Evidence-Based Management Guidelines on Peyronie's Disease.

PubMed

Chung, Eric; Ralph, David; Kagioglu, Ates; Garaffa, Guilio; Shamsodini, Ahmed; Bivalacqua, Trinity; Glina, Sidney; Hakim, Lawrence; Sadeghi-Nejad, Hossein; Broderick, Gregory

2016-06-01

Despite recent advances in our knowledge and treatment strategies in Peyronie's Disease (PD), much remained unknown about this disease. To provide a clinical framework and key guideline statements to assist clinicians in an evidence-based management of PD. A systematic literature search was conducted to identify published literature relevant to PD. The search included all relevant articles published up to June 2015, including preclinical studies and published guidelines. References used in the text were assessed according to their level of evidence, and guideline recommendations were graded based on the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Owing to the paucity of larger series and randomized placebo-controlled trials with regard to surgical intervention, guideline statements are provided as clinical principle or expert opinion. This literature was discussed at a panel meeting, and selected articles with the highest evidence available were used to create consensus guideline statements for the Fourth International Consultation on Sexual Medicine guidelines on PD. In addition to existing Third International Consultation on Sexual Medicine guidelines on PD, seven new summary recommendations were created. A greater understanding of the scientific basis of PD is greatly needed to address our understanding of the pathophysiology, clinical epidemiology, psychosocial, and diagnostic assessment as well as treatment strategies. Copyright © 2016 International Society for Sexual Medicine. All rights reserved.

Analysis of Existing Guidelines for the Systematic Planning Process of Clinical Registries.

PubMed

Löpprich, Martin; Knaup, Petra

2016-01-01

Clinical registries are a powerful method to observe the clinical practice and natural disease history. In contrast to clinical trials, where guidelines and standardized methods exist and are mandatory, only a few initiatives have published methodological guidelines for clinical registries. The objective of this paper was to review these guidelines and systematically assess their completeness, usability and feasibility according to a SWOT analysis. The results show that each guideline has its own strengths and weaknesses. While one supports the systematic planning process, the other discusses clinical registries in great detail. However, the feasibility was mostly limited and the special requirements of clinical registries, their flexible, expandable and adaptable technological structure was not addressed consistently.

The Canadian critical care nutrition guidelines in 2013: an update on current recommendations and implementation strategies.

PubMed

Dhaliwal, Rupinder; Cahill, Naomi; Lemieux, Margot; Heyland, Daren K

2014-02-01

Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioners and patient decisions about appropriate healthcare for specific clinical circumstances, and are designed to minimize practice variation, improve costs, and improve clinical outcomes. The Canadian Critical Care Practice Guidelines (CCPGs) were first published in 2003 and most recently updated in 2013. A total of 68 new randomized controlled trials were identified since the last version in 2009, 50 of them published between 2009 and 2013. The remaining articles were trials published before 2009 but were not identified in previous iterations of the CCPGs. For clinical practice guidelines to be useful to practitioners, they need to be up-to-date and be reflective of the current body of evidence. Herein we describe the process by which the CCPGs were updated. This process resulted in 10 new sections or clinical topics. Of the old clinical topics, 3 recommendations were upgraded, 4 were downgraded, and 27 remained the same. To influence decision making at the bedside, these updated guidelines need to be accompanied by active guideline implementation strategies. Optimal implementation strategies should be guided by local contextual factors including barriers and facilitators to best practice recommendations. Moreover, evaluating and monitoring performance, such as participating in the International Nutrition Survey of practice, should be part of any intensive care unit's performance improvement strategy. The active implementation of the updated CCPGs may lead to better nutrition care and improved patient outcomes in the critical care setting.

[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.

Quality of clinical practice guidelines in delirium: a systematic appraisal.

PubMed

Bush, Shirley H; Marchington, Katie L; Agar, Meera; Davis, Daniel H J; Sikora, Lindsey; Tsang, Tammy W Y

2017-03-10

To determine the accessibility and currency of delirium guidelines, guideline summary papers and evaluation studies, and critically appraise guideline quality. Systematic literature search for formal guidelines (in English or French) with focus on delirium assessment and/or management in adults (≥18 years), guideline summary papers and evaluation studies.Full appraisal of delirium guidelines published between 2008 and 2013 and obtaining a 'Rigour of Development' domain screening score cut-off of >40% using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Multiple bibliographic databases, guideline organisation databases, complemented by a grey literature search. 3327 database citations and 83 grey literature links were identified. A total of 118 retrieved delirium guidelines and related documents underwent full-text screening. A final 21 delirium guidelines (with 10 being >5 years old), 12 guideline summary papers and 3 evaluation studies were included. For 11 delirium guidelines published between 2008 and 2013, the screening AGREE II 'Rigour' scores ranged from 3% to 91%, with seven meeting the cut-off score of >40%. Overall, the highest rating AGREE II domains were 'Scope and Purpose' (mean 80.1%, range 64-100%) and 'Clarity and Presentation' (mean 76.7%, range 38-97%). The lowest rating domains were 'Applicability' (mean 48.7%, range 8-81%) and 'Editorial Independence' (mean 53%, range 2-90%). The three highest rating guidelines in the 'Applicability' domain incorporated monitoring criteria or audit and costing templates, and/or implementation strategies. Delirium guidelines are best sourced by a systematic grey literature search. Delirium guideline quality varied across all six AGREE II domains, demonstrating the importance of using a formal appraisal tool prior to guideline adaptation and implementation into clinical settings. Adding more knowledge translation resources to guidelines may improve their practical application and effective monitoring. More delirium guideline evaluation studies are needed to determine their effect on clinical practice. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

No. 247-Antibiotic Prophylaxis in Obstetric Procedures.

PubMed

van Schalkwyk, Julie; Van Eyk, Nancy

2017-09-01

To review the evidence and provide recommendations on antibiotic prophylaxis for obstetrical procedures. Outcomes evaluated include need and effectiveness of antibiotics to prevent infections in obstetrical procedures. Published literature was retrieved through searches of Medline and The Cochrane Library on the topic of antibiotic prophylaxis in obstetrical procedures. Results were restricted to systematic reviews, randomized controlled trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis and articles published from January 1978 to June2009 were incorporated in the guideline. Current guidelines published by the American College of Obstetrics and Gynecology were also incorporated. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The evidence obtained was reviewed and evaluated by the Infectious Diseases Committee of the Society of Obstetricians and Gynaecologists of Canada under the leadership of the principal authors, and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care (Table 1). Implementation of this guideline should reduce the cost and harm resulting from the administration of antibiotics when they are not required and the harm resulting from failure to administer antibiotics when they would be beneficial. RECOMMENDATIONS. Copyright © 2017. Published by Elsevier Inc.

The CARE guidelines: consensus-based clinical case report guideline development.

PubMed

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2014-01-01

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.

Castration-resistant prostate cancer: AUA Guideline.

PubMed

Cookson, Michael S; Roth, Bruce J; Dahm, Philipp; Engstrom, Christine; Freedland, Stephen J; Hussain, Maha; Lin, Daniel W; Lowrance, William T; Murad, Mohammad Hassan; Oh, William K; Penson, David F; Kibel, Adam S

2013-08-01

This Guideline is intended to provide a rational basis for the management of patients with castration-resistant prostate cancer based on currently available published data. A systematic review and meta-analysis of the published literature was conducted using controlled vocabulary supplemented with keywords relating to the relevant concepts of prostate cancer and castration resistance. The search strategy was developed and executed by reference librarians and methodologists to create an evidence report limited to English-language, published peer-reviewed literature. This review yielded 303 articles published from 1996 through 2013 that were used to form a majority of the guideline statements. Clinical Principles and Expert Opinions were used for guideline statements lacking sufficient evidence-based data. Guideline statements were created to inform clinicians on the appropriate use of observation, androgen-deprivation and antiandrogen therapy, androgen synthesis inhibitors, immunotherapy, radionuclide therapy, systemic chemotherapy, palliative care and bone health. These were based on six index patients developed to represent the most common scenarios encountered in clinical practice. As a direct result of the significant increase in FDA-approved therapeutic agents for use in patients with metastatic CRPC, clinicians are challenged with a multitude of treatment options and potential sequencing of these agents that, consequently, make clinical decision-making more complex. Given the rapidly evolving nature of this field, this guideline should be used in conjunction with recent systematic literature reviews and an understanding of the individual patient's treatment goals. In all cases, patients' preferences and personal goals should be considered when choosing management strategies. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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.

A Systematic Scoping Literature Review of Publications Supporting Treatment Guidelines for Pediatric Atopic Dermatitis in Contrast to Clinical Practice Patterns.

PubMed

Siegfried, Elaine C; Jaworski, Jennifer C; Mina-Osorio, Paola

2018-06-01

Treatment guidelines endorse a variety of strategies for atopic dermatitis (AD) which may vary from published data and clinical practice patterns. The objective of this review was to quantify the volume of available medical literature supporting pediatric AD treatments and compare these patterns to those recommended by published guidelines and/or clinical practice patterns. Searches of Embase (2005-2016) and abstracts from selected meetings (2014-2016) related to AD treatment in patients younger than 17 years of age yielded references that were assessed by study design, primary treatment, age groups, and AD severity. Published literature partially supports clinical guidelines, with emollients and topical medications being the most investigated. There were disproportionately more publications for topical calcineurin inhibitors (TCI) compared with topical corticosteroids (TCS); however, the search interval may have biased the results toward treatments approved near the beginning of the time frame. In contrast, publications documenting clinical practice patterns reflect greater use of emollients and TCS (over TCI), as well as systemic corticosteroids. Data is relatively limited for long-term and combination treatment, treatment of severe AD, and patients younger than 2 years of age, and completely lacking for systemic corticosteroids. This scoping review demonstrates that available medical literature largely supports published guidelines for topical therapy; however, clinical practice patterns are less aligned. There is a lack of data for older, more frequently used generic treatments, including oral antihistamines, oral antibiotics, and systemic corticosteroids. Overall, literature is lacking for long-term treatment, treatment for patients younger than 2 years of age, and for systemic treatment for severe disease. Regeneron Pharmaceuticals Inc.

Systematic evaluation of clinical practice guidelines for pharmacogenomics.

PubMed

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

2018-06-01

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

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

PubMed

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

2016-03-15

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

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.

Reporting and publishing guidelines: article 12 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Wilson, Kevin C; Irwin, Richard S; File, Thomas M; Schünemann, Holger J; Guyatt, Gordon H; Rabe, Klaus F

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the twelfth of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases. This article discusses the reporting and publishing of guidelines. The authors formulated and discussed the following questions on the reporting and publishing of guidelines. (1) What should be reported in guidelines? (2) How should guidelines be written? (3) How should the bottom-line message be conveyed? (4) How should guidelines be packaged? (5) Where should guidelines be published? (6) Who benefits from the publication of guidelines? (7) What information should be vetted by the editor(s)? (8) How should guidelines be peer reviewed? We conducted a review of the literature, looking for systematic reviews and methodological research that addressed these questions, but we did not conduct a full systematic review. Our conclusions are based on the available evidence from the published literature and logical arguments from experienced guideline developers. There is little empirical evidence that addresses the reporting and publishing of guidelines. A standard format for reporting guidelines is desirable to ensure that guidelines are comprehensive and that all of the information necessary to judge their quality is presented. In addition, guidelines should contain concise evidence-based recommendations. To facilitate the use of guidelines by consumers, it is preferable to publish them in journals that serve the target audience and to package them in multiple ways. Editors and peer reviewers should ensure that reporting standards have been met, potential conflicts of interest have been adequately addressed and made public, and that the recommendations address important clinical questions.

Challenges of implementing fibromyalgia treatment guidelines in current clinical practice.

PubMed

Arnold, Lesley M; Clauw, Daniel J

2017-09-01

The current diagnostic and treatment pathway for patients with fibromyalgia (FM) is lengthy, complex, and characterized by multiple physician visits with an average 2-year wait until diagnosis. It is clear that effective identification and appropriate treatment of FM remain a challenge in current clinical practice. Ideally, FM management involves a multidisciplinary approach with the preferable patient pathway originating in primary care but supported by a range of health care providers, including referral to specialist care when necessary. After the publication of individual clinical studies, high-quality reviews, and meta-analyses, recently published FM treatment guidelines have transitioned from an expert consensus to an evidence-based approach. Evidence-based guidelines provide a framework for ensuring early diagnosis and timely adoption of appropriate treatment. However, for successful outcomes, FM treatments must adopt a more holistic approach, which addresses more than just pain. Impact on the associated symptoms of fatigue and cognitive problems, sleep and mood disturbances, and lowered functional status are also important in judging the success of FM therapy. Recently published guidelines recommend the adoption of a symptom-based approach to guide pharmacologic treatment. Emerging treatment options for FM may be best differentiated on the basis of their effect on comorbid symptoms that are often associated with pain (e.g. sleep disturbance, mood, fatigue). The current review discusses the most recently published Canadian guidelines and the implications of the recent European League Against Rheumatism (EULAR) recommendations, with a focus on the challenges of implementing these guidelines in current clinical practice.

Added value of involving patients in the first step of multidisciplinary guideline development: a qualitative interview study among infertile patients.

PubMed

den Breejen, Elvira M E; Hermens, Rosella P M G; Galama, Wienke H; Willemsen, Wim N P; Kremer, Jan A M; Nelen, Willianne L D M

2016-06-01

Patient involvement in scoping the guideline is emphasized, but published initiatives actively involving patients are generally limited to the writing and reviewing phase. To assess patients' added value to the scoping phase of a multidisciplinary guideline on infertility. Qualitative interview study. We conducted interviews among 12 infertile couples and 17 professionals. We listed and compared the couples' and professionals' key clinical issues (=care aspects that need improvement) to be addressed in the guideline according to four domains: current guidelines, professionals, patients and organization of care. Main key clinical issues suggested by more than three quarters of the infertile couples and/or at least two professionals were identified and compared. Overall, we identified 32 key clinical issues among infertile couples and 23 among professionals. Of the defined main key clinical issues, infertile couples mentioned eight issues that were not mentioned by the professionals. These main key clinical issues mainly concerned patient-centred (e.g. poor information provision and poor alignment of care) aspects of care on the professional and organizational domain. Both groups mentioned two main key clinical issues collectively that were interpreted differently: the lack of emotional support and respect for patients' values. Including patients from the first phase of the guideline development process leads to valuable additional main key clinical issues for the next step of a multidisciplinary guideline development process and broadens the scope of the guideline, particularly regarding patient-centredness and organizational issues from a patients' perspective. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

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

Methodological Quality of Consensus Guidelines in Implant Dentistry.

PubMed

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

2017-01-01

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

Methodological Quality of Consensus Guidelines in Implant Dentistry

PubMed Central

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

2017-01-01

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

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.

Singapore Armed Forces Medical Corps-Ministry of Health clinical practice guidelines: management of heat injury.

PubMed

Lee, L; Fock, K M; Lim, C L F; Ong, E H M; Poon, B H; Pwee, K H; O'Muircheartaigh, C R; Seet, B; Tan, C L B; Teoh, C S

2010-10-01

The Singapore Armed Forces (SAF) Medical Corps and the Ministry of Health (MOH) have published clinical practice guidelines on Management of Heat Injury to provide doctors and patients in Singapore with evidence-based guidance on the prevention and clinical management of exertional heat injuries. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the SAF Medical Corps-MOH clinical practice guidelines on Management of Heat Injury, for the information of readers of the Singapore Medical Journal. Chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/mohcorp/publications.aspx?id=25178. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

[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.

A Critical Review of Low Back Pain Guidelines.

PubMed

Chetty, Laran

2017-09-01

Low back pain (LBP) remains one of the most common and challenging musculoskeletal conditions encountered by health care professionals and is a leading cause of absenteeism. Clinical guidelines are often considered best evidence in health care. The aim of this critical review was to assess the quality and recommendations of LBP guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument. Electronic databases were used to identify LBP guidelines published between 2000 and 2015. Nine guidelines were selected for review from a total of 17. Only five guidelines effectively addressed the AGREE scoring. On the basis of the appraisal and domain scores, only four guidelines were strongly recommended. Improved translation of research evidence from guidelines to clinical practice is needed.

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

Pediatric constipation therapy using guidelines and polyethylene glycol 3350.

PubMed

Bell, Edward A; Wall, Geoffrey C

2004-04-01

To review current guidelines on the treatment of functional constipation in pediatric patients, with an emphasis on the role of polyethylene glycol 3350 (PEG 3350). Primary medical literature published in English was identified by MEDLINE search (1980-May 2003). Recently published treatment guidelines relating to pediatric functional constipation and its pharmacotherapy are assessed and compared. Published trials evaluating PEG 3350 in pediatric subjects are discussed and their results applied to the clinical role and use of this new agent. Constipation is a common disorder among children. A number of factors may play a role. A variety of medications are commonly used for this disorder, although few treatments have undergone evaluation by controlled clinical trials. Consensus guidelines recommend either osmotic laxatives, mineral oil, or their combination for maintenance treatment in concert with patient and parental education and behavioral training. PEG 3350 solution (MiraLax) has been shown in recent clinical studies to be an effective maintenance treatment for pediatric constipation. PEG 3350 is an effective and well-tolerated treatment choice for pediatric constipation, especially as an adjunct to education and behavioral training. PEG 3350 is an option for children with constipation who have failed or are intolerant of other pharmacotherapies.

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

PubMed

Helou, A; Ollenschläger, G

1998-06-01

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

Implementing clinical guidelines to prevent catheter-associated urinary tract infections and improve catheter care in nursing homes: Systematic review.

PubMed

Gould, Dinah; Gaze, Sarah; Drey, Nicholas; Cooper, Tracey

2017-05-01

Catheter-associated urinary tract infection is the most common health care-associated infection, is considered avoidable, and has cost implications for health services. Prevalence is high in nursing homes, but little research has been undertaken to establish whether implementing clinical guidelines can reduce infection rates in long-term care or improve quality of urinary catheter care. Systematic search and critical appraisal of the literature. Three studies evaluated the impact of implementing a complete clinical guideline. Five additional studies evaluated the impact of implementing individual elements of a clinical guideline. Prevention of catheter-associated urinary tract infection in nursing homes has received little clinical or research attention. Studies concerned with whole guideline implementation emerged as methodologically poor using recognized criteria for critically appraising epidemiologic studies concerned with infection prevention. Research evaluating the impact of single elements of clinical guidelines is more robust, and their findings could be implemented to prevent urinary infections in nursing homes. Copyright © 2017. Published by Elsevier Inc.

Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for Pharmacogenetics-Guided Warfarin Dosing: 2017 Update.

PubMed

Johnson, J A; Caudle, K E; Gong, L; Whirl-Carrillo, M; Stein, C M; Scott, S A; Lee, M T; Gage, B F; Kimmel, S E; Perera, M A; Anderson, J L; Pirmohamed, M; Klein, T E; Limdi, N A; Cavallari, L H; Wadelius, M

2017-09-01

This document is an update to the 2011 Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for CYP2C9 and VKORC1 genotypes and warfarin dosing. Evidence from the published literature is presented for CYP2C9, VKORC1, CYP4F2, and rs12777823 genotype-guided warfarin dosing to achieve a target international normalized ratio of 2-3 when clinical genotype results are available. In addition, this updated guideline incorporates recommendations for adult and pediatric patients that are specific to continental ancestry. © 2017 American Society for Clinical Pharmacology and Therapeutics.

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/.

[Elaboration and critical evaluation of clinical guidelines].

PubMed

García Villar, C

2015-11-01

Clinical guidelines are documents to help professionals and patients select the best diagnostic or therapeutic option. Elaborating guidelines requires an efficient literature search and a critical evaluation of the articles found to select the most appropriate ones. After that, the recommendations are formulated and then must be externally evaluated before they can be disseminated. Even when the guidelines are very thorough and rigorous, it is important to know whether they fulfill all the methodological requisites before applying them. With this aim, various scales have been developed to critically appraise guidelines. Of these, the AGREE II instrument is currently the most widely used. This article explains the main steps in elaborating clinical guidelines and the main aspects that should be analyzed to know whether the guidelines are well written. Copyright © 2015 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

Responsible Translation of Stem Cell Research: An Assessment of Clinical Trial Registration and Publications.

PubMed

Fung, Moses; Yuan, Yan; Atkins, Harold; Shi, Qian; Bubela, Tania

2017-05-09

We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most publications reported safety, and 67.3% (mainly early-stage trials) reported positive outcomes. A higher proportion of industry trials reported positive efficacy. Heightened patient expectations for stem cell therapies give rise to ethical obligations for the transparent conduct of clinical trials. Reporting guidelines need to be developed that are specific to early-phase clinical trials. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

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.

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

PubMed

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

2014-09-01

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

Clinical practice guidelines for the treatment of primary liver cancer with integrative traditional Chinese and Western medicine.

PubMed

Ling, Chang-Quan; Fan, Jia; Lin, Hong-Sheng; Shen, Feng; Xu, Zhen-Ye; Lin, Li-Zhu; Qin, Shu-Kui; Zhou, Wei-Ping; Zhai, Xiao-Feng; Li, Bai; Zhou, Qing-Hui

2018-05-17

Traditional Chinese medicine (TCM) is an important part of the treatment of primary liver cancer (PLC) in China; however, the current instructions for the integrative use of traditional Chinese and Western medicine for PLC are mostly based on expert opinion. There is no evidence-based guideline for clinical practice in this field. Therefore, the Shanghai Association of Chinese Integrative Medicine has established a multidisciplinary working group to develop this guideline, which focuses on the most important questions about the use of TCM during PLC treatment. This guideline was developed following the methodological process recommended by the World Health Organization Handbook for Guideline Development. Two rounds of questionnaire survey were performed to identify clinical questions; published evidence was searched; the Grading of Recommendations Assessment, Development and Evaluation approach was used to evaluate the body of evidence; and recommendations were formulated by combining the quality of evidence, patient preferences and values, and other risk factors. The guideline was written based on the Reporting Items for Practice Guidelines in Healthcare tool. This guideline contains 10 recommendations related to 8 questions, including recommendations for early treatment by TCM after surgery, TCM combined with transcatheter arterial chemoembolization for advanced PLC, TCM drugs for external use, and acupuncture and moxibustion therapy. Copyright © 2018 Shanghai Changhai Hospital. Published by Elsevier B.V. All rights reserved.

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.

Early intervention for acute back injury: can we finally develop an evidence-based approach?

PubMed

Smith, Daphne; McMurray, Nancy; Disler, Peter

2002-02-01

Several reviews of the treatment of acute low back pain have been published in the past and have formed the basis of clinical guidelines. However, these lack consistency in some areas and valid data in others. As the literature in this field has continued to expand, the present review was undertaken to establish whether the guidelines in current use are supported by more recently published, scientifically rigorous research, and whether additional consensus regarding treatment of acute low back injury has been forthcoming in recent years. A review, and critical analysis, of literature relating to the treatment of acute low back pain that has been published since the production of the currently used clinical guidelines. The guidelines have been reviewed to assess whether their recommendations remain supportable. Recent research appears to support current clinical guidelines, i.e. exercise may have a positive effect while bed rest is ineffective and may be harmful, simple analgesics and nonsteroidal anti-inflammatory drugs (NSAIDs) have short-term benefits, and spinal manipulation may be effective in the first four weeks; no evidence was found for traction or back schools. However, we need more randomized controlled trials of treatments shown to be successful with the chronic population, e.g. focused on understanding psychological determinants, and using a multidisciplinary biopsychosocial approach. In the future this may help us to prevent acute low back progressing to the chronic state.

International guidelines for the in vivo assessment of skin properties in non-clinical settings: Part 2. transepidermal water loss and skin hydration.

PubMed

du Plessis, Johan; Stefaniak, Aleksandr; Eloff, Fritz; John, Swen; Agner, Tove; Chou, Tzu-Chieh; Nixon, Rosemary; Steiner, Markus; Franken, Anja; Kudla, Irena; Holness, Linn

2013-08-01

There is an emerging perspective that it is not sufficient to just assess skin exposure to physical and chemical stressors in workplaces, but that it is also important to assess the condition, i.e. skin barrier function of the exposed skin at the time of exposure. The workplace environment, representing a non-clinical environment, can be highly variable and difficult to control, thereby presenting unique measurement challenges not typically encountered in clinical settings. An expert working group convened a workshop as part of the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals (OEESC) to develop basic guidelines and best practices (based on existing clinical guidelines, published data, and own experiences) for the in vivo measurement of transepidermal water loss (TEWL) and skin hydration in non-clinical settings with specific reference to the workplace as a worst-case scenario. Key elements of these guidelines are: (i) to minimize or recognize, to the extent feasible, the influences of relevant endogenous-, exogenous-, environmental- and measurement/instrumentation-related factors; (ii) to measure TEWL with a closed-chamber type instrument; (iii) report results as a difference or percent change (rather than absolute values); and (iv) accurately report any notable deviations from this guidelines. It is anticipated that these guidelines will promote consistent data reporting, which will facilitate inter-comparison of study results. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

No. 348-Joint SOGC-CCMG Guideline: Update on Prenatal Screening for Fetal Aneuploidy, Fetal Anomalies, and Adverse Pregnancy Outcomes.

PubMed

Audibert, Francois; De Bie, Isabelle; Johnson, Jo-Ann; Okun, Nanette; Wilson, R Douglas; Armour, Christine; Chitayat, David; Kim, Raymond

2017-09-01

To review the available prenatal screening options in light of the recent technical advances and to provide an update of previous guidelines in the field of prenatal screening. Health care providers involved in prenatal screening, including general practitioners, obstetricians, midwives, maternal fetal medicine specialists, geneticists, and radiologists. All pregnant women receiving counselling and providing informed consent for prenatal screening. Published literature was retrieved through searches of Medline, PubMed, and the Cochrane Library in and prior to March 2016 using an appropriate controlled vocabulary (prenatal diagnosis, amniocentesis, chorionic villi sampling, non-invasive prenatal screening) and key words (prenatal screening, prenatal genetic counselling). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1985 to May 2016. Searches were updated on a regular basis and incorporated in the guideline. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical speciality societies. Evidence will be reviewed 5 years after publication to determine whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

The ARIA guidelines in specialist practice: a nationwide survey.

PubMed

Van Hoecke, H; Van Cauwenberge, P; Thas, O; Watelet, J B

2010-03-01

In 2001, the ARIA guidelines were published to assist healthcare practitioners in managing allergic rhinitis (AR) according to the best evidence. Very limited information, however, is avail-able on the impact of these guidelines on clinical practice. All Belgian Otorhinolaryngologists were invited to complete a questionnaire, covering demographic and professional characteristics, knowledge, use and perception of the ARIA guidelines and 4 clinical case scenarios of AR. Of the 258 (44%) Belgian Otorhinolaryngologists who participated, almost 90% had ever heard about ARIA and 64% had followed a lecture specifically dedicated to the ARIA guidelines. Furthermore, 62% stated to always or mostly follow the ARIA treatment algorithms in the daily management of AR patients. In the clinical case section, adherence to the ARIA guidelines raised with increased self-reported knowledge and use of the ARIA guidelines and among participants that considered the guidelines more userfriendly. Of the respondents, 51% were considered as good com-pliers. Younger age was a significant predictor for good compliance. More efforts are required to improve the translation of scientific knowledge into clinical practice and to further identify which factors may influence guideline compliance.

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

Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines.

PubMed

Daley, George Q; Hyun, Insoo; Apperley, Jane F; Barker, Roger A; Benvenisty, Nissim; Bredenoord, Annelien L; Breuer, Christopher K; Caulfield, Timothy; Cedars, Marcelle I; Frey-Vasconcells, Joyce; Heslop, Helen E; Jin, Ying; Lee, Richard T; McCabe, Christopher; Munsie, Megan; Murry, Charles E; Piantadosi, Steven; Rao, Mahendra; Rooke, Heather M; Sipp, Douglas; Studer, Lorenz; Sugarman, Jeremy; Takahashi, Masayo; Zimmerman, Mark; Kimmelman, Jonathan

2016-06-14

The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

Health Promotion Board-Ministry of Health clinical practice guidelines: functional screening for older adults in the community.

PubMed

Thilagaratnam, S; Ding, Y Y; Au Eong, K G; Chiam, P C; Chow, Y L; Khoo, G; Lim, H B; Lim, H Y L; Lim, W S; Lim, W Y; Peh, K C; Phua, K T; Sitoh, Y Y; Tan, B Y; Wong, S F; Wong, W P; Yee, R

2010-06-01

The Health Promotion Board (HPB) and the Ministry of Health (MOH) publish clinical practice guidelines to provide doctors and patients in Singapore with evidence-based guidance on managing important medical conditions. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the HPB-MOH clinical practice guidelines on Functional Screening for Older Adults in the Community, for the information of readers of the Singapore Medical Journal. Chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Health Promotion Board website (http://www.hpb.gov.sg/uploadedFiles/HPB_Online/Publications/CPGFunctionalscreening.pdf). The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

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.

Quality of clinical practice guidelines in delirium: a systematic appraisal

PubMed Central

Marchington, Katie L; Agar, Meera; Davis, Daniel H J; Sikora, Lindsey; Tsang, Tammy W Y

2017-01-01

Objective To determine the accessibility and currency of delirium guidelines, guideline summary papers and evaluation studies, and critically appraise guideline quality. Design Systematic literature search for formal guidelines (in English or French) with focus on delirium assessment and/or management in adults (≥18 years), guideline summary papers and evaluation studies. Full appraisal of delirium guidelines published between 2008 and 2013 and obtaining a ‘Rigour of Development’ domain screening score cut-off of >40% using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Data sources Multiple bibliographic databases, guideline organisation databases, complemented by a grey literature search. Results 3327 database citations and 83 grey literature links were identified. A total of 118 retrieved delirium guidelines and related documents underwent full-text screening. A final 21 delirium guidelines (with 10 being >5 years old), 12 guideline summary papers and 3 evaluation studies were included. For 11 delirium guidelines published between 2008 and 2013, the screening AGREE II ‘Rigour’ scores ranged from 3% to 91%, with seven meeting the cut-off score of >40%. Overall, the highest rating AGREE II domains were ‘Scope and Purpose’ (mean 80.1%, range 64–100%) and ‘Clarity and Presentation’ (mean 76.7%, range 38–97%). The lowest rating domains were ‘Applicability’ (mean 48.7%, range 8–81%) and ‘Editorial Independence’ (mean 53%, range 2–90%). The three highest rating guidelines in the ‘Applicability’ domain incorporated monitoring criteria or audit and costing templates, and/or implementation strategies. Conclusions Delirium guidelines are best sourced by a systematic grey literature search. Delirium guideline quality varied across all six AGREE II domains, demonstrating the importance of using a formal appraisal tool prior to guideline adaptation and implementation into clinical settings. Adding more knowledge translation resources to guidelines may improve their practical application and effective monitoring. More delirium guideline evaluation studies are needed to determine their effect on clinical practice. PMID:28283488

Barriers to primary care clinician adherence to clinical guidelines for the management of low back pain: protocol of a systematic review and meta-synthesis of qualitative studies.

PubMed

Slade, Susan C; Kent, Peter; Bucknall, Tracey; Molloy, Elizabeth; Patel, Shilpa; Buchbinder, Rachelle

2015-04-21

Low back pain is the highest ranked condition contributing to years lived with disability, and is a significant economic and societal burden. Evidence-based clinical practice guidelines are designed to improve quality of care and reduce practice variation by providing graded recommendations based on the best available evidence. Studies of low back pain guideline implementation have shown no or modest effects at changing clinical practice. To identify enablers and barriers to adherence to clinical practice guidelines for the management of low back pain. A systematic review and meta-synthesis of qualitative studies that will be conducted and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement guidelines. Eight databases will be searched using a priori inclusion/exclusion criteria. Two independent reviewers will conduct a structured review and meta-synthesis, and a third reviewer will arbitrate where there is disagreement. This protocol has been registered on PROSPERO 2014. Ethical approval is not required. The systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically, in print and at conferences. Updates of the review will be conducted to inform and guide healthcare translation into practice. PROSPERO 2014:CRD42014012961. Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014012961. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Adherence of hip and knee arthroplasty studies to RSA standardization guidelines

PubMed Central

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

2014-01-01

Background and purpose Guidelines for standardization of radiostereometry (RSA) of implants were published in 2005 to facilitate comparison of outcomes between various research groups. In this systematic review, we determined how well studies have adhered to these guidelines. Methods We carried out a literature search to identify all articles published between January 2000 and December 2011 that used RSA in the evaluation of hip or knee prosthesis migration. 2 investigators independently evaluated each of the studies for adherence to the 13 individual guideline items. Since some of the 13 points included more than 1 criterion, studies were assessed on whether each point was fully met, partially met, or not met. Results 153 studies that met our inclusion criteria were identified. 61 of these were published before the guidelines were introduced (2000–2005) and 92 after the guidelines were introduced (2006–2011). The methodological quality of RSA studies clearly improved from 2000 to 2011. None of the studies fully met all 13 guidelines. Nearly half (43) of the studies published after the guidelines demonstrated a high methodological quality and adhered at least partially to 10 of the 13 guidelines, whereas less than one-fifth (11) of the studies published before the guidelines had the same methodological quality. Commonly unaddressed guideline items were related to imaging methodology, determination of precision from double examinations, and also mean error of rigid-body fitting and condition number cutoff levels. Interpretation The guidelines have improved methodological reporting in RSA studies, but adherence to these guidelines is still relatively low. There is a need to update and clarify the guidelines for clinical hip and knee arthroplasty RSA studies. PMID:24954489

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 CARE guidelines: consensus-based clinical case reporting guideline development

PubMed Central

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2013-01-01

A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. PMID:24155002

Evaluation of Internet-Based Clinical Decision Support Systems

PubMed Central

Thomas, Karl W; Dayton, Charles S

1999-01-01

Background Scientifically based clinical guidelines have become increasingly used to educate physicians and improve quality of care. While individual guidelines are potentially useful, repeated studies have shown that guidelines are ineffective in changing physician behavior. The Internet has evolved as a potentially useful tool for guideline education, dissemination, and implementation because of its open standards and its ability to provide concise, relevant clinical information at the location and time of need. Objective Our objective was to develop and test decision support systems (DSS) based on clinical guidelines which could be delivered over the Internet for two disease models: asthma and tuberculosis (TB) preventive therapy. Methods Using open standards of HTML and CGI, we developed an acute asthma severity assessment DSS and a preventative tuberculosis treatment DSS based on content from national guidelines that are recognized as standards of care. Both DSS's are published on the Internet and operate through a decision algorithm developed from the parent guidelines with clinical information provided by the user at the point of clinical care. We tested the effectiveness of each DSS in influencing physician decisions using clinical scenario testing. Results We first validated the asthma algorithm by comparing asthma experts' decisions with the decisions reached by nonpulmonary nurses using the computerized DSS. Using the DSS, nurses scored the same as experts (89% vs. 88%; p = NS). Using the same scenario test instrument, we next compared internal medicine residents using the DSS with residents using a printed version of the National Asthma Education Program-2 guidelines. Residents using the computerized DSS scored significantly better than residents using the paper-based guidelines (92% vs. 84%; p <0.002). We similarly compared residents using the computerized TB DSS to residents using a printed reference card; the residents using the computerized DSS scored significantly better (95.8% vs. 56.6% correct; p<0.001). Conclusions Previous work has shown that guidelines disseminated through traditional educational interventions have minimal impact on physician behavior. Although computerized DSS have been effective in altering physician behavior, many of these systems are not widely available. We have developed two clinical DSS's based on national guidelines and published them on the Internet. Both systems improved physician compliance with national guidelines when tested in clinical scenarios. By providing information that is coupled to relevant activity, we expect that these widely available DSS's will serve as effective educational tools to positively impact physician behavior. PMID:11720915

No. 279-Female Sexual Health Consensus Clinical Guidelines.

PubMed

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

2018-06-01

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

WOCN Society Clinical Guideline: Management of the Adult Patient With a Fecal or Urinary Ostomy-An Executive Summary.

PubMed

This article provides an executive summary of the recommendations from the Clinical Guideline: Management of the Adult Patient With a Fecal or Urinary Ostomy, published by the Wound, Ostomy and Continence Nurses Society (WOCN Society). It presents an overview of the process used to update and develop the guideline and lists specific recommendations from the guideline. We provide recommendations that include the following topics: stoma construction, preoperative education, stoma site marking, selection of an ostomy pouching system, postoperative education, postoperative management issues, follow-up care after discharge from the acute care setting, health-related quality of life, and stomal and peristomal complications. The intent of the guideline is to provide information that will assist healthcare providers to manage adult patients with ostomies, prevent or decrease complications, and improve patient outcomes. The full text of the published guideline, which includes available evidence supporting the recommendations and a complete reference list, is available in print and as a mobile application from the WOCN Society's online bookstore (http://www.wocn.org). Refer to Supplemental Digital Content 1 (available at: http://links.lww.com/JWOCN/A40) associated with this article for a complete reference list for the guideline.

[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.

The appraisal of clinical guidelines in dentistry.

PubMed

Glenny, Anne-Marie; Worthington, Helen V; Clarkson, Jan E; Esposito, Marco

2009-01-01

To appraise the reported processes involved in the development of published dental guidelines. Electronic databases were searched to identify guidelines making recommendations for any health professional within dentistry. All included guidelines were appraised using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument. A total of 105 guidelines met the inclusion criteria. The appraised guidelines showed lack of rigour in their development (median score 14.3%; range 0% to 100%). Only 10 (9.5%) were coded as 'strongly recommend' by at least two assessors. If recommendations within clinical guidelines are to be relied upon, the methods used in their development must be explicit and free from bias. When using the AGREE checklist to make decisions on whether or not to implement individual sets of guidelines, the findings of the present assessment reinforce the need for more than two assessors to be included in the appraisal of each set of guidelines.

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

PubMed

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

2012-10-01

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

GRADE equity guidelines 1: considering health equity in GRADE guideline development: introduction and rationale.

PubMed

Welch, Vivian A; Akl, Elie A; Guyatt, Gordon; Pottie, Kevin; Eslava-Schmalbach, Javier; Ansari, Mohammed T; de Beer, Hans; Briel, Matthias; Dans, Tony; Dans, Inday; Hultcrantz, Monica; Jull, Janet; Katikireddi, Srinivasa Vittal; Meerpohl, Joerg; Morton, Rachael; Mosdol, Annhild; Petkovic, Jennifer; Schünemann, Holger J; Sharaf, Ravi N; Singh, Jasvinder A; Stanev, Roger; Tonia, Thomy; Tristan, Mario; Vitols, Sigurd; Watine, Joseph; Tugwell, Peter

2017-10-01

This article introduces the rationale and methods for explicitly considering health equity in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for development of clinical, public health, and health system guidelines. We searched for guideline methodology articles, conceptual articles about health equity, and examples of guidelines that considered health equity explicitly. We held three meetings with GRADE Working Group members and invited comments from the GRADE Working Group listserve. We developed three articles on incorporating equity considerations into the overall approach to guideline development, rating certainty, and assembling the evidence base and evidence to decision and/or recommendation. Clinical and public health guidelines have a role to play in promoting health equity by explicitly considering equity in the process of guideline development. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

New clinical practice guidelines on the classification, evaluation and management of childhood interstitial lung disease in infants: what do they mean?

PubMed

Wambach, Jennifer A; Young, Lisa R

2014-12-01

The American Thoracic Society (ATS) recently published a clinical practice guideline regarding the classification, evaluation, and management of childhood interstitial lung disease in infancy (chILD). As disease entities among infants with ILD are often distinct from forms seen in older children and adults, the guideline encourages an age-based classification system and focuses on the diagnostic approach to neonates and infants <2 years of age. The guideline reviews current evidence and recommendations for the evaluation, relevant genetic studies, and management of symptomatic infants. Here, we summarize the ATS guideline, highlight the major concepts, and discuss future strategies aimed at addressing current gaps in knowledge.

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.

Clinical prediction rules in practice: review of clinical guidelines and survey of GPs

PubMed Central

Plüddemann, Annette; Wallace, Emma; Bankhead, Clare; Keogh, Claire; Van der Windt, Danielle; Lasserson, Daniel; Galvin, Rose; Moschetti, Ivan; Kearley, Karen; O’Brien, Kirsty; Sanders, Sharon; Mallett, Susan; Malanda, Uriell; Thompson, Matthew; Fahey, Tom; Stevens, Richard

2014-01-01

Background The publication of clinical prediction rules (CPRs) studies has risen significantly. It is unclear if this reflects increasing usage of these tools in clinical practice or how this may vary across clinical areas. Aim To review clinical guidelines in selected areas and survey GPs in order to explore CPR usefulness in the opinion of experts and use at the point of care. Design and setting A review of clinical guidelines and survey of UK GPs. Method Clinical guidelines in eight clinical domains with published CPRs were reviewed for recommendations to use CPRs including primary prevention of cardiovascular disease, transient ischaemic attack (TIA) and stroke, diabetes mellitus, fracture risk assessment in osteoporosis, lower limb fractures, breast cancer, depression, and acute infections in childhood. An online survey of 401 UK GPs was also conducted. Results Guideline review: Of 7637 records screened by title and/or abstract, 243 clinical guidelines met inclusion criteria. CPRs were most commonly recommended in guidelines regarding primary prevention of cardiovascular disease (67%) and depression (67%). There was little consensus across various clinical guidelines as to which CPR to use preferentially. Survey: Of 401 responders to the GP survey, most were aware of and applied named CPRs in the clinical areas of cardiovascular disease and depression. The commonest reasons for using CPRs were to guide management and conform to local policy requirements. Conclusion GPs use CPRs to guide management but also to comply with local policy requirements. Future research could focus on which clinical areas clinicians would most benefit from CPRs and promoting the use of robust, externally validated CPRs. PMID:24686888

Vascular Access Guidelines: Summary, Rationale, and Controversies.

PubMed

Sequeira, Adrian; Naljayan, Mihran; Vachharajani, Tushar J

2017-03-01

Dialysis vascular access management in the United States changed significantly after National Kidney Foundation-Kidney Disease Outcome Quality Initiative (NKF-KDOQI) clinical practice guidelines were first published in 1997. The Centers for Medicare and Medicaid Service adopted these guidelines and in collaboration with the End-Stage Renal Disease Networks established the Fistula First Breakthrough Initiative (FFBI) in 2003 to improve the rate of arteriovenous fistula use over arteriovenous graft and central venous catheter in the dialysis population. The implementation of guidelines and FFBI has led to a significant increase in the arteriovenous fistula use in the prevalent dialysis population. The guidelines are criticized for being opinion based and often impractical. Over the past 2 decades, the patient population undergoing dialysis has become older with complex comorbidities and challenges for creating an ideal vascular access. Advancing knowledge about access pathophysiology, improved treatment options, and improved process of care with team approach model point toward diminishing relevance of few of the existing guidelines. Moreover, several guidelines remain controversial and may be leading to clinical decisions that may be unfavorable to the patients. The review discusses the historical aspect of vascular access care in the United States and evolution of current practice standards and controversies surrounding few of these guidelines in the current time. Published by Elsevier Inc.

Hypertonic Saline for the Treatment of Bronchiolitis in Infants and Young Children: A Critical Review of the Literature

PubMed Central

Baron, Jeffrey

2016-01-01

Bronchiolitis, an infection of the lower respiratory tract, is the leading cause of infant and child hospitalization in the United States. Therapeutic options for management of bronchiolitis are limited. Hypertonic saline inhalation therapy has been studied in numerous clinical trials with mixed results. In 2014, the American Academy of Pediatrics (AAP) published updated guidelines on the diagnosis and management of bronchiolitis, which include new recommendations on the use of hypertonic saline. We reviewed all published clinical trials mentioned in the 2014 AAP guidelines, as well as additional trials published since the guidelines, and critically evaluated each trial to determine efficacy, safety, and expectations of hypertonic saline inhalation therapy. A total of 2682 infants were studied over the course of 22 clinical trials. Nine trials were carried out in the outpatient/clinic/emergency department and 13 in the inpatient setting. We agree with the AAP guidelines regarding the recommendation to use nebulized hypertonic saline for infants hospitalized with bronchiolitis, with the expectation of reducing bronchiolitis scores and length of stay when it is expected to last more than 72 hours. However, we also believe there might be an advantage for hypertonic saline in reducing admission rates from the emergency department, based on close examination of the results of recent trials. This review also highlights important gaps in the available literature that need to be addressed in order to define the role of inhaled hypertonic saline therapy. PMID:26997926

Clinical utility of EEG in diagnosing and monitoring epilepsy in adults.

PubMed

Tatum, W O; Rubboli, G; Kaplan, P W; Mirsatari, S M; Radhakrishnan, K; Gloss, D; Caboclo, L O; Drislane, F W; Koutroumanidis, M; Schomer, D L; Kasteleijn-Nolst Trenite, D; Cook, Mark; Beniczky, S

2018-05-01

Electroencephalography (EEG) remains an essential diagnostic tool for people with epilepsy (PWE). The International Federation of Clinical Neurophysiology produces new guidelines as an educational service for clinicians to address gaps in knowledge in clinical neurophysiology. The current guideline was prepared in response to gaps present in epilepsy-related neurophysiological assessment and is not intended to replace sound clinical judgement in the care of PWE. Furthermore, addressing specific pathophysiological conditions of the brain that produce epilepsy is of primary importance though is beyond the scope of this guideline. Instead, our goal is to summarize the scientific evidence for the utility of EEG when diagnosing and monitoring PWE. Copyright © 2018 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

PubMed

Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

2015-05-01

A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

[Revised Japanese guidelines for the clinical management of bacterial meningitis].

PubMed

Ishikawa, Harumi; Kamei, Satoshi

2014-01-01

Improvement of outcomes represents the most important problem in the treatment of bacterial meningitis. To achieve such improvement, revision of the guidelines for the clinical management of bacterial meningitis in Japan has been carried out, and these revised Japanese guidelines will soon be published. The choice of specific antimicrobial agents for initial treatment in bacterial meningitis is influenced by a number of factors, including patient age, systemic symptoms, and local patterns of bacterial resistance. In the revised Japanese guidelines, antimicrobial agents based on current knowledge of the epidemiology in Japan are recommended. Bacterial meningitis is a medical emergency, and patients with this disease require immediate medical assessment and appropriate treatment. Rapid diagnosis and treatment of bacterial meningitis reduces mortality and neurological sequelae. We describe the revised Japanese guidelines for the clinical management of bacterial meningitis 2014, with a focus on adults.

Impact of an evidence-based guideline on the management of community-acquired bacterial meningitis: a prospective cohort study.

PubMed

Costerus, J M; Brouwer, M C; Bijlsma, M W; Tanck, M W; van der Ende, A; van de Beek, D

2016-11-01

To study the impact of an evidence-based guideline on the management of community-acquired bacterial meningitis. We performed an interrupted time series analysis in a prospective nationwide cohort study from 2006 to 2015. The guideline stresses the importance of cranial imaging before lumbar puncture (LP) in selected patients based on clinical criteria, and early treatment with amoxicillin and a third-generation cephalosporin for adults with suspected community-acquired bacterial meningitis. The guideline was published in April 2013. We included 1326 episodes before and 210 episodes after guideline introduction. Cranial imaging was performed before LP in 497 (84%) of 591 episodes with clinical criteria warranting computed tomography (CT). The guideline did not improve this (increase of 2%; 95% confidence interval (CI), -15 to 19). Without these criteria, imaging before LP occurred in 606 (67%) of 900 episodes, also without effect of the guideline (increase of 1%; 95% CI, -25 to 28). The estimate of effect of the guideline for treatment with the recommended antibiotic regimen was an increase of 19.5% (95% CI, 13.5 to 25.5), and there was a trend towards more frequent initiation of treatment before CT. There was no association between delay in antibiotic treatment due to imaging before LP and unfavourable outcome (odds ratio, 1.14; 95% CI 0.86 to 1.52). Cranial imaging is performed before LP in the majority of patients with bacterial meningitis, irrespective of guideline indications. The guideline introduction was associated with a trend towards early initiation of treatment before imaging and with increased adherence to antibiotic policy. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Guidelines for diagnosis and treatment of 21-hydroxylase deficiency (2014 revision)

PubMed Central

Ishii, Tomohiro; Anzo, Makoto; Adachi, Masanori; Onigata, Kazumichi; Kusuda, Satoshi; Nagasaki, Keisuke; Harada, Shohei; Horikawa, Reiko; Minagawa, Masanori; Minamitani, Kanshi; Mizuno, Haruo; Yamakami, Yuji; Fukushi, Masaru; Tajima, Toshihiro

2015-01-01

Purpose of developing the guidelines: The first guidelines for diagnosis and treatment of 21-hydroxylase deficiency (21-OHD) were published as a diagnostic handbook in Japan in 1989, with a focus on patients with severe disease. The “Guidelines for Treatment of Congenital Adrenal Hyperplasia (21-Hydroxylase Deficiency) Found in Neonatal Mass Screening (1999 revision)” published in 1999 were revised to include 21-OHD patients with very mild or no clinical symptoms. Accumulation of cases and experience has subsequently improved diagnosis and treatment of the disease. Based on these findings, the Mass Screening Committee of the Japanese Society for Pediatric Endocrinology further revised the guidelines for diagnosis and treatment. Target disease/conditions: 21-hydroxylase deficiency. Users of the guidelines: Physician specialists in pediatric endocrinology, pediatric specialists, referring pediatric practitioners, general physicians; and patients. PMID:26594092

Financial Conflicts of Interest Among Authors of Urology Clinical Practice Guidelines.

PubMed

Carlisle, Austin; Bowers, Aaron; Wayant, Cole; Meyer, Chase; Vassar, Matt

2018-05-07

Recent studies have highlighted the presence of disclosed and undisclosed financial conflicts of interest among authors of clinical practice guidelines. We sought to determine to what extent urology guideline authors receive and report industry payments in accordance with the Physician Payment Sunshine Act. We selected the 13 urology guidelines that were published by the American Urological Association (AUA) after disclosure was mandated by the Physician Payment Sunshine Act. Payments received by guideline authors were searched independently by two investigators using the Open Payments database. Our primary outcome measure was the number of authors receiving payments from industry, stratified by amount thresholds. Our secondary outcome measure was the number of authors with accurate conflict of interest disclosure statements. We identified a total of 54 author disclosures. Thirty-two authors (59.3%) received at least one payment from industry. Twenty (37.0%) received >$10 000 and six (11.1%) received >$50 000. Median total payments were $578 (interquartile range $0-19 228). Twenty (37.0%) disclosure statements were inaccurate. Via Dollars for Docs, we identified $74 195.13 paid for drugs and devices directly related to guideline recommendations. We were limited in our ability to determine when authors began working on guideline panels, as this information was not provided, and by the lack of specificity in Dollars for Docs. Many of the AUA guideline authors received payments from industry, some in excess of $50 000. A significant portion of disclosure statements were inaccurate, indicating a need for more stringent enforcement of the AUA disclosure policy. Pharmaceutical company payments to doctors have been shown to influence how doctors treat patients. If these doctors are charged with making clinical recommendations to other doctors, in the form of clinical practice guidelines, the issue of industry payments becomes more severe. We found that many urologists on guideline panels receive money from industry and that a significant portion did not disclose all payments received. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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 Novel Approach to Improving Utilization of Laboratory Testing.

PubMed

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

2018-02-01

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

International CPR guidelines - perspectives in CPR.

PubMed

Nolan, Jerry P

2013-09-01

The International Liaison Committee on Resuscitation (ILCOR) co-ordinates regular reviews of cardiopulmonary resuscitation (CPR) science and publishes consensus on science statements and treatment recommendations. These outputs are used by international resuscitation organisations to generate clinical guidelines. This review will outline the history behind the development of international CPR guidelines and will provide a detailed description of the current guideline generating process. A perspective is provided on the future of this process and the prospects for completely unified international CPR guidelines. Copyright © 2013 Elsevier Ltd. All rights reserved.

Diagnosis of stable ischemic heart disease: summary of a clinical practice guideline from the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons.

PubMed

Qaseem, Amir; Fihn, Stephan D; Williams, Sankey; Dallas, Paul; Owens, Douglas K; Shekelle, Paul

2012-11-20

The American College of Physicians (ACP) developed this guideline in collaboration with the American College of Cardiology Foundation (ACCF), American Heart Association (AHA), American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, and Society of Thoracic Surgeons to help clinicians diagnose known or suspected stable ischemic heart disease. Literature on this topic published before November 2011 was identified by using MEDLINE, Embase, Cochrane CENTRAL, PsychINFO, AMED, and SCOPUS. Searches were limited to human studies published in English. This guideline grades the evidence and recommendations according to a translation of the ACCF/AHA grading system into ACP's clinical practice guidelines grading system. This guideline includes 28 recommendations that address the following issues: the initial diagnosis of the patient who might have stable ischemic heart disease, cardiac stress testing to assess the risk for death or myocardial infarction in patients diagnosed with stable ischemic heart disease, and coronary angiography for risk assessment.

Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update.

PubMed

Sarin, S K; Kumar, M; Lau, G K; Abbas, Z; Chan, H L Y; Chen, C J; Chen, D S; Chen, H L; Chen, P J; Chien, R N; Dokmeci, A K; Gane, Ed; Hou, J L; Jafri, W; Jia, J; Kim, J H; Lai, C L; Lee, H C; Lim, S G; Liu, C J; Locarnini, S; Al Mahtab, M; Mohamed, R; Omata, M; Park, J; Piratvisuth, T; Sharma, B C; Sollano, J; Wang, F S; Wei, L; Yuen, M F; Zheng, S S; Kao, J H

2016-01-01

Worldwide, some 240 million people have chronic hepatitis B virus (HBV), with the highest rates of infection in Africa and Asia. Our understanding of the natural history of HBV infection and the potential for therapy of the resultant disease is continuously improving. New data have become available since the previous APASL guidelines for management of HBV infection were published in 2012. The objective of this manuscript is to update the recommendations for the optimal management of chronic HBV infection. The 2015 guidelines were developed by a panel of Asian experts chosen by the APASL. The clinical practice guidelines are based on evidence from existing publications or, if evidence was unavailable, on the experts' personal experience and opinion after deliberations. Manuscripts and abstracts of important meetings published through January 2015 have been evaluated. This guideline covers the full spectrum of care of patients infected with hepatitis B, including new terminology, natural history, screening, vaccination, counseling, diagnosis, assessment of the stage of liver disease, the indications, timing, choice and duration of single or combination of antiviral drugs, screening for HCC, management in special situations like childhood, pregnancy, coinfections, renal impairment and pre- and post-liver transplant, and policy guidelines. However, areas of uncertainty still exist, and clinicians, patients, and public health authorities must therefore continue to make choices on the basis of the evolving evidence. The final clinical practice guidelines and recommendations are presented here, along with the relevant background information.

Knowledge-based verification of clinical guidelines by detection of anomalies.

PubMed

Duftschmid, G; Miksch, S

2001-04-01

As shown in numerous studies, a significant part of published clinical guidelines is tainted with different types of semantical errors that interfere with their practical application. The adaptation of generic guidelines, necessitated by circumstances such as resource limitations within the applying organization or unexpected events arising in the course of patient care, further promotes the introduction of defects. Still, most current approaches for the automation of clinical guidelines are lacking mechanisms, which check the overall correctness of their output. In the domain of software engineering in general and in the domain of knowledge-based systems (KBS) in particular, a common strategy to examine a system for potential defects consists in its verification. The focus of this work is to present an approach, which helps to ensure the semantical correctness of clinical guidelines in a three-step process. We use a particular guideline specification language called Asbru to demonstrate our verification mechanism. A scenario-based evaluation of our method is provided based on a guideline for the artificial ventilation of newborn infants. The described approach is kept sufficiently general in order to allow its application to several other guideline representation formats.

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

Evidence-based medicine in the treatment of peritoneal carcinomatosis: Past, present, and future.

PubMed

Nissan, Aviram; Stojadinovic, Alexander; Garofalo, Alfredo; Esquivel, Jesus; Piso, Pompiliu

2009-09-15

The current treatment of peritoneal surface malignancies (PSMs) is moving from a nihilistic approach, into a combined modality approach offering selected patients long-term survival. As primary PSM are rare, extrapolation of data from clinical trials of related disease is necessary to develop treatment guidelines. Secondary PSM are more common, and therefore, treatment guidelines should be developed based on prospective clinical trials. We reviewed the published and ongoing clinical trials studying the treatment of PSM. (c) 2009 Wiley-Liss, Inc.

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.

[Experience of the Mexican National Health System in the development of clinical practice guidelines].

PubMed

Sosa-García, Jesús Ojino; Nieves-Hernández, Pedro; Puentes-Rosas, Esteban; Pineda-Pérez, Dayana; Viniegra-Osorio, Arturo; Torres-Arreola, Laura del Pilar; Valenzuela-Flores, Adriana Abigail; Barragán-Padilla, Sergio Baltazar; Díaz-González, Ruth; Chávez-Valdez, Lizbeth; Ramírez-López, Juan Carlos

2016-01-01

Clinical practice guidelines are tools that have been able to streamline decisions made in health issues and to decrease the gap between clinical action and scientific evidence. The objective of the study is to share the experience in the development and to update the guidelines by the National Health System of Mexico. The methodology in the development of the guidelines consists of 5 phases: prioritisation, establishment of work groups, development by adoption of international guidelines of de novo, validation and integration in the Master catalogue of clinical practice guidelines for its dissemination. The Master catalogue of clinical practice guidelines contains 664 guidelines, distributed in 42% Internal Medicine, 22% Surgery, 24% Pediatrics and 12% Gynecology. From the total of guidelines coverage is granted at an 85% of the Universal catalogue of health services, an 84% of the Catastrophic expenses protection fund and a 61% of the XXI Century Medical Insurance of the National Commission of Social Protection in Health. The result is the sum of a great effort of coordination and cooperation between the institutions of the National Health System, political wills and a commitment of 3,477 health professionals that participate in guidelines' development and update. Master catalogue guidelines' integration, diffusion and implantation improve quality of attention and security of the users of the National Health System. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

PubMed Central

Huang, Hongyun; Young, Wise; Chen, Lin; Feng, Shiqing; Zoubi, Ziad M. Al; Sharma, Hari Shanker; Saberi, Hooshang; Moviglia, Gustavo A.; He, Xijing; Muresanu, Dafin F.; Sharma, Alok; Otom, Ali; Andrews, Russell J.; Al-Zoubi, Adeeb; Bryukhovetskiy, Andrey S.; Chernykh, Elena R.; Domańska-Janik, Krystyna; Jafar, Emad; Johnson, W. Eustace; Li, Ying; Li, Daqing; Luan, Zuo; Mao, Gengsheng; Shetty, Ashok K.; Siniscalco, Dario; Skaper, Stephen; Sun, Tiansheng; Wang, Yunliang; Wiklund, Lars; Xue, Qun; You, Si-Wei; Zheng, Zuncheng; Dimitrijevic, Milan R.; Masri, W. S. El; Sanberg, Paul R.; Xu, Qunyuan; Luan, Guoming; Chopp, Michael; Cho, Kyoung-Suok; Zhou, Xin-Fu; Wu, Ping; Liu, Kai; Mobasheri, Hamid; Ohtori, Seiji; Tanaka, Hiroyuki; Han, Fabin; Feng, Yaping; Zhang, Shaocheng; Lu, Yingjie; Zhang, Zhicheng; Rao, Yaojian; Tang, Zhouping; Xi, Haitao; Wu, Liang; Shen, Shunji; Xue, Mengzhou; Xiang, Guanghong; Guo, Xiaoling; Yang, Xiaofeng; Hao, Yujun; Hu, Yong; Li, Jinfeng; AO, Qiang; Wang, Bin; Zhang, Zhiwen; Lu, Ming; Li, Tong

2018-01-01

Cell therapy has been shown to be a key clinical therapeutic option for central nervous system diseases or damage. Standardization of clinical cell therapy procedures is an important task for professional associations devoted to cell therapy. The Chinese Branch of the International Association of Neurorestoratology (IANR) completed the first set of guidelines governing the clinical application of neurorestoration in 2011. The IANR and the Chinese Association of Neurorestoratology (CANR) collaborated to propose the current version “Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)”. The IANR council board members and CANR committee members approved this proposal on September 1, 2016, and recommend it to clinical practitioners of cellular therapy. These guidelines include items of cell type nomenclature, cell quality control, minimal suggested cell doses, patient-informed consent, indications for undergoing cell therapy, contraindications for undergoing cell therapy, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, do not charge patients for unproven therapies, basic principles of cell therapy, and publishing responsibility. PMID:29637817

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

PubMed

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

2018-06-11

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

[Treatment of anemia in chronic kidney disease--position statement of the Croatian Society for Nephrology, Dialysis and Transplantation and review of the KDIGO and ERPB guidelines].

PubMed

Rački, Sanjin; Bašić-Jukić, Nikolina; Kes, Petar; Ljutić, Dragan; Lovčić, Vesna; Prkačin, Ingrid; Radić, Josipa; Vujičić, Božidar; Bubić, Ivan; Jakić, Marko; Belavić, Žarko; Sefer, Siniša; Pehai, Mario; Klarić, Dragan; Gulin, Marijana

2014-04-01

Renal anemia is the result of chronic kidney disease (CKD) and deteriorates with disease progression. Anemia may be the first sign of kidney disease. In all patients with anemia and CKD, diagnostic evaluation is required. Prior to diagnosing renal anemia, it is necessary to eliminate the other possible causes. Direct correlation between the concentration of hemoglobin and the stage of renal failure is well known. Early development of anemia is common in diabetic patients. Correction of anemia may slow the progression of CKD. Anemia is an independent risk factor for developing cardiovascular disease in patients with CKD. Treatment of anemia in patients with CKD is based on current guidelines. Recently, the Kidney Disease: Improving Global Outcomes (KDIGO) group has produced comprehensive clinical practice guidelines for the management of anemia in CKD patients and ERBP (European Renal Best Practice) group its position statement and comments on the KDIGO guidelines. The Croatian Society of Nephrology, Dialysis and Transplantation (HDNDT) has already published its own guidelines based on the recommendations and positive experience of European and international professional societies, as well as on own experience. The latest version of Croatian guidelines was published in 2008. Since then, on the basis of research and clinical practice, there have been numerous changes in the modern understanding of the treatment of anemia in CKD. Consequently, HDNDT hereby publishes a review of the recent recommendations of international professional societies, expressing the attitude about treating anemia in CKD as a basis for new guidelines tailored to the present time.

[The role of atherogenic dyslipidaemia in clinical practice guidelines].

PubMed

Pedro-Botet, Juan; Mantilla-Morató, Teresa; Díaz-Rodríguez, Ángel; Brea-Hernando, Ángel; González-Santos, Pedro; Hernández-Mijares, Antonio; Pintó, Xavier; Millán Núñez-Cortés, Jesús

2016-01-01

Atherogenic dyslipidaemia is underdiagnosed, undertreated, and under-controlled. The aim of the present study was to assess the positioning of clinical guidelines as regards atherogenic dyslipidaemia. The major clinical guidelines of scientific societies or official agencies issued between January 1, 2012 and March 31, 2015 were collected from the MEDLINE database. High-density lipoprotein (HDL) cholesterol, triglycerides, atherogenic dyslipidaemia, non-HDL cholesterol, and apolipoprotein (apo) B were gathered from the 10 selected guidelines, and it was assessed whether these parameters were considered a cardiovascular risk factor, a therapeutic target, or proposed a pharmacological strategy. American guidelines, except the National Lipid Association (NLA), do not consider HDL cholesterol and triglycerides in cardiovascular prevention. The NLA emphasises the relevance of atherogenic dyslipidaemia. The Canadian guidelines introduced non-HDL cholesterol and ApoB as alternative targets, and proposes non-statin treatment in the presence of low HDL cholesterol and hypertriglyceridaemia. The International Atherosclerosis Society (IAS) and National Institute for Health and Care Excellence (NICE) guidelines promote the importance of non-HDL cholesterol. European, Brazilian and Japanese guidelines highlight HDL cholesterol and triglycerides, but with the limitation that the main evidence comes from sub-analysis of clinical studies. The clinical guidelines analysed do not consider, or unconvincingly address, the importance of atherogenic dyslipidaemia. Copyright © 2016 Sociedad Española de Arteriosclerosis. Published by Elsevier España. All rights reserved.

Underreporting of conflicts of interest in clinical practice guidelines: cross sectional study

PubMed Central

2013-01-01

Background Conflicts of interest affect recommendations in clinical guidelines and disclosure of such conflicts is important. However, not all conflicts of interest are disclosed. Using a public available disclosure list we determined the prevalence and underreporting of conflicts of interest among authors of clinical guidelines on drug treatments. Methods We included up to five guidelines published from July 2010 to March 2012 from each Danish clinical specialty society. Using the disclosure list of the Danish Health and Medicines Authority, we identified author conflicts of interest and compared them with the disclosures in the guidelines. For each guideline we extracted methodological characteristics of guideline development. Results Forty-five guidelines from 14 specialty societies were included. Of 254 authors, 135 (53%) had conflicts of interest, corresponding to 43 of the 45 guidelines (96%) having one or more authors with a conflict of interest. Only one of the 45 guidelines (2%) disclosed author conflicts of interest. The most common type of conflict of interest (83 of the 135) was being a consultant, an advisory board member or a company employee. Only 10 guidelines (22%) described the methods used for guideline development, 27 (60%) used references in the text and 11 (24%) graded the types of evidence. Conclusions Conflicts of interest were common, but disclosures were very rare. Most guidelines did not describe how they were developed and many did not describe the evidence behind specific recommendations. Publicly available disclosure lists may assist guideline issuing bodies in ensuring that all conflicts are disclosed. PMID:23642105

Lipid Management Guidelines from the Departments of Veteran Affairs and Defense: A Critique.

PubMed

Bennet, Catherine S; Dahagam, Chanukya R; Virani, Salim S; Martin, Seth S; Blumenthal, Roger S; Michos, Erin D; McEvoy, John W

2016-09-01

In December 2014, the US Department of Veterans Affairs and Department of Defense (VA/DoD) published an independent clinical practice guideline for the management of dyslipidemia and cardiovascular disease risk, adding to the myriad of recently published guidelines on this topic. The VA/DoD guidelines differ from major US guidelines published by the American College of Cardiology/American Heart Association in 2013 in the following ways: recommending moderate-intensity statins for the majority of patients with statin indications regardless of atherosclerotic cardiovascular disease risk; advocating for limited on-treatment lipid monitoring; and deemphasizing ancillary data, such as coronary artery calcium testing, to improve atherosclerotic cardiovascular disease risk estimation. In the context of manifold treatment recommendations from numerous guideline committees, the VA/DoD recommendations may generate further confusion and mixed messages among healthcare providers about the optimal treatment of dyslipidemia. In this review, we critically appraise the VA/DoD recommendations with a focus on the evidence base for each area where the VA/DoD guidelines differ from the American College of Cardiology/American Heart Association guidelines. We also call for harmonization of lipid treatment guidelines to ensure high-quality and consistent care for patients with, and at risk for, atherosclerotic cardiovascular disease. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Evidenced-Based Guidelines on the Treatment of Fibromyalgia Patients: Are They Consistent and If Not, Why Not? Have Effective Psychological Treatments Been Overlooked?

