, practical guidelines for feminist nursing research are proposed on the basis of 10 idea categories related to issues/concerns from the 3 studies.

Impact of the Centers for Disease Control's HIV Preexposure Prophylaxis Guidelines for Men Who Have Sex With Men in the United States.

PubMed

Jenness, Samuel M; Goodreau, Steven M; Rosenberg, Eli; Beylerian, Emily N; Hoover, Karen W; Smith, Dawn K; Sullivan, Patrick

2016-12-15

 Preexposure prophylaxis (PrEP) is effective for preventing human immunodeficiency virus (HIV) infection among men who have sex with men (MSM) within trial settings. Population impact will depend on clinical indications for PrEP initiation, coverage levels, and drug adherence. No modeling studies have estimated the impact of clinical practice guidelines for PrEP issued by the Centers for Disease Control and Prevention (CDC).  Mathematical models of HIV transmission among MSM were used to estimate the percentage of infections averted (PIA) and the number needed to treat (NNT) under behavioral indications of the CDC's PrEP guidelines. We modeled the contribution of these indications while varying treatment coverage and adherence.  At 40% coverage of indicated MSM over the next decade, application of CDC guidelines would avert 1162 infections per 100 000 person-years, 33.0% of expected infections. The predicted NNT for the guidelines would be 25. Increasing coverage and adherence jointly raise the PIA, but reductions to the NNT were associated with better adherence only.  Implementation of CDC PrEP guidelines would result in strong and sustained reductions in HIV incidence among MSM in the United States. The guidelines strike a good balance between epidemiological impact (PIA) and efficiency (NNT) at plausible scale-up levels. Adherence counseling could maximize public health investment in PrEP by decreasing the NNT. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Clinical Practice Guidelines for Irritable Bowel Syndrome in Korea, 2017 Revised Edition

PubMed Central

Song, Kyung Ho; Jung, Hye-Kyung; Kim, Hyun Jin; Koo, Hoon Sup; Kwon, Yong Hwan; Shin, Hyun Duk; Lim, Hyun Chul; Shin, Jeong Eun; Kim, Sung Eun; Cho, Dae Hyeon; Kim, Jeong Hwan; Kim, Hyun Jung

2018-01-01

In 2011, the Korean Society of Neurogastroenterology and Motility (KSNM) published clinical practice guidelines on the management of irritable bowel syndrome (IBS) based on a systematic review of the literature. The KSNM planned to update the clinical practice guidelines to support primary physicians, reduce the socioeconomic burden of IBS, and reflect advances in the pathophysiology and management of IBS. The present revised version of the guidelines is in continuity with the previous version and targets adults diagnosed with, or suspected to have, IBS. A librarian created a literature search query, and a systematic review was conducted to identify candidate guidelines. Feasible documents were verified based on predetermined inclusion and exclusion criteria. The candidate seed guidelines were fully evaluated by the Guidelines Development Committee using the Appraisal of Guidelines for Research and Evaluation II quality assessment tool. After selecting 7 seed guidelines, the committee prepared evidence summaries to generate data exaction tables. These summaries comprised the 4 main themes of this version of the guidelines: colonoscopy; a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols; probiotics; and rifaximin. To adopt the core recommendations of the guidelines, the Delphi technique (ie, a panel of experts on IBS) was used. To enhance dissemination of the clinical practice guidelines, a Korean version will be made available, and a food calendar for patients with IBS is produced. PMID:29605976

Smoking, dietary, and breast and cervical cancer screening knowledge and screening practices of employees in an urban medical center.

PubMed

Hyman, R B; Greenwald, E S; Hacker, S

1995-01-01

This paper reports results of a survey of 500 health care workers in a private New York City Hospital that assessed knowledge and behaviors in the areas of smoking and cancer, diet and cancer, and breast and cervical cancer screening. Given the small number of knowledge items, the results indicated good knowledge concerning diet and cancer, smoking and cancer, and mammography and Pap test guidelines. Conformity with American Cancer Society guidelines for Pap testing was comparable to national figures, but with women over 50 as likely to obtain Pap smears as younger women. Conformity with mammography guidelines was excellent, although compliance with breast self-examination recommendations was low (25.4%). Of female employees over age 50, 87.4% had ever had mammography and 77.6% reported yearly mammography. Only 19% of the respondents admitted to current smoking. Although methodologic differences made comparison of knowledge of diet and cancer with the work of others difficult, knowledge of the risks of smoking was comparable to levels found in other studies.

Compliance with infection control standard precautions guidelines: a survey among dental healthcare workers in Hail Region, Saudi Arabia

PubMed Central

Haridi, Hassan Kasim; Al-Ammar, Abdalmohsen Saud; Al-Mansour, Moazzy Ibraheim

2016-01-01

Background: The concept of standard precautions (SP) has been a cornerstone of dental infection control (IC) practice. Full adherence with SP guidelines is still a matter of concern in many institutions. The objectives of the present study were to assess and characterise compliance with SP guidelines among dental healthcare workers (DHCWs) and to analyse factors that affect compliance. Methods: A regional cross-sectional questionnaire survey among DHCWs in all health facilities was carried out from August to November 2014. Results: A total of 307 returned valid self-report questionnaires with a response rate of 73.1%. Most participants (86.3%) were aware of the SP guidelines, 84.4% received IC training and 88.9% received hepatitis B vaccination. Compliance with SP was found to be high; the majority (90.1%) attained 75% on the compliance scale. In the multivariate logistic regression model, perceived higher institutional commitment as regard IC requirements (odds ratio [OR], 4.34; P <0.001), perceived training as adequate (OR, 3.51; P = 0.003), dentist job (OR, 2.99; P = 0.035) and younger age (OR, 0.59; P = 0.041) were independently predicted as good compliant behaviour. Conclusions: This survey revealed high self-reported compliance with SP guidelines. Institutional factors appear to have an important role. Attention should be paid to dental assistants and private DHCWs. PMID:28989490

Ministry of Health clinical practice guidelines: Management of Rhinosinusitis and Allergic Rhinitis.

PubMed

Siow, J K; Alshaikh, N A; Balakrishnan, A; Chan, K O; Chao, S S; Goh, L G; Hwang, S Y; Lee, C Y; Leong, J L; Lim, L; Menon, A; Sethi, D S; Tan, H; Wang, D Y

2010-03-01

The Ministry of Health publishes national clinical practice guidelines to provide doctors and patients in Singapore with evidence-based guidance on managing important medical conditions. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the Ministry of Health clinical practice guidelines on Management of Rhinosinusitis and Allergic Rhinitis, for the information of readers of the Singapore Medical Journal. Chapters, page and figure numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website (http://www.moh.gov.sg/mohcorp/publications.aspx?id=24046). The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

Development of the Champlain primary care cardiovascular disease prevention and management guideline

PubMed Central

Montoya, Lorraine; Liddy, Clare; Hogg, William; Papadakis, Sophia; Dojeiji, Laurie; Russell, Grant; Akbari, Ayub; Pipe, Andrew; Higginson, Lyall

2011-01-01

Abstract Problem addressed A well documented gap remains between evidence and practice for clinical practice guidelines in cardiovascular disease (CVD) care. Objective of program As part of the Champlain CVD Prevention Strategy, practitioners in the Champlain District of Ontario launched a large quality-improvement initiative that focused on increasing the uptake in primary care practice settings of clinical guidelines for heart disease, stroke, diabetes, and CVD risk factors. Program description The Champlain Primary Care CVD Prevention and Management Guideline is a desktop resource for primary care clinicians working in the Champlain District. The guideline was developed by more than 45 local experts to summarize the latest evidence-based strategies for CVD prevention and management, as well as to increase awareness of local community-based programs and services. Conclusion Evidence suggests that tailored strategies are important when implementing specific practice guidelines. This article describes the process of creating an integrated clinical guideline for improvement in the delivery of cardiovascular care. PMID:21673196

A review of clinical practice guidelines for lung cancer

PubMed Central

Ball, David; Silvestri, Gerard A.

2013-01-01

Clinical practice guidelines are important evidence-based resources to guide complex clinical decision making. However, it is challenging for health professionals to keep abreast available guidelines and to know how and where to access relevant guidelines. This review examines currently available guidelines for lung cancer published in the English language. Important key features are listed for each identified guideline. The methodology, approaches to dissemination and implementation, and associated resources are summarised. General challenges in the area of guideline development are highlighted. The potential to collaborate more widely across lung cancer guideline developers by sharing literature searches and assessments is discussed. PMID:24163752

Clinical practice guidelines in complementary and alternative medicine. An analysis of opportunities and obstacles. Practice and Policy Guidelines Panel, National Institutes of Health Office of Alternative Medicine.

PubMed

1997-01-01

An estimated 1 of 3 Americans uses some form of complementary and alternative medicine (CAM), such as acupuncture, homeopathy, or herbal medicine. In 1995, the National Institutes of Health Office of Alternative Medicine convened an expert panel to examine the role of clinical practice guidelines in CAM. The panel concluded that CAM practices currently are unsuitable for the development of evidence-based practice guidelines, in part because of the lack of relevant outcomes data from well-designed clinical trials. Moreover, the notions of standardization and appropriateness, inherent in guideline development, face challenging methodologic problems when applied to CAM, which considers many different treatment practices appropriate and encourages highly individualized care. Due to different belief systems and divergent theories about the nature of health and illness, CAM disciplines have fundamental differences in how they define target conditions, causes of disease, interventions, and outcome measures of effectiveness. These differences are even more striking when compared with those used by Western medicine. The panel made a series of recommendations on strategies to strengthen the evidence base for future guideline development in CAM and to meet better the current information needs of clinicians, patients, and guideline developers who seek information about CAM treatments.

How can clinical practice guidelines be adapted to facilitate shared decision making? A qualitative key-informant study.

PubMed

van der Weijden, Trudy; Pieterse, Arwen H; Koelewijn-van Loon, Marije S; Knaapen, Loes; Légaré, France; Boivin, Antoine; Burgers, Jako S; Stiggelbout, Anne M; Faber, Marjan; Elwyn, Glyn

2013-10-01

To explore how clinical practice guidelines can be adapted to facilitate shared decision making. This was a qualitative key-informant study with group discussions and semi-structured interviews. First, 75 experts in guideline development or shared decision making participated in group discussions at two international conferences. Next, health professionals known as experts in depression or breast cancer, experts on clinical practice guidelines and/or shared decision making, and patient representatives were interviewed (N=20). Using illustrative treatment decisions on depression or breast cancer, we asked the interviewees to indicate as specifically as they could how guidelines could be used to facilitate shared decision making. Interviewees suggested some generic strategies, namely to include a separate chapter on the importance of shared decision making, to use language that encourages patient involvement, and to develop patient versions of guidelines. Recommendation-specific strategies, related to specific decision points in the guideline, were also suggested: These include structuring the presentation of healthcare options to increase professionals' option awareness; structuring the deliberation process between professionals and patients; and providing relevant patient support tools embedded at important decision points in the guideline. This study resulted in an overview of strategies to adapt clinical practice guidelines to facilitate shared decision making. Some strategies seemed more contentious than others. Future research should assess the feasibility and impact of these strategies to make clinical practice guidelines more conducive to facilitate shared decision making.

Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.

PubMed

2003-02-01

International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. To develop and validate an international instrument for assessing the quality of the process and reporting of clinical practice guideline development. The instrument was developed through a multi-staged process of item generation, selection and scaling, field testing, and refinement procedures. 100 guidelines selected from 11 participating countries were evaluated independently by 194 appraisers with the instrument. Following refinement the instrument was further field tested on three guidelines per country by a new set of 70 appraisers. The final version of the instrument contained 23 items grouped into six quality domains with a 4 point Likert scale to score each item (scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, editorial independence). 95% of appraisers found the instrument useful for assessing guidelines. Reliability was acceptable for most domains (Cronbach's alpha 0.64-0.88). Guidelines produced as part of an established guideline programme had significantly higher scores on editorial independence and, after the publication of a national policy, had significantly higher quality scores on rigour of development (p<0.005). Guidelines with technical documentation had higher scores on that domain (p<0.0001). This is the first time an appraisal instrument for clinical practice guidelines has been developed and tested internationally. The instrument is sensitive to differences in important aspects of guidelines and can be used consistently and easily by a wide range of professionals from different backgrounds. The adoption of common standards should improve the consistency and quality of the reporting of guideline development worldwide and provide a framework to encourage international comparison of clinical practice guidelines.

Consensus clinical management guidelines for Niemann-Pick disease type C.

PubMed

Geberhiwot, Tarekegn; Moro, Alessandro; Dardis, Andrea; Ramaswami, Uma; Sirrs, Sandra; Marfa, Mercedes Pineda; Vanier, Marie T; Walterfang, Mark; Bolton, Shaun; Dawson, Charlotte; Héron, Bénédicte; Stampfer, Miriam; Imrie, Jackie; Hendriksz, Christian; Gissen, Paul; Crushell, Ellen; Coll, Maria J; Nadjar, Yann; Klünemann, Hans; Mengel, Eugen; Hrebicek, Martin; Jones, Simon A; Ory, Daniel; Bembi, Bruno; Patterson, Marc

2018-04-06

Niemann-Pick Type C (NPC) is a progressive and life limiting autosomal recessive disorder caused by mutations in either the NPC1 or NPC2 gene. Mutations in these genes are associated with abnormal endosomal-lysosomal trafficking, resulting in the accumulation of multiple tissue specific lipids in the lysosomes. The clinical spectrum of NPC disease ranges from a neonatal rapidly progressive fatal disorder to an adult-onset chronic neurodegenerative disease. The age of onset of the first (beyond 3 months of life) neurological symptom may predict the severity of the disease and determines life expectancy.NPC has an estimated incidence of ~ 1: 100,000 and the rarity of the disease translate into misdiagnosis, delayed diagnosis and barriers to good care. For these reasons, we have developed clinical guidelines that define standard of care for NPC patients, foster shared care arrangements between expert centres and family physicians, and empower patients. The information contained in these guidelines was obtained through a systematic review of the literature and the experiences of the authors in their care of patients with NPC. We adopted the Appraisal of Guidelines for Research & Evaluation (AGREE II) system as method of choice for the guideline development process. We made a series of conclusive statements and scored them according to level of evidence, strengths of recommendations and expert opinions. These guidelines can inform care providers, care funders, patients and their carers of best practice of care for patients with NPC. In addition, these guidelines have identified gaps in the knowledge that must be filled by future research. It is anticipated that the implementation of these guidelines will lead to a step change in the quality of care for patients with NPC irrespective of their geographical location.

A Systematic Review of Clinical Practice Guidelines' Recommendations on Levothyroxine Therapy Alone versus Combination Therapy (LT4 plus LT3) for Hypothyroidism.

PubMed

Kraut, Eyal; Farahani, Pendar

2015-12-04

Patients with hypothyroidism are increasingly enquiring about the benefit of using combination therapy of levothyroxine (LT4) and liothyronine (LT3) as a potential treatment for hypothyroidism. Combination therapy, however, remains controversial. The purpose of this study was to systematically review available hypothyroidism treatment recommendations from clinical practice guidelines from around the world to identify the consensus regarding combination therapy. Clinical practice guidelines were obtained from searches of PubMed, EMBASE, and MEDLINE, using several combinations of MeSH terms. The search was limited to clinical guidelines in English-language publications, published between January 1, 1990 and May 1, 2015. A quantitative approach was utilized for data synthesis. Thirteen guidelines were identified, including three regarding pregnancy, two regarding pediatric populations and eight regarding adult populations. There were six guidelines from North America, four guidelines from Europe and three guidelines from South America. Twelve of the guidelines were published after 2010. Nine guidelines addressed combination therapy of LT4 plus LT3, and all nine concluded that LT4 therapy alone is the standard of care, with insufficient evidence to recommend widespread combination therapy. Only the 2012 ETA Guidelines and the 2015 BTA Guidelines concluded that combination therapy could be used, although only in certain circumstances and as an experimental treatment. This systematic review illustrates that clinical practice guidelines worldwide do not recommend and do not support routine use of combination LT4 and LT3 therapy to treat hypothyroidism.

Cervical cancer screening in adolescents: an evidence-based internet education program for practice improvement among advanced practice nurses.