PubMed

Thieme, Kati; Mathys, Marc; Turk, Dennis C

2017-07-01

We compared the recommendations and methodology of several recent evidence-based guidelines for the management of patients with fibromyalgia published by professional organizations: 1) American Pain Society (APS; 2005), 2) Association of the Scientific Medical Societies in Germany (AWMF; 2012), 3) Canadian Pain Society (CPS; 2013; also used in the United Kingdom), and 4) European League Against Rheumatism (EULAR; 2016). Each guideline used systematic reviews and meta-analyses as highest level of evidence; APS, CPS, and AWMF also included individual randomized clinical trials. The APS, CPS, and AWMF assigned the highest ranking of recommendation to aerobic exercise, cognitive-behavioral therapy, amitriptyline, and multicomponent treatment. In contrast, the most recent EULAR guidelines assign the highest level of recommendation to exercise, contrary to the 2008 EULAR guidelines, which recommended pharmacotherapy. Although there was some consistency for pharmacological treatment recommendations among the 4 guidelines, APS, CPS, and AWMF guidelines gave the higher ranking to cognitive-behavioral therapy and multicomponent treatments. The inconsistencies across guidelines can be attributed to the criteria used for study inclusion, outcome measures used, weighting systems, and composition of the review panels. A guideline consensus is needed to harmonize the discrepancies. This article presents an overview and highlights the inconsistencies of 4 recent clinical practice guidelines for treatment of fibromyalgia patients related to study inclusion criteria, outcome measures used, ranking system used, and composition of the review panels. The discrepancies suggest a need to create a guideline consensus to synthesize guidelines. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

EAU guidelines on surgical treatment of urinary incontinence.

PubMed

Lucas, M G; Bosch, R J L; Burkhard, F C; Cruz, F; Madden, T B; Nambiar, A K; Neisius, A; de Ridder, D J M K; Tubaro, A; Turner, W H; Pickard, R S

2013-09-01

The European Association of Urology (EAU) guidelines on urinary incontinence published in March 2012 have been rewritten based on an independent systematic review carried out by the EAU guidelines panel using a sustainable methodology. We present a short version here of the full guidelines on the surgical treatment of patients with urinary incontinence, with the aim of dissemination to a wider audience. Evidence appraisal included a pragmatic review of existing systematic reviews and independent new literature searches based on Population, Intervention, Comparator, Outcome (PICO) questions. The appraisal of papers was carried out by an international panel of experts, who also collaborated in a series of consensus discussions, to develop concise structured evidence summaries and action-based recommendations using a modified Oxford system. The full version of the guidance is available online (www.uroweb.org/guidelines/online-guidelines/). The guidance includes algorithms that refer the reader back to the supporting evidence and have greater accessibility in daily clinical practice. Two original meta-analyses were carried out specifically for these guidelines and are included in this report. These new guidelines present an up-to-date summary of the available evidence, together with clear clinical algorithms and action-based recommendations based on the best available evidence. Where high-level evidence is lacking, they present a consensus of expert panel opinion. Copyright © 2012 AEU. Published by Elsevier Espana. All rights reserved.

Hormonal Replacement in Hypopituitarism in Adults: An Endocrine Society Clinical Practice Guideline.

PubMed

Fleseriu, Maria; Hashim, Ibrahim A; Karavitaki, Niki; Melmed, Shlomo; Murad, M Hassan; Salvatori, Roberto; Samuels, Mary H

2016-11-01

To formulate clinical practice guidelines for hormonal replacement in hypopituitarism in adults. The participants include an Endocrine Society-appointed Task Force of six experts, a methodologist, and a medical writer. The American Association for Clinical Chemistry, the Pituitary Society, and the European Society of Endocrinology co-sponsored this guideline. The Task Force developed this evidence-based guideline using the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, the American Association for Clinical Chemistry, the Pituitary Society, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Using an evidence-based approach, this guideline addresses important clinical issues regarding the evaluation and management of hypopituitarism in adults, including appropriate biochemical assessments, specific therapeutic decisions to decrease the risk of co-morbidities due to hormonal over-replacement or under-replacement, and managing hypopituitarism during pregnancy, pituitary surgery, and other types of surgeries.

Exploration of the methodological quality and clinical usefulness of a cross-sectional sample of published guidance about exercise training and physical activity for the secondary prevention of coronary heart disease.

PubMed

Abell, Bridget; Glasziou, Paul; Hoffmann, Tammy

2017-06-13

Clinicians are encouraged to use guidelines to assist in providing evidence-based secondary prevention to patients with coronary heart disease. However, the expanding number of publications providing guidance about exercise training may confuse cardiac rehabilitation clinicians. We therefore sought to explore the number, scope, publication characteristics, methodological quality, and clinical usefulness of published exercise-based cardiac rehabilitation guidance. We included publications recommending physical activity, exercise or cardiac rehabilitation for patients with coronary heart disease. These included systematically developed clinical practice guidelines, as well as other publications intended to support clinician decision making, such as position papers or consensus statements. Publications were obtained via electronic searches of preventive cardiology societies, guideline databases and PubMed, to November 2016. Publication characteristics were extracted, and two independent assessors evaluated quality using the 23-item Appraisal of Guidelines Research and Evaluation II (AGREE) tool. Fifty-four international publications from 1994 to 2016 were identified. Most were found on preventive cardiology association websites (n = 35; 65%) and were freely accessible (n = 50; 93%). Thirty (56%) publications contained only broad recommendations for physical activity and cardiac rehabilitation referral, while 24 (44%) contained the necessary detailed exercise training recommendations. Many were labelled as "guidelines", however publications with other titles (e.g. scientific statements) were common (n = 24; 44%). This latter group of publications contained a significantly greater proportion of detailed exercise training recommendations than clinical guidelines (p = 0.017). Wide variation in quality also existed, with 'applicability' the worst scoring AGREE II domain for clinical guidelines (mean score 53%) and 'rigour of development' rated lowest for other guidance types (mean score 33%). While a large number of guidance documents provide recommendations for exercise-based cardiac rehabilitation, most have limitations in either methodological quality or clinical usefulness. The lack of rigorously developed guidelines which also contain necessary detail about exercise training remains a substantial problem for clinicians.

No. 263-Maternity Leave in Normal Pregnancy.

PubMed

Leduc, Dean

2017-10-01

To assist maternity care providers in recognizing and discussing health- and illness-related issues in pregnancy and their relationship to maternity benefits. Published literature was retrieved through searches of PubMed or Medline, CINAHL, and The Cochrane Library in 2009 using appropriate controlled vocabulary (e.g., maternity benefits) and key words (e.g., maternity, benefits, pregnancy). Results were restricted to systematic reviews, randomized controlled trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to December 2009. Grey (unpublished) literature was identified through searching the web sites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Copyright © 2017. Published by Elsevier Inc.

SOGC clinical practice guidelines: Substance use in pregnancy: no. 256, April 2011.

PubMed

Wong, Suzanne; Ordean, Alice; Kahan, Meldon

2011-08-01

To improve awareness and knowledge of problematic substance use in pregnancy and to provide evidence-based recommendations for the management of this challenging clinical issue for all health care providers. This guideline reviews the use of screening tools, general approach to care, and recommendations for clinical management of problematic substance use in pregnancy. Evidence-based recommendations for screening and management of problematic substance use during pregnancy and lactation. Medline, PubMed, CINAHL, and The Cochrane Library were searched for articles published from 1950 using the following key words: substance-related disorders, mass screening, pregnancy complications, pregnancy, prenatal care, cocaine, cannabis, methadone, opioid, tobacco, nicotine, solvents, hallucinogens, and amphetamines. Results were initially restricted to systematic reviews and randomized control trials/controlled clinical trials. A subsequent search for observational studies was also conducted because there are few RCTs in this field of study. Articles were restricted to human studies published in English. Additional articles were located by hand searching through article reference lists. Searches were updated on a regular basis and incorporated in the guideline up to December 2009. Grey (unpublished) literature was also identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence was rated using the criteria described in the Report of the Canadian Task Force on the Preventive Health Care. Recommendations for practice were ranked according to the method described in that report (Table 1). This guideline is intended to increase the knowledge and comfort level of health care providers caring for pregnant women who have substance use disorders. Improved access to health care and assistance with appropriate addiction care leads to reduced health care costs and decreased maternal and neonatal morbidity and mortality.

Executable medical guidelines with Arden Syntax-Applications in dermatology and obstetrics.

PubMed

Seitinger, Alexander; Rappelsberger, Andrea; Leitich, Harald; Binder, Michael; Adlassnig, Klaus-Peter

2016-08-12

Clinical decision support systems (CDSSs) are being developed to assist physicians in processing extensive data and new knowledge based on recent scientific advances. Structured medical knowledge in the form of clinical alerts or reminder rules, decision trees or tables, clinical protocols or practice guidelines, score algorithms, and others, constitute the core of CDSSs. Several medical knowledge representation and guideline languages have been developed for the formal computerized definition of such knowledge. One of these languages is Arden Syntax for Medical Logic Systems, an International Health Level Seven (HL7) standard whose development started in 1989. Its latest version is 2.10, which was presented in 2014. In the present report we discuss Arden Syntax as a modern medical knowledge representation and processing language, and show that this language is not only well suited to define clinical alerts, reminders, and recommendations, but can also be used to implement and process computerized medical practice guidelines. This section describes how contemporary software such as Java, server software, web-services, XML, is used to implement CDSSs based on Arden Syntax. Special emphasis is given to clinical decision support (CDS) that employs practice guidelines as its clinical knowledge base. Two guideline-based applications using Arden Syntax for medical knowledge representation and processing were developed. The first is a software platform for implementing practice guidelines from dermatology. This application employs fuzzy set theory and logic to represent linguistic and propositional uncertainty in medical data, knowledge, and conclusions. The second application implements a reminder system based on clinically published standard operating procedures in obstetrics to prevent deviations from state-of-the-art care. A to-do list with necessary actions specifically tailored to the gestational week/labor/delivery is generated. Today, with the latest versions of Arden Syntax and the application of contemporary software development methods, Arden Syntax has become a powerful and versatile medical knowledge representation and processing language, well suited to implement a large range of CDSSs, including clinical-practice-guideline-based CDSSs. Moreover, such CDS is provided and can be shared as a service by different medical institutions, redefining the sharing of medical knowledge. Arden Syntax is also highly flexible and provides developers the freedom to use up-to-date software design and programming patterns for external patient data access. Copyright © 2016. Published by Elsevier B.V.

Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.

PubMed

Pappas, Peter G; Kauffman, Carol A; Andes, David R; Clancy, Cornelius J; Marr, Kieren A; Ostrosky-Zeichner, Luis; Reboli, Annette C; Schuster, Mindy G; Vazquez, Jose A; Walsh, Thomas J; Zaoutis, Theoklis E; Sobel, Jack D

2016-02-15

It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

[Management of Patients on Antithrombotic Agents Undergoing Endoscopy].

PubMed

Kim, Joon Sung; Kim, Byung Wook

2018-05-25

Antithrombotic agents are used increasingly in Asia. The management of patients on antithrombotics undergoing elective or emergency endoscopy has become an increasing clinical challenge for gastroenterologists. Current practice guidelines have been developed by societies from western countries. On the other hand, these guidelines cannot meet the specific needs of the Asian Pacific region, raising the need for separate guidelines in Asia. This review compares the recommendations of previous guidelines with the most recently published Asian guidelines regarding the management of patients on antithrombotic agents undergoing elective and emergency endoscopy.

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

PubMed

Jones, Christine E; Munoz, Flor M; Spiegel, Hans M L; Heininger, Ulrich; Zuber, Patrick L F; Edwards, Kathryn M; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T

2016-12-01

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. Copyright © 2016. Published by Elsevier Ltd.

The Society of Thoracic Surgeons, The Society of Cardiovascular Anesthesiologists, and The American Society of ExtraCorporeal Technology: Clinical Practice Guidelines for Cardiopulmonary Bypass--Temperature Management During Cardiopulmonary Bypass.

PubMed

Engelman, Richard; Baker, Robert A; Likosky, Donald S; Grigore, Alina; Dickinson, Timothy A; Shore-Lesserson, Linda; Hammon, John W

2015-08-01

In order to improve our understanding of the evidence-based literature supporting temperature management during adult cardiopulmonary bypass, The Society of Thoracic Surgeons, the Society of Cardiovascular Anesthesiology and the American Society of ExtraCorporeal Technology tasked the authors to conduct a review of the peer-reviewed literature, including: 1) optimal site for temperature monitoring, 2) avoidance of hyperthermia, 3) peak cooling temperature gradient and cooling rate, and 4) peak warming temperature gradient and rewarming rate. Authors adopted the American College of Cardiology/American Heart Association method for development clinical practice guidelines, and arrived at the following recommendations: No Recommendation No recommendation for a guideline is provided concerning optimal temperature for weaning from CPB due to insufficient published evidence. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Evaluation of the methodological quality of two contradictory guidelines recently published by the Haute autorité de santé.

PubMed

Watine, Joseph; Wils, Julien; Augereau, Christine

2017-02-01

Two clinical practice guidelines published in 2012 and in 2013 by the Haute autorité de santé (HAS) respectively entitled "Adult chronic kidney disease" (clinical pathway guidelines) and "Clinical utility of vitamin D measurements" (Health technology assessment) contradict each other on a notable point: in 2012 the HAS recommend to measure blood concentrations of vitamin D once a year in all patients with chronic kidney disease whereas in 2013 the HAS recommend to use this test only for the ambulatory follow-up of patients three months after kidney transplantation. This contradiction encouraged us to evaluate the methodological quality of these two guidelines with the help of the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument which is consensual at an international level, in particular at the WHO (World Health Organization) and at the European Union. At the end of this comparative evaluation this preliminary hypothesis might be proposed: a more rigorous development (AGREE domain n̊3) as well as a higher editorial independence (AGREE domain n̊6) in 2013 than in 2012 (scores respectively are 57% and 56% in 2013 versus 24% and 25% in 2012) ensure a higher validity to the 2013 recommendations than to the 2012 recommendations. However this hypothesis is weakened by the subjective intrinsic value of the AGREE tool, and by various methodological shortcomings in these two guidelines. Therefore we conclude, using the AGREE terminology, that the methods for developing those guidelines are too uncertain, above all in 2012, for recommending their use without modifications.

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.

No. 354-Canadian HIV Pregnancy Planning Guidelines.

PubMed

Loutfy, Mona; Kennedy, V Logan; Poliquin, Vanessa; Dzineku, Frederick; Dean, Nicola L; Margolese, Shari; Symington, Alison; Money, Deborah M; Hamilton, Scot; Conway, Tracey; Khan, Sarah; Yudin, Mark H

2018-01-01

The objective of the Canadian HIV Pregnancy Planning Guidelines is to provide clinical information and recommendations for health care providers to assist Canadians affected by HIV with their fertility, preconception, and pregnancy planning decisions. These guidelines are evidence- and community-based and flexible and take into account diverse and intersecting local/population needs based on the social determinants of health. EVIDENCE: Literature searches were conducted by a librarian using the Medline, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase databases for published articles in English and French related to HIV and pregnancy and HIV and pregnancy planning for each section of the guidelines. The full search strategy is available upon request. The evidence obtained was reviewed and evaluated by the Infectious Diseases Committee of the SOGC under the leadership of the principal authors, and recommendations were made according to the guidelines developed by the Canadian Task Force on Preventive Health Care and through use of the Appraisal of Guidelines Research and Evaluation instrument for the development of clinical guidelines. Guideline implementation should assist the practitioner in developing an evidence-based approach for the prevention of unplanned pregnancy, preconception, fertility, and pregnancy planning counselling in the context of HIV infection. These guidelines have been reviewed and approved by the Infectious Disease Committee and the Executive and Council of the SOGC. Canadian Institutes of Health Research Grant Planning and Dissemination grant (Funding Reference # 137186), which funded a Development Team meeting in 2016. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

Clinical imaging guidelines part 4: challenges in identifying, engaging and collaborating with stakeholders.

PubMed

Bettmann, Michael A; Oikarinen, Helja; Rehani, Madan; Holmberg, Ola; del Rosario Perez, Maria; Naidoo, Anusha; Do, Kyung-Hyun; Dreyer, Keith; Ebdon-Jackson, Steve

2015-04-01

The effective development and use of clinical imaging guidelines requires an understanding of who the stakeholders are, what their interests in the process are, and what roles they should play. If the appropriate stakeholders are not engaged in the right roles, it is unlikely that clinical imaging guidelines will be successfully developed, relied on, and actually used. Some stakeholders are obvious: for the development of clinical imaging guidelines, both imagers and those who request examinations, such as general practitioners, internists, and medical specialists, must be involved. To gain acceptance, other relevant groups are stakeholders, including medical societies, other health care professionals, insurers, health IT experts and vendors, and patients. The role of stakeholders must be dictated by their specific interest. For some, involvement in the creation of guidelines is the right role. For others, such as regulators or insurers, reviews or invitations to comment are required, and for others, such as medical educators, it is probably sufficient to provide information and create awareness. Only through a careful consideration of who the stakeholders are and what are their interests are the successful development, acceptance, and use of clinical imaging guidelines likely to occur. Future efforts must focus on collaboration, particularly among groups that create clinical imaging guidelines and those that can support their use, and on regulatory roles and mandates. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Provider Adherence to Implementation of Clinical Practice Guidelines for Neurogenic Bowel in Adults With Spinal Cord Injury

PubMed Central

Goetz, Lance L; Nelson, Audrey L; Guihan, Marylou; Bosshart, Helen T; Harrow, Jeffrey J; Gerhart, Kevin D; Krasnicka, Barbara; Burns, Stephen P

2005-01-01

Background/Objectives: Clinical Practice Guidelines (CPGs) have been published on a number of topics in spinal cord injury (SCI) medicine. Research in the general medical literature shows that the distribution of CPGs has a minimal effect on physician practice without targeted implementation strategies. The purpose of this study was to determine (a) whether dissemination of an SCI CPG improved the likelihood that patients would receive CPG recommended care and (b) whether adherence to CPG recommendations could be improved through a targeted implementation strategy. Specifically, this study addressed the “Neurogenic Bowel Management in Adults with Spinal Cord Injury” Clinical Practice Guideline published in March 1998 by the Consortium for Spinal Cord Medicine Methods: CPG adherence was determined from medical record review at 6 Veterans Affairs SCI centers for 3 time periods: before guideline publication (T1), after guideline publication but before CPG implementation (T2), and after targeted CPG implementation (T3). Specific implementation strategies to enhance guideline adherence were chosen to address the barriers identified by SCI providers in focus groups before the intervention. Results: Overall adherence to recommendations related to neurogenic bowel did not change between T1 and T2 (P = not significant) but increased significantly between T2 and T3 (P < 0.001) for 3 of 6 guideline recommendations. For the other 3 guideline recommendations, adherence rates were noted to be high at T1. Conclusions: While publication of the CPG alone did not alter rates of provider adherence, the use of a targeted implementation plan resulted in increases in adherence rates with some (3 of 6) CPG recommendations for neurogenic bowel management. PMID:16869086

Clinical algorithms to aid osteoarthritis guideline dissemination.

PubMed

Meneses, S R F; Goode, A P; Nelson, A E; Lin, J; Jordan, J M; Allen, K D; Bennell, K L; Lohmander, L S; Fernandes, L; Hochberg, M C; Underwood, M; Conaghan, P G; Liu, S; McAlindon, T E; Golightly, Y M; Hunter, D J

2016-09-01

Numerous scientific organisations have developed evidence-based recommendations aiming to optimise the management of osteoarthritis (OA). Uptake, however, has been suboptimal. The purpose of this exercise was to harmonize the recent recommendations and develop a user-friendly treatment algorithm to facilitate translation of evidence into practice. We updated a previous systematic review on clinical practice guidelines (CPGs) for OA management. The guidelines were assessed using the Appraisal of Guidelines for Research and Evaluation for quality and the standards for developing trustworthy CPGs as established by the National Academy of Medicine (NAM). Four case scenarios and algorithms were developed by consensus of a multidisciplinary panel. Sixteen guidelines were included in the systematic review. Most recommendations were directed toward physicians and allied health professionals, and most had multi-disciplinary input. Analysis for trustworthiness suggests that many guidelines still present a lack of transparency. A treatment algorithm was developed for each case scenario advised by recommendations from guidelines and based on panel consensus. Strategies to facilitate the implementation of guidelines in clinical practice are necessary. The algorithms proposed are examples of how to apply recommendations in the clinical context, helping the clinician to visualise the patient flow and timing of different treatment modalities. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

ACC/AHA Special Report: Clinical Practice Guideline Implementation Strategies: A Summary of Systematic Reviews by the NHLBI Implementation Science Work Group: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

PubMed

Chan, Wiley V; Pearson, Thomas A; Bennett, Glen C; Cushman, William C; Gaziano, Thomas A; Gorman, Paul N; Handler, Joel; Krumholz, Harlan M; Kushner, Robert F; MacKenzie, Thomas D; Sacco, Ralph L; Smith, Sidney C; Stevens, Victor J; Wells, Barbara L

2017-02-28

In 2008, the National Heart, Lung, and Blood Institute convened an Implementation Science Work Group to assess evidence-based strategies for effectively implementing clinical practice guidelines. This was part of a larger effort to update existing clinical practice guidelines on cholesterol, blood pressure, and overweight/obesity. Review evidence from the published implementation science literature and identify effective or promising strategies to enhance the adoption and implementation of clinical practice guidelines. This systematic review was conducted on 4 critical questions, each focusing on the adoption and effectiveness of 4 intervention strategies: (1) reminders, (2) educational outreach visits, (3) audit and feedback, and (4) provider incentives. A scoping review of the Rx for Change database of systematic reviews was used to identify promising guideline implementation interventions aimed at providers. Inclusion and exclusion criteria were developed a priori for each question, and the published literature was initially searched up to 2012, and then updated with a supplemental search to 2015. Two independent reviewers screened the returned citations to identify relevant reviews and rated the quality of each included review. Audit and feedback and educational outreach visits were generally effective in improving both process of care (15 of 21 reviews and 12 of 13 reviews, respectively) and clinical outcomes (7 of 12 reviews and 3 of 5 reviews, respectively). Provider incentives showed mixed effectiveness for improving both process of care (3 of 4 reviews) and clinical outcomes (3 reviews equally distributed between generally effective, mixed, and generally ineffective). Reminders showed mixed effectiveness for improving process of care outcomes (27 reviews with 11 mixed and 3 generally ineffective results) and were generally ineffective for clinical outcomes (18 reviews with 6 mixed and 9 generally ineffective results). Educational outreach visits (2 of 2 reviews), reminders (3 of 4 reviews), and provider incentives (1 of 1 review) were generally effective for cost reduction. Educational outreach visits (1 of 1 review) and provider incentives (1 of 1 review) were also generally effective for cost-effectiveness outcomes. Barriers to clinician adoption or adherence to guidelines included time constraints (8 reviews/overviews); limited staffing resources (2 overviews); timing (5 reviews/overviews); clinician skepticism (5 reviews/overviews); clinician knowledge of guidelines (4 reviews/overviews); and higher age of the clinician (1 overview). Facilitating factors included guideline characteristics such as format, resources, and end-user involvement (6 reviews/overviews); involving stakeholders (5 reviews/overviews); leadership support (5 reviews/overviews); scope of implementation (5 reviews/overviews); organizational culture such as multidisciplinary teams and low-baseline adherence (9 reviews/overviews); and electronic guidelines systems (3 reviews). The strategies of audit and feedback and educational outreach visits were generally effective in improving both process of care and clinical outcomes. Reminders and provider incentives showed mixed effectiveness, or were generally ineffective. No general conclusion could be reached about cost effectiveness, because of limitations in the evidence. Important gaps exist in the evidence on effectiveness of implementation interventions, especially regarding clinical outcomes, cost effectiveness and contextual issues affecting successful implementation. Copyright © 2017 American College of Cardiology Foundation and American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.

Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.

PubMed

Kanji, Salmaan; Hayes, Meghan; Ling, Adam; Shamseer, Larissa; Chant, Clarence; Edwards, David J; Edwards, Scott; Ensom, Mary H H; Foster, David R; Hardy, Brian; Kiser, Tyree H; la Porte, Charles; Roberts, Jason A; Shulman, Rob; Walker, Scott; Zelenitsky, Sheryl; Moher, David

2015-07-01

Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies. Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study. Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies. The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these studies and allow for better assessment of utility for clinical applications.

AHCPR clinical practice guideline on surgical pain management: adoption and outcomes.

PubMed

Devine, E C; Bevsek, S A; Brubakken, K; Johnson, B P; Ryan, P; Sliefert, M K; Rodgers, B

1999-04-01

Pain management practices and short-term patient outcomes in nine acute care hospitals in Milwaukee, Wisconsin, were studied at two points in time. One-and-a-half years after the Agency for Health Care Policy and Research's (AHCPR) Clinical Practice Guideline on Acute Pain Management was published, data from 330 adult surgical patients were collected (Time I). These data were contrasted with data from 373 adult surgical patients collected 2 years later (Time II). There were significant increases in the percentage of patients who reported being taught how to report pain using a pain rating scale and about setting a pain goal preoperatively; in the percentage of patient hospital records with at least one documented numeric pain rating; and in the percentage of patients who received analgesics by intravenous administration. However, pain management practices continued to differ from recommendations in the AHCPR guideline. No significant improvement was noted in the short-term outcomes of patient-rated pain or patient satisfaction with pain management. Availability of well-published guidelines alone may be insufficient to ensure comprehensive adoption of guidelines that are multidimensional in nature and to obtain improvements in patient outcome.

Medicare Utilization of Vertebral Augmentation 2001 to 2014: Effects of Randomized Clinical Trials and Guidelines on Vertebroplasty and Kyphoplasty.

PubMed

Degnan, Andrew J; Hemingway, Jennifer; Hughes, Danny R

2017-08-01

Vertebral fractures have a substantial impact on the health and quality of life of elderly individuals as one of the most common complications of osteoporosis. Vertebral augmentation procedures including vertebroplasty and kyphoplasty have been supported as means of reducing pain and mitigating disability associated with these fractures. However, use of vertebroplasty is debated, with negative randomized controlled trials published in 2009 and divergent clinical guidelines. The effect of changing evidence and guidelines on different practitioners' utilization of both kyphoplasty and vertebroplasty in the years after these developments and publication of data supporting their use is poorly understood. Using national aggregate Medicare claims data from 2002 through 2014, vertebroplasty and kyphoplasty procedures were identified by provider type. Changes in utilization by procedure type and provider were studied. Total vertebroplasty billing increased 101.6% from 2001 (18,911) through 2008 (38,123). Total kyphoplasty billing frequency increased 17.2% from 2006 (54,329) through 2008 (63,684). Vertebroplasty billing decreased 60.9% from 2008 through 2014 to its lowest value (14,898). Kyphoplasty billing decreased 8.4% from 2008 (63,684) through 2010 (58,346), but then increased 7.6% from 2010 to 2013 (62,804). Vertebroplasty billing decreased substantially beginning in 2009 and continued to decrease through 2014 despite publication of more favorable studies in 2010 to 2012, suggesting studies published in 2009 and AAOS guidelines in 2010 may have had a persistent negative effect. Kyphoplasty did not decrease as substantially and increased in more recent years, suggesting a clinical practice response to favorable studies published during this period. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Subarachnoid haemorrhage guidelines and clinical practice: a cross-sectional study of emergency department consultants' and neurospecialists' views and risk tolerances.

PubMed

Lansley, J; Selai, C; Krishnan, A S; Lobotesis, K; Jäger, H R

2016-09-15

To establish if emergency medicine and neuroscience specialist consultants have different risk tolerances for investigation of suspected spontaneous subarachnoid haemorrhage (SAH), and to establish if their risk-benefit appraisals concur with current guidelines. 4 major neuroscience centres in London. 58 consultants in emergency medicine and neuroscience specialities (neurology, neurosurgery and neuroradiology) participated in an anonymous survey. The primary outcome measure was the highest stated acceptable risk of missing SAH in the neurologically intact patient presenting with sudden onset headache. Secondary outcome measures included agreement with guideline recommendations, risk/benefit appraisal and required performance of diagnostic tests, including lumbar puncture. Emergency department clinicians accepted almost 3 times the risk of a missed SAH diagnosis compared with the neuroscience specialists (2.8% vs 1.1%; p=0.02), were more likely to accept a higher risk of missed diagnosis for the benefit of a non-invasive test (p=0.04) and were more likely to disagree with current published guidelines stipulating the need for LP in all CT-negative cases (p=0.001). Divergence from recognised procedures for SAH investigation is often criticised and attributed to a lack of knowledge of guidelines. This study indicates that divergence from guidelines may be explained by alternative risk-benefit appraisals made by doctors with their patients. Guideline recommendations may gain wider acceptance if they accommodate the requirements of the doctors and patients using them. Further study of clinical risk tolerance may help explain patterns of diagnostic test use and other variations in healthcare delivery. 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/

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.

[Guidelines for management of epilepsy--commentary on Scottish ("SIGN") guidelines].

PubMed

Planjar-Prvan, Miljenka; Granić, Davorka

2005-01-01

The choice of AED (antiepileptic drug), worldwide and in Croatia, is been still based on the physician's subjective decision, personal experience, knowledge and marketing pressure made by big pharmaceutical industries. Therefore, according to some opinions, there is a need of treatment guidelines for epilepsy that would provide relevant information based on scientific evidence on the efficacy, tolerability and safety of AEDs. The guidelines, published by a competent source, should be designed as to allow for easy access to the information on the best practice in specific cases. An extensive background literature review was made to identify such a type of guidelines for the management of epilepsy. The literature review revealed a number of references with the recommendations for treating epilepsy in different groups of patients and from various, specific aspects of epilepsy treatment. However, only one comprehensive set of guidelines for the diagnosis and treatment of epilepsy treatment was found, i.e. the evidence-based guidelines published by the Scottish Intercollegiate Guidelines Network (SIGN). The development of this set of guidelines is quite extensively described in order to illustrate how rigorous and long-lasting the process was, including a great number of health professionals at the national level. Such a type of well designed guidelines facilitates access to highest educational standards for all professionals involved in the primary and secondary care of people with epilepsy. However, it is clear that guidelines can fully replace the standards of clinical practice based on critical evaluation and integration of all clinical data of each individual patient. No guidelines can replace the physician's obligation to keep informed of the novel achievements in the epileptology either.

Korean clinical practice guideline for benign prostatic hyperplasia

PubMed Central

Yeo, Jeong Kyun; Choi, Hun; Bae, Jae Hyun; Kim, Jae Heon; Yang, Seong Ok; Oh, Chul Young; Cho, Young Sam; Kim, Kyoung Woo

2016-01-01

In 2014, the Korean Urological Association organized the Benign Prostatic Hyperplasia Guideline Developing Committee composed of experts in the field of benign prostatic hyperplasia (BPH) with the participation of the Korean Academy of Family Medicine and the Korean Continence Society to develop a Korean clinical practice guideline for BPH. The purpose of this clinical practice guideline is to provide current and comprehensive recommendations for the evaluation and treatment of BPH. The committee developed the guideline mainly by adapting existing guidelines and partially by using the de novo method. A comprehensive literature review was carried out primarily from 2009 to 2013 by using medical search engines including data from Korea. Based on the published evidence, recommendations were synthesized, and the level of evidence of the recommendations was determined by using methods adapted from the 2011 Oxford Centre for Evidence-Based Medicine. Meta-analysis was done for one key question and four recommendations. A draft guideline was reviewed by expert peer reviewers and discussed at an expert consensus meeting until final agreement was achieved. This evidence-based guideline for BPH provides recommendations to primary practitioners and urologists for the diagnosis and treatment of BPH in men older than 40 years. PMID:26966724

Transparency in the reporting of in vivo pre-clinical pain research: The relevance and implications of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines.

PubMed

Rice, Andrew S C; Morland, Rosemary; Huang, Wenlong; Currie, Gillian L; Sena, Emily S; Macleod, Malcolm R

2017-12-29

Clear reporting of research is crucial to the scientific process. Poorly designed and reported studies are damaging not only to the efforts of individual researchers, but also to science as a whole. Standardised reporting methods, such as those already established for reporting randomised clinical trials, have led to improved study design and facilitated the processes of clinical systematic review and meta-analysis. Such standards were lacking in the pre-clinical field until the development of the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines. These were prompted following a survey which highlighted a widespread lack of robust and consistent reporting of pre-clinical in vivo research, with reports frequently omitting basic information required for study replication and quality assessment. The resulting twenty item checklist in ARRIVE covers all aspects of experimental design with particular emphasis on bias reduction and methodological transparency. Influential publishers and research funders have already adopted ARRIVE. Further dissemination and acknowledgement of the importance of these guidelines is vital to their widespread implementation. Conclusions and implications Wide implementation of the ARRIVE guidelines for reporting of in vivo preclinical research, especially pain research, are essential for a much needed increased transparency and quality in publishing such research. ARRIVE will also positively influence improvements in experimental design and quality, assist the conduct of accurate replication studies of important new findings and facilitate meta-analyses of preclinical research.

American college of gastroenterology monograph on the management of irritable bowel syndrome.

PubMed

Camilleri, Michael

2015-04-01

This editorial reviews a recently published guideline on management of irritable bowel syndrome. The guideline illustrates problems arising from the quality of clinical trials used in systematic reviews and the potential impact of the inherent weaknesses of those trials on rating the strength of evidence and the resulting recommendations.

Royal Australian and New Zealand College of Psychiatrists clinical practice guideline for the management of deliberate self-harm.

PubMed

Carter, Gregory; Page, Andrew; Large, Matthew; Hetrick, Sarah; Milner, Allison Joy; Bendit, Nick; Walton, Carla; Draper, Brian; Hazell, Philip; Fortune, Sarah; Burns, Jane; Patton, George; Lawrence, Mark; Dadd, Lawrence; Robinson, Jo; Christensen, Helen

2016-10-01

To provide guidance for the organisation and delivery of clinical services and the clinical management of patients who deliberately self-harm, based on scientific evidence supplemented by expert clinical consensus and expressed as recommendations. Articles and information were sourced from search engines including PubMed, EMBASE, MEDLINE and PsycINFO for several systematic reviews, which were supplemented by literature known to the deliberate self-harm working group, and from published systematic reviews and guidelines for deliberate self-harm. Information was reviewed by members of the deliberate self-harm working group, and findings were then formulated into consensus-based recommendations and clinical guidance. The guidelines were subjected to successive consultation and external review involving expert and clinical advisors, the public, key stakeholders, professional bodies and specialist groups with interest and expertise in deliberate self-harm. The Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for deliberate self-harm provide up-to-date guidance and advice regarding the management of deliberate self-harm patients, which is informed by evidence and clinical experience. The clinical practice guidelines for deliberate self-harm is intended for clinical use and service development by psychiatrists, psychologists, physicians and others with an interest in mental health care. The clinical practice guidelines for deliberate self-harm address self-harm within specific population sub-groups and provide up-to-date recommendations and guidance within an evidence-based framework, supplemented by expert clinical consensus. © The Royal Australian and New Zealand College of Psychiatrists 2016.

Pediatric Sepsis Guidelines: Summary for resource-limited countries

PubMed Central

Khilnani, Praveen; Singhi, Sunit; Lodha, Rakesh; Santhanam, Indumathi; Sachdev, Anil; Chugh, Krishan; Jaishree, M.; Ranjit, Suchitra; Ramachandran, Bala; Ali, Uma; Udani, Soonu; Uttam, Rajiv; Deopujari, Satish

2010-01-01

Justification: Pediatric sepsis is a commonly encountered global issue. Existing guidelines for sepsis seem to be applicable to the developed countries, and only few articles are published regarding application of these guidelines in the developing countries, especially in resource-limited countries such as India and Africa. Process: An expert representative panel drawn from all over India, under aegis of Intensive Care Chapter of Indian Academy of Pediatrics (IAP) met to discuss and draw guidelines for clinical practice and feasibility of delivery of care in the early hours in pediatric patient with sepsis, keeping in view unique patient population and limited availability of equipment and resources. Discussion included issues such as sepsis definitions, rapid cardiopulmonary assessment, feasibility of early aggressive fluid therapy, inotropic support, corticosteriod therapy, early endotracheal intubation and use of positive end expiratory pressure/mechanical ventilation, initial empirical antibiotic therapy, glycemic control, and role of immunoglobulin, blood, and blood products. Objective: To achieve a reasonable evidence-based consensus on the basis of published literature and expert opinion to formulating clinical practice guidelines applicable to resource-limited countries such as India. Recommendations: Pediatric sepsis guidelines are presented in text and flow chart format keeping resource limitations in mind for countries such as India and Africa. Levels of evidence are indicated wherever applicable. It is anticipated that once the guidelines are used and outcomes data evaluated, further modifications will be necessary. It is planned to periodically review and revise these guidelines every 3–5 years as new body of evidence accumulates. PMID:20606908

2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer

PubMed Central

Alexander, Erik K.; Bible, Keith C.; Doherty, Gerard M.; Mandel, Susan J.; Nikiforov, Yuri E.; Pacini, Furio; Randolph, Gregory W.; Sawka, Anna M.; Schlumberger, Martin; Schuff, Kathryn G.; Sherman, Steven I.; Sosa, Julie Ann; Steward, David L.; Tuttle, R. Michael; Wartofsky, Leonard

2016-01-01

Background: Thyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association's (ATA's) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid nodules and differentiated thyroid cancer. Methods: The specific clinical questions addressed in these guidelines were based on prior versions of the guidelines, stakeholder input, and input of task force members. Task force panel members were educated on knowledge synthesis methods, including electronic database searching, review and selection of relevant citations, and critical appraisal of selected studies. Published English language articles on adults were eligible for inclusion. The American College of Physicians Guideline Grading System was used for critical appraisal of evidence and grading strength of recommendations for therapeutic interventions. We developed a similarly formatted system to appraise the quality of such studies and resultant recommendations. The guideline panel had complete editorial independence from the ATA. Competing interests of guideline task force members were regularly updated, managed, and communicated to the ATA and task force members. Results: The revised guidelines for the management of thyroid nodules include recommendations regarding initial evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy, interpretation of fine-needle aspiration biopsy results, use of molecular markers, and management of benign thyroid nodules. Recommendations regarding the initial management of thyroid cancer include those relating to screening for thyroid cancer, staging and risk assessment, surgical management, radioiodine remnant ablation and therapy, and thyrotropin suppression therapy using levothyroxine. Recommendations related to long-term management of differentiated thyroid cancer include those related to surveillance for recurrent disease using imaging and serum thyroglobulin, thyroid hormone therapy, management of recurrent and metastatic disease, consideration for clinical trials and targeted therapy, as well as directions for future research. Conclusions: We have developed evidence-based recommendations to inform clinical decision-making in the management of thyroid nodules and differentiated thyroid cancer. They represent, in our opinion, contemporary optimal care for patients with these disorders. PMID:26462967

2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer.

PubMed

Haugen, Bryan R; Alexander, Erik K; Bible, Keith C; Doherty, Gerard M; Mandel, Susan J; Nikiforov, Yuri E; Pacini, Furio; Randolph, Gregory W; Sawka, Anna M; Schlumberger, Martin; Schuff, Kathryn G; Sherman, Steven I; Sosa, Julie Ann; Steward, David L; Tuttle, R Michael; Wartofsky, Leonard

2016-01-01

Thyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association's (ATA's) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid nodules and differentiated thyroid cancer. The specific clinical questions addressed in these guidelines were based on prior versions of the guidelines, stakeholder input, and input of task force members. Task force panel members were educated on knowledge synthesis methods, including electronic database searching, review and selection of relevant citations, and critical appraisal of selected studies. Published English language articles on adults were eligible for inclusion. The American College of Physicians Guideline Grading System was used for critical appraisal of evidence and grading strength of recommendations for therapeutic interventions. We developed a similarly formatted system to appraise the quality of such studies and resultant recommendations. The guideline panel had complete editorial independence from the ATA. Competing interests of guideline task force members were regularly updated, managed, and communicated to the ATA and task force members. The revised guidelines for the management of thyroid nodules include recommendations regarding initial evaluation, clinical and ultrasound criteria for fine-needle aspiration biopsy, interpretation of fine-needle aspiration biopsy results, use of molecular markers, and management of benign thyroid nodules. Recommendations regarding the initial management of thyroid cancer include those relating to screening for thyroid cancer, staging and risk assessment, surgical management, radioiodine remnant ablation and therapy, and thyrotropin suppression therapy using levothyroxine. Recommendations related to long-term management of differentiated thyroid cancer include those related to surveillance for recurrent disease using imaging and serum thyroglobulin, thyroid hormone therapy, management of recurrent and metastatic disease, consideration for clinical trials and targeted therapy, as well as directions for future research. We have developed evidence-based recommendations to inform clinical decision-making in the management of thyroid nodules and differentiated thyroid cancer. They represent, in our opinion, contemporary optimal care for patients with these disorders.

Elevating the quality of disability and rehabilitation research: mandatory use of the reporting guidelines.

PubMed

Chan, Leighton; Heinemann, Allen W; Roberts, Jason

2014-01-01

Note from the AJOT Editor-in-Chief: Since 2010, the American Journal of Occupational Therapy (AJOT) has adopted reporting standards based on the Consolidated Standards of Reporting Trials (CONSORT) Statement and American Psychological Association (APA) guidelines in an effort to publish transparent clinical research that can be easily evaluated for methodological and analytical rigor (APA Publications and Communications Board Working Group on Journal Article Reporting Standards, 2008; Moher, Schulz, & Altman, 2001). AJOT has now joined 28 other major rehabilitation and disability journals in a collaborative initiative to enhance clinical research reporting standards through adoption of the EQUATOR Network reporting guidelines, described below. Authors will now be required to use these guidelines in the preparation of manuscripts that will be submitted to AJOT. Reviewers will also use these guidelines to evaluate the quality and rigor of all AJOT submissions. By adopting these standards we hope to further enhance the quality and clinical applicability of articles to our readers. Copyright © 2014 by the American Occupational Therapy Association, Inc.

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

PubMed

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

2014-08-01

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

Update on community-acquired bacterial meningitis: guidance and challenges.

PubMed

van Ettekoven, C N; van de Beek, D; Brouwer, M C

2017-09-01

The existing heterogeneity in diagnostic work-up and treatment strategies in bacterial meningitis was the incentive to develop a European evidence-based guideline, which was published in 2016 by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group on Infections of the Brain (ESGIB). To summarize salient features of the guideline, identify recent developments and challenges currently faced. The ESCMID guideline, ongoing trial registries. Epidemiology, clinical symptoms, diagnostic work-up and therapy strategies of acute bacterial meningitis. The incidence of bacterial meningitis has decreased following pneumococcal and meningococcal conjugate vaccine introduction. In the diagnosis of bacterial meningitis the clinical characteristics and laboratory parameters are of limited diagnostic accuracy and therefore cerebrospinal fluid analysis remains the principal contributor to the final diagnosis. The ESCMID guideline advises to start empiric treatment within one hour of arrival in all suspected meningitis cases, and choice of antibiotics needs to be differentiated according to the patient's age, risk factors, and local resistance rates of pneumococci. Dexamethasone is the only proven adjunctive treatment and should be started together with the antibiotics. The follow-up of surviving patients should include evaluation for hearing loss and pneumococcal vaccination to prevent recurrences. Future perspectives include further development and implementation of vaccines, and new treatments aimed at further reducing the inflammatory response. Studies on implementation of the new guideline should determine adherence and evaluate whether improved prognosis can be achieved by following protocolled management strategies. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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

PubMed

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

2017-10-01

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

How to report a research study.

PubMed

Cronin, Paul; Rawson, James V; Heilbrun, Marta E; Lee, Janie M; Kelly, Aine M; Sanelli, Pina C; Bresnahan, Brian W; Paladin, Angelisa M

2014-09-01

Incomplete reporting hampers the evaluation of results and bias in clinical research studies. Guidelines for reporting study design and methods have been developed to encourage authors and journals to include the required elements. Recent efforts have been made to standardize the reporting of clinical health research including clinical guidelines. In this article, the reporting of diagnostic test accuracy studies, screening studies, therapeutic studies, systematic reviews and meta-analyses, cost-effectiveness assessments (CEA), recommendations and/or guidelines, and medical education studies is discussed. The available guidelines, many of which can be found at the Enhancing the QUAlity and Transparency Of health Research network, on how to report these different types of health research are also discussed. We also hope that this article can be used in academic programs to educate the faculty and trainees of the available resources to improve our health research. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

Reconciling the clinical practice guidelines on Bell's palsy from the AAO-HNSF and the AAN.

PubMed

Schwartz, Seth R; Jones, Stephanie L; Getchius, Thomas S D; Gronseth, Gary S

2014-05-01

Bell's palsy, named after the Scottish anatomist, Sir Charles Bell, is the most common acute mononeuropathy, or disorder affecting a single nerve, and is the most common diagnosis associated with facial nerve weakness/paralysis. In the past 2 years, both the American Academy of Neurology (AAN) and the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) have published clinical practice guidelines aimed to improve the quality of care and outcomes for patients diagnosed with Bell's palsy. This commentary aims to address the similarities and differences in the scope and final recommendations made by each guideline development group.

Late-life dementia. Review of the APA guidelines for patient management.

PubMed

Schindler, R J; Cucio, C P

2000-10-01

Management of dementia in older patients requires an individualized and multimodal approach that involves use of psychiatric, psychotherapeutic, psychosocial, and somatic tools and treatments, in addition to patient and family education. The progressive nature of dementia and the invariable presence of comorbidity complicates the management task, although symptoms characteristic of dementia's phases can provide helpful clinical clues to guide evolving care. In 1997, the American Psychiatric Association published the "Practice guideline for the treatment of patients with Alzheimer's disease and other dementias of late life." To date, this is the most comprehensive clinical guideline available to physicians caring for patients with Alzheimer's disease and other related dementias.

Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark?

PubMed

Bannuru, Raveendhara R; Vaysbrot, Elizaveta E; McIntyre, Louis F

2014-01-01

The American Academy of Orthopaedic Surgeons (AAOS) 2013 guidelines for knee osteoarthritis recommended against the use of viscosupplementation for failing to meet the criterion of minimum clinically important improvement (MCII). However, the AAOS's methodology contained numerous flaws in obtaining, displaying, and interpreting MCII-based results. The current state of research on MCII allows it to be used only as a supplementary instrument, not a basis for clinical decision making. The AAOS guidelines should reflect this consideration in their recommendations to avoid condemning potentially viable treatments in the context of limited available alternatives. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2017-01-03

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

The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials.

PubMed

Macrae, Duncan J

2007-05-01

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war crimes trials, more specifically the "Doctors' Trial." From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV/AIDS research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

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.

Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America.

PubMed

Stevens, Dennis L; Bisno, Alan L; Chambers, Henry F; Dellinger, E Patchen; Goldstein, Ellie J C; Gorbach, Sherwood L; Hirschmann, Jan V; Kaplan, Sheldon L; Montoya, Jose G; Wade, James C

2014-07-15

A panel of national experts was convened by the Infectious Diseases Society of America (IDSA) to update the 2005 guidelines for the treatment of skin and soft tissue infections (SSTIs). The panel's recommendations were developed to be concordant with the recently published IDSA guidelines for the treatment of methicillin-resistant Staphylococcus aureus infections. The focus of this guideline is the diagnosis and appropriate treatment of diverse SSTIs ranging from minor superficial infections to life-threatening infections such as necrotizing fasciitis. In addition, because of an increasing number of immunocompromised hosts worldwide, the guideline addresses the wide array of SSTIs that occur in this population. These guidelines emphasize the importance of clinical skills in promptly diagnosing SSTIs, identifying the pathogen, and administering effective treatments in a timely fashion. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America.

PubMed

Stevens, Dennis L; Bisno, Alan L; Chambers, Henry F; Dellinger, E Patchen; Goldstein, Ellie J C; Gorbach, Sherwood L; Hirschmann, Jan V; Kaplan, Sheldon L; Montoya, Jose G; Wade, James C

2014-07-15

A panel of national experts was convened by the Infectious Diseases Society of America (IDSA) to update the 2005 guidelines for the treatment of skin and soft tissue infections (SSTIs). The panel's recommendations were developed to be concordant with the recently published IDSA guidelines for the treatment of methicillin-resistant Staphylococcus aureus infections. The focus of this guideline is the diagnosis and appropriate treatment of diverse SSTIs ranging from minor superficial infections to life-threatening infections such as necrotizing fasciitis. In addition, because of an increasing number of immunocompromised hosts worldwide, the guideline addresses the wide array of SSTIs that occur in this population. These guidelines emphasize the importance of clinical skills in promptly diagnosing SSTIs, identifying the pathogen, and administering effective treatments in a timely fashion. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

NCCN Consensus Guidelines for the Diagnosis and Management of Breast Implant-Associated Anaplastic Large Cell Lymphoma.

PubMed

Clemens, Mark W; Horwitz, Steven M

2017-03-01

Published case series demonstrate a lack of treatment standardization for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) with a wide variety of therapeutic strategies being employed at all stages of disease. The National Comprehensive Cancer Network (NCCN) annually publishes Clinical Practice Guidelines for Non-Hodgkin Lymphomas. For the first time, BIA-ALCL management will be included which signifies an important and needed guideline addition. The new BIA-ALCL guideline was achieved by a consensus of lymphoma oncologists, plastic surgeons, radiation oncologists, and surgical oncologists. NCCN guidelines focus on the diagnosis and management throughout the stages of many lymphoma subtypes based upon the most current data available. This article summarizes the essential recommendations and optimal therapeutic strategies of the NCCN guidelines critical to the plastic surgery community. We encourage international adoption of these BIA-ALCL treatment standards by our specialty societies across the oncology and surgery disciplines. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Myasthenia gravis: Association of British Neurologists' management guidelines.

PubMed

Sussman, Jon; Farrugia, Maria E; Maddison, Paul; Hill, Marguerite; Leite, M Isabel; Hilton-Jones, David

2015-06-01

Myasthenia gravis is an autoimmune disease of the neuromuscular junction for which many therapies were developed before the era of evidence based medicine. The basic principles of treatment are well known, however, patients continue to receive suboptimal treatment as a result of which a myasthenia gravis guidelines group was established under the aegis of The Association of British Neurologists. These guidelines attempt to steer a path between evidence-based practice where available, and established best practice where evidence is unavailable. Where there is insufficient evidence or a choice of options, the guidelines invite the clinician to seek the opinion of a myasthenia expert. The guidelines support clinicians not just in using the right treatments in the right order, but in optimising the use of well-known therapeutic agents. Clinical practice can be audited against these guidelines. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

[Multidisciplinary guidelines for the management of community-acquired pneumonia].

PubMed

Torres, Antoni; Barberán, José; Falguera, Miquel; Menéndez, Rosario; Molina, Jesús; Olaechea, Pedro; Rodríguez, Alejandro

2013-03-02

Community-acquired pneumonia (CAP) is an infectious respiratory disease with an incidence that ranges from 3 to 8 cases per 1,000 inhabitants per year. This incidence increases with age and comorbidities. Forty per cent of CAP patients require hospitalization and around 10% of these patients are admitted in an Intensive Care Unit (ICU). Several studies have suggested that the implementation of clinical guidelines has a positive impact in the outcome of patients including mortality and length of stay. The more recent and used guidelines are those from Infectious Diseases Society of America/American Thoracic Society, published in 2007, the 2009 from the British Thoracic Society, and that from the European Respiratory Society/European Society of Clinical Microbiology and Infectious Diseases, published in 2010. In Spain, the most recently released guideline is the Sociedad Española de Neumología y Cirugía Torácica-2011 guideline. The present guidelines GNAC are designed to be used by the majority of health-care professionals that can participate in the care of CAP patients including diagnosis, decision of hospital and ICU admission, treatment and prevention. The Centro Cochrane Iberoamericano (CCIB) has participated in summarizing the previous guidelines and in the bibliography search. For each one of the following sections the panel of experts has developed a table with recommendations classified according to its evidence, strength and practical applicability using the Grading of Recommendations of Assessment Development and Evaluations (GRADE) system: 1. Epidemiology, microbiological etiology and antibiotic resistances.2. Clinical and microbiological diagnosis.3. Prognostic scales and decision of hospital admission.4. ICU admission criteria. 5. Empirical and definitive antibiotic treatment.6. Treatment failure. 7. Prevention. Copyright © 2012 Elsevier España, S.L. All rights reserved.

[Cancer pain management: Systematic review and critical appraisal of clinical practice guidelines].

PubMed

Martínez-Nicolás, I; Ángel-García, D; Saturno, P J; López-Soriano, F

2016-01-01

Although several clinical practice guidelines have been developed in the last decades, cancer pain management is still deficient. The purpose of this work was to carry out a comprehensive and systematic literature review of current clinical practice guidelines on cancer pain management, and critically appraise their methodology and content in order to evaluate their quality and validity to cope with this public health issue. A systematic review was performed in the main databases, using English, French and Spanish as languages, from 2008 to 2013. Reporting and methodological quality was rated with the Appraisal of Guidelines, Research and Evaluation II (AGREE-II) tool, including an inter-rater reliability analysis. Guideline recommendations were extracted and classified into several categories and levels of evidence, aiming to analyse guidelines variability and evidence-based content comprehensiveness. Six guidelines were included. A wide variability was found in both reporting and methodological quality of guidelines, as well as in the content and the level of evidence of their recommendations. The Scottish Intercollegiate Guidelines Network guideline was the best rated using AGREE-II, while the Sociedad Española de Oncología Médica guideline was the worst rated. The Ministry of Health Malaysia guideline was the most comprehensive, and the Scottish Intercollegiate Guidelines Network guideline was the second one. The current guidelines on cancer pain management have limited quality and content. We recommend Ministry of Health Malaysia and Scottish Intercollegiate Guidelines Network guidelines, whilst Sociedad Española de Oncología Médica guideline still needs to improve. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

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.

SIOP‐PODC adapted risk stratification and treatment guidelines: Recommendations for neuroblastoma in low‐ and middle‐income settings

PubMed Central

Howard, Scott C.; Chantada, Guillermo; Israels, Trijn; Khattab, Mohammed; Alcasabas, Patricia; Lam, Catherine G.; Faulkner, Lawrence; Park, Julie R.; London, Wendy B.; Matthay, Katherine K.

2015-01-01

Neuroblastoma is the most common extracranial solid tumor in childhood in high‐income countries (HIC), where consistent treatment approaches based on clinical and tumor biological risk stratification have steadily improved outcomes. However, in low‐ and middle‐ income countries (LMIC), suboptimal diagnosis, risk stratification, and treatment may occur due to limited resources and unavailable infrastructure. The clinical practice guidelines outlined in this manuscript are based on current published evidence and expert opinions. Standard risk stratification and treatment explicitly adapted to graduated resource settings can improve outcomes for children with neuroblastoma by reducing preventable toxic death and relapse. Pediatr Blood Cancer 2015;62:1305–1316. © 2015 The Authors. Pediatric Blood & Cancer, published by Wiley Periodicals, Inc. PMID:25810263

Guidelines for clinical use of CBCT: a review.

PubMed

Horner, K; O'Malley, L; Taylor, K; Glenny, A-M

2015-01-01

To identify guidelines on the clinical use of CBCT in dental and maxillofacial radiology, in particular selection criteria, to consider how they were produced, to appraise their quality objectively and to compare their recommendations. A literature search using MEDLINE (Ovid(®)) was undertaken prospectively from 1 January 2000 to identify published material classifiable as "guidelines" pertaining to the use of CBCT in dentistry. This was supplemented by searches on websites, an internet search engine, hand searching of theses and by information from personal contacts. Quality assessment of publications was performed using the AGREE II instrument. Publications were examined for areas of agreement and disagreement. 26 publications were identified, 11 of which were specifically written to give guidelines on the clinical use of CBCT and contained sections on selection criteria. The remainder were a heterogeneous mixture of publications that included guidelines relating to CBCT. Two had used a formal evidence-based approach for guideline development and two used consensus methods. The quality of publications was frequently low as assessed using AGREE II, with many lacking evidence of adequate methodology. There was broad agreement between publications on clinical use, apart from treatment planning, in implant dentistry. Reporting of guideline development is often poorly presented. Guideline development panels should aim to perform and report their work using the AGREE II instrument as a template to raise standards and avoid the risk of suspicions of bias.

2018 AAHA Diabetes Management Guidelines for Dogs and Cats.

PubMed

Behrend, Ellen; Holford, Amy; Lathan, Patty; Rucinsky, Renee; Schulman, Rhonda

Diabetes mellitus (DM) is a common disease encountered in canine and feline medicine. The 2018 AAHA Diabetes Management Guidelines for Dogs and Cats revise and update earlier guidelines published in 2010. The 2018 guidelines retain much of the information in the earlier guidelines that continues to be applicable in clinical practice, along with new information that represents current expert opinion on controlling DM. An essential aspect of successful DM management is to ensure that the owner of a diabetic dog or cat is capable of administering insulin, recognizing the clinical signs of inadequately managed DM, and monitoring blood glucose levels at home, although this is ideal but not mandatory; all topics that are reviewed in the guidelines. Insulin therapy is the mainstay of treatment for clinical DM. The guidelines provide recommendations for using each insulin formulation currently available for use in dogs and cats, the choice of which is generally based on efficacy and duration of effect in the respective species. Also discussed are non-insulin therapeutic medications and dietary management. These treatment modalities, along with insulin therapy, give the practitioner an assortment of options for decreasing the clinical signs of DM while avoiding hypoglycemia, the two conditions that represent the definition of a controlled diabetic. The guidelines review identifying and monitoring patients at risk for developing DM, which are important for avoiding unnecessary insulin therapy in patients with transient hyperglycemia or mildly elevated blood glucose.

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.

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.

[Management of chronic heart failure - a systematic review of guidelines in the context of the DMP revision].

PubMed

Kötter, Thomas; Bartel, Carmen; Schramm, Susanne; Lange, Petra; Höfer, Eva; Hänsel, Michaela; Waffenschmidt, Siw; Waldt, Susanne Ein; Hoffmann-Eßer, Wiebke; Rüther, Alric; Lühmann, Dagmar; Scherer, Martin

2013-01-01

Disease Management Programmes (DMPs) are structured treatment programmes for chronic diseases. The DMP requirements are primarily derived from evidence-based guidelines. DMPs are regularly revised to ensure that they reflect current best practice and medical knowledge. The aim of this study was to assess the need for updating the German DMP module on heart failure by comparing it to relevant guidelines and identifying recommendations that should be revised. We systematically searched for clinical guidelines on heart failure published in German, English or French, and extracted relevant guideline recommendations. All included guidelines were assessed for methodological quality. To identify revision needs in the DMP, we performed a synoptic analysis of the extracted guideline recommendations and DMP requirements. 27 guidelines were included. The extracted recommendations covered all aspects of the management of heart failure. The comparison of guideline recommendations with DMP requirements showed that, overall, guideline recommendations were more detailed than DMP requirements, and that the guidelines covered topics not included in the DMP module. The DMP module is largely consistent with current guidelines on heart failure. We did not identify any need for significant revision of the DMP requirements. However, some specific recommendations of the DMP module could benefit from revision. Copyright © 2013. Published by Elsevier GmbH.

Publishing web-based guidelines using interactive decision models.

PubMed

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

2001-05-01

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

Consumer involvement in topic and outcome selection in the development of clinical practice guidelines.

PubMed

Tong, Allison; Lopez-Vargas, Pamela; Howell, Martin; Phoon, Richard; Johnson, David; Campbell, Denise; Walker, Rowan G; Craig, Jonathan C

2012-12-01

Consumer involvement in guideline development is advocated, but minimal participation, such as a nominated consumer representative on a guideline working group, can inhibit their decision-making power and contribution. Little is known about how to involve consumers more effectively in guideline development. To describe a targeted approach for involving consumers actively in guideline development, by focusing on topic and outcome selection, and to discuss the impact on content and structure of the final guideline. Descriptive study. Patients and carers (n = 24) from a tertiary hospital in Sydney attended three structured peer-facilitated workshops to complete group-based exercises on topic and outcome selection for guidelines for early stage chronic kidney disease. These workshops were run in parallel with the guideline-writing group. For each exercise, participants formed small groups and facilitated their own discussion, recorded their responses and presented them to the wider group. The topics and outcomes identified were fed back to the guideline writers. The participants actively engaged in the workshop discussions and articulated topics and outcomes they perceived should be included in clinical guidelines. Four main changes to guideline-related outputs were observed. A new guideline subtopic was introduced, guidelines were consumer-endorsed, guideline recommendations and suggestions for clinical care were augmented with consumer-focused issues, and plain English guidelines were developed. Consumer workshops in parallel and feeding into guideline development can be a feasible and effective approach for active consumer contribution. This process can inform the development of both consumer-focused guidelines for clinicians and specific versions for consumers. © 2011 Blackwell Publishing Ltd.

2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines.

PubMed

Ferraris, Victor A; Brown, Jeremiah R; Despotis, George J; Hammon, John W; Reece, T Brett; Saha, Sibu P; Song, Howard K; Clough, Ellen R; Shore-Lesserson, Linda J; Goodnough, Lawrence T; Mazer, C David; Shander, Aryeh; Stafford-Smith, Mark; Waters, Jonathan; Baker, Robert A; Dickinson, Timothy A; FitzGerald, Daniel J; Likosky, Donald S; Shann, Kenneth G

2011-03-01

Practice guidelines reflect published literature. Because of the ever changing literature base, it is necessary to update and revise guideline recommendations from time to time. The Society of Thoracic Surgeons recommends review and possible update of previously published guidelines at least every three years. This summary is an update of the blood conservation guideline published in 2007. The search methods used in the current version differ compared to the previously published guideline. Literature searches were conducted using standardized MeSH terms from the National Library of Medicine PUBMED database list of search terms. The following terms comprised the standard baseline search terms for all topics and were connected with the logical 'OR' connector--Extracorporeal circulation (MeSH number E04.292), cardiovascular surgical procedures (MeSH number E04.100), and vascular diseases (MeSH number C14.907). Use of these broad search terms allowed specific topics to be added to the search with the logical 'AND' connector. In this 2011 guideline update, areas of major revision include: 1) management of dual anti-platelet therapy before operation, 2) use of drugs that augment red blood cell volume or limit blood loss, 3) use of blood derivatives including fresh frozen plasma, Factor XIII, leukoreduced red blood cells, platelet plasmapheresis, recombinant Factor VII, antithrombin III, and Factor IX concentrates, 4) changes in management of blood salvage, 5) use of minimally invasive procedures to limit perioperative bleeding and blood transfusion, 6) recommendations for blood conservation related to extracorporeal membrane oxygenation and cardiopulmonary perfusion, 7) use of topical hemostatic agents, and 8) new insights into the value of team interventions in blood management. Much has changed since the previously published 2007 STS blood management guidelines and this document contains new and revised recommendations. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Chinese guidelines for treatment of adult primary immune thrombocytopenia.

PubMed

Liu, Xin-Guang; Bai, Xiao-Chuan; Chen, Fang-Ping; Cheng, Yun-Feng; Dai, Ke-Sheng; Fang, Mei-Yun; Feng, Jian-Ming; Gong, Yu-Ping; Guo, Tao; Guo, Xin-Hong; Han, Yue; Hong, Luo-Jia; Hu, Yu; Hua, Bao-Lai; Huang, Rui-Bing; Li, Yan; Peng, Jun; Shu, Mi-Mi; Sun, Jing; Sun, Pei-Yan; Sun, Yu-Qian; Wang, Chun-Sen; Wang, Shu-Jie; Wang, Xiao-Min; Wu, Cong-Ming; Wu, Wen-Man; Yan, Zhen-Yu; Yang, Feng-E; Yang, Lin-Hua; Yang, Ren-Chi; Yang, Tong-Hua; Ye, Xu; Zhang, Guang-Sen; Zhang, Lei; Zheng, Chang-Cheng; Zhou, Hu; Zhou, Min; Zhou, Rong-Fu; Zhou, Ze-Ping; Zhu, Hong-Li; Zhu, Tie-Nan; Hou, Ming

2018-06-01

Primary immune thrombocytopenia (ITP) is a bleeding disorder commonly encountered in clinical practice. The International Working Group (IWG) on ITP has published several landmark papers on terminology, definitions, outcome criteria, bleeding assessment, diagnosis, and management of ITP. The Chinese consensus reports for diagnosis and management of adult ITP have been updated to the 4th edition. Based on current consensus positions and new emerging clinical evidence, the thrombosis and hemostasis group of the Chinese Society of Hematology issued Chinese guidelines for management of adult ITP, which aim to provide evidence-based recommendations for clinical decision making.

Oncology biomarkers: discovery, validation, and clinical use.

PubMed

Heckman-Stoddard, Brandy M

2012-05-01

To discuss the discovery, validation, and clinical use of multiple types of biomarkers. Medical literature and published guidelines. Formal validation of biomarkers should include both retrospective analyses of well-characterized samples as well as a prospective clinical trial in which the biomarker is tested for its ability to predict the presence of disease or the efficacy of a cancer therapy. Biomarker development is complicated, with very few biomarker discoveries leading to clinically useful tests. Nurses should understand how a biomarker was developed, including the sensitivity and specificity before applying new biomarkers in the clinical setting. Copyright © 2012. Published by Elsevier Inc.

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

PubMed

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

2017-12-01

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

Treatment algorithms and protocolized care.

PubMed

Morris, Alan H

2003-06-01

Excess information in complex ICU environments exceeds human decision-making limits and likely contributes to unnecessary variation in clinical care, increasing the likelihood of clinical errors. I reviewed recent critical care clinical trials searching for information about the impact of protocol use on clinically pertinent outcomes. Several recently published clinical trials illustrate the importance of distinguishing efficacy and effectiveness trials. One of these trials illustrates the danger of conducting effectiveness trials before the efficacy of an intervention is established. The trials also illustrate the importance of distinguishing guidelines and inadequately explicit protocols from adequately explicit protocols. Only adequately explicit protocols contain enough detail to lead different clinicians to the same decision when faced with the same clinical scenario. Differences between guidelines and protocols are important. Guidelines lack detail and provide general guidance that requires clinicians to fill in many gaps. Computerized or paper-based protocols are detailed and, when used for complex clinical ICU problems, can generate patient-specific, evidence-based therapy instructions that can be carried out by different clinicians with almost no interclinician variability. Individualization of patient therapy can be preserved by these protocols when they are driven by individual patient data. Explicit decision-support tools (eg, guidelines and protocols) have favorable effects on clinician and patient outcomes and can reduce the variation in clinical practice. Guidelines and protocols that aid ICU decision makers should be more widely distributed.

How updating textual clinical practice guidelines impacts clinical decision support systems: a case study with bladder cancer management.

PubMed

Bouaud, Jacques; Séroussi, Brigitte; Brizon, Ambre; Culty, Thibault; Mentré, France; Ravery, Vincent

2007-01-01

Guideline-based clinical decision support systems (CDSSs) can be effective in increasing physician compliance with recommendations. However, the ever growing pace at which medical knowledge is produced requires that clinical practice guidelines (CPGs) be updated regularly. It is therefore mandatory that CDSSs be revised accordingly. The French Association for Urology publishes CPGs on bladder cancer management every 2 years. We studied the impact of the 2004 revision of these guidelines, with respect to the 2002 version with a CDSS, UroDoc. We proposed a typology of knowledge base modifications resulting from the update of CPGs making the difference between practice, clinical conditions and recommendations refinement as opposed to new practice and new recommendations. The number of formalized recommendations increased from 577 in 2002 to 1,081 in 2004. We evaluated the two versions of UroDoc on a randomized sample of patient records. A single new practice that modifies a decision taken in 49% of all recorded decisions leads to a fall from 67% to 46% of the compliance rate of decisions.

Japanese Clinical Guidelines for Endoscopic Treatment of Pancreatolithiasis.