PubMed

Choma, Kim; McKeever, Amy E

2015-02-01

The literature reports great variation in the knowledge levels and application of the recent changes of cervical cancer screening guidelines into clinical practice. Evidence-based screening guidelines for the prevention and early detection of cervical cancer offers healthcare providers the opportunity to improve practice patterns among female adolescents by decreasing psychological distress as well as reducing healthcare costs and morbidities associated with over-screening. The purpose of this pilot intervention study was to determine the effects of a Web-based continuing education unit (CEU) program on advanced practice nurses' (APNs) knowledge of current cervical cancer screening evidence-based recommendations and their application in practice. This paper presents a process improvement project as an example of a way to disseminate updated evidence-based practice guidelines among busy healthcare providers. This Web-based CEU program was developed, piloted, and evaluated specifically for APNs. The program addressed their knowledge level of cervical cancer and its relationship with high-risk human papillomavirus. It also addressed the new cervical cancer screening guidelines and the application of those guidelines into clinical practice. Results of the study indicated that knowledge gaps exist among APNs about cervical cancer screening in adolescents. However, when provided with a CEU educational intervention, APNs' knowledge levels increased and their self-reported clinical practice behaviors changed in accordance with the new cervical cancer screening guidelines. Providing convenient and readily accessible up-to-date electronic content that provides CEU enhances the adoption of clinical practice guidelines, thereby decreasing the potential of the morbidities associated with over-screening for cervical cancer in adolescents and young women. © 2014 Sigma Theta Tau International.

Child neurology practice guidelines: past, present, and future.

PubMed

Hurwitz, Benjamin A; Hurwitz, Kathleen Bretzius; Ashwal, Stephen

2015-03-01

Practice guidelines have been developed in child neurology during the last fifteen years to address important clinical questions and provide evidence-based recommendations for patient care. This review describes the guideline development process and how it has evolved to meet the needs of child neurologists. Several current child neurology guidelines are reviewed and the advantages and disadvantages of guidelines, as well as the legal consequences of using them to determine a standard of care are discussed. The future of guidelines and of their influence on integrated support systems also is considered. Child neurology practice guidelines are a helpful resource for clinicians, families and institutions as they provide evidence-based recommendations concerning the diagnosis and management of common neurological conditions affecting children. Incorporating consensus processes has allowed expansion of clinically relevant recommendations that has increased the utility of guidelines. Copyright © 2015 Elsevier Inc. All rights reserved.

Value for money in changing clinical practice: should decisions about guidelines and implementation strategies be made sequentially or simultaneously?

PubMed

Hoomans, Ties; Severens, Johan L; Evers, Silvia M A A; Ament, Andre J H A

2009-01-01

Decisions about clinical practice change, that is, which guidelines to adopt and how to implement them, can be made sequentially or simultaneously. Decision makers adopting a sequential approach first compare the costs and effects of alternative guidelines to select the best set of guideline recommendations for patient management and subsequently examine the implementation costs and effects to choose the best strategy to implement the selected guideline. In an integral approach, decision makers simultaneously decide about the guideline and the implementation strategy on the basis of the overall value for money in changing clinical practice. This article demonstrates that the decision to use a sequential v. an integral approach affects the need for detailed information and the complexity of the decision analytic process. More importantly, it may lead to different choices of guidelines and implementation strategies for clinical practice change. The differences in decision making and decision analysis between the alternative approaches are comprehensively illustrated using 2 hypothetical examples. We argue that, in most cases, an integral approach to deciding about change in clinical practice is preferred, as this provides more efficient use of scarce health-care resources.

Plan for the control of Legionella infections in long-term care facilities: role of environmental monitoring.

PubMed

Cristino, Sandra; Legnani, Pier Paolo; Leoni, Erica

2012-04-01

In accordance with the international and national guidelines, the Emilia-Romagna Region (Italy) has established regional guidelines for the surveillance and prevention of legionellosis based on the concept of risk assessment, with particular attention to environmental monitoring. The aim of this study was to verify how environmental surveillance in the context of risk assessment plans could help to guide decisions about preventive strategies against Legionella infections in Long Term Care Facilities (LTCF). In six LTCFs in the city of Bologna (Emilia-Romagna Region) a self-control plan was implemented that included the environmental monitoring of Legionella spp. and the surveillance of hospital-acquired Legionnaires' Disease. At baseline, four hot water systems were colonized by Legionella pneumophila (3 LCTFs) and Legionella londiniensis (1 LCTF). In each establishment specific control measures were adopted based on the characteristics of the system, the virulence of the strain and the level of the contamination. The monitoring, carried out for around two years, was also extended to the ways in which the system and the distal water distribution points were used and maintained with respect to the good practices in operation and management. The adopted actions (shock and/or continuous disinfection treatments) and the implementation of the good practice measures reduced the contamination to acceptable and stable levels. No cases of hospital-acquired legionellosis occurred during the period of study. The environmental surveillance was successful in evaluating the risk and identifying the most suitable preventive strategies. Copyright © 2011 Elsevier GmbH. All rights reserved.

Tacit knowledge as the unifying factor in evidence based medicine and clinical judgement.

PubMed

Thornton, Tim

2006-03-17

The paper outlines the role that tacit knowledge plays in what might seem to be an area of knowledge that can be made fully explicit or codified and which forms a central element of Evidence Based Medicine. Appeal to the role the role of tacit knowledge in science provides a way to unify the tripartite definition of Evidence Based Medicine given by Sackett et al: the integration of best research evidence with clinical expertise and patient values. Each of these three elements, crucially including research evidence, rests on an ineliminable and irreducible notion of uncodified good judgement. The paper focuses on research evidence, drawing first on the work of Kuhn to suggest that tacit knowledge contributes, as a matter of fact, to puzzle solving within what he calls normal science. A stronger argument that it must play a role in research is first motivated by looking to Collins' first hand account of replication in applied physics and then broader considerations of replication in justifying knowledge claims in scientific research. Finally, consideration of an argument from Wittgenstein shows that whatever explicit guidelines can be drawn up to guide judgement the specification of what counts as correctly following them has to remain implicit.Overall, the paper sets out arguments for the claim that even though explicit guidelines and codifications can play a practical role in informing clinical practice, they rest on a body of tacit or implicit skill that is in principle ineliminable. It forms the bedrock of good judgement and unites the integration of research, expertise and values.

Tacit knowledge as the unifying factor in evidence based medicine and clinical judgement

PubMed Central

Thornton, Tim

2006-01-01

The paper outlines the role that tacit knowledge plays in what might seem to be an area of knowledge that can be made fully explicit or codified and which forms a central element of Evidence Based Medicine. Appeal to the role the role of tacit knowledge in science provides a way to unify the tripartite definition of Evidence Based Medicine given by Sackett et al: the integration of best research evidence with clinical expertise and patient values. Each of these three elements, crucially including research evidence, rests on an ineliminable and irreducible notion of uncodified good judgement. The paper focuses on research evidence, drawing first on the work of Kuhn to suggest that tacit knowledge contributes, as a matter of fact, to puzzle solving within what he calls normal science. A stronger argument that it must play a role in research is first motivated by looking to Collins' first hand account of replication in applied physics and then broader considerations of replication in justifying knowledge claims in scientific research. Finally, consideration of an argument from Wittgenstein shows that whatever explicit guidelines can be drawn up to guide judgement the specification of what counts as correctly following them has to remain implicit. Overall, the paper sets out arguments for the claim that even though explicit guidelines and codifications can play a practical role in informing clinical practice, they rest on a body of tacit or implicit skill that is in principle ineliminable. It forms the bedrock of good judgement and unites the integration of research, expertise and values. PMID:16759426

Identification and assessment of professional competencies for implementation of nanotechnology in engineering education

NASA Astrophysics Data System (ADS)

Jean, Ming-Der; Jiang, Ji-Bin; Chien, Jia-Yi

2017-11-01

The purpose of this study was to construct the indicators of professional competencies of the nanotechnology-based sputtering system industry based on industry requirements and analyse the core competencies of the industry for promoting the human resource of physical vapour deposition technology. The document analysis, expert interview, and Delphi technique surveys were considered and the survey items with 32 items divided into 7 domains were selected according to consensus opinions of 10 experts by the Delphi survey technique. Through three questionnaire surveys' analysis, the professional competence scales for the K-S tests showed a good internal consistency. The findings of this study provide guidelines for professional competence for nanotechnology-based sputtering technology by applying surface heat-treatment industry. These guidelines can also reveal the practical competency requirements of nanotechnology-based sputtering technology to deal with any subsequent challenges, future developments, and invisible services for students in a technology institute programme.

A sensible technique to detect mollicutes impurities in human cells cultured in GMP condition.

PubMed

Ugolotti, Elisabetta; Vanni, Irene

2014-01-01

In therapeutic trials the use of manipulated cell cultures for clinical applications is often required. Mollicutes microorganism contamination of tissue cultures is a major problem because it can determine various and severe alterations in cellular function. Thus methods able to detect and trace cell cultures with Mollicutes contamination are needed in the monitoring of cells grown under good manufacturing practice conditions, and cell lines in continuous culture must be tested at regular intervals. We here describe a multiplex quantitative polymerase chain reaction assay able to detect contaminant Mollicutes species in a single-tube reaction through analysis of 16S-23S rRNA intergenic spacer regions and Tuf and P1 cytoadhesin genes. The method shows a sensitivity, specificity, and robustness comparable with the culture and the indicator cell culture as required by the European Pharmacopoeia guidelines and was validated following International Conference on Harmonization guidelines and Food and Drug Administration requirements.

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

PubMed

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

2018-03-01

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

Evidence based medicine guidelines: a solution to rationing or politics disguised as science?

PubMed

Saarni, S I; Gylling, H A

2004-04-01

"Evidence based medicine" (EBM) is often seen as a scientific tool for quality improvement, even though its application requires the combination of scientific facts with value judgments and the costing of different treatments. How this is done depends on whether we approach the problem from the perspective of individual patients, doctors, or public health administrators. Evidence based medicine exerts a fundamental influence on certain key aspects of medical professionalism. Since, when clinical practice guidelines are created, costs affect the content of EBM, EBM inevitably becomes a form of rationing and adopts a public health point of view. This challenges traditional professionalism in much the same way as managed care has done in the US. Here we chart some of these major philosophical issues and show why simple solutions cannot be found. The profession needs to pay more attention to different uses of EBM in order to preserve the good aspects of professionalism.

Guidelines for project-level traffic forecasting for Hawaii Department of Transportation.

DOT National Transportation Integrated Search

2015-12-01

These guidelines describe both best practice and acceptable practice for performing project-level traffic : forecasts for the State of Hawaii. The guidelines describe a number of techniques and options that are all : acceptable within their intended ...

Considerations affecting dietary behaviour of immigrants with type 2 diabetes: a qualitative study among Surinamese in the Netherlands.

PubMed

Kohinor, Mirjam J E; Stronks, Karien; Nicolaou, Mary; Haafkens, Joke A

2011-06-01

The purpose of this study was to explore the sociocultural factors affecting the dietary behaviour of Dutch Surinamese patients with type 2 diabetes. In this qualitative study, 32 Surinamese primary care patients with type 2 diabetes mellitus participated in semi-structured interviews (16 African Surinamese and 16 Hindustani Surinamese). Interviews were recorded and transcripts were analysed and coded into themes using principles of grounded theory and MAXQDA software. Surinamese food was eaten regularly by all respondents. Most participants were aware of the need to change their diet but reported difficulty with changing their dietary behaviour to meet dietary guidelines. Many perceived these guidelines to be based on Dutch eating habits, making it difficult to reconcile them with Surinamese cooking and eating practices. Firstly, respondents indicated that they did not choose foods based on their nutritional qualities. Instead, choices were based on Surinamese beliefs regarding 'good' (e.g., bitter vegetables) or 'bad' (e.g., spicy dishes) foods for diabetes. Secondly, respondents often perceived recommendations such as eating at fixed times as interfering with traditional values, for example hospitality. Above all, the maintenance of Surinamese cooking and eating practices was regarded as extremely important since the respondents perceived these to be a core element of their identity as Surinamese. For Surinamese diabetes patients, cooking and eating practices are related to deeply rooted cultural beliefs and values. The wish to maintain one's Surinamese identity may pose difficulty for patients' adherence to dietary guidelines, as these are perceived as being based on 'Dutch' habits. This suggests that immigrants with a long duration of residence in the host country like the Surinamese, who are seen as well integrated might benefit from culturally sensitive diabetes education that is adapted at surface and deep structure.

Recommendations to Improve Employee Thermal Comfort When Working in 40°F Refrigerated Cold Rooms.

PubMed

Ceballos, Diana; Mead, Kenneth; Ramsey, Jessica

2015-01-01

Cold rooms are commonly used for food storage and preparation, and are usually kept around 40°F following food safety guidelines. Some food preparation employees may spend 8 or more hours inside cold rooms. These employees may not be aware of the risks associated with mildly cold temperatures, dampness, and limited ventilation. We performed an evaluation of cold rooms at an airline catering facility because of concerns with exposure to cold temperatures. We spoke with and observed employees in two cold rooms, reviewed daily temperature logs, evaluated employee's physical activity, work/rest schedule, and protective clothing. We measured temperature, percent relative humidity, and air velocities at different work stations inside the cold rooms. We concluded that thermal comfort concerns perceived by cold room employees may have been the result of air drafts at their workstations, insufficient use of personal protective equipment due to dexterity concerns, work practices, and lack of knowledge about good health and safety practices in cold rooms. These moderately cold work conditions with low air velocities are not well covered in current occupational health and safety guidelines, and wind chill calculations do not apply. We provide practical recommendations to improve thermal comfort of cold room employees. Engineering control recommendations include the redesigning of air deflectors and installing of suspended baffles. Administrative controls include the changing out of wet clothing, providing hand warmers outside of cold rooms, and educating employees on cold stress. We also recommended providing more options on personal protective equipment. However, there is a need for guidelines and educational materials tailored to employees in moderately cold environments to improve thermal comfort and minimize health and safety problems.

Guidelines for the creation and management of geographic data bases within a GIS environment, version 1.0

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

Durfee, R.C.; Land, M.L.; McCord, R.A.

1994-07-01

A Geographic Information System (GIS) provides the ability to manage and analyze all types of geographic and environmental information. It performs these functions by providing the tools necessary to capture, access, analyze, and display spatially referenced information in graphic and tabular form. Typical data elements that can be visualized in a map might include roads, buildings, topography, streams, waste areas, monitoring wells, groundwater measurements, soil sample results, landcover, and demography. The intent of this document is to provide data management and quality assurance (QA) guidelines that will aid implementors and users of GIS technology and data bases. These guidelines shouldmore » be useful in all, phases of GIS activities, including the following: (1) project planning, (2) data collection and generation, (3) data maintenance and management, (4) QA and standards, (5) project implementation, (6) spatial analysis and data interpretation, (7) data transformation and exchange, and (8) output and reporting. The daily use of desktop GIS technologies within Martin Marietta Energy Systems, Inc. (Energy Systems), is a relatively new phenomenon, but usage is increasing rapidly. Large volumes of GIS-related data are now being collected and analyzed for the U.S. Department of Energy (DOE) Oak Ridge Reservation (ORR) and its facilities. It is very important to establish and follow good data management practices for GIS. In the absence of such practices, data-related problems will overwhelm users for many years. In comparison with traditional data processing and software life-cycle management, there is limited information on GIS QA techniques, data standards and structures, configuration control, and documentation practices. This lack of information partially results from the newness of the technology and the complexity of spatial information and geographic analysis techniques as compared to typical tabular data management.« less

Recommendations to Improve Employee Thermal Comfort When Working in 40°F Refrigerated Cold Rooms

PubMed Central

Ceballos, Diana; Mead, Kenneth; Ramsey, Jessica

2015-01-01

Cold rooms are commonly used for food storage and preparation, and are usually kept around 40°F following food safety guidelines. Some food preparation employees may spend 8 or more hours inside cold rooms. These employees may not be aware of the risks associated with mildly cold temperatures, dampness, and limited ventilation. We performed an evaluation of cold rooms at an airline catering facility because of concerns with exposure to cold temperatures. We spoke with and observed employees in two cold rooms, reviewed daily temperature logs, evaluated employee’s physical activity, work/rest schedule, and protective clothing. We measured temperature, percent relative humidity, and air velocities at different work stations inside the cold rooms. We concluded that thermal comfort concerns perceived by cold room employees may have been the result of air drafts at their workstations, insufficient use of personal protective equipment due to dexterity concerns, work practices, and lack of knowledge about good health and safety practices in cold rooms. These moderately cold work conditions with low air velocities are not well covered in current occupational health and safety guidelines, and wind chill calculations do not apply. We provide practical recommendations to improve thermal comfort of cold room employees. Engineering control recommendations include the redesigning of air deflectors and installing of suspended baffles. Administrative controls include the changing out of wet clothing, providing hand warmers outside of cold rooms, and educating employees on cold stress. We also recommended providing more options on personal protective equipment. However, there is a need for guidelines and educational materials tailored to employees in moderately cold environments to improve thermal comfort and minimize health and safety problems. PMID:25961447

Systematic Review of Mindfulness Practice for Reducing Job Burnout

PubMed Central

Sammons, Amanda

2016-01-01

OBJECTIVE. A systematic search and critical appraisal of interdisciplinary literature was conducted to evaluate the evidence for practicing mindfulness to treat job burnout and to explore implications for occupational therapy practitioners. METHOD. Eight articles met inclusion criteria. Each study was assessed for quality using the Physiotherapy Evidence Database scale. We used the U.S. Agency for Health Care Policy and Research guidelines to determine strength of evidence. RESULTS. Of the studies reviewed, participants included health care professionals and teachers; no studies included occupational therapy practitioners. Six of the 8 studies demonstrated statistically significant decreases in job burnout after mindfulness training. Seven of the studies were of fair to good quality. CONCLUSION. There is strong evidence for the use of mindfulness practice to reduce job burnout among health care professionals and teachers. Research is needed to fill the gap on whether mindfulness is effective for treating burnout in occupational therapy practitioners. PMID:26943107

Systematic Review of Mindfulness Practice for Reducing Job Burnout.