PubMed

Inui, Kazuo; Igarashi, Yoshinori; Irisawa, Atsushi; Ohara, Hirotaka; Tazuma, Susumu; Hirooka, Yoshiki; Fujita, Naotaka; Miyakawa, Hiroyuki; Sata, Naohiro; Shimosegawa, Tooru; Tanaka, Masao; Shiratori, Keiko; Sugiyama, Masanori; Takeyama, Yoshifumi

2015-10-01

In addition to surgery, procedures for patients with pancreatolithiasis are developing; therefore, establishing practical guidelines for the management of pancreatolithiasis is required. Three committees (the professional committee for asking clinical questions (CQs) and statements by Japanese endoscopists, the expert panel committee for rating statements by the modified Delphi method, and the evaluating committee by moderators) were organized. Eight endoscopists and a surgeon for pancreatolithiasis made the CQs and statements from a total of 694 reports of published literature by PubMed search (from 1983 to 2012). The expert panelists individually rated these clinical statements using a modified Delphi approach, in which a clinical statement receiving a median score greater than 7 on a 9-point scale from the panel was regarded as valid. The professional committee made 3, 7, and 10 CQs and statements for the concept and pathogenesis, diagnosis, and treatment, respectively. The expert panelists regarded them as valid after a 2-round modified Delphi approach. After evaluation by the moderators, the Japanese clinical guidelines for pancreatolithiasis were established. Further discussions and studies for international guidelines are needed.

No. 292-Abnormal Uterine Bleeding in Pre-Menopausal Women.

PubMed

Singh, Sukhbir; Best, Carolyn; Dunn, Sheila; Leyland, Nicholas; Wolfman, Wendy Lynn

2018-05-01

Abnormal uterine bleeding is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for this problem during their reproductive years. This guideline replaces previous clinical guidelines on the topic and is aimed to enable health care providers with the tools to provide the latest evidence-based care in the diagnosis and the medical and surgical management of this common problem. To provide current evidence-based guidelines for the diagnosis and management of abnormal uterine bleeding (AUB) among women of reproductive age. Outcomes evaluated include the impact of AUB on quality of life and the results of interventions including medical and surgical management of AUB. Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of location in Canada, type of practice, subspecialty expertise, and general gynaecology background. The committee reviewed relevant evidence in the English medical literature including published guidelines. Recommendations were established as consensus statements. The final document was reviewed and approved by the Executive and Council of the SOGC. This document provides a summary of up-to-date evidence regarding diagnosis, investigations, and medical and surgical management of AUB. The resulting recommendations may be adapted by individual health care workers when serving women with this condition. Abnormal uterine bleeding is a common and sometimes debilitating condition in women of reproductive age. Standardization of related terminology, a systematic approach to diagnosis and investigation, and a step-wise approach to intervention is necessary. Treatment commencing with medical therapeutic modalities followed by the least invasive surgical modalities achieving results satisfactory to the patient is the ultimate goal of all therapeutic interventions. Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e. g., uterine hemorrhage, menorrhagia) and key words (e. g., menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology- related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered. RECOMMENDATIONS. Copyright © 2018. Published by Elsevier Inc.

No. 341-Diagnosis and Management of Adnexal Torsion in Children, Adolescents, and Adults.

PubMed

Kives, Sari; Gascon, Suzy; Dubuc, Élise; Van Eyk, Nancy

2017-02-01

To review the evidence and provide recommendations on the diagnosis and management of adnexal torsion in children, adolescents, and women. Elements evaluated include the risk factors, diagnostic accuracy, management options, and outcomes of adnexal torsion. Published literature was retrieved through searches of MEDLINE, Embase, CINAHL, and the Cochrane Library using appropriate controlled vocabulary and key words ("adnexal torsion," "ovarian torsion"). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis and new material incorporated in the guideline to December 2014. Grey (unpublished) literature was identified through searching the websites of health technology assessment and related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The evidence obtained was reviewed and evaluated by the Canadian Paediatric and Adolescent Gynaecology and Obstetrics Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) under the leadership of the principal authors. Recommendations were made according to guidelines developed by the Canadian Task Force on the Periodic Health Examination. Guideline implementation should assist the practitioner in developing an optimal approach to the diagnosis and management of adnexal torsion while minimizing harm and improving patient outcomes. These guidelines have been reviewed and approved by the Gynaecology Committee of the SOGC and approved by the council of the SOGC. The Society of Obstetricians and Gynaecologists of Canada SUMMARY STATEMENTS: RECOMMENDATIONS. Copyright © 2017. Published by Elsevier Inc.

Quality of Author Guidelines in Nursing Journals

PubMed Central

Nicoll, Leslie H.; Chinn, Peggy L.; Conklin, Jamie L.; McCarty, Midori; Amarasekara, Sathya

2018-01-01

Abstract Purpose The aims of this study were to (a) describe the information provided in author guidelines in nursing journals, (b) assess the completeness of this information, and (c) identify the extent and types of reporting guidelines used in nursing journals. Design Content analysis of author guidelines for 245 nursing journals included in the Directory of Nursing Journals maintained at the International Academy of Nursing Editors website. Methods Using Research Electronic Data Capture, data on 19 criteria for completeness were extracted from published author guidelines. Additional details about journal requirements, such as allowed length of manuscripts and format for the abstract, were also recorded. Reliability was established by simultaneous review of 25 journals (10%) by the research assistant and a senior member of the research team. Findings Author guidelines were easily accessible at journal websites or through links to download the information. A majority (73.5%) had completeness scores of 75% or higher; six journals had guidelines that were 100% complete. Half of the journals used the American Psychological Association reference style, and 26.3% used the American Medical Association style. Less than one fourth had stated requirements to use reporting guidelines such as Consolidated Standards of Reporting Trials (CONSORT) and Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA). Conclusions Author guidelines for nursing journals are generally complete and informative. Although specific reporting guidelines such as CONSORT and PRISMA improve the accuracy and completeness of manuscripts on various types of studies, most nursing journals do not indicate use of these for manuscript preparation. Editors who want to improve their author guidelines should use the 19 criteria for completeness as a gauge for updating and revision. Clinical Relevance Nurses rely on the published literature to inform their practice and ensure that it is based on evidence. Guidelines for publishing in the scholarly literature assist clinicians and scholars to ensure that published articles are complete, current, concise, and accurate. PMID:29645403

Guidelines for Guidelines: Are They Up to the Task? A Comparative Assessment of Clinical Practice Guideline Development Handbooks

PubMed Central

Ansari, Shabnam; Rashidian, Arash

2012-01-01

Objectives We conducted a comparative review of clinical practice guideline development handbooks. We aimed to identify the main guideline development tasks, assign weights to the importance of each task using expert opinions and identify the handbooks that provided a comprehensive coverage of the tasks. Methods We systematically searched and included handbooks published (in English language) by national, international or professional bodies responsible for evidenced-based guideline development. We reviewed the handbooks to identify the main guideline development tasks and scored each handbook for each task from 0 (the handbook did not mention the task) to 2 (the task suitably addressed and explained), and calculated a weighted score for each handbook. The tasks included in over 75% of the handbooks were considered as ‘necessary’ tasks. Result Nineteen guideline development handbooks and twenty seven main tasks were identified. The guideline handbooks’ weighted scores ranged from 100 to 220. Four handbooks scored over 80% of the maximum possible score, developed by the National Institute for Health and Clinical Excellence, Swiss Centre for International Health, Scottish Intercollegiate Guidelines Network and World Health Organization. Necessary tasks were: selecting the guideline topic, determining the guideline scope, identifying relevant existing guidelines, involving the consumers, forming guideline development group,, developing clinical questions, systematic search for evidence, selecting relevant evidence, appraising identifies research evidence, making group decision, grading available evidence, creating recommendations, final stakeholder consultation, guideline implementation strategies, updating recommendations and correcting potential errors. Discussion Adequate details for evidence based development of guidelines were still lacking from many handbooks. The tasks relevant to ethical issues and piloting were missing in most handbooks. The findings help decision makers in identifying the necessary tasks for guideline development, provide an updated comparative list of guideline development handbooks, and provide a checklist to assess the comprehensiveness of guideline development processes. PMID:23189167

International Society for Magnetic Resonance in Medicine

MedlinePlus

... Exchange Program 2018 Deadline 23 February 2018! Clinical & research guidelines re gadolinium deposition on the brain, published ... Mar Quantitative Body Imaging More… Cultivate the MR Leaders of ...

Systematic review of colorectal cancer screening guidelines for average-risk adults: Summarizing the current global recommendations.

PubMed

Bénard, Florence; Barkun, Alan N; Martel, Myriam; von Renteln, Daniel

2018-01-07

To summarize and compare worldwide colorectal cancer (CRC) screening recommendations in order to identify similarities and disparities. A systematic literature search was performed using MEDLINE, EMBASE, Scopus, CENTRAL and ISI Web of knowledge identifying all average-risk CRC screening guideline publications within the last ten years and/or position statements published in the last 2 years. In addition, a hand-search of the webpages of National Gastroenterology Society websites, the National Guideline Clearinghouse, the BMJ Clinical Evidence website, Google and Google Scholar was performed. Fifteen guidelines were identified. Six guidelines were published in North America, four in Europe, four in Asia and one from the World Gastroenterology Organization. The majority of guidelines recommend screening average-risk individuals between ages 50 and 75 using colonoscopy (every 10 years), or flexible sigmoidoscopy (FS, every 5 years) or fecal occult blood test (FOBT, mainly the Fecal Immunochemical Test, annually or biennially). Disparities throughout the different guidelines are found relating to the use of colonoscopy, rank order between test, screening intervals and optimal age ranges for screening. Average risk individuals between 50 and 75 years should undergo CRC screening. Recommendations for optimal surveillance intervals, preferred tests/test cascade as well as the optimal timing when to start and stop screening differ regionally and should be considered for clinical decision making. Furthermore, local resource availability and patient preferences are important to increase CRC screening uptake, as any screening is better than none.

Health economics and European Renal Best Practice--is it time to bring health economics into evidence-based guideline production in Europe?

PubMed

Haller, Maria C; Vanholder, Raymond; Oberbauer, Rainer; Zoccali, Carmine; Van Biesen, Wim

2014-11-01

Medical management of patients with kidney disease is complex and resource intensive. In times of limited health care budgets, economic evaluations have become more important over the past few years in identifying interventions with a beneficial cost-effectiveness to maximize the benefits served from the available resources. However, integrating evidence from health-economic evaluations into clinical practice guidelines remains a challenge. European Renal Best Practice (ERBP), the official guideline body of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) herewith presents some lines of thought that need consideration in the discussion on incorporating health-economic considerations into clinical guideline development. © The Author 2013. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

[Clinical practice guidelines for assessment and treatment of transsexualism. SEEN Identity and Sexual Differentiation Group (GIDSEEN)].

PubMed

Moreno-Pérez, Oscar; Esteva De Antonio, Isabel

2012-01-01

Transsexual patients can only be diagnosed and treated at functional gender identity Units with provision of high quality care, development of clinical practice guidelines, and interdisciplinary working groups. The therapeutic process has three mainstays: initial psychological diagnostic evaluation and psychotherapy, endocrinological evaluation and hormone therapy, and sex reassignment surgery. Cross-sex hormone therapy is essential for the anatomical and psychological transition process in duly selected patients. Hormones help optimize real-life sex identity, improve quality of life, and limit psychiatric co-morbidities often associated to lack of treatment. Development of this clinical practice guideline addresses the need for implementing a coordinated action protocol for comprehensive health care for transgender people in the National Health System. Copyright © 2012 SEEN. Published by Elsevier Espana. All rights reserved.

No. 127-The Evaluation of Stress Incontinence Prior to Primary Surgery.

PubMed

Farrell, Scott A

2018-02-01

To provide clinical guidelines for the evaluation of women with stress urinary incontinence prior to primary anti-incontinence surgery. The modalities of evaluation range from basic pelvic examination through to the use of adjuncts including ultrasound and urodynamic testing. These guidelines provide a comprehensive approach to the preoperative evaluation of urinary incontinence to ensure that excessive evaluation is avoided without sacrificing diagnostic accuracy. Published opinions of experts, supplemented by evidence from clinical trials, where appropriate. The quality of the evidence is rated using the criteria described by the Canadian Task Force on the Periodic Health Examination. Comprehensive evaluation of women considering surgery to treat urinary incontinence is essential to rule out causes of incontinence that may not be amenable to surgical treatment. Simplifying the evaluation minimizes the discomfort and embarrassment potentially experienced by women. VALIDATION: These guidelines have been approved by the Urogynaecology Committee and the Executive and Council of The Society of Obstetricians and Gynaecologists of Canada. Copyright © 2018. Published by Elsevier Inc.

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

PubMed

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

2014-01-01

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

Value of XML in the implementation of clinical practice guidelines--the issue of content retrieval and presentation.

PubMed

Hoelzer, S; Schweiger, R K; Boettcher, H A; Tafazzoli, A G; Dudeck, J

2001-01-01

The purpose of guidelines in clinical practice is to improve the effectiveness and efficiency of clinical care. It is known that nationally or internationally produced guidelines which, in particular, do not involve medical processes at the time of consultation, do not take local factors into account, and have no consistent implementation strategy, have limited impact in changing either the behaviour of physicians, or patterns of care. The literature provides evidence for the effectiveness of computerization of CPGs for increasing compliance and improving patient outcomes. Probably the most effective concepts are knowledge-based functions for decision support or monitoring that are integrated in clinical information systems. This approach is mostly restricted by the effort required for development and maintenance of the information systems and the limited number of implemented medical rules. Most of the guidelines are text-based, and are primarily published in medical journals and posted on the internet. However, internet-published guidelines have little impact on the behaviour of physicians. It can be difficult and time-consuming to browse the internet to find (a) the correct guidelines to an existing diagnosis and (b) and adequate recommendation for a specific clinical problem. Our objective is to provide a web-based guideline service that takes as input clinical data on a particular patient and returns as output a customizable set of recommendations regarding diagnosis and treatment. Information in healthcare is to a very large extent transmitted and stored as unstructured or slightly structured text such as discharge letters, reports, forms, etc. The same applies for facilities containing medical information resources for clinical purposes and research such as text books, articles, guidelines, etc. Physicians are used to obtaining information from text-based sources. Since most guidelines are text-based, it would be practical to use a document-based solution that preserves the original cohesiveness. The lack of structure limits the automatic identification and extraction of the information contained in these resources. For this reason, we have chosen a document-based approach using eXtensible Markup Language (XML) with its schema definition and related technologies. XML empowers the applications for in-context searching. In addition it allows the same content to be represented in different ways. Our XML reference clinical data model for guidelines has been realized with the XML schema definition. The schema is used for structuring new text-based guidelines and updating existing documents. It is also used to establish search strategies on the document base. We hypothesize that enabling the physicians to query the available CPGs easily, and to get access to selected and specific information at the point of care will foster increased use. Based on current evidence we are confident that it will have substantial impact on the care provided, and will improve health outcomes.

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.

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

PubMed

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

2017-11-01

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

EAACI Food Allergy and Anaphylaxis Guidelines. Food allergy health-related quality of life measures.

PubMed

Muraro, A; Dubois, A E J; DunnGalvin, A; Hourihane, J O'B; de Jong, N W; Meyer, R; Panesar, S S; Roberts, G; Salvilla, S; Sheikh, A; Worth, A; Flokstra-de Blok, B M J

2014-07-01

Instruments have been developed and validated for the measurement of health-related quality of life in patients with food allergy. This guideline has been prepared by the European Academy of Allergy and Clinical Immunology's (EAACI) Guidelines for Food Allergy and Anaphylaxis Group. It draws on a systematic review of the literature on quality of life instruments for food allergy and the Appraisal of Guidelines for Research & Evaluation (AGREE II) guideline development process. Guidance is provided on the use of such instruments in research, and the current limitations of their use in clinical practice are described. Gaps in current knowledge as well as areas of future interest are also discussed. This document is relevant to healthcare workers dealing with food-allergic patients, scientists engaging in food allergy research and policy makers involved in regulatory aspects concerning food allergy and safety. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Methodological quality of guidelines in gastroenterology.

PubMed

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

2014-06-01

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

2010 Canadian Cardiovascular Society/Canadian Society of Echocardiography Guidelines for Training and Maintenance of Competency in Adult Echocardiography.

PubMed

Burwash, Ian G; Basmadjian, Arsene; Bewick, David; Choy, Jonathan B; Cujec, Bibiana; Jassal, Davinder S; MacKenzie, Scott; Nair, Parvathy; Rudski, Lawrence G; Yu, Eric; Tam, James W

2011-01-01

Guidelines for the provision of echocardiography in Canada were jointly developed and published by the Canadian Cardiovascular Society and the Canadian Society of Echocardiography in 2005. Since their publication, recognition of the importance of echocardiography to patient care has increased, along with the use of focused, point-of-care echocardiography by physicians of diverse clinical backgrounds and variable training. New guidelines for physician training and maintenance of competence in adult echocardiography were required to ensure that physicians providing either focused, point-of-care echocardiography or comprehensive echocardiography are appropriately trained and proficient in their use of echocardiography. In addition, revision of the guidelines was required to address technological advances and the desire to standardize echocardiography training across the country to facilitate the national recognition of a physician's expertise in echocardiography. This paper summarizes the new Guidelines for Physician Training and Maintenance of Competency in Adult Echocardiography, which are considerably more comprehensive than earlier guidelines and address many important issues not previously covered. These guidelines provide a blueprint for physician training despite different clinical backgrounds and help standardize physician training and training programs across the country. Adherence to the guidelines will ensure that physicians providing echocardiography have acquired sufficient expertise required for their specific practice. The document will also provide a framework for other national societies to standardize their training programs in echocardiography and will provide a benchmark by which competency in adult echocardiography may be measured. Copyright © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. 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.

Management of bleeding following major trauma: an updated European guideline

PubMed Central

2010-01-01

Introduction Evidence-based recommendations are needed to guide the acute management of the bleeding trauma patient, which when implemented may improve patient outcomes. Methods The multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document presents an updated version of the guideline published by the group in 2007. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature. Results Key changes encompassed in this version of the guideline include new recommendations on coagulation support and monitoring and the appropriate use of local haemostatic measures, tourniquets, calcium and desmopressin in the bleeding trauma patient. The remaining recommendations have been reevaluated and graded based on literature published since the last edition of the guideline. Consideration was also given to changes in clinical practice that have taken place during this time period as a result of both new evidence and changes in the general availability of relevant agents and technologies. Conclusions This guideline provides an evidence-based multidisciplinary approach to the management of critically injured bleeding trauma patients. PMID:20370902

The use of behavior change theory in Internet-based asthma self-management interventions: a systematic review.

PubMed

Al-Durra, Mustafa; Torio, Monika-Bianca; Cafazzo, Joseph A

2015-04-02

The high prevalence rate of asthma represents a major societal burden. Advancements in information technology continue to affect the delivery of patient care in all areas of medicine. Internet-based solutions, social media, and mobile technology could address some of the problems associated with increasing asthma prevalence. This review evaluates Internet-based asthma interventions that were published between 2004 and October 2014 with respect to the use of behavioral change theoretical frameworks, applied clinical guidelines, and assessment tools. The search term (Asthma AND [Online or Internet or Mobile or Application or eHealth or App]) was applied to six bibliographic databases (Ovid MEDLINE, PubMed, BioMed Central, ProQuest Computing, Web of Knowledge, and ACM Digital Library) including only English-language articles published between 2004 and October 2014. In total, 3932 articles matched the priori search terms and were reviewed by the primary reviewer based on their titles, index terms, and abstracts. The matching articles were then screened by the primary reviewer for inclusion or exclusion based on their abstract, study type, and intervention objectives with respect to the full set of priori inclusion and exclusion criteria; 331 duplicates were identified and removed. A total of 85 articles were included for in-depth review and the remaining 3516 articles were excluded. The primary and secondary reviewer independently reviewed the complete content of the 85 included articles to identify the applied behavioral change theories, clinical guidelines, and assessment tools. Findings and any disagreement between reviewers were resolved by in-depth discussion and through a consolidation process for each of the included articles. The reviewers identified 17 out of 85 interventions (20%) where at least one model, framework, and/or construct of a behavioral change theory were applied. The review identified six clinical guidelines that were applied across 30 of the 85 interventions (35%) as well as a total of 21 assessment tools that were applied across 32 of the 85 interventions (38%). The findings of this literature review indicate that the majority of published Internet-based interventions do not use any documented behavioral change theory, clinical guidelines, and/or assessment tools to inform their design. Further, it was found that the application of clinical guidelines and assessment tools were more salient across the reviewed interventions. A consequence, as such, is that many Internet-based asthma interventions are designed in an ad hoc manner, without the use of any notable evidence-based theoretical frameworks, clinical guidelines, and/or assessment tools.

Comparison of the Treatment Guidelines for Actinic Keratosis: A Critical Appraisal and Review.

PubMed

Fleming, Patrick; Zhou, Stephanie; Bobotsis, Robert; Lynde, Charles

There are currently several reputable guidelines on the treatment of actinic keratosis (AK) from groups in Canada, the United Kingdom, and Europe. These recommendations, based on evidence or expert consensus, offer clinicians a variety of treatment options for the different clinical presentations of AKs. Although the guidelines are similar in some regards, variations exist in treatment options, duration, and strength of recommendation. Some guidelines also lack input on specific therapies and certain types of AK, such as hypertrophic or thin presentations. The purpose of this article is to review and compare guidelines published by Canadian, UK, and European groups for the management of AKs in patients.

Clinical practice guideline for the management of chronic kidney disease in patients infected with HIV: 2014 update by the HIV Medicine Association of the Infectious Diseases Society of America.

PubMed

Lucas, Gregory M; Ross, Michael J; Stock, Peter G; Shlipak, Michael G; Wyatt, Christina M; Gupta, Samir K; Atta, Mohamed G; Wools-Kaloustian, Kara K; Pham, Paul A; Bruggeman, Leslie A; Lennox, Jeffrey L; Ray, Patricio E; Kalayjian, Robert C

2014-11-01

It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Clinical practice guideline: allergic rhinitis executive summary.

PubMed

Seidman, Michael D; Gurgel, Richard K; Lin, Sandra Y; Schwartz, Seth R; Baroody, Fuad M; Bonner, James R; Dawson, Douglas E; Dykewicz, Mark S; Hackell, Jesse M; Han, Joseph K; Ishman, Stacey L; Krouse, Helene J; Malekzadeh, Sonya; Mims, James Whit W; Omole, Folashade S; Reddy, William D; Wallace, Dana V; Walsh, Sandra A; Warren, Barbara E; Wilson, Meghan N; Nnacheta, Lorraine C

2015-02-01

The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) has published a supplement to this issue featuring the new Clinical Practice Guideline: Allergic Rhinitis. To assist in implementing the guideline recommendations, this article summarizes the rationale, purpose, and key action statements. The 14 recommendations developed address the evaluation of patients with allergic rhinitis, including performing and interpretation of diagnostic testing and assessment and documentation of chronic conditions and comorbidities. It will then focus on the recommendations to guide the evaluation and treatment of patients with allergic rhinitis, to determine the most appropriate interventions to improve symptoms and quality of life for patients with allergic rhinitis. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

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.

Guidelines for clinical use of CBCT: a review

PubMed Central

O'Malley, L; Taylor, K; Glenny, A-M

2015-01-01

Objectives: To identify guidelines on the clinical use of CBCT in dental and maxillofacial radiology, in particular selection criteria, to consider how they were produced, to appraise their quality objectively and to compare their recommendations. Methods: A literature search using MEDLINE (Ovid®) was undertaken prospectively from 1 January 2000 to identify published material classifiable as “guidelines” pertaining to the use of CBCT in dentistry. This was supplemented by searches on websites, an internet search engine, hand searching of theses and by information from personal contacts. Quality assessment of publications was performed using the AGREE II instrument. Publications were examined for areas of agreement and disagreement. Results: 26 publications were identified, 11 of which were specifically written to give guidelines on the clinical use of CBCT and contained sections on selection criteria. The remainder were a heterogeneous mixture of publications that included guidelines relating to CBCT. Two had used a formal evidence-based approach for guideline development and two used consensus methods. The quality of publications was frequently low as assessed using AGREE II, with many lacking evidence of adequate methodology. There was broad agreement between publications on clinical use, apart from treatment planning, in implant dentistry. Conclusions: Reporting of guideline development is often poorly presented. Guideline development panels should aim to perform and report their work using the AGREE II instrument as a template to raise standards and avoid the risk of suspicions of bias. PMID:25270063

International experts' practice in the antibiotic therapy of infective endocarditis is not following the guidelines.

PubMed

Tissot-Dupont, H; Casalta, J P; Gouriet, F; Hubert, S; Salaun, E; Habib, G; Fernandez-Gerlinger, M P; Mainardi, J L; Tattevin, P; Revest, M; Lucht, F; Botelho-Nevers, E; Gagneux-Brunon, A; Snygg-Martin, U; Chan, K L; Bishara, J; Vilacosta, I; Olmos, C; San Román, J A; López, J; Tornos, P; Fernández-Hidalgo, N; Durante-Mangoni, E; Utili, R; Paul, M; Baddour, L M; DeSimone, D C; Sohail, M R; Steckelberg, J M; Wilson, W R; Raoult, D

2017-10-01

The management of infective endocarditis (IE) may differ from international guidelines, even in reference centres. This is probably because most recommendations are not based on hard evidence, so the consensus obtained for the guidelines does not represent actual practices. For this reason, we aimed to evaluate this question in the particular field of antibiotic therapy. Thirteen international centres specialized in the management of IE were selected, according to their reputation, clinical results, original research publications and quotations. They were asked to detail their actual practice in terms of IE antibiotic treatment in various bacteriological and clinical situations. They were also asked to declare their IE-related in-hospital mortality for the year 2015. The global compliance with guidelines concerning antibiotic therapy was 58%, revealing the differences between theoretical 'consensus', local recommendations and actual practice. Some conflicts of interest were also probably expressed. The adherence to guidelines was 100% when the protocol was simple, and decreased with the seriousness of the situation (Staphylococus spp. 54%-62%) or in blood-culture-negative endocarditis (0%-15%) that requires adaptation to clinical and epidemiological data. Worldwide experts in IE management, although the majority of them were involved and co-signed the guidelines, do not follow international consensus guidelines on the particular point of the use of antibiotics. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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

PubMed

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

2015-10-01

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

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

PubMed

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

2017-02-01

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

ELEVATING QUALITY WITH MANDITORY USE OF STANDARD REPORTING GUIDELINES

PubMed Central

L.Voight, Michael

2014-01-01

The Editorial staff of The International Journal of Sports Physical Therapy (IJSPT) is dedicated to the review, critical appraisal, and publication of high quality scientific and clinical research, systematic reviews, meta‐analyses, and case reports. As IJSPT progresses through its' ninth year of providing high quality research evidence as well as relevant clinical commentary and suggestions for the international sports physical therapy community, we offer the following editorial. We, along with many other prestigious journals are committed to elevating the quality of published research related to disability and rehabilitation and agree to adherence to the following reporting guidelines, which will be required by IJSPT as of January 1, 2015. Many of these guidelines are all ready in place and have been implemented by IJSPT. This Editorial is a reprint of a previously published Editorial in The Archives of Physical Medicine and Rehabilitation, and is used with permission. (http://dx.doi.org/10.1016/j.apmr.2013.12.010) For citation purposes, please use the original publication details: Chan L, Heinemann AW, and Roberts J, Elevating the Quality of Disability and Rehabilitation Research: Mandatory use of the Reporting Guidelines. Archives of Physical Medicine and Rehabilitation, 2014: 95: 414‐417 PMID:25133069

Systematic review of oral cryotherapy for management of oral mucositis caused by cancer therapy.

PubMed

Peterson, Douglas E; Ohrn, Kerstin; Bowen, Joanne; Fliedner, Monica; Lees, Judith; Loprinzi, Charles; Mori, Takehiko; Osaguona, Anthony; Weikel, Dianna S; Elad, Sharon; Lalla, Rajesh V

2013-01-01

This systematic review analyzed the strength of the literature and defined clinical practice guidelines for the use of oral cryotherapy for the prevention and/or treatment of oral mucositis caused by cancer therapy. A systematic review on relevant oral cryotherapy studies indexed prior to 31 December 2010 was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO) using OVID/MEDLINE, with publications selected for review based on defined inclusion and exclusion criteria. Findings from the reviewed studies were integrated into guidelines based on the overall level of evidence for each intervention. Guidelines were classified into three types: recommendation, suggestion, or no guideline possible. Twenty-two clinical studies and two meta-analyses were analyzed. Results were compared with the MASCC/ISOO guidelines published in 2007. The recommendation for the use of oral cryotherapy to prevent oral mucositis in patients receiving bolus fluorouracil (5-FU) was maintained, in agreement with the 2007 guidelines. A suggestion for use of oral cryotherapy to prevent oral mucositis in patients receiving high-dose melphalan as conditioning regimen with or without total body irradiation for HCST was revised from the 2007 guidelines. No guideline was possible for any other intervention, due to insufficient evidence. The evidence continues to support the use of oral cryotherapy for prevention of oral mucositis in patients receiving bolus 5-FU chemotherapy or high-dose melphalan. This intervention is consistent with the MASCC/ISOO guidelines published in 2007. The literature is limited by the fact that utilization of a double-blind study design is not feasible. Future studies that compare efficacy of oral cryotherapy with other mucositis agents in patients receiving chemotherapy with relatively short plasma half-lives would be useful.

Bridging the guideline implementation gap: a systematic, document-centered approach to guideline implementation.

PubMed

Shiffman, Richard N; Michel, George; Essaihi, Abdelwaheb; Thornquist, Elizabeth

2004-01-01

A gap exists between the information contained in published clinical practice guidelines and the knowledge and information that are necessary to implement them. This work describes a process to systematize and make explicit the translation of document-based knowledge into workflow-integrated clinical decision support systems. This approach uses the Guideline Elements Model (GEM) to represent the guideline knowledge. Implementation requires a number of steps to translate the knowledge contained in guideline text into a computable format and to integrate the information into clinical workflow. The steps include: (1) selection of a guideline and specific recommendations for implementation, (2) markup of the guideline text, (3) atomization, (4) deabstraction and (5) disambiguation of recommendation concepts, (6) verification of rule set completeness, (7) addition of explanations, (8) building executable statements, (9) specification of origins of decision variables and insertions of recommended actions, (10) definition of action types and selection of associated beneficial services, (11) choice of interface components, and (12) creation of requirement specification. The authors illustrate these component processes using examples drawn from recent experience translating recommendations from the National Heart, Lung, and Blood Institute's guideline on management of chronic asthma into a workflow-integrated decision support system that operates within the Logician electronic health record system. Using the guideline document as a knowledge source promotes authentic translation of domain knowledge and reduces the overall complexity of the implementation task. From this framework, we believe that a better understanding of activities involved in guideline implementation will emerge.

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

PubMed

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

2014-11-01

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

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

Hepatitis A and B immunization for individuals with inherited bleeding disorders.

PubMed

Steele, M; Cochrane, A; Wakefield, C; Stain, A-M; Ling, S; Blanchette, V; Gold, R; Ford-Jones, L

2009-03-01

Hepatitis A and B vaccines are highly effective tools that can greatly reduce infection risk in the bleeding disorder population. Although hepatitis A and B immunization for individuals with bleeding disorders is universally recommended, various advisory bodies often differ with respect to many practical aspects of vaccination. To review the published literature and guidelines and form a practical, comprehensive and consistent approach to hepatitis A and B immunization for individuals with bleeding disorders. We reviewed published immunization guidelines from North American immunization advisory bodies and published statements from North American and international haemophilia advisory bodies. A search of the MEDLINE database was performed to find original published literature pertaining to hepatitis A or B immunization of patients with haemophilia or bleeding disorder patients that provided supporting or refuting evidence for advisory body guidelines. Various advisory bodies' immunization guidelines regarding individuals with bleeding disorders have contradictory statements and often did not clarify issues (e.g. post vaccination surveillance). Published literature addressing immunization in bleeding disorder patients is sparse and mostly examines route of vaccine administration, complications and corresponding antibody response. Although the risk of hepatitis A and B infection is low, the use of simple measures such as vaccination is reasonable and advocated by haemophilia advisory bodies. Following our review of the available literature and North American guidelines, we have developed comprehensive and practical recommendations addressing hepatitis A and B immunization for the bleeding disorder population that may be applicable in Bleeding Disorder clinics.

World Allergy Organization Anaphylaxis Guidelines: 2013 update of the evidence base.

PubMed

Simons, F Estelle R; Ardusso, Ledit R F; Dimov, Vesselin; Ebisawa, Motohiro; El-Gamal, Yehia M; Lockey, Richard F; Sanchez-Borges, Mario; Senna, Gian Enrico; Sheikh, Aziz; Thong, Bernard Y; Worm, Margitta

2013-01-01

The World Allergy Organization (WAO) Guidelines for the assessment and management of anaphylaxis are a widely disseminated and used resource for information about anaphylaxis. They focus on patients at risk, triggers, clinical diagnosis, treatment in health care settings, self-treatment in the community, and prevention of recurrences. Their unique strengths include a global perspective informed by prior research on the global availability of essentials for anaphylaxis assessment and management and a global agenda for anaphylaxis research. Additionally, detailed colored illustrations are linked to key concepts in the text [Simons et al.: J Allergy Clin Immunol 2011;127:593.e1-e22]. The recommendations in the original WAO Anaphylaxis Guidelines for management of anaphylaxis in health care settings and community settings were based on evidence published in peer-reviewed, indexed medical journals to the end of 2010. These recommendations remain unchanged and clinically relevant. An update of the evidence base was published in 2012 [Simons et al.: Curr Opin Allergy Clin Immunol 2012;12:389-399]. In 2012 and early 2013, major advances were reported in the following areas: further characterization of patient phenotypes; development of in vitro tests (for some allergens) that help distinguish clinical risk of anaphylaxis from asymptomatic sensitization; epinephrine (adrenaline) research, including studies of a new epinephrine auto-injector for use in community settings, and randomized controlled trials of immunotherapy to prevent food-induced anaphylaxis. Despite these advances, the need for additional prospective studies, including randomized controlled trials of interventions in anaphylaxis is increasingly apparent. This 2013 Update highlights publications from 2012 and 2013 that further contribute to the evidence base for the recommendations made in the original WAO Anaphylaxis Guidelines. Ideally, it should be used in conjunction with these Guidelines and with the 2012 Guidelines Update. © 2013 S. Karger AG, Basel.

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

PubMed

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

2017-02-01

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

Diagnosis of Upper-Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of APTA

PubMed Central

Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

2017-01-01

Introduction: The Oncology Section of APTA developed a clinical practice guideline to aid the clinician in diagnosing secondary upper-quadrant cancer-related lymphedema. Methods: Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in their diagnostic process. Overall, clinical practice recommendations were formulated on the basis of the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. Recommendations: In an effort to make these clinically applicable, recommendations were based on the characteristics as to the location and stage of a patient's upper-quadrant lymphedema. PMID:28748128

[Identifying gaps between guidelines and clinical practice in Clostridium difficile infection].

PubMed

Rodríguez-Martín, C; Serrano-Morte, A; Sánchez-Muñoz, L A; de Santos-Castro, P A; Bratos-Pérez, M A; Ortiz de Lejarazu-Leonardo, R

2016-01-01

The first aim was to determine whether patients are being treated in accordance with the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America (IDSA/SHEA) Clostridium difficile guidelines and whether adherence impacts patient outcomes. The second aim was to identify specific action items in the guidelines that are not being translated into clinical practice, for their subsequent implementation. A retrospective, descriptive study was conducted over a 36 month period, on patients with compatible clinical symptoms and positive test for C. difficile toxins A and/or B in stool samples, in an internal medicine department of a tertiary medical centre. Patient demographic and clinical data (outcomes, comorbidity, risk factors) and compliance with guidelines, were examined A total of 77 patients with C. difficile infection were identified (87 episodes). Stratified by disease severity criteria, 49.3% of patients were mild-moderate, 35.1% severe, and 15.6% severe-complicated. Full adherence with the guidelines was observed in only 40.2% of patients, and was significantly better for mild-moderate (71.0%), than in severe (7.4%) or severe-complicated patients (16.6%) (P<.003). Adherence was significantly associated with clinical cure (57% vs 42%), fewer recurrences (22.2% vs 77.7%), and mortality (25% vs 75%) (P<.01). The stratification of severity of the episode, and the adequacy of antibiotic to clinical severity, need improvement. Overall adherence with the guidelines for management of Clostridium difficile infection was poor, especially in severe and severe-complicated patients, being associated with worse clinical outcomes. Educational interventions aimed at improving guideline adherence are warranted. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Analysis of evidence within the AUA's clinical practice guidelines.

PubMed

Antoine, Samuel G; Small, Alexander C; McKiernan, James M; Shah, Ojas

2018-02-01

Surgical subspecialty societies release clinical practice guidelines (CPGs) to provide topic-specific recommendations to healthcare providers. We hypothesize that there may be significant differences in statement strength and evidence quality both within the American Urological Association (AUA) guidelines and compared to those published by the American Academy of Orthopedic Surgeons (AAOS) and American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). CPGs issued through 2017 were extracted from the AUAnet.org. Statements were characterized by evidence basis, strength, and evidence quality. CPGs were compared among urologic subspecialties and to those from the AAOS and AAO-HNS. Analysis used Fisher's exact tests and Student's t-tests with significance p < 0.05. A total of 25 AUA CPGs (672 statements) were reviewed and 34.6% were non-evidence based with the highest proportions in pediatrics (47.5%) and sexual medicine (46.5%). The AUA has published over twice as many statements as the AAOS and quadruple that of the AAO-HNS. A smaller proportion of the AUA statements were evidence-based (65.4%) compared to the AAOS (80.5%, p < 0.001) and AAO-HNS (99.8%, p < 0.001), and fewer used "high" quality evidence (AUA 7.2% versus AAOS 21.2%, p < 0.001; versus AAO-HNS 16.1%, p < 0.001). The AUA has published broad CPGs that far exceed those from the AAOS and AAO-HNS. The AUA has utilized extensive resources to provide guidance to help standardize care among urologists. The AAOS and AAO-HNS may not provide guidelines when evidence is limited. With the continued increase of high quality clinical trials, the AUA will be able to continue improving its robust set of evidence-based CPGs.

HGML: a hypertext guideline markup language.

PubMed Central

Hagerty, C. G.; Pickens, D.; Kulikowski, C.; Sonnenberg, F.

2000-01-01

Existing text-based clinical practice guidelines can be difficult to put into practice. While a growing number of such documents have gained acceptance in the medical community and contain a wealth of valuable information, the time required to digest them is substantial. Yet the expressive power, subtlety and flexibility of natural language pose challenges when designing computer tools that will help in their application. At the same time, formal computer languages typically lack such expressiveness and the effort required to translate existing documents into these languages may be costly. We propose a method based on the mark-up concept for converting text-based clinical guidelines into a machine-operable form. This allows existing guidelines to be manipulated by machine, and viewed in different formats at various levels of detail according to the needs of the practitioner, while preserving their originally published form. PMID:11079898

Guidelines for the Diagnosis and Treatment of Chronic Functional Constipation in Korea, 2015 Revised Edition

PubMed Central

Shin, Jeong Eun; Jung, Hye-Kyung; Lee, Tae Hee; Jo, Yunju; Lee, Hyuk; Song, Kyung Ho; Hong, Sung Noh; Lim, Hyun Chul; Lee, Soon Jin; Chung, Soon Sup; Lee, Joon Seong; Rhee, Poong-Lyul; Lee, Kwang Jae; Choi, Suck Chei; Shin, Ein Soon

2016-01-01

The Korean Society of Neurogastroenterology and Motility first published guidelines for chronic constipation in 2005 and was updated in 2011. Although the guidelines were updated using evidence-based process, they lacked multidisciplinary participation and did not include a diagnostic approach for chronic constipation. This article includes guidelines for diagnosis and treatment of chronic constipation to realistically fit the situation in Korea and to be applicable to clinical practice. The guideline development was based upon the adaptation method because research evidence was limited in Korea, and an organized multidisciplinary group carried out systematical literature review and series of evidence-based evaluations. Six guidelines were selected using the Appraisal of Guidelines for Research & Evaluation (AGREE) II process. A total 37 recommendations were adopted, including 4 concerning the definition and risk factors of chronic constipation, 8 regarding diagnoses, and 25 regarding treatments. The guidelines are intended to help primary physicians and general health professionals in clinical practice in Korea, to provide the principles of medical treatment to medical students, residents, and other healthcare professionals, and to help patients for choosing medical services based on the information. These guidelines will be updated and revised periodically to reflect new diagnostic and therapeutic methods. PMID:27226437

Diagnosis and management of hymenoptera venom allergy: British Society for Allergy and Clinical Immunology (BSACI) guidelines.

PubMed

Krishna, M T; Ewan, P W; Diwakar, L; Durham, S R; Frew, A J; Leech, S C; Nasser, S M

2011-09-01

This guidance for the management of patients with hymenoptera venom allergy has been prepared by the Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI). The guideline is based on evidence as well as on expert opinion and is for use by both adult physicians and pediatricians practising allergy. During the development of these guidelines, all BSACI members were included in the consultation process using a web-based system. Their comments and suggestions were carefully considered by the SOCC. Where evidence was lacking, consensus was reached by the experts on the committee. Included in this guideline are epidemiology, risk factors, clinical features, diagnostic tests, natural history of hymenoptera venom allergy and guidance on undertaking venom immunotherapy (VIT). There are also separate sections on children, elevated baseline tryptase and mastocytosis and mechanisms underlying VIT. Finally, we have made recommendations for potential areas of future research. © 2011 Blackwell Publishing Ltd.

Diagnosis and treatment of bone metastasis: comprehensive guideline of the Japanese Society of Medical Oncology, Japanese Orthopedic Association, Japanese Urological Association, and Japanese Society for Radiation Oncology.

PubMed

Shibata, H; Kato, S; Sekine, I; Abe, K; Araki, N; Iguchi, H; Izumi, T; Inaba, Y; Osaka, I; Kato, S; Kawai, A; Kinuya, S; Kodaira, M; Kobayashi, E; Kobayashi, T; Sato, J; Shinohara, N; Takahashi, S; Takamatsu, Y; Takayama, K; Takayama, K; Tateishi, U; Nagakura, H; Hosaka, M; Morioka, H; Moriya, T; Yuasa, T; Yurikusa, T; Yomiya, K; Yoshida, M

2016-01-01

Diagnosis and treatment of bone metastasis requires various types of measures, specialists and caregivers. To provide better diagnosis and treatment, a multidisciplinary team approach is required. The members of this multidisciplinary team include doctors of primary cancers, radiologists, pathologists, orthopaedists, radiotherapists, clinical oncologists, palliative caregivers, rehabilitation doctors, dentists, nurses, pharmacists, physical therapists, occupational therapists, medical social workers, etc. Medical evidence was extracted from published articles describing meta-analyses or randomised controlled trials concerning patients with bone metastases mainly from 2003 to 2013, and a guideline was developed according to the Medical Information Network Distribution Service Handbook for Clinical Practice Guideline Development 2014. Multidisciplinary team meetings are helpful in diagnosis and treatment. Clinical benefits such as physical or psychological palliation obtained using the multidisciplinary team approaches are apparent. We established a guideline describing each specialty field, to improve understanding of the different fields among the specialists, who can further provide appropriate treatment, and to improve patients' outcomes.

Survey of Implementation of Antiemetic Prescription Standards in Indian Oncology Practices and Its Adherence to the American Society of Clinical Oncology Antiemetic Clinical Guideline

PubMed Central

Patil, Vijay; Noronha, Vanita; Joshi, Amit; Parikh, Purvish; Bhattacharjee, Atanu; Chakraborty, Santam; Jandyal, Sunny; Muddu, Vamshi; Ramaswamy, Anant; Babu, K. Govinda; Lokeshwar, Nilesh; Hingmire, Sachin; Ghadyalpatil, Nikhil; Banavali, Shripad

2017-01-01

Purpose Adherence to international antiemetic prophylaxis guidelines like those of ASCO can result in better control of chemotherapy-induced nausea and vomiting; however, the extent of implementation of such guidelines in India is unknown. Therefore, this survey was planned. Methods This study was an anonymized cross-sectional survey approved by the ethics committee. Survey items were generated from the clinical questions given in the ASCO guidelines. The survey was disseminated through personal contacts at an oncology conference and via e-mail to various community oncology centers across India. The B1, B2, and B3 domains included questions regarding the optimal antiemetic prophylaxis for high, moderate, and low-minimal emetogenic regimens. Results Sixty-six (62.9%) of 105 responded and 65 centers (98.5%) were aware of the published guidelines. The partial, full, and no implementation scores were 92.5%, 4.5%, and 3.0%, respectively. Full implementation was better for the low-minimal emetogenic regimens (34.8%) than the highly emetogenic regimens (6.1%). The three most frequent reasons for hampered implementation of ASCO guidelines in routine chemotherapy practice cited by centers were a lack of sensitization (26 centers; 39.4%), lack of national guidelines (12 centers; 18.2%), and lack of administrative support (10 centers; 15.2%). Conclusion Awareness regarding ASCO antiemetic guidelines is satisfactory in Indian oncology practices; however, there is a need for sensitization of oncologists toward complete implementation of these guidelines in their clinical practice. PMID:28831443

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 3: The Clinical Guidelines.

PubMed

Fountoulakis, Konstantinos N; Grunze, Heinz; Vieta, Eduard; Young, Allan; Yatham, Lakshmi; Blier, Pierre; Kasper, Siegfried; Moeller, Hans Jurgen

2017-02-01

The current paper introduces the actual International College of Neuro-Psychopharmacology clinical guidelines for the treatment of bipolar disorder. The current clinical guidelines are based on evidence-based data, but they also intend to be clinically useful, while a rigid algorithm was developed on the basis of firm evidence alone. Monotherapy was prioritized over combination therapy. There are separate recommendations for each of the major phases of bipolar disorder expressed as a 5-step algorithm. The current International College of Neuro-Psychopharmacology clinical guidelines for the treatment of bipolar disorder are the most up-to-date guidance and are as evidence based as possible. They also include recommendations concerning the use of psychotherapeutic interventions, again on the basis of available evidence. This adherence of the workgroup to the evidence in a clinically oriented way helped to clarify the role of specific antidepressants and traditional agents like lithium, valproate, or carbamazepine. The additional focus on specific clinical characteristics, including predominant polarity, mixed features, and rapid cycling, is also a novel approach. Many issues need further studies, data are sparse and insufficient, and many questions remain unanswered. The most important and still unmet need is to merge all the guidelines that concern different phases of the illness into a single one and in this way consider BD as a single unified disorder, which is the real world fact. However, to date the research data do not permit such a unified approach. © The Author 2016. Published by Oxford University Press on behalf of CINP.

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 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.

A critical appraisal of guidelines for electronic communication between patients and clinicians: the need to modernize current recommendations.

PubMed

Lee, Joy L; Matthias, Marianne S; Menachemi, Nir; Frankel, Richard M; Weiner, Michael

2018-04-01

Patient-provider electronic communication has proliferated in recent years, yet there is a dearth of published research either leading to, or including, recommendations that improve clinical care and prevent unintended negative consequences. We critically appraise published guidelines and suggest an agenda for future work in this area. To understand how existing guidelines align with current practice, evidence, and technology. We performed a narrative review of provider-targeted guidelines for electronic communication between patients and providers, searching Ovid MEDLINE, Embase, and PubMed databases using relevant terms. We limited the search to articles published in English, and manually searched the citations of relevant articles. For each article, we identified and evaluated the suggested practices. Across 11 identified guidelines, the primary focus was on technical and administrative concerns, rather than on relational communication. Some of the security practices recommended by the guidelines are no longer needed because of shifts in technology. It is unclear the extent to which the recommendations that are still relevant are being followed. Moreover, there is no guideline-cited evidence of the effectiveness of the practices that have been proposed. Our analysis revealed major weaknesses in current guidelines for electronic communication between patients and providers: the guidelines appear to be based on minimal evidence and offer little guidance on how best to use electronic tools to communicate effectively. Further work is needed to systematically evaluate and identify effective practices, create a framework to evaluate quality of communication, and assess the relationship between electronic communication and quality of care.

No. 233-Antibiotic Therapy in Preterm Premature Rupture of the Membranes.

PubMed

Yudin, Mark H; van Schalkwyk, Julie; Van Eyk, Nancy

2017-09-01

To review the evidence and provide recommendations on the use of antibiotics in preterm premature rupture of the membranes (PPROM). Outcomes evaluated include the effect of antibiotic treatment on maternal infection, chorioamnionitis, and neonatal morbidity and mortality. Published literature was retrieved through searches of Medline, EMBASE, CINAHL, and The Cochrane Library, using appropriate controlled vocabulary and key words (PPROM, infection, and antibiotics). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and new material incorporated in the guideline to July 2008. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The evidence obtained was reviewed and evaluated by the Infectious Diseases Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) under the leadership of the principal authors, and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care. Guideline implementation should assist the practitioner in developing an approach to the use of antibiotics in women with PPROM. Patients will benefit from appropriate management of this condition. This guideline has been reviewed and approved by the Infectious Diseases Committee and the Maternal Fetal Medicine Committee of the SOGC, and approved by the Executive and Council of the SOGC. The Society of Obstetricians and Gynaecologists of Canada. Copyright © 2017. Published by Elsevier Inc.

NICE recommendations for the assessment of stable chest pain: assessing the early economic and service impact in the rapid-access chest pain service.

PubMed

Ashrafi, Reza; Raga, Santosh; Abdool, Ali; Disney, Andrew; Wong, Peter; Davis, Gershan K

2013-05-01

In 2010, guidelines published by the National Institute for Clinical Excellence (NICE) suggested a change in the way patients with stable chest pain of suspected cardiac origin were investigated. These guidelines removed exercise treadmill testing from routine use and introduced cardiac CT to regular use. To investigate whether these guidelines had improved our service provision by reducing the number of further investigations required to make a diagnosis, and to see if our costs had increased now that the less expensive exercise treadmill tests were not recommended. Clinic letters were used to assess patients pretest likelihood of coronary artery disease for two six-month cohorts of consecutive patients seen in the rapid access chest pain clinic (January-June 2010 and July-December 2011) using NICE published methodology, and to ascertain which investigations patients had. Using NICE modelled costs, we generated comparative hypothetical costs for each cohort and an average cost per patient. In the January-June 2010 cohort, 435 patients with chest pain were seen, and in July-December 2011, 334 patients were seen. In the pre-NICE guidelines cohort, 23% of patients required two investigations as compared with 11.4% in the post-NICE guidelines cohort, with no patient requiring three investigations as compared with 3% in the original cohort. There was no significant increase in costs per patient in the post-NICE guidance group. Implementing NICE guidance reduced the number of investigations needed per patient, and did not prove more expensive for our department in the short term.

Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study.

PubMed

Neuman, Jennifer; Korenstein, Deborah; Ross, Joseph S; Keyhani, Salomeh

2011-10-11

To determine the prevalence of financial conflicts of interest among members of panels producing clinical practice guidelines on screening, treatment, or both for hyperlipidaemia or diabetes. Cross sectional study. Relevant guidelines published by national organisations in the United States and Canada between 2000 and 2010. Members of guideline panels. Prevalence of financial conflicts of interest among members of guideline panels and chairs of panels. Fourteen guidelines met our search criteria, of which five had no accompanying declaration of conflicts of interest by panel members. 288 panel members had participated in the guideline development process. Among the 288 panel members, 138 (48%) reported conflicts of interest at the time of the publication of the guideline and 150 (52%) either stated that they had no such conflicts or did not have an opportunity to declare any. Among 73 panellists who formally declared no conflicts, 8 (11%) were found to have one or more. Twelve of the 14 guideline panels evaluated identified chairs, among whom six had financial conflicts of interest. Overall, 150 (52%) panel members had conflicts, of which 138 were declared and 12 were undeclared. Panel members from government sponsored guidelines were less likely to have conflicts of interest compared with guidelines sponsored by non-government sources (15/92 (16%) v 135/196 (69%); P<0.001). The prevalence of financial conflicts of interest and their under-reporting by members of panels producing clinical practice guidelines on hyperlipidaemia or diabetes was high, and a relatively high proportion of guidelines did not have public disclosure of conflicts of interest. Organisations that produce guidelines should minimise conflicts of interest among panel members to ensure the credibility and evidence based nature of the guidelines' content.

Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology.

PubMed

Sepulveda, Antonia R; Hamilton, Stanley R; Allegra, Carmen J; Grody, Wayne; Cushman-Vokoun, Allison M; Funkhouser, William K; Kopetz, Scott E; Lieu, Christopher; Lindor, Noralane M; Minsky, Bruce D; Monzon, Federico A; Sargent, Daniel J; Singh, Veena M; Willis, Joseph; Clark, Jennifer; Colasacco, Carol; Rumble, R Bryan; Temple-Smolkin, Robyn; Ventura, Christina B; Nowak, Jan A

2017-03-01

To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. Twenty-one guideline statements were established. Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented. Key Words: Molecular diagnostics; Gastrointestinal; Histology; Genetics; Oncology. Copyright © 2017 American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, American Society for Clinical Oncology, and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

Guidelines for the diagnosis and treatment of Helicobacter pylori infection in Korea, 2013 revised edition.

PubMed

Kim, Sang Gyun; Jung, Hye-Kyung; Lee, Hang Lak; Jang, Jae Young; Lee, Hyuk; Kim, Chan Gyoo; Shin, Woon Geon; Shin, Ein Soon; Lee, Yong Chan

2014-01-01

The Korean College of Helicobacter and Upper Gastrointestinal Research first developed guidelines for the diagnosis and treatment of Helicobacter pylori (H. pylori) infection in 1998, and revised guidelines were proposed in 2009 by the same group. Although the revised guidelines were based on a comprehensive review of published articles and the consensus of expert opinions, the revised guidelines were not developed using an evidence-based process. The new guidelines presented in this study include specific changes regarding indication and treatment of H. pylori infection in Korea, and were developed through the adaptation process using an evidence-based approach. After systematic review of the literature, six guidelines were selected using the Appraisal of Guidelines for Research and Evaluation (AGREE) II process. A total of 21 statements were proposed with the grading system and revised using the modified Delphi method. After the guideline revisions, 11 statements about indication of test and treatment, four statements about diagnosis, and four statements about treatment of H. pylori infection were developed. The revised guidelines were reviewed by external experts before receiving official endorsement from the Korean College of Helicobacter and Upper Gastrointestinal Research, and disseminated to physicians and other medical professionals for use in clinical practice in Korea. The guidelines will continue to be updated and revised periodically. © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

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

PubMed

Pool, Felicity; Goergen, Stacy

2010-08-01

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

Guideline for primary care management of headache in adults

PubMed Central

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

2015-01-01

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

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

PubMed

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

2018-04-27

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

Critical Evaluation of the Lund Concept for Treatment of Severe Traumatic Head Injury, 25 Years after Its Introduction.

PubMed

Grände, Per-Olof

2017-01-01

When introduced in 1992, the Lund concept (LC) was the first complete guideline for treatment of severe traumatic brain injury (s-TBI). It was a theoretical approach, based mainly on general physiological principles-i.e., of brain volume control and optimization of brain perfusion and oxygenation of the penumbra zone. The concept gave relatively strict outlines for cerebral perfusion pressure, fluid therapy, ventilation, sedation, nutrition, the use of vasopressors, and osmotherapy. The LC strives for treatment of the pathophysiological mechanisms behind symptoms rather than just treating the symptoms. The treatment is standardized, with less need for individualization. Alternative guidelines published a few years later (e.g., the Brain Trauma Foundation guidelines and European guidelines) were mainly based on meta-analytic approaches from clinical outcome studies and to some extent from systematic reviews. When introduced, they differed extensively from the LC. We still lack any large randomized outcome study comparing the whole concept of BTF guidelines with other guidelines including the LC. From that point of view, there is limited clinical evidence favoring any of the s-TBI guidelines used today. In principle, the LC has not been changed since its introduction. Some components of the alternative guidelines have approached those in the LC. In this review, I discuss some important principles of brain hemodynamics that have been lodestars during formulation of the LC. Aspects of ventilation, nutrition, and temperature control are also discussed. I critically evaluate the most important components of the LC 25 years after its introduction, based on hemodynamic principles and on the results of own an others experimental and human studies that have been published since then.

Critical Evaluation of the Lund Concept for Treatment of Severe Traumatic Head Injury, 25 Years after Its Introduction

PubMed Central

Grände, Per-Olof

2017-01-01

When introduced in 1992, the Lund concept (LC) was the first complete guideline for treatment of severe traumatic brain injury (s-TBI). It was a theoretical approach, based mainly on general physiological principles—i.e., of brain volume control and optimization of brain perfusion and oxygenation of the penumbra zone. The concept gave relatively strict outlines for cerebral perfusion pressure, fluid therapy, ventilation, sedation, nutrition, the use of vasopressors, and osmotherapy. The LC strives for treatment of the pathophysiological mechanisms behind symptoms rather than just treating the symptoms. The treatment is standardized, with less need for individualization. Alternative guidelines published a few years later (e.g., the Brain Trauma Foundation guidelines and European guidelines) were mainly based on meta-analytic approaches from clinical outcome studies and to some extent from systematic reviews. When introduced, they differed extensively from the LC. We still lack any large randomized outcome study comparing the whole concept of BTF guidelines with other guidelines including the LC. From that point of view, there is limited clinical evidence favoring any of the s-TBI guidelines used today. In principle, the LC has not been changed since its introduction. Some components of the alternative guidelines have approached those in the LC. In this review, I discuss some important principles of brain hemodynamics that have been lodestars during formulation of the LC. Aspects of ventilation, nutrition, and temperature control are also discussed. I critically evaluate the most important components of the LC 25 years after its introduction, based on hemodynamic principles and on the results of own an others experimental and human studies that have been published since then. PMID:28725211

Is traditional Chinese medicine recommended in Western medicine clinical practice guidelines in China? A systematic analysis.

PubMed

Ren, Jun; Li, Xun; Sun, Jin; Han, Mei; Yang, Guo-Yan; Li, Wen-Yuan; Robinson, Nicola; Lewith, George; Liu, Jian-Ping

2015-06-03

Evidence-based medicine promotes and relies on the use of evidence in developing clinical practice guidelines (CPGs). The Chinese healthcare system includes both traditional Chinese medicine (TCM) and Western medicine, which are expected to be equally reflected in Chinese CPGs. To evaluate the inclusion of TCM-related information in Western medicine CPGs developed in China and the adoption of high level evidence. All CPGs were identified from the China Guideline Clearinghouse (CGC), which is the main Chinese organisation maintaining the guidelines issued by the Ministry of Health of China, the Chinese Medical Association and the Chinese Medical Doctors' Association.TCM-related contents were extracted from all the CPGs identified. Extracted information comprised the institution issuing the guideline, date of issue, disease, recommendations relating to TCM, evidence level of the recommended content and references supporting the recommendations. A total of 604 CPGs were identified, only a small number of which (74/604; 12%) recommended TCM therapy and only five guidelines (7%) had applied evidence grading. The 74 CPGs involved 13 disease systems according to the International Classification of Diseases 10th edition. TCM was mainly recommended in the treatment part of the guidelines (73/74, 99%), and more than half of the recommendations (43/74, 58%) were related to Chinese herbal medicine (single herbs or herbal treatment based on syndrome differentiation). Few Chinese Western medicine CPGs recommend TCM therapies and very few provide evidence grading for the TCM recommendation. We suggest that future guideline development should be based on systematic searches for evidence to support CPG recommendations and involve a multidisciplinary approach including TCM expertise. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Application of Agree II Instrument for Appraisal of Postpartum Hemorrhage Clinical Practice Guidelines in Bosnia and Herzegovina

PubMed Central

Novo, Ahmed; Subotic-popovic, Andreja; Strbac, Savka; Kandic, Alma; Horga, Mihai

2016-01-01

Introduction: Federal Minister of Health and Minister of Health and Social Welfare of the Republika Srpska as a Governmental health authorities in Federation of Bosnia and Herzegovina (FBiH) and the Republika Srpska nominated/appointed health professionals as their representatives to a multidisciplinary Guidelines Adaptation Group (GAG). This group started with its work in September 2015. The main purpose of the guidelines development exercise is to develop guidelines with worldwide recognized methodology for clinical guidelines development and adaptation. At the end of this consultancy, GAG would have develop a clinical practice guideline on Postpartum hemorrhage (PPH) through the adaptation method, starting from published international clinical guidelines and adapting it according to the country specific requirements. Methodology: During the process of identifying the best guideline for adaptation, the GAG had to pass several steps. One of the crucial steps was to identify the questions related to clinical practice and health policy for which answers are needed to be addressed by the guideline. These questions included relevant issues regarding the topic area such as diagnosis, prognosis, intervention, service delivery, and training. After that, six guidelines have been researched by the six members of the GAG to see if they answered the identified questions. Evaluating the methodological quality of the selected clinical guidelines was a second essential step before deciding which ones could best fit the needs and interests. AGREE II instrument has been chosen as methods for evaluating clinical guideline quality and appropriateness. Four appraisers conducted the assessment of each of the selected guidelines for PPH. All appraisers passed the training for the AGREE II instrument before conducting appraisals, as recommended by the AGREE collaboration. Each of the four guidelines was rated independently with the AGREE II tool by each appraiser. Results: The highest score was obtained by the WHO recommendations for postpartum hemorrhage guidelines and each of four assessors recommended it to be adapted and further implemented. Discussion: In spite of several serous attempts and two Agencies for quality improvement in BiH the whole process of guideline adaptation is still in the beginning and therefore the establishment of a strong connection with similar institutions and organizations from our region and the rest of the world is very important. Cooperation and collaboration across institutions and countries and key stakeholders have potential to significantly improve the validity and quality of the adapted guidelines and to positively influence implementation. PMID:27482138

Spanish Clinical Guidelines on Vascular Access for Haemodialysis.

PubMed

Ibeas, José; Roca-Tey, Ramon; Vallespín, Joaquín; Moreno, Teresa; Moñux, Guillermo; Martí-Monrós, Anna; Del Pozo, José Luis; Gruss, Enrique; Ramírez de Arellano, Manel; Fontseré, Néstor; Arenas, María Dolores; Merino, José Luis; García-Revillo, José; Caro, Pilar; López-Espada, Cristina; Giménez-Gaibar, Antonio; Fernández-Lucas, Milagros; Valdés, Pablo; Fernández-Quesada, Fidel; de la Fuente, Natalia; Hernán, David; Arribas, Patricia; Sánchez de la Nieta, María Dolores; Martínez, María Teresa; Barba, Ángel

2017-11-01

Vascular access for haemodialysis is key in renal patients both due to its associated morbidity and mortality and due to its impact on quality of life. The process, from the creation and maintenance of vascular access to the treatment of its complications, represents a challenge when it comes to decision-making, due to the complexity of the existing disease and the diversity of the specialities involved. With a view to finding a common approach, the Spanish Multidisciplinary Group on Vascular Access (GEMAV), which includes experts from the five scientific societies involved (nephrology [S.E.N.], vascular surgery [SEACV], vascular and interventional radiology [SERAM-SERVEI], infectious diseases [SEIMC] and nephrology nursing [SEDEN]), along with the methodological support of the Cochrane Center, has updated the Guidelines on Vascular Access for Haemodialysis, published in 2005. These guidelines maintain a similar structure, in that they review the evidence without compromising the educational aspects. However, on one hand, they provide an update to methodology development following the guidelines of the GRADE system in order to translate this systematic review of evidence into recommendations that facilitate decision-making in routine clinical practice, and, on the other hand, the guidelines establish quality indicators which make it possible to monitor the quality of healthcare. Copyright © 2017 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

Comparison of international guideline programs to evaluate and update the Dutch program for clinical guideline development in physical therapy

PubMed Central

Van der Wees, Philip J; Hendriks, Erik JM; Custers, Jan WH; Burgers, Jako S; Dekker, Joost; de Bie, Rob A

2007-01-01

Background Clinical guidelines are considered important instruments to improve quality in health care. Since 1998 the Royal Dutch Society for Physical Therapy (KNGF) produced evidence-based clinical guidelines, based on a standardized program. New developments in the field of guideline research raised the need to evaluate and update the KNGF guideline program. Purpose of this study is to compare different guideline development programs and review the KNGF guideline program for physical therapy in the Netherlands, in order to update the program. Method Six international guideline development programs were selected, and the 23 criteria of the AGREE Instrument were used to evaluate the guideline programs. Information about the programs was retrieved from published handbooks of the organizations. Also, the Dutch program for guideline development in physical therapy was evaluated using the AGREE criteria. Further comparison the six guideline programs was carried out using the following elements of the guideline development processes: Structure and organization; Preparation and initiation; Development; Validation; Dissemination and implementation; Evaluation and update. Results Compliance with the AGREE criteria of the guideline programs was high. Four programs addressed 22 AGREE criteria, and two programs addressed 20 AGREE criteria. The previous Dutch program for guideline development in physical therapy lacked in compliance with the AGREE criteria, meeting only 13 criteria. Further comparison showed that all guideline programs perform systematic literature searches to identify the available evidence. Recommendations are formulated and graded, based on evidence and other relevant factors. It is not clear how decisions in the development process are made. In particular, the process of translating evidence into practice recommendations can be improved. Conclusion As a result of international developments and consensus, the described processes for developing clinical practice guidelines have much in common. The AGREE criteria are common basis for the development of guidelines, although it is not clear how final decisions are made. Detailed comparison of the different guideline programs was used for updating the Dutch program. As a result the updated KNGF program complied with 22 AGREE criteria. International discussion is continuing and will be used for further improvement of the program. PMID:18036215

Comparison of international guideline programs to evaluate and update the Dutch program for clinical guideline development in physical therapy.

PubMed

Van der Wees, Philip J; Hendriks, Erik J M; Custers, Jan W H; Burgers, Jako S; Dekker, Joost; de Bie, Rob A

2007-11-23

Clinical guidelines are considered important instruments to improve quality in health care. Since 1998 the Royal Dutch Society for Physical Therapy (KNGF) produced evidence-based clinical guidelines, based on a standardized program. New developments in the field of guideline research raised the need to evaluate and update the KNGF guideline program. Purpose of this study is to compare different guideline development programs and review the KNGF guideline program for physical therapy in the Netherlands, in order to update the program. Six international guideline development programs were selected, and the 23 criteria of the AGREE Instrument were used to evaluate the guideline programs. Information about the programs was retrieved from published handbooks of the organizations. Also, the Dutch program for guideline development in physical therapy was evaluated using the AGREE criteria. Further comparison the six guideline programs was carried out using the following elements of the guideline development processes: Structure and organization; Preparation and initiation; Development; Validation; Dissemination and implementation; Evaluation and update. Compliance with the AGREE criteria of the guideline programs was high. Four programs addressed 22 AGREE criteria, and two programs addressed 20 AGREE criteria. The previous Dutch program for guideline development in physical therapy lacked in compliance with the AGREE criteria, meeting only 13 criteria. Further comparison showed that all guideline programs perform systematic literature searches to identify the available evidence. Recommendations are formulated and graded, based on evidence and other relevant factors. It is not clear how decisions in the development process are made. In particular, the process of translating evidence into practice recommendations can be improved. As a result of international developments and consensus, the described processes for developing clinical practice guidelines have much in common. The AGREE criteria are common basis for the development of guidelines, although it is not clear how final decisions are made. Detailed comparison of the different guideline programs was used for updating the Dutch program. As a result the updated KNGF program complied with 22 AGREE criteria. International discussion is continuing and will be used for further improvement of the program.

Endocrine and metabolic consequences due to restrictive carbohydrate diets in children with type 1 diabetes: An illustrative case series.

PubMed

de Bock, Martin; Lobley, Kristine; Anderson, Donald; Davis, Elizabeth; Donaghue, Kim; Pappas, Marcelle; Siafarikas, Aris; Cho, Yoon Hi; Jones, Timothy; Smart, Carmel

2018-02-01

Low carbohydrate diets for the management of type 1 diabetes have been popularised by social media. The promotion of a low carbohydrate diet in lay media is in contrast to published pediatric diabetes guidelines that endorse a balanced diet from a variety of foods for optimal growth and development in children with type 1 diabetes. This can be a source of conflict in clinical practice. We describe a series of 6 cases where adoption of a low carbohydrate diet in children impacted growth and cardiovascular risk factors with potential long-term sequelae. These cases support current clinical guidelines for children with diabetes that promote a diet where total energy intake is derived from balanced macronutrient sources. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The iSCREEN Electronic Diabetes Dashboard: A Tool to Improve Knowledge and Implementation of Pediatric Clinical Practice Guidelines.