PubMed

Luken, Michelle; Sammons, Amanda

2016-01-01

A systematic search and critical appraisal of interdisciplinary literature was conducted to evaluate the evidence for practicing mindfulness to treat job burnout and to explore implications for occupational therapy practitioners. Eight articles met inclusion criteria. Each study was assessed for quality using the Physiotherapy Evidence Database scale. We used the U.S. Agency for Health Care Policy and Research guidelines to determine strength of evidence. Of the studies reviewed, participants included health care professionals and teachers; no studies included occupational therapy practitioners. Six of the 8 studies demonstrated statistically significant decreases in job burnout after mindfulness training. Seven of the studies were of fair to good quality. There is strong evidence for the use of mindfulness practice to reduce job burnout among health care professionals and teachers. Research is needed to fill the gap on whether mindfulness is effective for treating burnout in occupational therapy practitioners. Copyright © 2016 by the American Occupational Therapy Association, Inc.

Practice organisational characteristics can impact on compliance with the BTS/SIGN asthma guideline: qualitative comparative case study in primary care.

PubMed

Wiener-Ogilvie, Sharon; Huby, Guro; Pinnock, Hilary; Gillies, John; Sheikh, Aziz

2008-06-04

Although the BTS-SIGN asthma guideline is one of the most well known and widely respected guidelines in the world, implementation in UK primary care remains patchy. Building on extensive earlier descriptive work, we sought to explore the way teamwork and inter-professional relationships impact on the implementation of the BTS-SIGN guideline on asthma in general practice. Qualitative comparative case study using nine in-depth interviews and 2 focus groups with general practitioners and practice nurses, involved in delivering asthma care. Participants were purposively recruited from practices in a Scottish health board with high and low compliance with the BTS-SIGN asthma guideline. There was a marked difference in the way respondents from practices with high compliance and respondents from practices with low compliance spoke about the value of guidelines and the challenges of implementing them. On both accounts, the former were more positive than the latter and were able to be more specific about the strategies they used to overcome barriers to implementation. We explored the reason for this difference in response and identified practice organisation, centring on delegation of work to nurses, as a factor mediating the practice's level of compliance. Effective delegation was underpinned by organisation of asthma work among practice members who have the appropriate level of skills and knowledge, know and understand each others' work and responsibilities, communicate well among themselves and trust each others' skills. It was the combination of these factors which made for successful delegation and guideline implementation, not any one factor in isolation. In our sample of practices, teamwork and organisation of care within practices appeared to impact on guideline implementation and further larger studies are needed to explore this issue further. Isolated interventions such as measures to improve staff's knowledge or increased clinical resource and time, which are currently being considered, are unlikely to be effective unless practices are supported in developing their teams in a way which supports the deployment of these resources.

Influence of qualitative research on women's health screening guidelines.

PubMed

Abadir, Anna Maria; Lang, Ariella; Klein, Talia; Abenhaim, Haim Arie

2014-01-01

Considerable time and resources are allocated to carry out qualitative research. The purpose of our study was to evaluate the availability of qualitative research on women's health screening and assess its influence on screening practice guidelines in the United States, Canada, and the United Kingdom. Medline, CINHAL, and WEB of Science databases were used to identify the availability of qualitative research conducted in the past 15 years on 3 different women's health screening topics: cervical cancer screening, breast cancer screening, and prenatal first-trimester screening. Key national practice guidelines on women's health screening were selected using the National Guideline Clearinghouse web site. Bibliometric analysis was used to determine the frequency of qualitative references cited in the guidelines. A total of 272 qualitative research papers on women's health screening was identified: 109 on cervical cancer screening, 104 on breast cancer screening, and 59 on prenatal first-trimester screening. The qualitative studies focused on health care provider perspectives as well as ethical, ethnographic, psychological, and social issues surrounding screening. Fifteen national clinical practice guidelines on women's health screening were identified. A total of 943 references was cited, only 2 of which comprised of qualitative research cited by only 1 clinical practice guideline. Although there is considerable qualitative research that has been carried out on women's health screening, its incorporation into clinical practice guidelines is minimal. Further exploration of the disconnect between the two is important for enhancing knowledge translation of qualitative research within clinical practice. Copyright © 2014 Mosby, Inc. All rights reserved.

Pay for performance in thoracic surgery.

PubMed

Varela, Gonzalo

2007-08-01

In the context of improving the quality of the medical practice, PFP programs have been developed to reward best medical practice. Early studies showed little gain in quality after implementing PFP family practice programs and some unintended consequences, like excluding high-risk patients from medical services when good outcomes were linked to payment. To date, no PFP programs have been implemented in surgical practice, but it is expected that value-based purchasing philosophy will be extended to surgical specialties in the near future. Quality initiatives in surgery can be based on outcome or process measures. Outcomes-focused quality approaches rely on accurate information obtained from multiinstitutional clinical databases for calculation of risk-adjusted models. Primary outcomes such surgical mortality are uncommon in modern thoracic surgery and outcome measures should rely on more prevalent intermediate outcomes such as specific postoperative morbidities or emergency readmission. Process-based quality approaches need to be based on scientific evidence linking process to outcomes. It is our responsibility to develop practice guidelines or international practice consensus to facilitate the parameters to be evaluated in the near future.

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest

PubMed Central

2012-01-01

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development. PMID:22762776

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest.

PubMed

Eccles, Martin P; Grimshaw, Jeremy M; Shekelle, Paul; Schünemann, Holger J; Woolf, Steven

2012-07-04

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development.

Best Practice No 177: Best practice guideline: writing a business case for service development in pathology.

PubMed

Galloway, M J

2004-04-01

This guideline reviews the introduction and development of business planning in the National Health Service. A guideline for writing a business case for service development that would form part of a pathology business plan has been developed. This guideline outlines six steps that are required in the preparation of a business case. The format of the guideline has been developed largely from other national guidelines that have been published for the development of capital projects. In view of the publication of these guidelines, the scope of this guideline excludes business cases for information, management, and technology projects and large capital projects.

Review of the International Society for Heart and Lung Transplantation Practice guidelines for management of heart failure in children.

PubMed

Colan, Steven D

2015-08-01

In 2004, practice guidelines for the management of heart failure in children by Rosenthal and colleagues were published in conjunction with the International Society for Heart and Lung Transplantation. These guidelines have not been updated or reviewed since that time. In general, there has been considerable controversy as to the utility and purpose of clinical practice guidelines, but there is general recognition that the relentless progress of medicine leads to the progressive irrelevance of clinical practice guidelines that do not undergo periodic review and updating. Paediatrics and paediatric cardiology, in particular, have had comparatively minimal participation in the clinical practice guidelines realm. As a result, most clinical practice guidelines either specifically exclude paediatrics from consideration, as has been the case for the guidelines related to cardiac failure in adults, or else involve clinical practice guidelines committees that include one or two paediatric cardiologists and produce guidelines that cannot reasonably be considered a consensus paediatric opinion. These circumstances raise a legitimate question as to whether the International Society for Heart and Lung Transplantation paediatric heart failure guidelines should be re-reviewed. The time, effort, and expense involved in producing clinical practice guidelines should be considered before recommending an update to the International Society for Heart and Lung Transplantation Paediatric Heart Failure guidelines. There are specific areas of rapid change in the evaluation and management of heart failure in children that are undoubtedly worthy of updating. These domains include areas such as use of serum and imaging biomarkers, wearable and implantable monitoring devices, and acute heart failure management and mechanical circulatory support. At the time the International Society for Heart and Lung Transplantation guidelines were published, echocardiographic tissue Doppler, 3 dimensional imaging, and strain and strain rate were either novel or non-existent and have now moved into the main stream. Cardiac magnetic resonance imaging (MRI) had very limited availability, and since that time imaging and assessment of myocardial iron content, delayed gadolinium enhancement, and extracellular volume have moved into the mainstream. The only devices discussed in the International Society for Heart and Lung Transplantation guidelines were extracorporeal membrane oxygenators, pacemakers, and defibrillators. Since that time, ventricular assist devices have become mainstream. Despite the relative lack of randomised controlled trials in paediatric heart failure, advances continue to occur. These advances warrant implementation of an update and review process, something that is best done under the auspices of the national and international cardiology societies. A joint activity that includes the International Society for Heart and Lung Transplantation, American College of Cardiology/American Heart Association, the Association for European Paediatric and Congenital Cardiology (AEPC), European Society of Cardiology, Canadian Cardiovascular Society, and others will have more credibility than independent efforts by any of these organisations.

Standards for Reporting Implementation Studies (StaRI): explanation and elaboration document

PubMed Central

Pinnock, Hilary; Barwick, Melanie; Carpenter, Christopher R; Eldridge, Sandra; Grandes, Gonzalo; Griffiths, Chris J; Rycroft-Malone, Jo; Meissner, Paul; Murray, Elizabeth; Patel, Anita; Sheikh, Aziz; Taylor, Stephanie J C

2017-01-01

Objectives Implementation studies are often poorly reported and indexed, reducing their potential to inform the provision of healthcare services. The Standards for Reporting Implementation Studies (StaRI) initiative aims to develop guidelines for transparent and accurate reporting of implementation studies. Methods An international working group developed the StaRI guideline informed by a systematic literature review and e-Delphi prioritisation exercise. Following a face-to-face meeting, the checklist was developed iteratively by email discussion and critical review by international experts. Results The 27 items of the checklist are applicable to the broad range of study designs employed in implementation science. A key concept is the dual strands, represented as 2 columns in the checklist, describing, on the one hand, the implementation strategy and, on the other, the clinical, healthcare or public health intervention being implemented. This explanation and elaboration document details each of the items, explains the rationale and provides examples of good reporting practice. Conclusions Previously published reporting statements have been instrumental in improving reporting standards; adoption by journals and authors may achieve a similar improvement in the reporting of implementation strategies that will facilitate translation of effective interventions into routine practice. PMID:28373250

Evidence, Engagement, and Technology: Themes of and the State of Primary Care Practice-based Network Research.

PubMed

Nease, Donald E

2016-01-01

Practice-based research supported by practice-based research network (PBRN) infrastructure has historically provided an important method for challenging guidelines and evidence arising from secondary and tertiary care settings. This sample of current practice-based research in this issue of the JABFM provides an opportunity to ask whether practice-based research continues to address questions relevant to primary care practices and clinicians and whether a PBRN infrastructure is instrumental to maintaining the relevance and feasibility of practice-based research. Based on this issue's articles, the current state of practice-based research seems to be good, at face value addressing relevant issues for primary care practices. Less clear is the degree to which PBRN infrastructures and relationships informed the questions asked and facilitated the implementation of the studies presented. Practice-based research-related articles that routinely report about how study questions arose-from practices and their clinicians, staff and communities, or elsewhere-could help directly answer questions of relevance. In addition, reporting how practices are recruited to practice-based research studies could inform the degree to which ongoing relationships central to PBRNs facilitate the recruitment and conduct of practice-based research. © Copyright 2016 by the American Board of Family Medicine.

Oncology nurses' use of National Comprehensive Cancer Network clinical practice guidelines for chemotherapy-induced and febrile neutropenia.

PubMed

Nirenberg, Anita; Reame, Nancy K; Cato, Kenrick D; Larson, Elaine L

2010-11-01

To describe oncology nurses' use of National Comprehensive Cancer Network (NCCN) clinical practice guidelines for chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Cross-sectional survey design; descriptive, correlational analysis. E-mail invitation to Web-based survey. Random sample of 309 Oncology Nursing Society (ONS) members with e-mail addresses who provide care to adult patients receiving chemotherapy. The investigator-developed Neutropenia Oncology Nurses Survey was used. Descriptive tests compared respondents' personal and professional characteristics to those of general ONS members; nonparametric chi-square and Kruskal-Wallis tests were used to correlate respondents' survey subscale scores with demographic data. Significant associations were entered into multiple logistic regression models. The Neutropenia Oncology Nurses Survey's subscales measured subjective norm, attitude, perceived competence and confidence, perceived barriers, and use of NCCN clinical practice guidelines for CIN and FN. Response rate of nurses who opened the survey was 50%. Most practiced in community versus academic centers. Eighty percent reported using the NCCN clinical practice guidelines for CIN and FN. Respondents were more likely to use clinical practice guidelines when they were expected to by physician and nurse colleagues, they perceived fewer barriers, or they held advanced oncology certification. This study was the first to assess oncology nurses' reported use of NCCN clinical practice guidelines for CIN and FN. It also demonstrated the feasibility of partnering with ONS for Web-based survey research. The findings give insight into work-place barriers to evidence-based practice in various settings. Expanding dissemination and implementation of clinical practice guideline recommendations will support the development of oncology nursing standards for risk assessment, management, and patient and family education in CIN and FN.

Good manufacturing practice and viral safety.

PubMed

Kerner, B

1995-07-01

The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.

[Current status of practice of providing dietary advice to pregnant women by members of the Japanese Midwives' Association. Knowledge and utilization of the "Dietary Guidelines for Pregnant and Lactating Women"].

PubMed

Takimoto, Hidemi; Yonezawa, Junko; Shimada, Marie; Kato, Noriko; Yokoyama, Tetsuji

2013-01-01

Midwives are actively involved in providing dietary advice to pregnant women. In order to describe the current status of prenatal dietary advice provided by midwives, we conducted a questionnaire survey inquiring about their knowledge and usage of the "Dietary Guidelines for Pregnant and Lactating Women" (Guidelines) issued by the Ministry of Health, Labour, and Welfare in 2006. In total, 2000 members of the Japanese Midwives' Association were randomly selected for administration of the questionnaire. The recovery rate was 42.1%, and 785 responses were eligible for analyses. The questionnaire collected information on the respondent's age, years of work experience, current involvement in delivery practice, number of deliveries per year in the current affiliation, provision of dietary advice to pregnant women, and knowledge and usage of the Guidelines. The proportion of respondents in their 20 s was low (1.8%). About half of the respondents were practicing delivery. Further, 66.1% (519 midwives) reported they had knowledge of the Guidelines. Among those who had knowledge of the Guidelines and were currently providing dietary advice (426 midwives), 88.0% were using the Guidelines. The most frequently used item in the Guidelines was "Diet for preventing anemia" (75.8%). The least used item was "Shoku-iku (diet and nutrition education) for pregnant and lactating women" (58.5%). Midwives who were practicing delivery showed a significantly lower usage of the Guidelines than those who were not (84.9% vs. 92.6%, P = 0.02). Among midwives practicing delivery, the most common reason for not using the Guidelines was "using original educational material produced by oneself or the facility." Providing dietary advice to pregnant women constituted a large fraction of midwives' duties as well as delivery practice. About 90% of the midwives, who had knowledge of the Guidelines and provided dietary advice, were using the Guidelines. In order to increase the usage of individual items of the Guidelines, ready-to-use brochures should be developed for midwives.

Society for Academic Continuing Medical Education Intervention Guideline Series: Guideline 2, Practice Facilitation.

PubMed

Van Hoof, Thomas J; Grant, Rachel E; Campbell, Craig; Colburn, Lois; Davis, David; Dorman, Todd; Fischer, Michael; Horsley, Tanya; Jacobs-Halsey, Virginia; Kane, Gabrielle; LeBlanc, Constance; Moore, Donald E; Morrow, Robert; Olson, Curtis A; Silver, Ivan; Thomas, David C; Turco, Mary; Kitto, Simon

2015-01-01

The Society for Academic Continuing Medical Education commissioned a study to clarify and, if possible, standardize the terminology for a set of important educational interventions. In the form of a guideline, this article describes one such intervention, practice facilitation, which is a common strategy in primary care to help practices develop capacity and infrastructure to support their ability to improve patient care. Based on a review of recent evidence and a facilitated discussion with US and Canadian experts, we describe practice facilitation, its terminology, and other important information about the intervention. We encourage leaders and researchers to consider and build on this guideline as they plan, implement, evaluate, and report practice facilitation efforts. Clear and consistent use of terminology is imperative, along with complete and accurate descriptions of interventions, to improve the use and study of practice facilitation.

A decision-making tool to prescribe knee orthoses in daily practice for patients with osteoarthritis.