PubMed

Zahanova, Stacy; Tsouka, Alexandra; Palmert, Mark R; Mahmud, Farid H

2017-12-01

Clinical practice guidelines (CPG) provide evidence-based recommendations for patient care but may not be optimally applied in clinical settings. As a pilot study, we evaluated the impact of a computerized, point-of-care decision support system (CDSS) on guideline knowledge and adherence in our diabetes clinic. iSCREEN, a CDSS, integrated with a province-wide electronic health record, was designed based on the Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Evaluation data were gathered by retrospective chart review and clinician questionnaire prior to and after implementation of iSCREEN. Records of patients with type 1 diabetes, 14 to 18 years of age, were assessed for appropriate screening for complications and comorbidities. To assess guideline adherence, 50 charts were reviewed at 2 time periods (25 before and 25 after launch of iSCREEN). Results revealed improved frequency of appropriate screening for diabetic nephropathy (p=0.03) and retinopathy (p=0.04), accompanied by a decrease in under- and overscreening for these outcomes. To assess guideline knowledge, 58 surveys were collected (31 prior to and 27 after the launch of iSCREEN) from care providers in the field of pediatric diabetes. There was a trend toward improved guideline knowledge in all team members (p=0.06). Implementation of a de novo CDSS was associated with improved rates of appropriate screening for diabetes-related complications. A trend toward improvement in health professionals' knowledge of the guidelines was also observed. Evaluation of this point-of-care computerized decision support tool suggests that it may facilitate diabetes care by optimizing complication screening and CPG knowledge, with the potential for broader implementation. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

Systematic review of emergency medicine clinical practice guidelines: Implications for research and policy.

PubMed

Venkatesh, Arjun K; Savage, Dan; Sandefur, Benjamin; Bernard, Kenneth R; Rothenberg, Craig; Schuur, Jeremiah D

2017-01-01

Over 25 years, emergency medicine in the United States has amassed a large evidence base that has been systematically assessed and interpreted through ACEP Clinical Policies. While not previously studied in emergency medicine, prior work has shown that nearly half of all recommendations in medical specialty practice guidelines may be based on limited or inconclusive evidence. We sought to describe the proportion of clinical practice guideline recommendations in Emergency Medicine that are based upon expert opinion and low level evidence. Systematic review of clinical practice guidelines (Clinical Policies) published by the American College of Emergency Physicians from January 1990 to January 2016. Standardized data were abstracted from each Clinical Policy including the number and level of recommendations as well as the reported class of evidence. Primary outcomes were the proportion of Level C equivalent recommendations and Class III equivalent evidence. The primary analysis was limited to current Clinical Policies, while secondary analysis included all Clinical Policies. A total of 54 Clinical Policies including 421 recommendations and 2801 cited references, with an average of 7.8 recommendations and 52 references per guideline were included. Of 19 current Clinical Policies, 13 of 141 (9.2%) recommendations were Level A, 57 (40.4%) Level B, and 71 (50.4%) Level C. Of 845 references in current Clinical Policies, 67 (7.9%) were Class I, 272 (32.3%) Class II, and 506 (59.9%) Class III equivalent. Among all Clinical Policies, 200 (47.5%) recommendations were Level C equivalent, and 1371 (48.9%) of references were Class III equivalent. Emergency medicine clinical practice guidelines are largely based on lower classes of evidence and a majority of recommendations are expert opinion based. Emergency medicine appears to suffer from an evidence gap that should be prioritized in the national research agenda and considered by policymakers prior to developing future quality standards.

Do Levels of Evidence Affect Breadth of Service? A Study on the Use of Clinical Guidance in a Learning Disability Service

ERIC Educational Resources Information Center

Pateraki, Eleni; Macmahon, Kenneth

2017-01-01

Abstract: For services across the UK, increasing emphasis is placed on the use of evidence-based psychological treatments. In this context, the Scottish Government published the MATRIX, a best-practice clinical governance document, with a brief section on therapies for people with learning disabilities. As with most clinical guidelines, randomised…

Perils of the new labor management guidelines.

PubMed

Cohen, Wayne R; Friedman, Emanuel A

2015-04-01

Recent guidelines issued jointly by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine for assessing labor progress differ substantially from those described initially by Friedman, which have guided clinical practice for decades. The guidelines are based on results obtained from new and untested methods of analyzing patterns of cervical dilatation and fetal descent. Before these new guidelines are adopted into clinical practice, the results obtained by these unconventional analytic approaches should be validated and shown to be superior, or at least equivalent, to currently accepted standards. The new guidelines indicate the patterns of labor originally described by Friedman are incorrect and, further, are inapplicable to modern obstetric practice. We contend that the original descriptions of normal and abnormal labor progress, which were based on direct clinical observations, accurately describe progress in dilatation and descent, and that the differences reported more recently are likely attributable to patient selection and the potential inaccuracy of very high-order polynomial curve-fitting methods. The clinical evaluation of labor is a process of serially estimating the likelihood of a safe vaginal delivery. Because many factors contribute to that likelihood, such as cranial molding, head position and attitude, and the bony architecture and capacity of the pelvis, graphic labor patterns should never be used in isolation. The new guidelines are based heavily on unvalidated notions of labor progress and ignore clinical parameters that should remain cornerstones of intrapartum decision-making. Copyright © 2015. Published by Elsevier Inc.

International guidelines for the in vivo assessment of skin properties in non-clinical settings: Part 2. transepidermal water loss and skin hydration

PubMed Central

du Plessis, Johan; Stefaniak, Aleksandr; Eloff, Fritz; John, Swen; Agner, Tove; Chou, Tzu-Chieh; Nixon, Rosemary; Steiner, Markus; Franken, Anja; Kudla, Irena; Holness, Linn

2015-01-01

Background There is an emerging perspective that it is not sufficient to just assess skin exposure to physical and chemical stressors in workplaces, but that it is also important to assess the condition, i.e. skin barrier function of the exposed skin at the time of exposure. The workplace environment, representing a non-clinical environment, can be highly variable and difficult to control, thereby presenting unique measurement challenges not typically encountered in clinical settings. Methods An expert working group convened a workshop as part of the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals (OEESC) to develop basic guidelines and best practices (based on existing clinical guidelines, published data, and own experiences) for the in vivo measurement of transepidermal water loss (TEWL) and skin hydration in non-clinical settings with specific reference to the workplace as a worst-case scenario. Results Key elements of these guidelines are: (i) to minimize or recognize, to the extent feasible, the influences of relevant endogenous-, exogenous-, environmental- and measurement/instrumentation-related factors; (ii) to measure TEWL with a closed-chamber type instrument; (iii) report results as a difference or percent change (rather than absolute values); and (iv) accurately report any notable deviations from this guidelines. Conclusion It is anticipated that these guidelines will promote consistent data reporting, which will facilitate inter-comparison of study results. PMID:23331328

[Comparative evaluation of clinical practice guidelines for the treatment of schizophrenia].

PubMed

Delessert, D; Pomini, V; Grasset, F; Baumann, P

2008-01-01

Many clinical practice guidelines (CPG) have been published in reply to the development of the concept of "evidence-based medicine" (EBM) and as a solution to the difficulty of synthesizing and selecting relevant medical literature. Taking into account the expansion of new CPG, the question of choice arises: which CPG to consider in a given clinical situation? It is of primary importance to evaluate the quality of the CPG, but until recently, there has been no standardized tool of evaluation or comparison of the quality of the CPG. An instrument of evaluation of the quality of the CPG, called "AGREE" for appraisal of guidelines for research and evaluation was validated in 2002. The six principal CPG concerning the treatment of schizophrenia are compared with the help of the "AGREE" instrument: (1) "the Agence nationale pour le développement de l'évaluation médicale (ANDEM) recommendations"; (2) "The American Psychiatric Association (APA) practice guideline for the treatment of patients with schizophrenia"; (3) "The quick reference guide of APA practice guideline for the treatment of patients with schizophrenia"; (4) "The schizophrenia patient outcomes research team (PORT) treatment recommendations"; (5) "The Texas medication algorithm project (T-MAP)" and (6) "The expert consensus guideline for the treatment of schizophrenia". The results of our study were then compared with those of a similar investigation published in 2005, structured on 24 CPG tackling the treatment of schizophrenia. The "AGREE" tool was also used by two investigators in their study. In general, the scores of the two studies differed little and the two global evaluations of the CPG converged; however, each of the six CPG is perfectible. The rigour of elaboration of the six CPG was in general average. The consideration of the opinion of potential users was incomplete, and an effort made in the presentation of the recommendations would facilitate their clinical use. Moreover, there was little consideration by the authors regarding the applicability of the recommendations. Globally, two CPG are considered as strongly recommended: "the quick reference guide of the APA practice guideline for the treatment of patients with schizophrenia" and "the T-MAP".

Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline.

PubMed

Peters, Anne L; Ahmann, Andrew J; Battelino, Tadej; Evert, Alison; Hirsch, Irl B; Murad, M Hassan; Winter, William E; Wolpert, Howard

2016-11-01

To formulate clinical practice guidelines for the use of continuous glucose monitoring and continuous subcutaneous insulin infusion in adults with diabetes. The participants include an Endocrine Society-appointed Task Force of seven experts, a methodologist, and a medical writer. The American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology co-sponsored this guideline. The Task Force developed this evidence-based guideline using the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned one systematic review and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Continuous subcutaneous insulin infusion and continuous glucose monitoring have an important role in the treatment of diabetes. Data from randomized controlled trials are limited on the use of medical devices, but existing studies support the use of diabetes technology for a wide variety of indications. This guideline presents a review of the literature and practice recommendations for appropriate device use.

Peri-operative management of the obese surgical patient 2015: Association of Anaesthetists of Great Britain and Ireland Society for Obesity and Bariatric Anaesthesia.

PubMed

Nightingale, C E; Margarson, M P; Shearer, E; Redman, J W; Lucas, D N; Cousins, J M; Fox, W T A; Kennedy, N J; Venn, P J; Skues, M; Gabbott, D; Misra, U; Pandit, J J; Popat, M T; Griffiths, R

2015-07-01

Guidelines are presented for the organisational and clinical peri-operative management of anaesthesia and surgery for patients who are obese, along with a summary of the problems that obesity may cause peri-operatively. The advice presented is based on previously published advice, clinical studies and expert opinion. © 2015 The Authors. Anaesthesia published by John Wiley & Sons Ltd on behalf of Association of Anaesthetists of Great Britain and Ireland.

A comparison of current practice patterns of US dermatologists versus published guidelines for the biopsy, initial management, and follow up of patients with primary cutaneous melanoma.

PubMed

Farberg, Aaron S; Rigel, Darrell S

2016-12-01

Guidelines exist for the management of cutaneous malignant melanoma, but their adoption, prevalence, and impact have not yet been determined. To determine current melanoma clinical management practices of US dermatologists and the variance from guidelines that might exist. A cross-sectional e-mail survey study assessing preferred biopsy methods for lesions suspicious for melanoma, margins used for excision, and recommended follow-up intervals were sent to 6177 US dermatologists (540 responding). The representative nature of the responding subset was verified by comparing their demographics to that from the American Academy of Dermatology (AAD) membership. Management varied from published guidelines. Shave biopsy (35%) was the most commonly used method followed by narrow excisional biopsy (31%), saucerization/scoop shave (12%), punch (11%), and wide excision (3%). Excisional margins narrower than recommended were noted and follow-up intervals varied. There were significant management differences noted for dermatologists by practice setting and by years in practice. The impact of patient history, lesion anatomic site, and size of lesion were not assessed. Recall and nonresponder sampling bias may exist. Variations in dermatologists' approaches to melanoma management and variance from current guidelines suggest that a knowledge gap may exist representing an educational opportunity. However, emerging data may also justify deviations from existing guidelines, suggesting a reassessment of the guidelines may be indicated. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Bridging the Guideline Implementation Gap: A Systematic, Document-Centered Approach to Guideline Implementation

PubMed Central

Shiffman, Richard N.; Michel, George; Essaihi, Abdelwaheb; Thornquist, Elizabeth

2004-01-01

Objective: A gap exists between the information contained in published clinical practice guidelines and the knowledge and information that are necessary to implement them. This work describes a process to systematize and make explicit the translation of document-based knowledge into workflow-integrated clinical decision support systems. Design: This approach uses the Guideline Elements Model (GEM) to represent the guideline knowledge. Implementation requires a number of steps to translate the knowledge contained in guideline text into a computable format and to integrate the information into clinical workflow. The steps include: (1) selection of a guideline and specific recommendations for implementation, (2) markup of the guideline text, (3) atomization, (4) deabstraction and (5) disambiguation of recommendation concepts, (6) verification of rule set completeness, (7) addition of explanations, (8) building executable statements, (9) specification of origins of decision variables and insertions of recommended actions, (10) definition of action types and selection of associated beneficial services, (11) choice of interface components, and (12) creation of requirement specification. Results: The authors illustrate these component processes using examples drawn from recent experience translating recommendations from the National Heart, Lung, and Blood Institute's guideline on management of chronic asthma into a workflow-integrated decision support system that operates within the Logician electronic health record system. Conclusion: Using the guideline document as a knowledge source promotes authentic translation of domain knowledge and reduces the overall complexity of the implementation task. From this framework, we believe that a better understanding of activities involved in guideline implementation will emerge. PMID:15187061

Everolimus as first line therapy for pancreatic neuroendocrine tumours: current knowledge and future perspectives.

PubMed

Gallo, Marco; Malandrino, Pasqualino; Fanciulli, Giuseppe; Rota, Francesca; Faggiano, Antongiulio; Colao, Annamaria

2017-07-01

Everolimus has been shown to be effective for advanced pancreatic neuroendocrine tumours (pNETs), but its positioning in the therapeutic algorithm for pNETs is matter of debate. With the aim to shed light on this point, we performed an up-to-date critical review taking into account the results of both retrospective and prospective published studies, and the recommendations of international guidelines. In addition, we performed an extensive search on the Clinical Trial Registries databases worldwide, to gather information on the ongoing clinical trials related to this specific topic. We identified eight retrospective published studies, two prospective published studies, and five registered clinical trials. Moreover, we analyzed the content of four widespread international guidelines. Our critical review confirms the lack of high-quality data to recommend everolimus as the first line therapy for pNETs. The ongoing clinical trials reported in this review will hopefully help clinicians, in the near future, to better evaluate the role of everolimus as the first line therapy for pNETs. However, at the moment, there is already enough evidence to recommend everolimus as the first line therapy for patients with symptomatic malignant unresectable insulin-secreting pNETs, to control the endocrine syndrome regardless of tumour growth.

Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association

PubMed Central

Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

2017-01-01

Abstract The Oncology Section of the American Physical Therapy Association (APTA) developed a clinical practice guideline to aid the clinician in diagnosing secondary upper quadrant cancer-related lymphedema. Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in the diagnostic process. Overall clinical practice recommendations were formulated based on the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. In an effort to maximize clinical applicability, recommendations were based on the characteristics as to the location and stage of a patient's upper quadrant lymphedema. PMID:28838217

Topical Treatment of Degenerative Knee Osteoarthritis.

PubMed

Meng, Zengdong; Huang, Rongzhong

2018-01-01

This article reviews topical management strategies for degenerative osteoarthritis (OA) of the knee. A search of Pubmed, Embase and the Cochrane library using MeSH terms including "topical," "treatment," "knee" and "osteoarthritis" was carried out. Original research and review articles on the effectiveness and safety, recommendations from international published guidelines and acceptability studies of topical preparations were included. Current topical treatments included for the management of knee OA include topical nonsteroidal anti-inflammatory drugs, capsaicin, salicylates and physical treatments such as hot or cold therapy. Current treatment guidelines recommend topical nonsteroidal anti-inflammatory drugs as an alternative and even first-line therapy for OA management, especially among elderly patients. Guidelines on other topical treatments vary, from recommendations against their use, to in favor as alternative or simultaneous therapy, especially for patients with contraindications to other analgesics. Although often well-tolerated and preferred by many patients, clinical care still lags in the adoption of topical treatments. Aspects of efficacy, safety and patient quality of life data require further research. Copyright © 2018 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.

[Guidelines in Practice: The New S3 Guideline "Sleeping Disorders - Sleep-Related Abnormal Breathing"].

PubMed

Gerlach, Martin; Sanner, Bernd

2017-10-01

Sleep related breathing disorders include central sleep apnea (CSA), obstructive sleep apnea (OSA), sleep-related hypoventilation, and sleep-related hypoxia. These disorders are frequent and growing in clinical relevance. The related chapter of the S3 guideline "Non-restorative sleep/Sleep disorders", published by the German Sleep Society (DGSM), has recently been updated in November 2016. Epidemiology, diagnostics, therapeutic procedures, and classification of sleep related disorders have been revised. Concerning epidemiology, a considerably higher mortality rate among pregnant women with OSA has been emphasized. With regards to diagnostics, the authors point out that respiratory polygraphy may be sufficient in diagnosing OSA, if a typical clinical condition is given. For CSA, recommendations were changed to diagnose CSA with low apnea rates present. Significant changes for treating CSA in patients with left ventricular dysfunction have been introduced. In addition, there is now to be differentiated between sleep-related hypoventilation and sleep-related hypoxaemia. Obesity hypoventilation syndrome is discussed in more detail. This article sums up and comments on the published changes. Georg Thieme Verlag KG Stuttgart · New York.

[Guidelines in Practice: The New S3 Guideline "Sleeping Disorders - Sleep-Related Abnormal Breathing"].

PubMed

Gerlach, M; Sanner, B

2017-08-01

Sleep related breathing disorders include central sleep apnea (CSA), obstructive sleep apnea (OSA), sleep-related hypoventilation, and sleep-related hypoxia. These disorders are frequent and growing in clinical relevance. The related chapter of the S3 guideline "Non-restorative sleep/Sleep disorders", published by the German Sleep Society (DGSM), has recently been updated in November 2016. Epidemiology, diagnostics, therapeutic procedures, and classification of sleep related disorders have been revised. Concerning epidemiology, a considerably higher mortality rate among pregnant women with OSA has been emphasized. With regards to diagnostics, the authors point out that respiratory polygraphy may be sufficient in diagnosing OSA, if a typical clinical condition is given. For CSA, recommendations were changed to diagnose CSA with low apnea rates present. Significant changes for treating CSA in patients with left ventricular dysfunction have been introduced. In addition, there is now to be differentiated between sleep-related hypoventilation and sleep-related hypoxaemia. Obesity hypoventilation syndrome is discussed in more detail. This article sums up and comments on the published changes. © Georg Thieme Verlag KG Stuttgart · New York.

Legal Decision-Making by People with Aphasia: Critical Incidents for Speech Pathologists

ERIC Educational Resources Information Center

Ferguson, Alison; Duffield, Gemma; Worrall, Linda

2010-01-01

Background: The assessment and management of a person with aphasia for whom decision-making capacity is queried represents a highly complex clinical issue. In addition, there are few published guidelines and even fewer published accounts of empirical research to assist. Aims: The research presented in this paper aimed to identify the main issues…

[The practice guideline 'The STD consultation' from the Dutch College of General Practitioners; a response from the perspective of dermatology].

PubMed

Neumann, H A M

2005-08-06

Sexually transmitted diseases (STDs) constitute an important health problem in the Netherlands. Although there are several STD outpatient clinics, such facilities remain unavailable outside the larger cities. The members of the Dutch College of General Practitioners, who published the practice guideline on STD consultation, provide the majority of STD care. An important aspect of this guideline is the fact that GPs are able to assess the risk by taking a sexual history and then determine their own policy on additional investigations. This prevents the omission of investigations that would exclude an STD, but carries the risk, at least theoretically, that it may be missed. It is noteworthy that scabies is not discussed in these guidelines. The most important difference between the guidelines followed by dermatological/STD clinics throughout the Netherlands is the level of triage practiced by GPs. It seems that GPs have a well-thought out and responsible policy, which also merits attention from dermatologists/venereologists.

Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

PubMed

Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

2017-12-05

The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Quality assessment of recent evidence-based clinical practice guidelines for management of type 2 diabetes mellitus in adults using the AGREE II instrument.

PubMed

Anwer, Muhammad A; Al-Fahed, Ousama B; Arif, Samir I; Amer, Yasser S; Titi, Maher A; Al-Rukban, Mohammed O

2018-02-01

Type 2 diabetes mellitus (T2DM) is a worldwide and national public health problem that has a great impact on the population in Saudi Arabia. High-quality clinical practice guidelines (CPGs) are cornerstones in improving the health care provided for patients with diabetes. This study evaluated the methodological rigour, transparency, and applicability of recently published CPGs. Our group conducted a systematic search for recently published CPGs for T2DM. The searching and screening for Source CPGs were guided by tools from the ADAPTE methods with specific inclusion/exclusion criteria. Five reviewers using the second version of the Appraisal of Guidelines for Research and Evaluation (AGREE II) Instrument independently assessed the quality of the retrieved Source CPGs. Domains of Scope and purpose and Clarity of presentation received the highest scores in all CPGs. Most of the assessed CPGs (86%) were considered with high overall quality and were recommended for use. Rigour of development and applicability domains were together highest in 3 CPGs (43%). The overall high quality of DM CPGs published in the last 3 years demonstrated the continuous development and improvement in CPG methodologies and standards. Health care professionals should consider the quality of any CPG for T2DM before deciding to use it in their daily clinical practice. Three CPGs have been identified, using the AGREE criteria, as high-quality and trustworthy. Ideally, the resources provided by the AGREE trust including the AGREE II Instrument should be used by a clinician to scan through the large number of published T2DM CPGs to identify the CPGs with high methodological quality and applicability. © 2017 John Wiley & Sons, Ltd.

Applying Evidence-Based Medicine in Telehealth: An Interactive Pattern Recognition Approximation

PubMed Central

Fernández-Llatas, Carlos; Meneu, Teresa; Traver, Vicente; Benedi, José-Miguel

2013-01-01

Born in the early nineteen nineties, evidence-based medicine (EBM) is a paradigm intended to promote the integration of biomedical evidence into the physicians daily practice. This paradigm requires the continuous study of diseases to provide the best scientific knowledge for supporting physicians in their diagnosis and treatments in a close way. Within this paradigm, usually, health experts create and publish clinical guidelines, which provide holistic guidance for the care for a certain disease. The creation of these clinical guidelines requires hard iterative processes in which each iteration supposes scientific progress in the knowledge of the disease. To perform this guidance through telehealth, the use of formal clinical guidelines will allow the building of care processes that can be interpreted and executed directly by computers. In addition, the formalization of clinical guidelines allows for the possibility to build automatic methods, using pattern recognition techniques, to estimate the proper models, as well as the mathematical models for optimizing the iterative cycle for the continuous improvement of the guidelines. However, to ensure the efficiency of the system, it is necessary to build a probabilistic model of the problem. In this paper, an interactive pattern recognition approach to support professionals in evidence-based medicine is formalized. PMID:24185841

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.

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

PubMed

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

2018-05-01

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

Food protein-induced enterocolitis syndrome: a review of the new guidelines.

PubMed

Leonard, Stephanie A; Pecora, Valentina; Fiocchi, Alessandro Giovanni; Nowak-Wegrzyn, Anna

2018-01-01

Food protein-induced enterocolitis syndrome (FPIES) is a non IgE-mediated gastrointestinal food allergy that presents with delayed vomiting after ingestion primarily in infants. While the pathophysiology of FPIES is poorly understood, the clinical presentation of acute FPEIS reactions has been well characterized. The first International Consensus Guidelines for the Diagnosis and Management of Food Protein-induced Enterocolitis Syndrome were published in 2017 and reviewed epidemiology, clinical presentation, and prognosis of acute and chronic FPIES. The workgroup outlined clinical phenotypes, proposed diagnostic criteria, and made recommendations on management. This article summarizes the guidelines and adds recent updates. FPIES is gaining recognition, however there continues to be delays in diagnosis and misdiagnosis due to overlap of symptoms with over conditions, lack of a diagnostic test, and because some of the common trigger foods are not thought of as allergenic. More research into disease mechanisms and factors influencing differences between populations is needed.

Number and type of guideline implementation tools varies by guideline, clinical condition, country of origin, and type of developer organization: content analysis of guidelines.

PubMed

Liang, Laurel; Abi Safi, Jhoni; Gagliardi, Anna R

2017-11-15

Guideline implementation tools (GI tools) can improve clinician behavior and patient outcomes. Analyses of guidelines published before 2010 found that many did not offer GI tools. Since 2010 standards, frameworks and instructions for GI tools have emerged. This study analyzed the number and types of GI tools offered by guidelines published in 2010 or later. Content analysis and a published GI tool framework were used to categorize GI tools by condition, country, and type of organization. English-language guidelines on arthritis, asthma, colorectal cancer, depression, diabetes, heart failure, and stroke management were identified in the National Guideline Clearinghouse. Screening and data extraction were in triplicate. Findings were reported with summary statistics. Eighty-five (67.5%) of 126 eligible guidelines published between 2010 and 2017 offered one or more of a total of 464 GI tools. The mean number of GI tools per guideline was 5.5 (median 4.0, range 1 to 28) and increased over time. The majority of GI tools were for clinicians (239, 51.5%), few were for patients (113, 24.4%), and fewer still were to support implementation (66, 14.3%) or evaluation (46, 9.9%). Most clinician GI tools were guideline summaries (116, 48.5%), and most patient GI tools were condition-specific information (92, 81.4%). Government agencies (patient 23.5%, clinician 28.9%, implementation 24.1%, evaluation 23.5%) and developers in the UK (patient 18.5%, clinician 25.2%, implementation 27.2%, evaluation 29.1%) were more likely to generate guidelines that offered all four types of GI tools. Professional societies were more likely to generate guidelines that included clinician GI tools. Many guidelines do not include any GI tools, or a variety of GI tools for different stakeholders that may be more likely to prompt guideline uptake (point-of-care forms or checklists for clinicians, decision-making or self-management tools for patients, implementation and evaluation tools for managers and policy-makers). While this may vary by country and type of organization, and suggests that developers could improve the range of GI tools they develop, further research is needed to identify determinants and potential solutions. Research is also needed to examine the cost-effectiveness of various types of GI tools so that developers know where to direct their efforts and scarce resources.

Graduate Medical Education Training in Clinical Epidemiology, Critical Appraisal, and Evidence-Based Medicine: A Critical Review of Curricula.

ERIC Educational Resources Information Center

Green, Michael L.

1999-01-01

A study systematically reviewed published literature on graduate medical-education curricula in clinical epidemiology, critical appraisal, and evidence-based medicine (EBM). The 18 reports found in the search provide useful guidelines for medical educators but many suffer from incomplete descriptions and inadequate curriculum evaluations.…

The impact of psychopharmacology on contemporary clinical psychiatry.

PubMed

Vázquez, Gustavo H

2014-08-01

Clinical psychiatric evaluations of patients have changed dramatically in recent decades. Both initial assessments and follow-up visits have become brief and superficial, focused on searching for categorical diagnostic criteria from checklists, with limited inquiry into patient-reported symptomatic status and tolerability of treatments. The virtually exclusive therapeutic task has become selecting a plausible psychotropic, usually based on expert consensus guidelines. These guidelines and practice patterns rest mainly on published monotherapy trials that may or may not be applicable to particular patients but are having a profound impact, not only on modern psychiatric practice but also on psychiatric education, research, and theory.

A case report of embryo donation: ethical and clinical implications for psychologists.

PubMed

Rizk, Marianne; Pawlak, Stacey

2016-10-01

Third-party reproduction is a growing field, and an increasing body of literature considers the ethics of embryo donation. Due to the psychosocial complexities that generally accompany the donation and/or use of donor embryos, psychologists can play a pivotal role in these specialised fertility cases. While laws in the USA are in place to regulate the medical procedures involved in embryo donation, only unenforceable guidelines exist for psychologists specialising in fertility cases. The presentation of this case study aims to: (1) clarify the ethical concerns that fertility psychologists should consider in similar situations by assessing whether American Society of Reproductive Medicine (ASRM) and the American Psychological Association (APA) guidelines compete or complement one another within this case of embryo donation and (2) consider the interests, obligations and rights of all parties involved. Several principles, standards and guidelines that must be considered are described. Overall, the APA Ethics Code and the ASRM Guidelines appear to complement one another for most aspects of this case. Fertility psychologists should consider the clinical implications of the interests, rights and duties of all involved parties, including themselves. 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/

Review of clinical practice guidelines for the management of LDL-related risk.

PubMed

Morris, Pamela B; Ballantyne, Christie M; Birtcher, Kim K; Dunn, Steven P; Urbina, Elaine M

2014-07-15

Managing risk related to low-density lipoprotein (LDL) is vital in therapy for patients at risk for atherosclerotic cardiovascular disease (ASCVD) events given its important etiologic role in atherogenesis. Despite decades of research showing reduction of ASCVD risk with multiple approaches to lowering of LDL cholesterol, there continue to be significant gaps in care with inadequate numbers of patients receiving standard of care lipid-lowering therapy. Confusion regarding implementation of the multiple published clinical practice guidelines has been identified as one contributor to suboptimal management of LDL-related risk. This review summarizes the current guidelines for reduction of LDL-related cardiovascular risk provided by a number of major professional societies, which have broad applicability to diverse populations worldwide. Statements have varied in the process and methodology of development of recommendations, the grading system for level and strength of evidence, the inclusion or exclusion of expert opinion, the suggested ASCVD risk assessment tool, the lipoproteins recommended for risk assessment, and the lipoprotein targets of therapy. The similarities and differences among important guidelines in the United States and internationally are discussed, with recommendations for future strategies to improve consistency in approaches to LDL-related ASCVD risk and to reduce gaps in implementation of evidence-based therapies. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Antipsychotic-induced hyperprolactinemia: synthesis of world-wide guidelines and integrated recommendations for assessment, management and future research.

PubMed

Grigg, Jasmin; Worsley, Roisin; Thew, Caroline; Gurvich, Caroline; Thomas, Natalie; Kulkarni, Jayashri

2017-11-01

Hyperprolactinemia is a highly prevalent adverse effect of many antipsychotic agents, with potentially serious health consequences. Several guidelines have been developed for the management of this condition; yet, their concordance has not been evaluated. The objectives of this paper were (1) to review current clinical guidelines; (2) to review key systematic evidence for management; and (3) based on our findings, to develop an integrated management recommendation specific to male and female patients who are otherwise clinically stabilised on antipsychotics. We performed searches of Medline and EMBASE, supplemented with guideline-specific database and general web searches, to identify clinical guidelines containing specific recommendations for antipsychotic-induced hyperprolactinemia, produced/updated 01/01/2010-15/09/2016. A separate systematic search was performed to identify emerging management approaches described in reviews and meta-analyses published ≥ 2010. There is some consensus among guidelines relating to baseline PRL screening (8/12 guidelines), screening for differential diagnosis (7/12) and discontinuing/switching PRL-raising agent (7/12). Guidelines otherwise diverge substantially regarding most aspects of screening, monitoring and management (e.g. treatment with dopamine agonists). There is an omission of clear sex-specific recommendations. Systematic literature on management approaches is promising; more research is needed. An integrated management recommendation is presented to guide sex-specific clinical response to antipsychotic-induced hyperprolactinemia. Key aspects include asymptomatic hyperprolactinemia monitoring and fertility considerations with PRL normalisation. Further empirical work is key to shaping robust guidelines for antipsychotic-induced hyperprolactinemia. The integrated management recommendation can assist clinician and patient decision-making, with the goal of balancing effective psychiatric treatment while minimising PRL-related adverse health effects in male and female patients.

Screening, Assessment, and Management of Fatigue in Adult Survivors of Cancer: An American Society of Clinical Oncology Clinical Practice Guideline Adaptation

PubMed Central

Bower, Julienne E.; Bak, Kate; Berger, Ann; Breitbart, William; Escalante, Carmelita P.; Ganz, Patricia A.; Schnipper, Hester Hill; Lacchetti, Christina; Ligibel, Jennifer A.; Lyman, Gary H.; Ogaily, Mohammed S.; Pirl, William F.; Jacobsen, Paul B.

2014-01-01

Purpose This guideline presents screening, assessment, and treatment approaches for the management of adult cancer survivors who are experiencing symptoms of fatigue after completion of primary treatment. Methods A systematic search of clinical practice guideline databases, guideline developer Web sites, and published health literature identified the pan-Canadian guideline on screening, assessment, and care of cancer-related fatigue in adults with cancer, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Cancer-Related Fatigue and the NCCN Guidelines for Survivorship. These three guidelines were appraised and selected for adaptation. Results It is recommended that all patients with cancer be evaluated for the presence of fatigue after completion of primary treatment and be offered specific information and strategies for fatigue management. For those who report moderate to severe fatigue, comprehensive assessment should be conducted, and medical and treatable contributing factors should be addressed. In terms of treatment strategies, evidence indicates that physical activity interventions, psychosocial interventions, and mind-body interventions may reduce cancer-related fatigue in post-treatment patients. There is limited evidence for use of psychostimulants in the management of fatigue in patients who are disease free after active treatment. Conclusion Fatigue is prevalent in cancer survivors and often causes significant disruption in functioning and quality of life. Regular screening, assessment, and education and appropriate treatment of fatigue are important in managing this distressing symptom. Given the multiple factors contributing to post-treatment fatigue, interventions should be tailored to each patient's specific needs. In particular, a number of nonpharmacologic treatment approaches have demonstrated efficacy in cancer survivors. PMID:24733803

How institutional change and individual researchers helped advance clinical guidelines in American health care.

PubMed

Nigam, Amit

2013-06-01

Clinical guidelines are important tools for managing health care quality. Research on the origins of guidelines primarily focuses on the institutional causes of their emergence and growth. Individual medical researchers, however, have played important roles. This paper develops knowledge of the role of individual medical researchers in advancing guidelines, and of how researchers' efforts were enabled or constrained by broader institutional changes. Drawing on an analytical case study focused on the role of Kerr White, John Wennberg, and Robert Brook, it shows that guidelines were a product of the interplay between institutional change in the medical field and actions by individual researchers, acting as institutional entrepreneurs. Increased government involvement in the health care field triggered the involvement of a range of new actors in health care. These new organizations created a context that allowed individual researchers to advance guidelines by creating job opportunities, providing research funding, and creating opportunities for researchers to engage with the policy process. Individual researchers availed of this context to both advance their ideas, and to draw new actors into the field. Copyright © 2013. Published by Elsevier Ltd.

The Asia-Pacific Clinical Practice Guidelines for the Management of Frailty.

PubMed

Dent, Elsa; Lien, Christopher; Lim, Wee Shiong; Wong, Wei Chin; Wong, Chek Hooi; Ng, Tze Pin; Woo, Jean; Dong, Birong; de la Vega, Shelley; Hua Poi, Philip Jun; Kamaruzzaman, Shahrul Bahyah Binti; Won, Chang; Chen, Liang-Kung; Rockwood, Kenneth; Arai, Hidenori; Rodriguez-Mañas, Leocadio; Cao, Li; Cesari, Matteo; Chan, Piu; Leung, Edward; Landi, Francesco; Fried, Linda P; Morley, John E; Vellas, Bruno; Flicker, Leon

2017-07-01

To develop Clinical Practice Guidelines for the screening, assessment and management of the geriatric condition of frailty. An adapted Grading of Recommendations, Assessment, Development, and Evaluation approach was used to develop the guidelines. This process involved detailed evaluation of the current scientific evidence paired with expert panel interpretation. Three categories of Clinical Practice Guidelines recommendations were developed: strong, conditional, and no recommendation. Strong recommendations were (1) use a validated measurement tool to identify frailty; (2) prescribe physical activity with a resistance training component; and (3) address polypharmacy by reducing or deprescribing any inappropriate/superfluous medications. Conditional recommendations were (1) screen for, and address modifiable causes of fatigue; (2) for persons exhibiting unintentional weight loss, screen for reversible causes and consider food fortification and protein/caloric supplementation; and (3) prescribe vitamin D for individuals deficient in vitamin D. No recommendation was given regarding the provision of a patient support and education plan. The recommendations provided herein are intended for use by healthcare providers in their management of older adults with frailty in the Asia Pacific region. It is proposed that regional guideline support committees be formed to help provide regular updates to these evidence-based guidelines. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Thinking styles and doctors' knowledge and behaviours relating to acute coronary syndromes guidelines

PubMed Central

Sladek, Ruth M; Bond, Malcolm J; Huynh, Luan T; Chew, Derek PB; Phillips, Paddy A

2008-01-01

Background How humans think and make decisions is important in understanding behaviour. Hence an understanding of cognitive processes among physicians may inform our understanding of behaviour in relation to evidence implementation strategies. A personality theory, Cognitive-Experiential Self Theory (CEST) proposes a relationship between different ways of thinking and behaviour, and articulates pathways for behaviour change. However prior to the empirical testing of interventions based on CEST, it is first necessary to demonstrate its suitability among a sample of healthcare workers. Objectives To investigate the relationship between thinking styles and the knowledge and clinical practices of doctors directly involved in the management of acute coronary syndromes. Methods Self-reported doctors' thinking styles (N = 74) were correlated with results from a survey investigating knowledge, attitudes, and clinical practice, and evaluated against recently published acute coronary syndrome clinical guidelines. Results Guideline-discordant practice was associated with an experiential style of thinking. Conversely, guideline-concordant practice was associated with a higher preference for a rational style of reasoning. Conclusion Findings support that while guidelines might be necessary to communicate evidence, other strategies may be necessary to target discordant behaviours. Further research designed to examine the relationships found in the current study is required. PMID:18439250

The quantity and quality of complementary and alternative medicine clinical practice guidelines on herbal medicines, acupuncture and spinal manipulation: systematic review and assessment using AGREE II.

PubMed

Ng, Jeremy Y; Liang, Laurel; Gagliardi, Anna R

2016-10-29

Complementary and alternative medicine (CAM) use is often not disclosed by patients, and can be unfamiliar to health care professionals. This may lead to underuse of beneficial CAM therapies, and overuse of other CAM therapies with little proven benefit or known contraindications. No prior research has thoroughly evaluated the credibility of knowledge-based resources. The purpose of this research was to assess the quantity and quality of CAM guidelines. A systematic review was conducted to identify CAM guidelines. MEDLINE, EMBASE and CINAHL were searched in January 2016 from 2003 to 2015. The National Guideline Clearinghouse, National Center for Complementary and Integrative Health web site, and two CAM journals were also searched. Eligible guidelines published in English language by non-profit agencies on herbal medicine, acupuncture, or spinal manipulation for adults with any condition were assessed with the Appraisal of Guidelines, Research and Evaluation II (AGREE II) instrument. From 3,126 unique search results, 17 guidelines (two herbal medicine, three acupuncture, four spinal manipulation, eight mixed CAM therapies) published in 2003 or later and relevant to several clinical conditions were eligible. Scaled domain percentages from highest to lowest were clarity of presentation (85.3 %), scope and purpose (83.3 %), rigour of development (61.2 %), editorial independence (60.1 %), stakeholder involvement (52.0 %) and applicability (20.7 %). Quality varied within and across guidelines. None of the 17 guidelines were recommended by both appraisers; 14 were recommended as Yes or Yes with modifications. Guidelines that scored well could be used by patients and health care professionals as the basis for discussion about the use of these CAM therapies. In future updates, guidelines that achieved variable or lower scores could be improved according to specifications in the AGREE II instrument, and with insight from a large number of resources that are available to support guideline development and implementation. Future research should identify CAM therapies other than those reviewed here for which guidelines are available. Research is also needed on the safety and effectiveness of CAM therapies.

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

PubMed

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

2016-06-01

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

Management of bleeding and coagulopathy following major trauma: an updated European guideline

PubMed Central

2013-01-01

Introduction Evidence-based recommendations are needed to guide the acute management of the bleeding trauma patient. When these recommendations are implemented patient outcomes may be improved. Methods The multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document represents an updated version of the guideline published by the group in 2007 and updated in 2010. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature. Results Key changes encompassed in this version of the guideline include new recommendations on the appropriate use of vasopressors and inotropic agents, and reflect an awareness of the growing number of patients in the population at large treated with antiplatelet agents and/or oral anticoagulants. The current guideline also includes recommendations and a discussion of thromboprophylactic strategies for all patients following traumatic injury. The most significant addition is a new section that discusses the need for every institution to develop, implement and adhere to an evidence-based clinical protocol to manage traumatically injured patients. The remaining recommendations have been re-evaluated and graded based on literature published since the last edition of the guideline. Consideration was also given to changes in clinical practice that have taken place during this time period as a result of both new evidence and changes in the general availability of relevant agents and technologies. Conclusions A comprehensive, multidisciplinary approach to trauma care and mechanisms with which to ensure that established protocols are consistently implemented will ensure a uniform and high standard of care across Europe and beyond. Please see related letter by Morel et alhttp://ccforum.com/content/17/4/442 PMID:23601765

ACC/AHA Special Report: Clinical Practice Guideline Implementation Strategies: A Summary of Systematic Reviews by the NHLBI Implementation Science Work Group: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

PubMed

Chan, Wiley V; Pearson, Thomas A; Bennett, Glen C; Cushman, William C; Gaziano, Thomas A; Gorman, Paul N; Handler, Joel; Krumholz, Harlan M; Kushner, Robert F; MacKenzie, Thomas D; Sacco, Ralph L; Smith, Sidney C; Stevens, Victor J; Wells, Barbara L; Castillo, Graciela; Heil, Susan K R; Stephens, Jennifer; Vann, Julie C Jacobson

2017-02-28

In 2008, the National Heart, Lung, and Blood Institute convened an Implementation Science Work Group to assess evidence-based strategies for effectively implementing clinical practice guidelines. This was part of a larger effort to update existing clinical practice guidelines on cholesterol, blood pressure, and overweight/obesity. Review evidence from the published implementation science literature and identify effective or promising strategies to enhance the adoption and implementation of clinical practice guidelines. This systematic review was conducted on 4 critical questions, each focusing on the adoption and effectiveness of 4 intervention strategies: (1) reminders, (2) educational outreach visits, (3) audit and feedback, and (4) provider incentives. A scoping review of the Rx for Change database of systematic reviews was used to identify promising guideline implementation interventions aimed at providers. Inclusion and exclusion criteria were developed a priori for each question, and the published literature was initially searched up to 2012, and then updated with a supplemental search to 2015. Two independent reviewers screened the returned citations to identify relevant reviews and rated the quality of each included review. Audit and feedback and educational outreach visits were generally effective in improving both process of care (15 of 21 reviews and 12 of 13 reviews, respectively) and clinical outcomes (7 of 12 reviews and 3 of 5 reviews, respectively). Provider incentives showed mixed effectiveness for improving both process of care (3 of 4 reviews) and clinical outcomes (3 reviews equally distributed between generally effective, mixed, and generally ineffective). Reminders showed mixed effectiveness for improving process of care outcomes (27 reviews with 11 mixed and 3 generally ineffective results) and were generally ineffective for clinical outcomes (18 reviews with 6 mixed and 9 generally ineffective results). Educational outreach visits (2 of 2 reviews), reminders (3 of 4 reviews), and provider incentives (1 of 1 review) were generally effective for cost reduction. Educational outreach visits (1 of 1 review) and provider incentives (1 of 1 review) were also generally effective for cost-effectiveness outcomes. Barriers to clinician adoption or adherence to guidelines included time constraints (8 reviews/overviews); limited staffing resources (2 overviews); timing (5 reviews/overviews); clinician skepticism (5 reviews/overviews); clinician knowledge of guidelines (4 reviews/overviews); and higher age of the clinician (1 overview). Facilitating factors included guideline characteristics such as format, resources, and end-user involvement (6 reviews/overviews); involving stakeholders (5 reviews/overviews); leadership support (5 reviews/overviews); scope of implementation (5 reviews/overviews); organizational culture such as multidisciplinary teams and low-baseline adherence (9 reviews/overviews); and electronic guidelines systems (3 reviews). The strategies of audit and feedback and educational outreach visits were generally effective in improving both process of care and clinical outcomes. Reminders and provider incentives showed mixed effectiveness, or were generally ineffective. No general conclusion could be reached about cost effectiveness, because of limitations in the evidence. Important gaps exist in the evidence on effectiveness of implementation interventions, especially regarding clinical outcomes, cost effectiveness and contextual issues affecting successful implementation. © 2017 by the American College of Cardiology Foundation and the American Heart Association, Inc.

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.

Prevention of infections associated with combat-related thoracic and abdominal cavity injuries.

PubMed

Martin, Gregory J; Dunne, James R; Cho, John M; Solomkin, Joseph S

2011-08-01

Trauma-associated injuries of the thorax and abdomen account for the majority of combat trauma-associated deaths, and infectious complications are common in those who survive the initial injury. This review focuses on the initial surgical and medical management of torso injuries intended to diminish the occurrence of infection. The evidence for recommendations is drawn from published military and civilian data in case reports, clinical trials, meta-analyses, and previously published guidelines, in the interval since publication of the 2008 guidelines. The emphasis of these recommendations is on actions that can be taken in the forward-deployed setting within hours to days of injury. This evidence-based medicine review was produced to support the Guidelines for the Prevention of Infections Associated With Combat-Related Injuries: 2011 Update contained in this supplement of Journal of Trauma.

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.

Imaging for metastatic disease in patients with newly diagnosed breast cancer: are doctor's perceptions in keeping with the guidelines?

PubMed

Simos, Demetrios; Hutton, Brian; Graham, Ian D; Arnaout, Angel; Caudrelier, Jean-Michel; Clemons, Mark

2015-02-01

Despite multiple guidelines advocating against routine radiological evaluation for metastases in women with early stage breast cancer, imaging is still frequently overused. The objective of this study was to assess doctor's views on imaging guidelines, and an attempt to establish why personal and local clinical practice patterns regarding imaging may differ from current guidelines. Canadian doctors who treat breast cancer were invited by email to complete an online survey developed by members of the research team. Responses were received from 173 physicians (26% response rate). Most (82%) indicated awareness of at least one published imaging guideline. Sixty per cent indicated that they had read the recommendations of the 2012 American Society of Clinical Oncology 'Top 5' list for choosing wisely in oncology imaging and, of those, 81% agreed with it. However, most indicated that this recommendation has not influenced them to order less imaging. Over 95% of doctors identified suspicious history, physical examination findings and inflammatory breast cancer as important factors for performing imaging. The majority did not feel that patient demand, fear of litigation or ease of access to imaging influenced their ordering for imaging. The majority of breast cancer doctors are aware of and generally agree that guidelines pertaining to staging imaging for early breast cancer are reflective of evidence. Despite this, adherence is variable and factors such as local practice patterns and disease biology may play a role. Alternative strategies, beyond simply publishing recommendations, are therefore required if there is to be a sustained change in doctor behaviour. © 2014 John Wiley & Sons, Ltd.

Abnormal uterine bleeding in pre-menopausal women.

PubMed

Singh, Sukhbir; Best, Carolyn; Dunn, Sheila; Leyland, Nicholas; Wolfman, Wendy Lynn

2013-05-01

Abnormal uterine bleeding is the direct cause of a significant health care burden for women, their families, and society as a whole. Up to 30% of women will seek medical assistance for this problem during their reproductive years. This guideline replaces previous clinical guidelines on the topic and is aimed to enable health care providers with the tools to provide the latest evidence-based care in the diagnosis and the medical and surgical management of this common problem. To provide current evidence-based guidelines for the diagnosis and management of abnormal uterine bleeding (AUB) among women of reproductive age. Outcomes evaluated include the impact of AUB on quality of life and the results of interventions including medical and surgical management of AUB. Members of the guideline committee were selected on the basis of individual expertise to represent a range of practical and academic experience in terms of location in Canada, type of practice, subspecialty expertise, and general gynaecology background. The committee reviewed relevant evidence in the English medical literature including published guidelines. Recommendations were established as consensus statements. The final document was reviewed and approved by the Executive and Council of the SOGC. This document provides a summary of up-to-date evidence regarding diagnosis, investigations, and medical and surgical management of AUB. The resulting recommendations may be adapted by individual health care workers when serving women with this condition. Abnormal uterine bleeding is a common and sometimes debilitating condition in women of reproductive age. Standardization of related terminology, a systematic approach to diagnosis and investigation, and a step-wise approach to intervention is necessary. Treatment commencing with medical therapeutic modalities followed by the least invasive surgical modalities achieving results satisfactory to the patient is the ultimate goal of all therapeutic interventions. Published literature was retrieved through searches of MEDLINE and the Cochrane Library in March 2011 using appropriate controlled vocabulary (e.g. uterine hemorrhage, menorrhagia) and key words (e.g. menorrhagia, heavy menstrual bleeding, abnormal uterine bleeding). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies written in English and published from January 1999 to March 2011. Searches were updated on a regular basis and incorporated in the guideline to February 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table). Implementation of the guideline recommendations will improve the health and well-being of women with abnormal uterine bleeding, their families, and society. The economic cost of implementing these guidelines in the Canadian health care system was not considered.

Clinical practice guideline development manual: A quality-driven approach for translating evidence into action

PubMed Central

Rosenfeld, Richard M.; Shiffman, Richard N.

2010-01-01

Background Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing healthcare variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective – or potentially harmful – interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. Purpose This manual describes the principles and practices used successfully by the American Academy of Otolaryngology – Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multi-disciplinary applicability. The development process, which allows moving from conception to completion in twelve months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence. Conclusions As clinical practice guidelines become more prominent as a key metric of quality healthcare, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are – and are not – and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals. PMID:19464525

Current management of gender identity disorder in childhood and adolescence: guidelines, barriers and areas of controversy.

PubMed

Shumer, Daniel E; Spack, Norman P

2013-02-01

The approach to gender identity disorder (GID) in childhood and adolescence has been rapidly evolving and is in a state of flux. In an effort to form management recommendations on the basis of the available literature, The Endocrine Society published clinical practice guidelines in 2009. The guidelines recommend against sex role change in prepubertal children, but they recommend the use of gonadotropin-releasing hormone (GnRH) agonists to suppress puberty in adolescence, and the use of cross-sex hormones starting around age 16 for eligible patients. In actual practice, the approach to GID is quite variable due to continued lack of consensus and specific barriers to treatment that are unique to GID. Recent literature has focused on the mental health approach to prepubertal children with GID and short-term outcomes using pubertal suppression and cross-sex steroids in adolescents with GID. This review will describe the literature published since the release of The Endocrine Society guidelines regarding the management of GID in both children and adolescents.

Usability Evaluation of Clinical Guidelines on the Web Using Eye-Tracker.

PubMed

Khodambashi, Soudabeh; Gilstad, Heidi; Nytrø, Øystein

2016-01-01

Publishing clinical guidelines (GLs) on the web increases their accessibility. However, evaluating their usability and understanding how users interact with the websites has been neglected. In this study we used Tobii eye-tracker to analyse users' interaction with five commercial and public GL sites popular in Norway (four in Norwegian and one English of US origin (UpToDate)). We measured number of clicks and usage rate for search functions, task completion time, users' objective and perception of task success rate. We also measured learning effect for inexperienced users. We found a direct correlation between participant's satisfaction regarding website usability and the time spent, number of mouse clicks and use of search function to obtain the desired results. Our study showed that users' perceived success rate was not reliable and GL publishers should evaluate their website regarding presentation format, layout, navigation bar and search function.

[Between collegial conversation and controlled trials: hospital-based neurologists' sources of information and their practical knowledge in the treatment of stroke patients].

PubMed

Hasenbein, Uwe; Schulze, Axel; Frank, Bernd; Wallesch, Claus-Werner

2006-01-01

The application of evidence-based and standardized knowledge is an important basis for coordinated and effective clinical work. A multicenter study, which was conducted in 30 clinical neurology departments and included 99 junior and senior registrars, addressed aspects of practical knowledge of stroke treatment by open structured oral interviews which were analyzed with respect to interphysician and guideline conformity. In addition, the participants were asked to rate the usefulness of various informational sources and describe their informational sources used according to the aspects of practical knowledge addressed. The respective departmental directors were questioned about the sources of medical knowledge accessible in their clinic. In almost all hospitals, physicians had access to a library and the Internet. However, departments differed with respect to their information management (frequency and type of medical education, quality management, participation in research activities). In accordance with other studies, the knowledge sources reported most often were textbooks, journals and clinical studies. For most sources, the usefulness rankings largely corresponded to the rankings of user behavior. Both were only weak predictors for interphysician and guideline conformity. They are more closely related to the within-department homogeneity of practical knowledge than to interdepartmental and guideline conformity. Within-department homogeneity is enhanced by the use of recent, published and evidence-based sources and topical interaction with clinical colleagues. Guideline conformity was related to the use of databases and professional journals. A preference for colleagues from out-patient practices diminished both interphysician and guideline conformity. It seems there is still untapped potential for within-department knowledge management, such as medical education, implementation and use of guidelines and topical discussions, which may enhance the homogeneity and guideline conformity of the practical knowledge that clinicians apply.

European Fissure Sealant Guidelines: assessment using AGREE II.

PubMed

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

2017-02-01

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

European Respiratory Society guidelines for the management of adult bronchiectasis.

PubMed

Polverino, Eva; Goeminne, Pieter C; McDonnell, Melissa J; Aliberti, Stefano; Marshall, Sara E; Loebinger, Michael R; Murris, Marlene; Cantón, Rafael; Torres, Antoni; Dimakou, Katerina; De Soyza, Anthony; Hill, Adam T; Haworth, Charles S; Vendrell, Montserrat; Ringshausen, Felix C; Subotic, Dragan; Wilson, Robert; Vilaró, Jordi; Stallberg, Bjorn; Welte, Tobias; Rohde, Gernot; Blasi, Francesco; Elborn, Stuart; Almagro, Marta; Timothy, Alan; Ruddy, Thomas; Tonia, Thomy; Rigau, David; Chalmers, James D

2017-09-01

Bronchiectasis in adults is a chronic disorder associated with poor quality of life and frequent exacerbations in many patients. There have been no previous international guidelines.The European Respiratory Society guidelines for the management of adult bronchiectasis describe the appropriate investigation and treatment strategies determined by a systematic review of the literature.A multidisciplinary group representing respiratory medicine, microbiology, physiotherapy, thoracic surgery, primary care, methodology and patients considered the most relevant clinical questions (for both clinicians and patients) related to management of bronchiectasis. Nine key clinical questions were generated and a systematic review was conducted to identify published systematic reviews, randomised clinical trials and observational studies that answered these questions. We used the GRADE approach to define the quality of the evidence and the level of recommendations. The resulting guideline addresses the investigation of underlying causes of bronchiectasis, treatment of exacerbations, pathogen eradication, long term antibiotic treatment, anti-inflammatories, mucoactive drugs, bronchodilators, surgical treatment and respiratory physiotherapy.These recommendations can be used to benchmark quality of care for people with bronchiectasis across Europe and to improve outcomes. Copyright ©ERS 2017.

Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors

PubMed Central

Lindeman, Neal I.; Cagle, Philip T.; Beasley, Mary Beth; Chitale, Dhananjay Arun; Dacic, Sanja; Giaccone, Giuseppe; Jenkins, Robert Brian; Kwiatkowski, David J.; Saldivar, Juan-Sebastian; Squire, Jeremy; Thunnissen, Erik; Ladanyi, Marc

2014-01-01

Objective To establish evidence-based recommendations for the molecular analysis of lung cancers that are that are required to guide EGFR- and ALK-directed therapies, addressing which patients and samples should be tested, and when and how testing should be performed. Participants Three cochairs without conflicts of interest were selected, one from each of the 3 sponsoring professional societies: College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Writing and advisory panels were constituted from additional experts from these societies. Evidence Three unbiased literature searches of electronic databases were performed to capture articles published published from January 2004 through February 2012, yielding 1533 articles whose abstracts were screened to identify 521 pertinent articles that were then reviewed in detail for their relevance to the recommendations. Evidence was formally graded for each recommendation. Consensus Process Initial recommendations were formulated by the cochairs and panel members at a public meeting. Each guideline section was assigned to at least 2 panelists. Drafts were circulated to the writing panel (version 1), advisory panel (version 2), and the public (version 3) before submission (version 4). Conclusions The 37 guideline items address 14 subjects, including 15 recommendations (evidence grade A/B). The major recommendations are to use testing for EGFR mutations and ALK fusions to guide patient selection for therapy with an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) inhibitor, respectively, in all patients with advanced-stage adenocarcinoma, regardless of sex, race, smoking history, or other clinical risk factors, and to prioritize EGFR and ALK testing over other molecular predictive tests. As scientific discoveries and clinical practice outpace the completion of randomized clinical trials, evidence-based guidelines developed by expert practitioners are vital for communicating emerging clinical standards. Already, new treatments targeting genetic alterations in other, less common driver oncogenes are being evaluated in lung cancer, and testing for these may be addressed in future versions of these guidelines. PMID:23552377

European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases.

PubMed

Ladas, S D; Triantafyllou, K; Spada, C; Riccioni, M E; Rey, J-F; Niv, Y; Delvaux, M; de Franchis, R; Costamagna, G

2010-03-01

These recommendations on video capsule endoscopy, an emerging technology with an impact on the practice of endoscopy, were developed by the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines Committee. The first draft of each section was prepared by one or two members of the writing team, who were selected as experts on the content of that section on the basis of their published work. They used evidence-based methodology, performing MEDLINE and PubMed literature searches to identify relevant clinical studies. Abstracts from scientific meetings were included only if there was no published full paper on a particular topic. If there was disagreement, the first author of the Guideline made the final decision. Recommendations were graded according to the strength of the supporting evidence. The draft guideline was critically reviewed by all authors and submitted to the ESGE councillors for their critical review before approval of the final document. The ESGE Guidelines Committee acknowledges that this document is based on a critical review of the data available at the time of preparation and that further studies may be needed to clarify some aspects. Moreover, this Guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. This document should be regarded as supplying recommendations only to gastroenterologists in providing care to their patients. It is not a set of rules and should not be construed as establishing a legal standard of care, or as encouraging, advocating, requiring, or discouraging any particular treatment. These recommendations must be interpreted according to the clinician's knowledge, expertise, and clinical judgment in the management of individual patients and, if necessary, a course of action that varies from recommendations must be undertaken. Georg Thieme Verlag KG Stuttgart. New York.

Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches.

PubMed

Fletcher, Mark P

2011-09-01

As part of long term commitment of the Biologicals and Vaccines Committee (B&V) of the International Federation of Pharmaceutical Manufacturers and Association (IFPMA) to provide expert input to the WHO on their recently finalized GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs), and in response to WHO's request, the IFPMA B&V prepared a clinical case study at a recent WHO workshop in Seoul, Korea. The case study, presented by Mark Fletcher on behalf of B&V, involved a model scenario for a clinical efficacy trial to support the approval of a Similar Biotherapeutic Product (SBP) as part of the required comparative clinical program against a Reference Biotherapeutic Product (RBP). A key goal was to understand and illustrate key clinical and statistical principles, and considerations described in the WHO Guidance for regulatory authorities when designing and implementing WHO guidelines and post-approval regulatory oversight for SBPs. Using this model SBP/RBP pair, an interactive discussion was carried out among the workshop participants on the pros and cons of using equivalence vs. non-inferiority designs to assess the two products' similarity. Through discussion of the case, the complexity of demonstrating similar efficacy and safety of a SBP vs. RBP for biotherapeutic products is outlined and discussed in the context of the key principles laid out in the recently published WHO GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs). The exercise illustrates the need for a case-by-case approach when interpreting clinical data from SBP dossiers to adequately assure similar efficacy and safety of SBPs for any studied indication. Copyright © 2011. Published by Elsevier Ltd.

Peripartum management of bipolar disorder: what do the latest guidelines recommend?

PubMed

Sharma, Verinder; Sharma, Sapna

2017-04-01

Many women with bipolar disorder experience significant morbidity during pregnancy and the postpartum period. The use of evidence-based and up-to-date guidelines has the potential to improve maternal and neonatal care. We review the latest clinical practice guidelines to gather recommendations for the peripartum management of bipolar disorder. Areas covered: Three electronic databases, MEDLINE/PubMed, the Cochrane Library, and the National Guidelines Clearinghouse were searched using various combinations of the following terms: bipolar disorder, pregnancy, postpartum, peripartum, puerperal, antenatal, postnatal, and guidelines. All guidelines retrieved were published, revised, or reaffirmed during the period from November 2010-June 2016. Expert commentary: To date there are no exclusive guidelines for the peripartum management of bipolar disorder. Currently available guidelines do not provide sufficient guidance for clinicians to deliver optimal care to women before, during, and after pregnancy. The guidelines reflect the paucity of available literature on the peripartum management of bipolar disorder. Further research is urgently needed to strengthen the evidence supporting the guidelines recommendations.

Recruiting egg donors online: an analysis of in vitro fertilization clinic and agency websites' adherence to American Society for Reproductive Medicine guidelines.

PubMed

Keehn, Jason; Holwell, Eve; Abdul-Karim, Ruqayyah; Chin, Lisa Judy; Leu, Cheng-Shiun; Sauer, Mark V; Klitzman, Robert

2012-10-01

To examine compliance with ethical guidelines of the American Society for Reproductive Medicine (ASRM) regarding trait-based payment variation, presentation of risks, and minimum recruitment age. In June 2010, we systematically examined 207 websites, of which 102 were egg donor agency or IVF clinic websites that both recruited online and displayed compensation amounts. The Internet. None. Not applicable. Mention of increased payment for particular donor traits, recruitment age less than 21 years, noting risks to donors. Of the 102 sites, considerable numbers were noncompliant with ASRM's guidelines that prohibit varying compensation based on a donor's traits (34%), and recommend an age of 21 years or older (41%), and presentation of risks alongside compensation (56%). Trait-based payment variation was associated with being an agency rather than a clinic, location in the West, not being endorsed by ASRM or Society of Assisted Reproductive Technology (SART), and referring to ASRM's guidelines about compensation. Of sites mentioning traits, prior donation success was the most commonly paid for trait (64%). Our data, the first to systematically analyze agency and clinic websites reveal that many do not follow ASRM's guidelines. These data have critical implications for policy, practice, and research, suggesting needs for consideration of possible changes in guidelines, and/or improvements in compliance and monitoring by ASRM or others. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Sustainability of professionals' adherence to clinical practice guidelines in medical care: a systematic review.

PubMed

Ament, Stephanie M C; de Groot, Jeanny J A; Maessen, José M C; Dirksen, Carmen D; van der Weijden, Trudy; Kleijnen, Jos

2015-12-29

To evaluate (1) the state of the art in sustainability research and (2) the outcomes of professionals' adherence to guideline recommendations in medical practice. Systematic review. Searches were conducted until August 2015 in MEDLINE, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and the Guidelines International Network (GIN) library. A snowball strategy, in which reference sections of other reviews and of included papers were searched, was used to identify additional papers. Studies needed to be focused on sustainability and on professionals' adherence to clinical practice guidelines in medical care. Studies had to include at least 2 measurements: 1 before (PRE) or immediately after implementation (EARLY POST) and 1 measurement longer than 1 year after active implementation (LATE POST). The search retrieved 4219 items, of which 14 studies met the inclusion criteria, involving 18 sustainability evaluations. The mean timeframe between the end of active implementation and the sustainability evaluation was 2.6 years (minimum 1.5-maximum 7.0). The studies were heterogeneous with respect to their methodology. Sustainability was considered to be successful if performance in terms of professionals' adherence was fully maintained in the late postimplementation phase. Long-term sustainability of professionals' adherence was reported in 7 out of 18 evaluations, adherence was not sustained in 6 evaluations, 4 evaluations showed mixed sustainability results and in 1 evaluation it was unclear whether the professional adherence was sustained. (2) Professionals' adherence to a clinical practice guideline in medical care decreased after more than 1 year after implementation in about half of the cases. (1) Owing to the limited number of studies, the absence of a uniform definition, the high risk of bias, and the mixed results of studies, no firm conclusion about the sustainability of professionals' adherence to guidelines in medical practice can be drawn. 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/

Nonoperative management of blunt hepatic injury: an Eastern Association for the Surgery of Trauma practice management guideline.

PubMed

Stassen, Nicole A; Bhullar, Indermeet; Cheng, Julius D; Crandall, Marie; Friese, Randall; Guillamondegui, Oscar; Jawa, Randeep; Maung, Adrian; Rohs, Thomas J; Sangosanya, Ayodele; Schuster, Kevin; Seamon, Mark; Tchorz, Kathryn M; Zarzuar, Ben L; Kerwin, Andrew

2012-11-01

During the last century, the management of blunt force trauma to the liver has changed from observation and expectant management in the early part of the 1900s to mainly operative intervention, to the current practice of selective operative and nonoperative management. These issues were first addressed by the Eastern Association for the Surgery of Trauma in the Practice Management Guidelines for Nonoperative Management of Blunt Injury to the Liver and Spleen published online in 2003. Since that time, a large volume of literature on these topics has been published requiring a reevaluation of the previous Eastern Association for the Surgery of Trauma guideline. The National Library of Medicine and the National Institutes of Health MEDLINE database were searched using PubMed (http://www.pubmed.gov). The search was designed to identify English-language citations published after 1996 (the last year included in the previous guideline) using the keywords liver injury and blunt abdominal trauma. One hundred seventy-six articles were reviewed, of which 94 were used to create the current practice management guideline for the selective nonoperative management of blunt hepatic injury. Most original hepatic guidelines remained valid and were incorporated into the greatly expanded current guidelines as appropriate. Nonoperative management of blunt hepatic injuries currently is the treatment modality of choice in hemodynamically stable patients, irrespective of the grade of injury or patient age. Nonoperative management of blunt hepatic injuries should only be considered in an environment that provides capabilities for monitoring, serial clinical evaluations, and an operating room available for urgent laparotomy. Patients presenting with hemodynamic instability and peritonitis still warrant emergent operative intervention. Intravenous contrast enhanced computed tomographic scan is the diagnostic modality of choice for evaluating blunt hepatic injuries. Repeated imaging should be guided by a patient's clinical status. Adjunctive therapies like angiography, percutaneous drainage, endoscopy/endoscopic retrograde cholangiopancreatography and laparoscopy remain important adjuncts to nonoperative management of hepatic injuries. Despite the explosion of literature on this topic, many questions regarding nonoperative management of blunt hepatic injuries remain without conclusive answers in the literature.

Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update.

PubMed

Omata, Masao; Cheng, Ann-Lii; Kokudo, Norihiro; Kudo, Masatoshi; Lee, Jeong Min; Jia, Jidong; Tateishi, Ryosuke; Han, Kwang-Hyub; Chawla, Yoghesh K; Shiina, Shuichiro; Jafri, Wasim; Payawal, Diana Alcantara; Ohki, Takamasa; Ogasawara, Sadahisa; Chen, Pei-Jer; Lesmana, Cosmas Rinaldi A; Lesmana, Laurentius A; Gani, Rino A; Obi, Shuntaro; Dokmeci, A Kadir; Sarin, Shiv Kumar

2017-07-01

There is great geographical variation in the distribution of hepatocellular carcinoma (HCC), with the majority of all cases worldwide found in the Asia-Pacific region, where HCC is one of the leading public health problems. Since the "Toward Revision of the Asian Pacific Association for the Study of the Liver (APASL) HCC Guidelines" meeting held at the 25th annual conference of the APASL in Tokyo, the newest guidelines for the treatment of HCC published by the APASL has been discussed. This latest guidelines recommend evidence-based management of HCC and are considered suitable for universal use in the Asia-Pacific region, which has a diversity of medical environments.

OARSI guidelines for the non-surgical management of knee osteoarthritis.

PubMed

McAlindon, T E; Bannuru, R R; Sullivan, M C; Arden, N K; Berenbaum, F; Bierma-Zeinstra, S M; Hawker, G A; Henrotin, Y; Hunter, D J; Kawaguchi, H; Kwoh, K; Lohmander, S; Rannou, F; Roos, E M; Underwood, M

2014-03-01

To develop concise, up-to-date, patient-focused, evidence-based, expert consensus guidelines for the management of knee osteoarthritis (OA), intended to inform patients, physicians, and allied healthcare professionals worldwide. Thirteen experts from relevant medical disciplines (primary care, rheumatology, orthopedics, physical therapy, physical medicine and rehabilitation, and evidence-based medicine), three continents and ten countries (USA, UK, France, Netherlands, Belgium, Sweden, Denmark, Australia, Japan, and Canada) and a patient representative comprised the Osteoarthritis Guidelines Development Group (OAGDG). Based on previous OA guidelines and a systematic review of the OA literature, 29 treatment modalities were considered for recommendation. Evidence published subsequent to the 2010 OARSI guidelines was based on a systematic review conducted by the OA Research Society International (OARSI) evidence team at Tufts Medical Center, Boston, USA. Medline, EMBASE, Google Scholar, Web of Science, and the Cochrane Central Register of Controlled Trials were initially searched in first quarter 2012 and last searched in March 2013. Included evidence was assessed for quality using Assessment of Multiple Systematic Reviews (AMSTAR) criteria, and published criticism of included evidence was also considered. To provide recommendations for individuals with a range of health profiles and OA burden, treatment recommendations were stratified into four clinical sub-phenotypes. Consensus recommendations were produced using the RAND/UCLA Appropriateness Method and Delphi voting process. Treatments were recommended as Appropriate, Uncertain, or Not Appropriate, for each of four clinical sub-phenotypes and accompanied by 1-10 risk and benefit scores. Appropriate treatment modalities for all individuals with knee OA included biomechanical interventions, intra-articular corticosteroids, exercise (land-based and water-based), self-management and education, strength training, and weight management. Treatments appropriate for specific clinical sub-phenotypes included acetaminophen (paracetamol), balneotherapy, capsaicin, cane (walking stick), duloxetine, oral non-steroidal anti-inflammatory drugs (NSAIDs; COX-2 selective and non-selective), and topical NSAIDs. Treatments of uncertain appropriateness for specific clinical sub-phenotypes included acupuncture, avocado soybean unsaponfiables, chondroitin, crutches, diacerein, glucosamine, intra-articular hyaluronic acid, opioids (oral and transdermal), rosehip, transcutaneous electrical nerve stimulation, and ultrasound. Treatments voted not appropriate included risedronate and electrotherapy (neuromuscular electrical stimulation). These evidence-based consensus recommendations provide guidance to patients and practitioners on treatments applicable to all individuals with knee OA, as well as therapies that can be considered according to individualized patient needs and preferences. Copyright © 2014 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Maternity leave in normal pregnancy.

PubMed

Leduc, Dean

2011-08-01

To assist maternity care providers in recognizing and discussing health- and illness-related issues in pregnancy and their relationship to maternity benefits. Published literature was retrieved through searches of PubMed or Medline, CINAHL, and The Cochrane Library in 2009 using appropriate controlled vocabulary (e.g., maternity benefits) and key words (e.g., maternity, benefits, pregnancy). Results were restricted to systematic reviews, randomized controlled trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to December 2009. Grey (unpublished) literature was identified through searching the web sites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.

Saudi Oncology Society and Saudi Urology Association combined clinical management guidelines for prostate cancer 2017.

PubMed

Aljubran, Ali; Abusamra, Ashraf; Alkhateeb, Sultan; Alotaibi, Mohammed; Rabah, Danny; Bazarbashi, Shouki; Alkushi, Hussain; Al-Mansour, Mubarak; Alharbi, Hulayel; Eltijani, Amin; Alghamdi, Abdullah; Alsharm, Abdullah; Ahmad, Imran; Murshid, Esam

2018-01-01

This is an update to the previously published Saudi guidelines for the evaluation and medical and surgical management of patients diagnosed with prostate cancer. Prostate cancer is categorized according to the stage of the disease using the tumor node metastasis staging system 7 th edition. The guidelines are presented with supporting evidence levels based on a comprehensive literature review, several internationally recognized guidelines, and the collective expertise of the guidelines committee members (authors) who were selected by the Saudi Oncology Society and Saudi Urological Association. Local factors, such as availability, logistic feasibility, and familiarity of various treatment modalities, have been taken into consideration. These guidelines should serve as a roadmap for the urologists, oncologists, general physicians, support groups, and health-care policymakers in the management of patients diagnosed with adenocarcinoma of the prostate.

Guidelines for seizure management in palliative care: Proposal for an updated clinical practice model based on a systematic literature review.

PubMed

León Ruiz, M; Rodríguez Sarasa, M L; Sanjuán Rodríguez, L; Pérez Nieves, M T; Ibáñez Estéllez, F; Arce Arce, S; García-Albea Ristol, E; Benito-León, J

2017-02-27

Very little has been written on seizure management in palliative care (PC). Given this situation, and considering the forthcoming setting up of the Palliative Care Unit at our neurorehabilitation centre, the Clínica San Vicente, we decided to establish a series of guidelines on the use of antiepileptic drugs (AEDs) for handling seizures in PC. We conducted a literature search in PubMed to identify articles, recent manuals, and clinical practice guidelines on seizure management in PC published by the most relevant scientific societies. Clinical practice guidelines are essential to identify patients eligible for PC, manage seizures adequately, and avoid unnecessary distress to these patients and their families. Given the profile of these patients, we recommend choosing AEDs with a low interaction potential and which can be administered by the parenteral route, preferably intravenously. Diazepam and midazolam appear to be the most suitable AEDs during the acute phase whereas levetiracetam, valproic acid, and lacosamide are recommended for refractory cases and long-term treatment. These guidelines provide general recommendations that must be adapted to each particular clinical case. Nevertheless, we will require further well-designed randomised controlled clinical trials including large samples of patients eligible for PC to draft a consensus document recommending adequate, rational, and effective use of AEDs, based on a high level of evidence, in this highly complex area of medical care. Copyright © 2017 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.

Evidence-based Medicine in Pediatric Orthopaedics: Evidence-based Practice Committee Summary of Levels of Evidence, Clinical Practice Guidelines, Appropriate Use Criteria, and Best Practice Guidelines.

PubMed

Gandhi, Jigar S; Shea, Kevin G; Sponseller, Paul D; Brighton, Brian K; Ganley, Theodore J

2018-04-30

The concept of evidence-based medicine has evolved over the past 2 decades, and has become a cornerstone to clinical decision-making in virtually every aspect of medicine. With a commitment to providing its members with high-quality evidence-based guidelines, the American Academy of Orthopaedic Surgeons has instituted concerted efforts since 2006 to develop clinical practice guidelines (CPGs) and appropriate use criteria (AUCs) for certain orthopaedic conditions. Many of these CPGs and AUCs detail the management of pediatric orthopaedic conditions. By the same token, members of the Pediatric Orthopaedic Society of North America (POSNA) Evidence Based Practice Committee have been publishing succinct evaluations of randomized controlled trials in pediatric orthopaedic surgery to create an evidence-based repository for quick reference to available high-level evidence as well as resource to identify gaps in the current research and identify opportunities for future investigation. In instances where higher-level evidence needed to develop CPGs is not available to address a critically important clinical question, consensus recommendations from experts in the field have been obtained to develop best practice guidelines (BPGs). The purpose of this review is to provide readers with a deeper understanding of the key principles of evidence-based medicine and methodologies used for the development of CPGs, AUCs, and BPGs.

Quality of registration for clinical trials published in emergency medicine journals.

PubMed

Jones, Christopher W; Platts-Mills, Timothy F

2012-10-01

In 2005, the International Committee of Medical Journal Editors established clinical trial registration as a requirement for articles submitted to member journals, with the goal of improving the transparency of clinical research. The objective of this study is to characterize the registration of clinical trials published in emergency medicine journals. Randomized trials involving human subjects and published between June 1, 2008, and May 31, 2011 in the 5 emergency medicine journals with the highest impact factors were included. We assessed the clarity of registered primary outcomes, timing of registration relative to patient enrollment, and consistency between registered and published outcomes. Of the 123 trials included, registry entries were identified for 57 (46%). Of the 57 registered studies, 45 (79%) were registered after the initiation of subject enrollment, 9 (16%) had registered outcomes that were unclear, and 26 (46%) had discrepancies between registered and published outcomes. Only 5 studies were registered before patient enrollment with a clear primary outcome that was consistent with the published primary outcome. Annals of Emergency Medicine was the only journal in which the majority of trials were registered. Current compliance with clinical trial registration guidelines is poor among trials published in emergency medicine journals. Copyright © 2012. Published by Mosby, Inc.

Clinical guidelines for management of diabetes insipidus and syndrome of inappropriate antidiuretic hormone secretion after pituitary surgery.

PubMed

Lamas, Cristina; del Pozo, Carlos; Villabona, Carles

2014-04-01

Changes in water metabolism and regulation of vasopressin (AVP) or antidiuretic hormone (ADH) are common complications of pituitary surgery. The scarcity of studies comparing different treatment and monitoring strategies for these disorders and the lack of prior clinical guidelines makes it difficult to provide recommendations following a methodology based on grades of evidence. This study reviews the pathophysiology of diabetes insipidus and inappropriate ADH secretion after pituitary surgery, and is intended to serve as a guide for their diagnosis, differential diagnosis, treatment, and monitoring. Copyright © 2013 SEEN. Published by Elsevier Espana. All rights reserved.

Assessing clinicians' management of first episode schizophrenia using clinical case vignettes.

PubMed

Huffman, Jeff C; Freudenreich, Oliver; Romeo, Sarah; Baer, Lee; Sutton-Skinner, Kelly; Petersen, Tim; Fromson, John A; Birnbaum, Robert J

2010-02-01

Patients with first episode schizophrenia may present in a variety of clinical settings to providers who have a range of knowledge and skills. A thoughtful workup of patients with new-onset psychosis is critical, and the treatment of first episode schizophrenia differs from that of chronic psychotic disorders. Clinical case vignettes with free-form responses can be used to carefully assess whether front line practitioners provide guideline-adherent management of first episode psychosis. A clinical case vignette, presenting a patient with first episode schizophrenia, was created and administered to the attendees of a continuing medical education programme. Free-form responses to questions regarding differential diagnosis, workup, treatment and treatment duration were scored based on published practice guidelines. Response frequencies were tabulated and performance was compared among professional disciplines. Sixty-two attendees completed the vignette. Though the attendees typically considered a broad differential diagnosis and appropriately initiated treatment with antipsychotics, the respondents' proposed medical workup was limited, and they prescribed antipsychotics at higher doses and for a shorter duration than recommended in the literature. The prescribers outperformed the non-prescribers on treatment questions (P = 0.006), but the two groups' performance did not significantly differ on the assessment questions (P = 0.08). The front line clinicians who encounter patients with first episode schizophrenia may have significant practice gaps in the initial and follow-up care of these patients. Given the preliminary nature of this study and the debate about the optimal care for first episode psychosis, further study is needed. If such gaps are confirmed, additional educational interventions are required to align clinical management with published practice guidelines.

Research Gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings From a Review of the Evidence for an American Pain Society Clinical Practice Guideline.

PubMed

Gordon, Debra B; de Leon-Casasola, Oscar A; Wu, Christopher L; Sluka, Kathleen A; Brennan, Timothy J; Chou, Roger

2016-02-01

Acute postoperative pain is a common clinical condition that, when poorly controlled, can result in a number of significant negative consequences. The American Pain Society commissioned an evidence-based guideline on the management of postoperative pain to promote evidence-based, safe, and effective perioperative pain management. An interdisciplinary panel developed 31 key questions and inclusion criteria to guide the evidence review. Investigators reviewed 6556 abstracts from multiple electronic databases up to November 2012, an updated evidence review to October 2014, and key references suggested by expert reviewers. More than 800 primary studies not included in a systematic review and 107 systematic reviews were included. Despite a large body of evidence, a number of critical research gaps were identified where only low-quality or insufficient evidence was found to help guide clinical practice recommendations. This report identifies evidence gaps including optimal methods and timing of perioperative patient education, nonpharmacological modalities, combinations of analgesic techniques, monitoring of patient response to treatment, techniques for neuraxial and regional analgesia, and organizational care delivery models. Recommendations to help guide the design of future perioperative studies are offered. Acute postoperative pain is a common clinical condition requiring an evidence-based, planned, and multimodal approach. Despite the plethora of published evidence, much of it is weak and key questions remain unanswered. Researchers are encouraged to work together to produce strong evidence to help guide clinical decisions in perioperative pain management. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

Diabetes prevention information in Japanese magazines with the largest print runs. Content analysis using clinical guidelines as a standard.

PubMed

Noda, Emi; Mifune, Taka; Nakayama, Takeo

2013-01-01

To characterize information on diabetes prevention appearing in Japanese general health magazines and to examine the agreement of the content with that in clinical practice guidelines for the treatment of diabetes in Japan. We used the Japanese magazines' databases provided by the Media Research Center and selected magazines with large print runs published in 2006. Two medical professionals independently conducted content analysis based on items in the diabetes prevention guidelines. The number of pages for each item and agreement with the information in the guidelines were determined. We found 63 issues of magazines amounting to 8,982 pages; 484 pages included diabetes prevention related content. For 23 items included in the diabetes prevention guidelines, overall agreement of information printed in the magazines with that in the guidelines was 64.5% (471 out of 730). The number of times these items were referred to in the magazines varied widely, from 247 times for food items to 0 times for items on screening for pregnancy-induced diabetes, dyslipidemia, and hypertension. Among the 20 items that were referred to at least once, 18 items showed more than 90% agreement with the guidelines. However, there was poor agreement for information on vegetable oil (2/14, 14%) and for specific foods (5/247, 2%). For the fatty acids category, "fat" was not mentioned in the guidelines; however, the term frequently appeared in magazines. "Uncertainty" was never mentioned in magazines for specific food items. The diabetes prevention related content in the health magazines differed from that defined in clinical practice guidelines. Most information in the magazines agreed with the guidelines, however some items were referred to inappropriately. To disseminate correct information to the public on diabetes prevention, health professionals and the media must collaborate.

A systematic review of recent clinical practice guidelines and best practice statements for the evaluation of the infertile male.

PubMed

Esteves, Sandro C; Chan, Peter

2015-09-01

We systematically identified and reviewed the methods and consistency of recommendations of recently developed clinical practice guidelines (CPG) and best practice statements (BPS) on the evaluation of the infertile male. MEDLINE and related engines as well as guidelines' Web sites were searched for CPG and BPS written in English on the general evaluation of male infertility published between January 2008 and April 2015. Four guidelines were identified, all of which reported to have been recently updated. Systematic review was not consistently used in the BPS despite being reported in the CPG. Only one of them reported having a patient representative in its development team. The CPG issued by the European Association of Urology (EAU) graded some recommendations and related that to levels (but not quality) of evidence. Overall, the BPS issued respectively by the American Urological Association and American Society for Reproductive Medicine concurred with each other, but both differed from the EAU guidelines with regard to methods of collection, extraction and interpretation of data. None of the guidelines incorporated health economics. Important specific limitations of conventional semen analysis results were ignored by all guidelines. Besides variation in the methodological quality, implementation strategies were not reported in two out of four guidelines. While the various panels of experts who contributed to the development of the CPG and BPS reviewed should be commended on their tremendous efforts aiming to establish a clinical standard in both the evaluation and management of male infertility, we recognized inconsistencies in the methodology of their synthesis and in the contents of their final recommendations. These discrepancies pose a barrier in the general implementation of these guidelines and may limit their utility in standardizing clinical practice or improving health-related outcomes. Continuous efforts are needed to generate high-quality evidence to allow further development of these important guidelines for the evaluation and management of males suffering from infertility.

Research Gaps in Wilderness Medicine.

PubMed

Tritz, Daniel; Dormire, Kody; Brachtenbach, Travis; Gordon, Joshua; Sanders, Donald; Gearheart, David; Crawford, Julia; Vassar, Matt

2018-05-18

Wilderness medicine involves the treatment of individuals in remote, austere environments. Given the high potential for injuries as well as the unique treatment modalities required in wilderness medicine, evidence-based clinical practice guidelines are necessary to provide optimal care. In this study, we identify evidence gaps from low-quality recommendations in wilderness medicine clinical practice guidelines and identify new/ongoing research addressing them. We included relevant clinical practice guidelines from the Wilderness Medical Society and obtained all 1C or 2C level recommendations. Patient/Problem/Population, intervention, comparison, outcome (PICO) questions were created to address each recommendation. Using 24 search strings, we extracted titles, clinical trial registry number, and recruitment status for 8899 articles. We categorized the articles by trial design to infer the effect they may have on future recommendations. Twelve clinical practice guidelines met inclusion criteria. From these we located 275 low-quality recommendations and used them to create 275 PICO questions. Thirty-three articles were relevant to the PICO questions. Heat-related illness had the highest number of relevant articles (n=9), but acute pain and altitude sickness had the most randomized clinical trials (n=6). Overall, few studies were being conducted to address research gaps in wilderness medicine. Heat-related illness had the most new or ongoing research, whereas no studies were being conducted to address gaps in eye injuries, basic wound management, or spine immobilization. Animals, cadavers, and mannequin research are useful in cases in which human evidence is difficult to obtain. Establishing research priorities is recommended for addressing research gaps identified by guideline panels. Copyright © 2018 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

COMP report: CPQR technical quality control guidelines for low-dose-rate permanent seed brachytherapy.

PubMed

Beaulieu, Luc; Radford, Dee-Ann; Eduardo Villarreal-Barajas, J

2018-03-14

The Canadian Organization of Medical Physicists (COMP), in close partnership with the Canadian Partnership for Quality Radiotherapy (CPQR) has developed a series of Technical Quality Control (TQC) guidelines for radiation treatment equipment. These guidelines outline the performance objectives that equipment should meet in order to ensure an acceptable level of radiation treatment quality. The TQC guidelines have been rigorously reviewed and field tested in a variety of Canadian radiation treatment facilities. The development process enables rapid review and update to keep the guidelines current with changes in technology. This article contains detailed performance objectives and safety criteria for low-dose-rate (LDR) permanent seed brachytherapy. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Systematic Review and Quality Appraisal of Practice Guidelines for Self-Harm in Children and Adolescents.

PubMed

Courtney, Darren B; Duda, Stephanie; Szatmari, Peter; Henderson, Joanna; Bennett, Kathryn

2018-05-02

This study aimed to systematically identify and appraise clinical practice guidelines (CPGs) relating to the assessment and management of suicide risk and self-harm in children and adolescents. Our research question is as follows: For young people (under 18 years old) presenting to clinical care with suicide ideation or a history of self-harm, what is the quality of up-to-date CPGs? Using the PRISMA format, we systematically identified CPGs meeting our inclusion and exclusion criteria. Subsequently, two independent raters conducted appraisals of the eligible CPGs using the Appraisal of Guidelines for Research and Evaluation II instrument. CPGs were then classified as "poor quality," "minimum quality," and "high quality" using operationally defined criteria developed a priori. We identified 10 eligible CPGs published or renewed between 2005 and May 2017. Only the long-term management of self-harm CPGs produced by the National Institute for Health and Care Excellence met "high-quality" criteria. Despite multiple options of CPGs published to choose from, only one was identified as "high quality," where bias is adequately minimized. Clinicians are advised to direct resources to implementing the "high-quality" CPG. © 2018 The American Association of Suicidology.

Management of patients with implanted cardiac devices during radiotherapy: results of a Spanish survey in radiation oncology departments.

PubMed

Sabater, S; Montero, A; López Fernández, T; González Ferrer, J J; Arenas, M

2018-05-23

There is an increasing number of patients with cardiac implantable electronic devices (CIED), either pacemakers or defibrillators, who are receiving a course of radiotherapy. Several guidelines have been published by national societies, but no Spanish national guidelines for management of these patients have been published. More importantly, national clinical practice regarding these patients is not standardised. Members of the Spanish Breast Cancer Radiation Oncology Group (GEORM in Spanish) were surveyed through an online questionnaire on behalf of the Spanish radiation oncology departments. Only 39.3% of the Spanish radiation oncology departments have policies aimed at CIED carrier patients. Regardless of that, 96.4% of those who responded to the survey refer these patients to their Cardiology department before the start of the course of radiotherapy, and 17.8% of respondents said to manipulate the CIED without any cardiology department direction. A wide range of responses was obtained related to concepts such as "distance from the irradiation field to the CIED" or "safe accumulated doses". Our results demonstrate the need for national guidelines for CIED patients and the need to promote educational activities addressed to standardise clinical management of these patients in the radiation oncology departments.

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.

Diabetic Dyslipidemia Review: An Update on Current Concepts and Management Guidelines of Diabetic Dyslipidemia.

PubMed

Dake, Andrew W; Sora, Nicoleta D

2016-04-01

Cardiovascular disease is the most common cause of morbidity and mortality in patients with diabetes and the major source of cost in the care of diabetes. Treatment of dyslipidemia with cholesterol-lowering medications has been shown to decrease cardiovascular events. However, available guidelines for the treatment of dyslipidemia often contain significant differences in their recommendations. Lipid guidelines from National Cholesterol Education Program Adult Treatment Panel III, American Association of Clinical Endocrinologists, American Diabetes Association and American Heart Association/American College of Cardiology were reviewed. In addition a literature review was performed using PubMed to research diabetic peculiarities to the topic of lipids. Summarized within this article are the aforementioned, commonly-used guidelines as they relate to diabetes, as well as information regarding the diabetic phenotype of dislipidemia and the association between statins and new-onset diabetes. While the multitude of guidelines and the differences between them may contribute to confusion for practitioners, they are best viewed as tools to help tailor appropriate treatment plans for individual patients. Copyright © 2016 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.

Guidelines in CHARGE syndrome and the missing link: Cranial imaging

PubMed Central

de Geus, Christa M.; Free, Rolien H.; Verbist, Berit M.; Sival, Deborah A.; Blake, Kim D.; Meiners, Linda C.

2017-01-01

“CHARGE syndrome” is a complex syndrome with high and extremely variable comorbidity. As a result, clinicians may struggle to provide accurate and comprehensive care, and this has led to the publication of several clinical surveillance guidelines and recommendations for CHARGE syndrome, based on both single case observations and cohort studies. Here we perform a structured literature review to examine all the existing advice. Our findings provide additional support for the validity of the recently published Trider checklist. We also identified a gap in literature when reviewing all guidelines and recommendations, and we propose a guideline for neuroradiological evaluation of patients with CHARGE syndrome. This is of importance, as patients with CHARGE are at risk for peri‐anesthetic complications, making recurrent imaging procedures under anesthesia a particular risk in clinical practice. However, comprehensive cranial imaging is also of tremendous value for timely diagnosis, proper treatment of symptoms and for further research into CHARGE syndrome. We hope the guideline for neuroradiological evaluation will help clinicians provide efficient and comprehensive care for individuals with CHARGE syndrome. PMID:29168326

A 21st Century Update on Neurotoxicity Risk Assessment

EPA Science Inventory

In 1998, EPA published Guidelines for Neurotoxicity Risk Assessment as the basis for interpreting neurotoxicity results. At that time, the focus was on traditional toxicity testing and human clinical /epidemiological data. More recently, a change in approach to toxicity testing ...

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

PubMed

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

2017-08-01

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

Guidelines for randomized clinical trial protocol content: a systematic review

PubMed Central

2012-01-01

Background All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. Methods We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Results Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed. PMID:23006870

Guidelines for randomized clinical trial protocol content: a systematic review.

PubMed

Tetzlaff, Jennifer M; Chan, An-Wen; Kitchen, Jessica; Sampson, Margaret; Tricco, Andrea C; Moher, David

2012-09-24

All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies. Reporting guidelines may improve the content of research reports and, if developed using robust methods, may increase the utility of reports to stakeholders. The objective of this study was to systematically identify and review RCT protocol guidelines, to assess their characteristics and methods of development, and to compare recommendations. We conducted a systematic review of indexed literature (MEDLINE, EMBASE and the Cochrane Methodology Register from inception to September 2010; reference lists; related article features; forward citation searching) and a targeted search of supplementary sources, including a survey of major trial funding agencies in six countries. Records were eligible if they described a content guideline in English or French relevant to RCT protocols. Guidelines were excluded if they specified content for protocols for trials of specific procedures or conditions or were intended to assess trial quality. We extracted guideline characteristics and methods. Content was mapped for a subset of guidelines that described development methods or had institutional endorsement. Forty guidelines published in journals, books and institutional reports were included in the review; seven were specific to RCT protocols. Only eight (20%) described development methods which included informal consensus methods, pilot testing and formal validation; no guideline described all of these methods. No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development. The guidelines included a median of 23 concepts per guideline (interquartile range (IQR) = 14 to 34; range = 7 to 109). Among the subset of guidelines (n = 23) for which content was mapped, approximately 380 concepts were explicitly addressed (median concepts per guideline IQR = 31 (24,80); range = 16 to 150); most concepts were addressed in a minority of guidelines. Existing guidelines for RCT protocol content varied substantially in their recommendations. Few reports described the methods of guideline development, limiting comparisons of guideline validity. Given the importance of protocols to diverse stakeholders, we believe a systematically developed, evidence-informed guideline for clinical trial protocols is needed.

Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).

PubMed

Biancone, Livia; Annese, Vito; Ardizzone, Sandro; Armuzzi, Alessandro; Calabrese, Emma; Caprioli, Flavio; Castiglione, Fabiana; Comberlato, Michele; Cottone, Mario; Danese, Silvio; Daperno, Marco; D'Incà, Renata; Frieri, Giuseppe; Fries, Walter; Gionchetti, Paolo; Kohn, Anna; Latella, Giovanni; Milla, Monica; Orlando, Ambrogio; Papi, Claudio; Petruzziello, Carmelina; Riegler, Gabriele; Rizzello, Fernando; Saibeni, Simone; Scribano, Maria Lia; Vecchi, Maurizio; Vernia, Piero; Meucci, Gianmichele

2017-04-01

Inflammatory bowel diseases are chronic conditions of unknown etiology, showing a growing incidence and prevalence in several countries, including Italy. Although the etiology of Crohn's disease and ulcerative colitis is unknown, due to the current knowledge regarding their pathogenesis, effective treatment strategies have been developed. Several guidelines are available regarding the efficacy and safety of available drug treatments for inflammatory bowel diseases. Nevertheless, national guidelines provide additional information adapted to local feasibility, costs and legal issues related to the use of the same drugs. These observations prompted the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) to establish Italian guidelines on the safety of currently available treatments for Crohn's disease and ulcerative colitis. These guidelines discuss the use of aminosalicylates, systemic and low bioavailability corticosteroids, antibiotics (metronidazole, ciprofloxacin, rifaximin), thiopurines, methotrexate, cyclosporine A, TNFα antagonists, vedolizumab, and combination therapies. These guidelines are based on current knowledge derived from evidence-based medicine coupled with clinical experience of a national working group. Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Japanese guideline for the management of hyperuricemia and gout: second edition.

PubMed

Yamanaka, Hisashi

2011-12-01

Gout is a urate deposition disease caused by persistent hyperuricemia. Because gout patients present with a variety of clinical symptoms, it is necessary to have a guideline for the standard management and care of gout and hyperuricemia. The Japanese Society of Gout and Nucleic Acid Metabolism, a scientific society committed to study nucleic acid metabolism and related diseases, established the first edition of the "Guideline for the Management of Hyperuricemia and Gout" in 2002, and published the revised version in January 2010. This second edition is not only evidence based on a search of systemic literature, but also includes consensus levels by a Delphi exercise to determine the strength of the recommendations. A draft version of this guideline was reviewed by internal and external reviewers as well as a patient. In this guideline, key messages from each chapter are listed as statements together with the evidence level, consensus level, and strength of the recommendation. In this proceeding, several selected chapters on the clinical management of gout and hyperuricemia are described. We hope this guideline is appropriately used for the standard management and care of patients with hyperuricemia and gout in daily practice.

Compliance With the AAOS Guidelines for Treatment of Osteoarthritis of the Knee: A Survey of the American Association of Hip and Knee Surgeons.

PubMed

Carlson, Victor Rex; Ong, Alvin Chua; Orozco, Fabio Ramiro; Hernandez, Victor Hugo; Lutz, Rex William; Post, Zachary Douglas

2018-02-01

The American Academy of Orthopaedic Surgeons (AAOS) published a series of evidence-based guidelines for treatment of knee osteoarthritis (OA). We studied compliance with these guidelines among orthopaedic surgeons. We sent a survey to members of the American Association of Hip and Knee Surgeons. It included five clinical vignettes based on the Kellgren-Lawrence radiographic system for classification of knee OA. Respondents selected treatment currently supported or not supported by the AAOS guidelines. Of 345 responses, the frequency of use of recommended interventions was 80%, 82%, 21%, 50%, and 98% for OA at stages 0 through 4, respectively. For stage 2 and stage 3 OA, intra-articular hyaluronic acid was the most commonly selected intervention not recommended by the AAOS. Apparently, AAOS guidelines on the treatment of OA have not reached the orthopaedic community, resulting in lack of treatment consensus and continued use of modalities with no proven patient benefits. Management of moderate to severe knee OA does not align with AAOS guidelines. We encourage researchers to conduct clinical trials to identify the role of intra-articular corticosteroids in treating this condition.

Improving pain management of abdominal pain in children presenting to the paediatric emergency department: a pre-post interventional study.

PubMed

Williams, Suzanne; Holzhauser, Kerri; Bonney, Donna; Burmeister, Elizabeth; Gilhotra, Yuri; Oliver, Randall; Gordon, Kerry

2012-08-01

In 2007, the Mater Children's Hospital Emergency Department participated in the Emergency Care Pain Management Initiative funded by the National Health and Medical Research Council National Institute of Clinical Studies (NHMRC-NICS). The findings of this NHMRC-NICS research across eleven paediatric emergency departments highlighted deficits in pain management of abdominal pain. Specifically pain assessment, timeliness of analgesia, and pain management guidelines were found to be lacking. In response to the NICS report local practice was reviewed and a pilot research project undertaken to develop a clinical guideline for the pain management of abdominal pain in children presenting to the emergency department. The guideline was developed by an expert panel and trialled using a pre and post intervention design. The results demonstrated improved compliance to assessment and documentation of pain scores and assimilation of the best practice principles recommended in the guideline. This project raised local awareness in the pain management of abdominal pain and provides baseline information for future improvement. The guideline has been trialled in the clinical setting of paediatric emergency and has the potential to improve pain management practices in children presenting to the emergency department with abdominal pain. Copyright © 2012 College of Emergency Nursing Australasia Ltd. Published by Elsevier Ltd. All rights reserved.

Exercise Blood Pressure Guidelines: Time to Re-evaluate What is Normal and Exaggerated?

PubMed

Currie, Katharine D; Floras, John S; La Gerche, Andre; Goodman, Jack M

2018-03-24

Blood pressure responses to graded exercise testing can provide important diagnostic and prognostic information. While published guidelines outline what constitutes a "normal" and "abnormal" (i.e., exaggerated) blood pressure response to exercise testing, the widespread use of exaggerated blood pressure responses as a clinical tool is limited due to sparse and inconsistent data. A review of the original sources from these guidelines reveals an overall lack of empirical evidence to support both the normal blood pressure responses and their upper limits. In this current opinion, we critically evaluate the current exercise blood pressure guidelines including (1) the normal blood pressure responses to graded exercise testing; (2) the upper limits of this normal response; (3) the blood pressure criteria for test termination; and (4) the thresholds for exaggerated blood pressure responses. We provide evidence that exercise blood pressure responses vary according to subject characteristics, and subsequently a re-evaluation of what constitutes normal and abnormal responses is necessary to strengthen the clinical utility of this assessment.

Development of World Health Organization (WHO) recommendations for appropriate clinical trial endpoints for next-generation Human Papillomavirus (HPV) vaccines.

PubMed

Prabhu, Malavika; Eckert, Linda O

2016-12-01

The World Health Organization (WHO) serves as a key organization to bring together experts along the continuum of vaccine development and regulatory approval, among its other functions. Using the revision of WHO's guidelines on prophylactic human papillomavirus (HPV) vaccine as an example, we describe the process by which (1) a need to revise the guidelines was identified; (2) a group of stakeholders with complementary expertise and key questions were identified; (3) a scientific review was conducted; (4) consensus on revisions was achieved; (5) guidelines were updated, reviewed widely, and approved. This multi-year process resulted in the consensus that regulatory agencies could consider additional endpoints, such as persistent HPV infection or immune equivalence, depending on the design of the HPV vaccine trials. Updating the guidelines will now accelerate vaccine development, reduce costs of clinical trials, and lead to faster regulatory approval. Copyright © 2016. Published by Elsevier B.V.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

PubMed

Harris, Lyndsay N; Ismaila, Nofisat; McShane, Lisa M; Andre, Fabrice; Collyar, Deborah E; Gonzalez-Angulo, Ana M; Hammond, Elizabeth H; Kuderer, Nicole M; Liu, Minetta C; Mennel, Robert G; Van Poznak, Catherine; Bast, Robert C; Hayes, Daniel F

2016-04-01

To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. © 2016 by American Society of Clinical Oncology.

Use of antidepressants in the treatment of depression in Asia: guidelines, clinical evidence, and experience revisited.

PubMed

Treuer, Tamás; Liu, Chia-Yih; Salazar, Gerardo; Kongsakon, Ronnachai; Jia, Fujun; Habil, Hussain; Lee, Min-Soo; Lowry, Amanda; Dueñas, Héctor

2013-12-01

Major depressive disorder is prevalent worldwide, and only about half of those affected will experience no further episodes or symptoms. Additionally, depressive symptoms can be challenging to identify, with many patients going undiagnosed despite a wide variety of available treatment options. Antidepressants are the cornerstone of depression treatment; however, a large number of factors must be considered in selecting the treatment best suited to the individual. To help support physicians in this process, international and national treatment guidelines have been developed. This review evaluates the current use of antidepressant treatment for major depressive disorder in six Asian countries (China, Korea, Malaysia, Philippines, Taiwan, and Thailand). No remarkable differences were noted between Asian and international treatment guidelines or among those from within Asia as these are adapted from western guidelines, although there were some local variations. Importantly, a shortage of evidence-based information at a country level is the primary problem in developing guidelines appropriate for Asia, so most of the guidelines are consensus opinions derived from western research data utilized in western guidelines. Treatment guidelines need to evolve from being consensus based to evidence based when evidence is available, taking into consideration cost/effectiveness or cost/benefit with an evidence-based approach that more accurately reflects clinical experience as well as the attributes of each antidepressant. In everyday practice, physicians must tailor their treatment to the patient's clinical needs while considering associated external factors; better tools are needed to help them reach the best possible prescribing decisions which are of maximum benefit to patients. Copyright © 2013 Wiley Publishing Asia Pty Ltd.

Clinical imaging guidelines part 2: Risks, benefits, barriers, and solutions.

PubMed

Malone, James; del Rosario-Perez, Maria; Van Bladel, Lodewijk; Jung, Seung Eun; Holmberg, Ola; Bettmann, Michael A

2015-02-01

A recent international meeting was convened by two United Nations bodies to focus on international collaboration on clinical appropriateness/referral guidelines for use in medical imaging. This paper, the second of 4 from this technical meeting, addresses barriers to the successful development/deployment of clinical imaging guidelines and means of overcoming them. It reflects the discussions of the attendees, and the issues identified are treated under 7 headings: ■ Practical Strategy for Development and Deployment of Guidelines; ■ Governance Arrangements and Concerns with Deployment of Guidelines; ■ Finance, Sustainability, Reimbursement, and Related Issues; ■ Identifying Benefits and Radiation Risks from Radiological Examinations; ■ Information Given to Patients and the Public, and Consent Issues; ■ Special Concerns Related to Pregnancy; and ■ The Research Agenda. Examples of topics identified include the observation that guideline development is a global task and there is no case for continuing it as the project of the few professional organizations that have been brave enough to make the long-term commitment required. Advocacy for guidelines should include the expectations that they will facilitate: (1) better health care delivery; (2) lower cost of that delivery; with (3) reduced radiation dose and associated health risks. Radiation protection issues should not be isolated; rather, they should be integrated with the overall health care picture. The type of dose/radiation risk information to be provided with guidelines should include the uncertainty involved and advice on application of the precautionary principle with patients. This principle may be taken as an extension of the well-established medical principle of "first do no harm." Copyright © 2015. Published by Elsevier Inc.

[Clinical guidelines for the prevention of infective endocarditis].

PubMed

Pérez-Lescure Picarzo, J; Crespo Marcos, D; Centeno Malfaz, F

2014-03-01

This article sets out the recommendations for the prevention of infective endocarditis (IE), contained in the guidelines developed by the American Heart Association (AHA) and the European Society of Cardiology (ESC), from which the recommendations of the Spanish Society of Paediatric Cardiology and Congenital Heart Disease have been agreed. In recent years, there has been a considerable change in the recommendations for the prevention of IE, mainly due to the lack of evidence on the effectiveness of antibiotic prophylaxis in prevention, and the risk of the development of antibiotic resistance. The main change is a reduction of the indications for antibiotic prophylaxis, both in terms of patients and procedures considered at risk. Clinical practice guidelines and recommendations should assist health professionals in making clinical decisions in their daily practice. However, the ultimate judgment regarding the care of a particular patient must be taken by the physician responsible. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for rasburicase therapy in the context of G6PD deficiency genotype.

PubMed

Relling, M V; McDonagh, E M; Chang, T; Caudle, K E; McLeod, H L; Haidar, C E; Klein, T; Luzzatto, L

2014-08-01

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is associated with development of acute hemolytic anemia (AHA) induced by a number of drugs. We provide guidance as to which G6PD genotypes are associated with G6PD deficiency in males and females. Rasburicase is contraindicated in G6PD-deficient patients due to the risk of AHA and possibly methemoglobinemia. Unless preemptive genotyping has established a positive diagnosis of G6PD deficiency, quantitative enzyme assay remains the mainstay of screening prior to rasburicase use. The purpose of this article is to help interpret the results of clinical G6PD genotype tests so that they can guide the use of rasburicase. Detailed guidelines on other aspects of the use of rasburicase, including analyses of cost-effectiveness, are beyond the scope of this document. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines are published and updated periodically on https://www.pharmgkb.org/page/cpic to reflect new developments in the field.

Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas

PubMed Central

Albert, Nathalie L.; Weller, Michael; Suchorska, Bogdana; Galldiks, Norbert; Soffietti, Riccardo; Kim, Michelle M.; la Fougère, Christian; Pope, Whitney; Law, Ian; Arbizu, Javier; Chamberlain, Marc C.; Vogelbaum, Michael; Ellingson, Ben M.

2016-01-01

This guideline provides recommendations for the use of PET imaging in gliomas. The review examines established clinical benefit in glioma patients of PET using glucose (18F-FDG) and amino acid tracers (11C-MET, 18F-FET, and 18F-FDOPA). An increasing number of studies have been published on PET imaging in the setting of diagnosis, biopsy, and resection as well radiotherapy planning, treatment monitoring, and response assessment. Recommendations are based on evidence generated from studies which validated PET findings by histology or clinical course. This guideline emphasizes the clinical value of PET imaging with superiority of amino acid PET over glucose PET and provides a framework for the use of PET to assist in the management of patients with gliomas. PMID:27106405

French national consensus clinical guidelines for the management of ulcerative colitis.

PubMed

Peyrin-Biroulet, Laurent; Bouhnik, Yoram; Roblin, Xavier; Bonnaud, Guillaume; Hagège, Hervé; Hébuterne, Xavier

2016-07-01

Ulcerative colitis (UC) is a chronic inflammatory bowel disease of multifactorial etiology that primarily affects the colonic mucosa. The disease progresses over time, and clinical management guidelines should reflect its dynamic nature. There is limited evidence supporting UC management in specific clinical situations, thus precluding an evidence-based approach. To use a formal consensus method - the nominal group technique (NGT) - to develop a clinical practice expert opinion to outline simple algorithms and practices, optimize UC management, and assist clinicians in making treatment decisions. The consensus was developed by an expert panel of 37 gastroenterologists from various professional organizations with experience in UC management using the qualitative and iterative NGT, incorporating deliberations based on the European Crohn's and Colitis Organisation recommendations, recent reviews of scientific literature, and pertinent discussion topics developed by a steering committee. Examples of clinical cases for which there are limited evidence-based data from clinical trials were used. Two working groups proposed and voted on treatment algorithms that were then discussed and voted for by the nominal group as a whole, in order to reach a consensus. A clinical practice guideline covering management of the following clinical situations was developed: (i) moderate and severe UC; (ii) acute severe UC; (iii) pouchitis; (iv) refractory proctitis, in the form of treatment algorithms. Given the limited available evidence-based data, a formal consensus methodology was used to develop simple treatment guidelines for UC management in different clinical situations that is now accessible via an online application. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Nutrition management guideline for maple syrup urine disease: an evidence- and consensus-based approach.

PubMed

Frazier, Dianne M; Allgeier, Courtney; Homer, Caroline; Marriage, Barbara J; Ogata, Beth; Rohr, Frances; Splett, Patricia L; Stembridge, Adrya; Singh, Rani H

2014-07-01

In an effort to increase harmonization of care and enable outcome studies, the Genetic Metabolic Dietitians International (GMDI) and the Southeast Regional Newborn Screening and Genetics Collaborative (SERC) are partnering to develop nutrition management guidelines for inherited metabolic disorders (IMD) using a model combining both evidence- and consensus-based methodology. The first guideline to be completed is for maple syrup urine disease (MSUD). This report describes the methodology used in its development: formulation of five research questions; review, critical appraisal and abstraction of peer-reviewed studies and unpublished practice literature; and expert input through Delphi surveys and a nominal group process. This report includes the summary statements for each research question and the nutrition management recommendations they generated. Each recommendation is followed by a standardized rating based on the strength of the evidence and consensus used. The application of technology to build the infrastructure for this project allowed transparency during development of this guideline and will be a foundation for future guidelines. Online open access of the full, published guideline allows utilization by health care providers, researchers, and collaborators who advise, advocate and care for individuals with MSUD and their families. There will be future updates as warranted by developments in research and clinical practice. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Selective nonoperative management of blunt splenic injury: an Eastern Association for the Surgery of Trauma practice management guideline.

PubMed

Stassen, Nicole A; Bhullar, Indermeet; Cheng, Julius D; Crandall, Marie L; Friese, Randall S; Guillamondegui, Oscar D; Jawa, Randeep S; Maung, Adrian A; Rohs, Thomas J; Sangosanya, Ayodele; Schuster, Kevin M; Seamon, Mark J; Tchorz, Kathryn M; Zarzuar, Ben L; Kerwin, Andrew J

2012-11-01

During the last century, the management of blunt force trauma to the spleen has changed from observation and expectant management in the early part of the 1900s to mainly operative intervention, to the current practice of selective operative and nonoperative management. These issues were first addressed by the Eastern Association for the Surgery of Trauma (EAST) in the Practice Management Guidelines for Non-operative Management of Blunt Injury to the Liver and Spleen published online in 2003. Since that time, a large volume of literature on these topics has been published requiring a reevaluation of the current EAST guideline. The National Library of Medicine and the National Institute of Health MEDLINE database was searched using Pub Med (www.pubmed.gov). The search was designed to identify English-language citations published after 1996 (the last year included in the previous guideline) using the keywords splenic injury and blunt abdominal trauma. One hundred seventy-six articles were reviewed, of which 125 were used to create the current practice management guideline for the selective nonoperative management of blunt splenic injury. There has been a plethora of literature regarding nonoperative management of blunt splenic injuries published since the original EAST practice management guideline was written. Nonoperative management of blunt splenic injuries is now the treatment modality of choice in hemodynamically stable patients, irrespective of the grade of injury, patient age, or the presence of associated injuries. Its use is associated with a low overall morbidity and mortality when applied to an appropriate patient population. Nonoperative management of blunt splenic injuries should only be considered in an environment that provides capabilities for monitoring, serial clinical evaluations, and has an operating room available for urgent laparotomy. Patients presenting with hemodynamic instability and peritonitis still warrant emergent operative intervention. Intravenous contrast enhanced computed tomographic scan is the diagnostic modality of choice for evaluating blunt splenic injuries. Repeat imaging should be guided by a patient's clinical status. Adjunctive therapies like angiography with embolization are increasingly important adjuncts to nonoperative management of splenic injuries. Despite the explosion of literature on this topic, many questions regarding nonoperative management of blunt splenic injuries remain without conclusive answers in the literature.

Japanese Guideline for Allergic Rhinitis 2014.

PubMed

Okubo, Kimihiro; Kurono, Yuichi; Fujieda, Shigeharu; Ogino, Satoshi; Uchio, Eiichi; Odajima, Hiroshi; Takenaka, Hiroshi

2014-09-01

Like asthma and atopic dermatitis, allergic rhinitis is an allergic disease, but of the three, it is the only type I allergic disease. Allergic rhinitis includes pollinosis, which is intractable and reduces quality of life (QOL) when it becomes severe. A guideline is needed to understand allergic rhinitis and to use this knowledge to develop a treatment plan. In Japan, the first guideline was prepared after a symposium held by the Japanese Society of Allergology in 1993. The current 7th edition was published in 2013, and is widely used today. To incorporate evidence based medicine (EBM) introduced from abroad, the most recent collection of evidence/literature was supplemented to the Practical Guideline for the Management of Allergic Rhinitis in Japan 2013. The revised guideline includes assessment of diagnosis/treatment and prescriptions for children and pregnant women, for broad clinical applications. An evidence-based step-by-step strategy for treatment is also described. In addition, the QOL concept and cost benefit analyses are also addressed. Along with Allergic Rhinitis and its Impact of Asthma (ARIA), this guideline is widely used for various clinical purposes, such as measures for patients with sinusitis, childhood allergic rhinitis, oral allergy syndrome, and anaphylaxis and for pregnant women. A Q&A section regarding allergic rhinitis in Japan was added to the end of this guideline.

ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff.

PubMed

Gameiro, S; Boivin, J; Dancet, E; de Klerk, C; Emery, M; Lewis-Jones, C; Thorn, P; Van den Broeck, U; Venetis, C; Verhaak, C M; Wischmann, T; Vermeulen, N

2015-11-01

Based on the best available evidence in the literature, what is the optimal management of routine psychosocial care at infertility and medically assisted reproduction (MAR) clinics? Using the structured methodology of the Manual for the European Society of Human Reproduction and Embryology (ESHRE) Guideline Development, 120 recommendations were formulated that answered the 12 key questions on optimal management of routine psychosocial care by all fertility staff. The 2002 ESHRE Guidelines for counselling in infertility has been a reference point for best psychosocial care in infertility for years, but this guideline needed updating and did not focus on routine psychosocial care that can be delivered by all fertility staff. This guideline was produced by a group of experts in the field according to the 12-step process described in the ESHRE Manual for Guideline Development. After scoping the guideline and listing a set of 12 key questions in PICO (Patient, Intervention, Comparison and Outcome) format, thorough systematic searches of the literature were conducted; evidence from papers published until April 2014 was collected, evaluated for quality and analysed. A summary of evidence was written in a reply to each of the key questions and used as the basis for recommendations, which were defined by consensus within the guideline development group (GDG). Patient and additional clinical input was collected during the scoping and the review phase of the guideline development. The guideline group, comprising psychologists, two medical doctors, a midwife, a patient representative and a methodological expert, met three times to discuss evidence and reach consensus on the recommendations. 120 recommendations that aim at guiding fertility clinic staff in providing optimal evidence-based routine psychosocial care to patients dealing with infertility and MAR. The guideline is written in two sections. The first section describes patients' preferences regarding the psychosocial care they would like to receive at clinics and how this care is associated with their well-being. The second section of the guideline provides information about the psychosocial needs patients experience across their treatment pathway (before, during and after treatment) and how fertility clinic staff can detect and address these. Needs refer to conditions assumed necessary for patients to have a healthy experience of the fertility treatment. Needs can be behavioural (lifestyle, exercise, nutrition and compliance), relational (relationship with partner if there is one, family friends and larger network, and work), emotional (well-being, e.g. anxiety, depression and quality of life) and cognitive (treatment concerns and knowledge). We identified many areas in care for which robust evidence was lacking. Gaps in evidence were addressed by formulating good practice points, based on the expert opinion of the GDG, but it is critical for such recommendations to be empirically validated. The evidence presented in this guideline shows that providing routine psychosocial care is associated with or has potential to reduce stress and concerns about medical procedures and improve lifestyle outcomes, fertility-related knowledge, patient well-being and compliance with treatment. As only 45 (36.0%) of the 125 recommendations were based on high-quality evidence, the guideline group formulated recommendations to guide future research with the aim of increasing the body of evidence. © The Author 2015. 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.

Patient reported outcomes (PROs) in clinical trials: is 'in-trial' guidance lacking? a systematic review.

PubMed

Kyte, Derek G; Draper, Heather; Ives, Jonathan; Liles, Clive; Gheorghe, Adrian; Calvert, Melanie

2013-01-01

Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting) and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. Systematic review of 1,362 articles identified 18 eligible papers containing 'in-trial' guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86-0.97), and validity (<2% residual category coding). The majority of guidelines present were concerned with 'pre-trial' activities (72%), for example, outcome measure selection and study design issues, or 'post-trial' activities (16%) such as data analysis, reporting and interpretation. 'In-trial' guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection.

Guidelines for Adolescent Depression in Primary Care (GLAD-PC): Part II. Treatment and Ongoing Management.

PubMed

Cheung, Amy H; Zuckerbrot, Rachel A; Jensen, Peter S; Laraque, Danielle; Stein, Ruth E K

2018-02-26

To update clinical practice guidelines to assist primary care (PC) in the screening and assessment of depression. In this second part of the updated guidelines, we address treatment and ongoing management of adolescent depression in the PC setting. By using a combination of evidence- and consensus-based methodologies, the guidelines were updated in 2 phases as informed by (1) current scientific evidence (published and unpublished) and (2) revision and iteration among the steering committee, including youth and families with lived experience. These updated guidelines are targeted for youth aged 10 to 21 years and offer recommendations for the management of adolescent depression in PC, including (1) active monitoring of mildly depressed youth, (2) treatment with evidence-based medication and psychotherapeutic approaches in cases of moderate and/or severe depression, (3) close monitoring of side effects, (4) consultation and comanagement of care with mental health specialists, (5) ongoing tracking of outcomes, and (6) specific steps to be taken in instances of partial or no improvement after an initial treatment has begun. The strength of each recommendation and the grade of its evidence base are summarized. The Guidelines for Adolescent Depression in Primary Care cannot replace clinical judgment, and they should not be the sole source of guidance for adolescent depression management. Nonetheless, the guidelines may assist PC clinicians in the management of depressed adolescents in an era of great clinical need and a shortage of mental health specialists. Additional research concerning the management of depressed youth in PC is needed, including the usability, feasibility, and sustainability of guidelines, and determination of the extent to which the guidelines actually improve outcomes of depressed youth. Copyright © 2018 by the American Academy of Pediatrics.

Patient Reported Outcomes (PROs) in Clinical Trials: Is ‘In-Trial’ Guidance Lacking? A Systematic Review

PubMed Central

Kyte, Derek G.; Draper, Heather; Ives, Jonathan; Liles, Clive; Gheorghe, Adrian; Calvert, Melanie

2013-01-01

Background Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on ‘in-trial’ activity (recruitment, data collection and data inputting) and the management of ‘concerning’ PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. Methods and Findings Systematic review of 1,362 articles identified 18 eligible papers containing ‘in-trial’ guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86–0.97), and validity (<2% residual category coding). The majority of guidelines present were concerned with ‘pre-trial’ activities (72%), for example, outcome measure selection and study design issues, or ‘post-trial’ activities (16%) such as data analysis, reporting and interpretation. ‘In-trial’ guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. Conclusions The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection. PMID:23560103

Treatment of metastatic breast cancer: a large observational study on adherence to French prescribing guidelines and financial cost of the anti-HER2 antibody trastuzumab.

PubMed

Poncet, Bénédicte; Colin, Cyrille; Bachelot, Thomas; Jaisson-Hot, Isabelle; Derain, Laure; Magaud, Laurent; Fournel-Federico, Cécile; Mousseau, Mireille; Tigaud, Jean-Dominique; Jacquin, Jean-Philippe; Trillet-Lenoir, Véronique

2009-08-01

This observational study aimed at analyzing adherence to prescribing guidelines of anti-HER2 monoclonal antibody trastuzumab treatment for metastatic breast cancer. Efficacy and costs were also evaluated. The adherence to the trastuzumab treatment plan was analyzed according to both the French postlicensing guidelines published in 2001 and clinical guidelines from the regional cancer network in a cohort of 131 consecutive patients. The level of appropriateness to the molecular target was very high (92% of the patients showed a positive HER2 status, defined as HER2 3+ confirmed by immunohistochemistry or 2+ confirmed by fluorescent in situ hybridization). The treatment plan was made according to the French postlicensing guidelines in 41 patients (31.3%) and to the regional clinical guidelines for 109 patients (83.2%). The main reason for the difference was the type of molecules authorized for combination to trastuzumab. The median overall survival of the studied population was 18.6 months and the median progression-free survival rate was 7.7 months. Up to death or end of the study, the overall cost for the treatment of breast cancer with trastuzumab per patient and per year was 47,832 euro. This quite low adherence of clinicians to the French postlicensing guidelines is in contrast with the high level of adherence to the regional clinical guidelines. The reason is that the latter are less rigid about previously received treatments and enlarge the potential associated cytotoxics to vinorelbine. This supports the French National Cancer Institute decision to get expert clinicians involved together with the French agency for sanitary security of health products and the high health authority in a common elaboration of guidelines.

Assessing the effect of guideline introduction on clinical practice and outcome in patients with endometrial cancer in Japan: a project of the Japan Society of Gynecologic Oncology (JSGO) guideline evaluation committee.

PubMed

Shigeta, Shogo; Nagase, Satoru; Mikami, Mikio; Ikeda, Masae; Shida, Masako; Sakaguchi, Isao; Ushioda, Norichika; Takahashi, Fumiaki; Yamagami, Wataru; Yaegashi, Nobuo; Udagawa, Yasuhiro; Katabuchi, Hidetaka

2017-11-01

The Japan Society of Gynecologic Oncology (JSGO) published the first practice guideline for endometrial cancer in 2006. The JSGO guideline evaluation committee assessed the effect of this guideline introduction on clinical practice and patient outcome using data provided by the Japan Society of Obstetrics and Gynecology (JSOG) cancer registration system. Data of patients with endometrial cancer registered between 2000 and 2012 were analyzed, and epidemiological and clinical trends were assessed. The influence of guideline introduction on survival was determined by analyzing data of patients registered between 2004 and 2009 using competing risk model. In total, 65,241 cases of endometrial cancer were registered. Total number of patients registered each year increased about 3 times in the analyzed period, and the proportion of older patients with type II endometrial cancer rapidly increased. The frequency of lymphadenectomy had decreased not only among the low-recurrence risk group but also among the intermediate- or high-recurrence risk group. Adjuvant therapy was integrated into chemotherapy (p<0.001). Overall survival did not significantly differ before and after the guideline introduction (hazard ratio [HR]=0.891; p=0.160). Additional analyses revealed patients receiving adjuvant chemotherapy showed better prognosis than those receiving adjuvant radiation therapy when limited to stage I or II (HR= 0.598; p=0.003). It was suggested that guideline introduction influenced the management of endometrial cancer at several aspects. Better organized information and continuous evaluation are necessary to understand the causal relationship between the guideline and patient outcome. Copyright © 2017. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology

2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis.

PubMed

Ross, Douglas S; Burch, Henry B; Cooper, David S; Greenlee, M Carol; Laurberg, Peter; Maia, Ana Luiza; Rivkees, Scott A; Samuels, Mary; Sosa, Julie Ann; Stan, Marius N; Walter, Martin A

2016-10-01

Thyrotoxicosis has multiple etiologies, manifestations, and potential therapies. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions and patient preference. This document describes evidence-based clinical guidelines for the management of thyrotoxicosis that would be useful to generalist and subspecialty physicians and others providing care for patients with this condition. The American Thyroid Association (ATA) previously cosponsored guidelines for the management of thyrotoxicosis that were published in 2011. Considerable new literature has been published since then, and the ATA felt updated evidence-based guidelines were needed. The association assembled a task force of expert clinicians who authored this report. They examined relevant literature using a systematic PubMed search supplemented with additional published materials. An evidence-based medicine approach that incorporated the knowledge and experience of the panel was used to update the 2011 text and recommendations. The strength of the recommendations and the quality of evidence supporting them were rated according to the approach recommended by the Grading of Recommendations, Assessment, Development, and Evaluation Group. Clinical topics addressed include the initial evaluation and management of thyrotoxicosis; management of Graves' hyperthyroidism using radioactive iodine, antithyroid drugs, or surgery; management of toxic multinodular goiter or toxic adenoma using radioactive iodine or surgery; Graves' disease in children, adolescents, or pregnant patients; subclinical hyperthyroidism; hyperthyroidism in patients with Graves' orbitopathy; and management of other miscellaneous causes of thyrotoxicosis. New paradigms since publication of the 2011 guidelines are presented for the evaluation of the etiology of thyrotoxicosis, the management of Graves' hyperthyroidism with antithyroid drugs, the management of pregnant hyperthyroid patients, and the preparation of patients for thyroid surgery. The sections on less common causes of thyrotoxicosis have been expanded. One hundred twenty-four evidence-based recommendations were developed to aid in the care of patients with thyrotoxicosis and to share what the task force believes is current, rational, and optimal medical practice.

Nordic guidelines for neuraxial blocks in disturbed haemostasis from the Scandinavian Society of Anaesthesiology and Intensive Care Medicine.

PubMed

Breivik, H; Bang, U; Jalonen, J; Vigfússon, G; Alahuhta, S; Lagerkranser, M

2010-01-01

Central neuraxial blocks (CNBs) for surgery and analgesia are an important part of anaesthesia practice in the Nordic countries. More active thromboprophylaxis with potent antihaemostatic drugs has increased the risk of bleeding into the spinal canal. National guidelines for minimizing this risk in patients who benefit from such blocks vary in their recommendations for safe practice. The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI) appointed a task force of experts to establish a Nordic consensus on recommendations for best clinical practice in providing effective and safe CNBs in patients with an increased risk of bleeding. We performed a literature search and expert evaluation of evidence for (1) the possible benefits of CNBs on the outcome of anaesthesia and surgery, for (2) risks of spinal bleeding from hereditary and acquired bleeding disorders and antihaemostatic drugs used in surgical patients for thromboprophylaxis, for (3) risk evaluation in published case reports, and for (4) recommendations in published national guidelines. Proposals from the taskforce were available for feedback on the SSAI web-page during the summer of 2008. Neuraxial blocks can improve comfort and reduce morbidity (strong evidence) and mortality (moderate evidence) after surgical procedures. Haemostatic disorders, antihaemostatic drugs, anatomical abnormalities of the spine and spinal blood vessels, elderly patients, and renal and hepatic impairment are risk factors for spinal bleeding (strong evidence). Published national guidelines are mainly based on experts' opinions (weak evidence). The task force reached a consensus on Nordic guidelines, mainly based on our experts' opinions, but we acknowledge different practices in heparinization during vascular surgery and peri-operative administration of non-steroidal anti-inflammatory drugs during neuraxial blocks. Experts from the five Nordic countries offer consensus recommendations for safe clinical practice of neuraxial blocks and how to minimize the risks of serious complications from spinal bleeding. A brief version of the recommendations is available on http://www.ssai.info.

Saudi Oncology Society and Saudi Urology Association combined clinical management guidelines for urothelial cell carcinoma of the urinary bladder 2017.

PubMed

Alharbi, Hulayel; Alkhateeb, Sultan; Murshid, Esam; Alotaibi, Mohammed; Abusamra, Ashraf; Rabah, Danny; Almansour, Mubarak; Alghamdi, Abdullah; Aljubran, Ali; Eltigani, Amin; Alkushi, Hussein; Ahmed, Imran; Alsharm, Abdullah; Bazarbashi, Shouki

2018-01-01

This is an update to the previously published Saudi guidelines for the evaluation and medical/surgical management of patients diagnosed with urothelial cell carcinoma of the urinary bladder. It is categorized according to the stage of the disease using the tumor node metastasis staging system, 7 th edition. The guidelines are presented with their accompanying supporting evidence level, which is based on comprehensive literature review, several internationally recognized guidelines, and the collective expertise of the guidelines committee members (authors) who were selected by the Saudi Oncology Society and Saudi Urological Association. Considerations to the local availability of drugs, technology, and expertise have been regarded. These guidelines should serve as a roadmap for the urologists, oncologists, general physicians, support groups, and health-care policymakers in the management of patients diagnosed with urothelial cell carcinoma of the urinary bladder.

Searching CINAHL did not add value to clinical questions posed in NICE guidelines.

PubMed

Beckles, Zosia; Glover, Sarah; Ashe, Joanna; Stockton, Sarah; Boynton, Janette; Lai, Rosalind; Alderson, Philip

2013-09-01

This study aims to quantify the unique useful yield from the Cumulative Index to Nursing and Allied Health Literature (CINAHL) database to National Institute for Health and Clinical Excellence (NICE) clinical guidelines. A secondary objective is to investigate the relationship between this yield and different clinical question types. It is hypothesized that the unique useful yield from CINAHL is low, and this database can therefore be relegated to selective rather than routine searching. A retrospective sample of 15 NICE guidelines published between 2005 and 2009 was taken. Information on clinical review question type, number of references, and reference source was extracted. Only 0.33% (95% confidence interval: 0.01-0.64%) of references per guideline were unique to CINAHL. Nursing- or allied health (AH)-related questions were nearly three times as likely to have references unique to CINAHL as non-nursing- or AH-related questions (14.89% vs. 5.11%), and this relationship was found to be significant (P<0.05). No significant relationship was found between question type and unique CINAHL yield for drug-related questions. The very low proportion of references unique to CINAHL strongly suggests that this database can be safely relegated to selective rather than routine searching. Nursing- and AH-related questions would benefit from selective searching of CINAHL. Copyright © 2013 Elsevier Inc. All rights reserved.

Factors influencing emergency medicine physicians' management of sports-related concussions: a community-wide study.

PubMed

Giebel, Stephen; Kothari, Rashmi; Koestner, Amy; Mohney, Gretchen; Baker, Robert

2011-12-01

Numerous guidelines to grade and manage sports-related concussions have been published. However, little is known about how frequently they are implemented in the emergency department. This study evaluates the current practices of emergency physicians (EPs) in managing sports-related concussions. To evaluate the current practice of EP evaluation and management of sports-related concussions. All EPs and emergency medicine residents in Kalamazoo County were surveyed regarding their management of sports-related concussions. The surveys obtained demographic data, participants' use of guidelines, and the importance of clinical and non-clinical factors in deciding when to allow a player to return to play. Of the 73 EP respondents, only 23% used a nationally recognized guideline, with no significant difference between attending and resident EPs. The symptomatic complaints of loss of consciousness, amnesia of the event, and difficulty concentrating were ranked most important by EPs in assessing patients with sports-related concussions. Among non-clinical factors, residents were significantly more likely than attendings to report that medical-legal, parental, and players' concerns were more likely to influence their decision in allowing a patient to return to play. EPs take into consideration important clinical factors in assessing patients with sports-related concussion. However, almost 75% do not use any nationally recognized guideline in their evaluation. Residents are more likely than attendings to be influenced by non-clinical factors. Copyright © 2011 Elsevier Inc. All rights reserved.

WHO consultation on clinical evaluation of vaccines, 17-18 July 2014, WHO Headquarters, Geneva, Switzerland.

PubMed

Knezevic, Ivana; Moorthy, Vasee; Sheets, Rebecca

2015-04-21

A World Health Organization (WHO) consultation on guidelines for National Regulatory Authorities (NRAs) and vaccine manufacturers on clinical evaluation of vaccines was held from 17 to 18 July 2014, to review key scientific challenges that regulators have been facing since the establishment of the WHO Guidelines on Clinical Evaluation of Vaccines. The guidelines, adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2001, have served as the basis for setting or updating national requirements for the evaluation and licensing of a broad range of vaccines as well as for WHO vaccine prequalification. Regulators from Australia, Brazil, China, Canada, Germany, India, Republic of Korea, South Africa, United States of America and the United Kingdom were represented. The International Federation for Pharmaceutical Manufacturers' Association (IFPMA) and the Developing Country Vaccine Manufacturers' Network (DCVMN) provided industry representation. The consultation concluded that the guidelines should be revised to address issues that were raised in the context of vaccines that were the subject of clinical development in the past decade. Although the current guidelines have served well over time, it was recognized that an update would further increase their utility and would help regulators, manufacturers, vaccine developers and academia to respond to the challenging questions regarding the safety, immunogenicity, efficacy and effectiveness of vaccines intended for global use. A summary of the main outcomes of the consultation and proposals for the next steps regarding the guidelines and beyond are provided in this report. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

British Thoracic Society guidelines for home oxygen use in adults.

PubMed

Hardinge, Maxine; Annandale, Joe; Bourne, Simon; Cooper, Brendan; Evans, Angela; Freeman, Daryl; Green, Angela; Hippolyte, Sabrine; Knowles, Vikki; MacNee, William; McDonnell, Lynn; Pye, Kathy; Suntharalingam, Jay; Vora, Vandana; Wilkinson, Tom

2015-06-01

The British Thoracic Society (BTS) Home Oxygen Guideline provides detailed evidence-based guidance for the use of home oxygen for patients out of hospital. Although the majority of evidence comes from the use of oxygen in patients with chronic obstructive pulmonary disease, the scope of the guidance includes patients with a variety of long-term respiratory illnesses and other groups in whom oxygen is currently ordered, such as those with cardiac failure, cancer and end-stage cardiorespiratory disease, terminal illness or cluster headache. It explores the evidence base for the use of different modalities of oxygen therapy and patient-related outcomes such as mortality, symptoms and quality of life. The guideline also makes recommendations for assessment and follow-up protocols, and risk assessments, particularly in the clinically challenging area of home oxygen users who smoke. The guideline development group is aware of the potential for confusion sometimes caused by the current nomenclature for different types of home oxygen, and rather than renaming them, has adopted the approach of clarifying those definitions, and in particular emphasising what is meant by long-term oxygen therapy and palliative oxygen therapy. The home oxygen guideline provides expert consensus opinion in areas where clinical evidence is lacking, and seeks to deliver improved prescribing practice, leading to improved compliance and improved patient outcomes, with consequent increased value to the health service. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

PubMed

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

2013-06-01

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

New Therapeutic Paradigms and Guidelines in the Management of Pulmonary Arterial Hypertension.

PubMed

Hill, Nicholas S; Cawley, Michael J; Heggen-Peay, Cherilyn L

2016-03-01

Recent and ongoing developments in the diagnosis, treatment, and management of pulmonary arterial hypertension (PAH) provide deeper insights into pathogenic mechanisms. Approvals of new pharmacotherapies that improve function and reduce morbidity and mortality risks; advances in clinical trial methods, including long-term, event-driven studies with clinically relevant and patient-centered endpoints; and trial results support a new therapeutic management strategy. This new paradigm involves initial treatment with combined therapies that act through different disease pathways. In addition, 2 new sets of clinical practice guidelines for PAH have been published since June 2014. Despite these advances, major gaps have been documented in the diagnosis, treatment, and management of patients with PAH. To present current knowledge and evidence on PAH to support managed care professionals and providers in achieving accurate differential diagnosis, promptly referring patients to specialists as necessary, and ensuring that patients receive appropriate, guideline-directed therapies. Major gaps in the quality of care provided to patients with PAH include oversights in clinicians' recognition of symptoms, delays in diagnosis, and misdiagnosis ensuing from incomplete evaluations, delays in referral of patients to centers of expertise and initiation of therapy, and inappropriate treatment regimens. To address deficiencies in PAH diagnosis, new practice guidelines emphasize the essential role of right heart catheterization in characterizing and confirming the disease, as well as referral to expert pulmonary hypertension centers to ensure appropriate evaluation and treatment. Updated disease and functional classifications of PAH, along with new research findings on prognostic factors and effects of comorbid conditions, offer key support for making effective therapy and management decisions for patients with PAH at different risk levels and stages of the disease. Since 2013, the U.S. Food and Drug Administration has approved new PAH therapies in the classes of endothelin receptor antagonists, guanylate cyclase stimulators, prostacyclin analogues, and prostacyclin receptor agonists. As demonstrated through phase 3 clinical trials, these generally well-tolerated therapies delay disease progression, improve hemodynamic and functional status, and decrease numbers of hospitalizations. Moreover, 2 sets of recently published guidelines-developed by the American College of Chest Physicians and the European Society of Cardiology/European Respiratory Society-provide evidence-based and expert consensus recommendations for achieving PAH treatment goals. The most recent guidelines include a recommendation for upfront combination therapy for patients with moderate disease, which is supported by new comparative clinical trial evidence. As addressed in this article, these advances in the field of PAH have important implications for managed care and clinical practice, including considerations of cost-benefit outcomes associated with different management strategies.

Clinical Guideline for Treatment of Symptomatic Thoracic Spinal Stenosis.

PubMed

Chen, Zhong-qiang; Sun, Chui-guo

2015-08-01

Thoracic spinal stenosis is a relatively common disorder causing paraplegia in the population of China. Until nowadays, the clinical management of thoracic spinal stenosis is still demanding and challenging with lots of questions remaining to be answered. A clinical guideline for the treatment of symptomatic thoracic spinal stenosis has been created by reaching the consensus of Chinese specialists using the best available evidence as a tool to aid practitioners involved with the care of this disease. In this guideline, many fundamental questions about thoracic spinal stenosis which were controversial have been explained clearly, including the definition of thoracic spinal stenosis, the standard procedure for diagnosing symptomatic thoracic spinal stenosis, indications for surgery, and so on. According to the consensus on the definition of thoracic spinal stenosis, the soft herniation of thoracic discs has been excluded from the pathological factors causing thoracic spinal stenosis. The procedure for diagnosing thoracic spinal stenosis has been quite mature, while the principles for selecting operative procedures remain to be improved. This guideline will be updated on a timely schedule and adhering to its recommendations should not be mandatory because it does not have the force of law. © 2015 Chinese Orthopaedic Association and Wiley Publishing Asia Pty Ltd.

Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C9 and HLA‐B Genotypes and Phenytoin Dosing

PubMed Central

Rettie, A E; Whirl‐Carrillo, M; Smith, L H; Mintzer, S; Lee, M T M; Klein, T E; Callaghan, J T

2014-01-01

Phenytoin is a widely used antiepileptic drug with a narrow therapeutic index and large interpatient variability, partly due to genetic variations in the gene encoding cytochrome P450 (CYP)2C9 (CYP2C9). Furthermore, the variant allele HLA‐B*15:02, encoding human leukocyte antigen, is associated with an increased risk of Stevens–Johnson syndrome and toxic epidermal necrolysis in response to phenytoin treatment. We summarize evidence from the published literature supporting these associations and provide recommendations for the use of phenytoin based on CYP2C9 and/or HLA‐B genotype (also available on PharmGKB: http://www.pharmgkb.org). The purpose of this guideline is to provide information for the interpretation of HLA‐B and/or CYP2C9 genotype tests so that the results can guide dosing and/or use of phenytoin. Detailed guidelines for the use of phenytoin as well as analyses of cost‐effectiveness are out of scope. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines are periodically updated at http://www.pharmgkb.org. Clinical Pharmacology & Therapeutics (2014); 96 5, 542–548. doi:10.1038/clpt.2014.159 PMID:25099164

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

PubMed

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

2014-11-05

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

Sedation assisted by an endoscopist (SAE) for complex endoscopic procedures. Is it time to change the current guidelines?

PubMed

Hernán Ocaña, Pablo

2018-04-01

Currently, sedation in endoscopic procedures is considered a necessary condition and a criterion of quality in digestive endoscopy. The role of SAE in conventional endoscopic procedures is clearly established in clinical guidelines, but this is not so clear in complex endoscopic procedures, such as ERCP. In recent years, numerous studies have been published, with results similar to those noticed in this article, endorsing the safety, efficacy and efficiency of SAE, when performed by properly trained staff.

The Surviving Sepsis Campaign: Where have we been and where are we going?

PubMed

Dellinger, R Phillip

2015-04-01

The Surviving Sepsis Campaign develops and promotes evidence-based guidelines and performance-improvement practices aimed at reducing deaths from sepsis worldwide. The most recent guidelines, published in 2013, provide detailed management strategies for acute care, fluid resuscitation, and vasopressor use. In addition, the campaign has developed simple, short protocols for what to do within 3 and 6 hours of recognition of sepsis. These protocols are associated with reduced mortality rates. Copyright © 2015 Cleveland Clinic.

Guidelines for the Management of Postoperative Pain after Total Knee Arthroplasty

PubMed Central

2012-01-01

This clinical practice guideline was approved by Korean Knee Society on February 28, 2012. It is based on a systematic review of published studies on the management of postoperative pain after total knee arthroplasty and was developed to include the overall pain management modalities. The purpose of the guideline is to help improve treatment based on current best evidence. Eleven recommendations have been developed based on a systematic review of research evidence and the consensus opinions of a multidisciplinary working group of experts. These recommendations will be revised regularly following systematic review of new research evidence as this becomes available. PMID:23269957

[An analysis of articles published by academic groups in pediatrics in Chinese Journal of Pediatrics and their citations].

PubMed

Song, Qiurong; Hu, Yanping; Li, Linping

2014-08-01

To explore academic significance and guiding function played by subspecialty groups of the Society of Pediatrics, Chinese Medical Association on Chinese pediatric clinical practice through a statistical analysis of the articles published by the subspecialty groups. Bibliometric methods were used to analyze the number of articles, article types, total citations, highly cited articles and the distribution of citing journals. Totally 7 156 articles were published in Chinese Journal of Pediatrics from 1993 (31) to 2012 (51), of which 187 by subspecialty groups of pediatrics (2.6%), with a total citations of 11 985. Among them, 137 articles were cited with a citation rate of 73.3% and average citations for each article was 64.1. Articles classified as clinical guidelines had been totally cited for 10 900 times with average citations of 123.86 per article. The article on Neonatal hypoxic ischemic encephalopathy diagnosis and clinical index was cited 1 791 times ranked in highly cited literatures. All the top three cited literature periodicals were core journals of pediatrics, and 10 periodicals among the top 20 were in pediatrics and the rest in other medical fields. The number of the articles published by the subspecialty groups of pediatrics was increasing year by year though the portion it in the total number of the articles in the journal was not large. However, the citation frequency of the articles by the subspecialty groups of pediatrics was high, making an obvious contribution to the total citations of Chinese Journal of Pediatrics. The total citation rate of clinical guideline articles and their average rate was higher than those of other articles published in this journal, which meant that this type of articles provided academic references with guiding significance for clinical practice of pediatrics and for other medical fields as well.

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

PubMed

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

2013-01-01

Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing health care variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective-or potentially harmful-interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. The third edition of this manual describes the principles and practices used successfully by the American Academy of Otolaryngology--Head and Neck Surgery Foundation to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for actionable recommendations with multidisciplinary applicability. The development process emphasizes a logical sequence of key action statements supported by amplifying text, action statement profiles, and recommendation grades linking action to evidence. New material in this edition includes standards for trustworthy guidelines, updated classification of evidence levels, increased patient and public involvement, assessing confidence in the evidence, documenting differences of opinion, expanded discussion of conflict of interest, and use of computerized decision support for crafting actionable recommendations. As clinical practice guidelines become more prominent as a key metric of quality health care, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are--and are not--and how they are best used to improve care. The information in this manual should help clinicians and organizations achieve these goals.

Smoking cessation in primary care clinics.

PubMed

Sippel, J M; Osborne, M L; Bjornson, W; Goldberg, B; Buist, A S

1999-11-01

To document smoking cessation rates achieved by applying the 1996 Agency for Health Care Policy and Research (AHCPR) smoking cessation guidelines for primary care clinics, compare these quit rates with historical results, and determine if quit rates improve with an additional motivational intervention that includes education as well as spirometry and carbon monoxide measurements. Randomized clinical trial. Two university-affiliated community primary care clinics. Two hundred five smokers with routinely scheduled appointments. All smokers were given advice and support according to AHCPR guidelines. Half of the subjects received additional education with spirometry and carbon monoxide measurements. Quit rate was evaluated at 9-month follow-up. Eleven percent of smokers were sustained quitters at follow-up. Sustained quit rate was no different for intervention and control groups (9% vs 14%; [OR] 0.6; 95% [CI] 0.2, 1.4). Nicotine replacement therapy was strongly associated with sustained cessation (OR 6.7; 95% CI 2.3, 19.6). Subjects without insurance were the least likely to use nicotine replacement therapy ( p =.05). Historical data from previously published studies showed that 2% of smokers quit following physician advice, and additional support similar to AHCPR guidelines increased the quit rate to 5%. The sustained smoking cessation rate achieved by following AHCPR guidelines was 11% at 9 months, which compares favorably with historical results. Additional education with spirometry did not improve the quit rate. Nicotine replacement therapy was the strongest predictor of cessation, yet was used infrequently owing to cost. These findings support the use of AHCPR guidelines in primary care clinics, but do not support routine spirometry for motivating patients similar to those studied here.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

PubMed Central

Harris, Lyndsay N.; McShane, Lisa M.; Andre, Fabrice; Collyar, Deborah E.; Gonzalez-Angulo, Ana M.; Hammond, Elizabeth H.; Kuderer, Nicole M.; Liu, Minetta C.; Mennel, Robert G.; Van Poznak, Catherine; Bast, Robert C.; Hayes, Daniel F.

2016-01-01

Purpose To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. Methods A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. Results The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. Recommendations In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences. PMID:26858339

ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents

PubMed Central

2015-01-01

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood and can profoundly affect the academic achievement, well-being, and social interactions of children; the American Academy of Pediatrics first published clinical recommendations for the diagnosis and evaluation of ADHD in children in 2000; recommendations for treatment followed in 2001. PMID:22003063

Do countries rely on the World Health Organization for translating research findings into clinical guidelines? A case study.

PubMed

Noor, Ramadhani A; Geldsetzer, Pascal; Bärnighausen, Till; Fawzi, Wafaie

2016-10-06

The World Health Organization's (WHO) antiretroviral therapy (ART) guidelines have generally been adopted rapidly and with high fidelity by countries in sub-Saharan Africa. Thus far, however, WHO has not published specific guidance on nutritional care and support for (non-pregnant) adults living with HIV despite a solid evidence base for some interventions. This offers an opportunity for a case study on whether national clinical guidelines in sub-Saharan Africa provide concrete recommendations in the face of limited guidance by WHO. This study, therefore, aims to determine if national HIV treatment guidelines in sub-Saharan Africa contain specific guidance on nutritional care and support for non-pregnant adults living with HIV. We identified the most recent national HIV treatment guidelines in sub-Saharan African countries with English as an official language. Using pre-specified criteria, we determined for each guideline whether it provides guidance to clinicians on each of five components of nutritional care and support for adults living with HIV: assessment of nutritional status, dietary counseling, micronutrient supplementation, ready-to-use therapeutic or supplementary foods, and food subsidies. We found that national HIV treatment guidelines in sub-Saharan Africa generally do not contain concrete recommendations on nutritional care and support for non-pregnant adults living with HIV. Given that decisions on nutritional care and support are inevitably being made at the clinician-patient level, and that clinicians have a relative disadvantage in systematically identifying, summarizing, and weighing up research evidence compared to WHO and national governments, there is a need for more specific clinical guidance. In our view, such guidance should at a minimum recommend daily micronutrient supplements for adults living with HIV who are in pre-ART stages, regular dietary counseling, periodic assessment of anthropometric status, and additional nutritional management of undernourished patients. More broadly, our findings suggest that countries in sub-Saharan Africa look to WHO for guidance in translating evidence into clinical guidelines. It is, thus, likely that the development of concrete recommendations by WHO on nutritional interventions for people living with HIV would lead to more specific guidelines at the country-level and, ultimately, better clinical decisions and treatment outcomes.

Discordant American College of Physicians and international rheumatology guidelines for gout management: consensus statement of the Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN).

PubMed

Dalbeth, Nicola; Bardin, Thomas; Doherty, Michael; Lioté, Frédéric; Richette, Pascal; Saag, Kenneth G; So, Alexander K; Stamp, Lisa K; Choi, Hyon K; Terkeltaub, Robert

2017-09-01

In November 2016, the American College of Physicians (ACP) published a clinical practice guideline on the management of acute and recurrent gout. This guideline differs substantially from the latest guidelines generated by the American College of Rheumatology (ACR), European League Against Rheumatism (EULAR) and 3e (Evidence, Expertise, Exchange) Initiative, despite reviewing largely the same body of evidence. The Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN) convened an expert panel to review the methodology and conclusions of these four sets of guidelines and examine possible reasons for discordance between them. The G-CAN position, presented here, is that the fundamental pathophysiological knowledge underlying gout care, and evidence from clinical experience and clinical trials, supports a treat-to-target approach for gout aimed at lowering serum urate levels to below the saturation threshold at which monosodium urate crystals form. This practice, which is truly evidence-based and promotes the steady reduction in tissue urate crystal deposits, is promoted by the ACR, EULAR and 3e Initiative recommendations. By contrast, the ACP does not provide a clear recommendation for urate-lowering therapy (ULT) for patients with frequent, recurrent flares or those with tophi, nor does it recommend monitoring serum urate levels of patients prescribed ULT. Results from emerging clinical trials that have gout symptoms as the primary end point are expected to resolve this debate for all clinicians in the near term future.

Development of a novel, multilayered presentation format for clinical practice guidelines.

PubMed

Kristiansen, Annette; Brandt, Linn; Alonso-Coello, Pablo; Agoritsas, Thomas; Akl, Elie A; Conboy, Tara; Elbarbary, Mahmoud; Ferwana, Mazen; Medani, Wedad; Murad, Mohammad Hassan; Rigau, David; Rosenbaum, Sarah; Spencer, Frederick A; Treweek, Shaun; Guyatt, Gordon; Vandvik, Per Olav

2015-03-01

Bridging the gap between clinical research and everyday health-care practice requires effective communication strategies. To address current shortcomings in conveying practice recommendations and supporting evidence, we are creating and testing presentation formats for clinical practice guidelines (CPGs). We carried out multiple cycles of brainstorming and sketching, developing a prototype. Physicians participating in the user testing viewed CPG formats linked to clinical scenarios and engaged in semistructured interviews applying a think-aloud method for exploring important aspects of user experience. We developed a multilayered presentation format that allows clinicians to successively view more in-depth information. Starting with the recommendations, clinicians can, on demand, access a rationale and a key information section containing statements on quality of the evidence, balance between desirable and undesirable consequences, values and preferences, and resource considerations. We collected feedback from 27 stakeholders and performed user testing with 47 practicing physicians from six countries. Advisory group feedback and user testing of the first version revealed problems with conceptual understanding of underlying CPG methodology, as well as difficulties with the complexity of the layout and content. Extensive revisions made before the second round of user testing resulted in most participants expressing overall satisfaction with the final presentation format. We have developed an electronic, multilayered, CPG format that enhances the usability of CPGs for frontline clinicians. We have implemented the format in electronic guideline tools that guideline organizations can now use when authoring and publishing their guidelines.

Clinical Translation of Cell Therapy, Tissue Engineering, and Regenerative Medicine Product in Malaysia and Its Regulatory Policy.

PubMed

Bt Hj Idrus, Ruszymah; Abas, Arpah; Ab Rahim, Fazillahnor; Saim, Aminuddin Bin

2015-12-01

With the worldwide growth of cell and tissue therapy (CTT) in treating diseases, the need of a standardized regulatory policy is of paramount concern. Research in CTT in Malaysia has reached stages of clinical trials and commercialization. In Malaysia, the regulation of CTT is under the purview of the National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH). NPCB is given the task of regulating CTT, under a new Cell and Gene Therapy Products framework, and the guidelines are currently being formulated. Apart from the laboratory accreditation, researchers are advised to follow Guidelines for Stem Cell Research and Therapy from the Medical Development Division, MOH, published in 2009.

Clinical Translation of Cell Therapy, Tissue Engineering, and Regenerative Medicine Product in Malaysia and Its Regulatory Policy

PubMed Central

Abas, Arpah; Ab Rahim, Fazillahnor; Saim, Aminuddin Bin

2015-01-01

With the worldwide growth of cell and tissue therapy (CTT) in treating diseases, the need of a standardized regulatory policy is of paramount concern. Research in CTT in Malaysia has reached stages of clinical trials and commercialization. In Malaysia, the regulation of CTT is under the purview of the National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH). NPCB is given the task of regulating CTT, under a new Cell and Gene Therapy Products framework, and the guidelines are currently being formulated. Apart from the laboratory accreditation, researchers are advised to follow Guidelines for Stem Cell Research and Therapy from the Medical Development Division, MOH, published in 2009. PMID:26192075

Canadian Thoracic Society 2012 guideline update: Diagnosis and management of asthma in preschoolers, children and adults

PubMed Central

Lougheed, M Diane; Lemiere, Catherine; Ducharme, Francine M; Licskai, Chris; Dell, Sharon D; Rowe, Brian H; FitzGerald, Mark; Leigh, Richard; Watson, Wade; Boulet, Louis-Philippe

2012-01-01

BACKGROUND: In 2010, the Canadian Thoracic Society (CTS) published a Consensus Summary for the diagnosis and management of asthma in children six years of age and older, and adults, including an updated Asthma Management Continuum. The CTS Asthma Clinical Assembly subsequently began a formal clinical practice guideline update process, focusing, in this first iteration, on topics of controversy and/or gaps in the previous guidelines. METHODS: Four clinical questions were identified as a focus for the updated guideline: the role of noninvasive measurements of airway inflammation for the adjustment of anti-inflammatory therapy; the initiation of adjunct therapy to inhaled corticosteroids (ICS) for uncontrolled asthma; the role of a single inhaler of an ICS/long-acting beta2-agonist combination as a reliever, and as a reliever and a controller; and the escalation of controller medication for acute loss of asthma control as part of a self-management action plan. The expert panel followed an adaptation process to identify and appraise existing guidelines on the specified topics. In addition, literature searches were performed to identify relevant systematic reviews and randomized controlled trials. The panel formally assessed and graded the evidence, and made 34 recommendations. RESULTS: The updated guideline recommendations outline a role for inclusion of assessment of sputum eosinophils, in addition to standard measures of asthma control, to guide adjustment of controller therapy in adults with moderate to severe asthma. Appraisal of the evidence regarding which adjunct controller therapy to add to ICS and at what ICS dose to begin adjunct therapy in children and adults with poor asthma control supported the 2010 CTS Consensus Summary recommendations. New recommendations for the adjustment of controller medication within written action plans are provided. Finally, priority areas for future research were identified. CONCLUSIONS: The present clinical practice guideline is the first update of the CTS Asthma Guidelines following the Canadian Respiratory Guidelines Committee’s new guideline development process. Tools and strategies to support guideline implementation will be developed and the CTS will continue to regularly provide updates reflecting new evidence. PMID:22536582

International Guidelines for the Management and Treatment of Morquio A Syndrome

PubMed Central

Hendriksz, Christian J; Berger, Kenneth I; Giugliani, Roberto; Harmatz, Paul; Kampmann, Christoph; Mackenzie, William G; Raiman, Julian; Villarreal, Martha Solano; Savarirayan, Ravi

2015-01-01

Morquio A syndrome (mucopolysaccharidosis IVA) is a lysosomal storage disorder associated with skeletal and joint abnormalities and significant non-skeletal manifestations including respiratory disease, spinal cord compression, cardiac disease, impaired vision, hearing loss, and dental problems. The clinical presentation, onset, severity and progression rate of clinical manifestations of Morquio A syndrome vary widely between patients. Because of the heterogeneous and progressive nature of the disease, the management of patients with Morquio A syndrome is challenging and requires a multidisciplinary approach, involving an array of specialists. The current paper presents international guidelines for the evaluation, treatment and symptom-based management of Morquio A syndrome. These guidelines were developed during two expert meetings by an international panel of specialists in pediatrics, genetics, orthopedics, pulmonology, cardiology, and anesthesia with extensive experience in managing Morquio A syndrome. © 2014 The Authors. American Journal of Medical Genetics Part A published by Wiley Periodicals, Inc. PMID:25346323

Singapore Urological Association Clinical Guidelines for Male Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia

PubMed Central

2017-01-01

The first clinical guidelines for male lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) were published in 2005. An update is urgently needed in view of BPH being recognised as one of ten chronic illnesses by the Ministry of Health, Singapore. This review summarises the definition of BPH and the epidemiology of male LUTS/BPH in Singapore. BPH can be phenotyped with noninvasive transabdominal ultrasonography, according to intravesical prostatic protrusion and prostate volume, and classified according to severity (staging) for individualised treatment. At the initial evaluation, the majority of patients (59%) can be managed with fluid adjustment, exercise and diet; 32% with medications, using alpha blockers and/or 5-alpha reductase inhibitors for prostates weighing more than 30 g; and 9% with surgical intervention for more advanced disease. The 2015 guidelines comprise updated evidence that will help family medicine practitioners and specialists manage this common ailment more cost-effectively. PMID:28848988

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

PubMed Central

Jones, Christine E.; Munoz, Flor M.; Spiegel, Hans M.L.; Heininger, Ulrich; Zuber, Patrick L.F.; Edwards, Kathryn M.; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S.; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M.; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O.; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T.

2017-01-01

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. PMID:27481360

ILCOR Scientific Knowledge Gaps and Clinical Research Priorities for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: A Consensus Statement.

PubMed

Kleinman, Monica E; Perkins, Gavin D; Bhanji, Farhan; Billi, John E; Bray, Janet E; Callaway, Clifton W; de Caen, Allan; Finn, Judith C; Hazinski, Mary Fran; Lim, Swee Han; Maconochie, Ian; Morley, Peter; Nadkarni, Vinay; Neumar, Robert W; Nikolaou, Nikolaos; Nolan, Jerry P; Reis, Amelia; Sierra, Alfredo F; Singletary, Eunice M; Soar, Jasmeet; Stanton, David; Travers, Andrew; Welsford, Michelle; Zideman, David

2018-04-26

Despite significant advances in the field of resuscitation science, important knowledge gaps persist. Current guidelines for resuscitation are based on the International Liaison Committee on Resuscitation 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations, which includes treatment recommendations supported by the available evidence. The writing group developed this consensus statement with the goal of focusing future research by addressing the knowledge gaps identified during and after the 2015 International Liaison Committee on Resuscitation evidence evaluation process. Key publications since the 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations are referenced, along with known ongoing clinical trials that are likely to affect future guidelines. © 2018 European Resuscitation Council and American Heart Association, Inc. Published by Elsevier B.V. All rights reserved. Copyright © 2018 European Resuscitation Council and American Heart Association, Inc. Published by Elsevier B.V. All rights reserved.

Order of draw practices in venous blood sampling at clinical biochemistry departments in the Danish health care system.

PubMed

Jacobsen, Katja Kemp; Brandt, Ida; Christensen, Anne Vindahl; Rimsø, Bjørk Anine; Krøier, Camilla Julie; Sørensen, Michelle; Smith, Julie; Jensen, Kathrine Overgaard Foss; Larsen, Jeppe Madura

2018-06-01

Deviation in blood collection procedures is a central source of preanalytical variation affecting overall analytical and diagnostic precision. The order of draw of venous sampling is suspected to affect analytical results, in particular for coagulation analysis. Here we compare the procedures in venous blood sampling among clinical biochemistry departments to assess the uniformity of order of blood draw and adherence to international guidelines in the Danish health care system. We collected venous order of draw procedures from 49 clinical biochemistry departments at 22 public hospitals in Denmark. Procedures were compared to the international guidelines fromthe Clinical Laboratory Standards Institute (CLSI) and World Health Organization (WHO), and assessed in relation to department ISO 15189:2012 accreditation. We observed seven different order of draw procedures related to citrate, serum, heparin, and EDTA tubes, and the use of discard tubes in relation to coagulation assays. 31 departments (63.3%) were found to adhere to CLSI and WHO guidelines. A majority of departments instructs the use of discard tubes before collection for coagulation assays in citrate tubes (44 departments; 89.8%). The citrate tube was the first sample tube to be drawn for most departments (35 departments; 75.5%); and the preferred order of non-citrate tubes was serum-heparin-EDTA (36 departments; 73.5%). Adherence to the CLSI and WHO guidelines was not associated with department ISO 15189:2012 accreditation (p = .57). Venous order of draw procedures is diverse at Danish clinical biochemistry departments and show moderate adherence to international guidelines. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

PubMed

Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

2016-09-27

Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. 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/

Economic modelling of diagnostic and treatment pathways in National Institute for Health and Care Excellence clinical guidelines: the Modelling Algorithm Pathways in Guidelines (MAPGuide) project.

PubMed

Lord, J; Willis, S; Eatock, J; Tappenden, P; Trapero-Bertran, M; Miners, A; Crossan, C; Westby, M; Anagnostou, A; Taylor, S; Mavranezouli, I; Wonderling, D; Alderson, P; Ruiz, F

2013-12-01

National Institute for Health and Care Excellence (NICE) clinical guidelines (CGs) make recommendations across large, complex care pathways for broad groups of patients. They rely on cost-effectiveness evidence from the literature and from new analyses for selected high-priority topics. An alternative approach would be to build a model of the full care pathway and to use this as a platform to evaluate the cost-effectiveness of multiple topics across the guideline recommendations. In this project we aimed to test the feasibility of building full guideline models for NICE guidelines and to assess if, and how, such models can be used as a basis for cost-effectiveness analysis (CEA). A 'best evidence' approach was used to inform the model parameters. Data were drawn from the guideline documentation, advice from clinical experts and rapid literature reviews on selected topics. Where possible we relied on good-quality, recent UK systematic reviews and meta-analyses. Two published NICE guidelines were used as case studies: prostate cancer and atrial fibrillation (AF). Discrete event simulation (DES) was used to model the recommended care pathways and to estimate consequent costs and outcomes. For each guideline, researchers not involved in model development collated a shortlist of topics suggested for updating. The modelling teams then attempted to evaluate options related to these topics. Cost-effectiveness results were compared with opinions about the importance of the topics elicited in a survey of stakeholders. The modelling teams developed simulations of the guideline pathways and disease processes. Development took longer and required more analytical time than anticipated. Estimates of cost-effectiveness were produced for six of the nine prostate cancer topics considered, and for five of eight AF topics. The other topics were not evaluated owing to lack of data or time constraints. The modelled results suggested 'economic priorities' for an update that differed from priorities expressed in the stakeholder survey. We did not conduct systematic reviews to inform the model parameters, and so the results might not reflect all current evidence. Data limitations and time constraints restricted the number of analyses that we could conduct. We were also unable to obtain feedback from guideline stakeholders about the usefulness of the models within project time scales. Discrete event simulation can be used to model full guideline pathways for CEA, although this requires a substantial investment of clinical and analytic time and expertise. For some topics lack of data may limit the potential for modelling. There are also uncertainties over the accessibility and adaptability of full guideline models. However, full guideline modelling offers the potential to strengthen and extend the analytical basis of NICE's CGs. Further work is needed to extend the analysis of our case study models to estimate population-level budget and health impacts. The practical usefulness of our models to guideline developers and users should also be investigated, as should the feasibility and usefulness of whole guideline modelling alongside development of a new CG. This project was funded by the Medical Research Council and the National Institute for Health Research through the Methodology Research Programme [grant number G0901504] and will be published in full in Health Technology Assessment; Vol. 17, No. 58. See the NIHR Journals Library website for further project information.

Of lamp posts, keys, and fabled drunkards: A perspectival tale of 4 guidelines.

PubMed

Greenhalgh, Trisha

2018-04-15

Evidence-based medicine is the application of research findings to inform individual clinical decisions. There is a tension-both philosophical and practical-between the average result from a population study and the circumstances and needs of an individual patient. This personal account of "evidence-based" trauma care illustrates and explores this tension. The author, a keen athlete, describes her experience of a high-impact cycle accident that led to limb fractures (which were diagnosed and treated according to evidence-based guidelines) and also an occult injury to the cervical spine (which was not diagnosed at the time). Some evidence-based guidelines are reviewed and applied to the case. The clinical record described the cycle accident as a "fall." Initial assessment directed the clinicians' gaze to the obvious injuries, whose treatment was straightforward. On admission, the patient (aged 55 years at the time) was offered "falls prevention" via a guideline-based checklist. Several months later, neurological sequelae indicated possible damage to the cervical spine. But the NICE Guideline recommending cervical spine imaging in cases of high-impact trauma had not been considered-perhaps because the clinical narrative had been prematurely assigned to the script of "older person with fall." Furthermore, the author, who was (appropriately) treated with neurosurgery, was surprised at the response of clinical colleagues, based on application of an irrelevant section of a guideline, that her cervical discectomy was "nonevidence based." Nonsteroidal anti-inflammatory drugs for postoperative pain were indicated in this patient even though they were not recommended for the average patient. As Sir John Grimley Evans' warned, we should avoid using evidence-based guidelines in the manner of the fabled drunkard who searched under the lamp post for his key because that was where the light was, even though he knew he had lost his key somewhere else. © 2018 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

Quick starting contraception after emergency contraception: have clinical guidelines made a difference?

PubMed

Simpson, Janine; Craik, Julie; Melvin, Louise

2014-07-01

When initiating contraception after emergency contraception (EC), conventional practice had been to wait until the next menses. Since 2010, UK guidelines have endorsed quick starting (QS) contraception, namely offering immediate start when requested. We conducted an audit to assess clinical practice before and after QS guidance publication. A full cycle audit was performed on the clinical notes of women requesting EC during two 2-month periods in 2010 and 2011 in an Integrated Sexual Health Service. All case notes were identified using the National Sexual Health database of sexual health records (Scotland). Information was collated and interpreted using Microsoft Excel and SPSS V.17. During January and February 2010 and 2011, 190 and 180 women, respectively, attended for EC, of whom 96 and 97 were identified as potential quick starters. Between 2010 and 2011, a statistically significant increase in QS practice was noted from 20.8% (n=20) to 37.1% (n=36) (p=0.011), with a corresponding decrease in the percentage of women traditionally started on hormonal contraception (HC): 24% (n=23) and 14.6% (n=14), respectively. There was also a decrease in those advised to return for commencement of HC [55.2% (n=53) vs 49% (n=47)]. Of those advised to return, 26.4% (n=14) and 31.9% (n=15) had no further contact with the service within at least 6 months. QS practice increased after the introduction of clinical guidelines. However, overall provision of HC remained low, with only around half of women prescribed a hormonal method. Published by the BMJ Publishing Group Limited.

Treatment Guidelines for Preoperative Radiation Therapy for Retroperitoneal Sarcoma: Preliminary Consensus of an International Expert Panel

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

Baldini, Elizabeth H., E-mail: ebaldini@partners.org; Wang, Dian; Haas, Rick L.M.

Purpose: Evidence for external beam radiation therapy (RT) as part of treatment for retroperitoneal sarcoma (RPS) is limited. Preoperative RT is the subject of a current randomized trial, but the results will not be available for many years. In the meantime, many practitioners use preoperative RT for RPS, and although this approach is used in practice, there are no radiation treatment guidelines. An international expert panel was convened to develop consensus treatment guidelines for preoperative RT for RPS. Methods and Materials: An expert panel of 15 academic radiation oncologists who specialize in the treatment of sarcoma was assembled. A systematicmore » review of reports related to RT for RPS, RT for extremity sarcoma, and RT-related toxicities for organs at risk was performed. Due to the paucity of high-quality published data on the subject of RT for RPS, consensus recommendations were based largely on expert opinion derived from clinical experience and extrapolation of relevant published reports. It is intended that these clinical practice guidelines be updated as pertinent data become available. Results: Treatment guidelines for preoperative RT for RPS are presented. Conclusions: An international panel of radiation oncologists who specialize in sarcoma reached consensus guidelines for preoperative RT for RPS. Many of the recommendations are based on expert opinion because of the absence of higher level evidence and, thus, are best regarded as preliminary. We emphasize that the role of preoperative RT for RPS has not been proven, and we await data from the European Organization for Research and Treatment of Cancer (EORTC) study of preoperative radiotherapy plus surgery versus surgery alone for patients with RPS. Further data are also anticipated pertaining to normal tissue dose constraints, particularly for bowel tolerance. Nonetheless, as we await these data, the guidelines herein can be used to establish treatment uniformity to aid future assessments of efficacy and toxicity.« less

Framework for enhancing clinical practice guidelines through continuous patient engagement.

PubMed

Armstrong, Melissa J; Rueda, Juan-David; Gronseth, Gary S; Mullins, C Daniel

2017-02-01

Patient engagement in clinical practice guideline (CPG) development is recommended by multiple institutions and instruments measuring guideline quality. Approaches to engaging patients, however, vary between oversight organizations, quality tools and guideline developers. We propose a ten-step framework outlining steps and options for patient engagement in guideline development with the goal of highlighting steps for patient engagement and methods by which this can be achieved. This framework provides a model for continuous patient engagement in CPGs by outlining ten steps of guideline development occurring at the levels of the developer/committee and the individual guideline project. At the developer level, patients can assist in topic nomination (step 1), topic prioritization (step 2) and guideline development group selection (step 3). Within specific guideline projects, patients' opinions may be incorporated when framing the question (step 4), creating an analytic framework and research plan (step 5), conducting the systematic review and conclusion formation (step 6), development of recommendations (step 7) and dissemination and implementation (step 8). At the end of process, patients can again be engaged at the developer level by helping determine when guidelines need updating (step 9) and evaluating the developer's approach to patient engagement (step 10). Patient engagement at each CPG development step has different purposes, mechanisms, advantages and disadvantages, and implications for resource utilization. This framework can serve as a resource for guideline developers desiring to increase patient engagement and reference for researchers investigating engagement methodology at different steps of the CPG lifecycle. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

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.

Implications of the 2013 ACC/AHA cholesterol guidelines on contemporary clinical practice for patients with atherosclerotic coronary and peripheral arterial disease.

PubMed

Gunasekaran, Prasad; Jeevanantham, Vinodh; Sharma, Suresh; Thapa, Rashmi; Gupta, Kamal

Cholesterol management guidelines from the American College of Cardiology/American Heart Association (ACC/AHA-2013) recommend fixed statin dosing (dose depends on age ≤ or >75years) compared to the earlier adult treatment panel III (ATPIII) guidelines which recommended specific low-density lipoprotein-cholesterol (LDL-C) targets. Clinical implications of this recommendation are not known. We retrospectively compared cholesterol levels and statin utilization across cohorts with coronary artery disease (CAD) (n=9563), peripheral arterial disease (PAD) (n=596) and CAD+PAD (n=975) by applying both guidelines. The percentage of patients who achieved guideline-specific targets using 2013 ACC/AHA (use of moderate/high intensity statins) or ATPIII guidelines (LDL-C<100mg/dl) was compared between all groups. Using both guidelines, the PAD only group demonstrated lower utilization and lower statin doses than the CAD or CAD+PAD groups. When applying the ACC/AHA guidelines, more patients in the CAD only group (age ≤75 years) were considered at goal as compared to the ATPIII guidelines (92.2% vs. 75%), primarily driven by the group placed on moderate/high intensity statins but had an LDL-C level >100mg/dl. Application of the ACC/AHA guidelines results in a higher percentage of patients considered to be 'at goal' when compared to the ATP III guidelines without changes in clinical practice. This is due to patients ≤75 years old on adequate statin doses but still have LDL-C levels >100mg/dl, thereby raising concerns that physicians may not pursue alternate LDL reduction strategies since they are now considered at goal despite LDL-C >100mg/dl. Lipid management of PAD patients remains sub-optimal as compared to CAD and CAD+PAD. Copyright © 2017. Published by Elsevier B.V.

Development of quality measures for monitoring and improving care in gastroenterology.

PubMed

Germansky, Katharine A; Leffler, Daniel A

2011-06-01

Over the past decade, most quality assurance (QA) efforts in gastroenterology have been aimed at endoscopy. Endoscopic quality improvement was the rational area to begin QA work in gastroenterology due to the relatively acute nature of complications and the high volume of procedures performed. While endoscopy is currently the focus of most quality assurance (QA) measures in gastroenterology, more recent efforts have begun to address clinical gastroenterology practices both in the outpatient and inpatient settings. Clinical outpatient and inpatient gastroenterology is laden with areas where standardization could benefit patient care. While data and experience in clinical gastroenterology QA is relatively limited, it is clear that inconsistent use of guidelines and practice variations in gastroenterology can lead to lower quality care. In this review, we review a variety of areas in clinical gastroenterology where existing guidelines and published data suggest both the need and practicality of active QA measures. Copyright © 2011 Elsevier Ltd. All rights reserved.

WE-F-201-00: Practical Guidelines for Commissioning Advanced Brachytherapy Dose Calculation Algorithms

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

NONE

2015-06-15

With the recent introduction of heterogeneity correction algorithms for brachytherapy, the AAPM community is still unclear on how to commission and implement these into clinical practice. The recently-published AAPM TG-186 report discusses important issues for clinical implementation of these algorithms. A charge of the AAPM-ESTRO-ABG Working Group on MBDCA in Brachytherapy (WGMBDCA) is the development of a set of well-defined test case plans, available as references in the software commissioning process to be performed by clinical end-users. In this practical medical physics course, specific examples on how to perform the commissioning process are presented, as well as descriptions of themore » clinical impact from recent literature reporting comparisons of TG-43 and heterogeneity-based dosimetry. Learning Objectives: Identify key clinical applications needing advanced dose calculation in brachytherapy. Review TG-186 and WGMBDCA guidelines, commission process, and dosimetry benchmarks. Evaluate clinical cases using commercially available systems and compare to TG-43 dosimetry.« less

Protein and calorie intakes in adult and pediatric subjects with urea cycle disorders participating in clinical trials of glycerol phenylbutyrate.

PubMed

Hook, Debra; Diaz, George A; Lee, Brendan; Bartley, James; Longo, Nicola; Berquist, William; Le Mons, Cynthia; Rudolph-Angelich, Ingrid; Porter, Marty; Scharschmidt, Bruce F; Mokhtarani, Masoud

2016-03-01

Little prospectively collected data are available comparing the dietary intake of urea cycle disorder (UCD) patients to UCD treatment guidelines or to healthy individuals. To examine the protein and calorie intakes of UCD subjects who participated in clinical trials of glycerol phenylbutyrate (GPB) and compare these data to published UCD dietary guidelines and nutritional surveys. Dietary data were recorded for 45 adult and 49 pediatric UCD subjects in metabolic control during participation in clinical trials of GPB. Protein and calorie intakes were compared to UCD treatment guidelines, average nutrient intakes of a healthy US population based on the National Health and Nutrition Examination Survey (NHANES) and Recommended Daily Allowances (RDA). In adults, mean protein intake was higher than UCD recommendations but lower than RDA and NHANES values, while calorie intake was lower than UCD recommendations, RDA and NHANES. In pediatric subjects, prescribed protein intake was higher than UCD guidelines, similar to RDA, and lower than NHANES data for all age groups, while calorie intake was at the lower end of the recommended UCD range and close to RDA and NHANES data. In pediatric subjects height, weight, and body mass index (BMI) Z-scores were within normal range (- 2 to 2). Pediatric patients treated with phenylbutyrate derivatives exhibited normal height and weight. Protein and calorie intakes in adult and pediatric UCD subjects differed from UCD dietary guidelines, suggesting that these guidelines may need to be reconsidered.

The 2014 International Pressure Ulcer Guideline: methods and development.

PubMed

Haesler, Emily; Kottner, Jan; Cuddigan, Janet

2017-06-01

A discussion of the methodology used to develop the Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. (2014). International experts representing National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance developed the second edition of this clinical guideline. Discussion paper - methodology. A comprehensive search for papers published up to July 2013 was conducted in 11 databases and identified 4286 studies. After critical appraisal, 356 studies were included and assigned a level of evidence. Guideline recommendations provide guidance on best practice in pressure ulcer prevention and treatment. Understanding the development process of a guideline increases the meaningfulness of recommendations to clinicians. Five hundred and seventy five recommendations arose from the research and its interpretation. The body of evidence supporting each recommendation was assigned a strength of evidence. A strength of recommendation was assigned to recommendation statements using the GRADE system. Recommendations are primarily supported by a body of evidence rated as C (87% of recommendations), representing low quality and/or indirect evidence (30%) and expert opinion (57%). Two hundred and forty seven recommendations (43%) received a strong recommendation ('Do it'). Recommendations were developed with consideration to research of the highest methodological quality evidence and studies that add to clinical insight and provide guidance for areas of care where minimal research has been conducted. Recommendations in the guideline reflect best practice and should be implemented with consideration to local context and resources and the individual's preferences and needs. © 2016 John Wiley & Sons Ltd.

[ESC guidelines on atrial fibrillation 2016 : Summary of the most relevant recommendations and modifications].

PubMed

Eckardt, L; Häusler, K G; Ravens, U; Borggrefe, M; Kirchhof, P

2016-12-01

The first European Society of Cardiology (ESC) guidelines on atrial fibrillation (AF) developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS) were published in August 2016. These guidelines replace the revised guidelines from 2012 and contain some interesting new aspects. The topics range from the pathophysiology through diagnostics, therapy and stroke prevention up to special clinical situations, such as atrial fibrillation in cardiopathy, sport and pregnancy. Early screening, patient informed consent, individualized therapy and the modification of factors promoting atrial fibrillation are of particular importance. The guidelines recommend the establishment of AF heart teams, containing specialists from various disciplines. The guidelines also underline the importance of non-vitamin K‑dependent oral anticoagulants (NOAC) for stroke prevention compared to standard anticoagulants with vitamin K antagonists. For symptomatic and especially paroxysmal atrial fibrillation, the guidelines emphasize the importance of an antiarrhythmic treatment with catheter ablation and/or pharmaceutical antiarrhythmic therapy in addition to a frequency regulating therapy.

Screening, Assessment, and Care of Anxiety and Depressive Symptoms in Adults With Cancer: An American Society of Clinical Oncology Guideline Adaptation

PubMed Central

Andersen, Barbara L.; DeRubeis, Robert J.; Berman, Barry S.; Gruman, Jessie; Champion, Victoria L.; Massie, Mary Jane; Holland, Jimmie C.; Partridge, Ann H.; Bak, Kate; Somerfield, Mark R.; Rowland, Julia H.

2014-01-01

Purpose A Pan-Canadian Practice Guideline on Screening, Assessment, and Care of Psychosocial Distress (Depression, Anxiety) in Adults With Cancer was identified for adaptation. Methods American Society of Clinical Oncology (ASCO) has a policy and set of procedures for adapting clinical practice guidelines developed by other organizations. The guideline was reviewed for developmental rigor and content applicability. Results On the basis of content review of the pan-Canadian guideline, the ASCO panel agreed that, in general, the recommendations were clear, thorough, based on the most relevant scientific evidence, and presented options that will be acceptable to patients. However, for some topics addressed in the pan-Canadian guideline, the ASCO panel formulated a set of adapted recommendations based on local context and practice beliefs of the ad hoc panel members. It is recommended that all patients with cancer be evaluated for symptoms of depression and anxiety at periodic times across the trajectory of care. Assessment should be performed using validated, published measures and procedures. Depending on levels of symptoms and supplementary information, differing treatment pathways are recommended. Failure to identify and treat anxiety and depression increases the risk for poor quality of life and potential disease-related morbidity and mortality. This guideline adaptation is part of a larger survivorship guideline series. Conclusion Although clinicians may not be able to prevent some of the chronic or late medical effects of cancer, they have a vital role in mitigating the negative emotional and behavioral sequelae. Recognizing and treating effectively those who manifest symptoms of anxiety or depression will reduce the human cost of cancer. PMID:24733793

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

PubMed

Ma, Irene; Viczko, Jeannine; Naugler, Christopher

2017-04-01

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

Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the management of schizophrenia and related disorders.

PubMed

Galletly, Cherrie; Castle, David; Dark, Frances; Humberstone, Verity; Jablensky, Assen; Killackey, Eóin; Kulkarni, Jayashri; McGorry, Patrick; Nielssen, Olav; Tran, Nga

2016-05-01

This guideline provides recommendations for the clinical management of schizophrenia and related disorders for health professionals working in Australia and New Zealand. It aims to encourage all clinicians to adopt best practice principles. The recommendations represent the consensus of a group of Australian and New Zealand experts in the management of schizophrenia and related disorders. This guideline includes the management of ultra-high risk syndromes, first-episode psychoses and prolonged psychoses, including psychoses associated with substance use. It takes a holistic approach, addressing all aspects of the care of people with schizophrenia and related disorders, not only correct diagnosis and symptom relief but also optimal recovery of social function. The writing group planned the scope and individual members drafted sections according to their area of interest and expertise, with reference to existing systematic reviews and informal literature reviews undertaken for this guideline. In addition, experts in specific areas contributed to the relevant sections. All members of the writing group reviewed the entire document. The writing group also considered relevant international clinical practice guidelines. Evidence-based recommendations were formulated when the writing group judged that there was sufficient evidence on a topic. Where evidence was weak or lacking, consensus-based recommendations were formulated. Consensus-based recommendations are based on the consensus of a group of experts in the field and are informed by their agreement as a group, according to their collective clinical and research knowledge and experience. Key considerations were selected and reviewed by the writing group. To encourage wide community participation, the Royal Australian and New Zealand College of Psychiatrists invited review by its committees and members, an expert advisory committee and key stakeholders including professional bodies and special interest groups. The clinical practice guideline for the management of schizophrenia and related disorders reflects an increasing emphasis on early intervention, physical health, psychosocial treatments, cultural considerations and improving vocational outcomes. The guideline uses a clinical staging model as a framework for recommendations regarding assessment, treatment and ongoing care. This guideline also refers its readers to selected published guidelines or statements directly relevant to Australian and New Zealand practice. This clinical practice guideline for the management of schizophrenia and related disorders aims to improve care for people with these disorders living in Australia and New Zealand. It advocates a respectful, collaborative approach; optimal evidence-based treatment; and consideration of the specific needs of those in adverse circumstances or facing additional challenges. © The Royal Australian and New Zealand College of Psychiatrists 2016.

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.

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

D’Souza, W; Zhang, B; Feigenberg, S

Purpose: To evaluate the compliance with evidence-based treatment planning organ-at-risk (OAR) guidelines in a single institution with four practice sites. Methods: Two hundred thirteen head and neck cancer patients treated between September 2009 and September 2013 were retrospectively selected. Consensus treatment planning guidelines, including OAR dose constraints, were established based on institutional experience and published data. Data spanned a time period of 2 years prior to (n=112) and 2 years post-enactment (n=101) of the guidelines. We investigated the differences in the frequency with which (1) OARs were contoured and (2) OAR DVH goals were met. Trends in the proportion withmore » OAR contours over time was tested using linear regression. Trends in the proportion of contoured OARs achieving clinical DVH goals were similarly tested. The proportion of patients contoured and meeting DVH goals before and after guidelines was compared using a test of proportions. Results: When the proportion of cases with OAR contours before and after guidelines were compared, we observed an increase from 75% to 87% (p=0.02) for the brainstem, decrease from 97% to 88% (p=0.01) for the cord and increase from 47% to 77% (p<0.001) for the mandible. For the proportion of cases with OAR contours in which clinical goals were met, a significant decrease from 99% to 90% was observed for the cord V48<0.3% (p=0.001). A significant decrease in the proportion of cases with left parotid contours (from 92% to 73% (p=0.03)) was observed over 2 years after guideline enactment and the proportion meeting the clinical DVH goal of V30<50% increased significantly from 36% to 50% (p=0.007) over the 2 years after guidelines. Conclusion: The enactment of OAR planning guidelines resulted in an increase in OAR contour compliance, overall. In cases with OAR contours, there was little to no change in the proportion that met clinical goals.« less

Brazilian guidelines for community-acquired pneumonia in immunocompetent adults - 2009.

PubMed

Corrêa, Ricardo de Amorim; Lundgren, Fernando Luiz Cavalcanti; Pereira-Silva, Jorge Luiz; Frare e Silva, Rodney Luiz; Cardoso, Alexandre Pinto; Lemos, Antônio Carlos Moreira; Rossi, Flávia; Michel, Gustavo; Ribeiro, Liany; Cavalcanti, Manuela Araújo de Nóbrega; de Figueiredo, Mara Rúbia Fernandes; Holanda, Marcelo Alcântara; Valery, Maria Inês Bueno de André; Aidê, Miguel Abidon; Chatkin, Moema Nudilemon; Messeder, Octávio; Teixeira, Paulo José Zimermann; Martins, Ricardo Luiz de Melo; da Rocha, Rosali Teixeira

2009-06-01

Community-acquired pneumonia continues to be the acute infectious disease that has the greatest medical and social impact regarding morbidity and treatment costs. Children and the elderly are more susceptible to severe complications, thereby justifying the fact that the prevention measures adopted have focused on these age brackets. Despite the advances in the knowledge of etiology and physiopathology, as well as the improvement in preliminary clinical and therapeutic methods, various questions merit further investigation. This is due to the clinical, social, demographical and structural diversity, which cannot be fully predicted. Consequently, guidelines are published in order to compile the most recent knowledge in a systematic way and to promote the rational use of that knowledge in medical practice. Therefore, guidelines are not a rigid set of rules that must be followed, but first and foremost a tool to be used in a critical way, bearing in mind the variability of biological and human responses within their individual and social contexts. This document represents the conclusion of a detailed discussion among the members of the Scientific Board and Respiratory Infection Committee of the Brazilian Thoracic Association. The objective of the work group was to present relevant topics in order to update the previous guidelines. We attempted to avoid the repetition of consensual concepts. The principal objective of creating this document was to present a compilation of the recent advances published in the literature and, consequently, to contribute to improving the quality of the medical care provided to immunocompetent adult patients with community-acquired pneumonia.

Guideline on the use of new anticancer drugs for the treatment of Hepatocellular Carcinoma 2010 update.

PubMed

Kaneko, Shuichi; Furuse, Junji; Kudo, Masatoshi; Ikeda, Kenji; Honda, Masao; Nakamoto, Yasunari; Onchi, Morikazu; Shiota, Goshi; Yokosuka, Osamu; Sakaida, Isao; Takehara, Tetsuo; Ueno, Yoshiyuki; Hiroishi, Kazumasa; Nishiguchi, Shuhei; Moriwaki, Hisataka; Yamamoto, Kazuhide; Sata, Michio; Obi, Shuntaro; Miyayama, Shiro; Imai, Yukinori

2012-06-01

The "Guideline on the Use of New Anticancer Drugs for the Treatment of Hepatocellular Carcinoma" was prepared by the Study Group on New Liver Cancer Therapies established by the "Research Project on Emergency Measures to Overcome Hepatitis" under the auspices of the Health and Labour Sciences Research Grant. The Guideline brings together data collected by the Study Group on the use and incidence of adverse events in 264 patients with advanced hepatocellular carcinoma (HCC) treated using sorafenib and in 535 patients with advanced HCC treated using miriplatin at 16 participating institutions up until 22 December 2010, as well as referring to the published studies, academic presentations, and reports from the private sector. The aim of this Guideline is to facilitate understanding and current thinking regarding the proper usage of new anticancer drugs towards actual use in therapy. In terms of the format, the Guideline presents "clinical questions" on issues pertaining to medical care, makes "recommendations" on diagnosis and treatment in response to each of these clinical questions, and provides a rationale for these recommendations in the form of "scientific statements". © 2012 The Japan Society of Hepatology.

Adherence to clinical practice guidelines for the treatment of candidemia at a Veterans Affairs Medical Center

PubMed Central

Ashong, Chester N.; Hunter, Andrew S.; Mansouri, M. David; Cadle, Richard M.; Hamill, Richard J.; Musher, Daniel M.

2017-01-01

Objectives: The primary objective of this study was to examine the appropriateness of candidemia management at a Veterans Affairs Medical Center as recommended by the 2009 Infectious Diseases Society of America (IDSA) guidelines for treatment of Candida infections. Methods: A retrospective analysis of 94 adult patients with blood cultures positive for Candida spp. was performed. Patients were stratified by severity of disease into two groups: non-neutropenic, mild-moderate disease (Group 1, n = 54, 56%) and non-neutropenic, moderate-severe disease (Group 2, n = 40, 42%). Results: Adherence to the IDSA recommendations for recommended antifungal drug, dose, and duration of therapy was low in both groups (16.7% in Group 1 and 17.5% in Group 2). Although adherence was not associated with higher clinical resolution of infection (P = 0.111), it was associated with a significantly lower mortality rate (P = 0.001) when compared to variance from the guidelines at 6 weeks. Conclusion: Although adherence to published guidelines for treating patients with candidemia was suboptimal at our institution, patients that were managed based on the guidelines had a statistically lower mortality rate. PMID:28936146

Performance and Practice Guideline for the Use of Neoadjuvant Systemic Therapy in the Management of Breast Cancer.

PubMed

Holmes, Dennis; Colfry, A; Czerniecki, Brian; Dickson-Witmer, Diana; Francisco Espinel, C; Feldman, Elizabeth; Gallagher, Kristalyn; Greenup, Rachel; Herrmann, Virginia; Kuerer, Henry; Malik, Manmeet; Manahan, Eric; O'Neill, Jennifer; Patel, Mita; Sebastian, Molly; Wheeler, Amanda; Kass, Rena

2015-10-01

The American Society of Breast Surgeons (ASBrS) sought to provide an evidence-based guideline on the use of neoadjuvant systemic therapy (NST) in the management of clinical stage II and III invasive breast cancer. A comprehensive nonsystematic review was performed of selected peer-reviewed literature published since 2000. The Education Committee of the ASBrS convened to develop guideline recommendations. A performance and practice guideline was prepared to outline the baseline assessment and perioperative management of patients with clinical stage II-III breast cancer under consideration for NST. Preoperative or NST is emerging as an important initial strategy for the management of invasive breast cancer. From the surgeon's perspective, the primary goal of NST is to increase the resectability of locally advanced breast cancer, increase the feasibility of breast-conserving surgery and sentinel node biopsy, and decrease surgical morbidity. To ensure optimal patient selection and efficient patient care, the guideline recommends: (1) baseline breast and axillary imaging; (2) minimally invasive biopsies of breast and axillary lesions; (3) determination of tumor biomarkers; (4) systemic staging; (5) care coordination, including referrals to medical oncology, radiation oncology, plastic surgery, social work, and genetic counseling, if indicated; (6) initiation of NST; (7) post-NST breast and axillary imaging; and (8) decision for surgery based on extent of disease at presentation, patient choice, clinical response to NST, and genetic testing results, if performed.

[A general description of the clinical guideline for the management of febrile neutropenia].

PubMed

Takamatsu, Yasushi

2013-06-01

The most serious adverse event in cancer patients who receive anti-neoplastic agents is febrile neutropenia(FN). The clinical guideline for the use of antimicrobial agents in managing patients with FN was published by the Infectious Diseases Society of America. However, the dosage and administration of antimicrobial agents are not completely adapted for Japanese insurance coverage. The Japanese Society of Medical Oncology therefore decided to develop a clinical guideline for the management of FN in Japanese patients. In this study, we provide a general description of the guideline. According to the guideline, fever is defined as a single axillary temperature of B37. 5°C(or an oral temperature of B38°C)and neutropenia is defined as a neutrophil count of <500/mL or <1, 000/mL if the count is expected to decrease to <500/mL within the next 48 h. In patients who develop FN, empirical anti-pseudomonal b-lactam agent monotherapy should be administered promptly at the onset of fever. Antibiotic therapy should continue until patients become afebrile and their neutrophil counts recover to B500/mL. If fever persists for 4-7 days under antibiotic therapy in high-risk patients, empirical antifungal therapy should be considered. Granulocyte colony-stimulating factor prophylaxis should be considered for high-risk patients with an anticipated risk of FN of B20%.

PMS2 monoallelic mutation carriers: the known unknown

PubMed Central

Goodenberger, McKinsey L.; Thomas, Brittany C.; Riegert-Johnson, Douglas; Boland, C. Richard; Plon, Sharon E.; Clendenning, Mark; Ko Win, Aung; Senter, Leigha; Lipkin, Steven M.; Stadler, Zsofia K.; Macrae, Finlay A.; Lynch, Henry T.; Weitzel, Jeffrey N.; de la Chapelle, Albert; Syngal, Sapna; Lynch, Patrick; Parry, Susan; Jenkins, Mark A.; Gallinger, Steven; Holter, Spring; Aronson, Melyssa; Newcomb, Polly A.; Burnett, Terrilea; Le Marchand, Loïc; Pichurin, Pavel; Hampel, Heather; Terdiman, Jonathan P.; Lu, Karen H.; Thibodeau, Stephen; Lindor, Noralane M.

2016-01-01

Germline mutations in MLH1, MSH2, MSH6 and PMS2 have been shown to cause Lynch syndrome. The penetrance for cancer and tumor spectrum has been repeatedly studied and multiple professional societies have proposed clinical management guidelines for affected individuals. Several studies have demonstrated a reduced penetrance for monoallelic carriers of PMS2 mutations compared to the other mismatch repair (MMR) genes, but clinical management guidelines have largely proposed the same screening recommendations for all MMR gene carriers. The authors considered whether enough evidence existed to propose new screening guidelines specific to PMS2 mutation carriers with regard to age of onset and frequency of colonic screening. Published reports of PMS2 germline mutations were combined with unpublished cases from the authors’ research registries and clinical practices, and a discussion of potential modification of cancer screening guidelines was pursued. A total of 234 monoallelic PMS2 mutation carriers from 170 families were included. Approximately 8% of those with CRC were diagnosed under age 30 and each of these tumors presented on the left-side of the colon. As it is currently unknown what causes the early-onset of CRC in some families with monoallelic PMS2 germline mutations, the authors recommend against reducing cancer surveillance guidelines in families found having monoallelic PMS2 mutations in spite of the documented reduced penetrance. PMID:25856668

PMS2 monoallelic mutation carriers: the known unknown.

PubMed

Goodenberger, McKinsey L; Thomas, Brittany C; Riegert-Johnson, Douglas; Boland, C Richard; Plon, Sharon E; Clendenning, Mark; Win, Aung Ko; Senter, Leigha; Lipkin, Steven M; Stadler, Zsofia K; Macrae, Finlay A; Lynch, Henry T; Weitzel, Jeffrey N; de la Chapelle, Albert; Syngal, Sapna; Lynch, Patrick; Parry, Susan; Jenkins, Mark A; Gallinger, Steven; Holter, Spring; Aronson, Melyssa; Newcomb, Polly A; Burnett, Terrilea; Le Marchand, Loïc; Pichurin, Pavel; Hampel, Heather; Terdiman, Jonathan P; Lu, Karen H; Thibodeau, Stephen; Lindor, Noralane M

2016-01-01

Germ-line mutations in MLH1, MSH2, MSH6, and PMS2 have been shown to cause Lynch syndrome. The penetrance of the cancer and tumor spectrum has been repeatedly studied, and multiple professional societies have proposed clinical management guidelines for affected individuals. Several studies have demonstrated a reduced penetrance for monoallelic carriers of PMS2 mutations compared with the other mismatch repair (MMR) genes, but clinical management guidelines have largely proposed the same screening recommendations for all MMR gene carriers. The authors considered whether enough evidence existed to propose new screening guidelines specific to PMS2 mutation carriers with regard to age at onset and frequency of colonic screening. Published reports of PMS2 germ-line mutations were combined with unpublished cases from the authors' research registries and clinical practices, and a discussion of potential modification of cancer screening guidelines was pursued. A total of 234 monoallelic PMS2 mutation carriers from 170 families were included. Approximately 8% of those with colorectal cancer (CRC) were diagnosed before age 30, and each of these tumors presented on the left side of the colon. As it is currently unknown what causes the early onset of CRC in some families with monoallelic PMS2 germline mutations, the authors recommend against reducing cancer surveillance guidelines in families found having monoallelic PMS2 mutations in spite of the reduced penetrance.Genet Med 18 1, 13-19.

Systematic review of the diagnosis of scabies in therapeutic trials.

PubMed

Thompson, M J; Engelman, D; Gholam, K; Fuller, L C; Steer, A C

2017-07-01

Human scabies (infestation with the mite Sarcoptes scabiei var hominis) causes a significant disease burden worldwide, yet there are no agreed diagnostic guidelines. We aimed to determine whether a consistent approach to diagnosing scabies has been used for published scabies therapeutic trials. The data sources used were the MEDLINE, Embase and Cochrane databases, from 1946 to 29 August 2013. Eligible studies were trials of therapeutic interventions against scabies in human subjects, published in English, enrolling patients with scabies, and using various therapeutic interventions. Language was a limitation of this study as some relevant trials published in languages other than English may have been excluded. Each study was reviewed by two independent authors, who assessed the clinical examination and testing approaches used for scabies diagnosis in the included studies. We found that of 71 included trials, 40 (56%) specified which clinical findings were used for diagnosis, which were predominantly rash, rash distribution, pruritus and mite burrows. Parasitological testing was used in 63% of trials (n = 45) and was used more frequently in clinic-based than in field studies. Nearly one-quarter of trials (24%, n = 17) did not define the diagnostic method used. Overall, the diagnostic approaches were poorly described, prohibiting accurate comparison of existing studies. This review further supports the need for consensus diagnostic guidelines for scabies. © 2017 British Association of Dermatologists.

Concept of biosimilar products in Jordan.

PubMed

Haddadin, Rania Dakhlallah

2011-09-01

After the expiration of patents on originator biological products, Jordanian local manufacturers and the agents of international pharmaceutical companies in Jordan started to submit registration dossiers for biosimilar products. The Jordan Food and Drug Administration (JFDA) is the national regulatory authority responsible for the registration of biosimilar products. Biosimilars are registered under the same regulations used for drugs until specific guidelines for registration of biological and biosimilar products are released. Those regulations are called Criteria of Registration of Drugs, Vaccines, Sera and Biological Products, the Renewal of its Registration and the Cancellation of Any of them which was published in the official gazette in 2004 under the Provisional Law Number 80 of the year 2001, Drug and Pharmacy Law and its amendments of the year 2003. Also, the JFDA follows the EMA guidelines on similar biological medicinal products for specific active biological substances for non-clinical and clinical studies requirements and the EMA guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. A post marketing surveillance study is requested after a biosimilar product is authorized. The JFDA keeps pace with all advances in the regulatory issues related to biosimilars in order to be capable of authorizing biosimilar products with a safe, effective and good quality profile. Copyright © 2011. Published by Elsevier Ltd.

The disconnect between the guidelines, the appropriate use criteria, and reimbursement coverage decisions: the ultimate dilemma.

PubMed

Fogel, Richard I; Epstein, Andrew E; Mark Estes, N A; Lindsay, Bruce D; DiMarco, John P; Kremers, Mark S; Kapa, Suraj; Brindis, Ralph G; Russo, Andrea M

Recently, the American College of Cardiology Foundation in collaboration with the Heart Rhythm Society published appropriate use criteria (AUC) for implantable cardioverter-defibrillators and cardiac resynchronization therapy. These criteria were developed to critically review clinical situations that may warrant implantation of an implantable cardioverter-defibrillator or cardiac resynchronization therapy device, and were based on a synthesis of practice guidelines and practical experience from a diverse group of clinicians. When the AUC was drafted, the writing committee recognized that some of the scenarios that were deemed "appropriate" or "may be appropriate" were discordant with the clinical requirements of many payers, including the Medicare National Coverage Determination (NCD). To charge Medicare for a procedure that is not covered by the NCD may be construed as fraud. Discordance between the guidelines, the AUC, and the NCD places clinicians in the difficult dilemma of trying to do the "right thing" for their patients, while recognizing that the "right thing" may not be covered by the payer or insurer. This commentary addresses these issues. Options for reconciling this disconnect are discussed, and recommendations to help clinicians provide the best care for their patients are offered. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A Systematic Literature Review on Evaluation of Digital Tools for Authoring Evidence-Based Clinical Guidelines.

PubMed

Khodambashi, Soudabeh; Nytrø, Øystein

2017-01-01

To facilitate the clinical guideline (GL) development process, different groups of researchers have proposed tools that enable computer-supported tools for authoring and publishing GLs. In a previous study we interviewed GL authors in different Norwegian institutions and identified tool shortcomings. In this follow-up study our goal is to explore to what extent GL authoring tools have been evaluated by researchers, guideline organisations, or GL authors. This article presents results from a systematic literature review of evaluation (including usability) of GL authoring tools. A controlled database search and backward snow-balling were used to identify relevant articles. From the 12692 abstracts found, 188 papers were fully reviewed and 26 papers were identified as relevant. The GRADEPro tool has attracted some evaluation, however popular tools and platforms such as DECIDE, Doctor Evidence, JBI-SUMARI, G-I-N library have not been subject to specific evaluation from an authoring perspective. Therefore, we found that little attention was paid to the evaluation of the tools in general. We could not find any evaluation relevant to how tools integrate and support the complex GL development workflow. The results of this paper are highly relevant to GL authors, tool developers and GL publishing organisations in order to improve and control the GL development and maintenance process.

The Prevention of Early-Onset Neonatal Group B Streptococcal Disease.

PubMed

Money, Deborah; Allen, Victoria M

2016-12-01

To review the evidence in the literature and to provide recommendations on the management of pregnant women in labour for the prevention of early-onset neonatal group B streptococcal disease. The key revisions in this updated guideline include changed recommendations for regimens for antibiotic prophylaxis, susceptibility testing, and management of women with pre-labour rupture of membranes. Maternal outcomes evaluated included exposure to antibiotics in pregnancy and labour and complications related to antibiotic use. Neonatal outcomes of rates of early-onset group B streptococcal infections are evaluated. Published literature was retrieved through searches of MEDLINE, CINAHL, and The Cochrane Library from January 1980 to July 2012 using appropriate controlled vocabulary and key words (group B streptococcus, antibiotic therapy, infection, prevention). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). The recommendations in this guideline are designed to help clinicians identify and manage pregnancies at risk for neonatal group B streptococcal disease to optimize maternal and perinatal outcomes. No cost-benefit analysis is provided. There is good evidence based on randomized control trial data that in women with pre-labour rupture of membranes at term who are colonized with group B streptococcus, rates of neonatal infection are reduced with induction of labour (I). There is no evidence to support safe neonatal outcomes with expectant management in this clinical situation. Copyright © 2016. Published by Elsevier Inc.

Insulin therapy for adult patients with type 2 diabetes mellitus: a position statement of the Korean Diabetes Association, 2017.

PubMed

Lee, Byung-Wan; Kim, Jin Hwa; Ko, Seung-Hyun; Hur, Kyu Yeon; Kim, Nan-Hee; Rhee, Sang Youl; Kim, Hyun Jin; Moon, Min Kyong; Park, Seok-O; Choi, Kyung Mook

2017-11-01

The Korean Diabetes Association (KDA) has regularly updated its Clinical Practice Guidelines. In 2017, the KDA published a position statement on the use of antihyperglycemic agents for patients with type 2 diabetes mellitus (T2DM). Growing evidence from new multinational clinical trials using novel and traditional insulin analogues has also been accumulated. Following global trends, many results of clinical trials, especially concerning the clinical efficacy and safety of insulin therapy, have been published about Korean patients with T2DM. After a systematic search of recent evidence, the KDA updated and modified its clinical practice recommendations regarding the initiation, choice, and intensification of insulin and created an insulin treatment algorithm for the first time to guide physicians caring for adult Korean patients with T2DM.

A hospital-site controlled intervention using audit and feedback to implement guidelines concerning inappropriate treatment of catheter-associated asymptomatic bacteriuria

PubMed Central

2011-01-01

Background Catheter-associated urinary tract infection (CAUTI) is one of the most common hospital-acquired infections. However, many cases treated as hospital-acquired CAUTI are actually asymptomatic bacteriuria (ABU). Evidence-based guidelines recommend that providers neither screen for nor treat ABU in most catheterized patients, but there is a significant gap between these guidelines and clinical practice. Our objectives are (1) to evaluate the effectiveness of an audit and feedback intervention for increasing guideline-concordant care concerning catheter-associated ABU and (2) to measure improvements in healthcare providers' knowledge of and attitudes toward the practice guidelines associated with the intervention. Methods/Design The study uses a controlled pre/post design to test an intervention using audit and feedback of healthcare providers to improve their compliance with ABU guidelines. The intervention and the control sites are two VA hospitals. For objective 1 we will review medical records to measure the clinical outcomes of inappropriate screening for and treatment of catheter-associated ABU. For objective 2 we will survey providers' knowledge and attitudes. Three phases of our protocol are proposed: the first 12-month phase will involve observation of the baseline incidence of inappropriate screening for and treatment of ABU at both sites. This surveillance for clinical outcomes will continue at both sites throughout the study. Phase 2 consists of 12 months of individualized audit and feedback at the intervention site and guidelines distribution at both sites. The third phase, also over 12 months, will provide unit-level feedback at the intervention site to assess sustainability. Healthcare providers at the intervention site during phase 2 and at both sites during phase 3 will complete pre/post surveys of awareness and familiarity (knowledge), as well as of acceptance and outcome expectancy (attitudes) regarding the relevant practice guidelines. Discussion Our proposal to bring clinical practice in line with published guidelines has significant potential to decrease overdiagnosis of CAUTI and associated inappropriate antibiotic use. Our study will also provide information about how to maximize effectiveness of audit and feedback to achieve guideline adherence in the inpatient setting. Trial Registration NCT01052545 PMID:21513539

A hospital-site controlled intervention using audit and feedback to implement guidelines concerning inappropriate treatment of catheter-associated asymptomatic bacteriuria.

PubMed

Trautner, Barbara W; Kelly, P Adam; Petersen, Nancy; Hysong, Sylvia; Kell, Harrison; Liao, Kershena S; Patterson, Jan E; Naik, Aanand D

2011-04-22

Catheter-associated urinary tract infection (CAUTI) is one of the most common hospital-acquired infections. However, many cases treated as hospital-acquired CAUTI are actually asymptomatic bacteriuria (ABU). Evidence-based guidelines recommend that providers neither screen for nor treat ABU in most catheterized patients, but there is a significant gap between these guidelines and clinical practice. Our objectives are (1) to evaluate the effectiveness of an audit and feedback intervention for increasing guideline-concordant care concerning catheter-associated ABU and (2) to measure improvements in healthcare providers' knowledge of and attitudes toward the practice guidelines associated with the intervention. The study uses a controlled pre/post design to test an intervention using audit and feedback of healthcare providers to improve their compliance with ABU guidelines. The intervention and the control sites are two VA hospitals. For objective 1 we will review medical records to measure the clinical outcomes of inappropriate screening for and treatment of catheter-associated ABU. For objective 2 we will survey providers' knowledge and attitudes. Three phases of our protocol are proposed: the first 12-month phase will involve observation of the baseline incidence of inappropriate screening for and treatment of ABU at both sites. This surveillance for clinical outcomes will continue at both sites throughout the study. Phase 2 consists of 12 months of individualized audit and feedback at the intervention site and guidelines distribution at both sites. The third phase, also over 12 months, will provide unit-level feedback at the intervention site to assess sustainability. Healthcare providers at the intervention site during phase 2 and at both sites during phase 3 will complete pre/post surveys of awareness and familiarity (knowledge), as well as of acceptance and outcome expectancy (attitudes) regarding the relevant practice guidelines. Our proposal to bring clinical practice in line with published guidelines has significant potential to decrease overdiagnosis of CAUTI and associated inappropriate antibiotic use. Our study will also provide information about how to maximize effectiveness of audit and feedback to achieve guideline adherence in the inpatient setting. NCT01052545.

Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines.

PubMed

Jefferson, Akilah A; Pearson, Steven D

2017-03-01

Little is known regarding whether Institute of Medicine (IOM) standards for managing conflicts of interest (COI) have been met in the development of recent important clinical guidelines. To evaluate adherence to the IOM standards for limits on commercial COI, guideline development, and evaluation of evidence by the 2013 American College of Cardiology and American Heart Association cholesterol management guideline and the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America hepatitis C virus management guideline. This study was a retrospective document review of the June 2014 print version of the cholesterol guideline and the final September 2015 print version of the hepatitis C virus guideline. Each guideline was assessed for adherence to the IOM standards for commercial COI published in the 2011 special report Clinical Practice Guidelines We Can Trust. The IOM standards call for no commercial COI among guideline committee chairs and cochairs and for less than 50% of committee members to have commercial COI. Guideline and contemporaneous article disclosure statements were used to evaluate adherence to these standards. Each guideline was also reviewed for adherence to other IOM standards for guideline development and evidence review. Among the 16 cholesterol guideline committee members, 7 (44%) disclosed commercial COI, all 7 reported industry-sponsored research, and 6 (38%) also reported consultancy. Of 3 guideline chairs and cochairs, 1 (33%) disclosed commercial COI. Review of contemporaneous articles identified additional commercial COI. Among the 29 hepatitis C virus guideline committee members, 21 (72%) reported commercial COI. Eighteen (62%) disclosed industry-sponsored research, 10 (34%) served on advisory boards, 5 (17%) served on data safety monitoring boards, 3 (10%) were consultants, and 3 (10%) reported other honoraria. Of 6 guideline cochairs, 4 (67%) disclosed commercial COI. All 4 disclosed additional COI in other publications that were not listed in their guideline disclosures. Contemporaneous literature review revealed an additional cochair with commercial COI. Of the 9 IOM guideline development and evidence standards, the cholesterol guideline met 5 (56%), and the hepatitis C virus guideline met them all. Neither the cholesterol guideline nor the hepatitis C virus guideline fully met the IOM standards for commercial COI management, and discordance between committee leader guideline disclosures and those in contemporaneous articles was common. Adherence to additional IOM standards for guideline development and evidence review was mixed. Adoption of consistent COI frameworks across specialty societies may help ensure that clinical guidelines are developed in a transparent and trustworthy manner.

Using whole disease modeling to inform resource allocation decisions: economic evaluation of a clinical guideline for colorectal cancer using a single model.

PubMed

Tappenden, Paul; Chilcott, Jim; Brennan, Alan; Squires, Hazel; Glynne-Jones, Rob; Tappenden, Janine

2013-06-01

To assess the feasibility and value of simulating whole disease and treatment pathways within a single model to provide a common economic basis for informing resource allocation decisions. A patient-level simulation model was developed with the intention of being capable of evaluating multiple topics within National Institute for Health and Clinical Excellence's colorectal cancer clinical guideline. The model simulates disease and treatment pathways from preclinical disease through to detection, diagnosis, adjuvant/neoadjuvant treatments, follow-up, curative/palliative treatments for metastases, supportive care, and eventual death. The model parameters were informed by meta-analyses, randomized trials, observational studies, health utility studies, audit data, costing sources, and expert opinion. Unobservable natural history parameters were calibrated against external data using Bayesian Markov chain Monte Carlo methods. Economic analysis was undertaken using conventional cost-utility decision rules within each guideline topic and constrained maximization rules across multiple topics. Under usual processes for guideline development, piecewise economic modeling would have been used to evaluate between one and three topics. The Whole Disease Model was capable of evaluating 11 of 15 guideline topics, ranging from alternative diagnostic technologies through to treatments for metastatic disease. The constrained maximization analysis identified a configuration of colorectal services that is expected to maximize quality-adjusted life-year gains without exceeding current expenditure levels. This study indicates that Whole Disease Model development is feasible and can allow for the economic analysis of most interventions across a disease service within a consistent conceptual and mathematical infrastructure. This disease-level modeling approach may be of particular value in providing an economic basis to support other clinical guidelines. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Management of testosterone therapy in adolescents and young men with hypogonadism: are we following adult clinical practice guidelines?

PubMed

Nahata, Leena; Yu, Richard N; Bhasin, Shalender; Cohen, Laurie E

2015-05-01

Male hypogonadism is a common disorder that is associated with low bone density, poor muscle mass, anemia, and sexual dysfunction. The Endocrine Society recently published a Clinical Practice Guideline for testosterone therapy in androgen-deficient men. Because treatment is frequently initiated in adolescence, the goal of this quality improvement initiative was to assess whether pediatric endocrinologists at a large tertiary care center follow these guidelines and to identify opportunities for improvement. We performed a retrospective chart review at Boston Children's Hospital. Inclusion criteria were as follows: current age ≥16 years, diagnosis of hypogonadism, and testosterone replacement therapy. Data were collected about current age, age at treatment initiation, diagnoses, pre- and on-treatment testosterone levels, route of testosterone administration and dose, bone density, hematocrit levels, and adherence with therapy. Fifty-nine patients were included. Fourteen (24%) were prescribed lower testosterone doses than those recommended in the Clinical Practice Guideline. Seven (12%) had no pre-treatment testosterone levels, and 10 (17%) had no on-treatment levels. In 49 patients with on-treatment testosterone levels, 36 had at least one value that was lower than the adult reference range. Ten (28%) of the 36 men with low testosterone levels had no dose adjustments. Thirty-seven (63%) of the 59 patients had no dual-energy X-ray absorptiometry scans, and 18 (31%) did not have hematocrit levels. Pediatric endocrinologists in this review did not consistently follow the Clinical Practice Guideline for testosterone therapy in hypogonadal adult males. Strategies that improve adherence to guidelines could help maximize the benefits of therapy and minimize treatment-associated risks.

Physical and mental health among cancer survivors: considerations for long-term care and quality of life.

PubMed

Naughton, Michelle J; Weaver, Kathryn E

2014-01-01

The physical and mental health of cancer patients needs to be addressed not only during active treatment but also throughout the continuum of survivorship care. This commentary provides an overview of issues pertinent to cancer survivors, with an emphasis on mental health issues and recommendations for annual clinical screening and monitoring using recently published guidelines from the American Society of Clinical Oncology.

Korean Clinical Practice Guidelines for Aneurysmal Subarachnoid Hemorrhage

PubMed Central

Cho, Won-Sang; Park, Sukh Que; Ko, Jun Kyeung; Kim, Dae-Won; Park, Jung Cheol; Yeon, Je Young; Chung, Seung Young; Chung, Joonho; Joo, Sung-Pil; Hwang, Gyojun; Kim, Deog Young; Chang, Won Hyuk; Choi, Kyu-Sun; Lee, Sung Ho; Sheen, Seung Hun; Kang, Hyun-Seung; Kim, Byung Moon; Bae, Hee-Joon; Oh, Chang Wan; Park, Hyeon Seon

2018-01-01

Despite advancements in treating ruptured cerebral aneurysms, an aneurysmal subarachnoid hemorrhage (aSAH) is still a grave cerebrovascular disease associated with a high rate of morbidity and mortality. Based on the literature published to date, worldwide academic and governmental committees have developed clinical practice guidelines (CPGs) to propose standards for disease management in order to achieve the best treatment outcomes for aSAHs. In 2013, the Korean Society of Cerebrovascular Surgeons issued a Korean version of the CPGs for aSAHs. The group researched all articles and major foreign CPGs published in English until December 2015 using several search engines. Based on these articles, levels of evidence and grades of recommendations were determined by our society as well as by other related Quality Control Committees from neurointervention, neurology and rehabilitation medicine. The Korean version of the CPGs for aSAHs includes risk factors, diagnosis, initial management, medical and surgical management to prevent rebleeding, management of delayed cerebral ischemia and vasospasm, treatment of hydrocephalus, treatment of medical complications and early rehabilitation. The CPGs are not the absolute standard but are the present reference as the evidence is still incomplete, each environment of clinical practice is different, and there is a high probability of variation in the current recommendations. The CPGs will be useful in the fields of clinical practice and research. PMID:29526058

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.

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

PubMed

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

2015-06-01

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

Tertiary care centre adherence to unified guidelines for management of periprosthetic joint infections: a gap analysis

PubMed Central

Armstrong, Mitchel D.; Carli, Alberto V.; Abdelbary, Hesham; Poitras, Stephane; Lapner, Peter; Beaulé, Paule E.

2018-01-01

Background The success rate of surgical treatment for periprosthetic joint infection (PJI) remains inconsistent in the literature. Variability in PJI clinical guidelines and surgeon adherence to guidelines could affect treatment success. The objectives of this study were to appraise current recommendations for PJI management and develop a unified clinical standard of care, to perform a gap analysis of PJI cases in a tertiary institution to determine the rate of guideline adherence, and to determine if adherence to unified PJI guidelines affected 2-year treatment outcomes. Methods We appraised the PJI guidelines from 3 academic medical societies, and consistent statements were aggregated. We retrospectively reviewed all PJI cases in a tertiary care institution. We defined PJI based on Musculoskeletal Infection Society PJI criteria. Surgeon adherence to preoperative, intraoperative, surgical and medical management guidelines was calculated, and we evaluated the association between guideline adherence and 2-year treatment outcomes. Results The institutional rate of PJI was 1.13% (38 of 3368). Treatment success was 57.8% at 2 years. Unified guideline adherence percentages varied substantially: 92% of patients had preoperative erythrocyte sedimentation rate and C-reactive protein, 97% had intraoperative tissue cultures, 42% had appropriate preoperative arthrocentesis, and 74% underwent guideline-appropriate surgery. Performing appropriate preoperative arthrocentesis significantly correlated with positive treatment outcomes at 2 years (p = 0.028). Conclusion Adherence to PJI guidelines varies considerably, indicating that clinicians are either unaware of them or do not recognize their value for PJI treatment. This study shows the need for institution-based PJI treatment pathways that are consistent with published guidelines and the need to monitor adherence. PMID:29368675

A selective annotated bibliography for clinical audiology (1988-2008): reference works.

PubMed

Ferrer-Vinent, Susan T; Ferrer-Vinent, Ignacio J

2009-06-01

This is the 1st in a series of 3 planned companion articles that present a selected, annotated, and indexed bibliography of clinical audiology publications from 1988 to 2008. Research and preparation of the bibliography were based on published guidelines, professional audiology experience, and professional librarian experience. This article presents reference works (dictionaries, encyclopedias, handbooks, and manuals). The future planned articles will cover other monographs, periodicals, and online resources. Audiologists and librarians can use these lists as a guide when seeking clinical audiology literature.

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

Lim, Karen; Small, William; Portelance, Lorraine

Purpose: Accurate target definition is vitally important for definitive treatment of cervix cancer with intensity-modulated radiotherapy (IMRT), yet a definition of clinical target volume (CTV) remains variable within the literature. The aim of this study was to develop a consensus CTV definition in preparation for a Phase 2 clinical trial being planned by the Radiation Therapy Oncology Group. Methods and Materials: A guidelines consensus working group meeting was convened in June 2008 for the purposes of developing target definition guidelines for IMRT for the intact cervix. A draft document of recommendations for CTV definition was created and used to aidmore » in contouring a clinical case. The clinical case was then analyzed for consistency and clarity of target delineation using an expectation maximization algorithm for simultaneous truth and performance level estimation (STAPLE), with kappa statistics as a measure of agreement between participants. Results: Nineteen experts in gynecological radiation oncology generated contours on axial magnetic resonance images of the pelvis. Substantial STAPLE agreement sensitivity and specificity values were seen for gross tumor volume (GTV) delineation (0.84 and 0.96, respectively) with a kappa statistic of 0.68 (p < 0.0001). Agreement for delineation of cervix, uterus, vagina, and parametria was moderate. Conclusions: This report provides guidelines for CTV definition in the definitive cervix cancer setting for the purposes of IMRT, building on previously published guidelines for IMRT in the postoperative setting.« less

[Sex and gender equity in research: rationale for the SAGER guidelines and recommended use].

PubMed

Heidari, Shirin; Babor, Thomas F; De Castro, Paola; Tort, Sera; Curno, Mirjam

2018-05-03

Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literatura search on sex and gender policies in scientific publishing. The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

2016 guideline strategies for the use of antifungal agents in patients with hematological malignancies or hematopoietic stem cell transplantation recipients in Taiwan.

PubMed

Ko, Bor-Sheng; Chen, Wei-Ting; Kung, Hsiang-Chi; Wu, Un-In; Tang, Jih-Luh; Yao, Ming; Chen, Yee-Chun; Tien, Hwei-Fang; Chang, Shan-Chwen; Chuang, Yin-Ching; Lin, Dong-Tsamn

2017-07-25

The Infectious Diseases Society of Taiwan (IDST), the Hematology Society of Taiwan, the Taiwan Society of Blood and Marrow Transplantation, Medical Foundation in Memory of Dr. Deh-Lin Cheng, Foundation of Professor Wei-Chuan Hsieh for Infectious Diseases Research and Education, and CY Lee's Research Foundation for Pediatric Infectious Diseases and Vaccines cooperatively published this guideline for the use of antifungal agents in hematological patients with invasive fungal diseases (IFDs) in Taiwan. The guideline is the first one endorsed by IDST focusing on selection of antifungal strategies, including prophylaxis, empirical (or symptom-driven) and pre-emptive (or diagnostic-driven) strategy. We suggest a risk-adapted dynamic strategy and provide an algorithm to facilitate decision making in population level as well as for individual patient. Risk assessment and management accordingly is explicitly emphasized. In addition, we highlight the importance of diagnosis in each antifungal strategy among five elements of the antimicrobial stewardship (diagnosis, drug, dose, de-escalation and duration). The rationale, purpose, and key recommendations for the choice of antifungal strategy are summarized, with concise review of international guidelines or recommendation, key original articles and local epidemiology reports. We point out the interaction and influence between elements of recommendations and limitation of and gap between evidences and daily practice. The guideline balances the quality of evidence and feasibility of recommendation in clinical practice. Finally, this version introduces the concept of health economics and provides data translated from local disease burdens. All these contents hopefully facilitate transparency and accountability in medical decision-making, improvements in clinical care and health outcomes, and appropriateness of medical resource allocation. Copyright © 2017. Published by Elsevier B.V.

Knee osteoarthritis related pain: a narrative review of diagnosis and treatment.

PubMed

Alshami, Ali M

2014-01-01

Osteoarthritis is a common progressive joint disease, involving not only the joint lining but also cartilage, ligaments, and bone. For the last ten years, majority of published review articles were not specific to osteoarthritis of the knee, and strength of evidence and clinical guidelines were not appropriately summarized. To appraise the literature by summarizing the findings of current evidence and clinical guidelines on the diagnosis and treatment of knee osteoarthritis pain. English journal articles that focused on knee osteoarthritis related pain were searched via PubMed (1 January 2002 - 26 August 2012) and Physiotherapy Evidence Database (PEDro) databases, using the terms 'knee', 'osteoarthritis' and 'pain'. In addition, reference lists from identified articles and related book chapters were included as comprehensive overviews. For knee osteoarthritis, the highest diagnostic accuracy can be achieved by presence of pain and five or more clinical or laboratory criteria plus osteophytes. Some inconsistencies in the recommendations and findings were found between the clinical guidelines and systematic reviews. Generally, paracetamol, oral and topical non-steroidal anti-inflammatory drugs, opioids, corticosteroid injections and physical therapy techniques, such as therapeutic exercises, joint manual therapy and transcutaneous electrical nerve stimulation, can help reduce pain and improve function. Patient education programs and weight reduction for overweight patients are important to be considered. Some inconsistencies in the recommendations and findings were found between the clinical guidelines and systematic reviews. However, it is likely that a combination of pharmacological and non-pharmacological treatments is most effective in treating patients with knee osteoarthritis.

Changes in the provision of post-exposure prophylaxis for HIV after sexual exposure following introduction of guidelines and publicity campaigns.

PubMed

Roedling, S; Reeves, I; Copas, A J; Beattie, A; Edwards, S G; Fisher, M; Benn, P

2008-04-01

In July 2004, British Association of Sexual Health and HIV (BASHH) published guidelines for post-exposure prophylaxis following sexual exposure (PEPSE) and the Terence Higgins Trust (THT) launched a campaign promoting PEPSE among men who have sex with men (MSM). We evaluated subsequent changes in PEPSE attendances. Individuals requesting PEPSE in 2004 were identified from clinic databases. Comparisons of clinical data, exposure characteristics and follow-up were made pre and post campaign. Data were available for 197/216 (91%) PEP attendances. The proportion requesting PEP following sexual exposure increased significantly following the campaign. The majority commencing PEPSE were MSM, with the proportion of MSM increasing significantly from 36/46 (78%) pre to 76/80 (95%) following the campaign. Most prescriptions were in high-risk groups and within guidelines. Times to initiation and completion rates were unchanged. Access to PEPSE following the THT campaign and introduction of BASHH guidelines increased. Promotion of earlier initiation of PEPSE and improvement of completion and follow-up is required.

Suboptimal Antituberculosis Drug Concentrations and Outcomes in Small and HIV-Coinfected Children in India: Recommendations for Dose Modifications.

PubMed

Guiastrennec, Benjamin; Ramachandran, Geetha; Karlsson, Mats O; Kumar, A K Hemanth; Bhavani, Perumal Kannabiran; Gangadevi, N Poorana; Swaminathan, Soumya; Gupta, Amita; Dooley, Kelly E; Savic, Radojka M

2017-12-16

This work aimed to evaluate the once-daily antituberculosis treatment as recommended by the new Indian pediatric guidelines. Isoniazid, rifampin, and pyrazinamide concentration-time profiles and treatment outcome were obtained from 161 Indian children with drug-sensitive tuberculosis undergoing thrice-weekly dosing as per previous Indian pediatric guidelines. The exposure-response relationships were established using a population pharmacokinetic-pharmacodynamic approach. Rifampin exposure was identified as the unique predictor of treatment outcome. Consequently, children with low body weight (4-7 kg) and/or HIV infection, who displayed the lowest rifampin exposure, were associated with the highest probability of unfavorable treatment (therapy failure, death) outcome (P unfavorable ). Model-based simulation of optimized (P unfavorable ≤ 5%) rifampin once-daily doses were suggested per treatment weight band and HIV coinfection status (33% and 190% dose increase, respectively, from the new Indian guidelines). The established dose-exposure-response relationship could be pivotal in the development of future pediatric tuberculosis treatment guidelines. © 2017, The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Guidelines of the Brazilian Dermatology Society for diagnosis, treatment and follow up of primary cutaneous melanoma - Part I*

PubMed Central

Castro, Luiz Guilherme Martins; Messina, Maria Cristina; Loureiro, Walter; Macarenco, Ricardo Silvestre; Duprat Neto, João Pedreira; Giacomo, Thais Helena Bello Di; Bittencourt, Flávia Vasques; Bakos, Renato Marchiori; Serpa, Sérgio Schrader; Stolf, Hamilton Ometto; Gontijo, Gabriel

2015-01-01

The last Brazilian guidelines on melanoma were published in 2002. Development in diagnosis and treatment made updating necessary. The coordinators elaborated ten clinical questions, based on PICO system. A Medline search, according to specific MeSH terms for each of the 10 questions was performed and articles selected were classified from A to D according to level of scientific evidence. Based on the results, recommendations were defined and classified according to scientific strength. The present Guidelines were divided in two parts for editorial and publication reasons. In the first part, the following clinical questions were answered: 1) The use of dermoscopy for diagnosis of primary cutaneous melanoma brings benefits for patients when compared with clinical examination? 2) Does dermoscopy favor diagnosis of nail apparatus melanoma? 3) Is there a prognostic difference when incisional or excisional biopsies are used? 4) Does revision by a pathologist trained in melanoma contribute to diagnosis and treatment of primary cutaneous melanoma? What margins should be used to treat lentigo maligna melanoma and melanoma in situ? PMID:26734867

What is the quality of information on social oocyte cryopreservation provided by websites of Society for Assisted Reproductive Technology member fertility clinics?

PubMed

Avraham, Sarit; Machtinger, Ronit; Cahan, Tal; Sokolov, Amit; Racowsky, Catherine; Seidman, Daniel S

2014-01-01

To evaluate adequacy and adherence to American Society for Reproductive Medicine (ASRM) guidelines of internet information provided by Society for Assisted Reproductive Technology (SART)-affiliated clinics regarding social oocyte cryopreservation (SOC). Systematic evaluation of websites of all SART member fertility clinics. The internet. None. All websites offering SOC services were scored using a 0-13 scale, based on 10 questions designed to assess website quality and adherence to the ASRM/SART guidelines. The websites were analyzed independently by two authors. Whenever disagreement occurred, a third investigator determined the score. Scores defined website quality as excellent, ≥9; moderate, 5-8; or poor, ≤4 points. Of the 387 clinics registered as SART members, 200 offered oocyte cryopreservation services for either medical or social reasons; 147 of these advertised SOC. The average website scores of those clinics offering SOC was 3.4 ± 2.1 (range, 2-11) points. There was no significant difference in scores between private versus academic clinics or clinics performing more or less than 500 cycles per year. The majority of the websites do not follow the SART/ASRM guidelines for SOC, indicating that there is a need to improve the type and quality of information provided on SOC by SART member websites. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Salient Features and Outline of the Joint Japanese Guidelines for Safe Handling of Cancer Chemotherapy Drugs

PubMed Central

Kanda, Kiyoko; Hirai, Kazue; Iino, Keiko; Nomura, Hisanaga; Yasui, Hisateru; Kano, Taro; Ichikawa, Chisato; Hiura, Sumiko; Morita, Tomoko; Mitsuma, Ayako; Komatsu, Hiroko

2017-01-01

The purpose of this paper is to introduce the outline and describe the salient features of the “Joint Guidelines for Safe Handling of Cancer Chemotherapy Drugs” (hereinafter, “Guideline”), which were published in July 2015. The purpose of this Guideline is to provide guidance to protect against occupational exposure to hazardous drugs (HDs) to all medical personnel involved in cancer chemotherapy, including physicians, pharmacists, and nurses and home health-care providers. The Guideline was developed according to the Medical Information Network Distribution Service guidance for developing clinical practice guidelines, with reference to five authoritative guidelines used worldwide. PubMed, Cumulative Index to Nursing and Allied Health Literature, Ichushi-Web, and Cochrane Central Register of Controlled Trials were used for a systematic search of the literature. Eight clinical questions (CQs) were eventually established, and the strength of recommendation for each CQ is presented based on 867 references. The salient features of the Guideline are that it was jointly developed by three societies (Japanese Society of Cancer Nursing, Japanese Society of Medical Oncology, and Japanese Society of Pharmaceutical Oncology), contains descriptions including the definition of HDs and the concept of hierarchy of controls, and addresses exposure control measures during handling of chemotherapy drugs. Our future task is to collect additional evidence for the recommended exposure control measures and to assess whether publication of the Guideline has led to adherence of measures to prevent occupational exposure. PMID:28966958

UK guidelines on oesophageal dilatation in clinical practice

PubMed Central

Sami, Sarmed S; Haboubi, Hasan N; Ang, Yeng; Boger, Philip; Bhandari, Pradeep; de Caestecker, John; Griffiths, Helen; Haidry, Rehan; Patel, Praful; Paterson, Stuart; Ragunath, Krish; Watson, Peter; Siersema, Peter D; Attwood, Stephen E

2018-01-01

These are updated guidelines which supersede the original version published in 2004. This work has been endorsed by the Clinical Services and Standards Committee of the British Society of Gastroenterology (BSG) under the auspices of the oesophageal section of the BSG. The original guidelines have undergone extensive revision by the 16 members of the Guideline Development Group with representation from individuals across all relevant disciplines, including the Heartburn Cancer UK charity, a nursing representative and a patient representative. The methodological rigour and transparency of the guideline development processes were appraised using the revised Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. Dilatation of the oesophagus is a relatively high-risk intervention, and is required by an increasing range of disease states. Moreover, there is scarcity of evidence in the literature to guide clinicians on how to safely perform this procedure. These guidelines deal specifically with the dilatation procedure using balloon or bougie devices as a primary treatment strategy for non-malignant narrowing of the oesophagus. The use of stents is outside the remit of this paper; however, for cases of dilatation failure, alternative techniques—including stents—will be listed. The guideline is divided into the following subheadings: (1) patient preparation; (2) the dilatation procedure; (3) aftercare and (4) disease-specific considerations. A systematic literature search was performed. The Grading of Recommendations Assessment, Develop­ment and Evaluation (GRADE) tool was used to evaluate the quality of evidence and decide on the strength of recommendations made. PMID:29478034

The Pharmacogenomics Research Network Translational Pharmacogenetics Program: Outcomes and Metrics of Pharmacogenetic Implementations Across Diverse Healthcare Systems.

PubMed

Luzum, J A; Pakyz, R E; Elsey, A R; Haidar, C E; Peterson, J F; Whirl-Carrillo, M; Handelman, S K; Palmer, K; Pulley, J M; Beller, M; Schildcrout, J S; Field, J R; Weitzel, K W; Cooper-DeHoff, R M; Cavallari, L H; O'Donnell, P H; Altman, R B; Pereira, N; Ratain, M J; Roden, D M; Embi, P J; Sadee, W; Klein, T E; Johnson, J A; Relling, M V; Wang, L; Weinshilboum, R M; Shuldiner, A R; Freimuth, R R

2017-09-01

Numerous pharmacogenetic clinical guidelines and recommendations have been published, but barriers have hindered the clinical implementation of pharmacogenetics. The Translational Pharmacogenetics Program (TPP) of the National Institutes of Health (NIH) Pharmacogenomics Research Network was established in 2011 to catalog and contribute to the development of pharmacogenetic implementations at eight US healthcare systems, with the goal to disseminate real-world solutions for the barriers to clinical pharmacogenetic implementation. The TPP collected and normalized pharmacogenetic implementation metrics through June 2015, including gene-drug pairs implemented, interpretations of alleles and diplotypes, numbers of tests performed and actionable results, and workflow diagrams. TPP participant institutions developed diverse solutions to overcome many barriers, but the use of Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines provided some consistency among the institutions. The TPP also collected some pharmacogenetic implementation outcomes (scientific, educational, financial, and informatics), which may inform healthcare systems seeking to implement their own pharmacogenetic testing programs. © 2017, The American Society for Clinical Pharmacology and Therapeutics.

The U.S. prevention of cardiovascular disease guidelines and implications for implementation in LMIC.

PubMed

Wong, Nathan D; Moran, Andrew E

2014-12-01

The 2013 guidelines for the Prevention of Cardiovascular Disease released by the American College of Cardiology and the American Heart Association included guidelines of assessment of cardiovascular disease (CVD) risk, lifestyle management, management of overweight and obesity, and treatment of blood cholesterol. In addition, there were also 2014 guidelines on hypertension management released by members appointed to the Eighth Joint National Committee. Taken together, these guidelines, though extensively discussed and disseminated in the United States, have not been widely recognized beyond the United States, nor have their implications been considered for lower- and middle-income developing countries. With an estimated 80% of the global burden in CVD occurring in developing countries, it is important to develop strategies to adequately detect those at increased CVD risk and to manage their risk through lifestyle and where appropriate, pharmacologic means. Though certain aspects of each guideline may be suitable for implementation globally, including in developing countries, other recommendations would be unrealistic for many countries based on local epidemiology and resources. CVD prevention priorities can be set using guidance from recently published CVD prevention guidelines if appropriately modified to the context of lower- and middle-income developing countries. Establishment of global CVD prevention standards and rapid adaptation and dissemination of clinical guidelines are of paramount importance if we are to make significant progress into achieving World Health Organization 2025 goals to reduce the burden from CVD and other noncommunicable diseases. Copyright © 2014 World Heart Federation (Geneva). Published by Elsevier B.V. All rights reserved.

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

PubMed

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

2013-12-01

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

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Management of sepsis in neutropenic patients: 2014 updated guidelines from the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology (AGIHO).

PubMed

Penack, Olaf; Becker, Carolin; Buchheidt, Dieter; Christopeit, Maximilian; Kiehl, Michael; von Lilienfeld-Toal, Marie; Hentrich, Marcus; Reinwald, Marc; Salwender, Hans; Schalk, Enrico; Schmidt-Hieber, Martin; Weber, Thomas; Ostermann, Helmut

2014-07-01

Sepsis is a major cause of mortality during the neutropenic phase after intensive cytotoxic therapies for malignancies. Improved management of sepsis during neutropenia may reduce the mortality of cancer therapies. Clinical guidelines on sepsis treatment have been published by others. However, optimal management may differ between neutropenic and non-neutropenic patients. Our aim is to give evidence-based recommendations for haematologist, oncologists and intensive care physicians on how to manage adult patients with neutropenia and sepsis.

Guidelines of care for the management of acne vulgaris.

PubMed

Zaenglein, Andrea L; Pathy, Arun L; Schlosser, Bethanee J; Alikhan, Ali; Baldwin, Hilary E; Berson, Diane S; Bowe, Whitney P; Graber, Emmy M; Harper, Julie C; Kang, Sewon; Keri, Jonette E; Leyden, James J; Reynolds, Rachel V; Silverberg, Nanette B; Stein Gold, Linda F; Tollefson, Megha M; Weiss, Jonathan S; Dolan, Nancy C; Sagan, Andrew A; Stern, Mackenzie; Boyer, Kevin M; Bhushan, Reva

2016-05-01

Acne is one of the most common disorders treated by dermatologists and other health care providers. While it most often affects adolescents, it is not uncommon in adults and can also be seen in children. This evidence-based guideline addresses important clinical questions that arise in its management. Issues from grading of acne to the topical and systemic management of the disease are reviewed. Suggestions on use are provided based on available evidence. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

ICCS/ESCCA consensus guidelines to detect GPI-deficient cells in paroxysmal nocturnal hemoglobinuria (PNH) and related disorders part 4 - assay validation and quality assurance.

PubMed

Oldaker, Teri; Whitby, Liam; Saber, Maryam; Holden, Jeannine; Wallace, Paul K; Litwin, Virginia

2018-01-01

Over the past six years, a diverse group of stakeholders have put forth recommendations regarding the analytical validation of flow cytometric methods and described in detail the differences between cell-based and traditional soluble analyte assay validations. This manuscript is based on these general recommendations as well as the published experience of experts in the area of PNH testing. The goal is to provide practical assay-specific guidelines for the validation of high-sensitivity flow cytometric PNH assays. Examples of the reports and validation data described herein are provided in Supporting Information. © 2017 International Clinical Cytometry Society. © 2017 International Clinical Cytometry Society.

Emotional Freedom Techniques to Treat Posttraumatic Stress Disorder in Veterans: Review of the Evidence, Survey of Practitioners, and Proposed Clinical Guidelines

PubMed Central

Church, Dawson; Stern, Sheri; Boath, Elizabeth; Stewart, Antony; Feinstein, David; Clond, Morgan

2017-01-01

Background High prevalence rates of posttraumatic stress disorder (PTSD) in active military and veterans present a treatment challenge. Many PTSD studies have demonstrated the efficacy and safety of Emotional Freedom Techniques (EFT). Objectives To develop clinical best practice guidelines for the use of EFT to treat PTSD, on the basis of the published literature, practitioner experience, and typical case histories. Methods We surveyed 448 EFT practitioners to gather information on their experiences with PTSD treatment. This included their demographic profiles, prior training, professional settings, use of assessments, and PTSD treatment practices. We used their responses, with the research evidence base, to formulate clinical guidelines applying the “stepped care” treatment model used by the United Kingdom’s National Institute for Health and Clinical Excellence. Results Most practitioners (63%) reported that even complex PTSD can be remediated in 10 or fewer EFT sessions. Some 65% of practitioners found that more than 60% of PTSD clients are fully rehabilitated, and 89% stated that less than 10% of clients make little or no progress. Practitioners combined EFT with a wide variety of other approaches, especially cognitive therapy. Practitioner responses, evidence from the literature, and the results of a meta-analysis were aggregated into a proposed clinical guideline. Conclusion We recommend a stepped care model, with 5 EFT therapy sessions for subclinical PTSD and 10 sessions for clinical PTSD, in addition to group therapy, online self-help resources, and social support. Clients who fail to respond should be referred for appropriate further care. PMID:28678690

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.

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016).

PubMed

Nishida, Osamu; Ogura, Hiroshi; Egi, Moritoki; Fujishima, Seitaro; Hayashi, Yoshiro; Iba, Toshiaki; Imaizumi, Hitoshi; Inoue, Shigeaki; Kakihana, Yasuyuki; Kotani, Joji; Kushimoto, Shigeki; Masuda, Yoshiki; Matsuda, Naoyuki; Matsushima, Asako; Nakada, Taka-Aki; Nakagawa, Satoshi; Nunomiya, Shin; Sadahiro, Tomohito; Shime, Nobuaki; Yatabe, Tomoaki; Hara, Yoshitaka; Hayashida, Kei; Kondo, Yutaka; Sumi, Yuka; Yasuda, Hideto; Aoyama, Kazuyoshi; Azuhata, Takeo; Doi, Kent; Doi, Matsuyuki; Fujimura, Naoyuki; Fuke, Ryota; Fukuda, Tatsuma; Goto, Koji; Hasegawa, Ryuichi; Hashimoto, Satoru; Hatakeyama, Junji; Hayakawa, Mineji; Hifumi, Toru; Higashibeppu, Naoki; Hirai, Katsuki; Hirose, Tomoya; Ide, Kentaro; Kaizuka, Yasuo; Kan'o, Tomomichi; Kawasaki, Tatsuya; Kuroda, Hiromitsu; Matsuda, Akihisa; Matsumoto, Shotaro; Nagae, Masaharu; Onodera, Mutsuo; Ohnuma, Tetsu; Oshima, Kiyohiro; Saito, Nobuyuki; Sakamoto, So; Sakuraya, Masaaki; Sasano, Mikio; Sato, Norio; Sawamura, Atsushi; Shimizu, Kentaro; Shirai, Kunihiro; Takei, Tetsuhiro; Takeuchi, Muneyuki; Takimoto, Kohei; Taniguchi, Takumi; Tatsumi, Hiroomi; Tsuruta, Ryosuke; Yama, Naoya; Yamakawa, Kazuma; Yamashita, Chizuru; Yamashita, Kazuto; Yoshida, Takeshi; Tanaka, Hiroshi; Oda, Shigeto

2018-01-01

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016), a Japanese-specific set of clinical practice guidelines for sepsis and septic shock created jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in February 2017 and published in the Journal of JSICM , [2017; Volume 24 (supplement 2)] 10.3918/jsicm.24S0001 and Journal of Japanese Association for Acute Medicine [2017; Volume 28, (supplement 1)] http://onlinelibrary.wiley.com/doi/10.1002/jja2.2017.28.issue-S1/issuetoc.This abridged English edition of the J-SSCG 2016 was produced with permission from the Japanese Association of Acute Medicine and the Japanese Society for Intensive Care Medicine. Members of the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine were selected and organized into 19 committee members and 52 working group members. The guidelines were prepared in accordance with the Medical Information Network Distribution Service (Minds) creation procedures. The Academic Guidelines Promotion Team was organized to oversee and provide academic support to the respective activities allocated to each Guideline Creation Team. To improve quality assurance and workflow transparency, a mutual peer review system was established, and discussions within each team were open to the public. Public comments were collected once after the initial formulation of a clinical question (CQ) and twice during the review of the final draft. Recommendations were determined to have been adopted after obtaining support from a two-thirds (> 66.6%) majority vote of each of the 19 committee members. A total of 87 CQs were selected among 19 clinical areas, including pediatric topics and several other important areas not covered in the first edition of the Japanese guidelines (J-SSCG 2012). The approval rate obtained through committee voting, in addition to ratings of the strengths of the recommendation, and its supporting evidence were also added to each recommendation statement. We conducted meta-analyses for 29 CQs. Thirty-seven CQs contained recommendations in the form of an expert consensus due to insufficient evidence. No recommendations were provided for five CQs. Based on the evidence gathered, we were able to formulate Japanese-specific clinical practice guidelines that are tailored to the Japanese context in a highly transparent manner. These guidelines can easily be used not only by specialists, but also by non-specialists, general clinicians, nurses, pharmacists, clinical engineers, and other healthcare professionals.

Updated Clinical Guidelines for Diagnosing Fetal Alcohol Spectrum Disorders

PubMed Central

Kalberg, Wendy O.; Elliott, Amy J.; Blankenship, Jason; Buckley, David; Marais, Anna-Susan; Manning, Melanie A.; Robinson, Luther K.; Adam, Margaret P.; Abdul-Rahman, Omar; Jewett, Tamison; Coles, Claire D.; Chambers, Christina; Jones, Kenneth L.; Adnams, Colleen M.; Shah, Prachi E.; Riley, Edward P.; Charness, Michael E.; Warren, Kenneth R.; May, Philip A.

2016-01-01

The adverse effects of prenatal alcohol exposure constitute a continuum of disabilities (fetal alcohol spectrum disorders [FASD]). In 1996, the Institute of Medicine established diagnostic categories delineating the spectrum but not specifying clinical criteria by which diagnoses could be assigned. In 2005, the authors published practical guidelines operationalizing the Institute of Medicine categories, allowing for standardization of FASD diagnoses in clinical settings. The purpose of the current report is to present updated diagnostic guidelines based on a thorough review of the literature and the authors’ combined expertise based on the evaluation of >10 000 children for potential FASD in clinical settings and in epidemiologic studies in conjunction with National Institute on Alcohol Abuse and Alcoholism–funded studies, the Collaborative Initiative on Fetal Alcohol Spectrum Disorders, and the Collaboration on FASD Prevalence. The guidelines were formulated through conference calls and meetings held at National Institute on Alcohol Abuse and Alcoholism offices in Rockville, MD. Specific areas addressed include the following: precise definition of documented prenatal alcohol exposure; neurobehavioral criteria for diagnosis of fetal alcohol syndrome, partial fetal alcohol syndrome, and alcohol-related neurodevelopmental disorder; revised diagnostic criteria for alcohol-related birth defects; an updated comprehensive research dysmorphology scoring system; and a new lip/philtrum guide for the white population, incorporating a 45-degree view. The guidelines reflect consensus among a large and experienced cadre of FASD investigators in the fields of dysmorphology, epidemiology, neurology, psychology, developmental/behavioral pediatrics, and educational diagnostics. Their improved clarity and specificity will guide clinicians in accurate diagnosis of infants and children prenatally exposed to alcohol. PMID:27464676

Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel.

PubMed

Boyce, Joshua A; Assa'ad, Amal; Burks, A Wesley; Jones, Stacie M; Sampson, Hugh A; Wood, Robert A; Plaut, Marshall; Cooper, Susan F; Fenton, Matthew J; Arshad, S Hasan; Bahna, Sami L; Beck, Lisa A; Byrd-Bredbenner, Carol; Camargo, Carlos A; Eichenfield, Lawrence; Furuta, Glenn T; Hanifin, Jon M; Jones, Carol; Kraft, Monica; Levy, Bruce D; Lieberman, Phil; Luccioli, Stefano; McCall, Kathleen M; Schneider, Lynda C; Simon, Ronald A; Simons, F Estelle R; Teach, Stephen J; Yawn, Barbara P; Schwaninger, Julie M

2010-12-01

Food allergy is an important public health problem that affects children and adults and may be increasing in prevalence. Despite the risk of severe allergic reactions and even death, there is no current treatment for food allergy: the disease can only be managed by allergen avoidance or treatment of symptoms. The diagnosis and management of food allergy also may vary from one clinical practice setting to another. Finally, because patients frequently confuse nonallergic food reactions, such as food intolerance, with food allergies, there is an unfounded belief among the public that food allergy prevalence is higher than it truly is. In response to these concerns, the National Institute of Allergy and Infectious Diseases, working with 34 professional organizations, federal agencies, and patient advocacy groups, led the development of clinical guidelines for the diagnosis and management of food allergy. These Guidelines are intended for use by a wide variety of health care professionals, including family practice physicians, clinical specialists, and nurse practitioners. The Guidelines include a consensus definition for food allergy, discuss comorbid conditions often associated with food allergy, and focus on both IgE-mediated and non-IgE-mediated reactions to food. Topics addressed include the epidemiology, natural history, diagnosis, and management of food allergy, as well as the management of severe symptoms and anaphylaxis. These Guidelines provide 43 concise clinical recommendations and additional guidance on points of current controversy in patient management. They also identify gaps in the current scientific knowledge to be addressed through future research. Published by Mosby, Inc.

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder.

PubMed

Yatham, Lakshmi N; Kennedy, Sidney H; Parikh, Sagar V; Schaffer, Ayal; Bond, David J; Frey, Benicio N; Sharma, Verinder; Goldstein, Benjamin I; Rej, Soham; Beaulieu, Serge; Alda, Martin; MacQueen, Glenda; Milev, Roumen V; Ravindran, Arun; O'Donovan, Claire; McIntosh, Diane; Lam, Raymond W; Vazquez, Gustavo; Kapczinski, Flavio; McIntyre, Roger S; Kozicky, Jan; Kanba, Shigenobu; Lafer, Beny; Suppes, Trisha; Calabrese, Joseph R; Vieta, Eduard; Malhi, Gin; Post, Robert M; Berk, Michael

2018-03-01

The Canadian Network for Mood and Anxiety Treatments (CANMAT) previously published treatment guidelines for bipolar disorder in 2005, along with international commentaries and subsequent updates in 2007, 2009, and 2013. The last two updates were published in collaboration with the International Society for Bipolar Disorders (ISBD). These 2018 CANMAT and ISBD Bipolar Treatment Guidelines represent the significant advances in the field since the last full edition was published in 2005, including updates to diagnosis and management as well as new research into pharmacological and psychological treatments. These advances have been translated into clear and easy to use recommendations for first, second, and third- line treatments, with consideration given to levels of evidence for efficacy, clinical support based on experience, and consensus ratings of safety, tolerability, and treatment-emergent switch risk. New to these guidelines, hierarchical rankings were created for first and second- line treatments recommended for acute mania, acute depression, and maintenance treatment in bipolar I disorder. Created by considering the impact of each treatment across all phases of illness, this hierarchy will further assist clinicians in making evidence-based treatment decisions. Lithium, quetiapine, divalproex, asenapine, aripiprazole, paliperidone, risperidone, and cariprazine alone or in combination are recommended as first-line treatments for acute mania. First-line options for bipolar I depression include quetiapine, lurasidone plus lithium or divalproex, lithium, lamotrigine, lurasidone, or adjunctive lamotrigine. While medications that have been shown to be effective for the acute phase should generally be continued for the maintenance phase in bipolar I disorder, there are some exceptions (such as with antidepressants); and available data suggest that lithium, quetiapine, divalproex, lamotrigine, asenapine, and aripiprazole monotherapy or combination treatments should be considered first-line for those initiating or switching treatment during the maintenance phase. In addition to addressing issues in bipolar I disorder, these guidelines also provide an overview of, and recommendations for, clinical management of bipolar II disorder, as well as advice on specific populations, such as women at various stages of the reproductive cycle, children and adolescents, and older adults. There are also discussions on the impact of specific psychiatric and medical comorbidities such as substance use, anxiety, and metabolic disorders. Finally, an overview of issues related to safety and monitoring is provided. The CANMAT and ISBD groups hope that these guidelines become a valuable tool for practitioners across the globe. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Review of Research Reporting Guidelines for Radiology Researchers.

PubMed

Cronin, Paul; Rawson, James V

2016-05-01

Prior articles have reviewed reporting guidelines and study evaluation tools for clinical research. However, only some of the many available accepted reporting guidelines at the Enhancing the QUAlity and Transparency Of health Research Network have been discussed in previous reports. In this paper, we review the key Enhancing the QUAlity and Transparency Of health Research reporting guidelines that have not been previously discussed. The study types include diagnostic and prognostic studies, reliability and agreement studies, observational studies, analytical and descriptive, experimental studies, quality improvement studies, qualitative research, health informatics, systematic reviews and meta-analyses, economic evaluations, and mixed methods studies. There are also sections on study protocols, and statistical analyses and methods. In each section, there is a brief overview of the study type, and then the reporting guideline(s) that are most applicable to radiology researchers including radiologists involved in health services research are discussed. Copyright © 2016 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

Natural Products for Cancer Prevention: Clinical Update 2016.

PubMed

Sanders, Kathleen; Moran, Zelda; Shi, Zaixing; Paul, Rachel; Greenlee, Heather

2016-08-01

To present a clinical update of natural products for cancer prevention and provide oncology nurses with an evidence-based review of natural products for patient counseling and education. Clinical trials published in PubMed. In the past 4 years since the publication of the original review there have been minimal changes in the conclusions of the published literature on the use of natural products for cancer prevention. To date, clinical trials have not demonstrated conclusive benefit of using natural products for cancer prevention, and current guidelines do not recommend their use. This review provides an update on published and ongoing trials and can serve as an updated resource for nurses. Evidence-based natural products databases can help nurses stay current with the scientific literature and be effective educators and health coaches for their patients, who can be influenced by marketing of unregulated products. Patients often discuss the use of natural products with nurses. Nurses have an opportunity to educate and coach patients in effective preventive lifestyle practices. Copyright © 2016 Elsevier Inc. All rights reserved.

Diagnostics and Treatment of Thyroid Carcinoma.

PubMed

Jarząb, Barbara; Dedecjus, Marek; Handkiewicz-Junak, Daria; Lange, Dariusz; Lewiński, Andrzej; Nasierowska-Guttmejer, Anna; Ruchała, Marek; Słowińska-Klencka, Dorota; Nauman, Janusz; Adamczewski, Zbigniew; Bagłaj, Maciej; Bałdys-Waligórska, Agata; Barczyński, Marcin; Bednarczuk, Tomasz; Cichocki, Andrzej; Czarniecka, Agnieszka; Czepczyński, Rafał; Gawlik, Aneta; Hubalewska-Dydejczyk, Alicja; Jażdżewski, Krystian; Kamiński, Grzegorz; Karbownik-Lewińska, Małgorzata; Kos-Kudła, Beata; Kułakowski, Andrzej; Kuzdak, Krzysztof; Łącka, Katarzyna; Małecka-Tendera, Ewa; Niedziela, Marek; Pomorski, Lech; Sporny, Stanisław; Stojcev, Zoran; Syrenicz, Anhelli; Włoch, Jan; Krajewska, Jolanta; Szpak-Ulczok, Sylwia; Kalemba, Michal; Buziak-Bereza, Monika

2016-01-01

Revised Guidelines of Polish National Societies Prepared on the initiative of the Polish Group for Endocrine Tumours approved in their final version between November 16th and 28th, 2015 by the Scientific Committee of the V Conference "Thyroid Cancer and other malignancies of endocrine glands" organised between November 14th and 17th, 2015 in Wisla, Poland; called by the following Societies: Polish Endocrine Society, Polish Society of Oncology, Polish Thyroid Association, Polish Society of Pathologists, Society of Polish Surgeons, Polish Society of Surgical Oncology, Polish Society of Clinical Oncology, Polish Society of Radiation Oncology, Polish Society of Nuclear Medicine, Polish Society of Paediatric Endocrinology, Polish Society of Paediatric Surgeons, Polish Society of Ultrasonography Gliwice-Wisła, 2015 DECLARATION: These recommendations are created by the group of delegates of the National Societies, which declare their willingness to participate in the preparation of the revised version of the Polish Guidelines. The members of the Working Group have been chosen from the specialists involved in medical care of patients with thyroid carcinoma. Directly before the preparation of the Polish national recommendations the American Thyroid Association (ATA) published its own guidelines together with a wide comment fulfilling evidence-based medicine (EBM) criteria. ATA Guidelines are consistent with National Comprehensive Cancer Network (NCCN) Recommendation. According to the members of the Working Group, it is necessary to adapt them to both the specific Polish epidemiological situation as well as to the rules referring to the Polish health system. Therefore, the Polish recommendations constitute a consensus of the experts' group, based on ATA information. The experts analysed previous Polish Guidelines, published in 2010, and other available data, and after discussion summed up the results in the form of these guidelines. It should be added that Part II, which constitutes a pathological part, has been available at the website of the Polish Society of Pathologists for acceptance of the members of the Society, and no essential comments have been proposed. The Members of the Group decided that a subgroup elected from among them would update the Guidelines, according to EBM rules, every year. The Revised Guidelines should help physicians to make reasonable choices in their daily practice; however, the final decision concerning an individual patient should be made by the caring physician responsible for treatment, or optimally by a therapeutic tumour board together with the patient, and should take into consideration the patient's health condition. It should be emphasised that the recommendations may not constitute a strict standard of clinical management imposed on medical staff. The data from clinical trials concerning numerous clinical situations are scarce. In such moments the opinion of the management may differ from the recommendations after considering possible benefits and disadvantages for the patient.

Pakistan’s Recommendations for Optimal Management of diabetes from Primary to Tertiary care level (PROMPT)

PubMed Central

Shera, A. Samad; Basit, Abdul; Team, PROMPT

2017-01-01

Pakistan is a developing country with limited resources and diverse socio-economic standards. Pakistan has high prevalence of diabetes and its complications, which is a great challenge to the existing health care system. National action plans for control of diabetes have been developed and initiatives have been taken but not at an ideal pace. First National Practice Guidelines for Pakistan were published in 1999. It was very helpful in standardizing the management of Type-2 diabetes. In view of important developments in the field of diabetes during the recent years, it was felt that 1999 National Clinical Practice Guidelines edited, should be revised. Also with rapidly increasing number of diabetic patients and the escalating burden on health economy, it is essential to develop a primary to secondary / tertiary care referral system. These guidelines are developed after an extensive research and cover many aspects of diabetes management. This special communication is an extract of a PROMPT document that has already been published as a Supplement in Pakistan Journal of Medical Sciences in 2017. We hope that these guidelines will help in improving the diabetes care in Pakistan. PMID:29142579

Implementation of national body contouring surgery guidelines following massive weight loss: A national cross-sectional survey of commissioning in England.

PubMed

Dunne, Jonathan A; Wormald, Justin C R; Ghedia, Reshma; Soldin, Mark

2017-01-01

National guidelines for commissioning of body contouring surgery (BCS) following massive weight loss (MWL) in England were published in 2014. Nearly three-quarters of patients who have MWL seek BCS; however, access is known to vary according to the region. The aim of national guidelines was to standardise access. The purpose of this study was to determine implementation of the national guidelines by clinical commissioning groups (CCGs) in England. A cross-sectional, web-based survey was sent to all CCG chairs in England. Of 211 potential respondents, 108 completed the survey or provided funding guidelines (response rate = 52%). Eight CCGs (7%) had implemented the guidelines. A total of 69 CCGs were aware of the new guidelines (64%), and 66 CCGs stated that they fund BCS after MWL (61%). A total of 81 CCGs (75%) identified local funding guidelines, while 15 CCGs (14%) cited individual funding requests (IFRs) as the means of accessing funding. To improve patient access to BCS; 58 of 65 respondents (89%) stated cost-effectiveness, whereas 56 of 75 respondents (75%) thought patient-reported outcome measures were key. Qualitative data to improve access included an integrated pathway from bariatric surgery to BCS, an improved evidence base and greater CCG finances. One CCG stated that it cannot afford to fund cosmetic procedures. The purpose of national guidelines was to simplify the pathway to BCS after MWL and create fair distribution of funds across the country to needy patients; however, their uptake has been poor. Access to funding for BCS across England varies according to the location. Copyright © 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Screening Tool for Older Persons' Appropriate Prescriptions for Japanese: Report of the Japan Geriatrics Society Working Group on "Guidelines for medical treatment and its safety in the elderly".

PubMed

Kojima, Taro; Mizukami, Katsuyoshi; Tomita, Naoki; Arai, Hiroyuki; Ohrui, Takashi; Eto, Masato; Takeya, Yasushi; Isaka, Yoshitaka; Rakugi, Hiromi; Sudo, Noriko; Arai, Hidenori; Aoki, Hiroaki; Horie, Shigeo; Ishii, Shinya; Iwasaki, Koh; Takayama, Shin; Suzuki, Yusuke; Matsui, Toshifumi; Mizokami, Fumihiro; Furuta, Katsunori; Toba, Kenji; Akishita, Masahiro

2016-09-01

In 2005, the Japan Geriatrics Society published a list of potentially inappropriate medication that was an extract from the "Guidelines for medical treatment and its safety in the elderly 2005." The 2005 guidelines are due for a revision, and a new comprehensive list of potentially inappropriate medications is required. A total of 15 diseases, conditions and special areas related to their clinical care were selected. We originated clinical questions and keywords for these 15 areas, carried out a systematic review using these search criteria, and formulated guidelines applying the Grading of Recommendations Assessment, Development and Evaluation system advocated by Minds2014. If we did not find good evidence despite the drug being clinically important, we looked for evidence of efficacy and for disease-specific guidelines, and incorporated them into our guidelines. We selected 2098 articles (140 articles per area), and extracted another 186 articles through a manual search. We further added guidelines based on disease entity and made two lists, one of "drugs to be prescribed with special caution" and the other of "drugs to consider starting," primarily considering individuals aged 75 years or older or those who are frail or in need of special care. New lists of potentially inappropriate medications and potential prescribing omissions called "Screening Tool for Older Person's Appropriate Prescriptions for Japanese" were constructed. We anticipate that future studies will highlight more evidence regarding the safety of high-quality drugs, further improving the provision of appropriate medical care for the elderly. Geriatr Gerontol Int 2016: 16: 983-1001. © 2016 Japan Geriatrics Society.

[Web Visit Patterns for the Clinical Practice Guidelines for Management of Depressive Disorder and Alcohol Abuse-Dependence].

PubMed

Suárez-Obando, Fernando; Restrepo, Carlos Gómez

Clinical practice guidelines (CPG) are a set of recommendations for professionals, patients, and families, in order to make decisions about health care. The CPG respond to the need for concise, accurate, practical, and up to date information. In the field of mental health, Colombia has developed three GPC; alcohol (GPC-OH), depression (GPC-TDA), and schizophrenia. To describe the Web Portal traffic related to psychiatry guidelines, with emphasis on the number of visits, distribution throughout Colombian cities, and estimating user behaviour patterns. An evaluation was made of the traffic at the Clinical Practice Guidelines Web Portal of the Ministry of Health and Social Protection between 2013 and 2015 (two years of observation since the inauguration of the Portal). Out of the 45 GPC published on the website, the CPG-OH represented 1.21% of all page views of the Portal. CPG-TDA reached 1.52% (accumulated percentage of 2.73%), being the eighth most consulted guideline, with CPG-OH being number 16. The highest mean monthly number of visits for this group of guideliness was for the CPG-OH for health professionals (353 visits/month), and the lowest was for the CPG-AD for patients and relatives (24 single visits/month). Bogotá D.C. was the city where health carers accessed the guidelines more often. The guidelines for patients and relatives were consulted more in Villavicencio, Cúcuta, Manizales, Pereira, and Pasto. The web portal partially fulfills the purpose of circulating the CPG in Colombia. The visits to the CPG of mental health is quite low, and requires better dissemination strategies that allow the use of information and communication technology. Copyright © 2016 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. 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.

Comparison of the diabetes guidelines from the ADA/EASD and the AACE/ACE.

PubMed

Cornell, Susan

To compare recent diabetes guideline updates from the American Diabetes Association-European Association for the Study of Diabetes (ADA/EASD) and the American Association of Clinical Endocrinologists-American College of Endocrinology (AACE/ACE). The ADA/EASD guideline continues to advocate a stepwise approach to glycemic control that initiates with metformin and intensifies treatment incrementally to dual and triple therapy at 3-month intervals until the patient is at their individualized goal. The AACE/ACE guideline provides a broader choice of first-line medications, with a suggested hierarchy of use, and it encourages initial dual and triple therapy if the glycated hemoglobin (A1C) level is high enough at diagnosis (7.5%-9.0% and >9.0%, respectively). Target A1C levels are higher in the ADA/EASD guideline (≤7.0%) compared with the AACE/ACE guideline (≤6.5%), although both statements indicate that targets should be adjusted to specific clinical scenarios based on safety. Both guidelines now include the new sodium-glucose cotransporter-2 inhibitors among their choices of acceptable glucose-lowering medications and endorse the overall cardiovascular and pancreatic safety of incretin therapies, and the safety of pioglitazone vis-a-vis bladder cancer. In practice, the ADA/EASD guidelines tend to be more user-friendly for general practitioners because of the simple stepwise intensification regimen, whereas the AACE/ACE guidelines are more commonly followed by specialists (endocrinologists) because of the more aggressive A1C targets. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Treatment Considerations for the Cardiometabolic Signs of Polycystic Ovary Syndrome: A Review of the Literature Since the 2013 Endocrine Society Clinical Practice Guidelines.

PubMed

Fields, Errol L; Trent, Maria E

2016-05-01

Polycystic ovary syndrome is characterized by an excess in androgen levels, ovarian dysfunction, and polycystic ovarian morphology but is also associated with metabolic dysfunction and risk factors for cardiovascular disease. To our knowledge, there are few therapeutic recommendations for these cardiometabolic risk factors and little evidence of their long-term clinical relevance to cardiovascular health. To determine metabolic and/or cardiovascular outcomes in polycystic ovary syndrome treatment literature since the publication of the most recent Endocrine Society clinical practice guidelines in 2013. We searched PubMed using a string of variations of polycystic ovary syndrome, therapy/treatment, and adolescence, and we included English-language original research articles published while the 2013 clinical practice guidelines were disseminated (ie, articles published from January 1, 2011, to June 1, 2015). Articles that appeared relevant based on a review of titles and abstracts were read in full to determine relevancy. References from relevant articles were reviewed for additional studies. Four topic areas emerged: (1) lifestyle modification, (2) metformin vs placebo or estrogen-progestin oral contraceptives, (3) insulin-sensitizing agents, and (4) estrogen-progestin formulations. Most studies assessed the role of metformin as a monotherapy or dual therapy supplement and found significant benefit when including metformin in polycystic ovary syndrome treatment regimens. Studies showed improvements in cardiometabolic risk factors and, in several, androgen excess and cutaneous and menstrual symptoms. Studies were limited by sample size (range, 22-171), few adolescent participants, and short-term outcomes. Findings show potential for metformin and estrogen-progestin dual therapy but warrant longitudinal studies examining outcomes from adolescence through middle age to determine the effect on long-term cardiovascular health.

Undue industry influences that distort healthcare research, strategy, expenditure and practice: a review.

PubMed

Stamatakis, Emmanuel; Weiler, Richard; Ioannidis, John P A

2013-05-01

Expenditure on industry products (mostly drugs and devices) has spiraled over the last 15 years and accounts for substantial part of healthcare expenditure. The enormous financial interests involved in the development and marketing of drugs and devices may have given excessive power to these industries to influence medical research, policy, and practice. Review of the literature and analysis of the multiple pathways through which the industry has directly or indirectly infiltrated the broader healthcare systems. We present the analysis of the industry influences at the following levels: (i) evidence base production, (ii) evidence synthesis, (iii) understanding of safety and harms issues, (iv) cost-effectiveness evaluation, (v) clinical practice guidelines formation, (vi) healthcare professional education, (vii) healthcare practice, (viii) healthcare consumer's decisions. We located abundance of consistent evidence demonstrating that the industry has created means to intervene in all steps of the processes that determine healthcare research, strategy, expenditure, practice and education. As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed, and clinical guidelines, medical practice, and healthcare expenditure decisions are biased. To serve its interests, the industry masterfully influences evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluations, clinical practice guidelines and healthcare professional education and also exerts direct influences on professional decisions and health consumers. There is an urgent need for regulation and other action towards redefining the mission of medicine towards a more objective and patient-, population- and society-benefit direction that is free from conflict of interests. © 2013 Stichting European Society for Clinical Investigation Journal Foundation. Published by Blackwell Publishing Ltd.

Aligning Documentation With Congenital Muscular Torticollis Clinical Practice Guidelines: Administrative Case Report.

PubMed

Gutierrez, Dennis; Kaplan, Sandra L

2016-01-01

A hospital-based pediatric outpatient center, wanting to weave evidence into practice, initiated an update of knowledge, skills, and documentation patterns with its staff physical therapists and occupational therapists who treat people with congenital muscular torticollis (CMT). This case report describes 2 cycles of implementation: (1) the facilitators and barriers to implementation and (2) selected quality improvement outcomes aligned with published clinical practice guidelines (CPGs). The Pediatric Therapy Services of St Joseph's Regional Medical Center in New Jersey has 4 full-time, 1 part-time, and 3 per diem staff. Chart audits in 2012 revealed variations in measurement, interventions, and documentation that led to quality improvement initiatives. An iterative process, loosely following the knowledge-to-action cycle, included a series of in-service training sessions to review the basic anatomy, pathokinesiology, and treatment strategies for CMT; reading assignments of the available CPGs; journal review; documentation revisions; and training on the recommended measurements to implement 2 published CPGs and measure outcomes. A previous 1-page generic narrative became a 3-page CMT-specific form aligned with the American Physical Therapy Association Section on Pediatrics CMT CPG recommendations. Staff training on the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale, classification of severity, type of CMT, prognostication, measures of cervical range of motion, and developmental progression improved documentation consistency from 0% to 81.9% to 100%. Clinicians responded positively to using the longer initial evaluation form. Successful implementation of both clinical and documentation practices were facilitated by a multifaceted approach to knowledge translation that included a culture supportive of evidence-based practice, administrative support for training and documentation redesign, commitment by clinicians to embrace changes aimed at improved care, and clinical guidelines that provide implementable recommendations. © 2016 American Physical Therapy Association.

Prevalence and correlates of treatment failure among Kenyan children hospitalised with severe community-acquired pneumonia: a prospective study of the clinical effectiveness of WHO pneumonia case management guidelines.

PubMed

Agweyu, Ambrose; Kibore, Minnie; Digolo, Lina; Kosgei, Caroline; Maina, Virginia; Mugane, Samson; Muma, Sarah; Wachira, John; Waiyego, Mary; Maleche-Obimbo, Elizabeth

2014-11-01

To determine the extent and pattern of treatment failure (TF) among children hospitalised with community-acquired pneumonia at a large tertiary hospital in Kenya. We followed up children aged 2-59 months with WHO-defined severe pneumonia (SP) and very severe pneumonia (VSP) for up to 5 days for TF using two definitions: (i) documentation of pre-defined clinical signs resulting in change of treatment (ii) primary clinician's decision to change treatment with or without documentation of the same pre-defined clinical signs. We enrolled 385 children. The risk of TF varied between 1.8% (95% CI 0.4-5.1) and 12.4% (95% CI 7.9-18.4) for SP and 21.4% (95% CI 15.9-27) and 39.3% (95% CI 32.5-46.4) for VSP depending on the definition applied. Higher rates were associated with early changes in therapy by clinician in the absence of an obvious clinical rationale. Non-adherence to treatment guidelines was observed for 70/169 (41.4%) and 67/201 (33.3%) of children with SP and VSP, respectively. Among children with SP, adherence to treatment guidelines was associated with the presence of wheeze on initial assessment (P = 0.02), while clinician non-adherence to guideline-recommended treatments for VSP tended to occur in children with altered consciousness (P < 0.001). Using propensity score matching to account for imbalance in the distribution of baseline clinical characteristics among children with VSP revealed no difference in TF between those treated with the guideline-recommended regimen vs. more costly broad-spectrum alternatives [risk difference 0.37 (95% CI -0.84 to 0.51)]. Before revising current pneumonia case management guidelines, standardised definitions of TF and appropriate studies of treatment effectiveness of alternative regimens are required. © 2014 The Authors. Tropical Medicine & International Health published by John Wiley & Sons Ltd.

Evaluation of Pulmonary Nodules: Clinical Practice Consensus Guidelines for Asia.

PubMed

Bai, Chunxue; Choi, Chang-Min; Chu, Chung Ming; Anantham, Devanand; Chung-Man Ho, James; Khan, Ali Zamir; Lee, Jang-Ming; Li, Shi Yue; Saenghirunvattana, Sawang; Yim, Anthony

2016-10-01

American College of Chest Physicians (CHEST) clinical practice guidelines on the evaluation of pulmonary nodules may have low adoption among clinicians in Asian countries. Unique patient characteristics of Asian patients affect the diagnostic evaluation of pulmonary nodules. The objective of these clinical practice guidelines was to adapt those of CHEST to provide consensus-based recommendations relevant to practitioners in Asia. A modified ADAPTE process was used by a multidisciplinary group of pulmonologists and thoracic surgeons in Asia. An initial panel meeting analyzed all CHEST recommendations to achieve consensus on recommendations and identify areas that required further investigation before consensus could be achieved. Revised recommendations were circulated to panel members for iterative review and redrafting to develop the final guidelines. Evaluation of pulmonary nodules in Asia broadly follows those of the CHEST guidelines with important caveats. Practitioners should be aware of the risk of lung cancer caused by high levels of indoor and outdoor air pollution, as well as the high incidence of adenocarcinoma in female nonsmokers. Furthermore, the high prevalence of granulomatous disease and other infectious causes of pulmonary nodules need to be considered. Therefore, diagnostic risk calculators developed in non-Asian patients may not be applicable. Overall, longer surveillance of nodules than those recommended by CHEST should be considered. TB in Asia favors lesser reliance on PET scanning and greater use of nonsurgical biopsy over surgical diagnosis or surveillance. Practitioners in Asia are encouraged to use these adapted consensus guidelines to facilitate consistent evaluation of pulmonary nodules. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Protein and calorie intakes in adult and pediatric subjects with urea cycle disorders participating in clinical trials of glycerol phenylbutyrate☆

PubMed Central

Hook, Debra; Diaz, George A.; Lee, Brendan; Bartley, James; Longo, Nicola; Berquist, William; Le Mons, Cynthia; Rudolph-Angelich, Ingrid; Porter, Marty; Scharschmidt, Bruce F.; Mokhtarani, Masoud

2016-01-01

Background Little prospectively collected data are available comparing the dietary intake of urea cycle disorder (UCD) patients to UCD treatment guidelines or to healthy individuals. Objective To examine the protein and calorie intakes of UCD subjects who participated in clinical trials of glycerol phenylbutyrate (GPB) and compare these data to published UCD dietary guidelines and nutritional surveys. Design Dietary data were recorded for 45 adult and 49 pediatric UCD subjects in metabolic control during participation in clinical trials of GPB. Protein and calorie intakes were compared to UCD treatment guidelines, average nutrient intakes of a healthy US population based on the National Health and Nutrition Examination Survey (NHANES) and Recommended Daily Allowances (RDA). Results In adults, mean protein intake was higher than UCD recommendations but lower than RDA and NHANES values, while calorie intake was lower than UCD recommendations, RDA and NHANES. In pediatric subjects, prescribed protein intake was higher than UCD guidelines, similar to RDA, and lower than NHANES data for all age groups, while calorie intake was at the lower end of the recommended UCD range and close to RDA and NHANES data. In pediatric subjects height, weight, and body mass index (BMI) Z-scores were within normal range (− 2 to 2). Conclusions Pediatric patients treated with phenylbutyrate derivatives exhibited normal height and weight. Protein and calorie intakes in adult and pediatric UCD subjects differed from UCD dietary guidelines, suggesting that these guidelines may need to be reconsidered. PMID:27014577

Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults. I. Classification, burden and principles of management.

PubMed

Patten, Scott B; Kennedy, Sidney H; Lam, Raymond W; O'Donovan, Claire; Filteau, Marie J; Parikh, Sagar V; Ravindran, Arun V

2009-10-01

Major depressive disorder (MDD) is one of the most burdensome illnesses in Canada. The purpose of this introductory section of the 2009 revised CANMAT guidelines is to provide definitions of the depressive disorders (with an emphasis on MDD), summarize Canadian data concerning their epidemiology and describe overarching principles of managing these conditions. This section on "Classification, Burden and Principles of Management" is one of 5 guideline articles in the 2009 CANMAT guidelines. The CANMAT guidelines are based on a question-answer format to enhance accessibility to clinicians. An evidence-based format was used with updated systematic reviews of the literature and recommendations were graded according to the Level of Evidence using pre-defined criteria. Lines of Treatment were identified based on criteria that included evidence and expert clinical support. Epidemiologic data indicate that MDD afflicts 11% of Canadians at some time in their lives, and approximately 4% during any given year. MDD has a detrimental impact on overall health, role functioning and quality of life. Detection of MDD, accurate diagnosis and provision of evidence-based treatment are challenging tasks for both clinicians and for the health systems in which they work. Epidemiologic and clinical data cannot be seamlessly linked due to heterogeneity of syndromes within the population. In the eight years since the last CANMAT Guidelines for Treatment of Depressive Disorders were published, progress has been made in understanding the epidemiology and treatment of these disorders. Evidence supporting specific therapeutic interventions is summarized and evaluated in subsequent sections.

Implementation of the guidelines for targeted temperature management after cardiac arrest: a longitudinal qualitative study of barriers and facilitators perceived by hospital resuscitation champions.

PubMed

Kim, Young-Min; Lee, Seung Joon; Jo, Sun Jin; Park, Kyu Nam

2016-01-05

To identify the barriers to and facilitators of implementing guidelines for targeted temperature management (TTM) after cardiac arrest perceived by hospital resuscitation champions and to investigate the changes in their perceptions over the early implementation period. A longitudinal qualitative study (up to 2 serial semistructured interviews over 1 year and focus groups). The individual interviews and focus groups were transcribed and coded by 2 independent assessors. Contents were analysed thematically; group interaction was also examined. 21 hospitals, including community and tertiary care centres in South Korea. 21 hospital champions (14 acting champions and 7 managerial champions). The final data set included 40 interviews and 2 focus groups. The identified barriers and facilitators could be classified into 3 major themes: (1) healthcare professionals' perceptions of the guidelines and protocols, (2) interdisciplinary and interprofessional collaboration and (3) organisational resources. Lack of resources was the most commonly agreed on barrier for the acting champions, whereas lack of interdisciplinary collaboration was the most common barrier for the managerial champions. Educational activities and sharing successfully treated cases were the most frequently identified facilitators. Most of the participants identified and agreed that cooling equipment was an important barrier as well as a facilitator of successful TTM implementation. Perception of the guidelines and protocols has improved with the accumulation of clinical experience over the study period. Healthcare professionals' internal barriers to TTM implementation may be influenced by new guidelines and can be changed with the accumulation of successful clinical experiences during the early implementation period. Promoting interprofessional and interdisciplinary collaboration through educational activities and the use of cooling equipment with an automated feedback function can improve adherence to guidelines in hospitals with limited human resources in critical care. 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/

Metastatic Pancreatic Cancer: ASCO Clinical Practice Guideline Update.

PubMed

Sohal, Davendra P S; Kennedy, Erin B; Khorana, Alok; Copur, Mehmet S; Crane, Christopher H; Garrido-Laguna, Ignacio; Krishnamurthi, Smitha; Moravek, Cassadie; O'Reilly, Eileen M; Philip, Philip A; Ramanathan, Ramesh K; Ruggiero, Joseph T; Shah, Manish A; Urba, Susan; Uronis, Hope E; Lau, Michelle W; Laheru, Daniel

2018-05-23

Purpose In 2016, ASCO published a guideline to assist in clinical decision making in metastatic pancreatic cancer for initial assessment after diagnosis, first- and second-line treatment options, palliative and supportive care, and follow-up. The purpose of this update is to incorporate new evidence related to second-line therapy for patients who have experienced disease progression or intolerable toxicity during first-line therapy. Methods ASCO convened an Expert Panel to conduct a systematic review of the literature on second-line therapy published between June 2015 and January 2018. Recommendations on other topics covered in the 2016 Metastatic Pancreatic Cancer Guideline were endorsed by the Expert Panel. Results Two new studies were found that met the inclusion criteria. Recommendations For second-line therapy, gemcitabine plus nanoparticle albumin-bound paclitaxel should be offered to patients with first-line treatment with FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin), an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1, and a favorable comorbidity profile; fluorouracil plus nanoliposomal irinotecan can be offered to patients with first-line treatment with gemcitabine plus NAB-paclitaxel, an ECOG PS of 0 to 1, and a favorable comorbidity profile; fluorouracil plus irinotecan or fluorouracil plus oxaliplatin may be offered when there is a lack of availability of fluorouracil plus nanoliposomal irinotecan; gemcitabine or fluorouracil should be offered to patients with either an ECOG PS of 2 or a comorbidity profile that precludes other regimens. Testing select patients for mismatch repair deficiency or microsatellite instability is recommended, and pembrolizumab is recommended for patients with mismatch repair deficiency or high microsatellite instability tumors. Endorsed recommendations from the 2016 version of this guideline for computed tomography, baseline performance status and comorbidity profile, defining goals of care, first-line therapy, and palliative care are also contained within the full guideline text. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines .

Introducing guidelines into clinical practice.

PubMed

Fowkes, F G; Roberts, C J

1984-04-01

The impetus for guidelines of practice has been accelerated by a worldwide trend towards insurance based systems of health care. In the past it has been the tradition for the clinician to order all the diagnostic procedures that conceivably might help to clarify what is wrong with a patient, or what course of treatment should be followed. This traditional view ignores the stubborn economic reality that resources are finite and that it is no longer possible to be both endlessly generous and continually fair. Making judgements about the need for, and value of, services now forms an important part of coping with this problem. Clinical practice has to strive to be as safe as possible and to produce a given benefit at a socially acceptable cost. Guidelines are recommendations, preferably developed by clinicians themselves, which describe how and when individual clinical activities should be offered in order to achieve these objectives. Utilisation review of current practice is a valuable source of information for the development of guidelines. In the United Kingdom the Royal College of Radiologists attempted to do this in connection with the use of pre-operative chest X-rays. In 1979 they published the findings of a multicentre review of 10,619 consecutive cases of elective non-cardiopulmonary surgery undertaken in 8 centres throughout the United Kingdom. Substantial variations were found in national practice. Use of pre-operative chest X-rays varied from 11.5% of patients in one centre to 54.2% of patients in another centre. The study also found that the chest X-ray report did not seem to have much influence on the decision to operate nor on the decision to use inhalation anaesthesia. The College study failed to find "any evidence at all for the effectiveness of pre-operative chest X-ray when used routinely" and it was estimated that even if the procedure was 10% effective the costs of avoiding one death would be approximately 1 million pounds. These findings provided the impetus for the College to develop guidelines for the use of pre-operative chest X-rays in hospitals in the United Kingdom. Creating a change in clinical practice through the introduction of guidelines is a three stage process: Stage I: introducing the idea of a change in practice. Stage II: introduction of guidelines into clinical practice. Stage III: sustained implementation of guidelines in clinical practice.(ABSTRACT TRUNCATED AT 400 WORDS)

The Spanish Neurological Society official clinical practice guidelines in epilepsy.

PubMed

Mercadé Cerdá, J M; Toledo Argani, M; Mauri Llerda, J A; López Gonzalez, F J; Salas Puig, X; Sancho Rieger, J

2016-03-01

Previous Official Clinical Practice Guidelines (CPGs) in Epilepsy were based on expert opinions and developed by the Epilepsy Study Group of the Spanish Neurological Society (GE-SEN). The current CPG in epilepsy is based on the scientific method, which extracts recommendations from published scientific evidence. A reduction in the variability in clinical practice through standardization of medical practice has become its main function. This CPG is focused on comprehensive care for individuals affected by epilepsy as a primary and predominant symptom, regardless of the age of onset and medical policy. 1. Creation of GE-SEN neurologists working group, in collaboration with Neuropediatricians, Neurophysiologists and Neuroradiologists. 2. Identification of clinical areas to be covered: diagnosis, prognosis and treatment. 3. Search and selection of the relevant scientific evidence. 4. Formulation of recommendations based on the classification of the available scientific evidence. It contains 161 recommendations of which 57% are consensus between authors and publishers, due to an important lack of awareness in many fields of this pathology. This Epilepsy CPG formulates recommendations based on explicit scientific evidence as a result of a formal and rigorous methodology, according to the current knowledge in the pre-selected areas. This paper includes the CPG chapter dedicated to emergency situations in seizures and epilepsy, which may present as a first seizure, an unfavorable outcome in a patient with known epilepsy, or status epilepticus as the most severe manifestation. Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

The updating of clinical practice guidelines: insights from an international survey

PubMed Central

2011-01-01

Background Clinical practice guidelines (CPGs) have become increasingly popular, and the methodology to develop guidelines has evolved enormously. However, little attention has been given to the updating process, in contrast to the appraisal of the available literature. We conducted an international survey to identify current practices in CPG updating and explored the need to standardize and improve the methods. Methods We developed a questionnaire (28 items) based on a review of the existing literature about guideline updating and expert comments. We carried out the survey between March and July 2009, and it was sent by email to 106 institutions: 69 members of the Guidelines International Network who declared that they developed CPGs; 30 institutions included in the U.S. National Guideline Clearinghouse database that published more than 20 CPGs; and 7 institutions selected by an expert committee. Results Forty-four institutions answered the questionnaire (42% response rate). In the final analysis, 39 completed questionnaires were included. Thirty-six institutions (92%) reported that they update their guidelines. Thirty-one institutions (86%) have a formal procedure for updating their guidelines, and 19 (53%) have a formal procedure for deciding when a guideline becomes out of date. Institutions describe the process as moderately rigorous (36%) or acknowledge that it could certainly be more rigorous (36%). Twenty-two institutions (61%) alert guideline users on their website when a guideline is older than three to five years or when there is a risk of being outdated. Twenty-five institutions (64%) support the concept of "living guidelines," which are continuously monitored and updated. Eighteen institutions (46%) have plans to design a protocol to improve their guideline-updating process, and 21 (54%) are willing to share resources with other organizations. Conclusions Our study is the first to describe the process of updating CPGs among prominent guideline institutions across the world, providing a comprehensive picture of guideline updating. There is an urgent need to develop rigorous international standards for this process and to minimize duplication of effort internationally. PMID:21914177

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.

Recommendations for an update of the 2010 European regulatory guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis and reflections about related clinically relevant outcomes: expert consensus statement.

PubMed

Reginster, J-Y; Reiter-Niesert, S; Bruyère, O; Berenbaum, F; Brandi, M-L; Branco, J; Devogelaer, J-P; Herrero-Beaumont, G; Kanis, J; Maggi, S; Maheu, E; Richette, P; Rizzoli, R; Cooper, C

2015-12-01

The European Society on Clinical and Economic aspects of Osteoporosis and Osteoarthritis (ESCEO) organised a working group to evaluate the need for updating the current European guideline on clinical investigation of drugs used in the treatment of osteoarthritis (OA). Areas of potential attention were identified and the need for modifications, update or clarification was examined. Proposals were then developed based on literature reviews and through a consensus process. It was agreed that the current guideline overall still reflects the current knowledge in OA, although two possible modifications were identified. The first relates to the number and timing of measurements required as primary endpoints during clinical trials of symptom-relieving drugs, either drugs with rapid onset of action or slow acting drugs. The suggested modifications are intended to take into consideration the time related clinical need and expected time response to these drugs - i.e., a more early effect for the first category in addition to the maintenance of effect, a more continuous benefit over the long-term for the latter - in the timing of assessments. Secondly, values above which a benefit over placebo should be considered clinically relevant were considered. Based on literature reviews, the most consensual values were determined for primary endpoints of both symptom-relieving drugs (i.e., pain intensity on a visual analogue scale (VAS)) and disease-modifying drugs (i.e., radiographic joint-space narrowing). This working document might be considered by the European regulatory authorities in a future update of the guideline for the registration of drugs in OA. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Insulin Therapy for Adult Patients with Type 2 Diabetes Mellitus: A Position Statement of the Korean Diabetes Association, 2017.

PubMed

Lee, Byung Wan; Kim, Jin Hwa; Ko, Seung Hyun; Hur, Kyu Yeon; Kim, Nan Hee; Rhee, Sang Youl; Kim, Hyun Jin; Moon, Min Kyong; Park, Seok O; Choi, Kyung Mook

2017-10-01

The Korean Diabetes Association (KDA) has regularly updated its Clinical Practice Guidelines. In 2017, the KDA published a position statement on the use of antihyperglycemic agents for patients with type 2 diabetes mellitus (T2DM). Growing evidence from new multinational clinical trials using novel and traditional insulin analogues has also been accumulated. Following global trends, many results of clinical trials, especially concerning the clinical efficacy and safety of insulin therapy, have been published about Korean patients with T2DM. After a systematic search of recent evidence, the KDA updated and modified its clinical practice recommendations regarding the initiation, choice, and intensification of insulin and created an insulin treatment algorithm for the first time to guide physicians caring for adult Korean patients with T2DM. Copyright © 2017 Korean Diabetes Association.

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.

The full spectrum of ethical issues in dementia care: systematic qualitative review.

PubMed

Strech, Daniel; Mertz, Marcel; Knüppel, Hannes; Neitzke, Gerald; Schmidhuber, Martina

2013-06-01

Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.

Conceptual Models and Guidelines for Clinical Assessment of Financial Capacity.

PubMed

Marson, Daniel

2016-09-01

The ability to manage financial affairs is a life skill of critical importance, and neuropsychologists are increasingly asked to assess financial capacity across a variety of settings. Sound clinical assessment of financial capacity requires knowledge and appreciation of applicable clinical conceptual models and principles. However, the literature has presented relatively little conceptual guidance for clinicians concerning financial capacity and its assessment. This article seeks to address this gap. The article presents six clinical models of financial capacity : (1) the early gerontological IADL model of Lawton, (2) the clinical skills model and (3) related cognitive psychological model developed by Marson and colleagues, (4) a financial decision-making model adapting earlier decisional capacity work of Appelbaum and Grisso, (5) a person-centered model of financial decision-making developed by Lichtenberg and colleagues, and (6) a recent model of financial capacity in the real world developed through the Institute of Medicine. Accompanying presentation of the models is discussion of conceptual and practical perspectives they represent for clinician assessment. Based on the models, the article concludes by presenting a series of conceptually oriented guidelines for clinical assessment of financial capacity. In summary, sound assessment of financial capacity requires knowledge and appreciation of clinical conceptual models and principles. Awareness of such models, principles and guidelines will strengthen and advance clinical assessment of financial capacity. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

ESCMID guidelines for the management of the infection control measures to reduce transmission of multidrug-resistant Gram-negative bacteria in hospitalized patients.

PubMed

Tacconelli, E; Cataldo, M A; Dancer, S J; De Angelis, G; Falcone, M; Frank, U; Kahlmeter, G; Pan, A; Petrosillo, N; Rodríguez-Baño, J; Singh, N; Venditti, M; Yokoe, D S; Cookson, B

2014-01-01

Healthcare-associated infections due to multidrug-resistant Gram-negative bacteria (MDR-GNB) are a leading cause of morbidity and mortality worldwide. These evidence-based guidelines have been produced after a systematic review of published studies on infection prevention and control interventions aimed at reducing the transmission of MDR-GNB. The recommendations are stratified by type of infection prevention and control intervention and species of MDR-GNB and are presented in the form of 'basic' practices, recommended for all acute care facilities, and 'additional special approaches' to be considered when there is still clinical and/or epidemiological and/or molecular evidence of ongoing transmission, despite the application of the basic measures. The level of evidence for and strength of each recommendation, were defined according to the GRADE approach. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

The past, present, and future of selective progesterone receptor modulators in the management of uterine fibroids.

PubMed

Singh, Sukhbir S; Belland, Liane; Leyland, Nicholas; von Riedemann, Sarah; Murji, Ally

2017-12-21

Uterine fibroids are common in women of reproductive age and can have a significant impact on quality of life and fertility. Although a number of international obstetrics/gynecology societies have issued evidence-based clinical practice guidelines for the management of symptomatic uterine fibroids, many of these guidelines do not yet reflect the most recent clinical evidence and approved indication for one of the key medical management options: the selective progesterone receptor modulator class. This article aims to share the clinical experience gained with selective progesterone receptor modulators in Europe and Canada by reviewing the historical development of selective progesterone receptor modulators, current best practices for selective progesterone receptor modulator use based on available data, and potential future uses for selective progesterone receptor modulators in uterine fibroids and other gynecologic conditions. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Mutation Detection in Patients With Advanced Cancer by Universal Sequencing of Cancer-Related Genes in Tumor and Normal DNA vs Guideline-Based Germline Testing.

PubMed

Mandelker, Diana; Zhang, Liying; Kemel, Yelena; Stadler, Zsofia K; Joseph, Vijai; Zehir, Ahmet; Pradhan, Nisha; Arnold, Angela; Walsh, Michael F; Li, Yirong; Balakrishnan, Anoop R; Syed, Aijazuddin; Prasad, Meera; Nafa, Khedoudja; Carlo, Maria I; Cadoo, Karen A; Sheehan, Meg; Fleischut, Megan H; Salo-Mullen, Erin; Trottier, Magan; Lipkin, Steven M; Lincoln, Anne; Mukherjee, Semanti; Ravichandran, Vignesh; Cambria, Roy; Galle, Jesse; Abida, Wassim; Arcila, Marcia E; Benayed, Ryma; Shah, Ronak; Yu, Kenneth; Bajorin, Dean F; Coleman, Jonathan A; Leach, Steven D; Lowery, Maeve A; Garcia-Aguilar, Julio; Kantoff, Philip W; Sawyers, Charles L; Dickler, Maura N; Saltz, Leonard; Motzer, Robert J; O'Reilly, Eileen M; Scher, Howard I; Baselga, Jose; Klimstra, David S; Solit, David B; Hyman, David M; Berger, Michael F; Ladanyi, Marc; Robson, Mark E; Offit, Kenneth

2017-09-05

Guidelines for cancer genetic testing based on family history may miss clinically actionable genetic changes with established implications for cancer screening or prevention. To determine the proportion and potential clinical implications of inherited variants detected using simultaneous sequencing of the tumor and normal tissue ("tumor-normal sequencing") compared with genetic test results based on current guidelines. From January 2014 until May 2016 at Memorial Sloan Kettering Cancer Center, 10 336 patients consented to tumor DNA sequencing. Since May 2015, 1040 of these patients with advanced cancer were referred by their oncologists for germline analysis of 76 cancer predisposition genes. Patients with clinically actionable inherited mutations whose genetic test results would not have been predicted by published decision rules were identified. Follow-up for potential clinical implications of mutation detection was through May 2017. Tumor and germline sequencing compared with the predicted yield of targeted germline sequencing based on clinical guidelines. Proportion of clinically actionable germline mutations detected by universal tumor-normal sequencing that would not have been detected by guideline-directed testing. Of 1040 patients, the median age was 58 years (interquartile range, 50.5-66 years), 65.3% were male, and 81.3% had stage IV disease at the time of genomic analysis, with prostate, renal, pancreatic, breast, and colon cancer as the most common diagnoses. Of the 1040 patients, 182 (17.5%; 95% CI, 15.3%-19.9%) had clinically actionable mutations conferring cancer susceptibility, including 149 with moderate- to high-penetrance mutations; 101 patients tested (9.7%; 95% CI, 8.1%-11.7%) would not have had these mutations detected using clinical guidelines, including 65 with moderate- to high-penetrance mutations. Frequency of inherited mutations was related to case mix, stage, and founder mutations. Germline findings led to discussion or initiation of change to targeted therapy in 38 patients tested (3.7%) and predictive testing in the families of 13 individuals (1.3%), including 6 for whom genetic evaluation would not have been initiated by guideline-based testing. In this referral population with selected advanced cancers, universal sequencing of a broad panel of cancer-related genes in paired germline and tumor DNA samples was associated with increased detection of individuals with potentially clinically significant heritable mutations over the predicted yield of targeted germline testing based on current clinical guidelines. Knowledge of these additional mutations can help guide therapeutic and preventive interventions, but whether all of these interventions would improve outcomes for patients with cancer or their family members requires further study. clinicaltrials.gov Identifier: NCT01775072.

Celiac disease diagnosis: impact of guidelines on medical prescription in France.

PubMed

Pham, Bach Nga; Musset, Lucile; Chyderiotis, Georges; Olsson, Nils Olivier; Fabien, Nicole

2014-08-01

Celiac disease is a complex autoimmune disease affecting patients of any age, who may present a wide variety of clinical manifestations. Different guidelines for the diagnosis and management of celiac disease have been recently published. The aim of this study was to determine whether the recommendations issued in these guidelines have been adopted by physicians in France when celiac disease was suspected. A total of 5521 physicians were asked to fill in a detailed questionnaire on diagnosing celiac disease to evaluate their medical practice, as to the type of symptoms leading to the suspicion of celiac disease, the prescription of duodenal biopsy or serological tests, the type of serological tests (anti-tissue transglutaminase, anti-endomysium, anti-gliadin and anti-reticulin antibodies, total immunoglobulin A measurement) prescribed to diagnose celiac disease. The analysis of the responses of 256 general practitioners (GPs), 221 gastroenterologists and 227 pediatricians showed that the protean clinical presentations of celiac disease might be better recognized by gastroenterologists and pediatricians than by GPs. Gastroenterologists asked for duodenal biopsy much more often than GPs and pediatricians when celiac disease was suspected. Serological testing and knowledge of critical markers, prescribed to diagnose celiac disease, differed among GPs, gastroenterologists and pediatricians. Analysis of medical prescriptions showed that the recommendations for celiac disease diagnosis are not necessarily followed by physicians, emphasizing the fact that the impact of national or international guidelines on medical behavior should be evaluated. © 2014 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

On heterogeneity of treatment effects and clinical freedom.

PubMed

Sacristán, J A; Avendaño-Solá, C

2015-01-01

Three decades ago, John R Hampton announced the death of clinical freedom. Since then, evidence-based medicine has been the predominant paradigm in clinical research. By applying a population-based approach, the randomised controlled trial has become the cornerstone for demonstrating the overall effect of a treatment and for developing guidelines. The new patient-centred medicine movement is rediscovering the important implications of heterogeneity of treatment effects for clinical practice and that a better understanding of such variability can contribute to improve health outcomes for individual patients through practicing a science-based clinical freedom. © 2015 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Implementation of national palliative care guidelines in Swedish acute care hospitals: A qualitative content analysis of stakeholders' perceptions.

PubMed

Lind, S; Wallin, L; Brytting, T; Fürst, C J; Sandberg, J

2017-11-01

In high-income countries a large proportion of all deaths occur in hospitals. A common way to translate knowledge into clinical practice is developing guidelines for different levels of health care organisations. During 2012, national clinical guidelines for palliative care were published in Sweden. Later, guidance for palliative care was issued by the National Board of Health and Welfare. The aim of this study was two-fold: to investigate perceptions regarding these guidelines and identify obstacles and opportunities for implementation of them in acute care hospitals. Interviews were conducted with local politicians, chief medical officers and health professionals at acute care hospitals. The Consolidated Framework for Implementation Research was used in a directed content analysis approach. The results showed little knowledge of the two documents at all levels of the health care organisation. Palliative care was primarily described as end of life care and only few of the participants talked about the opportunity to integrate palliative care early in a disease trajectory. The environment and culture at hospitals, characterised by quick decisions and actions, were perceived as obstacles to implementation. Health professionals' expressed need for palliative care training is an opportunity for implementation of clinical guidelines. There is a need for further implementation of palliative care in hospitals. One option for further research is to evaluate implementation strategies tailored to acute care. Copyright © 2017 Elsevier B.V. All rights reserved.

The Inter-Organizational Summit on Education and Training (ISET) 2010 survey on the influence of the Houston conference training guidelines.

PubMed

Sweet, Jerry J; Perry, William; Ruff, Ronald M; Shear, Paula K; Breting, Leslie M Guidotti

2012-11-01

A conference specific to the education and training of clinical neuropsychology was held in 1997, which led to a report published in the Archives of Clinical Neuropsychology (Hannay, J., Bieliauskas, L., Crosson, B., Hammeke, T., Hamsher, K., & Koffler, S. (1998). Proceedings of the Houston Conference on Specialty Education and Training in Clinical Neuropsychology. Archives of Clinical Neuropsychology, 13, 157-250.). The guidelines produced by this conference have been referred to as the Houston Conference (HC) guidelines. Since that time, there has been considerable discussion, and some disagreement, about whether the HC guidelines produced a positive outcome in the training of neuropsychologists. To explore this question and determine how widely the HC guidelines were implemented, a meeting was held in 2006. Present and past leaders of the American Psychological Association Division 40 (Clinical Neuropsychology), the National Academy of Neuropsychology, and the Association of Postdoctoral Programs in Clinical Neuropsychology met to discuss the possible need for an Inter-Organizational Summit on Education and Training (ISET). A decision was reached to have the ISET Steering Committee conduct a survey of clinical neuropsychologists that could address the extent to which HC guidelines were present in the specialty and whether the influence of the HC guidelines was positive. An online survey was constructed, with data gathered in 2010. The current paper presents and discusses the ISET survey results. Specific findings need to be viewed cautiously due to the relatively low response rate. However, with some direct parallels to a larger recent survey of clinical neuropsychologists, the following general conclusions appear well founded: (a) the demographics of respondents in the ISET survey are comparable with a recent larger professional practice survey and thus may reasonably represent the specialty; (b) the HC guidelines appear to have been widely adopted by training programs, in that a large proportion of younger practitioners endorsed having had HC-adherent training; and (c) HC-adherent training is associated with a higher frequency endorsement of being well prepared to engage in key professional activities subsequent to the completion of training when compared with those not having HC-adherent training. Overall, the ISET Steering Committee has concluded that the HC guidelines have been widely adopted and that trainees associate participation in HC-adherent training as advantageous. A potential revision based on unfavorable outcomes is deemed unnecessary. Nonetheless, the ISET Steering Committee recognizes that training needs change as a function of the broadening of our field and the introduction of related new technologies, which may prompt updates. The ISET Steering Committee supports the idea that periodic review and updating of training models is prudent.

Showcasing a profession: getting nursing on the newsstand.

PubMed

Hobdell, E F; Slusser, M; Patterson, J; Burgess, E

1991-01-01

Interacting with the media is a method of showcasing the nursing profession. Clinical nurse specialists (CNSs) have a variety of opportunities available for these interactions: appearing on television, participating in a radio program or writing to the media. A survey completed by the authors indicated that CNSs had many media interactions, yet overall, only 17% of all nurses surveyed used writing. This paper begins by discussing where to publish and how to prepare and target the audience. General and specific guidelines for publishing feature articles, health tips, letters to the editor, and other publishing possibilities are presented.

Brazilian guidelines for diagnosis, treatment and follow-up of primary cutaneous melanoma - Part II*

PubMed Central

Castro, Luiz Guilherme Martins; Bakos, Renato Marchiori; Duprat Neto, João Pedreira; Bittencourt, Flávia Vasques; Giacomo, Thais Helena Bello Di; Serpa, Sérgio Schrader; Messina, Maria Cristina de Lorenzo; Loureiro, Walter Refkalefsky; Macarenco, Ricardo Silvestre e Silva; Stolf, Hamilton Ometto; Gontijo, Gabriel

2016-01-01

The last Brazilian guidelines on melanoma were published in 2002. Development in diagnosis and treatment made updating necessary. The coordinators elaborated ten clinical questions, based on PICO system. A Medline search, according to specific MeSH terms for each of the 10 questions was performed and articles selected were classified from A to D according to level of scientific evidence. Based on the results, recommendations were defined and classified according to scientific strength. The present Guidelines were divided in two parts for editorial and publication reasons. In this second part, the following clinical questions were answered: 1) which patients with primary cutaneous melanoma benefit from sentinel lymph node biopsy? 2) Follow-up with body mapping is indicated for which patients? 3) Is preventive excision of acral nevi beneficious to patients? 4) Is preventive excision of giant congenital nevi beneficious to patients? 5) How should stages 0 and I primary cutaneous melanoma patients be followed? PMID:26982779

Updates in medical malpractice: an otology perspective.

PubMed

Ruhl, Douglas S; Littlefield, Philip D

2015-10-01

Most surgeons at some point are involved in a medical malpractice case. There has been an increase in the number of manuscripts that analyse malpractice databases and insurance claims, as well as commentaries on the current medicolegal climate recently. This manuscript broadly reviews articles of interest to all providers and then focuses on malpractice in otology. Medical malpractice articles (particularly topics related to otologic surgery published within the last 1-2 years) were searched. The growing body of literature can be divided into the themes of general negligence, mitigating injuries and the use of clinical practice guidelines in the courtroom as guidance for expert witnesses. Recent findings suggest that the frequency of malpractice claims may be decreasing. Hearing loss and facial nerve injury are the most common injuries associated with otologic surgery. These injuries can be costly when negligence is found. Clinic practice guidelines are slowly being used as evidence in the courtroom and there are established guidelines that an expert witness must follow should a surgeon be called to give testimony.

Singapore Urological Association Clinical Guidelines for Male Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia.

PubMed

2017-08-01

The first clinical guidelines for male lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) were published in 2005. An update is urgently needed in view of BPH being recognised as one of ten chronic illnesses by the Ministry of Health, Singapore. This review summarises the definition of BPH and the epidemiology of male LUTS/BPH in Singapore. BPH can be phenotyped with noninvasive transabdominal ultrasonography, according to intravesical prostatic protrusion and prostate volume, and classified according to severity (staging) for individualised treatment. At the initial evaluation, the majority of patients (59%) can be managed with fluid adjustment, exercise and diet; 32% with medications, using alpha blockers and/or 5-alpha reductase inhibitors for prostates weighing more than 30 g; and 9% with surgical intervention for more advanced disease. The 2015 guidelines comprise updated evidence that will help family medicine practitioners and specialists manage this common ailment more cost-effectively. Copyright: © Singapore Medical Association.

In-hospital rehabilitation after multiple joint procedures of the lower extremities in haemophilia patients: clinical guidelines for physical therapists.

PubMed

De Kleijn, P; Fischer, K; Vogely, H Ch; Hendriks, C; Lindeman, E

2011-11-01

This project aimed to develop guidelines for use during in-hospital rehabilitation after combinations of multiple joint procedures (MJP) of the lower extremities in persons with haemophilia (PWH). MJP are defined as surgical procedures on the ankles, knees and hips, performed in any combination, staged, or during a single session. MJP that we studied included total knee arthroplasty, total hip arthroplasty and ankle arthrodesis. Literature on rheumatoid arthritis demonstrated promising functional results, fewer hospitalization days and days lost from work. However, the complication rate is higher and rehabilitation needs optimal conditions. Since 1995, at the Van Creveldkliniek, 54 PWH have undergone MJP. During the rehabilitation in our hospital performed by experienced physical therapists, regular guidelines seemed useless. Guidelines will guarantee an optimal physical recovery and maximum benefit from this enormous investment. This will lead to an optimal functional capability and optimal quality of life for this elderly group of PWH. There are no existing guidelines for MJP, in haemophilia, revealed through a review of the literature. Therefore, a working group was formed to develop and implement such guidelines and the procedure is explained. The total group of PWH who underwent MJP is described, subdivided into combinations of joints. For these subgroups, the number of days in hospital, complications and profile at discharge, as well as a guideline on the clinical rehabilitation, are given. It contains a general part and a part for each specific subgroup. © 2011 Blackwell Publishing Ltd.

Japan Society of Gynecologic Oncology guidelines 2013 for the treatment of uterine body neoplasms.

PubMed

Ebina, Yasuhiko; Katabuchi, Hidetaka; Mikami, Mikio; Nagase, Satoru; Yaegashi, Nobuo; Udagawa, Yasuhiro; Kato, Hidenori; Kubushiro, Kaneyuki; Takamatsu, Kiyoshi; Ino, Kazuhiko; Yoshikawa, Hiroyuki

2016-06-01

The third version of the Japan Society of Gynecologic Oncology guidelines for the treatment of uterine body neoplasms was published in 2013. The guidelines comprise nine chapters and nine algorithms. Each chapter includes a clinical question, recommendations, background, objectives, explanations, and references. This revision was intended to collect up-to-date international evidence. The highlights of this revision are to (1) newly specify costs and conflicts of interest; (2) describe the clinical significance of pelvic lymph node dissection and para-aortic lymphadenectomy, including variant histologic types; (3) describe more clearly the indications for laparoscopic surgery as the standard treatment; (4) provide guidelines for post-treatment hormone replacement therapy; (5) clearly differentiate treatment of advanced or recurrent cancer between the initial treatment and the treatment carried out after the primary operation; (6) collectively describe fertility-sparing therapy for both atypical endometrial hyperplasia and endometrioid adenocarcinoma (corresponding to G1) and newly describe relapse therapy after fertility-preserving treatment; and (7) newly describe the treatment of trophoblastic disease. Overall, the objective of these guidelines is to clearly delineate the standard of care for uterine body neoplasms in Japan with the goal of ensuring a high standard of care for all Japanese women diagnosed with uterine body neoplasms.

Functional Hypothalamic Amenorrhea: An Endocrine Society Clinical Practice Guideline.

PubMed

Gordon, Catherine M; Ackerman, Kathryn E; Berga, Sarah L; Kaplan, Jay R; Mastorakos, George; Misra, Madhusmita; Murad, M Hassan; Santoro, Nanette F; Warren, Michelle P

2017-05-01

The American Society for Reproductive Medicine, the European Society of Endocrinology, and the Pediatric Endocrine Society. This guideline was funded by the Endocrine Society. To formulate clinical practice guidelines for the diagnosis and treatment of functional hypothalamic amenorrhea (FHA). The participants include an Endocrine Society-appointed task force of eight experts, a methodologist, and a medical writer. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Endocrine Society committees and members and cosponsoring organizations reviewed and commented on preliminary drafts of this guideline. FHA is a form of chronic anovulation, not due to identifiable organic causes, but often associated with stress, weight loss, excessive exercise, or a combination thereof. Investigations should include assessment of systemic and endocrinologic etiologies, as FHA is a diagnosis of exclusion. A multidisciplinary treatment approach is necessary, including medical, dietary, and mental health support. Medical complications include, among others, bone loss and infertility, and appropriate therapies are under debate and investigation. Copyright © 2017 Endocrine Society

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

A Cost-effectiveness Analysis of Surgery, Endothermal Ablation, Ultrasound-guided Foam Sclerotherapy and Compression Stockings for Symptomatic Varicose Veins.

PubMed

Marsden, G; Perry, M; Bradbury, A; Hickey, N; Kelley, K; Trender, H; Wonderling, D; Davies, A H

2015-12-01

The aim was to investigate the cost-effectiveness of interventional treatment for varicose veins (VV) in the UK NHS, and to inform the national clinical guideline on VV, published by the National Institute of Health and Care Excellence. An economic analysis was constructed to compare the cost-effectiveness of surgery, endothermal ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS), and compression stockings (CS). The analysis was based on a Markov decision model, which was developed in consultation with members of the NICE guideline development group (GDG). The model had a 5-year time horizon, and took the perspective of the UK National Health Service. Clinical inputs were based on a network meta-analysis (NMA), informed by a systematic review of the clinical literature. Outcomes were expressed as costs and quality-adjusted life years (QALYs). All interventional treatments were found to be cost-effective compared with CS at a cost-effectiveness threshold of £20,000 per QALY gained. ETA was found to be the most cost-effective strategy overall, with an incremental cost-effectiveness ratio of £3,161 per QALY gained compared with UGFS. Surgery and CS were dominated by ETA. Interventional treatment for VV is cost-effective in the UK NHS. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is suitable. The results of this research were used to inform recommendations within the NICE guideline on VV. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Improving the quality of health care: using international collaboration to inform guideline programmes by founding the Guidelines International Network (G-I-N)*

PubMed Central

Ollenschlager, G; Marshall, C; Qureshi, S; Rosenbrand, K; Burgers, J; Makela, M; Slutsky, J; t for

2004-01-01



 Clinical practice guidelines are regarded as powerful tools to achieve effective health care. Although many countries have built up experience in the development, appraisal, and implementation of guidelines, until recently there has been no established forum for collaboration at an international level. As a result, in different countries seeking similar goals and using similar strategies, efforts have been unnecessarily duplicated and opportunities for harmonisation lost because of the lack of a supporting organisational framework. This triggered a proposal in 2001 for an international guidelines network built on existing partnerships. A baseline survey confirmed a strong demand for such an entity. A multinational group of guideline experts initiated the development of a non-profit organisation aimed at promotion of systematic guideline development and implementation. The Guidelines International Network (G-I-N) was founded in November 2002. One year later the Network released the International Guideline Library, a searchable database which now contains more than 2000 guideline resources including published guidelines, guidelines under development, "guidelines for guidelines", training materials, and patient information tools. By June 2004, 52 organisations from 27 countries had joined the network including institutions from Oceania, North America, and Europe, and WHO. This paper describes the process that led to the foundation of the G-I-N, its characteristics, prime activities, and ideas on future projects and collaboration. PMID:15576708

Knee osteoarthritis related pain: a narrative review of diagnosis and treatment

PubMed Central

Alshami, Ali M.

2014-01-01

Background Osteoarthritis is a common progressive joint disease, involving not only the joint lining but also cartilage, ligaments, and bone. For the last ten years, majority of published review articles were not specific to osteoarthritis of the knee, and strength of evidence and clinical guidelines were not appropriately summarized. Objectives To appraise the literature by summarizing the findings of current evidence and clinical guidelines on the diagnosis and treatment of knee osteoarthritis pain. Methodology English journal articles that focused on knee osteoarthritis related pain were searched via PubMed (1 January 2002 – 26 August 2012) and Physiotherapy Evidence Database (PEDro) databases, using the terms ‘knee’, ‘osteoarthritis’ and ‘pain’. In addition, reference lists from identified articles and related book chapters were included as comprehensive overviews. Results For knee osteoarthritis, the highest diagnostic accuracy can be achieved by presence of pain and five or more clinical or laboratory criteria plus osteophytes. Some inconsistencies in the recommendations and findings were found between the clinical guidelines and systematic reviews. Generally, paracetamol, oral and topical non-steroidal anti-inflammatory drugs, opioids, corticosteroid injections and physical therapy techniques, such as therapeutic exercises, joint manual therapy and transcutaneous electrical nerve stimulation, can help reduce pain and improve function. Patient education programs and weight reduction for overweight patients are important to be considered. Conclusions Some inconsistencies in the recommendations and findings were found between the clinical guidelines and systematic reviews. However, it is likely that a combination of pharmacological and non-pharmacological treatments is most effective in treating patients with knee osteoarthritis. PMID:24899883

ACR Appropriateness Criteria® Chronic Ankle Pain.

PubMed

Chang, Eric Y; Tadros, Anthony S; Amini, Behrang; Bell, Angela M; Bernard, Stephanie A; Fox, Michael G; Gorbachova, Tetyana; Ha, Alice S; Lee, Kenneth S; Metter, Darlene F; Mooar, Pekka A; Shah, Nehal A; Singer, Adam D; Smith, Stacy E; Taljanovic, Mihra S; Thiele, Ralf; Kransdorf, Mark J

2018-05-01

Chronic ankle pain is a common clinical problem whose cause is often elucidated by imaging. The ACR Appropriateness Criteria for chronic ankle pain define best practices of image ordering. Clinical scenarios are followed by the imaging choices and their appropriateness. The information is in ordered tables with an accompanying narrative explanation to guide physicians to order the right test. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

ACR Appropriateness Criteria® Chronic Hip Pain.

PubMed

Mintz, Douglas N; Roberts, Catherine C; Bencardino, Jenny T; Baccei, Steven J; Caird, Michelle S; Cassidy, R Carter; Chang, Eric Y; Fox, Michael G; Gyftopoulos, Soterios; Kransdorf, Mark J; Metter, Darlene F; Morrison, William B; Rosenberg, Zehava S; Shah, Nehal A; Small, Kirstin M; Subhas, Naveen; Tambar, Siddharth; Towers, Jeffrey D; Yu, Joseph S; Weissman, Barbara N

2017-05-01

Chronic hip pain is a common clinical problem whose cause is often elucidated by imaging. The ACR Appropriateness Criteria for chronic hip pain define best practices of image ordering. Clinical scenarios are followed by the imaging choices and their appropriateness. The information is in ordered tables with an accompanying narrative explanation to guide physicians to order the right test. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer-reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Justice in international clinical research.

PubMed

Pratt, Bridget; Loff, Bebe

2011-08-01

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines. © 2010 Blackwell Publishing Ltd.

Managing Cardiovascular Disease Risk in Rheumatoid Arthritis: Clinical Updates and Three Strategic Approaches.

PubMed

Chodara, Ann M; Wattiaux, Aimée; Bartels, Christie M

2017-04-01

ᅟ: The increase in cardiovascular disease (CVD) risk in rheumatoid arthritis (RA) is well known; however, appropriate management of this elevated risk in rheumatology clinics is less clear. By critically reviewing literature published within the past 5 years, we aim to clarify current knowledge and gaps regarding CVD risk management in RA. We examine recent guidelines, recommendations, and evidence and discuss three approaches: (1) RA-specific management including treat-to-target and medication management, (2) assessment of comprehensive individual risk, and (3) targeting traditional CVD risk factors (hypertension, smoking, hyperlipidemia, diabetes, obesity, and physical inactivity) at a population level. Considering that 75% of US RA visits occur in specialty clinics, further research is needed regarding evidence-based strategies to manage and reduce CVD risk in RA. This review highlights clinical updates including US cardiology and international professional society guidelines, successful evidence-based population approaches from primary care, and novel opportunities in rheumatology care to reduce CVD risk in RA.

Guidelines for vaccination of dogs and cats in Korea.

PubMed

Song, Woo-Jin; Kim, Hyun-Tae; Yoo, Han-Sang; Youn, Hwa-Young

2014-07-01

This guideline contains the recommended vaccination schedules of dogs and cats from World Small Animal Veterinary Association (WSAVA) and American Animal Hospital Association (AAHA). In 2010, WSAVA published guidelines for the vaccination of dogs and cats. And, in 2011, AAHA also published guidelines for vaccination of dogs. In Korea, there is no published guideline for vaccination of dogs and cats yet. Therefore, the plane of vaccination also reports the present situation of vaccination schedule of dogs and cats in Korean animal hospitals.

Prevention of venous thromboembolism in hospitalized patients: analysis of reduced cost and improved clinical outcomes.

PubMed

Duff, Jed; Walker, Kim; Omari, Abdullah; Stratton, Charlie

2013-03-01

The impact of implementing a guideline on venous thromboembolism (VTE) prophylaxis was evaluated in a metropolitan private hospital with a before- and after-intervention study. This subsequent study aimed to identify if improved prophylaxis rates translated into cost savings and improved clinical outcomes. A conceptual decision-tree analytical model incorporating local treatment algorithms and clinical trial data was used to compare prophylaxis costs and clinical outcomes before and after the guideline implementation. The study analyzed data from 21,942 medical and surgical patients admitted to a 250-bed acute-care private hospital in Sydney, Australia. The modeled simulation estimated the incidence of symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as adverse events such as heparin-induced thrombocytopenia (HIT), post-thrombotic syndrome (PTS), major bleeding, and mortality. The costs of prophylaxis therapy and treating adverse events were also calculated. The improvement in prophylaxis rates following the implementation of the guideline was estimated to result in 13 fewer deaths, 84 fewer symptomatic DVTs, 19 fewer symptomatic PEs, and 512 fewer hospital-bed days. Improved adherence to evidence-based prophylaxis regimens was associated with overall cost savings of $245,439 over 12 months. We conclude that improved adherence to evidence-based guidelines for VTE prophylaxis is achievable and is likely to result in fewer deaths, fewer VTE events, and a significant overall cost saving. Copyright © 2013 Society for Vascular Nursing, Inc. Published by Mosby, Inc. All rights reserved.

Community-based preventive activities in the Public Dental Service in Norway.

PubMed

Widström, E; Tillberg, A; Byrkjeflot, L I; Stein, L; Skudutyte-Rysstad, R

2018-05-01

The purpose of this study was to describe community-based preventive interventions undertaken by the dental team outside the dental clinics in Norway, from the dental hygienists' and the dentists' perspective, with the main focus on target groups and existing guidelines and routines for these activities. A secondary aim was to identify the personnel responsible for developing the local guidelines and the knowledge sources for the guidelines. With the assistance of the Chief Dental Officers in 15 Public Dental Service (PDS) regions, questionnaires were emailed to the local clinics (n = 421). In each, the most experienced dental hygienist and dentist were asked to respond; 215 dentists and 166 and dental hygienists responded (60%). Almost 40% of the respondents reported that their clinic had guidelines on community-based activities conducted outside the clinics. Dental hygienists and local chief dentists were responsible for planning them. The main target groups were young children and the dependent elderly; the majority of the activities were carried out at child welfare centres and for personnel at nursing homes or for home care nurses. At the regional and local level, a more strategic and coordinated approach to the provision of community-based activities is needed, including assessment of oral health needs among population groups. Continuous documentation and evaluation of results are necessary for optimal use of available resources and to facilitate an evidence-based approach. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

Van de Velde, Joris, E-mail: joris.vandevelde@ugent.be; Department of Radiotherapy, Ghent University, Ghent; Audenaert, Emmanuel

Purpose: To develop contouring guidelines for the brachial plexus (BP) using anatomically validated cadaver datasets. Magnetic resonance imaging (MRI) and computed tomography (CT) were used to obtain detailed visualizations of the BP region, with the goal of achieving maximal inclusion of the actual BP in a small contoured volume while also accommodating for anatomic variations. Methods and Materials: CT and MRI were obtained for 8 cadavers positioned for intensity modulated radiation therapy. 3-dimensional reconstructions of soft tissue (from MRI) and bone (from CT) were combined to create 8 separate enhanced CT project files. Dissection of the corresponding cadavers anatomically validatedmore » the reconstructions created. Seven enhanced CT project files were then automatically fitted, separately in different regions, to obtain a single dataset of superimposed BP regions that incorporated anatomic variations. From this dataset, improved BP contouring guidelines were developed. These guidelines were then applied to the 7 original CT project files and also to 1 additional file, left out from the superimposing procedure. The percentage of BP inclusion was compared with the published guidelines. Results: The anatomic validation procedure showed a high level of conformity for the BP regions examined between the 3-dimensional reconstructions generated and the dissected counterparts. Accurate and detailed BP contouring guidelines were developed, which provided corresponding guidance for each level in a clinical dataset. An average margin of 4.7 mm around the anatomically validated BP contour is sufficient to accommodate for anatomic variations. Using the new guidelines, 100% inclusion of the BP was achieved, compared with a mean inclusion of 37.75% when published guidelines were applied. Conclusion: Improved guidelines for BP delineation were developed using combined MRI and CT imaging with validation by anatomic dissection.« less

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.

A selective annotated bibliography for clinical audiology (1989-2009): books.

PubMed

Ferrer-Vinent, Susan T; Ferrer-Vinent, Ignacio J

2010-12-01

This is the 2nd in a series of 3 planned companion articles that present a selected, annotated, and indexed bibliography of clinical audiology publications from 1989 through 2009. Research and preparation of the bibliography were based on published guidelines, professional audiology experience, and professional librarian experience. The first article in the series covered reference works. This article focuses on other books. The planned third companion article will present periodicals and online resources. Audiologists and librarians can use this bibliography to help them identify relevant clinical audiology literature.

Dutch guideline for clinical foetal-neonatal and paediatric post-mortem radiology, including a review of literature.

PubMed

Sonnemans, L J P; Vester, M E M; Kolsteren, E E M; Erwich, J J H M; Nikkels, P G J; Kint, P A M; van Rijn, R R; Klein, W M

2018-06-01

Clinical post-mortem radiology is a relatively new field of expertise and not common practice in most hospitals yet. With the declining numbers of autopsies and increasing demand for quality control of clinical care, post-mortem radiology can offer a solution, or at least be complementary. A working group consisting of radiologists, pathologists and other clinical medical specialists reviewed and evaluated the literature on the diagnostic value of post-mortem conventional radiography (CR), ultrasonography, computed tomography (PMCT), magnetic resonance imaging (PMMRI), and minimally invasive autopsy (MIA). Evidence tables were built and subsequently a Dutch national evidence-based guideline for post-mortem radiology was developed. We present this evaluation of the radiological modalities in a clinical post-mortem setting, including MIA, as well as the recently published Dutch guidelines for post-mortem radiology in foetuses, neonates, and children. In general, for post-mortem radiology modalities, PMMRI is the modality of choice in foetuses, neonates, and infants, whereas PMCT is advised in older children. There is a limited role for post-mortem CR and ultrasonography. In most cases, conventional autopsy will remain the diagnostic method of choice. Based on a literature review and clinical expertise, an evidence-based guideline was developed for post-mortem radiology of foetal, neonatal, and paediatric patients. What is Known: • Post-mortem investigations serve as a quality check for the provided health care and are important for reliable epidemiological registration. • Post-mortem radiology, sometimes combined with minimally invasive techniques, is considered as an adjunct or alternative to autopsy. What is New: • We present the Dutch guidelines for post-mortem radiology in foetuses, neonates and children. • Autopsy remains the reference standard, however minimal invasive autopsy with a skeletal survey, post-mortem computed tomography, or post-mortem magnetic resonance imaging can be complementary thereof.

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

PubMed

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

2014-12-01

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

Plantar Fasciitis: Will Physical Therapy Help My Foot Pain?

PubMed

2017-02-01

One out of 10 people in the United States experience persistent pain along the bottom of the foot, a condition known as plantar fasciitis. In 2014, the Orthopaedic Section of the American Physical Therapy Association published updated clinical practice guidelines on the best treatments for patients with plantar fasciitis. The guidelines present evidence that strongly suggests a combination of manual therapy and rehabilitative exercises to help patients with this foot condition. In a more recent study published in the February 2017 issue of JOSPT, researchers reviewed the records of people with plantar fasciitis who were sent to physical therapy. The results of this study support prior studies that show faster recovery time for those who receive evidence-based physical therapy for their foot pain. J Orthop Sports Phys Ther 2017;47(2):56. doi:10.2519/jospt.2017.0501.

Guideline-adherence and perspectives in the acute management of unstable angina - Initial results from the German chest pain unit registry.

PubMed

Breuckmann, Frank; Hochadel, Matthias; Darius, Harald; Giannitsis, Evangelos; Münzel, Thomas; Maier, Lars S; Schmitt, Claus; Schumacher, Burghard; Heusch, Gerd; Voigtländer, Thomas; Mudra, Harald; Senges, Jochen

2015-08-01

We investigated the current management of unstable angina pectoris (UAP) in certified chest pain units (CPUs) in Germany and focused on the European Society of Cardiology (ESC) guideline-adherence in the timing of invasive strategies or choice of conservative treatment options. More specifically, we analyzed differences in clinical outcome with respect to guideline-adherence. Prospective data from 1400 UAP patients were collected. Analyses of high-risk criteria with indication for invasive management and 3-month clinical outcome data were performed. Guideline-adherence was tested for a primarily conservative strategy as well as for percutaneous coronary intervention (PCI) within <24 and <72h after admission. Overall guideline-conforming management was performed in 38.2%. In UAP patients at risk, undertreatment caused by an insufficient consideration of risk criteria was obvious in 78%. Reciprocally, overtreatment in the absence of adequate risk markers was performed in 27%, whereas a guideline-conforming primarily conservative strategy was chosen in 73% of the low-risk patients. Together, the 3-month major adverse coronary and cerebrovascular events (MACCE) were low (3.6%). Nonetheless, guideline-conforming treatment was even associated with significantly lower MACCE rates (1.6% vs. 4.0%, p<0.05). The data suggest an inadequate adherence to ESC guidelines in nearly two thirds of the patients, particularly in those patients at high to intermediate risk with secondary risk factors, emphasizing the need for further attention to consistent risk profiling in the CPU and its certification process. Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Use of systematic reviews in clinical practice guidelines: case study of smoking cessation

PubMed Central

Silagy, C A; Stead, L F; Lancaster, T

2001-01-01

Objective To examine the extent to which recommendations in the national guidelines for the cessation of smoking are based on evidence from systematic reviews of controlled trials. Design Retrospective analysis of recommendations for the national guidelines for the cessation of smoking. Materials National guidelines in clinical practice on smoking cessation published in English. Main outcome measures The type of evidence (systematic review of controlled trials, individual trials, other studies, expert opinion) used to support each recommendation. We also assessed whether a Cochrane systematic review was available and could have been used in formulating the recommendation. Results Four national smoking cessation guidelines (from Canada, New Zealand, the United Kingdom, and the United States) covering 105 recommendations were identified. An explicit evidence base for 100%, 89%, 68%, and 98% of recommendations, respectively, was detected, of which 60%, 56%, 59%, and 47% were based on systematic reviews of controlled studies. Cochrane systematic reviews could have been used to develop between 39% and 73% of recommendations but were actually used in 0% to 36% of recommendations. The UK guidelines had the highest proportion of recommendations based on Cochrane systematic reviews. Conclusions Use of systematic reviews in guidelines is a measure of the “payback” on investment in research synthesis. Systematic reviews commonly underpinned recommendations in guidelines on smoking cessation. The extent to which they were used varied by country and there was evidence of duplication of effort in some areas. Greater international collaboration in developing and maintaining an evidence base of systematic reviews can improve the efficiency of use of research resources. PMID:11597966

Can the publication of guidelines change the management of early rheumatoid arthritis? An interrupted time series analysis from the United Kingdom.

PubMed

Judge, Andrew; Wallace, Gemma; Prieto-Alhambra, Dani; Arden, Nigel K; Edwards, Christopher J

2015-12-01

To assess whether publication of national treatment guidelines improved the management of early RA in the UK. Incident diagnoses of RA in persons aged over 18 years from 1995 to 2010 were identified from the Clinical Practice Research Datalink. Using a natural experimental study design, interrupted time series analysis was used to assess whether trends in the proportion of patients receiving DMARDs, within 3 and 12 months of diagnosis, changed following publication of British Society for Rheumatology guidelines in 2006. Between 1995 and 2010, 11 772 incident cases of RA were identified. There was a progressive increase in the proportion of patients prescribed any DMARD within 12 months from 43.3% in 1995 to 78.5% in 2010. After publication of the British Society for Rheumatology guidelines, the proportion of patients prescribed any DMARD within 12 months increased by 4.2% (P = 0.053). Prior to the guidance, prescribing was increasing by 1.64% per year, compared with 3.55% per year after publication (P < 0.001). Guidelines published by a national body can improve the proportion of patients receiving DMARD treatment in the first year after diagnosis of RA. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Adherence to the Otitis Media with Effusion Clinical Practice Guideline by Providers in a United States Air Force Medical Treatment Facility

DTIC Science & Technology

1999-05-07

making. The United States Agency for Health Care Policy and Research published the Otitis Media with Effusion (OME) in Young Children Clinical Practice...diagnosed with otitis media were audited using a checklist developed from the treatment algorithm. Twenty-three of these children had OME. Using summary...of pneumatic otoscopy and/or tympanometry to evaluate the tympanic membrane for OME and acute otitis media .

[Clinical practice guidelines in Peru: evaluation of its quality using the AGREE II instrument].

PubMed

Canelo-Aybar, Carlos; Balbin, Graciela; Perez-Gomez, Ángela; Florez, Iván D

2016-01-01

To evaluate the methodological quality of clinical practice guidelines (CPGs) put into practice by the Peruvian Ministry of Health (MINSA), 17 CPGs from the ministry, published between 2009 and 2014, were independently evaluated by three methodologic experts using the AGREE II instrument. The score of AGREE II domains was low and very low in all CPGs: scope and purpose (medium, 44%), clarity of presentation (medium, 47%), participation of decision-makers (medium, 8%), methodological rigor (medium, 5%), applicability (medium, 5%), and editorial independence (medium, 8%). In conclusion, the methodological quality of CPGs implemented by the MINSA is low. Consequently, its use could not be recommended. The implementation of the methodology for the development of CPGs described in the recentlypublished CPG methodological preparation manual in Peru is a pressing need.

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

PubMed

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

2017-12-01

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

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

PubMed

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

2014-01-01

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

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

PubMed

Siering, Ulrich; Rüther, Alric

2014-01-01

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

Thromboembolism prophylaxis in patients with Philadelphia-negative myeloproliferative neoplasms-Clinical practice among Nordic specialists.

PubMed

Bjerrum, Ole Weis; Samuelsson, Jan; Ghanima, Waleed; Kauppila, Marjut; Andersen, Christen Lykkegaard

2018-05-01

Patients with Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs) have higher risks of developing thromboembolisms compared to the general population. International guidelines on the management of MPNs therefore include recommendations concerning thromboembolism prophylaxis. In clinical practice, strict adherence to guidelines may be challenging and dependent on factors such as physician experience, outpatient clinic setting, and access to therapy; however, no data exist on physician adherence or patient compliance to thromboembolism prophylaxis in MPNs. The Nordic Myeloproliferative Neoplasm Study Group (NMPN) performed a survey among Nordic hematology specialists with the aim of documenting the implementation of international recommendations in a region of Northern Europe with similar healthcare systems. The study showed that Nordic specialists managed their patients in accordance with international guidelines concerning medical intervention, but to a lesser degree regarding the management of additional cardiovascular risk factors. The survey also drew attention to the common clinical dilemma of combining antiaggregatory agents with vitamin K antagonists (VKA), or novel oral anticoagulants (NOAC), as well as phlebotomy limits in female polycythemia vera patients. The results of this study highlight the importance of considering all risk factors for thrombosis and an optimal collaboration with the primary healthcare sector. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema.

PubMed

Aiello, Lloyd Paul; Beck, Roy W; Bressler, Neil M; Browning, David J; Chalam, K V; Davis, Matthew; Ferris, Frederick L; Glassman, Adam R; Maturi, Raj K; Stockdale, Cynthia R; Topping, Trexler M

2011-12-01

To describe the underlying principles used to develop a web-based algorithm that incorporated intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in a Diabetic Retinopathy Clinical Research Network (DRCR.net) randomized clinical trial. Discussion of treatment protocol for DME. Subjects with vision loss resulting from DME involving the center of the macula. The DRCR.net created an algorithm incorporating anti-VEGF injections in a comparative effectiveness randomized clinical trial evaluating intravitreal ranibizumab with prompt or deferred (≥24 weeks) focal/grid laser treatment in eyes with vision loss resulting from center-involved DME. Results confirmed that intravitreal ranibizumab with prompt or deferred laser provides superior visual acuity outcomes compared with prompt laser alone through at least 2 years. Duplication of this algorithm may not be practical for clinical practice. To share their opinion on how ophthalmologists might emulate the study protocol, participating DRCR.net investigators developed guidelines based on the algorithm's underlying rationale. Clinical guidelines based on a DRCR.net protocol. The treatment protocol required real-time feedback from a web-based data entry system for intravitreal injections, focal/grid laser treatment, and follow-up intervals. Guidance from this system indicated whether treatment was required or given at investigator discretion and when follow-up should be scheduled. Clinical treatment guidelines, based on the underlying clinical rationale of the DRCR.net protocol, include repeating treatment monthly as long as there is improvement in edema compared with the previous month or until the retina is no longer thickened. If thickening recurs or worsens after discontinuing treatment, treatment is resumed. Duplication of the approach used in the DRCR.net randomized clinical trial to treat DME involving the center of the macula with intravitreal ranibizumab may not be practical in clinical practice, but likely can be emulated based on an understanding of the underlying rationale for the study protocol. Inherent differences between a web-based treatment algorithm and a clinical approach may lead to differences in outcomes that are impossible to predict. The closer the clinical approach is to the algorithm used in the study, the more likely the outcomes will be similar to those published. Proprietary or commercial disclosure may be found after the references. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Antimicrobial Susceptibility Testing, Drug Resistance Mechanisms, and Therapy of Infections with Nontuberculous Mycobacteria

PubMed Central

Nash, Kevin A.; Wallace, Richard J.

2012-01-01

Summary: Within the past 10 years, treatment and diagnostic guidelines for nontuberculous mycobacteria have been recommended by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA). Moreover, the Clinical and Laboratory Standards Institute (CLSI) has published and recently (in 2011) updated recommendations including suggested antimicrobial and susceptibility breakpoints. The CLSI has also recommended the broth microdilution method as the gold standard for laboratories performing antimicrobial susceptibility testing of nontuberculous mycobacteria. This article reviews the laboratory, diagnostic, and treatment guidelines together with established and probable drug resistance mechanisms of the nontuberculous mycobacteria. PMID:22763637

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

PubMed

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

2016-08-01

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

2017 HIVMA of IDSA Clinical Practice Guideline for the Management of Chronic Pain in Patients Living With HIV.

PubMed

Bruce, R Douglas; Merlin, Jessica; Lum, Paula J; Ahmed, Ebtesam; Alexander, Carla; Corbett, Amanda H; Foley, Kathleen; Leonard, Kate; Treisman, Glenn Jordan; Selwyn, Peter

2017-10-30

Pain has always been an important part of human immunodeficiency virus (HIV) disease and its experience for patients. In this guideline, we review the types of chronic pain commonly seen among persons living with HIV (PLWH) and review the limited evidence base for treatment of chronic noncancer pain in this population. We also review the management of chronic pain in special populations of PLWH, including persons with substance use and mental health disorders. Finally, a general review of possible pharmacokinetic interactions is included to assist the HIV clinician in the treatment of chronic pain in this population.It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The Infectious Diseases Society of American considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Timing of dialysis initiation, duration and frequency of hemodialysis sessions, and membrane flux: a systematic review for a KDOQI clinical practice guideline.

PubMed

Slinin, Yelena; Greer, Nancy; Ishani, Areef; MacDonald, Roderick; Olson, Carin; Rutks, Indulis; Wilt, Timothy J

2015-11-01

In 2006, NKF-KDOQI (National Kidney Foundation-Kidney Disease Outcomes Quality Initiative) published clinical practice guidelines for hemodialysis adequacy. Recent studies evaluating hemodialysis adequacy as determined by initiation timing, frequency, duration, and membrane type and prompted an update to the guideline. Systematic review and evidence synthesis. Patients with advanced chronic kidney disease receiving hemodialysis. We screened publications from 2000 to March 2014, systematic reviews, and references and consulted the NKF-KDOQI Hemodialysis Adequacy Work Group members. We included randomized or controlled clinical trials in patients undergoing long-term hemodialysis if they reported outcomes of interest. Early versus late dialysis therapy initiation; more frequent (>3 times a week) or longer duration (>4.5 hours) compared to conventional hemodialysis; low- versus high-flux dialyzer membranes. All-cause and cardiovascular mortality, myocardial infarction, stroke, hospitalizations, quality of life, depression or cognitive function scores, blood pressure, number of antihypertensive medications, left ventricular mass, interdialytic weight gain, and harms or complications related to vascular access or the process of dialysis. We included 32 articles reporting on 19 trials. Moderate-quality evidence indicated that earlier dialysis therapy initiation (at estimated creatinine clearance [eClcr] of 10-14mL/min) did not reduce mortality compared to later initiation (eClcr of 5-7mL/min). More than thrice-weekly hemodialysis and extended-length hemodialysis during a short follow-up did not improve clinical outcomes compared to conventional hemodialysis and resulted in a greater number of vascular access procedures (very low-quality evidence). Hemodialysis using high-flux membranes did not reduce all-cause mortality, but reduced cardiovascular mortality compared to hemodialysis using low-flux membranes (moderate-quality evidence). Few studies were adequately powered to evaluate mortality. Heterogeneity of study designs and interventions precluded pooling data for most outcomes. Limited data indicate that earlier dialysis therapy initiation and more frequent and longer hemodialysis did not improve clinical outcomes compared to conventional hemodialysis. Published by Elsevier Inc.