PubMed

Coudeyre, Emmanuel; Nguyen, Christelle; Chabaud, Aurore; Pereira, Bruno; Beaudreuil, Johann; Coudreuse, Jean-Marie; Deat, Philippe; Sailhan, Frédéric; Lorenzo, Alain; Rannou, François

2018-03-01

To develop a decision-making tool (DMT) to facilitate the prescription of knee orthoses for patients with osteoarthritis (OA) in daily practice. A steering committee gathered a multidisciplinary task force experienced in OA management/clinical research. Two members performed a literature review with qualitative analysis of the highest-quality randomized controlled trials and practice guidelines to confirm evidence concerning knee orthosis for OA. A first DMT draft was presented to the task force in a 1-day meeting in January 2016. The first version of the DMT was criticized and discussed regarding everyday practice issues. Every step was discussed and amended until consensus agreement was achieved within the task force. Then 4 successive consultation rounds occurred by electronic communication, first with primary- and secondary-care physicians, then with international experts. All corrections and suggestions by each member were shared with the rest of the task force and included to reach final consensus. The final version was validated by the steering committee. The definition and indication of several types of knee orthoses (sleeve, patello-femoral, hinged or unicompartmental offloading braces) were detailed. Orthoses may be proposed in addition to first-line non-pharmacological treatment if patient acceptance is considered good. At every step, a specific clinical assessment is needed. Based on the latest high-level evidence, practice guidelines, and an expert panel, a DMT to facilitate daily practice prescription of knee orthoses for OA patients was designed. An evaluation of DMT implementation in a wide range of health professionals is still needed. Copyright © 2018 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.

Healthcare professionals' and policy makers' views on implementing a clinical practice guideline of hypertension management: a qualitative study.

PubMed

Lee, Ping Yein; Liew, Su May; Abdullah, Adina; Abdullah, Nurdiana; Ng, Chirk Jenn; Hanafi, Nik Sherina; Chia, Yook Chin; Lai, Pauline S M; Wong, Stalia S L; Khoo, Ee Ming

2015-01-01

Most studies have reported barriers to guideline usage mainly from doctors' perspective; few have reported the perspective of other stakeholders. This study aimed to determine the views and barriers to adherence of a national clinical practice guideline (CPG) on management of hypertension from the perspectives of policymakers, doctors and allied healthcare professionals. This study used a qualitative approach with purposive sampling. Seven in depth interviews and six focus group discussions were conducted with 35 healthcare professionals (policy makers, doctors, pharmacists and nurses) at a teaching hospital in Kuala Lumpur, Malaysia, between February and June 2013. All interviews were audio-recorded, transcribed verbatim and checked. Thematic approach was used to analyse the data. Two main themes and three sub-themes emerged from this study. The main themes were (1) variation in the use of CPG and (2) barriers to adherence to CPG. The three sub-themes for barriers were issues inherent to the CPG, systems and policy that is not supportive of CPG use, and attitudes and behaviour of stakeholders. The main users of the CPG were the primary care doctors. Pharmacists only partially use the guidelines, while nurses and policy makers were not using the CPG at all. Participants had suggested few strategies to improve usage and adherence to CPG. First, update the CPG regularly and keep its content simple with specific sections for allied health workers. Second, use technology to facilitate CPG accessibility and provide protected time for implementation of CPG recommendations. Third, incorporate local CPG in professional training, link CPG adherence to key performance indicators and provide incentives for its use. Barriers to the use of CPG hypertension management span across all stakeholders. The development and implementation of CPG focused mainly on doctors with lack of involvement of other healthcare stakeholders. Guidelines should be made simple, current, reliable, accessible, inclusive of all stakeholders and with good policy support.

Development of clinical practice guidelines for supportive care in childhood cancer--prioritization of topics using a Delphi approach.

PubMed

Loeffen, E A H; Mulder, R L; Kremer, L C M; Michiels, E M C; Abbink, F C H; Ball, L M; Segers, H; Mavinkurve-Groothuis, A M C; Smit, F J; Vonk, I J M; Vd Wetering, M D; Tissing, W J E

2015-07-01

Currently, very few guidelines for supportive care for children with cancer exist. In the Netherlands, nationwide guidelines are over 10 years old and mostly based on expert opinion. Consequently, there is growing support and need for clinical practice guidelines (CPGs), which ought to be developed with a well-defined methodology and include a systematic search of literature, evidence summaries, and a transparent description of the decision process for the final recommendations. Development of CPGs is time consuming; therefore, it is important to prioritize topics for which there is the greatest clinical demand. This study aims to prioritize childhood cancer supportive care topics for development of CPGs. A Delphi survey consisting of two rounds was conducted to prioritize relevant childhood cancer supportive care topics for the development of CPGs. A group of experts comprising 15 pediatric oncologists, 15 pediatric oncology nurses, and 15 general pediatricians involved in care for childhood cancer patients were invited to participate. All relevant supportive care topics in childhood cancer were rated. In both rounds, 36 panellists (82%) responded. Agreement between panellists was very good, with an intraclass correlation coefficient of 0.918 (95% confidence interval (CI) = 0.849-0.966, p < 0.001) in round 2. The ten topics with the highest score in the final round were infection, sepsis, febrile neutropenia, pain, nausea/vomiting, restrictions in daily life and activities, palliative care, procedural sedation, terminal care, and oral mucositis. We successfully used a Delphi survey to prioritize childhood cancer supportive care topics for the development of CPGs. This is a first step towards uniform and evidence-based Dutch guidelines in supportive care in childhood cancer. Even though performed nationally, we believe that this study can also be regarded as an example starting point for international development of CPGs in the field of supportive care in cancer or any other field for that matter.

Effect of evidence-based feeding guidelines on mortality of critically ill adults: a cluster randomized controlled trial.

PubMed

Doig, Gordon S; Simpson, Fiona; Finfer, Simon; Delaney, Anthony; Davies, Andrew R; Mitchell, Imogen; Dobb, Geoff

2008-12-17

Evidence demonstrates that providing nutritional support to intensive care unit (ICU) patients within 24 hours of ICU admission reduces mortality. However, early feeding is not universally practiced. Changing practice in complex multidisciplinary environments is difficult. Evidence supporting whether guidelines can improve ICU feeding practices and patient outcomes is contradictory. To determine whether evidence-based feeding guidelines, implemented using a multifaceted practice change strategy, improve feeding practices and reduce mortality in ICU patients. Cluster randomized trial in ICUs of 27 community and tertiary hospitals in Australia and New Zealand. Between November 2003 and May 2004, 1118 critically ill adult patients expected to remain in the ICU longer than 2 days were enrolled. All participants completed the study. Intensive care units were randomly assigned to guideline or control groups. Guideline ICUs developed an evidence-based guideline using Browman's Clinical Practice Guideline Development Cycle. A practice-change strategy composed of 18 specific interventions, leveraged by educational outreach visits, was implemented in guideline ICUs. Hospital discharge mortality. Secondary outcomes included ICU and hospital length of stay, organ dysfunction, and feeding process measures. Guideline and control ICUs enrolled 561 and 557 patients, respectively. Guideline ICUs fed patients earlier (0.75 vs 1.37 mean days to enteral nutrition start; difference, -0.62 [95% confidence interval {CI}, -0.82 to -0.36]; P < .001 and 1.04 vs 1.40 mean days to parenteral nutrition start; difference, -0.35 [95% CI, -0.61 to -0.01]; P = .04) and achieved caloric goals more often (6.10 vs 5.02 mean days per 10 fed patient-days; difference, 1.07 [95% CI, 0.12 to 2.22]; P = .03). Guideline and control ICUs did not differ with regard to hospital discharge mortality (28.9% vs 27.4%; difference, 1.4% [95% CI, -6.3% to 12.0%]; P = .75) or to hospital length of stay (24.2 vs 24.3 days; difference, -0.08 [95% CI, -3.8 to 4.4]; P = .97) or ICU length of stay (9.1 vs 9.9 days; difference, -0.86 [95% CI, -2.6 to 1.3]; P = .42). Using a multifaceted practice change strategy, ICUs successfully developed and introduced an evidence-based nutritional support guideline that promoted earlier feeding and greater nutritional adequacy. However, use of the guideline did not improve clinical outcomes. Trial Registration anzctr.org.au Identifier: ACTRN12608000407392.

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

PubMed

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

2014-07-01

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

Palliative Sedation: An Analysis of International Guidelines and Position Statements.

PubMed

Gurschick, Lauren; Mayer, Deborah K; Hanson, Laura C

2015-09-01

To describe the suggested clinical practice of palliative sedation as it is presented in the literature and discuss available guidelines for its use. CINAHL, PubMed, and Web of Science were searched for publications since 1997 for recommended guidelines and position statements on palliative sedation as well as data on its provision. Keywords included palliative sedation, terminal sedation, guidelines, United States, and end of life. Inclusion criteria were palliative sedation policies, frameworks, guidelines, or discussion of its practice, general or oncology patient population, performance of the intervention in an inpatient unit, for humans, and in English. Exclusion criteria were palliative sedation in children, acute illness, procedural, or burns, and predominantly ethical discussions. Guidelines were published by American College of Physicians-American Society of Internal Medicine (2000), Hospice and Palliative Nurses Association (2003), American Academy of Hospice and Palliative Medicine (2006), American Medical Association (2008), Royal Dutch Medical Association (2009), European Association for Palliative Care (2009), National Hospice and Palliative Care Organization (2010), and National Comprehensive Cancer Network (2012). Variances throughout guidelines include definitions of the practice, indications for its use, continuation of life-prolonging therapies, medications used, and timing/prognosis. The development and implementation of institutional-based guidelines with clear stance on the discussed variances is necessary for consistency in practice. Data on provision of palliative sedation after implementation of guidelines needs to be collected and disseminated for a better understanding of the current practice in the United States. © The Author(s) 2014.

Rapid Development and Distribution of Mobile Media-Rich Clinical Practice Guidelines Nationwide in Colombia.

PubMed

Flórez-Arango, José F; Sriram Iyengar, M; Caicedo, Indira T; Escobar, German

2017-01-01

Development and electronic distribution of Clinical Practice Guidelines production is costly and challenging. This poster presents a rapid method to represent existing guidelines in auditable, computer executable multimedia format. We used a technology that enables a small number of clinicians to, in a short period of time, develop a substantial amount of computer executable guidelines without programming.

A review of mammalian carcinogenicity study design and potential effects of alternate test procedures on the safety evaluation of food ingredients.

PubMed

Hayes, A W; Dayan, A D; Hall, W C; Kodell, R L; Williams, G M; Waddell, W D; Slesinski, R S; Kruger, C L

2011-06-01

Extensive experience in conducting long term cancer bioassays has been gained over the past 50 years of animal testing on drugs, pesticides, industrial chemicals, food additives and consumer products. Testing protocols for the conduct of carcinogenicity studies in rodents have been developed in Guidelines promulgated by regulatory agencies, including the US EPA (Environmental Protection Agency), the US FDA (Food and Drug Administration), the OECD (Organization for Economic Co-operation and Development) for the EU member states and the MAFF (Ministries of Agriculture, Forestries and Fisheries) and MHW (Ministry of Health and Welfare) in Japan. The basis of critical elements of the study design that lead to an accepted identification of the carcinogenic hazard of substances in food and beverages is the focus of this review. The approaches used by entities well-known for carcinogenicity testing and/or guideline development are discussed. Particular focus is placed on comparison of testing programs used by the US National Toxicology Program (NTP) and advocated in OECD guidelines to the testing programs of the European Ramazzini Foundation (ERF), an organization with numerous published carcinogenicity studies. This focus allows for a good comparison of differences in approaches to carcinogenicity testing and allows for a critical consideration of elements important to appropriate carcinogenicity study designs and practices. OECD protocols serve as good standard models for carcinogenicity testing protocol design. Additionally, the detailed design of any protocol should include attention to the rationale for inclusion of particular elements, including the impact of those elements on study interpretations. Appropriate interpretation of study results is dependent on rigorous evaluation of the study design and conduct, including differences from standard practices. Important considerations are differences in the strain of animal used, diet and housing practices, rigorousness of test procedures, dose selection, histopathology procedures, application of historical control data, statistical evaluations and whether statistical extrapolations are supported by, or are beyond the limits of, the data generated. Without due consideration, there can be result conflicting data interpretations and uncertainty about the relevance of a study's results to human risk. This paper discusses the critical elements of rodent (rat) carcinogenicity studies, particularly with respect to the study of food ingredients. It also highlights study practices and procedures that can detract from the appropriate evaluation of human relevance of results, indicating the importance of adherence to international consensus protocols, such as those detailed by OECD. Copyright © 2010. Published by Elsevier Inc.

The limitations of using randomised controlled trials as a basis for developing treatment guidelines.

PubMed

Mulder, Roger; Singh, Ajeet B; Hamilton, Amber; Das, Pritha; Outhred, Tim; Morris, Grace; Bassett, Darryl; Baune, Bernhard T; Berk, Michael; Boyce, Philip; Lyndon, Bill; Parker, Gordon; Malhi, Gin S

2018-02-01

Randomised controlled trials (RCTs) are considered the 'gold standard' by which novel psychotropic medications and psychological interventions are evaluated and consequently adopted into widespread clinical practice. However, there are some limitations to using RCTs as the basis for developing treatment guidelines. While RCTs allow researchers to determine whether a given medication or intervention is effective in a specific patient sample, for practicing clinicians it is more important to know whether it will work for their particular patient in their particular setting. This information cannot be garnered from an RCT. These inherent limitations are exacerbated by biases in design, recruitment, sample populations and data analysis that are inevitable in real-world studies. While trial registration and CONSORT have been implemented to correct and improve these issues, it is worrying that many trials fail to achieve such standards and yet their findings are used to inform clinical decision making. This perspective piece questions the assumptions of RCTs and highlights the widespread distortion of findings that currently undermine the credibility of this powerful design. It is recommended that the clinical guidelines include advice as to what should be considered good and relevant evidence and that external bodies continue to monitor RCTs to ensure that the outcomes published indeed reflect reality. © 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.

Experiences with the European guidelines on quality criteria for radiographic images in Tanzania

PubMed Central

Muhogora, W. E.; Nyanda, A. M.; Kazema, R. R.

2001-01-01

Objective assessment of the quality of radiographic images is practically a difficult task and protocols that address this problem are few. In 1996, the European union published nearly objective image quality criteria to unify the practices in Europe. However, experience with these criteria in countries of lower health care levels is little documented. As a case study in Tanzania, we present the general performance of European guidelines in some Tanzanian hospitals to a total of 200 radiographs obtained from some common x‐ray examinations. The results show that more than 70% of chest (PA), lumbar spine (AP), and pelvis AP radiographs passed the quality criteria, while the performance of lumbar spine LAT x‐ray examinations was about 50% and therefore less satisfactory. The corresponding mean entrance dose to the patient for specified x‐ray techniques was of range 0.08–0.56 mGy, 3.1–7.7 mGy, 2.53–5.4 mGy, and 4.0–16.78 mGy for chest PA, lumbar spine AP, pelvis AP and lumbar spine LAT x‐ray examinations, respectively. Although a good number of observers were not well familiar to the guidelines, the quality criteria have been found useful and their adoption in the country recommended. The need to provide relevant education and training to staff in the radiology departments is of utmost importance. PACS number(s): 87.57.–s, 87.52.–g PMID:11686743

[Implementation of clinical practice guidelines: how can we close the evidence-practice gap?].

PubMed

Muche-Borowski, Cathleen; Nothacker, M; Kopp, I

2015-01-01

Guidelines are intended as instruments of knowledge transfer to support decision-making by physicians, other health professionals and patients in clinical practice and thereby contribute to quality improvements in healthcare. To date they are an indispensable tool for healthcare. Their benefit for patients can only be seen in application, i.e. the implementation of guideline recommendations. For successful implementation, implementability and practicability play a crucial role and these characteristics can be influenced and should be promoted by the guideline development group. In addition, a force field analysis to identify barriers against and facilitators for the implementation of specific guideline recommendations from the perspective of physicians and patients is recommended to guide the development of an individual implementation strategy and the selection of appropriate interventions. However, implementation cannot be achieved by the guideline development group alone and a universal implementation strategy does not exist. Therefore, a process using theory, analysis, experience and shared responsibility of stakeholders in healthcare is recommended, with the aim to achieve sustainable behavioral change and improve the quality of care by guideline-oriented behavior.

Clinical practice guideline development manual: a quality-driven approach for translating evidence into action.

PubMed

Rosenfeld, Richard M; Shiffman, Richard N

2009-06-01

Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing health-care variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective-or potentially harmful-interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. This manual describes the principles and practices used successfully by the American Academy of Otolaryngology-Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multidisciplinary applicability. The development process, which allows moving from conception to completion in 12 months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence. As clinical practice guidelines become more prominent as a key metric of quality health care, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are-and are not-and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals.