The development of evidence-based guidelines in dentistry.

PubMed

Faggion, C M

2013-02-01

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

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

PubMed Central

López, Andrea; Black, Karen; Schillinger, Dean

2011-01-01

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

Gender Parity in Critical Care Medicine.

PubMed

Mehta, Sangeeta; Burns, Karen E A; Machado, Flavia R; Fox-Robichaud, Alison E; Cook, Deborah J; Calfee, Carolyn S; Ware, Lorraine B; Burnham, Ellen L; Kissoon, Niranjan; Marshall, John C; Mancebo, Jordi; Finfer, Simon; Hartog, Christiane; Reinhart, Konrad; Maitland, Kathryn; Stapleton, Renee D; Kwizera, Arthur; Amin, Pravin; Abroug, Fekri; Smith, Orla; Laake, Jon H; Shrestha, Gentle S; Herridge, Margaret S

2017-08-15

Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. These documents inform and shape patient care around the world. In this Perspective we discuss the importance of diversity on guideline panels, the disproportionately low representation of women on critical care guideline panels, and existing initiatives to increase the representation of women in corporations, universities, and government. We propose five strategies to ensure gender parity within critical care medicine.

[Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research and commentary].

PubMed

Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

2011-07-01

This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

[Draft of guidelines for human body dissection for clinical anatomy education and research and commentary].

PubMed

Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

2011-06-01

This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

Clinical Practice Guidelines for Delirium Management: Potential Application in Palliative Care

PubMed Central

Bush, Shirley H.; Bruera, Eduardo; Lawlor, Peter G.; Kanji, Salmaan; Davis, Daniel H.J.; Agar, Meera; Wright, David; Hartwick, Michael; Currow, David C.; Gagnon, Bruno; Simon, Jessica; Pereira, José L.

2014-01-01

Context Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. Objectives This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. Methods We searched PubMed (1990–2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. Results There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from “expert opinion” for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Conclusion Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. PMID:24766743

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.

Reporting Items for Updated Clinical Guidelines: Checklist for the Reporting of Updated Guidelines (CheckUp)

PubMed Central

Vernooij, Robin W. M.; Alonso-Coello, Pablo; Brouwers, Melissa

2017-01-01

Background Scientific knowledge is in constant development. Consequently, regular review to assure the trustworthiness of clinical guidelines is required. However, there is still a lack of preferred reporting items of the updating process in updated clinical guidelines. The present article describes the development process of the Checklist for the Reporting of Updated Guidelines (CheckUp). Methods and Findings We developed an initial list of items based on an overview of research evidence on clinical guideline updating, the Appraisal of Guidelines for Research and Evaluation (AGREE) II Instrument, and the advice of the CheckUp panel (n = 33 professionals). A multistep process was used to refine this list, including an assessment of ten existing updated clinical guidelines, interviews with key informants (response rate: 54.2%; 13/24), a three-round Delphi consensus survey with the CheckUp panel (33 participants), and an external review with clinical guideline methodologists (response rate: 90%; 53/59) and users (response rate: 55.6%; 10/18). CheckUp includes 16 items that address (1) the presentation of an updated guideline, (2) editorial independence, and (3) the methodology of the updating process. In this article, we present the methodology to develop CheckUp and include as a supplementary file an explanation and elaboration document. Conclusions CheckUp can be used to evaluate the completeness of reporting in updated guidelines and as a tool to inform guideline developers about reporting requirements. Editors may request its completion from guideline authors when submitting updated guidelines for publication. Adherence to CheckUp will likely enhance the comprehensiveness and transparency of clinical guideline updating for the benefit of patients and the public, health care professionals, and other relevant stakeholders. PMID:28072838

Coronary artery aneurysms in acute coronary syndrome: case series, review, and proposed management strategy.

PubMed

Boyer, Nathan; Gupta, Rajesh; Schevchuck, Alex; Hindnavis, Vindhya; Maliske, Seth; Sheldon, Mark; Drachman, Douglas; Yeghiazarians, Yerem

2014-06-01

Coronary artery aneurysm (CAA) is an uncommon clinical finding, with an incidence varying from 1.5%-4.9% in adults, and is usually considered a variant of coronary artery disease (CAD). CAA identified in the context of acute coronary syndrome (ACS) represents a unique management challenge, particularly if the morphology of the CAA is suspected to have provoked the acute clinical syndrome. CAA is associated with thrombus formation due to abnormal laminar flow, as well as abnormal platelet and endothelial-derived pathophysiologic factors within the CAA. Once formed, mural thrombus may potentiate the deposition of additional thrombus within aneurysmal segments. Percutaneous revascularization of CAA has been associated with complications including distal embolization of thrombus, no-reflow phenomenon, stent malapposition, dissection, and rupture. Presently, there are no formal guidelines to direct the management of CAA in patients presenting with ACS; controversies exist whether conservative, surgical, or catheter-based management should be pursued. In this manuscript, we present an extensive review of the existing literature and associated clinical guidelines, and propose a management algorithm for patients with this complex clinical scenario. Armed with this perspective, therapeutic decisions may be tailored to synthesize patient factors and preferences, individualized clinical assessment, and existing American Heart Association/American College of Cardiology guidelines for management of ACS.

Guideline funding and conflicts of interest: article 4 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Boyd, Elizabeth A; Akl, Elie A; Baumann, Michael; Curtis, J Randall; Field, Marilyn J; Jaeschke, Roman; Osborne, Molly; Schünemann, Holger J

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence. This is the fourth of a series of 14 articles prepared to advise guideline developers in respiratory and other disease. It focuses on commercial funding of guidelines and managing conflict of interest effectively in the context of guidelines. In this review, we addressed the following topics and questions. (1) How are clinical practice guidelines funded? (2) What are the risks associated with commercial sponsorship of guidelines? (3) What relationships should guideline committee members be required to disclose? (4) What is the most efficient way to obtain complete and accurate disclosures? (5) How should disclosures be publicly shared? (6) When do relationships require management? (7) How should individual conflicts of interest be managed? (8) How could conflict of interest policies be enforced? The literature review included a search of PubMed and other databases for existing systematic reviews and relevant methodological research. Our conclusions are based on available evidence, consideration of what guideline developers are doing, and workshop discussions. Professional societies often depend on industry funding to support clinical practice guideline development. In addition, members of guideline committees frequently have financial relationships with commercial entities, are invested in their intellectual work, or have conflicts related to clinical revenue streams. No systematic reviews or other rigorous evidence regarding best practices for funding models, disclosure mechanisms, management strategies, or enforcement presently exist, but the panel drew several conclusions that could improve transparency and process.

Clinical practice guidelines for delirium management: potential application in palliative care.

PubMed

Bush, Shirley H; Bruera, Eduardo; Lawlor, Peter G; Kanji, Salmaan; Davis, Daniel H J; Agar, Meera; Wright, David Kenneth; Hartwick, Michael; Currow, David C; Gagnon, Bruno; Simon, Jessica; Pereira, José L

2014-08-01

Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. We searched PubMed (1990-2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from "expert opinion" for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Clinical guidelines and practice: in search of the truth.

PubMed

Kereiakes, Dean J; Antman, Elliott M

2006-09-19

Data from randomized clinical trials, non-randomized studies, and registries, as well as expert panel consensus are appropriately weighted and woven into the context of clinical practice guidelines. Recent guidelines for the care of patients with ischemic heart disease have emphasized both risk stratification and early coronary angiography with revascularization of patients with high-risk indicators. Advances in our understanding of the pathogenesis of acute coronary syndromes and the dynamics of therapeutic innovation (improvement in catheter-based technologies and adjunctive pharmacotherapy) mandate the timely update and revision of practice guidelines. We believe that the weight of evidence remains clearly in support of an early invasive treatment strategy based on risk stratification. Arguments regarding treatment strategy (invasive vs. conservative) are misguided, and greater focus should be placed on improving the treatment-risk paradox demonstrated in clinical practice as well as on strategies to enhance current guideline compliance and utilization. Interest exists in establishing regional centers of excellence for care of patients with acute ischemic heart disease, analogous to the regionalized approach already established for patients with trauma or stroke. This approach is supported by data that demonstrate an inverse relationship between both institutional and operator procedural volumes and mortality, as well as by existing constraints in resources such as specialized nurses and subspecialty-trained physicians. It is appropriate at this time to briefly review specific aspects of the American College of Cardiology/American Heart Association practice guidelines and the current process of care for acute ischemic heart disease.

Enteral Formulas in Nutrition Support Practice: Is There a Better Choice for Your Patient?

PubMed

Escuro, Arlene A; Hummell, A Christine

2016-12-01

Over the past few decades, the number of enteral formulas for use in hospitalized, critically ill, and home enteral patients has dramatically increased. Several enteral nutrition (EN) formula categories exist, which makes it challenging for clinicians to sort through the product claims and find the appropriate formula for the patient. Many formulas are available within each category, some of which may be significantly different from one another. Numerous systematic reviews of existing research and clinical practice guidelines evaluate the use of specialty formulas. This review aims to examine the differences in various enteral formula categories, identify applications in clinical practice, and evaluate the existing evidence and guideline recommendations for use of specific types of enteral formulas.

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.

The McGill Interactive Pediatric OncoGenetic Guidelines: An approach to identifying pediatric oncology patients most likely to benefit from a genetic evaluation.

PubMed

Goudie, Catherine; Coltin, Hallie; Witkowski, Leora; Mourad, Stephanie; Malkin, David; Foulkes, William D

2017-08-01

Identifying cancer predisposition syndromes in children with tumors is crucial, yet few clinical guidelines exist to identify children at high risk of having germline mutations. The McGill Interactive Pediatric OncoGenetic Guidelines project aims to create a validated pediatric guideline in the form of a smartphone/tablet application using algorithms to process clinical data and help determine whether to refer a child for genetic assessment. This paper discusses the initial stages of the project, focusing on its overall structure, the methodology underpinning the algorithms, and the upcoming algorithm validation process. © 2017 Wiley Periodicals, Inc.

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.

Do Clinical Practice Guidelines Improve Quality?

PubMed

Baldassari, Cristina M

2017-07-01

Controversy exists surrounding how to best define and assess quality in the health care setting. Clinical practice guidelines (CPGs) have been developed to improve the quality of medical care by highlighting key clinical recommendations based on recent evidence. However, data linking CPGs to improvements in outcomes in otolaryngology are lacking. Numerous barriers contribute to difficulties in translating CPGs to improvements in quality. Future initiatives are needed to improve CPG adherence and define the impact of CPG recommendations on the quality of otolaryngologic care provided to our patients.

Regulations and guidelines governing stem cell based products: Clinical considerations

PubMed Central

George, Bobby

2011-01-01

The use of stem cells as medicines is a promising and upcoming area of research as they may be able to help the body to regenerate damaged or lost tissue in a host of diseases like Parkinson′s, multiple sclerosis, heart disease, liver disease, spinal cord damage, cancer and many more. Translating basic stem cell research into routine therapies is a complex multi-step process which entails the challenge related to managing the expected therapeutic benefits with the potential risks while complying with the existing regulations and guidelines. While in the United States (US) and European Union (EU) regulations are in place, in India, we do not have a well-defined regulatory framework for “stem cell based products (SCBP)”. There are several areas that need to be addressed as it is quite different from that of pharmaceuticals. These range from establishing batch consistency, product stability to product safety and efficacy through pre-clinical, clinical studies and marketing authorization. This review summarizes the existing regulations/guidelines in US, EU, India, and the associated challenges in developing SCBP with emphasis on clinical aspects. PMID:21897884

A scalable architecture for incremental specification and maintenance of procedural and declarative clinical decision-support knowledge.

PubMed

Hatsek, Avner; Shahar, Yuval; Taieb-Maimon, Meirav; Shalom, Erez; Klimov, Denis; Lunenfeld, Eitan

2010-01-01

Clinical guidelines have been shown to improve the quality of medical care and to reduce its costs. However, most guidelines exist in a free-text representation and, without automation, are not sufficiently accessible to clinicians at the point of care. A prerequisite for automated guideline application is a machine-comprehensible representation of the guidelines. In this study, we designed and implemented a scalable architecture to support medical experts and knowledge engineers in specifying and maintaining the procedural and declarative aspects of clinical guideline knowledge, resulting in a machine comprehensible representation. The new framework significantly extends our previous work on the Digital electronic Guidelines Library (DeGeL) The current study designed and implemented a graphical framework for specification of declarative and procedural clinical knowledge, Gesher. We performed three different experiments to evaluate the functionality and usability of the major aspects of the new framework: Specification of procedural clinical knowledge, specification of declarative clinical knowledge, and exploration of a given clinical guideline. The subjects included clinicians and knowledge engineers (overall, 27 participants). The evaluations indicated high levels of completeness and correctness of the guideline specification process by both the clinicians and the knowledge engineers, although the best results, in the case of declarative-knowledge specification, were achieved by teams including a clinician and a knowledge engineer. The usability scores were high as well, although the clinicians' assessment was significantly lower than the assessment of the knowledge engineers.

Genetic testing of aetiology of intellectual disability in a dedicated physical healthcare outpatient clinic for adults with intellectual disability.

PubMed

Wallace, R A

2016-02-01

No guidelines exist for assessment of aetiology of intellectual disability in adults with intellectual disability by adult physicians, although robust guidelines exist for paediatric populations. It was speculated that the paediatric guidelines would also be suitable for adults. In rural/regional setting with limited clinical genetics, to perform a quality assurance evaluation on genetics assessment of aetiology of developmental disability in adults attending a dedicated healthcare clinic for adults with intellectual disability, compared results with paediatric standards, speculates if these seem appropriate for adults and speculates on a role for clinical genetics services. Retrospective chart audit of eligible patients looking at genetic clinical assessment, tests selected (molecular karyotype, G banding, metabolics), and yields of positive results. The results were compared with the recommended paediatric guidelines. Of 117 eligible adult patients, ideal genetic history was incomplete for 40% of patients without Down syndrome because of physician cause and lack of information. The number of abnormal genetic results increased from 46% to 66%, mainly from the molecular karyotype, though not all may have been clinically relevant. The improved yield from this test was similar to that in paediatric studies. Use of G banding and metabolic testing could be refined. Improvement can be made in clinical genetic assessment, but results generally support use of molecular karyotyping as first tier testing of cause of unknown intellectual disability in adults, as in the case for paediatric populations. The study highlights a necessary complementary role for clinical geneticists to interpret abnormal results. © 2016 Royal Australasian College of Physicians.

Free and open source enabling technologies for patient-centric, guideline-based clinical decision support: a survey.

PubMed

Leong, T Y; Kaiser, K; Miksch, S

2007-01-01

Guideline-based clinical decision support is an emerging paradigm to help reduce error, lower cost, and improve quality in evidence-based medicine. The free and open source (FOS) approach is a promising alternative for delivering cost-effective information technology (IT) solutions in health care. In this paper, we survey the current FOS enabling technologies for patient-centric, guideline-based care, and discuss the current trends and future directions of their role in clinical decision support. We searched PubMed, major biomedical informatics websites, and the web in general for papers and links related to FOS health care IT systems. We also relied on our background and knowledge for specific subtopics. We focused on the functionalities of guideline modeling tools, and briefly examined the supporting technologies for terminology, data exchange and electronic health record (EHR) standards. To effectively support patient-centric, guideline-based care, the computerized guidelines and protocols need to be integrated with existing clinical information systems or EHRs. Technologies that enable such integration should be accessible, interoperable, and scalable. A plethora of FOS tools and techniques for supporting different knowledge management and quality assurance tasks involved are available. Many challenges, however, remain in their implementation. There are active and growing trends of deploying FOS enabling technologies for integrating clinical guidelines, protocols, and pathways into the main care processes. The continuing development and maturation of such technologies are likely to make increasingly significant contributions to patient-centric, guideline-based clinical decision support.

Requirements for guidelines systems: implementation challenges and lessons from existing software-engineering efforts.

PubMed

Shah, Hemant; Allard, Raymond D; Enberg, Robert; Krishnan, Ganesh; Williams, Patricia; Nadkarni, Prakash M

2012-03-09

A large body of work in the clinical guidelines field has identified requirements for guideline systems, but there are formidable challenges in translating such requirements into production-quality systems that can be used in routine patient care. Detailed analysis of requirements from an implementation perspective can be useful in helping define sub-requirements to the point where they are implementable. Further, additional requirements emerge as a result of such analysis. During such an analysis, study of examples of existing, software-engineering efforts in non-biomedical fields can provide useful signposts to the implementer of a clinical guideline system. In addition to requirements described by guideline-system authors, comparative reviews of such systems, and publications discussing information needs for guideline systems and clinical decision support systems in general, we have incorporated additional requirements related to production-system robustness and functionality from publications in the business workflow domain, in addition to drawing on our own experience in the development of the Proteus guideline system (http://proteme.org). The sub-requirements are discussed by conveniently grouping them into the categories used by the review of Isern and Moreno 2008. We cite previous work under each category and then provide sub-requirements under each category, and provide example of similar work in software-engineering efforts that have addressed a similar problem in a non-biomedical context. When analyzing requirements from the implementation viewpoint, knowledge of successes and failures in related software-engineering efforts can guide implementers in the choice of effective design and development strategies.

Requirements for guidelines systems: implementation challenges and lessons from existing software-engineering efforts

PubMed Central

2012-01-01

Background A large body of work in the clinical guidelines field has identified requirements for guideline systems, but there are formidable challenges in translating such requirements into production-quality systems that can be used in routine patient care. Detailed analysis of requirements from an implementation perspective can be useful in helping define sub-requirements to the point where they are implementable. Further, additional requirements emerge as a result of such analysis. During such an analysis, study of examples of existing, software-engineering efforts in non-biomedical fields can provide useful signposts to the implementer of a clinical guideline system. Methods In addition to requirements described by guideline-system authors, comparative reviews of such systems, and publications discussing information needs for guideline systems and clinical decision support systems in general, we have incorporated additional requirements related to production-system robustness and functionality from publications in the business workflow domain, in addition to drawing on our own experience in the development of the Proteus guideline system (http://proteme.org). Results The sub-requirements are discussed by conveniently grouping them into the categories used by the review of Isern and Moreno 2008. We cite previous work under each category and then provide sub-requirements under each category, and provide example of similar work in software-engineering efforts that have addressed a similar problem in a non-biomedical context. Conclusions When analyzing requirements from the implementation viewpoint, knowledge of successes and failures in related software-engineering efforts can guide implementers in the choice of effective design and development strategies. PMID:22405400

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.

Clinical Practice Guideline Implementation Strategy Patterns in Veterans Affairs Primary Care Clinics

PubMed Central

Hysong, Sylvia J; Best, Richard G; Pugh, Jacqueline A

2007-01-01

Background The Department of Veterans Affairs (VA) mandated the system-wide implementation of clinical practice guidelines (CPGs) in the mid-1990s, arming all facilities with basic resources to facilitate implementation; despite this resource allocation, significant variability still exists across VA facilities in implementation success. Objective This study compares CPG implementation strategy patterns used by high and low performing primary care clinics in the VA. Research Design Descriptive, cross-sectional study of a purposeful sample of six Veterans Affairs Medical Centers (VAMCs) with high and low performance on six CPGs. Subjects One hundred and two employees (management, quality improvement, clinic personnel) involved with guideline implementation at each VAMC primary care clinic. Measures Participants reported specific strategies used by their facility to implement guidelines in 1-hour semi-structured interviews. Facilities were classified as high or low performers based on their guideline adherence scores calculated through independently conducted chart reviews. Findings High performing facilities (HPFs) (a) invested significantly in the implementation of the electronic medical record and locally adapting it to provider needs, (b) invested dedicated resources to guideline-related initiatives, and (c) exhibited a clear direction in their strategy choices. Low performing facilities exhibited (a) earlier stages of development for their electronic medical record, (b) reliance on preexisting resources for guideline implementation, with little local adaptation, and (c) no clear direction in their strategy choices. Conclusion A multifaceted, yet targeted, strategic approach to guideline implementation emphasizing dedicated resources and local adaptation may result in more successful implementation and higher guideline adherence than relying on standardized resources and taxing preexisting channels. PMID:17355583

How are evidence and knowledge used in orthopaedic decision-making? Three comparative case studies of different approaches to implementation of clinical guidance in practice.

PubMed

Grove, Amy; Clarke, Aileen; Currie, Graeme

2018-05-31

The uptake and use of clinical guidelines is often insufficient to change clinical behaviour and reduce variation in practice. As a consequence of diverse organisational contexts, the simple provision of guidelines cannot ensure fidelity or guarantee their use when making decisions. Implementation research in surgery has focused on understanding what evidence exists for clinical practice decisions but limits understanding to the technical, educational and accessibility issues. This research aims to identify where, when and how evidence and knowledge are used in orthopaedic decision-making and how variation in these factors contributes to different approaches to implementation of clinical guidance in practice. We used in-depth case studies to examine guideline implementation in real-life surgical practice. We conducted comparative case studies in three English National Health Service hospitals over a 12-month period. Each in-depth case study consisted of a mix of qualitative methods including interviews, observations and document analysis. Data included field notes from observations of day-to-day practice, 64 interviews with NHS surgeons and staff and the collection of 121 supplementary documents. Case studies identified 17 sources of knowledge and evidence which influenced clinical decisions in elective orthopaedic surgery. A comparative analysis across cases revealed that each hospital had distinct approaches to decision-making. Decision-making is described as occurring as a result of how 17 types of knowledge and evidence were privileged and of how they interacted and changed in context. Guideline implementation was contingent and mediated through four distinct contextual levels. Implementation could be assessed for individual surgeons, groups of surgeons or the organisation as a whole, but it could also differ between these levels. Differences in how evidence and knowledge were used contributed to variations in practice from guidelines. A range of complex and competing sources of evidence and knowledge exists which influence the working practices of healthcare professionals. The dynamic selection, combination and use of each type of knowledge and evidence influence the implementation and use of clinical guidance in practice. Clinical guidelines are a fundamental part of practice, but represent only one type of evidence influencing clinical decisions. In the orthopaedic speciality, other distinct sources of evidence and knowledge are selected and used which impact on how guidelines are implemented. New approaches to guideline implementation need to appreciate and incorporate this diverse range of knowledge and evidence which influences clinical decisions and to take account of the changing contexts in which decisions are made.

Automating Guidelines for Clinical Decision Support: Knowledge Engineering and Implementation.

PubMed

Tso, Geoffrey J; Tu, Samson W; Oshiro, Connie; Martins, Susana; Ashcraft, Michael; Yuen, Kaeli W; Wang, Dan; Robinson, Amy; Heidenreich, Paul A; Goldstein, Mary K

2016-01-01

As utilization of clinical decision support (CDS) increases, it is important to continue the development and refinement of methods to accurately translate the intention of clinical practice guidelines (CPG) into a computable form. In this study, we validate and extend the 13 steps that Shiffman et al. 5 identified for translating CPG knowledge for use in CDS. During an implementation project of ATHENA-CDS, we encoded complex CPG recommendations for five common chronic conditions for integration into an existing clinical dashboard. Major decisions made during the implementation process were recorded and categorized according to the 13 steps. During the implementation period, we categorized 119 decisions and identified 8 new categories required to complete the project. We provide details on an updated model that outlines all of the steps used to translate CPG knowledge into a CDS integrated with existing health information technology.

TU-C-201-02: Clinical Implementation of HDR: Afterloader and Applicator Selection

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

Esthappan, J.

2015-06-15

Recent use of HDR has increased while planning has become more complex often necessitating 3D image-based planning. While many guidelines for the use of HDR exist, they have not kept pace with the increased complexity of 3D image-based planning. Furthermore, no comprehensive document exists to describe the wide variety of current HDR clinical indications. This educational session aims to summarize existing national and international guidelines for the safe implementation of an HDR program. A summary of HDR afterloaders available on the market and their existing applicators will be provided, with guidance on how to select the best fit for eachmore » institution’s needs. Finally, the use of checklists will be discussed as a means to implement a safe and efficient HDR program and as a method by which to verify the quality of an existing HDR program. This session will provide the perspective of expert HDR physicists as well as the perspective of a new HDR user. Learning Objectives: Summarize national and international safety and staffing guidelines for HDR implementation Discuss the process of afterloader and applicator selection for gynecologic, prostate, breast, interstitial, surface treatments Learn about the use of an audit checklist tool to measure of quality control of a new or existing HDR program Describe the evolving use of checklists within an HDR program.« less

TU-C-201-01: Clinical Implementation of HDR: A New User’s Perspective

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

Al-Hallaq, H.

2015-06-15

Recent use of HDR has increased while planning has become more complex often necessitating 3D image-based planning. While many guidelines for the use of HDR exist, they have not kept pace with the increased complexity of 3D image-based planning. Furthermore, no comprehensive document exists to describe the wide variety of current HDR clinical indications. This educational session aims to summarize existing national and international guidelines for the safe implementation of an HDR program. A summary of HDR afterloaders available on the market and their existing applicators will be provided, with guidance on how to select the best fit for eachmore » institution’s needs. Finally, the use of checklists will be discussed as a means to implement a safe and efficient HDR program and as a method by which to verify the quality of an existing HDR program. This session will provide the perspective of expert HDR physicists as well as the perspective of a new HDR user. Learning Objectives: Summarize national and international safety and staffing guidelines for HDR implementation Discuss the process of afterloader and applicator selection for gynecologic, prostate, breast, interstitial, surface treatments Learn about the use of an audit checklist tool to measure of quality control of a new or existing HDR program Describe the evolving use of checklists within an HDR program.« less

TU-C-201-00: Clinical Implementation of HDR Brachytherapy

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

NONE

2015-06-15

Recent use of HDR has increased while planning has become more complex often necessitating 3D image-based planning. While many guidelines for the use of HDR exist, they have not kept pace with the increased complexity of 3D image-based planning. Furthermore, no comprehensive document exists to describe the wide variety of current HDR clinical indications. This educational session aims to summarize existing national and international guidelines for the safe implementation of an HDR program. A summary of HDR afterloaders available on the market and their existing applicators will be provided, with guidance on how to select the best fit for eachmore » institution’s needs. Finally, the use of checklists will be discussed as a means to implement a safe and efficient HDR program and as a method by which to verify the quality of an existing HDR program. This session will provide the perspective of expert HDR physicists as well as the perspective of a new HDR user. Learning Objectives: Summarize national and international safety and staffing guidelines for HDR implementation Discuss the process of afterloader and applicator selection for gynecologic, prostate, breast, interstitial, surface treatments Learn about the use of an audit checklist tool to measure of quality control of a new or existing HDR program Describe the evolving use of checklists within an HDR program.« less

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

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

PubMed Central

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

2009-01-01

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

Modification and implementation of NCCN guidelines on lymphomas in the Middle East and North Africa region.

PubMed

Bazarbachi, Ali; Azim, Hamdy A; Alizadeh, Hussain; Aljurf, Mahmoud; Barista, Ibrahim; Chaudhri, Naeem A; Fahed, Zahira; Fahmy, Omar A; Ghavamzadeh, Ardeshir; Khalaf, Mohamed H; Khatib, Sami; Kutoubi, Aghiad; Paydas, Semra; Elayoubi, Hanadi Rafii; Zaatari, Ghazi; Zawam, Hamdy M; Zelenetz, Andrew D

2010-07-01

In the Middle East and North Africa (MENA) region, cancer has many epidemiologic and clinical features that are different from those in the rest of the world. Additionally, the region has a relatively young population and large disparities in the availability of resources at diagnostic and treatment levels. A critical need exists for regional guidelines on cancer care, including those for lymphoid malignancies. A panel of lymphoma experts from MENA reviewed the 2009 version of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) on Non-Hodgkin's Lymphoma and Hodgkin Lymphoma and suggested modifications for the region that were discussed with the United States NCCN Lymphoma Panels. This article presents the consensus recommendations.

Interventions for Age-Related Macular Degeneration: Are Practice Guidelines Based on Systematic Reviews?

PubMed

Lindsley, Kristina; Li, Tianjing; Ssemanda, Elizabeth; Virgili, Gianni; Dickersin, Kay

2016-04-01

Are existing systematic reviews of interventions for age-related macular degeneration incorporated into clinical practice guidelines? High-quality systematic reviews should be used to underpin evidence-based clinical practice guidelines and clinical care. We examined the reliability of systematic reviews of interventions for age-related macular degeneration (AMD) and described the main findings of reliable reviews in relation to clinical practice guidelines. Eligible publications were systematic reviews of the effectiveness of treatment interventions for AMD. We searched a database of systematic reviews in eyes and vision without language or date restrictions; the database was up to date as of May 6, 2014. Two authors independently screened records for eligibility and abstracted and assessed the characteristics and methods of each review. We classified reviews as reliable when they reported eligibility criteria, comprehensive searches, methodologic quality of included studies, appropriate statistical methods for meta-analysis, and conclusions based on results. We mapped treatment recommendations from the American Academy of Ophthalmology (AAO) Preferred Practice Patterns (PPPs) for AMD to systematic reviews and citations of reliable systematic reviews to support each treatment recommendation. Of 1570 systematic reviews in our database, 47 met inclusion criteria; most targeted neovascular AMD and investigated anti-vascular endothelial growth factor (VEGF) interventions, dietary supplements, or photodynamic therapy. We classified 33 (70%) reviews as reliable. The quality of reporting varied, with criteria for reliable reporting met more often by Cochrane reviews and reviews whose authors disclosed conflicts of interest. Anti-VEGF agents and photodynamic therapy were the only interventions identified as effective by reliable reviews. Of 35 treatment recommendations extracted from the PPPs, 15 could have been supported with reliable systematic reviews; however, only 1 recommendation cited a reliable intervention systematic review. No reliable systematic review was identified for 20 treatment recommendations, highlighting areas of evidence gaps. For AMD, reliable systematic reviews exist for many treatment recommendations in the AAO PPPs and should be cited to support these recommendations. We also identified areas where no high-level evidence exists. Mapping clinical practice guidelines to existing systematic reviews is one way to highlight areas where evidence generation or evidence synthesis is either available or needed. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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

PubMed

Graham, Tanya; Alderson, Phil; Stokes, Tim

2015-01-01

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

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

Analyzing the "CareGap": assessing gaps in adherence to clinical guidelines in adult soft tissue sarcoma.

PubMed

Waks, Zeev; Goldbraich, Esther; Farkash, Ariel; Torresani, Michele; Bertulli, Rossella; Restifo, Nicola; Locatelli, Paolo; Casali, Paolo; Carmeli, Boaz

2013-01-01

Clinical decision support systems (CDSSs) are gaining popularity as tools that assist physicians in optimizing medical care. These systems typically comply with evidence-based medicine and are designed with input from domain experts. Nonetheless, deviations from CDSS recommendations are abundant across a broad spectrum of disorders, raising the question as to why this phenomenon exists. Here, we analyze this gap in adherence to a clinical guidelines-based CDSS by examining the physician treatment decisions for 1329 adult soft tissue sarcoma patients in northern Italy using patient-specific parameters. Dubbing this analysis "CareGap", we find that deviations correlate strongly with certain disease features such as local versus metastatic clinical presentation. We also notice that deviations from the guideline-based CDSS suggestions occur more frequently for patients with shorter survival time. Such observations can direct physicians' attention to distinct patient cohorts that are prone to higher deviation levels from clinical practice guidelines. This illustrates the value of CareGap analysis in assessing quality of care for subsets of patients within a larger pathology.

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.

Interventions for Age-Related Macular Degeneration: Are Practice Guidelines Based on Systematic Reviews?

PubMed Central

Lindsley, Kristina; Li, Tianjing; Ssemanda, Elizabeth; Virgili, Gianni; Dickersin, Kay

2016-01-01

Topic Are existing systematic reviews of interventions for age-related macular degeneration incorporated into clinical practice guidelines? Clinical relevance High-quality systematic reviews should be used to underpin evidence-based clinical practice guidelines and clinical care. We have examined the reliability of systematic reviews of interventions for age-related macular degeneration (AMD) and described the main findings of reliable reviews in relation to clinical practice guidelines. Methods Eligible publications are systematic reviews of the effectiveness of treatment interventions for AMD. We searched a database of systematic reviews in eyes and vision and employed no language or date restrictions; the database is up-to-date as of May 6, 2014. Two authors independently screened records for eligibility and abstracted and assessed the characteristics and methods of each review. We classified reviews as “reliable” when they reported eligibility criteria, comprehensive searches, appraisal of methodological quality of included studies, appropriate statistical methods for meta-analysis, and conclusions based on results. We mapped treatment recommendations from the American Academy of Ophthalmology Preferred Practice Patterns (AAO PPP) for AMD to the identified systematic reviews and assessed whether any reliable systematic review was cited or could have been cited to support each treatment recommendation. Results Of 1,570 systematic reviews in our database, 47 met our inclusion criteria. Most of the systematic reviews targeted neovascular AMD and investigated anti-vascular endothelial growth factor (anti-VEGF) interventions, dietary supplements or photodynamic therapy. We classified over two-thirds (33/47) of the reports as reliable. The quality of reporting varied, with criteria for reliable reporting met more often for Cochrane reviews and for reviews whose authors disclosed conflicts of interest. Although most systematic reviews were reliable, anti-VEGF agents and photodynamic therapy were the only interventions identified as effective by reliable reviews. Of 35 treatment recommendations extracted from the AAO PPP, 15 could have been supported with reliable systematic reviews; however, only one recommendation had an accompanying intervention systematic review citation, which we assessed as a reliable systematic review. No reliable systematic review was identified for 20 treatment recommendations, highlighting areas of evidence gaps. Conclusions For AMD, reliable systematic reviews exist for many treatment recommendations in the AAO PPP and should be used to support these recommendations. We also identified areas where no high-level evidence exists. Mapping clinical practice guidelines to existing systematic reviews is one way to highlight areas where evidence generation or evidence synthesis is either available or needed. PMID:26804762

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.

Priority setting in guideline development: article 2 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Atkins, David; Perez-Padilla, Rogelio; Macnee, William; Buist, A Sonia; Cruz, Alvaro A

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. Priority setting is an essential component of developing clinical practice guidelines informed by the best available research evidence. It ensures that resources and attention are devoted to those areas in which clinical recommendations will provide the greatest benefit to patients, clinicians, and policy makers. This is the second of a series of 14 articles that methodologists and researchers from around the world prepared to advise guideline developers in respiratory and other diseases. This review focuses on priority setting, addressing five key questions. In this review, we addressed the following questions. (1) At which steps of guideline development should priorities be considered? (2) How do we create an initial list of potential topics within the guideline? (3) What criteria should be used to establish priorities? (4) What parties should be involved and what processes should be used to set priorities? (5)What are the potential challenges of setting priorities? We updated an existing review on priority setting, and searched PubMed and other databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on available evidence, our own experience working with guideline developers, and workshop discussions. Existing literature on priority setting largely applies to identifying priorities for which guidelines to develop rather than setting priorities for recommendations within a guideline. Nonetheless, there is substantial consensus about the general factors that should be considered in setting priorities. These include the burdens and costs of illness, potential impact of a recommendation, identified deficits or weak points in practice, variation or uncertainty in practice, and availability of evidence. The input of a variety of stakeholders is useful in setting priorities, although informal consultation is used more often than formal methods. Processes for setting priorities remains poorly described in most guidelines.

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.

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.

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

PubMed

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

2018-05-01

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

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

PubMed

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

2017-05-01

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

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

PubMed

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

2016-09-13

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

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

The GuideLine Interchange Format

PubMed Central

Ohno-Machado, Lucila; Gennari, John H.; Murphy, Shawn N.; Jain, Nilesh L.; Tu, Samson W.; Oliver, Diane E.; Pattison-Gordon, Edward; Greenes, Robert A.; Shortliffe, Edward H.; Barnett, G. Octo

1998-01-01

Objective: To allow exchange of clinical practice guidelines among institutions and computer-based applications. Design: The GuideLine Interchange Format (GLIF) specification consists of the GLIF model and the GLIF syntax. The GLIF model is an object-oriented representation that consists of a set of classes for guideline entities, attributes for those classes, and data types for the attribute values. The GLIF syntax specifies the format of the test file that contains the encoding. Methods: Researchers from the InterMed Collaboratory at Columbia University, Harvard University (Brigham and Women's Hospital and Massachusetts General Hospital), and Stanford University analyzed four existing guideline systems to derive a set of requirements for guideline representation. The GLIF specification is a consensus representation developed through a brainstorming process. Four clinical guidelines were encoded in GLIF to assess its expressivity and to study the variability that occurs when two people from different sites encode the same guideline. Results: The encoders reported that GLIF was adequately expressive. A comparison of the encodings revealed substantial variability. Conclusion: GLIF was sufficient to model the guidelines for the four conditions that were examined. GLIF needs improvement in standard representation of medical concepts, criterion logic, temporal information, and uncertainty. PMID:9670133

German guidelines for the diagnosis and therapy of localized scleroderma.

PubMed

Kreuter, Alexander; Krieg, Thomas; Worm, Margitta; Wenzel, Jörg; Moinzadeh, Pia; Kuhn, Annegret; Aberer, Elisabeth; Scharffetter-Kochanek, Karin; Horneff, Gerd; Reil, Emma; Weberschock, Tobias; Hunzelmann, Nicolas

2016-02-01

Localized scleroderma designates a heterogeneous group of sclerotic skin disorders. Depending on the subtype, severity, and site affected, adjacent structures such as adipose tissue, muscles, joints, and bones may be involved. This is an update of the existing German AWMF (Association of the Scientific Medical Societies in Germany) guidelines (classification: S2k). These guidelines provide an overview of the definition, epidemiology, classification, pathogenesis, laboratory workup, histopathology, clinical scoring systems, as well as imaging and device-based workup of localized scleroderma. Moreover, consensus-based recommendations are given on the management of localized scleroderma depending on its clinical subtype. Treatment recommendations are presented in a therapeutic algorithm. No financial support was given by any pharmaceutical company. The guidelines are valid until July 2019. © 2016 The Authors | Journal compilation © Blackwell Verlag GmbH, Berlin.

[Implementation of clinical practice guidelines: how can we close the evidence-practice gap?].

PubMed

Muche-Borowski, Cathleen; Nothacker, M; Kopp, I

2015-01-01

Guidelines are intended as instruments of knowledge transfer to support decision-making by physicians, other health professionals and patients in clinical practice and thereby contribute to quality improvements in healthcare. To date they are an indispensable tool for healthcare. Their benefit for patients can only be seen in application, i.e. the implementation of guideline recommendations. For successful implementation, implementability and practicability play a crucial role and these characteristics can be influenced and should be promoted by the guideline development group. In addition, a force field analysis to identify barriers against and facilitators for the implementation of specific guideline recommendations from the perspective of physicians and patients is recommended to guide the development of an individual implementation strategy and the selection of appropriate interventions. However, implementation cannot be achieved by the guideline development group alone and a universal implementation strategy does not exist. Therefore, a process using theory, analysis, experience and shared responsibility of stakeholders in healthcare is recommended, with the aim to achieve sustainable behavioral change and improve the quality of care by guideline-oriented behavior.

Computer Decision Support to Improve Autism Screening and Care in Community Pediatric Clinics

ERIC Educational Resources Information Center

Bauer, Nerissa S.; Sturm, Lynne A.; Carroll, Aaron E.; Downs, Stephen M.

2013-01-01

An autism module was added to an existing computer decision support system (CDSS) to facilitate adherence to recommended guidelines for screening for autism spectrum disorders in primary care pediatric clinics. User satisfaction was assessed by survey and informal feedback at monthly meetings between clinical staff and the software team. To assess…

An automated tool for an analysis of compliance to evidence-based clinical guidelines.

PubMed

Metfessel, B A

2001-01-01

Evidence-based clinical guidelines have been developed in an attempt to decrease practice variation and improve patient outcomes. Although a number of studies and a few commercial products have attempted to measure guideline compliance, there still exists a strong need for an automated product that can take as input large amounts of data and create systematic and detailed profiles of compliance to evidence-based guidelines. The Guideline Compliance Assessment Tool is a product presently under development in our group that will accept as input medical and pharmacy claims data and create a guideline compliance profile that assesses provider practice patterns as compared to evidence-based standards. The system components include an episode of care grouper to standardize classifications of illnesses, an evidence-based guideline knowledge base that potentially contains information on several hundred distinct conditions, a guideline compliance scoring system that emphasizes systematic guideline variance rather than random variances, and an advanced data warehouse that would allow drilling into specific areas of interest. As provider profiling begins to shift away from a primary emphasis on cost to an emphasis on quality, automated methods for measuring guideline compliance will become important in measuring provider performance and increasing guideline usage, consequently improving the standard of care and the potential for better patient outcomes.

Managing challenging interactions with family caregivers in the cancer setting: Guidelines for clinicians (TRIO Guidelines-2).

PubMed

Laidsaar-Powell, Rebekah; Butow, Phyllis; Boyle, Frances; Juraskova, Ilona

2018-06-01

Family caregivers can, at times, add complexity to clinical encounters. Difficult family caregivers and dynamics may: derail consultation communication, reduce patient autonomy, and compromise effective clinical care. A paucity of practical strategies guiding effective clinician-family communication exists. This study aimed to develop and evaluate the first comprehensive, evidence-based guidelines (the TRIO guidelines) for oncology physicians and nurses to better manage several complex/challenging situations involving family members. TRIO Guidelines were based on a comprehensive review of literature, relevant guidelines, and feedback from an expert advisory group (n = 10). Draft guidelines underwent two rounds of evaluation via an online Delphi consensus process involving international experts (n = 35). Guidelines incorporate topic areas, strategies, and sub-strategies on managing challenging family involvement (7 topics). Example wording, behaviours and level of evidence are provided. Challenging triadic interactions require skillful navigation, and the TRIO Guidelines provide clear, specific, and evidence-based strategies for clinicians to utilise in these potentially stressful encounters. Training based on these guidelines may improve both patient care and clinician confidence. Implementation of these guidelines into medical/nursing curricula and as a component of continuing professional development programs will likely be highly beneficial. Copyright © 2018 Elsevier B.V. All rights reserved.

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.

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

A systematic review of clinical practice guidelines and best practice statements for the diagnosis and management of varicocele in children and adolescents.

PubMed

Roque, Matheus; Esteves, Sandro C

2016-01-01

A systematic review was conducted to identify and qualitatively analyze the methods as well as recommendations of Clinical Practice Guidelines (CPG) and Best Practice Statements (BPS) concerning varicocele in the pediatric and adolescent population. An electronic search was performed with the MEDLINE, EMBASE, Science Direct, and Scielo databases, as well as guidelines' Web sites until September 2015. Four guidelines were included in the qualitative synthesis. In general, the recommendations provided by the CPG/BPS were consistent despite the existence of some gaps across the studies. The guidelines issued by the American Urological Association (AUA) and American Society for Reproductive Medicine (ASRM) did not provide evidence-based levels for the recommendations given. Most of the recommendations given by the European Association of Urology (EAU) and European Society of Pediatric Urology (ESPU) were derived from nonrandomized clinical trials, retrospective studies, and expert opinion. Among all CPG/BPS, only one was specifically designed for the pediatric population. The studied guidelines did not undertake independent cost-effectiveness and risk-benefit analysis. The main objectives of these guidelines were to translate the best evidence into practice and provide a framework of standardized care while maintaining clinical autonomy and physician judgment. However, the limitations identified in the CPG/BPS for the diagnosis and management of varicocele in children and adolescents indicate ample opportunities for research and future incorporation of higher quality standards in patient care.

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.

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

[Systemic validation of clinical practice guidelines: the AGREE network].

PubMed

Hannes, K; Van Royen, P; Aertgeerts, B; Buntinx, F; Ramaekers, D; Chevalier, P

2005-12-01

Over recent decades, the number of available clinical practice guidelines has enormously grown. Guidelines should meet specific quality criteria to ensure good quality. There is a growing need for the developement of a set of criteria to ensure that potential biases inherent in guideline development have been properly addressed and that the recommendations for practice are valid and reliable. The AGREE-collaboration is an international network that developed an instrument to critically appraise the methodological quality of guidelines. AGREE promotes a clear strategy to produce, disseminate and evaluate guidelines of high quality. In the first phase of the international project the AGREE-instrument was tested in 11 different countries. Based on this experience the instrument was refined and optimised. In the second phase it was disseminated, promoted and evaluated in 18 participating countries. Belgium was one of them. The Belgian partner in the AGREE-project developed 3 workshops and established 13 validation committees to validate guidelines from Belgian developer groups. We collected 33 questionnaires from participants of the workshops and the validation committees, in which we asked for primary experiences and information on the usefulness and applicability of the instrument. We were also interested in the shortcomings of the instrument and potential strategies to bridge them. More efforts should be made to train methodological experts to gain certain skills for a critical appraisal of clinical practice guidelines. Promoting the AGREE-instrument will lead to a broader knowledge and use of quality criteria in guideline development and appraisal. The development and dissemination of an international list of criteria to appraise the quality of guidelines will stimulate the development of methodologically sound guidelines. International comparisons between existing guidelines will lead to a better collaboration between guideline developers throughout the world.

NIAID-sponsored 2010 guidelines for managing food allergy: applications in the pediatric population.

PubMed

Burks, A Wesley; Jones, Stacie M; Boyce, Joshua A; Sicherer, Scott H; Wood, Robert A; Assa'ad, Amal; Sampson, Hugh A

2011-11-01

Data from many studies have suggested a rise in the prevalence of food allergies during the past 10 to 20 years. Currently, no curative treatments for food allergy exist, and there are no effective means of preventing the disease. Management of food allergy involves strict avoidance of the allergen in the patient's diet and treatment of symptoms as they arise. Because diagnosis and management of the disease can vary between clinical practice settings, the National Institute of Allergy and Infectious Diseases (NIAID) sponsored development of clinical guidelines for the diagnosis and management of food allergy. The guidelines establish consensus and consistency in definitions, diagnostic criteria, and management practices. They also provide concise recommendations on how to diagnose and manage food allergy and treat acute food allergy reactions. The original guidelines encompass practices relevant to patients of all ages, but food allergy presents unique and specific concerns for infants, children, and teenagers. To focus on those concerns, we describe here the guidelines most pertinent to the pediatric population.

Facilitating adherence to the tobacco use treatment guideline with computer-mediated decision support systems: physician and clinic office manager perspectives.

PubMed

Marcy, Theodore W; Skelly, Joan; Shiffman, Richard N; Flynn, Brian S

2005-08-01

A majority of physicians do not adhere to all the elements of the evidence-based USPHS guideline on tobacco use and dependence treatment. Among physicians and clinic office managers in Vermont we assessed perceived barriers to guideline adherence. We then assessed attitudes towards a computer-mediated clinical decision support system (CDSS) to gauge whether this type of intervention could support performance of the guideline. A random sample of 600 Vermont primary care and subspecialty physicians were surveyed with a mailed survey instrument. A separate survey instrument was mailed to the census of 93 clinic office managers. The response rates of physicians and clinic office managers were 67% and 76%, respectively. Though most physicians were aware of the guideline and had positive attitudes towards it, there was a lack of familiarity with Vermont's smoking cessation resources as 35% would refer smokers to non-existent counseling resources and only 48% would refer patients to a toll-free quit line. Time constraints and the perception that smokers are unreceptive to counseling were the two most common barriers cited by both physicians and office managers. The vast majority of physicians (92%) have access to a computer in their outpatient clinics, and 68% have used computers during the course of a patient's visit. Four of the eight information management services that a CDSS could provide were highly valued by both physicians and clinic office managers. Interventions to improve adherence to the guideline should address the inaccurate perception that smokers are unreceptive to counseling, and physicians' lack of familiarity with resources. A CDSS may improve knowledge of these resources if the design addresses cost, space, and time limitations.

A Survey of Colonoscopic Surveillance After Polypectomy

PubMed Central

2014-01-01

Purpose Several guidelines have been proposed for surveillance colonoscopy after polypectomy. However, some discrepancies still exist between the guidelines and clinical practice. This study was conducted to identify Korean doctors' recommendations for the colonoscopic surveillance interval after polypectomy. Methods A survey of the attendees at the symposium of the 64th Annual Congress of the Korean Surgical Society was conducted. When the prepared clinical scenarios were given, attendees answered using a wireless radio-frequency audience response system. All responders' results were automatically counted immediately. Frequencies of different answers to each question were calculated, and our results were compared with those of previous surveys performed using the same questionnaire in the United States or Japan. Results The number of responder varied from 38 to 41. About 50% of valid responders selected 'follow-up in 3 years' for low-risk lesions, such as a 6-mm hyperplastic polyp, a 6-mm tubular adenoma, or two 6-mm tubular adenomas. Responders most-commonly selected 'follow-up in 1 year' for high-risk lesions, such as a 12-mm tubular adenoma with high grade dysplasia or a 12-mm tubulovillous adenoma. The majority of Korean doctors recommend postpolypectomy colonoscopic surveillance more frequently than American physicians did. Conclusion A discrepancy between the guidelines and clinical practice for the surveillance after polypectomy still exists in Korea. A surveillance program that can be easily and widely applied in clinical practice needs to be established. PMID:24851219

American Society of Addiction Medicine (ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use.

PubMed

Kampman, Kyle; Jarvis, Margaret

2015-01-01

The Centers for Disease Control have recently described opioid use and resultant deaths as an epidemic. At this point in time, treating this disease well with medication requires skill and time that are not generally available to primary care doctors in most practice models. Suboptimal treatment has likely contributed to expansion of the epidemic and concerns for unethical practices. At the same time, access to competent treatment is profoundly restricted because few physicians are willing and able to provide it. This "Practice Guideline" was developed to assist in the evaluation and treatment of opioid use disorder, and in the hope that, using this tool, more physicians will be able to provide effective treatment. Although there are existing guidelines for the treatment of opioid use disorder, none have included all of the medications used at present for its treatment. Moreover, few of the existing guidelines address the needs of special populations such as pregnant women, individuals with co-occurring psychiatric disorders, individuals with pain, adolescents, or individuals involved in the criminal justice system. This Practice Guideline was developed using the RAND Corporation (RAND)/University of California, Los Angeles (UCLA) Appropriateness Method (RAM) - a process that combines scientific evidence and clinical knowledge to determine the appropriateness of a set of clinical procedures. The RAM is a deliberate approach encompassing review of existing guidelines, literature reviews, appropriateness ratings, necessity reviews, and document development. For this project, American Society of Addiction Medicine selected an independent committee to oversee guideline development and to assist in writing. American Society of Addiction Medicine's Quality Improvement Council oversaw the selection process for the independent development committee. Recommendations included in the guideline encompass a broad range of topics, starting with the initial evaluation of the patient, the selection of medications, the use of all the approved medications for opioid use disorder, combining psychosocial treatment with medications, the treatment of special populations, and the use of naloxone for the treatment of opioid overdose. Topics needing further research were noted.

Cancer related fatigue: implementing guidelines for optimal management.

PubMed

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

2017-07-18

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

Towards symbiosis in knowledge representation and natural language processing for structuring clinical practice guidelines.

PubMed

Weng, Chunhua; Payne, Philip R O; Velez, Mark; Johnson, Stephen B; Bakken, Suzanne

2014-01-01

The successful adoption by clinicians of evidence-based clinical practice guidelines (CPGs) contained in clinical information systems requires efficient translation of free-text guidelines into computable formats. Natural language processing (NLP) has the potential to improve the efficiency of such translation. However, it is laborious to develop NLP to structure free-text CPGs using existing formal knowledge representations (KR). In response to this challenge, this vision paper discusses the value and feasibility of supporting symbiosis in text-based knowledge acquisition (KA) and KR. We compare two ontologies: (1) an ontology manually created by domain experts for CPG eligibility criteria and (2) an upper-level ontology derived from a semantic pattern-based approach for automatic KA from CPG eligibility criteria text. Then we discuss the strengths and limitations of interweaving KA and NLP for KR purposes and important considerations for achieving the symbiosis of KR and NLP for structuring CPGs to achieve evidence-based clinical practice.

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.

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.

Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review.

PubMed

Francke, Anneke L; Smit, Marieke C; de Veer, Anke J E; Mistiaen, Patriek

2008-09-12

Nowadays more and more clinical guidelines for health care professionals are being developed. However, this does not automatically mean that these guidelines are actually implemented. The aim of this meta-review is twofold: firstly, to gain a better understanding of which factors affect the implementation of guidelines, and secondly, to provide insight into the "state-of-the-art" regarding research within this field. A search of five literature databases and one website was performed to find relevant existing systematic reviews or meta-reviews. Subsequently, a two-step inclusion process was conducted: (1) screening on the basis of references and abstracts and (2) screening based on full-text papers. After that, relevant data from the included reviews were extracted and the methodological quality of the reviews was assessed by using the Quality Assessment Checklist for Reviews. Twelve systematic reviews met our inclusion criteria. No previous systematic meta-reviews meeting all our inclusion criteria were found. Two of the twelve reviews scored high on the checklist used, indicating only "minimal" or "minor flaws". The other ten reviews scored in the lowest of middle ranges, indicating "extensive" or "major" flaws. A substantial proportion (although not all) of the reviews indicates that effective strategies often have multiple components and that the use of one single strategy, such as reminders only or an educational intervention, is less effective. Besides, characteristics of the guidelines themselves affect actual use. For instance, guidelines that are easy to understand, can easily be tried out, and do not require specific resources, have a greater chance of implementation. In addition, characteristics of professionals - e.g., awareness of the existence of the guideline and familiarity with its content - likewise affect implementation. Furthermore, patient characteristics appear to exert influence: for instance, co-morbidity reduces the chance that guidelines are followed. Finally, environmental characteristics may influence guideline implementation. For example, a lack of support from peers or superiors, as well as insufficient staff and time, appear to be the main impediments. Existing reviews describe various factors that influence whether guidelines are actually used. However, the evidence base is still thin, and future sound research - for instance comparing combinations of implementation strategies versus single strategies - is needed.

Antimicrobial Stewardship in the Emergency Department and Guidelines for Development

PubMed Central

May, Larissa; Cosgrove, Sara; L’Archeveque, Michelle; Talan, David A.; Payne, Perry; Rothman, Richard E.

2013-01-01

Antimicrobial resistance is a mounting public health concern. Emergency departments (EDs) represent a particularly important setting for addressing inappropriate antimicrobial prescribing practices, given the frequent use of antibiotics in this setting that sits at the interface of the community and the hospital. This article outlines the importance of antimicrobial stewardship in the ED setting and provides practical recommendations drawn from existing evidence for the application of various strategies and tools that could be implemented in the ED including advancement of clinical guidelines, clinical decision support systems, rapid diagnostics, and expansion of ED pharmacist programs. PMID:23122955

What are specialist mental health clinician attitudes to guideline recommendations for the treatment of depression in young people?

PubMed

Hetrick, Sarah E; Simmons, Magenta; Thompson, Andrew; Parker, Alexandra G

2011-11-01

We sought to examine potential barriers to the use of evidence-based guidelines for youth depression in a tertiary specialist mental health service, as part of an initiative to implement evidence based practice within the service. This was a qualitative study adopting a social constructionist perspective using focus groups. The focus groups, conducted with all clinicians (medical and allied health), were audiotaped, transcribed and thematic analysis was undertaken. Clinicians were asked about the barriers to implementing four key recommendations from the National Institute for Health and Clinical Excellence (NICE) guidelines. Barriers existed at (i) the individual clinician level; (ii) the clinical level in terms of the presentation of young people; and (iii) the service level. The key individual clinician level barrier was a stated belief that the guidelines were not relevant to the young people presenting to the service, with little evidence to guide practice. Related, the main barrier with regard to the clinical presentation was the severity and complexity of this presentation, often making the delivery of interventions like cognitive behavioural therapy (CBT) difficult. At the service level, a lack of integration with primary and secondary level care meant sequencing interventions according to guideline recommendations was difficult. There is a clear imperative to develop the evidence base to ensure that effective treatments for young people aged up to 25 years with severe and complex disorders that include comorbid conditions, suicide risk and psychosocial difficulties are investigated and disseminated. Furthermore, this work has highlighted the need for greater investment in models of care that ensure integration between existing primary and secondary care and enhanced specialist early intervention mental health services for young people.

Engaging Patients and Caregivers Managing Rare Diseases to Improve the Methods of Clinical Guideline Development: A Research Protocol

PubMed Central

Kinnett, Kathi; Grant, Sean; Lucas, Ann; Martin, Ann; Denger, Brian; Peay, Holly; Coulter, Ian; Fink, Arlene

2017-01-01

Background Clinical guidelines provide systematically developed recommendations for deciding on appropriate health care options for specific conditions and clinical circumstances. Up until recently, patients and caregivers have rarely been included in the process of developing care guidelines. Objective This project will develop and test a new online method for including patients and their caregivers in this process using Duchenne muscular dystrophy (DMD) care guidelines as an example. The new method will mirror and complement the RAND/UCLA Appropriateness Method (RAM)—the gold standard approach for conducting clinical expert panels that uses a modified Delphi format. RAM is often used in clinical guideline development to determine care appropriateness and necessity in situations where existing clinical evidence is uncertain, weak, or unavailable. Methods To develop the new method for engaging patients and their caregivers in guideline development, we will first conduct interviews with experts on RAM, guideline development, patient engagement, and patient-centeredness and engage with Duchenne patients and caregivers to identify how RAM should be modified for the purposes of patient engagement and what rating criteria should patients and caregivers use to provide their input during the process of guideline development. Once the new method is piloted, we will test it by conducting two concurrently run patient/caregiver panels that will rate patient-centeredness of a subset of DMD care management recommendations already deemed clinically appropriate and necessary. The ExpertLens™ system—a previously evaluated online modified Delphi system that combines two rounds of rating with a round of feedback and moderated online discussions—will be used to conduct these panels. In addition to developing and testing the new engagement method, we will work with the members of our project’s Advisory Board to generate a list of best practices for enhancing the level of patient and caregiver involvement in the guideline development process. We will solicit input on these best practice from Duchenne patients, caregivers, and clinicians by conducting a series of round-table discussions and making a presentation at an annual conference on Duchenne. Results The study protocol was reviewed by RAND’s Human Subjects Protection Committee, which determined it to be exempt from review. Interviews with RAM experts have been completed. The projected study completion date is May 2020. Conclusions We expect that the new method will make it easier to engage large numbers of patients and caregivers in the process of guideline development in a rigorous and culturally appropriate manner that is consistent with the way clinicians participate in guideline development. Moreover, this project will develop best practices that could help involve patients and caregivers in the clinical guideline development process in other clinical areas, thereby facilitating the work of guideline developers. PMID:28455279

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

PubMed Central

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

2007-01-01

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

Toward Clarity in Clinical Vitamin D Status Assessment: 25(OH)D Assay Standardization.

PubMed

Binkley, Neil; Carter, Graham D

2017-12-01

Widespread variation in 25-hydroxyvitamin D (25(OH)D) assays continues to compromise efforts to develop clinical and public health guidelines regarding vitamin D status. The Vitamin D Standardization Program helps alleviate this problem. Reference measurement procedures and standard reference materials have been developed to allow current, prospective, and retrospective standardization of 25(OH)D results. Despite advances in 25(OH)D measurement, substantial variability in clinical laboratory 25(OH)D measurement persists. Existing guidelines have not used standardized data and, as a result, it seems unlikely that consensus regarding definitions of vitamin D deficiency, inadequacy, sufficiency, and excess will soon be reached. Until evidence-based consensus is reached, a reasonable clinical approach is advocated. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

Patient participation in ERS guidelines and research projects: the EMBARC experience

PubMed Central

Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-01-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. Educational aims To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities. To understand the barriers and potential solutions to these barriers from a physician’s perspective, in order to ensure meaningful patient involvement in clinical projects. To understand the barriers and potential solutions from a patient’s perspective, in order to meaningfully involve patients in clinical projects. PMID:28894480

Patient participation in ERS guidelines and research projects: the EMBARC experience.

PubMed

Chalmers, James D; Timothy, Alan; Polverino, Eva; Almagro, Marta; Ruddy, Thomas; Powell, Pippa; Boyd, Jeanette

2017-09-01

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) is a European Respiratory Society (ERS) Clinical Research Collaboration dedicated to improving research and clinical care for people with bronchiectasis. EMBARC has created a European Bronchiectasis Registry, funded by the ERS and by the European Union (EU) Innovative Medicines Initiative Programme. From the outset, EMBARC had the ambition to be a patient-focussed project. In contrast to many respiratory diseases, however, there are no specific patient charities or European patient organisations for patients with bronchiectasis and no existing infrastructure for patient engagement. This article describes the experience of EMBARC and the European Lung Foundation in establishing a patient advisory group and then engaging this group in European guidelines, an international registry and a series of research studies. Patient involvement in research, clinical guidelines and educational activities is increasingly advocated and increasingly important. Genuine patient engagement can achieve a number of goals that are critical to the success of an EU project, including focussing activities on patient priorities, allowing patients to direct the clinical and research agenda, and dissemination of guidelines and research findings to patients and the general public. Here, we review lessons learned and provide guidance for future ERS task forces, EU-funded projects or clinical research collaborations that are considering patient involvement. To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities.To understand the barriers and potential solutions to these barriers from a physician's perspective, in order to ensure meaningful patient involvement in clinical projects.To understand the barriers and potential solutions from a patient's perspective, in order to meaningfully involve patients in clinical projects.

Primary Prevention of Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Guideline.

PubMed

Arrossi, Silvina; Temin, Sarah; Garland, Suzanne; Eckert, Linda O'Neal; Bhatla, Neerja; Castellsagué, Xavier; Alkaff, Sharifa Ezat; Felder, Tamika; Hammouda, Doudja; Konno, Ryo; Lopes, Gilberto; Mugisha, Emmanuel; Murillo, Rául; Scarinci, Isabel C; Stanley, Margaret; Tsu, Vivien; Wheeler, Cosette M; Adewole, Isaac Folorunso; de Sanjosé, Silvia

2017-10-01

To provide resource-stratified (four tiers), evidence-based recommendations on the primary prevention of cervical cancer globally. The American Society of Clinical Oncology convened a multidisciplinary, multinational panel of oncology, obstetrics/gynecology, public health, cancer control, epidemiology/biostatistics, health economics, behavioral/implementation science, and patient advocacy experts. The Expert Panel reviewed existing guidelines and conducted a modified ADAPTE process and a formal consensus-based process with additional experts (consensus ratings group) for one round of formal ratings. Existing sets of guidelines from five guideline developers were identified and reviewed; adapted recommendations formed the evidence base. Five systematic reviews, along with cost-effectiveness analyses, provided evidence to inform the formal consensus process, which resulted in agreement of ≥ 75%. In all resource settings, two doses of human papillomavirus vaccine are recommended for girls age 9 to 14 years, with an interval of at least 6 months and possibly up to 12 to 15 months. Individuals with HIV positivity should receive three doses. Maximal and enhanced settings: if girls are age ≥ 15 years and received their first dose before age 15 years, they may complete the series; if no doses were received before age 15 years, three doses should be administered; in both scenarios, vaccination may be through age 26 years. Limited and basic settings: if sufficient resources remain after vaccinating girls age 9 to 14 years, girls who received one dose may receive additional doses between age 15 and 26 years. Maximal, enhanced, and limited settings: if ≥ 50% coverage in the priority female target population, sufficient resources, and cost effectiveness, boys may be vaccinated to prevent other noncervical human papillomavirus-related cancers and diseases. Basic settings: vaccinating boys is not recommended. It is the view of the American Society of Clinical Oncology that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Gaps between Knowing and Doing: Understanding and Assessing the Barriers to Optimal Health Care

ERIC Educational Resources Information Center

Cochrane, Lorna J.; Olson, Curtis A.; Murray, Suzanne; Dupuis, Martin; Tooman, Tricia; Hayes, Sean

2007-01-01

Introduction: A significant gap exists between science and clinical practice guidelines, on the one hand, and actual clinical practice, on the other. An in-depth understanding of the barriers and incentives contributing to the gap can lead to interventions that effect change toward optimal practice and thus to better care. Methods: A systematic…

Screening and management of gestational diabetes mellitus in Scottish obstetric units: a national survey.

PubMed

Stirrat, Laura I; Denison, Fiona C; Love, Corinne D B; Lindsay, Robert S; Reynolds, Rebecca M

2015-02-01

The last study of screening practices for gestational diabetes (GDM) in the UK concluded that a lack of consensus about screening was due to a lack of clinical guidelines. We aimed to determine current practices in Scotland since new guidelines recommended that diagnosis should be made at a lower level of hyperglycaemia. An online questionnaire designed to investigate the screening and management of GDM was distributed to all maternity units in Scotland managing women with GDM (n = 15) for completion by relevant clinical team members. The response rate was 100%. Considerable variation in clinical practice existed between units. Thirteen units (86.7%) had adopted the lower glucose tolerance values for diagnosis of GDM (fasting ≥5.1 mmol/L; 2-h ≥8.5 mmol/L) recommended by the Scottish Intercollegiate Guidelines Network in 2010. Available data from units using this guideline (n = 3) revealed a significant increase in the percentage of women diagnosed with GDM between 2010 and 2012 (2010: 1.28%, 2012: 2.54%; p < 0.0001). Despite provision of clinical guidelines, there are still inconsistencies in screening and management of GDM in Scotland. If a similar increase in the prevalence of GDM is experienced across Scotland, there will be major implications for health care provision and resource allocation. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Modeling a Nursing Guideline with Standard Terminology and Unified Modeling Language for a Nursing Decision Support System: A Case Study.

PubMed

Choi, Jeeyae; Jansen, Kay; Coenen, Amy

In recent years, Decision Support Systems (DSSs) have been developed and used to achieve "meaningful use". One approach to developing DSSs is to translate clinical guidelines into a computer-interpretable format. However, there is no specific guideline modeling approach to translate nursing guidelines to computer-interpretable guidelines. This results in limited use of DSSs in nursing. Unified modeling language (UML) is a software writing language known to accurately represent the end-users' perspective, due to its expressive characteristics. Furthermore, standard terminology enabled DSSs have been shown to smoothly integrate into existing health information systems. In order to facilitate development of nursing DSSs, the UML was used to represent a guideline for medication management for older adults encode with the International Classification for Nursing Practice (ICNP®). The UML was found to be a useful and sufficient tool to model a nursing guideline for a DSS.

Modeling a Nursing Guideline with Standard Terminology and Unified Modeling Language for a Nursing Decision Support System: A Case Study

PubMed Central

Choi, Jeeyae; Jansen, Kay; Coenen, Amy

2015-01-01

In recent years, Decision Support Systems (DSSs) have been developed and used to achieve “meaningful use”. One approach to developing DSSs is to translate clinical guidelines into a computer-interpretable format. However, there is no specific guideline modeling approach to translate nursing guidelines to computer-interpretable guidelines. This results in limited use of DSSs in nursing. Unified modeling language (UML) is a software writing language known to accurately represent the end-users’ perspective, due to its expressive characteristics. Furthermore, standard terminology enabled DSSs have been shown to smoothly integrate into existing health information systems. In order to facilitate development of nursing DSSs, the UML was used to represent a guideline for medication management for older adults encode with the International Classification for Nursing Practice (ICNP®). The UML was found to be a useful and sufficient tool to model a nursing guideline for a DSS. PMID:26958174

Presentation of economic evaluation results.

PubMed

Chaikledkaew, Usa

2014-05-01

The first HTA guidelines for Thailand included a chapter outlining a set of guidelines on how best to report the findings of health economic evaluations, based on a review of best practice and existing guidelines on the presentation of economic evaluation results from around the world. In this second edition of HTA guidelines for Thailand, the recommendations build on the first edition by using a case study to illustrate how the guidelines can be applied in a real research context. The guidelines propose that all reporting include ten key elements: defining the scope of the study, selection of comparator(s), defining the type of economic evaluation, measurement of costs, measurement of clinical effects, handling time in economic evaluation studies, handling uncertainty and sensitivity analysis, presentation of the results, discussion of the results, and disclosure of funding and authors conflict of interest.

Recommendations for the inclusion of Fabry disease as a rare febrile condition in existing algorithms for fever of unknown origin.

PubMed

Manna, Raffaele; Cauda, Roberto; Feriozzi, Sandro; Gambaro, Giovanni; Gasbarrini, Antonio; Lacombe, Didier; Livneh, Avi; Martini, Alberto; Ozdogan, Huri; Pisani, Antonio; Riccio, Eleonora; Verrecchia, Elena; Dagna, Lorenzo

2017-10-01

Fever of unknown origin (FUO) is a rather rare clinical syndrome representing a major diagnostic challenge. The occurrence of more than three febrile attacks with fever-free intervals of variable duration during 6 months of observation has recently been proposed as a subcategory of FUO, Recurrent FUO (RFUO). A substantial number of patients with RFUO have auto-inflammatory genetic fevers, but many patients remain undiagnosed. We hypothesize that this undiagnosed subgroup may be comprised of, at least in part, a number of rare genetic febrile diseases such as Fabry disease. We aimed to identify key features or potential diagnostic clues for Fabry disease as a model of rare genetic febrile diseases causing RFUO, and to develop diagnostic guidelines for RFUO, using Fabry disease as an example of inserting other rare diseases in the existing FUO algorithms. An international panel of specialists in recurrent fevers and rare diseases, including internists, infectious disease specialists, rheumatologists, gastroenterologists, nephrologists, and medical geneticists convened to review the existing diagnostic algorithms, and to suggest recommendations for arriving at accurate diagnoses on the basis of available literature and clinical experience. By combining specific features of rare diseases with other diagnostic considerations, guidelines have been designed to raise awareness and identify rare diseases among other causes of FUO. The proposed guidelines may be useful for the inclusion of rare diseases in the diagnostic algorithms for FUO. A wide spectrum of patients will be needed to validate the algorithm in different clinical settings.

ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.

PubMed

Cavero, Icilio; Crumb, William

2005-05-01

The International Conference on Harmonization (ICH) stems from the initiative of three major world partners (Japan, USA, European Community) who composed a mutually accepted body of regulations concerning the safety, quality and efficacy requirements that new medicines have to meet in order to receive market approval. Documents on non-clinical safety pharmacology already composed by this organisation include two guidelines: the S7A adopted in 2000 and, its companion, the S7B guideline, in a draft form since 2001. The S7A guideline deals with general principles and recommendations on safety pharmacology studies designed to protect healthy volunteers and patients from potential drug-induced adverse reactions. The S7B recommends a general non-clinical testing strategy for determining the propensity of non-cardiovascular pharmaceuticals to delay ventricular repolarisation, an effect that at times progresses into life-threatening ventricular arrhythmia. In the most recent version of this document (June 2004), the strategy proposes experimental assays and a critical examination of other pertinent information for applying an 'evidence of risk' label to a compound. Regrettably, the guideline fails to deal satisfactorily with a number of crucial issues such as scoring the evidence of risk and the clinical consequences of such scoring. However, in the latter case, the S7B relies on the new ICH guideline E14 which is currently in preparation. E14 is the clinical counterpart of the S7B guideline which states that non-clinical data are a poor predictor of drug-induced repolarisation delay in humans. The present contribution summarises and assesses salient aspects of the S7A guideline as its founding principles are also applicable to the S7B guideline. The differences in strategies proposed by the various existing drafts of the latter document are critically examined together with some unresolved, crucial problems. The need for extending the objective of the S7B document to characterise the full electrophysiological profile of new pharmaceuticals is argued as this approach would more extensively assess the non-clinical cardiac safety of a drug. Finally, in order to overcome present difficulties in arriving at the definitive version of the S7B guideline, the Expert Working Group could reflect on the introduction of the S7B guideline recommendations in the S7A document, as originally intended, or on postponing the adoption of an harmonized text until the availability of novel scientific data allows solving presently contentious aspects of this and the E14 guidelines.

Couple/family therapy for posttraumatic stress disorder: review to facilitate interpretation of VA/DOD Clinical Practice Guideline.

PubMed

Monson, Candice M; Macdonald, Alexandra; Brown-Bowers, Amy

2012-01-01

A well-documented association exists among Veterans' posttraumatic stress disorder (PTSD) symptoms, family relationship problems, and mental health problems in partners and children of Veterans. This article reviews the recommendations regarding couple/family therapy offered in the newest version of the Department of Veterans Affairs (VA)/Department of Defense (DOD) VA/DOD Clinical Practice Guideline for Management of Post-Traumatic Stress. We then provide a heuristic for clinicians, researchers, and policy makers to consider when incorporating couple/family interventions into Veterans' mental health services. The range of research that has been conducted on couple/family therapy for Veterans with PTSD is reviewed using this heuristic, and suggestions for clinical practice are offered.

[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.

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.

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

Analyzing international clinical education practices for Canadian rehabilitation students.

PubMed

Ahluwalia, Puja; Cameron, Debra; Cockburn, Lynn; Ellwood, Lynn; Mori, Brenda; Nixon, Stephanie A

2014-09-09

Clinical training in low-income countries has become increasingly popular among pre-licensure trainees from high-income countries. The Working Group on Ethics Guidelines for Global Health Training ("WEIGHT Guidelines") were designed to identify and inform the complex and contentious field of international clinical education. The purpose of this study was to use the WEIGHT Guidelines to evaluate an international clinical internship programme for Master's-level rehabilitation students at a Canadian university. In-depth, semi-structured interviews were conducted with eight Canadian rehabilitation researchers, educations and/or clinicians responsible for administering international internships across three clinical training programmes. Interview questions were informed by the WEIGHT Guidelines. Directed content analysis was used to identify priorities for policy, practice and research. Five themes relating to strengthening international clinical education were identified: (1) from one-time internships to long-term partnerships, (2) starting a discussion about "costs", (3) a more informed approach to student selection, (4) expanding and harmonizing pre-departure training across disciplines, and (5) investing in post-internship debriefing. International clinical education is fraught with ethical, pedagogical and logistical issues that require recognition and ongoing management. This is the first study to use the WEIGHT Guidelines as a qualitative research tool for assessing an existing global health education programme. Results highlight new priorities for action at the Canadian "sending institution", including more explicit attention to the costs (broadly defined) borne by all parties. A crucial next step is deepened engagement with educational partners at the "receiving organizations" based in low-income countries to nurture dialogue regarding reciprocity, trust and sustainability of the partnership. Education research is also needed that evaluates models of pre-departure training and post-internship debriefing for trainees.

Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL.

PubMed

Deans, Zandra C; Costa, Jose Luis; Cree, Ian; Dequeker, Els; Edsjö, Anders; Henderson, Shirley; Hummel, Michael; Ligtenberg, Marjolijn Jl; Loddo, Marco; Machado, Jose Carlos; Marchetti, Antonio; Marquis, Katherine; Mason, Joanne; Normanno, Nicola; Rouleau, Etienne; Schuuring, Ed; Snelson, Keeda-Marie; Thunnissen, Erik; Tops, Bastiaan; Williams, Gareth; van Krieken, Han; Hall, Jacqueline A

2017-01-01

The clinical demand for mutation detection within multiple genes from a single tumour sample requires molecular diagnostic laboratories to develop rapid, high-throughput, highly sensitive, accurate and parallel testing within tight budget constraints. To meet this demand, many laboratories employ next-generation sequencing (NGS) based on small amplicons. Building on existing publications and general guidance for the clinical use of NGS and learnings from germline testing, the following guidelines establish consensus standards for somatic diagnostic testing, specifically for identifying and reporting mutations in solid tumours. These guidelines cover the testing strategy, implementation of testing within clinical service, sample requirements, data analysis and reporting of results. In conjunction with appropriate staff training and international standards for laboratory testing, these consensus standards for the use of NGS in molecular pathology of solid tumours will assist laboratories in implementing NGS in clinical services.

Unmet Primary Physicians' Needs for Allergic Rhinitis Care in Korea.

PubMed

Yang, Hyeon Jong; Kim, Young Hyo; Lee, Bora; Kong, Do Youn; Kim, Dong Kyu; Kim, Mi Ae; Kim, Bong Seong; Kim, Won Young; Kim, Jeong Hee; Park, Yang; Park, So Yeon; Bae, Woo Yong; Song, Keejae; Yang, Min Suk; Lee, Sang Min; Lee, Young Mok; Lee, Hyun Jong; Cho, Jae Hong; Jee, Hye Mi; Choi, Jeong Hee; Yoo, Young; Koh, Young Il

2017-05-01

Allergic rhinitis (AR) is one of the most common chronic allergic respiratory diseases worldwide. Various practical guidelines for AR have been developed and updated to improve the care of AR patients; however, up to 40% patients remain symptomatic. The unmet need for AR care is one of the greatest public health problems in the world. The gaps between guideline and real-world practice, and differences according to the region, culture, and medical environments may be the causes of unmet needs for AR care. Because there is no evidence-based AR practical guideline reflecting the Korean particularity, various needs are increasing. The purpose of the study was to evaluate whether existing guidelines are sufficient for AR patient management in real practice and whether development of regional guidelines to reflect regional differences is needed in Korea. A total of 99 primary physicians comprising internists, pediatricians, and otolaryngologists (n=33 for each) were surveyed by a questionnaire relating to unmet needs for AR care between June 2 and June 16 of 2014. Among 39 question items, participants strongly agreed on 15 items that existing guidelines were highly insufficient and needed new guidelines. However, there was some disagreement according to specialties for another 24 items. In conclusion, the survey results demonstrated that many physicians did not agree with the current AR guideline, and a new guideline reflecting Korean particularity was needed. Copyright © 2017 The Korean Academy of Asthma, Allergy and Clinical Immunology · The Korean Academy of Pediatric Allergy and Respiratory Disease.

Rules and guidelines in clinical practice: a qualitative study in operating theatres of doctors' and nurses' views

PubMed Central

McDonald, R; Waring, J; Harrison, S; Walshe, K; Boaden, R

2005-01-01

Background: The current orthodoxy within patient safety research and policy is characterised by a faith in rules based systems which limit the capacity for individual discretion, and hence fallibility. However, guidelines have been seen as stifling innovation and eroding trust. Our objectives were to explore the attitudes towards guidelines of doctors and nurses working together in surgical teams and to examine the extent to which trusting relationships are maintained in a context governed by explicit rules. Methods: Fourteen consultant grade surgeons of mixed specialty, 12 consultant anaesthetists, and 15 nurses were selected to reflect a range of roles. Participant observation was combined with semi-structured interviews. Results: Doctors' views about the contribution of guidelines to safety and to clinical practice differed from those of nurses. Doctors rejected written rules, instead adhering to the unwritten rules of what constitutes acceptable behaviour for members of the medical profession. In contrast, nurses viewed guideline adherence as synonymous with professionalism and criticised doctors for failing to comply with guidelines. Conclusions: While the creation of a "safety culture" requires a shared set of beliefs, attitudes and norms in relation to what is seen as safe clinical practice, differences of opinion on these issues exist which cannot be easily reconciled since they reflect deeply ingrained beliefs about what constitutes professional conduct. While advocates of standardisation (such as nurses) view doctors as rule breakers, doctors may not necessarily regard guidelines as legitimate or identify with the rules written for them by members of other social groups. Future safety research and policy should attempt to understand the unwritten rules which govern clinical behaviour and examine the ways in which such rules are produced, maintained, and accepted as legitimate. PMID:16076795

Cervical cancer screening in adolescents: an evidence-based internet education program for practice improvement among advanced practice nurses.

PubMed

Choma, Kim; McKeever, Amy E

2015-02-01

The literature reports great variation in the knowledge levels and application of the recent changes of cervical cancer screening guidelines into clinical practice. Evidence-based screening guidelines for the prevention and early detection of cervical cancer offers healthcare providers the opportunity to improve practice patterns among female adolescents by decreasing psychological distress as well as reducing healthcare costs and morbidities associated with over-screening. The purpose of this pilot intervention study was to determine the effects of a Web-based continuing education unit (CEU) program on advanced practice nurses' (APNs) knowledge of current cervical cancer screening evidence-based recommendations and their application in practice. This paper presents a process improvement project as an example of a way to disseminate updated evidence-based practice guidelines among busy healthcare providers. This Web-based CEU program was developed, piloted, and evaluated specifically for APNs. The program addressed their knowledge level of cervical cancer and its relationship with high-risk human papillomavirus. It also addressed the new cervical cancer screening guidelines and the application of those guidelines into clinical practice. Results of the study indicated that knowledge gaps exist among APNs about cervical cancer screening in adolescents. However, when provided with a CEU educational intervention, APNs' knowledge levels increased and their self-reported clinical practice behaviors changed in accordance with the new cervical cancer screening guidelines. Providing convenient and readily accessible up-to-date electronic content that provides CEU enhances the adoption of clinical practice guidelines, thereby decreasing the potential of the morbidities associated with over-screening for cervical cancer in adolescents and young women. © 2014 Sigma Theta Tau International.

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.

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

Building Chronic Kidney Disease Clinical Practice Guidelines Using the openEHR Guideline Definition Language.

PubMed

Lin, Ching-Heng; Lo, Ying-Chih; Hung, Pei-Yuan; Liou, Der-Ming

2016-12-07

As a result of the disease's high prevalence, chronic kidney disease (CKD) has become a global public health problem. A clinical decision support system that integrates with computer-interpretable guidelines (CIGs) should improve clinical outcomes and help to ensure patient safety. The openEHR guideline definition language (GDL) is a formal language used to represent CIGs. This study explores the feasibility of using a GDL approach for CKD; it also attempts to identify any potential gaps between the ideal concept and reality. Using the Kidney Disease Improving Global Outcomes (KDIGO) anemia guideline as material, we designed a development workflow in order to establish a series of GDL guidelines. Focus group discussions were conducted in order to identify important issues related to GDL implementation. Ten GDL guidelines and 37 archetypes were established using the KDIGO guideline document. For the focus group discussions, 16 clinicians and 22 IT experts were recruited and their perceptions, opinions and attitudes towards the GDL approach were explored. Both groups provided positive feedback regarding the GDL approach, but raised various concerns about GDL implementation. Based on the findings of this study, we identified some potential gaps that might exist during implementation between the GDL concept and reality. Three directions remain to be investigated in the future. Two of them are related to the openEHR GDL approach. Firstly, there is a need for the editing tool to be made more sophisticated. Secondly, there needs to be integration of the present approach into non openEHR-based hospital information systems. The last direction focuses on the applicability of guidelines and involves developing a method to resolve any conflicts that occur with insurance payment regulations.

Guidelines for the Pharmacotherapy of Schizophrenia in Adults.

PubMed

Remington, Gary; Addington, Donald; Honer, William; Ismail, Zahinoor; Raedler, Thomas; Teehan, Michael

2017-09-01

The present guidelines address the pharmacotherapy of schizophrenia in adults across different stages, phases, and symptom domains. Guidelines were developed using the ADAPTE process, which takes advantage of existing guidelines. Six guidelines were identified for adaptation, with recommendations extracted from each. For those specific to the pharmacotherapy of schizophrenia in adults, a working group selected between guidelines and recommendations to create an adapted guideline. Recommendations can be categorized into 6 areas that include 1) first-episode schizophrenia, 2) acute exacerbation, 3) relapse prevention and maintenance treatment, 4) treatment-resistant schizophrenia, 5) clozapine-resistant schizophrenia, and 6) specific symptom domains. For each category, recommendations are made based on the available evidence, which is discussed and linked to other established guidelines. In most cases, evidence-based recommendations are made that can be used to guide current clinical treatment and decision making. Notably, however, there is a paucity of established evidence to guide treatment decision making in the case of clozapine-resistant schizophrenia, a subsample that represents a sizable proportion of those with schizophrenia.

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.

Nurses’ Perceptions of Critical Issues Requiring Consideration in the Development of Guidelines for Professional Registered Nurse Staffing for Perinatal Units

PubMed Central

Simpson, Kathleen Rice; Lyndon, Audrey; Wilson, Jane; Ruhl, Catherine

2012-01-01

Objective To solicit input from registered nurse members of the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) on critical considerations for review and revision of existing nurse staffing guidelines. Design Thematic analysis of responses to a cross-sectional on-line survey question: “Please give the staffing task force your input on what they should consider in the development of recommendations for staffing of perinatal units.” Participants N = 884 AWHONN members. Main Outcome Measure Descriptions of staffing concerns that should be considered when evaluating and revising existing perinatal nurse staffing guidelines. Results Consistent themes identified included the need for revision of nurse staffing guidelines due to requirements for safe care, increases in patient acuity and complexity, invisibility of the fetus and newborn as separate and distinct patients, difficulties in providing comprehensive care during labor and for mother-baby couplets under current conditions, challenges in staffing small volume units, and the negative effect of inadequate staffing on nurse satisfaction and retention. Conclusion Participants overwhelmingly indicated current nurse staffing guidelines were inadequate to meet the needs of contemporary perinatal clinical practice and required revision based on significant changes that had occurred since 1983 when the original staffing guidelines were published. PMID:22690743

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.

Making a difference: initiating and maintaining a faith-based free health clinic.

PubMed

Dunn, Linda L

2009-01-01

This article is a summary of the challenges, struggles, and barriers that a group of churches encountered in developing a faith-based free health clinic. From the inception, this clinic has existed for the uninsured whose total household income aligns with the 2009 Fedral Poverty Guidelines. A voluntary interview with the executive director of The Good Samaritan Clinic revealed the experiential evolvement of this free health clinic. Numerous examples are shared that depict how this clinic has made a difference in the lives of many people.

TU-C-201-03: The Use of Checklists and Audit Tools for Safety and QA

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

Prisciandaro, J.

Recent use of HDR has increased while planning has become more complex often necessitating 3D image-based planning. While many guidelines for the use of HDR exist, they have not kept pace with the increased complexity of 3D image-based planning. Furthermore, no comprehensive document exists to describe the wide variety of current HDR clinical indications. This educational session aims to summarize existing national and international guidelines for the safe implementation of an HDR program. A summary of HDR afterloaders available on the market and their existing applicators will be provided, with guidance on how to select the best fit for eachmore » institution’s needs. Finally, the use of checklists will be discussed as a means to implement a safe and efficient HDR program and as a method by which to verify the quality of an existing HDR program. This session will provide the perspective of expert HDR physicists as well as the perspective of a new HDR user. Learning Objectives: Summarize national and international safety and staffing guidelines for HDR implementation Discuss the process of afterloader and applicator selection for gynecologic, prostate, breast, interstitial, surface treatments Learn about the use of an audit checklist tool to measure of quality control of a new or existing HDR program Describe the evolving use of checklists within an HDR program.« less

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.

Understanding the Contribution of Family History to Colorectal Cancer Risk and Its Clinical Implications: A State-of-the-Science Review

PubMed Central

Lowery, Jan T; Ahnen, Dennis J; Schroy, Paul C.; Hampel, Heather; Baxter, Nancy; Boland, C. Richard; Burt, Randall W; Butterly, Lynn; Doerr, Megan; Doroshenk, Mary; Feero, W. Gregory; Henrikson, Nora; Ladabaum, Uri; Lieberman, David; McFarland, Elizabeth G; Peterson, Susan K; Raymond, Martha; Samadder, N. Jewel; Syngal, Sapna; Weber, Thomas K.; Zauber, Ann G; Smith, Robert

2017-01-01

Background Persons with a family history (FH) of colorectal cancer (CRC) or adenomas that are not due to known hereditary syndromes have increased risk for CRC. Understanding these risks, screening recommendations and screening behaviors can inform strategies to reduce CRC burden in these families. Methods A comprehensive review of literature published within the past 10 years was conducted to assess what is known about cancer risk, screening guidelines, adherence and barriers to screening and effective interventions in persons with FH of CRC, and to identify FH tools used to identify these individuals and inform care. Results Existing data show that having one affected first-degree relative (FDR) increases CRC risk by 2-fold, and risk increases with multiple affected FDRs and younger age at diagnosis. There was variability in screening recommendations across consensus guidelines. Screening adherence was <50% and lower in persons under age 50. Having a provider’s recommendation, multiple affected relatives and family encouragement facilitated screening; insufficient collection of FH, low knowledge of guidelines, and poor family communication were important barriers. Effective interventions incorporated strategies for overcoming barriers but these have not been tested broadly in clinical settings. Conclusions Four strategies for reducing CRC in persons with familial risk are suggested: 1) improve how we collect and utilize cancer FH, 2) establish consensus for screening guidelines by FH, 3) enhance provider-patient knowledge of guidelines and communication about CRC risk, 4) encourage survivors to promote screening within their families, and partner with existing screening programs to expand reach to high-risk groups. PMID:27258162

Developing a questionnaire to identify perceived barriers for implementing the Dutch physical therapy COPD clinical practice guideline.

PubMed

van der Wees, Philip J; Zagers, Cor A M; de Die, Sara E; Hendriks, Erik J M; Nijhuis-van der Sanden, Maria W G; de Bie, Rob A

2013-05-01

Clinical practice guidelines have been developed to assist healthcare practitioners in clinical decision making. Publication of clinical practice guidelines does not automatically lead to their uptake and barrier identification has been recognized as an important step in implementation planning. This study aimed at developing a questionnaire to identify perceived barriers for implementing the Dutch COPD guideline for physical therapists and its recommended measurement instruments. An overall questionnaire, based on two existing questionnaires, was constructed to identify barriers and facilitators for implementing the COPD guideline. The construct of the questionnaire was assessed in a cross-sectional study among 246 chest physical therapists. Factor analysis was conducted to explore underlying dimensions. Psychometric properties were analyzed using Cronbach's alpha. Barriers and facilitators were assessed using descriptive statistics. Some 139 physical therapists (57%) responded. Factor analysis revealed 4-factor and 5-factor solutions with an explained variance of 36% and 39% respectively. Cronbach's alpha of the overall questionnaire was 0.90, and varied from 0.66 to 0.92 for the different factors. Underlying domains of the 5-factor solution were characterized as: attitude towards using measurement instruments, knowledge and skills of the physical therapist, applicability of the COPD guideline, required investment of time & money, and patient characteristics. Physical therapists showed a positive attitude toward using the COPD guideline. Main barriers for implementation were required time investment and financial constraints. The construct of the questionnaire revealed relevant underlying domains for the identification of barriers and facilitators for implementing the COPD guideline. The questionnaire allowed for tailoring to the target group and may be used across health care professionals as basis for in-depth analysis of barriers to specific recommendations in guidelines. The results of the questionnaire alone do not provide sufficient information to inform the development of an implementation strategy. The infrastructure for developing the guideline can be used for addressing key barriers by the guideline development group, using the questionnaire as well as in-depth analysis such as focus group interviews. Further development of methods for prospective identification of barriers and consequent tailoring of implementation interventions is required.

Developing a questionnaire to identify perceived barriers for implementing the Dutch physical therapy COPD clinical practice guideline

PubMed Central

2013-01-01

Background Clinical practice guidelines have been developed to assist healthcare practitioners in clinical decision making. Publication of clinical practice guidelines does not automatically lead to their uptake and barrier identification has been recognized as an important step in implementation planning. This study aimed at developing a questionnaire to identify perceived barriers for implementing the Dutch COPD guideline for physical therapists and its recommended measurement instruments. Methods An overall questionnaire, based on two existing questionnaires, was constructed to identify barriers and facilitators for implementing the COPD guideline. The construct of the questionnaire was assessed in a cross-sectional study among 246 chest physical therapists. Factor analysis was conducted to explore underlying dimensions. Psychometric properties were analyzed using Cronbach’s alpha. Barriers and facilitators were assessed using descriptive statistics. Results Some 139 physical therapists (57%) responded. Factor analysis revealed 4-factor and 5-factor solutions with an explained variance of 36% and 39% respectively. Cronbach’s alpha of the overall questionnaire was 0.90, and varied from 0.66 to 0.92 for the different factors. Underlying domains of the 5-factor solution were characterized as: attitude towards using measurement instruments, knowledge and skills of the physical therapist, applicability of the COPD guideline, required investment of time & money, and patient characteristics. Physical therapists showed a positive attitude toward using the COPD guideline. Main barriers for implementation were required time investment and financial constraints. Conclusions The construct of the questionnaire revealed relevant underlying domains for the identification of barriers and facilitators for implementing the COPD guideline. The questionnaire allowed for tailoring to the target group and may be used across health care professionals as basis for in-depth analysis of barriers to specific recommendations in guidelines. The results of the questionnaire alone do not provide sufficient information to inform the development of an implementation strategy. The infrastructure for developing the guideline can be used for addressing key barriers by the guideline development group, using the questionnaire as well as in-depth analysis such as focus group interviews. Further development of methods for prospective identification of barriers and consequent tailoring of implementation interventions is required. PMID:23631555

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

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

PubMed

Birkner, B

2000-09-01

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

Legal and ethical issues in research.

PubMed

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

2016-09-01

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

Enhancing system-wide implementation of opioid prescribing guidelines in primary care: protocol for a stepped-wedge quality improvement project.

PubMed

Zgierska, Aleksandra E; Vidaver, Regina M; Smith, Paul; Ales, Mary W; Nisbet, Kate; Boss, Deanne; Tuan, Wen-Jan; Hahn, David L

2018-06-05

Systematic implementation of guidelines for opioid therapy management in chronic non-cancer pain can reduce opioid-related harms. However, implementation of guideline-recommended practices in routine care is subpar. The goal of this quality improvement (QI) project is to assess whether a clinic-tailored QI intervention improves the implementation of a health system-wide, guideline-driven policy on opioid prescribing in primary care. This manuscript describes the protocol for this QI project. A health system with 28 primary care clinics caring for approximately 294,000 primary care patients developed and implemented a guideline-driven policy on long-term opioid therapy in adults with opioid-treated chronic non-cancer pain (estimated N = 3980). The policy provided multiple recommendations, including the universal use of treatment agreements, urine drug testing, depression and opioid misuse risk screening, and standardized documentation of the chronic pain diagnosis and treatment plan. The project team drew upon existing guidelines, feedback from end-users, experts and health system leadership to develop a robust QI intervention, targeting clinic-level implementation of policy-directed practices. The resulting multi-pronged QI intervention included clinic-wide and individual clinician-level educational interventions. The QI intervention will augment the health system's "routine rollout" method, consisting of a single educational presentation to clinicians in group settings and a separate presentation for staff. A stepped-wedge design will enable 9 primary care clinics to receive the intervention and assessment of within-clinic and between-clinic changes in adherence to the policy items measured by clinic-level electronic health record-based measures and process measures of the experience with the intervention. Developing methods for a health system-tailored QI intervention required a multi-step process to incorporate end-user feedback and account for the needs of targeted clinic team members. Delivery of such tailored QI interventions has the potential to enhance uptake of opioid therapy management policies in primary care. Results from this study are anticipated to elucidate the relative value of such QI activities.

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.

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.

A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing.

PubMed

Gifford, Wendy A; Davies, Barbara; Graham, Ian D; Lefebre, Nancy; Tourangeau, Ann; Woodend, Kirsten

2008-12-10

Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications) was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. Two phase mixed methods design is proposed (ISRCTN 12345678). Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers) will evaluate differences in outcomes between two implementation strategies. Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a) printed materials, b) one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c) three post-workshop teleconferences. This study will provide vital information on which leadership strategies are well received to facilitate and support guideline implementation. The anticipated outcomes will provide information to assist with effective management of foot ulcers for people with diabetes. By tracking clinical outcomes associated with guideline implementation, health care administrators will be better informed to influence organizational and policy decision-making to support evidence-based quality care. Findings will be useful to inform the design of future multi-centered trials on various clinical topics to enhance knowledge translation for positive outcomes.

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.

Korean clinical practice guidelines: otitis media in children.

PubMed

Lee, Hyo-Jeong; Park, Su-Kyoung; Choi, Kyu Young; Park, Su Eun; Chun, Young Myung; Kim, Kyu-Sung; Park, Shi-Nae; Cho, Yang-Sun; Kim, Young-Jae; Kim, Hyung-Jong; Korean Otologic Society

2012-08-01

Acute otitis media (AOM) and otitis media with effusion (OME) are common infections in children, and their diagnosis and treatment have significant impacts on the health of children and the costs of providing national medical care. In 2009, the Korean Otologic Society organized a committee composed of experts in the field of otolaryngology, pediatrics, and family medicine to develop Korean clinical practice guidelines (CPG) for otitis media in children with the goal of meeting regional medical and social needs in Korea. For this purpose, the committee adapted existing guidelines. A comprehensive literature review was carried out primarily from 2004 to 2009 using medical search engines including data from Korea. A draft was written after a national questionnaire survey and several public audits, and it was editorially supervised by senior advisors before publication of the final report. These evidence-based guidelines for the management of otitis media in children provide recommendations to primary practitioners for the diagnosis and treatment of children younger than 15 yr old with uncomplicated AOM and OME. The guidelines include recommendations regarding diagnosis, treatment options, prevention and parent education, medical records, referral, and complementary/alternative medicine for treating pediatric otitis media.

Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12,440 patients of the ESC Heart Failure Long-Term Registry.

PubMed

Maggioni, Aldo P; Anker, Stefan D; Dahlström, Ulf; Filippatos, Gerasimos; Ponikowski, Piotr; Zannad, Faiez; Amir, Offer; Chioncel, Ovidiu; Leiro, Marisa Crespo; Drozdz, Jaroslaw; Erglis, Andrejs; Fazlibegovic, Emir; Fonseca, Candida; Fruhwald, Friedrich; Gatzov, Plamen; Goncalvesova, Eva; Hassanein, Mahmoud; Hradec, Jaromir; Kavoliuniene, Ausra; Lainscak, Mitja; Logeart, Damien; Merkely, Bela; Metra, Marco; Persson, Hans; Seferovic, Petar; Temizhan, Ahmet; Tousoulis, Dimitris; Tavazzi, Luigi

2013-10-01

To evaluate how recommendations of European guidelines regarding pharmacological and non-pharmacological treatments for heart failure (HF) are adopted in clinical practice. The ESC-HF Long-Term Registry is a prospective, observational study conducted in 211 Cardiology Centres of 21 European and Mediterranean countries, members of the European Society of Cardiology (ESC). From May 2011 to April 2013, a total of 12,440 patients were enrolled, 40.5% with acute HF and 59.5% with chronic HF. Intravenous treatments for acute HF were heterogeneously administered, irrespective of guideline recommendations. In chronic HF, with reduced EF, renin-angiotensin system (RAS) blockers, beta-blockers, and mineralocorticoid antagonists (MRAs) were used in 92.2, 92.7, and 67.0% of patients, respectively. When reasons for non-adherence were considered, the real rate of undertreatment accounted for 3.2, 2.3, and 5.4% of the cases, respectively. About 30% of patients received the target dosage of these drugs, but a documented reason for not achieving the target dosage was reported in almost two-thirds of them. The more relevant reasons for non-implantation of a device, when clinically indicated, were related to doctor uncertainties on the indication, patient refusal, or logistical/cost issues. This pan-European registry shows that, while in patients with acute HF, a large heterogeneity of treatments exists, drug treatment of chronic HF can be considered largely adherent to recommendations of current guidelines, when the reasons for non-adherence are taken into account. Observations regarding the real possibility to adhere fully to current guidelines in daily clinical practice should be seriously considered when clinical practice guidelines have to be written.

Quality indicators for hip fracture care, a systematic review.

PubMed

Voeten, S C; Krijnen, P; Voeten, D M; Hegeman, J H; Wouters, M W J M; Schipper, I B

2018-05-17

Quality indicators are used to measure quality of care and enable benchmarking. An overview of all existing hip fracture quality indicators is lacking. The primary aim was to identify quality indicators for hip fracture care reported in literature, hip fracture audits, and guidelines. The secondary aim was to compose a set of methodologically sound quality indicators for the evaluation of hip fracture care in clinical practice. A literature search according to the PRISMA guidelines and an internet search were performed to identify hip fracture quality indicators. The indicators were subdivided into process, structure, and outcome indicators. The methodological quality of the indicators was judged using the Appraisal of Indicators through Research and Evaluation (AIRE) instrument. For structure and process indicators, the construct validity was assessed. Sixteen publications, nine audits and five guidelines were included. In total, 97 unique quality indicators were found: 9 structure, 63 process, and 25 outcome indicators. Since detailed methodological information about the indicators was lacking, the AIRE instrument could not be applied. Seven indicators correlated with an outcome measure. A set of nine quality indicators was extracted from the literature, audits, and guidelines. Many quality indicators are described and used. Not all of them correlate with outcomes of care and have been assessed methodologically. As methodological evidence is lacking, we recommend the extracted set of nine indicators to be used as the starting point for further clinical research. Future research should focus on assessing the clinimetric properties of the existing quality indicators.

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

PubMed Central

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

2017-01-01

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

Primary Prevention of Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Guideline

PubMed Central

Arrossi, Silvina; Temin, Sarah; Garland, Suzanne; Eckert, Linda O’Neal; Bhatla, Neerja; Castellsagué, Xavier; Alkaff, Sharifa Ezat; Felder, Tamika; Hammouda, Doudja; Konno, Ryo; Lopes, Gilberto; Mugisha, Emmanuel; Murillo, Rául; Scarinci, Isabel C.; Stanley, Margaret; Tsu, Vivien; Wheeler, Cosette M.; Adewole, Isaac Folorunso; de Sanjosé, Silvia

2017-01-01

Purpose To provide resource-stratified (four tiers), evidence-based recommendations on the primary prevention of cervical cancer globally. Methods The American Society of Clinical Oncology convened a multidisciplinary, multinational panel of oncology, obstetrics/gynecology, public health, cancer control, epidemiology/biostatistics, health economics, behavioral/implementation science, and patient advocacy experts. The Expert Panel reviewed existing guidelines and conducted a modified ADAPTE process and a formal consensus-based process with additional experts (consensus ratings group) for one round of formal ratings. Results Existing sets of guidelines from five guideline developers were identified and reviewed; adapted recommendations formed the evidence base. Five systematic reviews, along with cost-effectiveness analyses, provided evidence to inform the formal consensus process, which resulted in agreement of ≥ 75%. Recommendations In all resource settings, two doses of human papillomavirus vaccine are recommended for girls age 9 to 14 years, with an interval of at least 6 months and possibly up to 12 to 15 months. Individuals with HIV positivity should receive three doses. Maximal and enhanced settings: if girls are age ≥ 15 years and received their first dose before age 15 years, they may complete the series; if no doses were received before age 15 years, three doses should be administered; in both scenarios, vaccination may be through age 26 years. Limited and basic settings: if sufficient resources remain after vaccinating girls age 9 to 14 years, girls who received one dose may receive additional doses between age 15 and 26 years. Maximal, enhanced, and limited settings: if ≥ 50% coverage in the priority female target population, sufficient resources, and cost effectiveness, boys may be vaccinated to prevent other noncervical human papillomavirus–related cancers and diseases. Basic settings: vaccinating boys is not recommended. It is the view of the American Society of Clinical Oncology that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines. PMID:29094100

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.

75 FR 13550 - Office of Clinical and Preventive Services: National HIV Program

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

... (CDC) guidelines, and pre- and post-test counseling (when appropriate). Purpose These cooperative... tests with sexually transmitted diseases (STD) screening. II. Award Information Type of Awards... existing public health statutes. Test at least one previously-untested (not tested in the prior five years...

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

PubMed Central

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

2013-01-01

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

A cross-sectional survey of policies guiding second stage labor in urban Japanese hospitals, clinics and midwifery birth centers.

PubMed

Baba, Kaori; Kataoka, Yaeko; Nakayama, Kaori; Yaju, Yukari; Horiuchi, Shigeko; Eto, Hiromi

2016-02-24

The Japan Academy of Midwifery developed and disseminated the '2012 Evidence-based Guidelines for Midwifery Care (Guidelines for Midwives)' for low-risk births to achieve a more uniform standard of care during childbirth in Japan. The objective of this study was to cross-sectional survey policy implementation regarding care during the second stage of labor at Japanese hospitals, clinics, and midwifery birth centers, and to compare those policies with the recommendations in Guidelines for Midwives. This study was conducted in the four major urbanized areas (e.g. Tokyo) of the Kanto region of Japan. Respondents were chiefs of the institutions (obstetricians/midwives), nurse administrators (including midwives) of the obstetrical departments, or other nurse/midwives who were well versed in the routine care of the targeted institutions. The Guidelines implementation questionnaire comprised 12 items. Data was collected from October 2010 to July 2011. The overall response was 255 of the 684 institutions (37%). Of the total responses 46% were hospitals, 26% were clinics and 28% were midwifery birth centers. Few institutions reported perineal massage education for 'almost all cases'. Using 'active birth' were all midwifery birth centers, 56% hospitals and 32% clinics. Few institutions used water births. The majority of hospitals (73%) and clinics (80%) but a minority (39%) of midwifery birth centers reported 'not implemented' about applying warm compress to the perineum. Few midwifery birth centers (10%) and more hospitals (38%) and clinics (50%) had a policy for valsalva as routine care. Many hospitals (90%) and clinics (88%) and fewer midwifery birth centers (54%) offered hands-on technique to provide perineal support during birth. A majority of institutions used antiseptic solution for perineal disinfection. Few institutions routinely used episiotomies for multiparas, however routine use for primiparas was slightly more in hospitals (21%) and clinics (25%). All respondents used fundal pressure as consistent with guidelines. Not many institutions implemented the hands and knees position for correcting fetal abnormal rotation. This survey has provided new information about the policies instituted in three types of institutions guiding second stage labor in four metropolitan areas of Japan. There existed considerable differences among institutions' practice. There were also many gaps between reported policies and evidence-based Guidelines for Midwives, therefore new strategies are needed in Japan to realign institution's care policies with evidenced based guidelines.

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

Loin Pain Haematuria Syndrome - A Narrative Review of Pain Management Strategies

PubMed Central

2016-01-01

Loin pain haematuria syndrome (LPHS) is an uncommon clinical entity that has divided renal physicians, pain practitioners, and even psychiatrists since its initial description. A relative paucity of data exists regarding the condition, with best practice guidelines lacking amid the existing threads of anecdotal experiences and variable follow-up observations. The aim of this article was to review the cumulative published experience of pain relief strategies for LPHS. PMID:27103962

Designing healthcare information technology to catalyse change in clinical care.

PubMed

Lester, William T; Zai, Adrian H; Grant, Richard W; Chueh, Henry C

2008-01-01

The gap between best practice and actual patient care continues to be a pervasive problem in our healthcare system. Efforts to improve on this knowledge-performance gap have included computerised disease management programs designed to improve guideline adherence. However, current computerised reminder and decision support interventions directed at changing physician behaviour have had only a limited and variable effect on clinical outcomes. Further, immediate pay-for-performance financial pressures on institutions have created an environment where disease management systems are often created under duress, appended to existing clinical systems and poorly integrated into the existing workflow, potentially limiting their real-world effectiveness. The authors present a review of disease management as well as a conceptual framework to guide the development of more effective health information technology (HIT) tools for translating clinical information into clinical action.

Understanding the contribution of family history to colorectal cancer risk and its clinical implications: A state-of-the-science review.

PubMed

Lowery, Jan T; Ahnen, Dennis J; Schroy, Paul C; Hampel, Heather; Baxter, Nancy; Boland, C Richard; Burt, Randall W; Butterly, Lynn; Doerr, Megan; Doroshenk, Mary; Feero, W Gregory; Henrikson, Nora; Ladabaum, Uri; Lieberman, David; McFarland, Elizabeth G; Peterson, Susan K; Raymond, Martha; Samadder, N Jewel; Syngal, Sapna; Weber, Thomas K; Zauber, Ann G; Smith, Robert

2016-09-01

Persons with a family history (FH) of colorectal cancer (CRC) or adenomas that are not due to known hereditary syndromes have an increased risk for CRC. An understanding of these risks, screening recommendations, and screening behaviors can inform strategies for reducing the CRC burden in these families. A comprehensive review of the literature published within the past 10 years has been performed to assess what is known about cancer risk, screening guidelines, adherence and barriers to screening, and effective interventions in persons with an FH of CRC and to identify FH tools used to identify these individuals and inform care. Existing data show that having 1 affected first-degree relative (FDR) increases the CRC risk 2-fold, and the risk increases with multiple affected FDRs and a younger age at diagnosis. There is variability in screening recommendations across consensus guidelines. Screening adherence is <50% and is lower in persons under the age of 50 years. A provider's recommendation, multiple affected relatives, and family encouragement facilitate screening; insufficient collection of FH, low knowledge of guidelines, and poor family communication are important barriers. Effective interventions incorporate strategies for overcoming barriers, but these have not been broadly tested in clinical settings. Four strategies for reducing CRC in persons with familial risk are suggested: 1) improving the collection and utilization of the FH of cancer, 2) establishing a consensus for screening guidelines by FH, 3) enhancing provider-patient knowledge of guidelines and communication about CRC risk, and 4) encouraging survivors to promote screening within their families and partnering with existing screening programs to expand their reach to high-risk groups. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:2633-2645. © 2016 American Cancer Society. © 2016 American Cancer Society.

Guidelines for the Pharmacotherapy of Schizophrenia in Adults

PubMed Central

Addington, Donald; Honer, William; Ismail, Zahinoor; Raedler, Thomas; Teehan, Michael

2017-01-01

Objective: The present guidelines address the pharmacotherapy of schizophrenia in adults across different stages, phases, and symptom domains. Method: Guidelines were developed using the ADAPTE process, which takes advantage of existing guidelines. Six guidelines were identified for adaptation, with recommendations extracted from each. For those specific to the pharmacotherapy of schizophrenia in adults, a working group selected between guidelines and recommendations to create an adapted guideline. Results: Recommendations can be categorized into 6 areas that include 1) first-episode schizophrenia, 2) acute exacerbation, 3) relapse prevention and maintenance treatment, 4) treatment-resistant schizophrenia, 5) clozapine-resistant schizophrenia, and 6) specific symptom domains. For each category, recommendations are made based on the available evidence, which is discussed and linked to other established guidelines. Conclusions: In most cases, evidence-based recommendations are made that can be used to guide current clinical treatment and decision making. Notably, however, there is a paucity of established evidence to guide treatment decision making in the case of clozapine-resistant schizophrenia, a subsample that represents a sizable proportion of those with schizophrenia. PMID:28703015

Putting Meaning Back Into the Mean: A Comment on the Misuse of Elementary Statistics in a Sample of Manuscripts Submitted to Clinical Therapeutics.

PubMed

Forrester, Janet E

2015-12-01

Errors in the statistical presentation and analyses of data in the medical literature remain common despite efforts to improve the review process, including the creation of guidelines for authors and the use of statistical reviewers. This article discusses common elementary statistical errors seen in manuscripts recently submitted to Clinical Therapeutics and describes some ways in which authors and reviewers can identify errors and thus correct them before publication. A nonsystematic sample of manuscripts submitted to Clinical Therapeutics over the past year was examined for elementary statistical errors. Clinical Therapeutics has many of the same errors that reportedly exist in other journals. Authors require additional guidance to avoid elementary statistical errors and incentives to use the guidance. Implementation of reporting guidelines for authors and reviewers by journals such as Clinical Therapeutics may be a good approach to reduce the rate of statistical errors. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016.

PubMed

Kozek-Langenecker, Sibylle A; Ahmed, Aamer B; Afshari, Arash; Albaladejo, Pierre; Aldecoa, Cesar; Barauskas, Guidrius; De Robertis, Edoardo; Faraoni, David; Filipescu, Daniela C; Fries, Dietmar; Haas, Thorsten; Jacob, Matthias; Lancé, Marcus D; Pitarch, Juan V L; Mallett, Susan; Meier, Jens; Molnar, Zsolt L; Rahe-Meyer, Niels; Samama, Charles M; Stensballe, Jakob; Van der Linden, Philippe J F; Wikkelsø, Anne J; Wouters, Patrick; Wyffels, Piet; Zacharowski, Kai

2017-06-01

: The management of perioperative bleeding involves multiple assessments and strategies to ensure appropriate patient care. Initially, it is important to identify those patients with an increased risk of perioperative bleeding. Next, strategies should be employed to correct preoperative anaemia and to stabilise macrocirculation and microcirculation to optimise the patient's tolerance to bleeding. Finally, targeted interventions should be used to reduce intraoperative and postoperative bleeding, and so prevent subsequent morbidity and mortality. The objective of these updated guidelines is to provide healthcare professionals with an overview of the most recent evidence to help ensure improved clinical management of patients. For this update, electronic databases were searched without language restrictions from 2011 or 2012 (depending on the search) until 2015. These searches produced 18 334 articles. All articles were assessed and the existing 2013 guidelines were revised to take account of new evidence. This update includes revisions to existing recommendations with respect to the wording, or changes in the grade of recommendation, and also the addition of new recommendations. The final draft guideline was posted on the European Society of Anaesthesiology website for four weeks for review. All comments were collated and the guidelines were amended as appropriate. This publication reflects the output of this work.

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.

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

PubMed

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

2016-07-22

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

Canadian Treatment Guidelines on Psychosocial Treatment of Schizophrenia in Children and Youth.

PubMed

Lecomte, Tania; Abidi, Sabina; Garcia-Ortega, Iliana; Mian, Irfan; Jackson, Kevin; Jackson, Kim; Norman, Ross

2017-09-01

A panel of experts, including researchers, clinicians and people with lived experience, was brought together to develop the new Canadian schizophrenia guidelines for the psychosocial treatment of children and youth with schizophrenia or psychotic disorders. The ADAPTE process, which relies on adapting existing high-quality guidelines, was used. Existing guidelines for children and youth (mostly from the National Institute for Health and Care Excellence [NICE]), as well as CPA adult guidelines, were reviewed and discussed in terms of their adaptability to the Canadian context and their level of recommendation for children and youth. New treatments were also considered when recent meta-analyses suggested their usefulness. The children and youth psychosocial guidelines include many cross-sectional recommendations in terms of clinical and interpersonal skills needed to work with this clientele, setting and collaboration issues and needed adaptations for specific subpopulations. In terms of specific treatments, the treatments most strongly recommended are family intervention and cognitive behavior therapy. Also recommended, although with different degrees of support, are supported employment/supported education programs, patient education, cognitive remediation, and social skills training. Novel and upcoming psychosocial treatments are also briefly discussed. These novel Canadian guidelines for the psychosocial treatment of children and youth with schizophrenia or psychotic disorders report evidence-based treatments as well as important considerations for providers who work with this clientele. More studies with children and youth with schizophrenia and psychotic disorders are warranted. If followed, these guidelines should facilitate the recovery of children and youth with schizophrenia or psychotic disorders as well as the recovery of their families.

Canadian Treatment Guidelines on Psychosocial Treatment of Schizophrenia in Children and Youth

PubMed Central

Abidi, Sabina; Garcia-Ortega, Iliana; Mian, Irfan; Jackson, Kevin; Jackson, Kim; Norman, Ross

2017-01-01

Objective: A panel of experts, including researchers, clinicians and people with lived experience, was brought together to develop the new Canadian schizophrenia guidelines for the psychosocial treatment of children and youth with schizophrenia or psychotic disorders. Method: The ADAPTE process, which relies on adapting existing high-quality guidelines, was used. Existing guidelines for children and youth (mostly from the National Institute for Health and Care Excellence [NICE]), as well as CPA adult guidelines, were reviewed and discussed in terms of their adaptability to the Canadian context and their level of recommendation for children and youth. New treatments were also considered when recent meta-analyses suggested their usefulness. Results: The children and youth psychosocial guidelines include many cross-sectional recommendations in terms of clinical and interpersonal skills needed to work with this clientele, setting and collaboration issues and needed adaptations for specific subpopulations. In terms of specific treatments, the treatments most strongly recommended are family intervention and cognitive behavior therapy. Also recommended, although with different degrees of support, are supported employment/supported education programs, patient education, cognitive remediation, and social skills training. Novel and upcoming psychosocial treatments are also briefly discussed. Conclusion: These novel Canadian guidelines for the psychosocial treatment of children and youth with schizophrenia or psychotic disorders report evidence-based treatments as well as important considerations for providers who work with this clientele. More studies with children and youth with schizophrenia and psychotic disorders are warranted. If followed, these guidelines should facilitate the recovery of children and youth with schizophrenia or psychotic disorders as well as the recovery of their families. PMID:28886670

American Institutional Review Boards: Safeguards or Censorship?

ERIC Educational Resources Information Center

Hottenstein, Kristi N.

2018-01-01

The United States is a world leader in biomedical clinical research. America's existing human subject research regulations structure affords sizable protections for the ethical treatment of research volunteers. Early initiatives such as the Belmont Report were specific to federally funded research. Over the past several decades guidelines such as…

Guideline implementation strategies for specialist mental healthcare.

PubMed

Girlanda, Francesca; Fiedler, Ines; Ay, Esra; Barbui, Corrado; Koesters, Markus

2013-07-01

Clinical practice guidelines in mental healthcare are viewed as an essential asset if appropriately developed and implemented. The purpose of this article was to review the existing literature on how guidelines should be implemented to optimize their impact on provider performance and patient outcomes in specialist mental healthcare settings. Findings from recent studies suggest a trend toward an improvement in process and patient outcomes following guideline implementation. However, studies are heterogeneous in terms of design, implementation strategies and outcome measures, making it very difficult to draw firm conclusions about which implementation strategy is effective in different healthcare contexts. Current knowledge about how guidelines should be implemented is still sparse and inconclusive in mental healthcare. Future studies should attempt to employ more rigorous designs, including random allocation of patients or clusters of patients, to shed further light on this compelling issue. Research on guideline implementation strategies should additionally take into account potential barriers to knowledge translation, which can heavily influence the implementability of treatment recommendations.

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

Scandinavian guidelines for initial management of minor and moderate head trauma in children.

PubMed

Astrand, Ramona; Rosenlund, Christina; Undén, Johan

2016-02-18

The management of minor and moderate head trauma in children differs widely between countries. Presently, there are no existing guidelines for management of these children in Scandinavia. The purpose of this study was to produce new evidence-based guidelines for the initial management of head trauma in the paediatric population in Scandinavia. The primary aim was to detect all children in need of neurosurgical intervention. Detection of any traumatic intracranial injury on CT scan was an important secondary aim. General methodology according to the Appraisal of Guidelines for Research and Evaluation (AGREE) II and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used. Systematic evidence-based review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology and based upon relevant clinical questions with respect to patient-important outcomes. Quality ratings of the included studies were performed using Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 and Centre of Evidence Based Medicine (CEBM)-2 tools. Based upon the results, GRADE recommendations, a guideline, discharge instructions and in-hospital observation instructions were drafted. For elements with low evidence, a modified Delphi process was used for consensus, which included relevant clinical stakeholders. The guidelines include criteria for selecting children for CT scans, in-hospital observation or early discharge, and suggestions for monitoring routines and discharge advice for children and guardians. The guidelines separate mild head trauma patients into high-, medium- and low-risk categories, favouring observation for mild, low-risk patients as an attempt to reduce CT scans in children. We present new evidence and consensus based Scandinavian Neurotrauma Committee guidelines for initial management of minor and moderate head trauma in children. These guidelines should be validated before extensive clinical use and updated within four years due to rapid development of new diagnostic tools within paediatric neurotrauma.

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

PubMed

Sheikh, Asim A

2008-07-01

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

Lack of existing guidelines for a large group of patients in Sweden: a national survey across the acute surgical care delivery chain.

PubMed

Muntlin Athlin, Åsa; Juhlin, Claes; Jangland, Eva

2017-02-01

Evidence-informed healthcare is the fundament for practice, whereby guidelines based on the best available evidence should assist health professionals in managing patients. Patients seeking care for acute abdominal pain form a common group in acute care settings worldwide, for whom decision-making and timely treatment are of paramount importance. There is ambiguity about the existence, use and content of guidelines for patients with acute abdomen. The objective was to describe and compare guidelines and management of patients with acute abdomen in different settings across the acute care delivery chain in Sweden. A national cross-sectional design was used. Twenty-nine ambulance stations, 17 emergency departments and 33 surgical wards covering all six Swedish health regions were included, and 23 guidelines were quality appraised using the validated Appraisal of Guidelines for Research & Evaluation II tool. There is a lack of guidelines in use for the management of this large group of patients between and within different healthcare areas across the acute care delivery chain. The quality appraisal identified that several guidelines were of poor quality, especially the in-hospital ones. Further, range orders for analgesics are common in the ambulance services and the surgical wards, but are seldom present in the emergency departments. Also, education in pain management is more common in the ambulance services. These findings are noteworthy as, hypothetically, the same patient could be treated in three different ways during the same care episode. There is an urgent need to develop high-quality evidence-based clinical guidelines for this patient group, with the entire care process in focus. © 2016 John Wiley & Sons, Ltd.

Consensus clinical recommendations for the management of plasma lipid disorders in the Middle East.

PubMed

Al Sayed, Nasreen; Al Waili, Khalid; Alawadi, Fatheya; Al-Ghamdi, Saeed; Al Mahmeed, Wael; Al-Nouri, Fahad; Al Rukhaimi, Mona; Al-Rasadi, Khalid; Awan, Zuhier; Farghaly, Mohamed; Hassanein, Mohamed; Sabbour, Hani; Zubaid, Mohammad; Barter, Philip

2016-12-15

Plasma lipid disorders are key risk factors for the development of atherosclerotic cardiovascular disease (ASCVD) and are prevalent in the Middle East, with rates increasing in recent decades. Despite this, no region-specific guidelines for managing plasma lipids exist and there is a lack of use of guidelines developed in other regions. A multidisciplinary panel of regional experts was convened to develop consensus clinical recommendations for the management of plasma lipids in the Middle East. The panel considered existing international guidelines and regional clinical experience to develop recommendations. The panel's recommendations include plasma lipid screening, ASCVD risk calculation and treatment considerations. The panel recommend that plasma lipid levels should be measured in all at-risk patients and at regular intervals in all adults from the age of 20years. A scoring system should be used to calculate ASCVD risk that includes known lipid and non-lipid risk factors. Primary treatment targets include low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol. Lifestyle modifications should be first-line treatment for all patients; the first-line pharmacological treatment targeting plasma lipids in patients at moderate-to-high risk of ASCVD is statin therapy, with a number of adjunctive or second-line agents available. Guidance is also provided on the management of underlying conditions and special populations; of particular pertinence in the region are familial hypercholesterolaemia, diabetes and metabolic dyslipidaemia. These consensus clinical recommendations provide practicing clinicians with comprehensive, region-specific guidance to improve the detection and management of plasma lipid disorders in patients in the Middle East. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Management and Care of Women With Invasive Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Clinical Practice Guideline.

PubMed

Chuang, Linus T; Temin, Sarah; Camacho, Rolando; Dueñas-Gonzalez, Alfonso; Feldman, Sarah; Gultekin, Murat; Gupta, Vandana; Horton, Susan; Jacob, Graciela; Kidd, Elizabeth A; Lishimpi, Kennedy; Nakisige, Carolyn; Nam, Joo-Hyun; Ngan, Hextan Yuen Sheung; Small, William; Thomas, Gillian; Berek, Jonathan S

2016-10-01

To provide evidence-based, resource-stratified global recommendations to clinicians and policymakers on the management and palliative care of women diagnosed with invasive cervical cancer. ASCO convened a multidisciplinary, multinational panel of cancer control, medical and radiation oncology, health economic, obstetric and gynecologic, and palliative care experts to produce recommendations reflecting resource-tiered settings. A systematic review of literature from 1966 to 2015 failed to yield sufficiently strong quality evidence to support basic- and limited-resource setting recommendations; a formal consensus-based process was used to develop recommendations. A modified ADAPTE process was also used to adapt recommendations from existing guidelines. Five existing sets of guidelines were identified and reviewed, and adapted recommendations form the evidence base. Eight systematic reviews, along with cost-effectiveness analyses, provided indirect evidence to inform the consensus process, which resulted in agreement of 75% or greater. Clinicians and planners should strive to provide access to the most effective evidence-based antitumor and palliative care interventions. If a woman cannot access these within her own or neighboring country or region, she may need to be treated with lower-tier modalities, depending on capacity and resources for surgery, chemotherapy, radiation therapy, and supportive and palliative care. For women with early-stage cervical cancer in basic settings, cone biopsy or extrafascial hysterectomy may be performed. Fertility-sparing procedures or modified radical or radical hysterectomy may be additional options in nonbasic settings. Combinations of surgery, chemotherapy, and radiation therapy (including brachytherapy) should be used for women with stage IB to IVA disease, depending on available resources. Pain control is a vital component of palliative care. Additional information is available at www.asco.org/rs-cervical-cancer-treatment-guideline and www.asco.org/guidelineswiki. It is the view of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Co-occurring medical conditions in adults with Down syndrome: A systematic review toward the development of health care guidelines.

PubMed

Capone, George T; Chicoine, Brian; Bulova, Peter; Stephens, Mary; Hart, Sarah; Crissman, Blythe; Videlefsky, Andrea; Myers, Katherine; Roizen, Nancy; Esbensen, Anna; Peterson, Moya; Santoro, Stephanie; Woodward, Jason; Martin, Barry; Smith, David

2018-01-01

Adults with Down syndrome (DS) represent a unique population who are in need of clinical guidelines to address their medical care. The United States Preventive Service Task Force (USPSTF) has developed criteria for prioritizing conditions of public health importance with the potential for providing screening recommendations to improve clinical care. The quality of existing evidence needed to inform clinical guidelines has not been previously reviewed. Using the National Library of Medicine (NLM) database PubMed, we first identified 18 peer reviewed articles that addressed co-occurring medical conditions in adults with DS. Those conditions discussed in over half of the articles were prioritized for further review. Second, we performed detailed literature searches on these specific conditions. To inform the search strategy and review process a series of key questions were formulated a priori. The quality of available evidence was then graded and knowledge gaps were identified. The number of participating adults and the design of clinical studies varied by condition and were often inadequate for answering all of our key questions. We provide data on thyroid disease, cervical spine disease, hearing impairment, overweight-obesity, sleep apnea, congenital heart disease, and osteopenia-osteoporosis. Minimal evidence demonstrates massive gaps in our clinical knowledge that compromises clinical decision-making and management of these medically complex individuals. The development of evidence-based clinical guidance will require an expanded clinical knowledge-base in order to move forward. © 2017 Wiley Periodicals, Inc.

The advantages and limitations of guideline adaptation frameworks.

PubMed

Wang, Zhicheng; Norris, Susan L; Bero, Lisa

2018-05-29

The implementation of evidence-based guidelines can improve clinical and public health outcomes by helping health professionals practice in the most effective manner, as well as assisting policy-makers in designing optimal programs. Adaptation of a guideline to suit the context in which it is intended to be applied can be a key step in the implementation process. Without taking the local context into account, certain interventions recommended in evidence-based guidelines may be infeasible under local conditions. Guideline adaptation frameworks provide a systematic way of approaching adaptation, and their use may increase transparency, methodological rigor, and the quality of the adapted guideline. This paper presents a number of adaptation frameworks that are currently available. We aim to compare the advantages and limitations of their processes, methods, and resource implications. These insights into adaptation frameworks can inform the future development of guidelines and systematic methods to optimize their adaptation. Recent adaptation frameworks show an evolution from adapting entire existing guidelines, to adapting specific recommendations extracted from an existing guideline, to constructing evidence tables for each recommendation that needs to be adapted. This is a move towards more recommendation-focused, context-specific processes and considerations. There are still many gaps in knowledge about guideline adaptation. Most of the frameworks reviewed lack any evaluation of the adaptation process and outcomes, including user satisfaction and resources expended. The validity, usability, and health impact of guidelines developed via an adaptation process have not been studied. Lastly, adaptation frameworks have not been evaluated for use in low-income countries. Despite the limitations in frameworks, a more systematic approach to adaptation based on a framework is valuable, as it helps to ensure that the recommendations stay true to the evidence while taking local needs into account. The utilization of frameworks in the guideline implementation process can be optimized by increasing the understanding and upfront estimation of resource and time needed, capacity building in adaptation methods, and increasing the adaptability of the source recommendation document.

Investigation of Women with Postmenopausal Uterine Bleeding: Clinical Practice Recommendations

PubMed Central

Munro, Malcolm G

2014-01-01

Postmenopausal uterine bleeding is defined as uterine bleeding after permanent cessation of menstruation resulting from loss of ovarian follicular activity. Bleeding can be spontaneous or related to ovarian hormone replacement therapy or to use of selective estrogen receptor modulators (eg, tamoxifen adjuvant therapy for breast carcinoma). Because anovulatory “cycles” with episodes of multimonth amenorrhea frequently precede menopause, no consensus exists regarding the appropriate interval of amenorrhea before an episode of bleeding that allows for the definition of postmenopausal bleeding. The clinician faces the possibility that an underlying malignancy exists, knowing that most often the bleeding comes from a benign source. Formerly, the gold-standard clinical investigation of postmenopausal uterine bleeding was institution-based dilation and curettage, but there now exist office-based methods for the evaluation of women with this complaint. Strategies designed to implement these diagnostic methods must be applied in a balanced way considering the resource utilization issues of overinvestigation and the risk of missing a malignancy with underinvestigation. Consequently, guidelines and recommendations were developed to consider these issues and the diverse spectrum of practitioners who evaluate women with postmenopausal bleeding. The guideline development group determined that, for initial management of spontaneous postmenopausal bleeding, primary assessment may be with either endometrial sampling or transvaginal ultrasonography, allowing patients with an endometrial echo complex thickness of 4 mm or less to be managed expectantly. Guidelines are also provided for patients receiving selective estrogen receptor modulators or hormone replacement therapy, and for an endometrial echo complex with findings consistent with fluid in the endometrial cavity. PMID:24377427

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.

Legal and ethical issues in research

PubMed Central

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

2016-01-01

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

Obsessive-compulsive disorder for ICD-11: proposed changes to the diagnostic guidelines and specifiers

PubMed Central

Simpson, Helen Blair; Reddy, Y. C. Janardhan

2016-01-01

Since the approval of the ICD-10 by the World Health Organization (WHO) in 1990, global research on obsessive-compulsive disorder (OCD) has expanded dramatically. This article evaluates what changes may be needed to enhance the scientific validity, clinical utility, and global applicability of OCD diagnostic guidelines in preparation for ICD-11. Existing diagnostic guidelines for OCD were compared. Key issues pertaining to clinical description, differential diagnosis, and specifiers were identified and critically reviewed on the basis of the current literature. Specific modifications to ICD guidelines are recommended, including: clarifying the definition of obsessions (i.e., that obsessions can be thoughts, images, or impulses/urges) and compulsions (i.e., clarifying that these can be behaviors or mental acts and not calling these “stereotyped”); stating that compulsions are often associated with obsessions; and removing the ICD-10 duration requirement of at least 2 weeks. In addition, a diagnosis of OCD should no longer be excluded if comorbid with Tourette syndrome, schizophrenia, or depressive disorders. Moreover, the ICD-10 specifiers (i.e., predominantly obsessional thoughts, compulsive acts, or mixed) should be replaced with a specifier for insight. Based on new research, modifications to the ICD-10 diagnostic guidelines for OCD are recommended for ICD-11. PMID:25388607

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

Ethics of clinical trials.

PubMed

Palter, S F

1996-05-01

The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

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

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.

Index-TB Guidelines: Guidelines on extrapulmonary tuberculosis for India

PubMed Central

Sharma, Surendra K.; Ryan, H.; Khaparde, Sunil; Sachdeva, K. S.; Singh, Achintya D.; Mohan, Alladi; Sarin, Rohit; Paramasivan, C N; Kumar, Prahlad; Nischal, Neeraj; Khatiwada, Saurav; Garner, Paul; Tharyan, Prathap

2017-01-01

Extrapulmonary tuberculosis (EPTB) is frequently a diagnostic and therapeutic challenge. It is a common opportunistic infection in people living with HIV/AIDS and other immunocompromised states such as diabetes mellitus and malnutrition. There is a paucity of data from clinical trials in EPTB and most of the information regarding diagnosis and management is extrapolated from pulmonary TB. Further, there are no formal national or international guidelines on EPTB. To address these concerns, Indian EPTB guidelines were developed under the auspices of Central TB Division and Directorate of Health Services, Ministry of Health and Family Welfare, Government of India. The objective was to provide guidance on uniform, evidence-informed practices for suspecting, diagnosing and managing EPTB at all levels of healthcare delivery. The guidelines describe agreed principles relevant to 10 key areas of EPTB which are complementary to the existing country standards of TB care and technical operational guidelines for pulmonary TB. These guidelines provide recommendations on three priority areas for EPTB: (i) use of Xpert MTB/RIF in diagnosis, (ii) use of adjunct corticosteroids in treatment, and (iii) duration of treatment. The guidelines were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria, which were evidence based, and due consideration was given to various healthcare settings across India. Further, for those forms of EPTB in which evidence regarding best practice was lacking, clinical practice points were developed by consensus on accumulated knowledge and experience of specialists who participated in the working groups. This would also reflect the needs of healthcare providers and develop a platform for future research. PMID:28862176

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

PubMed

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

2016-05-01

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

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

PubMed Central

Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

2016-01-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-05

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

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.

Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders.

PubMed

Cassis, Linda; Cortès-Saladelafont, Elisenda; Molero-Luis, Marta; Yubero, Delia; González, Maria Julieta; Ormazábal, Aida; Fons, Carme; Jou, Cristina; Sierra, Cristina; Castejon Ponce, Esperanza; Ramos, Federico; Armstrong, Judith; O'Callaghan, M Mar; Casado, Mercedes; Montero, Raquel; Meavilla-Olivas, Silvia; Artuch, Rafael; Barić, Ivo; Bartoloni, Franco; Bellettato, Cinzia Maria; Bonifazi, Fedele; Ceci, Adriana; Cvitanović-Šojat, Ljerka; Dali, Christine I; D'Avanzo, Francesca; Fumic, Ksenija; Giannuzzi, Viviana; Lampe, Christina; Scarpa, Maurizio; Garcia-Cazorla, Ángels

2015-12-30

Inherited neurometabolic disorders (iNMDs) represent a group of almost seven hundred rare diseases whose common manifestations are clinical neurologic or cognitive symptoms that can appear at any time, in the first months/years of age or even later in adulthood. Early diagnosis and timely treatments are often pivotal for the favorable course of the disease. Thus, the elaboration of new evidence-based recommendations for iNMD diagnosis and management is increasingly requested by health care professionals and patients, even though the methodological quality of existing guidelines is largely unclear. InNerMeD-I-Network is the first European network on iNMDs that was created with the aim of sharing and increasing validated information about diagnosis and management of neurometabolic disorders. One of the goals of the project was to determine the number and the methodological quality of existing guidelines and recommendations for iNMDs. We performed a systematic search on PubMed, the National Guideline Clearinghouse (NGC), the Guidelines International Network (G-I-N), the Scottish Intercollegiate Guideline Network (SIGN) and the National Institute for Health and Care Excellence (NICE) to identify all the published guidelines and recommendations for iNMDs from January 2000 to June 2015. The methodological quality of the selected documents was determined using the AGREE II instrument, an appraisal tool composed of 6 domains covering 23 key items. A total of 55 records met the inclusion criteria, 11 % were about groups of disorders, whereas the majority encompassed only one disorder. Lysosomal disorders, and in particular Fabry, Gaucher disease and mucopolysaccharidoses where the most studied. The overall methodological quality of the recommendation was acceptable and increased over time, with 25 % of the identified guidelines strongly recommended by the appraisers, 64 % recommended, and 11 % not recommended. However, heterogeneity in the obtained scores for each domain was observed among documents covering different groups of disorders and some domains like 'stakeholder involvement' and 'applicability' were generally scarcely addressed. Greater efforts should be devoted to improve the methodological quality of guidelines and recommendations for iNMDs and AGREE II instrument seems advisable for new guideline development. The elaboration of new guidelines encompassing still uncovered disorders is badly needed.

Children's behaviour problems: a NICE mess.

PubMed

Timimi, S

2014-09-01

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

Guidelines for transoesophageal echocardiographic probe cleaning and disinfection from the British Society of Echocardiography.

PubMed

Kanagala, P; Bradley, C; Hoffman, P; Steeds, R P

2011-10-01

The clinical utility of transoesophageal echocardiography (TOE) is well established. Being a semi-invasive procedure, however, the potential for transmission of infection between sequential patients exists. This has implications for the protection of both patients and medical staff. Guidelines for disinfection during gastrointestinal endoscopy (GIE) have been in place for many years.(1,2) Unfortunately, similar guidance is lacking with respect to TOE. Although traversing the same body cavities and sharing many similarities with upper GIE, there are fundamental structural and procedural differences with TOE which merit special consideration in establishing a decontamination protocol. This document provides recommendations for TOE probe decontamination based on the available evidence, expert opinion, and modification of the current British Society of Gastroenterology guidelines.

UROTRAUMA: AUA GUIDELINE

PubMed Central

Morey, Allen F.; Brandes, Steve; Dugi, Daniel David; Armstrong, John H.; Breyer, Benjamin N.; Broghammer, Joshua A.; Erickson, Bradley A.; Holzbeierlein, Jeff; Hudak, Steven J.; Mirvis, Stuart; Pruitt, Jeffrey H.; Reston, James T.; Santucci, Richard A.; Smith, Thomas G.; Wessells, Hunter

2014-01-01

Purpose The authors of this guideline reviewed the urologic trauma literature to guide clinicians in the appropriate methods of evaluation and management of genitourinary injuries. Methods A systematic review of the literature using the MEDLINE® and EMBASE databases (search dates 1/1/90-9/19/12) was conducted to identify peer-reviewed publications relevant to urotrauma. The review yielded an evidence base of 372 studies after application of inclusion/exclusion criteria. These publications were used to inform the statements presented in the guideline as Standards, Recommendations or Options. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high), B (moderate) or C (low). In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. PMID:24857651

77 FR 36550 - Office of Clinical and Preventive Services Funding Opportunity: National HIV Program for Enhanced...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-19

... Disease Control and Prevention (CDC) guidelines, provide pre- and post-test counseling (when indicated... existing public health statutes. Test at least one previously untested (not tested in the prior five years... their test results, particularly clients who test positive. ii. Describe how the program will ensure...

Motivating Latino Caregivers of Children with Asthma to Quit Smoking: A Randomized Trial

ERIC Educational Resources Information Center

Borrelli, Belinda; McQuaid, Elizabeth L.; Novak, Scott P.; Hammond, S. Katharine; Becker, Bruce

2010-01-01

Objective: Secondhand smoke exposure is associated with asthma onset and exacerbation. Latino children have higher rates of asthma morbidity than other groups. The current study compared the effectiveness of a newly developed smoking cessation treatment with existing clinical guidelines for smoking cessation. Method: Latino caregivers who smoked…

Therapeutic management of anal eczema: an evidence-based review

PubMed Central

Havlickova, B; Weyandt, G H

2014-01-01

Aim To conduct a systematic review of treatments for anal eczema (AE). Methods We conducted a Medline search for clinical trial data for the treatment of perianal diseases including AE, including papers not published in the English language. We assessed the study reports using the system recommended by the Oxford Centre for Evidence-based Medicine. No meta-analysis was attempted. Results The evidence base for topical treatments used to treat AE is very poor: there are very few studies and many of those that exist are of poor quality. The best evidence was found for medications that are yet to be licensed for AE. Among products with existing licences for the treatment of eczema, our assessment found some evidence to support the continued use of mild-to-moderate corticosteroids first line in most patients. Discussion Features of the perianal region, and the fact that it is almost always occluded, mean that not all medications recommended in the general treatment guidelines for eczema are appropriate for AE. However, there are no specific treatment guidelines for these patients. This may in part be because of the lack of high-quality evidence-based medicine in this therapy area. Many frequently prescribed medications were developed and licensed many years ago, in an era when clinical trial design was not expected to be as rigorous as it is today. Conclusion This review highlights the need to conduct more high-quality clinical trials in patients with AE in order that specific guidelines for the management of this difficult proctological condition can be prepared. PMID:24898365

Tuberculosis infection control measures in health care facilities offering tb services in Ikeja local government area, Lagos, South West, Nigeria.

PubMed

Kuyinu, Y A; Mohammed, A S; Adeyeye, O O; Odugbemi, B A; Goodman, O O; Odusanya, O O

2016-03-15

Tuberculosis infection among health care workers is capable of worsening the existing health human resource problems of low--and middle-income countries. Tuberculosis infection control is often weakly implemented in these parts of the world therefore, understanding the reasons for poor implementation of tuberculosis infection control guidelines are important. This study was aimed at assessing tuberculosis infection control practices and barriers to its implementation in Ikeja, Nigeria. A cross-sectional study in 20 tuberculosis care facilities (16 public and 4 private) in Ikeja, Lagos was conducted. The study included a facility survey to assess the availability of tuberculosis infection control guidelines, the adequacy of facilities to prevent transmission of tuberculosis and observations of practices to assess the implementation of tuberculosis infection control guidelines. Four focus group discussions were carried out to highlight HCWs' perceptions on tuberculosis infection control guidelines and barriers to its implementation. The observational study showed that none of the clinics had a tuberculosis infection control plan. No clinic was consistently screening patients for cough. Twelve facilities (60%) consistently provided masks to patients who were coughing. Ventilation in the waiting areas was assessed to be adequate in 60% of the clinics while four clinics (20%) possessed N-95 respirators. Findings from the focus group discussions showed weak managerial support, poor funding, under-staffing, lack of space and not wanting to be seen as stigmatizing against tuberculosis patients as barriers that hindered the implementation of TB infection control measures. Tuberculosis infection control measures were not adequately implemented in health facilities in Ikeja, Nigeria. A multi-pronged approach is required to address the identified barriers to the implementation of tuberculosis infection control guidelines.

Obstetrical brachial plexus injury (OBPI): Canada's national clinical practice guideline

PubMed Central

Coroneos, Christopher J; Voineskos, Sophocles H; Christakis, Marie K; Thoma, Achilleas; Bain, James R; Brouwers, Melissa C

2017-01-01

Objective The objective of this study was to establish an evidence-based clinical practice guideline for the primary management of obstetrical brachial plexus injury (OBPI). This clinical practice guideline addresses 4 existing gaps: (1) historic poor use of evidence, (2) timing of referral to multidisciplinary care, (3) Indications and timing of operative nerve repair and (4) distribution of expertise. Setting The guideline is intended for all healthcare providers treating infants and children, and all specialists treating upper extremity injuries. Participants The evidence interpretation and recommendation consensus team (Canadian OBPI Working Group) was composed of clinicians representing each of Canada's 10 multidisciplinary centres. Outcome measures An electronic modified Delphi approach was used for consensus, with agreement criteria defined a priori. Quality indicators for referral to a multidisciplinary centre were established by consensus. An original meta-analysis of primary nerve repair and review of Canadian epidemiology and burden were previously completed. Results 7 recommendations address clinical gaps and guide identification, referral, treatment and outcome assessment: (1) physically examine for OBPI in newborns with arm asymmetry or risk factors; (2) refer newborns with OBPI to a multidisciplinary centre by 1 month; (3) provide pregnancy/birth history and physical examination findings at birth; (4) multidisciplinary centres should include a therapist and peripheral nerve surgeon experienced with OBPI; (5) physical therapy should be advised by a multidisciplinary team; (6) microsurgical nerve repair is indicated in root avulsion and other OBPI meeting centre operative criteria; (7) the common data set includes the Narakas classification, limb length, Active Movement Scale (AMS) and Brachial Plexus Outcome Measure (BPOM) 2 years after birth/surgery. Conclusions The process established a new network of opinion leaders and researchers for further guideline development and multicentre research. A structured referral form is available for primary care, including referral recommendations. PMID:28132014

MRI-guided stereotactic neurosurgical procedures in a diagnostic MRI suite: Background and safe practice recommendations.

PubMed

Larson, Paul S; Willie, Jon T; Vadivelu, Sudhakar; Azmi-Ghadimi, Hooman; Nichols, Amy; Fauerbach, Loretta Litz; Johnson, Helen Boehm; Graham, Denise

2017-07-01

The development of navigation technology facilitating MRI-guided stereotactic neurosurgery has enabled neurosurgeons to perform a variety of procedures ranging from deep brain stimulation to laser ablation entirely within an intraoperative or diagnostic MRI suite while having real-time visualization of brain anatomy. Prior to this technology, some of these procedures required multisite workflow patterns that presented significant risk to the patient during transport. For those facilities with access to this technology, safe practice guidelines exist only for procedures performed within an intraoperative MRI. There are currently no safe practice guidelines or parameters available for facilities looking to integrate this technology into practice in conventional MRI suites. Performing neurosurgical procedures in a diagnostic MRI suite does require precautionary measures. The relative novelty of technology and workflows for direct MRI-guided procedures requires consideration of safe practice recommendations, including those pertaining to infection control and magnet safety issues. This article proposes a framework of safe practice recommendations designed for assessing readiness and optimization of MRI-guided neurosurgical interventions in the diagnostic MRI suite in an effort to mitigate patient risk. The framework is based on existing clinical evidence, recommendations, and guidelines related to infection control and prevention, health care-associated infections, and magnet safety, as well as the clinical and practical experience of neurosurgeons utilizing this technology. © 2017 American Society for Healthcare Risk Management of the American Hospital Association.

[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.

Drug Development Pipeline

MedlinePlus

... Care Guidelines Newborn Screening Clinical Care Guidelines Sweat Test Clinical Care Guidelines Infection Prevention and Control Care Guidelines Allergic Bronchopulmonary Aspergillosis Clinical Care Guidelines ...

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.

Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol

PubMed Central

2010-01-01

Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003). Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition. Aims This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia) compliance with a clinical practice guideline for acute non-specific low back pain (LBP), compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP. Methods The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters) to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The intervention primarily consisted of an educational symposium. Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period, three months post the intervention symposia, are eligible for inclusion. Sample size calculations are based on recruiting between 15 to 40 patients per practice. Outcome assessors will be blinded to group allocation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609001022257 (date registered 25th November 2009) PMID:21067614

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

PubMed

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

2017-06-01

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

Clinical Case Reporting in the Peer-Reviewed Physical Therapy Literature: Time to Move Toward Functioning.

PubMed

Davenport, Todd E

2015-12-01

Physical therapists increasingly are contributing clinical case reports to the health literature, which form the basis for higher quality evidence that has been incorporated into clinical practice guidelines. Yet, few resources exist to assist physical therapists with the basic mechanics and quality standards of producing a clinical case report. This situation is further complicated by the absence of uniform standards for quality in case reporting. The importance of including a concise yet comprehensive description of patient functioning in all physical therapy case reports suggest the potential appropriateness of basing quality guidelines on the World Health Organization's International Classification of Functioning Disability and Health (ICF) model. The purpose of this paper is to assist physical therapists in creating high-quality clinical case reports for the peer-reviewed literature using the ICF model as a guiding framework. Along these lines, current recommendations related to the basic mechanics of writing a successful clinical case report are reviewed, as well and a proposal for uniform clinical case reporting requirements is introduced with the aim to improve the quality and feasibility of clinical case reporting in physical therapy that are informed by the ICF model. Copyright © 2013 John Wiley & Sons, Ltd.

Treatment of comorbid adolescent cannabis use and major depressive disorder.

PubMed

Kaminer, Yifrah; Connor, Daniel F; Curry, John F

2008-09-01

The comorbidity of unipolar depression with substance use disorders (SUD) in adolescents is well established and accounts for 24 to 50 percent in clinical samples. Very little empirical data exist on the treatment of dually diagnosed youth. The objective of this paper is twofold: 1) We will review the literature on SUD and unipolar depression; and 2) we will provide guidelines for a combined pharmacological and psychosocial intervention based on a clinical case example.

Development and technical basis of simplified guidelines for emergency triage assessment and treatment in developing countries. WHO Integrated Management of Childhood Illness (IMCI) Referral Care Project.

PubMed

Gove, S; Tamburlini, G; Molyneux, E; Whitesell, P; Campbell, H

1999-12-01

Simplified guidelines for the emergency care of children have been developed to improve the triage and rapid initiation of appropriate emergency treatments for children presenting to hospitals in developing countries. The guidelines are part of the effort to improve referral level paediatric care within the World Health Organisation/Unicef strategy integrated management of childhood illness (IMCI), based on evidence of significant deficiencies in triage and emergency care. Existing emergency guidelines have been modified according to resource limitations and significant differences in the epidemiology of severe paediatric illness and preventable death in developing countries with raised infant and child mortality rates. In these settings, it is important to address the emergency management of diarrhoea with severe dehydration, severe malaria, severe malnutrition, and severe bacterial pneumonia, and to focus attention on sick infants younger than 2 months of age. The triage assessment relies on a few clinical signs, which can be readily taught so that it can be used by health workers with limited clinical background. The assessment has been designed so that it can be carried out quickly if negative, making it functional for triaging children in queues.

Individual researcher liability for clinical research on humans.

PubMed

Miller, Ruth K

2003-01-01

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

Health, human rights, and the conduct of clinical research within oppressed populations

PubMed Central

Mills, Edward J; Singh, Sonal

2007-01-01

Background Clinical trials evaluating interventions for infectious diseases require enrolling participants that are vulnerable to infection. As clinical trials are conducted in increasingly vulnerable populations, issues of protection of these populations become challenging. In settings where populations are forseeably oppressed, the conduct of research requires considerations that go beyond common ethical concerns and into issues of international human rights law. Discussion Using examples of HIV prevention trials in Thailand, hepatitis-E prevention trials in Nepal and malaria therapeutic trials in Burma (Myanmar), we address the inadequacies of current ethical guidelines when conducting research within oppressed populations. We review existing legislature in the United States and United Kingdom that may be used against foreign investigators if trial hardships exist. We conclude by making considerations for research conducted within oppressed populations. PMID:17996056

Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults

PubMed Central

2009-01-01

Background: Obstructive sleep apnea (OSA) is a common chronic disorder that often requires lifelong care. Available practice parameters provide evidence-based recommendations for addressing aspects of care. Objective: This guideline is designed to assist primary care providers as well as sleep medicine specialists, surgeons, and dentists who care for patients with OSA by providing a comprehensive strategy for the evaluation, management and long-term care of adult patients with OSA. Methods: The Adult OSA Task Force of the American Academy of Sleep Medicine (AASM) was assembled to produce a clinical guideline from a review of existing practice parameters and available literature. All existing evidence-based AASM practice parameters relevant to the evaluation and management of OSA in adults were incorporated into this guideline. For areas not covered by the practice parameters, the task force performed a literature review and made consensus recommendations using a modified nominal group technique. Recommendations: Questions regarding OSA should be incorporated into routine health evaluations. Suspicion of OSA should trigger a comprehensive sleep evaluation. The diagnostic strategy includes a sleep-oriented history and physical examination, objective testing, and education of the patient. The presence or absence and severity of OSA must be determined before initiating treatment in order to identify those patients at risk of developing the complications of sleep apnea, guide selection of appropriate treatment, and to provide a baseline to establish the effectiveness of subsequent treatment. Once the diagnosis is established, the patient should be included in deciding an appropriate treatment strategy that may include positive airway pressure devices, oral appliances, behavioral treatments, surgery, and/or adjunctive treatments. OSA should be approached as a chronic disease requiring long-term, multidisciplinary management. For each treatment option, appropriate outcome measures and long-term follow-up are described. Citation: Epstein LJ; Kristo D; Strollo PJ; Friedman N; Malhotra A; Patil SP; Ramar K; Rogers R; Schwab RJ; Weaver EM; Weinstein MD. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med 2009;5(3):263–276. PMID:19960649

Portfolio assessment and evaluation: implications and guidelines for clinical nursing education.

PubMed

Chabeli, M M

2002-08-01

With the advent of Outcomes-Based Education in South Africa, the quality of nursing education is debatable, especially with regard to the assessment and evaluation of clinical nursing education, which is complex and renders the validity and reliability of the methods used questionable. This paper seeks to explore and describe the use of portfolio assessment and evaluation, its implications and guidelines for its effective use in nursing education. Firstly, the concepts of assessment, evaluation, portfolio and alternative methods of evaluation are defined. Secondly, a comparison of the characteristics of the old (traditional) methods and the new alternative methods of evaluation is made. Thirdly, through deductive analysis, synthesis and inference, implications and guidelines for the effective use of portfolio assessment and evaluation are described. In view of the qualitative, descriptive and exploratory nature of the study, a focus group interview with twenty students following a post-basic degree at a university in Gauteng regarding their perceptions on the use of portfolio assessment and evaluation method in clinical nursing education was used. A descriptive method of qualitative data analysis of open coding in accordance with Tesch's protocol (in Creswell 1994:155) was used. Resultant implications and guidelines were conceptualised and described within the existing theoretical framework. Principles of trustworthiness were maintained as described by (Lincoln & Guba 1985:290-327). Ethical considerations were in accordance with DENOSA's standards of research (1998:7).

Rationale and design of the Improving Care for Cardiovascular Disease in China (CCC) project: A national effort to prompt quality enhancement for acute coronary syndrome.

PubMed

Hao, Yongchen; Liu, Jing; Liu, Jun; Smith, Sidney C; Huo, Yong; Fonarow, Gregg C; Ma, Changsheng; Ge, Junbo; Taubert, Kathryn A; Morgan, Louise; Guo, Yang; Zhang, Qian; Wang, Wei; Zhao, Dong

2016-09-01

A sizeable gap exists between guideline recommendations for treatment of acute coronary syndrome (ACS) and application of these recommendations in clinical practice. The CCC-ACS project is a novel national quality enhancement registry designed to help medical care providers bridge this gap, thereby improving clinical outcomes for ACS patients in China. The CCC-ACS project uses data collection, analysis, feedback, rapid-cycle improvement, and performance recognition to extend the use of evidence-based guidelines throughout the health care system and improve cardiovascular health. The project was launched in 2014, with 150 centers recruited representing the diversity of care for ACS patients in tertiary hospitals across China. Clinical information for patients with ACS is collected via a Web-based data collecting platform, including patients' demographics, medical history, symptoms on arrival, in-hospital treatment and procedures, in-hospital outcomes, and discharge medications for secondary prevention. Improvement in adherence to guideline recommendations is facilitated through monthly benchmarked hospital quality reports, recognition of hospital quality achievement, and regular webinars. As of April 16, 2016, a total of 35,616 ACS cases have been enrolled. The CCC-ACS is a national hospital-based quality improvement program, aiming to increase adherence to ACS guidelines in China and improve patient outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Appraisal Tools for Clinical Practice Guidelines: A Systematic Review

PubMed Central

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

2013-01-01

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

Managing insulin therapy during exercise in type 1 diabetes mellitus.

PubMed

Toni, Sonia; Reali, Maria Francesca; Barni, Federica; Lenzi, Lorenzo; Festini, Filippo

2006-01-01

Exercise is integral to the life of T1DM subjects. Several factors influence the metabolic response to exercise in these patients. Despite physical and psychological benefits of exercise, its hypo- and hyperglycemic effects may cause discouragement from participation in sports and games. To use existing evidence from literature to provide practical indications for the management of insulin therapy in subjects with T1DM who practice sports or physical activities. Bibliographic research was performed on PubMed and the main Systematic Review and Guidelines database were also searched. Existing guidelines are useful but the exact adjustments of insulin dose must be made on an individual basis and these adjustments can be made only by "trial and error" approach. These clinical indications may be a starting point from which health care providers can find practical advices for each patient.

The interaction between research and practice: a pan-European approach to managing H.pylori infection in primary care.

PubMed

Hungin, A P

2000-08-01

The transposition of evidence into clinical care presents many challenges. New knowledge may be immediately translatable to the practice setting, with barriers to be overcome before implementation. The early guidelines on Helicobacter pylori management presented an overview but were not able to take into account local factors and health care traditions, such as the non-availability of tests and established primary-secondary care relationships. Primary care is a specific specialty across most of Europe, existing within different health care systems and clinical traditions. The creation of H. pylori management guidelines, aimed at European primary care but adaptable to local national circumstances, presented a challenge in methodology and formulation. The process exposed similarities but also tensions between differing health care systems, as well as variations in the conditions in which GPs practise. Clinical differences, such as varying ulcer prevalence and drug resistance rates, highlighted the importance of guidelines being adaptable. This paper analyses the European Society for Primary Care Gastroenterology process of pan-European primary care agreement towards H.pylori management and how diverse views, traditions and national settings were reconciled through an evidence-based approach.

Managing care pathways combining SNOMED CT, archetypes and an electronic guideline system.

PubMed

Bernstein, Knut; Andersen, Ulrich

2008-01-01

Today electronic clinical guideline systems exist, but they are not well integrated with electronic health records. This paper thus proposes that the patient's "position" in the pathway during the patient journey should be made visible to all involved healthcare parties and the patient. This requires that the generic knowledge, which is represented in the guidelines, is combined with the patient specific information - and then made accessible for all relevant parties. In addition to the decision support provided by the guideline system documentation support can be provided by templates based on archetypes. This paper provides a proposal for how the guideline system and the EHR can be integrated by the use of archetypes and SNOMED CT. SNOMED CT provides the common reference terminology and the semantic links between the systems. The proposal also includes the use of a National Patient Index for storing data about the patient's position in the pathway and for sharing this information by all involved parties.

[Patient's individuality and application of guidelines in surgery].

PubMed

Schulte, Michael

2005-01-01

Individual treatment decisions can become considerably conflictual in view of the co-existence of medical professional guidelines, recommendations based on evidence-based medicine (EBM), and juridical and economical directions. Medical guidelines are not subject to an external review process; also, due to reduced practicability, the surgeons' compliance with guidelines remains relatively low. Surgical treatment strategies can rely on randomized clinical trials (RCTs) in approximately 20% of the surgical procedures and on non-randomized trials in approximately 70% of the cases. No evidence is given in approximately 10% of the cases. Specific problems of implementation of EBM in surgical disciplines are represented by the difficulty of standardized procedures, the heterogeneity of the population, the impossibility to conduct double-blinded RCTs, a low statistical power, and a publication bias. Since individual diseases cannot be reduced to surgical cases manageable only by the application of guidelines, adequate treatment of individual patients requires the critical application of both external evidence and surgeon expertise (internal evidence).

Fifteen hundred guidelines and growing: the UK database of clinical guidelines.

PubMed

van Loo, John; Leonard, Niamh

2006-06-01

The National Library for Health offers a comprehensive searchable database of nationally approved clinical guidelines, called the Guidelines Finder. This resource, commissioned in 2002, is managed and developed by the University of Sheffield Health Sciences Library. The authors introduce the historical and political dimension of guidelines and the nature of guidelines as a mechanism to ensure clinical effectiveness in practice. The article then outlines the maintenance and organisation of the Guidelines Finder database itself, the criteria for selection, who publishes guidelines and guideline formats, usage of the Guidelines Finder service and finally looks at some lessons learnt from a local library offering a national service. Clinical guidelines are central to effective clinical practice at the national, organisational and individual level. The Guidelines Finder is one of the most visited resources within the National Library for Health and is successful in answering information needs related to specific patient care, clinical research, guideline development and education.

The development of a gender identity psychosocial clinic: treatment issues, logistical considerations, interdisciplinary cooperation, and future initiatives.

PubMed

Leibowitz, Scott F; Spack, Norman P

2011-10-01

Few interdisciplinary treatment programs that tend to the needs of youth with gender nonconforming behaviors, expressions, and identities exist in academic medical centers with formal residency training programs. Despite this, the literature provides evidence that these youth have higher rates of poor psychosocial adjustment and suicide attempts. This article explores the logistical considerations involved in developing a specialized interdisciplinary service to these gender minority youth in accordance with the existing treatment guidelines.Demographic data will be presented and treatment issues will be explored. The impact that a specialized interdisciplinary treatment program has on clinical expansion, research development, education and training, and community outreach initiatives is discussed.

Indications for MARS-MRI in Patients Treated With Metal-on-Metal Hip Resurfacing Arthroplasty.

PubMed

Connelly, James W; Galea, Vincent P; Matuszak, Sean J; Madanat, Rami; Muratoglu, Orhun; Malchau, Henrik

2018-06-01

Currently, there are no universally accepted guidelines on when to obtain metal artifact reduction sequence magnetic resonance imaging (MARS-MRI) in metal-on-metal (MoM) hip resurfacing arthroplasty (HRA) patients. Our primary aims were to identify which patient and clinical factors are predictive of adverse local tissue reaction (ALTR) and create an algorithm for indicating MARS-MRI in patients with Articular Surface Replacement (ASR) HRA. The secondary aim was to compare our algorithm to existing guidelines on when to perform MARS-MRI in MoM HRA patients. The study cohort consisted of 182 patients with unilateral ASR HRA from a prospective, multicenter study. Subjects received MARS-MRI at a mean of 7.8 years from surgery, regardless of symptoms. We determined which variables were predictive of ALTR and generated cutoffs for each variable. Finally, we created an algorithm to predict ALTR and indicate MARS-MRI in ASR HRA patients using these cutoffs and compared it to existing guidelines. We found high blood cobalt (Co) (odds ratio = 1.070; P = .011) and high blood chromium (Cr) (odds ratio = 1.162; P = .002) to be significant predictors of ALTR presence. Our algorithm using a blood Co cutoff of 1.15 ppb and a Cr cutoff of 1.09 ppb achieved 96.6% sensitivity and 35.3% specificity in predicting ALTR, which outperformed the existing guidelines. Blood Co and Cr levels are predictive of ALTR in ASR HRA patients. Our algorithm considering blood Co and Cr levels predicts ALTR in ASR HRA patients with higher sensitivity than previously established guidelines. Copyright © 2018 Elsevier Inc. All rights reserved.

Femoral Component Sizing in Oxford Unicompartmental Knee Replacement: Existing Guidelines Do Not Work for Indian Patients.

PubMed

Malhotra, Rajesh; Gaba, Sahil; Wahal, Naman; Kumar, Vijay; Srivastava, Deep N; Pandit, Hemant

2018-02-28

Oxford unicompartmental knee replacement (OUKR) has shown excellent long-term clinical outcomes as well as implant survival when used for correct indications with optimal surgical technique. Anteromedial osteoarthritis is highly prevalent in Indian patients, and OUKR is the ideal treatment option in such cases. Uncertainty prevails about the best method to determine femoral component size in OUKR. Preoperative templating has been shown to be inaccurate, while height- and gender-based guidelines based on European population might not apply to the Indian patients. Microplasty instrumentation introduced in 2012 introduced the sizing spoon, which has the dual function of femoral component sizing and determining the level of tibia cut. We aimed to check the accuracy of sizing spoon and also to determine whether the present guidelines are appropriate for use in the Indian patients. A total of 130 consecutive Oxford mobile bearing medial cemented UKR performed using the Microplasty instrumentation were included. The ideal femoral component size for each knee was recorded by looking for overhang and underhang in post-operative lateral knee radiograph. The accuracy of previous guidelines was determined by applying them to our study population. Previously published guidelines (which were based on Western population) proved to be accurate in only 37% of cases. Hence, based on the demographics of our study population, we formulated modified height- and gender-based guidelines, which would better suit the Indian population. Accuracy of modified guidelines was estimated to be 74%. The overall accuracy of sizing spoon (75%), when used as an intraoperative guide, was similar to that of modified guidelines. Existing guidelines for femoral component sizing do not work in Indian patients. Modified guidelines and use of intraoperative spoon should be used to choose the optimal implant size while performing OUKR in Indian patients. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Protocol-developing meta-ethnography reporting guidelines (eMERGe).

PubMed

France, E F; Ring, N; Noyes, J; Maxwell, M; Jepson, R; Duncan, E; Turley, R; Jones, D; Uny, I

2015-11-25

Designing and implementing high-quality health care services and interventions requires robustly synthesised evidence. Syntheses of qualitative research studies can provide evidence of patients' experiences of health conditions; intervention feasibility, appropriateness and acceptability to patients; and advance understanding of health care issues. The unique, interpretive, theory-based meta-ethnography synthesis approach is suited to conveying patients' views and developing theory to inform service design and delivery. However, meta-ethnography reporting is often poor quality, which discourages trust in, and use of, meta-ethnography findings. Users of evidence syntheses require reports that clearly articulate analytical processes and findings. Tailored research reporting guidelines can raise reporting standards but none exists for meta-ethnography. This study aims to create an evidence-based meta-ethnography reporting guideline articulating the methodological standards and depth of reporting required to improve reporting quality. The mixed-methods design of this National Institute of Health Research-funded study (http://www.stir.ac.uk/emerge/) follows good practice in research reporting guideline development comprising: (1) a methodological systematic review (PROSPERO registration: CRD42015024709) to identify recommendations and guidance in conducting/reporting meta-ethnography; (2) a review and audit of published meta-ethnographies to identify good practice principles and develop standards in conduct/reporting; (3) an online workshop and Delphi studies to agree guideline content with 45 international qualitative synthesis experts and 45 other stakeholders including patients; (4) development and wide dissemination of the guideline and its accompanying detailed explanatory document, a report template for National Institute of Health Research commissioned meta-ethnographies, and training materials on guideline use. Meta-ethnography, devised in the field of education, is now used widely in other disciplines. Methodological advances relevant to meta-ethnography conduct exist. The extent of discipline-specific adaptations of meta-ethnography and the fit of any adaptions with the underpinning philosophy of meta-ethnography require investigation. Well-reported meta-ethnography findings could inform clinical decision-making. A bespoke meta-ethnography reporting guideline is needed to improve reporting quality, but to be effective potential users must know it exists, trust it and use it. Therefore, a rigorous study has been designed to develop and promote a guideline. By raising reporting quality, the guideline will maximise the likelihood that high-quality meta-ethnographies will contribute robust evidence to improve health care and patient outcomes.

REVIEW OF CONCENTRATION STANDARDS AND GUIDELINES FOR FUNGI IN INDOOR AIR

EPA Science Inventory

The paper reviews and compares existing guidelines for indoor airborne fungi, discusses limitations of existing guidelines, and identifies research needs that should contribute to the development of realistic and useful guidelines for these important air pollutants. (NOTE: Exposu...

Home mechanical ventilation: A Canadian Thoracic Society clinical practice guideline

PubMed Central

McKim, Douglas A; Road, Jeremy; Avendano, Monica; Abdool, Steve; Côté, Fabien; Duguid, Nigel; Fraser, Janet; Maltais, François; Morrison, Debra L; O’Connell, Colleen; Petrof, Basil J; Rimmer, Karen; Skomro, Robert

2011-01-01

Increasing numbers of patients are surviving episodes of prolonged mechanical ventilation or benefitting from the recent availability of user-friendly noninvasive ventilators. Although many publications pertaining to specific aspects of home mechanical ventilation (HMV) exist, very few comprehensive guidelines that bring together all of the current literature on patients at risk for or using mechanical ventilatory support are available. The Canadian Thoracic Society HMV Guideline Committee has reviewed the available English literature on topics related to HMV in adults, and completed a detailed guideline that will help standardize and improve the assessment and management of individuals requiring noninvasive or invasive HMV. The guideline provides a disease-specific review of illnesses including amyotrophic lateral sclerosis, spinal cord injury, muscular dystrophies, myotonic dystrophy, kyphoscoliosis, post-polio syndrome, central hypoventilation syndrome, obesity hypoventilation syndrome, and chronic obstructive pulmonary disease as well as important common themes such as airway clearance and the process of transition to home. The guidelines have been extensively reviewed by international experts, allied health professionals and target audiences. They will be updated on a regular basis to incorporate any new information. PMID:22059178

Are HIV and reproductive health services adapted to the needs of female sex workers? Results of a policy and situational analysis in Tete, Mozambique.

PubMed

Lafort, Yves; Jocitala, Osvaldo; Candrinho, Balthazar; Greener, Letitia; Beksinska, Mags; Smit, Jenni A; Chersich, Matthew; Delva, Wim

2016-07-26

In the context of an implementation research project aiming at improving use of HIV and sexual and reproductive health (SRH) services for female sex workers (FSWs), a broad situational analysis was conducted in Tete, Mozambique, assessing if services are adapted to the needs of FSWs. Methods comprised (1) a policy analysis including a review of national guidelines and interviews with policy makers, and (2) health facility assessments at 6 public and 1 private health facilities, and 1 clinic specifically targeting FSWs, consisting of an audit checklist, interviews with 18 HIV/SRH care providers and interviews of 99 HIV/SRH care users. There exist national guidelines for most HIV/SRH care services, but none provides guidance for care adapted to the needs of high-risk women such as FSWs. The Ministry of Health recently initiated the process of establishing guidelines for attendance of key populations, including FSWs, at public health facilities. Policy makers have different views on the best approach for providing services to FSWs-integrated in the general health services or through parallel services for key populations-and there exists no national strategy. The most important provider of HIV/SRH services in the study area is the government. Most basic services are widely available, with the exception of certain family planning methods, cervical cancer screening, services for victims of sexual and gender-based violence, and termination of pregnancy (TOP). The public facilities face serious limitations in term of space, staff, equipment, regular supplies and adequate provider practices. A stand-alone clinic targeting key populations offers a limited range of services to the FSW population in part of the area. Private clinics offer only a few services, at commercial prices. There is a need to improve the availability of quality HIV/SRH services in general and to FSWs specifically, and to develop guidelines for care adapted to the needs of FSWs. Access for FSWs can be improved by either expanding the range of services and the coverage of the targeted clinic and/or by improving access to adapted care at the public health services and ensure a minimum standard of quality.

[How to Understand "Clinical Ethics" and "Research Ethics" in Clinical Settings--Incorporation of IRB, REC, and CEC in Hospital Organizations].

PubMed

Ita, Koichiro

2016-02-01

As the traditional definition of "medical ethics" has recently changed markedly with advances in medical knowledge and technology, medical doctors and researchers in Japan are required to understand and apply both research and clinical ethics. Quite frequently, ethical problems in clinical settings cannot be addressed by the simple application of good will, hard work, and perseverance by medical personnel. The Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) have jointly published "Ethical Guidelines for Clinical Studies;" however, clear guidelines (legal, ministerial, or governmental) outlining the expectations regarding clinical ethics do not exist. All medical personnel face deep ethical dilemmas. In these instances, if the fulfillment of 'ethics' relies solely on the capacity of personnel to apply their own individual moral efforts, the result will be burn-out among these workers who have a strong sense of responsibility. In order to avoid this, a system which comprises multiple physicians, nurses, and other personnel must be established, allowing collaboration when an appropriate response is required. A major factor supporting this approach is the offering of Clinical Ethics Consultations.

2014 Guidelines of Taiwan Society of Cardiology (TSOC) for the Management of Pulmonary Arterial Hypertension

PubMed Central

Hsu, Chih-Hsin; Ho, Wan-Jing; Huang, Wei-Chun; Chiu, Yu-Wei; Hsu, Tsu-Shiu; Kuo, Ping-Hung; Hsu, Hsao-Hsun; Chang, Jia-Kan; Cheng, Chin-Chang; Lai, Chao-Lun; Liang, Kae-Woei; Lin, Shoa-Lin; Sung, Hsao-Hsun; Tsai, Wei-Chuan; Weng, Ken-Pen; Hsieh, Kai-Sheng; Yin, Wei-Hsian; Lin, Shing-Jong; Wang, Kuo-Yang

2014-01-01

Pulmonary hypertension (PH) is a hemodynamic and pathophysiologic condition, defined as a mean pulmonary arterial pressure exceeding 25 mmHg at rest. According to the recent classifications, it is grouped into pulmonary arterial hypertension (PAH), heart-related, lung-related, thromboembolic, and miscellaneous PH. In the past two decades, tremendous advances have occurred in the field of PH. These include (1) development of clinical diagnostic algorithm and a monitoring strategy dedicated to PAH, (2) defining strong rationales for screening at-risk populations, (3) advent of pulmonary specific drugs which makes PAH manageable, (4) recognition of needs of having proper strategy of combining existing pulmonary specific drugs, and/or potential novel drugs, (5) pursuit of clinical trials with optimal surrogate endpoints and study durations, (6) recognition of critical roles of PH/right ventricular function, as well as interdependence of ventricles in different conditions, especially those with various phenotypes of heart failure, and (7) for rare diseases, putting equal importance on carefully designed observation studies, various registries, etc., besides double blind randomized studies. In addition, ongoing basic and clinical research has led to further understanding of relevant physiology, pathophysiology, epidemiology and genetics of PH/PAH. This guidelines from the working group of Pulmonary Hypertension of the Taiwan Society of Cardiology is to provide updated guidelines based on the most recent international guidelines as well as Taiwan’s domestic research on PH. The guidelines are mainly for the management of PAH (Group 1) ; however the majority of content can be helpful for managing other types of PH. PMID:27122817

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

PubMed

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

2013-08-01

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

Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee braces in knee osteoarthritis.

PubMed

Beaudreuil, Johann; Bendaya, Samy; Faucher, Marc; Coudeyre, Emmanuel; Ribinik, Patricia; Revel, Michel; Rannou, François

2009-12-01

To develop clinical practice guidelines concerning the use of bracing--rest orthosis, knee sleeves and unloading knee braces--for knee osteoarthritis. The French Physical Medicine and Rehabilitation Society (SOFMER) methodology, associating a systematic literature review, collection of everyday clinical practice, and external review by multidisciplinary expert panel, was used. Few high-level studies of bracing for knee osteoarthritis were found. No evidence exists for the effectiveness of rest orthosis. Evidence for knee sleeves suggests that they decrease pain in knee osteoarthritis, and their use is associated with subjective improvement. These actions do not appear to depend on a local thermal effect. The effectiveness of knee sleeves for disability is not demonstrated for knee osteoarthritis. Short- and mid-term follow-up indicates that valgus knee bracing decreases pain and disability in medial knee osteoarthritis, appears to be more effective than knee sleeves, and improves quality of life, knee proprioception, quadriceps strength, and gait symmetry, and decreases compressive loads in the medial femoro-tibial compartment. However, results of response to valgus knee bracing remain inconsistent; discomfort and side effects can result. Thrombophlebitis of the lower limbs has been reported with the braces. Braces, whatever kind, are infrequently prescribed in clinical practice for osteoarthritis of the lower limbs. Modest evidence exists for the effectiveness of bracing--rest orthosis, knee sleeves and unloading knee braces--for knee osteoarthritis, with only low level recommendations for its use. Braces are prescribed infrequently in French clinical practice for osteoarthritis of the knee. Randomized clinical trials concerning bracing in knee osteoarthritis are still necessary.

European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults.

PubMed

Bollerslev, Jens; Rejnmark, Lars; Marcocci, Claudio; Shoback, Dolores M; Sitges-Serra, Antonio; van Biesen, Wim; Dekkers, Olaf M

2015-08-01

Hypoparathyroidism (HypoPT) is a rare (orphan) endocrine disease with low calcium and inappropriately low (insufficient) circulating parathyroid hormone levels, most often in adults secondary to thyroid surgery. Standard treatment is activated vitamin D analogues and calcium supplementation and not replacement of the lacking hormone, as in other hormonal deficiency states. The purpose of this guideline is to provide clinicians with guidance on the treatment and monitoring of chronic HypoPT in adults who do not have end-stage renal disease. We intend to draft a practical guideline, focusing on operationalized recommendations deemed to be useful in the daily management of patients. This guideline was developed and solely sponsored by The European Society of Endocrinology, supported by CBO (Dutch Institute for Health Care Improvement) and based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) principles as a methodological base. The clinical question on which the systematic literature search was based and for which available evidence was synthesized was: what is the best treatment for adult patients with chronic HypoPT? This systematic search found 1100 articles, which was reduced to 312 based on title and abstract. The working group assessed these for eligibility in more detail, and 32 full-text articles were assessed. For the final recommendations, other literature was also taken into account. Little evidence is available on how best to treat HypoPT. Data on quality of life and the risk of complications have just started to emerge, and clinical trials on how to optimize therapy are essentially non-existent. Most studies are of limited sample size, hampering firm conclusions. No studies are available relating target calcium levels with clinically relevant endpoints. Hence it is not possible to formulate recommendations based on strict evidence. This guideline is therefore mainly based on how patients are managed in clinical practice, as reported in small case series and based on the experiences of the authors. © 2015 European Society of Endocrinology.

Truth-telling in clinical practice.

PubMed Central

Hébert, P. C.

1994-01-01

Disclosure by doctors to patients has changed during the past 30 years in the direction of honesty, but deception and nondisclosure are still common. Clear ethical and legal precedents and guidelines regarding truth-telling exist. Physicians should not protect patients from potentially upsetting information; they will be held responsible should patients be injured due to failure to disclose. PMID:7888823

Treatment Options for Back Pain Provided Online in Canadian Magazines: Comparison against Evidence from a Clinical Practice Guideline

ERIC Educational Resources Information Center

Sniderman, Jhase A.; Roffey, Darren M.; Lee, Richard; Papineau, Gabrielle D.; Miles, Isabelle H.; Wai, Eugene K.; Kingwell, Stephen P.

2017-01-01

Background: Evidence-based treatments for adult back pain have long been confirmed, with research continuing to narrow down the scope of recommended practices. However, a tension exists between research-driven treatments and unsubstantiated modalities and techniques promoted to the public. This disparity in knowledge translation, which results in…

Quality in genetic counselling for presymptomatic testing--clinical guidelines for practice across the range of genetic conditions.

PubMed

Skirton, Heather; Goldsmith, Lesley; Jackson, Leigh; Tibben, Aad

2013-03-01

Presymptomatic testing (PST) is the performance of a genetic test on an asymptomatic individual at risk of a condition to determine whether the person has inherited the disease-causing mutation. Although relevant guidelines exist for specific diseases, there is no overarching protocol that can be adapted to any disorder or clinical setting in which such testing is offered. The objective of this European project was to develop a set of coherent guidelines for PST (for adult-onset monogenic conditions) for use by health professionals working in a range of disciplines, countries or contexts. To ensure the guidelines were appropriate and practice based, we organised a workshop attended by an expert group of practitioners with relevant health professional backgrounds from 11 countries. Models of service for offering PST were presented, the group then discussed different aspects of testing and the standard of care required to ensure that patients were prepared to make decisions and deal with results and consequences. After the workshop, several rounds of consultation were used with a wider group of professionals to refine the guidelines. The guidelines include general principles governing the offer of testing (eg, autonomous choice of the patient), objectives of genetic counselling in this context (eg, facilitation of decision making), logistical considerations (eg, use of trained staff) and topics to be included during counselling discussion with the patient (eg, consequences of both positive and negative outcomes). We recommend the adoption of these guidelines to provide an equitable structure for those seeking PST in any country.

2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease

PubMed Central

Gerhard-Herman, Marie D.; Gornik, Heather L.; Barrett, Coletta; Barshes, Neal R.; Corriere, Matthew A.; Drachman, Douglas E.; Fleisher, Lee A.; Flowkes, Francis Gerry R.; Hamburg, Naomi M.; Kinlay, Scott; Lookstein, Robert; Misra, Sanjay; Mureebe, Leila; Olin, Jeffrey W.; Patel, Rajan A.G.; Regensteiner, Judith G.; Schanzer, Andres; Shishehbor, Mehdi H.; Stewart, Kerry J.; Treat-Jacobson, Diane; Walsh, M. Eileen; Halperin, Jonathan L.

2017-01-01

Preamble Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines with recommendations to improve cardiovascular health. These guidelines, based on systematic methods to evaluate and classify evidence, provide a cornerstone of quality cardiovascular care. In response to reports from the Institute of Medicine1,2 and a mandate to evaluate new knowledge and maintain relevance at the point of care, the ACC/AHA Task Force on Clinical Practice Guidelines (Task Force) modified its methodology.3–5 The relationships among guidelines, data standards, appropriate use criteria, and performance measures are addressed elsewhere.5 Intended Use Practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organizations may have a broader target. Although guidelines may be used to inform regulatory or payer decisions, the intent is to improve quality of care and align with patients' interests. Guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances, and should not replace clinical judgment. Guidelines are reviewed annually by the Task Force and are official policy of the ACC and AHA. Each guideline is considered current until it is updated, revised, or superseded by published addenda, statements of clarification, focused updates, or revised full-text guidelines. To ensure that guidelines remain current, new data are reviewed biannually to determine whether recommendations should be modified. In general, full revisions are posted in 5-year cycles.3–6 Modernization Processes have evolved to support the evolution of guidelines as “living documents” that can be dynamically updated. This process delineates a recommendation to address a specific clinical question, followed by concise text (ideally <250 words) and hyperlinked to supportive evidence. This approach accommodates time constraints on busy clinicians and facilitates easier access to recommendations via electronic search engines and other evolving technology. Evidence Review Writing committee members review the literature; weigh the quality of evidence for or against particular tests, treatments, or procedures; and estimate expected health outcomes. In developing recommendations, the writing committee uses evidence-based methodologies that are based on all available data.3–7 Literature searches focus on randomized controlled trials (RCTs) but also include registries, nonrandomized comparative and descriptive studies, case series, cohort studies, systematic reviews, and expert opinion. Only selected references are cited. The Task Force recognizes the need for objective, independent Evidence Review Committees (ERCs) that include methodologists, epidemiologists, clinicians, and biostatisticians who systematically survey, abstract, and assess the evidence to address systematic review questions posed in the PICOTS format (P=population, I=intervention, C=comparator, O=outcome, T=timing, S=setting).2,4–6 Practical considerations, including time and resource constraints, limit the ERCs to evidence that is relevant to key clinical questions and lends itself to systematic review and analysis that could affect the strength of corresponding recommendations. Guideline-Directed Management and Treatment The term “guideline-directed management and therapy” (GDMT) refers to care defined mainly by ACC/AHA Class I recommendations. For these and all recommended drug treatment regimens, the reader should confirm dosage with product insert material and carefully evaluate for contraindications and interactions. Recommendations are limited to treatments, drugs, and devices approved for clinical use in the United States. Class of Recommendation and Level of Evidence The Class of Recommendation (COR; ie, the strength of the recommendation) encompasses the anticipated magnitude and certainty of benefit in proportion to risk. The Level of Evidence (LOE) rates evidence supporting the effect of the intervention on the basis of the type, quality, quantity, and consistency of data from clinical trials and other reports (Table 1).3–5 Unless otherwise stated, recommendations are sequenced by COR and then by LOE. Where comparative data exist, preferred strategies take precedence. When >1 drug, strategy, or therapy exists within the same COR and LOE and no comparative data are available, options are listed alphabetically. Relationships With Industry and Other Entities The ACC and AHA sponsor the guidelines without commercial support, and members volunteer their time. The Task Force zealously avoids actual, potential, or perceived conflicts of interest that might arise through relationships with industry or other entities (RWI). All writing committee members and reviewers are required to disclose current industry relationships or personal interests, from 12 months before initiation of the writing effort. Management of RWI involves selecting a balanced writing committee and assuring that the chair and a majority of committee members have no relevant RWI (Appendix 1). Members are restricted with regard to writing or voting on sections to which their RWI apply. For transparency, members' comprehensive disclosure information is available online. Comprehensive disclosure information for the Task Force is also available online. The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic regions, sexes, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators. Individualizing Care in Patients With Associated Conditions and Comorbidities Managing patients with multiple conditions can be complex, especially when recommendations applicable to coexisting illnesses are discordant or interacting.8 The guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances. The recommendations should not replace clinical judgment. Clinical Implementation Management in accordance with guideline recommendations is effective only when followed. Adherence to recommendations can be enhanced by shared decision making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated conditions and comorbidities. Consequently, circumstances may arise in which deviations from these guidelines are appropriate. PMID:27840333

Australasian Society for Parenteral and Enteral Nutrition guidelines for supplementation of trace elements during parenteral nutrition.

PubMed

Osland, Emma J; Ali, Azmat; Isenring, Elizabeth; Ball, Patrick; Davis, Melvyn; Gillanders, Lyn

2014-01-01

This work represents the first part of a progressive review of AuSPEN's 1999 Guidelines for Provision of Micronutrient Supplementation in Adult Patients receiving Parenteral Nutrition, in recognition of the developments in the literature on this topic since that time. A systematic literature review was undertaken and recommendations were made based on the available evidence and with consideration to specific elements of the Australian and New Zealand practice environment. The strength of evidence underpinning each recommendation was assessed. External reviewers provided feedback on the guidelines using the AGREE II tool. Reduced doses of manganese, copper, chromium and molybdenum, and an increased dose of selenium are recommended when compared with the 1999 guidelines. Currently the composition of available multi-trace element formulations is recognised as an obstacle to aligning these guidelines with practice. A paucity of available literature and limitations with currently available methods of monitoring trace element status are acknowledged. The currently unknown clinical impact of changes to trace element contamination of parenteral solutions with contemporary practices highlights need for research and clinical vigilance in this area of nutrition support practice. Trace elements are essential and should be provided daily to patients receiving parenteral nutrition. Monitoring is generally only required in longer term parenteral nutrition, however should be determined on an individual basis. Industry is encouraged to modify existing multi-trace element solutions available in Australia and New Zealand to reflect changes in the literature outlined in these guidelines. Areas requiring research are highlighted.

An Interactive Teddy Bear Clinic Tour: Teaching Veterinary Students How to Interact with Young Children.

PubMed

Dalley, Jessica S; Creary, Patricia R; Durzi, Tiffany; McMurtry, C Meghan

Although there are existing guidelines for teaching and learning skillful client communication, there remains a need to integrate a developmental focus into veterinary medical curricula to prepare students for interactions with children who accompany their companion animals. The objectives of this teaching tip are (1) to describe the use of a Teddy Bear Clinic Tour as an innovative, applied practice method for teaching veterinary students about clinical communication with children, and (2) to provide accompanying resources to enable use of this method to teach clinical communication at other facilities. This paper includes practical guidelines for organizing a Teddy Bear Clinic Tour at training clinics or colleges of veterinary medicine; an anecdotal description of a pilot study at the Ontario Veterinary College Smith Lane Animal Hospital; and printable resources, including a list of specific clinical communication skills, a sample evaluation sheet for supervisors and students, recommendations for creating a child-friendly environment, examples of child-friendly veterinary vocabulary, and a sample script for a Teddy Bear Clinic Tour. Informed by the resources provided in this teaching tip paper, the Teddy Bear Clinic Tour can be used at your facility as a unique teaching method for clinical communication with children and as a community outreach program to advertise the services at the facility.

The administration of rescue medication to children with prolonged acute convulsive seizures in the community: what happens in practice?

PubMed

Wait, Suzanne; Lagae, Lieven; Arzimanoglou, Alexis; Beghi, Ettore; Bennett, Christine; Cross, J Helen; Mifsud, Janet; Schmidt, Dieter; Harvey, Gordon

2013-01-01

This paper presents the findings of a review of existing clinical and non-clinical guidance on the management of children with prolonged acute convulsive seizures (PCS) and the administration of rescue medication in community settings. Findings are based on desk- and web-based research in 6 countries. Published clinical guidelines are mostly limited to the hospital setting and offer few explicit recommendations for community settings. Non-clinical guidance on the management of medicines at school exists at the national or regional level in all 6 countries, however rescue epilepsy medication is often not mentioned specifically. Existing legal frameworks are vague and open to interpretation. As a result, whether a child receives rescue medication at school depends primarily on the availability of a willing teacher who accepts responsibility for administering it to that child during school hours. Comprehensive guidelines are clearly needed that provide practical guidance to ensure that children with PCS are treated as quickly as possible in all community settings. Recommendations for future action include: providing clearer information on PCS and rescue medication to parents and schools; putting in place an individual healthcare plan for every child with a history of PCS at his or her school; collecting more empirical data to gain a better understanding of the experience of children with PCS at school, their parents and teachers; and finally, implementing systematic training for all carers of children with PCS. The epilepsy specialist may play an important role in ensuring that these recommendations are put into place for their patients. Copyright © 2012 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Contextual and temporal clinical guidelines.

PubMed Central

Guarnero, A.; Marzuoli, M.; Molino, G.; Terenziani, P.; Torchio, M.; Vanni, K.

1998-01-01

In this paper, we propose an approach for managing clinical guidelines. We sketch a modular architecture, allowing us to separate conceptually distinct aspects in the management and use of clinical guidelines. In particular, we describe the clinical guidelines knowledge representation module and we sketch the acquisition module. The main focus of the paper is the definition of an expressive formalism for representing clinical guidelines, which allows one to deal with the context dependent character of clinical guidelines and takes into account different temporal aspects. PMID:9929306

75 FR 36756 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

... existing paragraph (b)(4) of the Rule, entitled ``Numerical Guidelines Applicable to Volatile Market Opens... existing paragraph (b)(2), which provides flexibility to FINRA to use different Numerical Guidelines or... of paragraph (b)(4) (``Numerical Guidelines Applicable to Volatile Market Opens'') of the existing...

Incidence of infection after Mohs micrographic and dermatologic surgery before and after implementation of new sterilization guidelines.

PubMed

Liu, Austin; Lawrence, Naomi

2014-06-01

Clinical guidelines regarding surgical instrument sterilization established by accrediting organizations should be based on peer-reviewed scientific literature. Few data exist in the scientific literature to support the changes in sterilization protocols imposed by accrediting organizations. We sought to determine whether recently established guidelines for the sterilization of surgical instruments have had any clinical impact on postsurgical infection rates. Infections rates after excisional and Mohs micrographic surgery before and after implementation of new Joint Commission on the Accreditation of Healthcare Organizations sterilization guidelines were examined retrospectively. All surgeries were performed at an academic outpatient office. In all, 1415 patients underwent a total of 1688 surgeries. No significant differences were observed in mean patient age (P = .113), mean number of Mohs micrographic surgical levels (P = .067), final defect size (P = .305), patient gender (P = .072), repair type (P = .691), or infection rate (P = .453). No major differences in predisposing factors were identified in patients who developed postsurgical infections. This was a retrospective study conducted at a single academic institution. In our practice, recent changes in surgical instrument sterilization protocols have had no impact on postsurgical infection rates. The implementation of such guidelines places an additional burden on the health care system without providing any improvement in patient outcomes. Copyright © 2014 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

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.

Follow-up after arthroplasty of the hip and knee : are we over-servicing or under-caring?

PubMed

Lovelock, T M; Broughton, N S

2018-01-01

The number of arthroplasties of the hip and knee is predicted to increase rapidly during the next 20 years. Accompanying this is the dilemma of how to follow-up these patients appropriately. Current guidelines recommend long-term follow-up to identify patients with aseptic loosening, which can occur more than a decade postoperatively. The current guidelines and practices of orthopaedic surgeons vary widely. Existing models take up much clinical time and are expensive. Pilot studies using 'virtual' clinics and advanced-practice physiotherapists have shown promise in decreasing the time and costs for orthopaedic surgeons and patients. This review discusses current practices and future trends in the follow-up of patients who have an arthroplasty. Cite this article: Bone Joint J 2018;100-B:6-10. ©2018 The British Editorial Society of Bone & Joint Surgery.

Maelstrom Research guidelines for rigorous retrospective data harmonization

PubMed Central

Fortier, Isabel; Raina, Parminder; Van den Heuvel, Edwin R; Griffith, Lauren E; Craig, Camille; Saliba, Matilda; Doiron, Dany; Stolk, Ronald P; Knoppers, Bartha M; Ferretti, Vincent; Granda, Peter; Burton, Paul

2017-01-01

Abstract Background: It is widely accepted and acknowledged that data harmonization is crucial: in its absence, the co-analysis of major tranches of high quality extant data is liable to inefficiency or error. However, despite its widespread practice, no formalized/systematic guidelines exist to ensure high quality retrospective data harmonization. Methods: To better understand real-world harmonization practices and facilitate development of formal guidelines, three interrelated initiatives were undertaken between 2006 and 2015. They included a phone survey with 34 major international research initiatives, a series of workshops with experts, and case studies applying the proposed guidelines. Results: A wide range of projects use retrospective harmonization to support their research activities but even when appropriate approaches are used, the terminologies, procedures, technologies and methods adopted vary markedly. The generic guidelines outlined in this article delineate the essentials required and describe an interdependent step-by-step approach to harmonization: 0) define the research question, objectives and protocol; 1) assemble pre-existing knowledge and select studies; 2) define targeted variables and evaluate harmonization potential; 3) process data; 4) estimate quality of the harmonized dataset(s) generated; and 5) disseminate and preserve final harmonization products. Conclusions: This manuscript provides guidelines aiming to encourage rigorous and effective approaches to harmonization which are comprehensively and transparently documented and straightforward to interpret and implement. This can be seen as a key step towards implementing guiding principles analogous to those that are well recognised as being essential in securing the foundational underpinning of systematic reviews and the meta-analysis of clinical trials. PMID:27272186

Prospective systematic review registration: perspective from the Guidelines International Network (G-I-N).

PubMed

Van der Wees, Philip; Qaseem, Amir; Kaila, Minna; Ollenschlaeger, Guenter; Rosenfeld, Richard

2012-02-09

Clinical practice and public health guidelines are important tools for translating research findings into practice with the aim of assisting health practitioners as well as patients and consumers in health behavior and healthcare decision-making. Numerous programs for guideline development exist around the world, with growing international collaboration to improve their quality. One of the key features in developing trustworthy guidelines is that recommendations should be based on high-quality systematic reviews of the best available evidence. The review process used by guideline developers to identify and grade relevant evidence for developing recommendations should be systematic, transparent and unbiased. In this paper, we provide an overview of current international developments in the field of practice guidelines and methods to develop guidelines, with a specific focus on the role of systematic reviews. The Guidelines International Network (G-I-N) aims to stimulate collaboration between guideline developers and systematic reviewers to optimize the use of available evidence in guideline development and to increase efficiency in the guideline development process. Considering the significant benefit of systematic reviews for the guideline community, the G-I-N Board of Trustees supports the international prospective register of systematic reviews (PROSPERO) initiative. G-I-N also recently launched a Data Extraction Resource (GINDER) to present and share data extracted from individual studies in a standardized template. PROSPERO and GINDER are complementary tools to enhance collaboration between guideline developers and systematic reviewers to allow for alignment of activities and a reduction in duplication of effort.

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.

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

PubMed

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

2017-06-01

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

75 FR 68296 - Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

... Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Sewage... ``Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Sewage... solid waste incineration units. In that action, EPA proposed NSPS and EG for sewage sludge incineration...

Representation of cardiovascular magnetic resonance in the AHA / ACC guidelines.

PubMed

von Knobelsdorff-Brenkenhoff, Florian; Pilz, Guenter; Schulz-Menger, Jeanette

2017-09-25

Whereas evidence supporting the diagnostic value of cardiovascular magnetic resonance (CMR) has increased, there exists significant worldwide variability in the clinical utilization of CMR. A recent study demonstrated that CMR is represented in the majority of European Society for Cardiology (ESC) guidelines, with a large number of specific recommendations in particular regarding coronary artery disease. To further investigate the gap between the evidence and clinical use of CMR, this study analyzed the role of CMR in the guidelines of the American College of Cardiology (ACC) and American Heart Association (AHA). Twenty-four AHA/ACC original guidelines, updates and new editions, published between 2006 and 2017, were screened for the terms "magnetic", "MRI", "CMR", "MR" and "imaging". Non-cardiovascular MR examinations were excluded. All CMR-related paragraphs and specific recommendations for CMR including the level of evidence (A, B, C) and the class of recommendation (I, IIa, IIb, III) were extracted. Twelve of the 24 guidelines (50.0%) contain specific recommendations regarding CMR. Four guidelines (16.7%) mention CMR in the text only, and 8 (33.3%) do not mention CMR. The 12 guidelines with recommendations for CMR contain in total 65 specific recommendations (31 class-I, 23 class-IIa, 6 class-IIb, 5 class-III). Most recommendations have evidence level C (44/65; 67.7%), followed by level B (21/65; 32.3%). There are no level A recommendations. 22/65 recommendations refer to vascular imaging, 17 to congenital heart disease, 8 to cardiomyopathies, 8 to myocardial stress testing, 5 to left and right ventricular function, 3 to viability, and 2 to valvular heart disease. CMR is represented in two thirds of the AHA/ACC guidelines, which contain a number of specific recommendations for the use of CMR. In a simplified comparison with the ESC guidelines, CMR is less represented in the AHA/ACC guidelines in particular in the field of coronary artery disease.

[Polish guidelines for the prevention and treatment of venous thromboembolism: 2009 update].

PubMed

Zawilska, Krystyna; Jaeschke, Roman; Tomkowski, Witold; Mayzner-Zawadzka, Ewa; Nizankowski, Rafał; Olejek, Anita; Pasierski, Tomasz; Torbicki, Adam; Undas, Anetta; Jawień, Arkadiusz; Gajewski, Piotr; Sznajd, Jan; Brozek, Jan

2009-01-01

The overall objective of the Polish guidelines for the prevention and treatment of venous thromboembolism is to increase patient benefit and safety by appropriate prevention and treatment of deep vein thrombosis and pulmonary embolism as well as proper management of the complications associated with antithrombotic and thrombolytic therapy. These guidelines apply to adult trauma, cancer, surgical, and medical patients as well as those at increased risk of venous thromboembolism. Specific recommendations have been formulated for pregnant women, patients requiring surgery while receiving long-term oral anticoagulant treatment, and patients undergoing regional anesthesia and/or analgesia. We systematically identified all current clinical practice guidelines concerning the prevention and/or treatment of venous thromboembolism and assessed their methodological quality using the AGREE instrument. We chose to update existing Polish guidelines by adapting the most recent high quality guidelines that we identified to Polish cultural and organizational setting rather than develop all recommendations de novo. We based our recommendations primarily on the 8th edition of the American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines on Antithrombotic and Thrombolytic Therapy and on the European Society of Cardiology (ESC) Guidelines on the Diagnosis and Management of Acute Pulmonary Embolism. To make recommendations regarding specific management issues that had not been addressed in ACCP guidelines, or whenever panel members felt they needed additional information to reach the decision we also consulted guidelines developed by other professional societies and organizations as well as additional sources of evidence. For each recommendation we explicitly assessed its relevance and applicability in the context of health care system in Poland. We adapted recommendations when necessary, explicitly stating the rationale for modification and judgements about the values and preferences we assumed. We developed original recommendations on the use of new oral anticoagulants that have recently become available, following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

Physiotherapy for cystic fibrosis in Australia and New Zealand: A clinical practice guideline*

PubMed Central

Wilson, Christine; Dentice, Ruth; Cox, Narelle S.; Middleton, Anna; Tannenbaum, Esta; Bishop, Jennifer; Cobb, Robyn; Burton, Kate; Wood, Michelle; Moran, Fiona; Black, Ryan; Bowen, Summar; Day, Rosemary; Depiazzi, Julie; Doiron, Katherine; Doumit, Michael; Dwyer, Tiffany; Elliot, Alison; Fuller, Louise; Hall, Kathleen; Hutchins, Matthew; Kerr, Melinda; Lee, Annemarie L.; Mans, Christina; O'Connor, Lauren; Steward, Ranjana; Potter, Angela; Rasekaba, Tshepo; Scoones, Rebecca; Tarrant, Ben; Ward, Nathan; West, Samantha; White, Dianne; Wilson, Lisa; Wood, Jamie; Holland, Anne E.

2016-01-01

Abstract Physiotherapy management is a key element of care for people with cystic fibrosis (CF) throughout the lifespan. Although considerable evidence exists to support physiotherapy management of CF, there is documented variation in practice. The aim of this guideline is to optimize the physiotherapy management of people with CF in Australia and New Zealand. A systematic review of the literature in key areas of physiotherapy practice for CF was undertaken. Recommendations were formulated based on National Health and Medical Research Council (Australia) guidelines and considered the quality, quantity and level of the evidence; the consistency of the body of evidence; the likely clinical impact; and applicability to physiotherapy practice in Australia and New Zealand. A total of 30 recommendations were made for airway clearance therapy, inhalation therapy, exercise assessment and training, musculoskeletal management, management of urinary incontinence, managing the newly diagnosed patient with CF, delivery of non‐invasive ventilation, and physiotherapy management before and after lung transplantation. These recommendations can be used to underpin the provision of evidence‐based physiotherapy care to people with CF in Australia and New Zealand. PMID:27086904

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

PubMed

Hsiao, Ju-Ling; Chen, Rai-Fu

2016-01-16

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

Management and Care of Women With Invasive Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Clinical Practice Guideline

PubMed Central

Chuang, Linus T.; Temin, Sarah; Camacho, Rolando; Dueñas-Gonzalez, Alfonso; Feldman, Sarah; Gultekin, Murat; Gupta, Vandana; Horton, Susan; Jacob, Graciela; Kidd, Elizabeth A.; Lishimpi, Kennedy; Nakisige, Carolyn; Nam, Joo-Hyun; Ngan, Hextan Yuen Sheung; Small, William; Thomas, Gillian; Berek, Jonathan S.

2016-01-01

Purpose To provide evidence-based, resource-stratified global recommendations to clinicians and policymakers on the management and palliative care of women diagnosed with invasive cervical cancer. Methods ASCO convened a multidisciplinary, multinational panel of cancer control, medical and radiation oncology, health economic, obstetric and gynecologic, and palliative care experts to produce recommendations reflecting resource-tiered settings. A systematic review of literature from 1966 to 2015 failed to yield sufficiently strong quality evidence to support basic- and limited-resource setting recommendations; a formal consensus-based process was used to develop recommendations. A modified ADAPTE process was also used to adapt recommendations from existing guidelines. Results Five existing sets of guidelines were identified and reviewed, and adapted recommendations form the evidence base. Eight systematic reviews, along with cost-effectiveness analyses, provided indirect evidence to inform the consensus process, which resulted in agreement of 75% or greater. Recommendations Clinicians and planners should strive to provide access to the most effective evidence-based antitumor and palliative care interventions. If a woman cannot access these within her own or neighboring country or region, she may need to be treated with lower-tier modalities, depending on capacity and resources for surgery, chemotherapy, radiation therapy, and supportive and palliative care. For women with early-stage cervical cancer in basic settings, cone biopsy or extrafascial hysterectomy may be performed. Fertility-sparing procedures or modified radical or radical hysterectomy may be additional options in nonbasic settings. Combinations of surgery, chemotherapy, and radiation therapy (including brachytherapy) should be used for women with stage IB to IVA disease, depending on available resources. Pain control is a vital component of palliative care. Additional information is available at www.asco.org/rs-cervical-cancer-treatment-guideline and www.asco.org/guidelineswiki. It is the view of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines. PMID:28717717

Paediatric type 1 diabetes in Ireland--results of the first national audit.

PubMed

Hawkes, C P; Murphy, N P

2014-04-01

The aim of this study was to describe the services provided for children with type 1 diabetes in the Republic of Ireland, and to identify a baseline from which services and outcomes might be improved. Lead clinicians in 17 of the 19 centres providing paediatric type 1 diabetes care responded to requests for information from 2012 regarding demographics, patient numbers, diagnostics, outpatient management, multidisciplinary team resources, comorbidity screening, transition policy, clinical guidelines, and use of insulin pumps. The total number of patients attending these centres was 2518. Eight centres initiate insulin pump therapy. Insulin pump usage ranged from 0 to 42% of patients attending each centre. Self reported clinic mean haemoglobin A1c ranged from 8.2 to 9.4% (66.1 to 79.2 mmol/mol). Variation existed in guideline availability, frequency of clinic appointments, age of transition and insulin types used. We recommend a national approach to standardising and improving care for these patients.

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

PubMed

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

2010-08-03

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

Pitfalls With the New American College of Obstetricians and Gynecologists Task Force on Hypertension in Pregnancy.

PubMed

Pauli, Jaimey M; Repke, John T

2017-03-01

The American College of Obstetricians and Gynecologists Task Force on Hypertension in Pregnancy was created to evaluate the existing literature, develop practice guidelines, and identify areas for future research focus. Several issues were identified that may not have been initially obvious during the process of developing this document, including limited practical use, a lack of high quality literature, conflicting recommendations, a potential for high resource utilization, need for continually updated information, and little headway in research that is clinically useful. The purpose of this review was to make suggestions to improving these guidelines' overall usefulness and consistency for the busy clinician.

Chronic Obstructive Pulmonary Disease: official diagnosis and treatment guidelines of the Czech Pneumological and Phthisiological Society; a novel phenotypic approach to COPD with patient-oriented care.

PubMed

Koblizek, Vladimir; Chlumsky, Jan; Zindr, Vladimir; Neumannova, Katerina; Zatloukal, Jakub; Zak, Jaroslav; Sedlak, Vratislav; Kocianova, Jana; Zatloukal, Jaromir; Hejduk, Karel; Pracharova, Sarka

2013-06-01

COPD is a global concern. Currently, several sets of guidelines, statements and strategies to managing COPD exist around the world. The Czech Pneumological and Phthisiological Society (CPPS) has commissioned an Expert group to draft recommended guidelines for the management of stable COPD. Subsequent revisions were further discussed at the National Consensus Conference (NCC). Reviewers' comments contributed to the establishment of the document's final version. The hallmark of the novel approach to COPD is the integrated evaluation of the patient's lung functions, symptoms, exacerbations and identifications of clinical phenotype(s). The CPPS defines 6 clinically relevant phenotypes: frequent exacerbator, COPD-asthma overlap, COPD-bronchiectasis overlap, emphysematic phenotype, bronchitic phenotype and pulmonary cachexia phenotype. Treatment recommendations can be divided into four steps. 1(st) step = Risk exposure elimination: reduction of smoking and environmental tobacco smoke (ETS), decrease of home and occupational exposure risks. 2(nd) step = Standard treatment: inhaled bronchodilators, regular physical activity, pulmonary rehabilitation, education, inhalation training, comorbidity treatment, vaccination. 3(rd) step = Phenotype-specific therapy: PDE4i, ICS+LABA, LVRS, BVR, AAT augmentation, physiotherapy, mucolytic, ABT. 4(th) step = Care for respiratory insufficiency and terminal COPD: LTOT, lung transplantation, high intensity-NIV and palliative care. Optimal treatment of COPD patients requires an individualised, multidisciplinary approach to the patient's symptoms, clinical phenotypes, needs and wishes. The new Czech COPD guideline reflects and covers these requirements.

Knowledge translation for nephrologists: strategies for improving the identification of patients with proteinuria.

PubMed

Hemmelgarn, Brenda R; Manns, Braden J; Straus, Sharon; Naugler, Christopher; Holroyd-Leduc, Jayna; Braun, Ted C; Levin, Adeera; Klarenbach, Scott; Lee, Patrick F; Hafez, Kevin; Schwartz, Daniel; Jindal, Kailash; Ervin, Kathy; Bello, Aminu; Turin, Tanvir Chowdhury; McBrien, Kerry; Elliott, Meghan; Tonelli, Marcello

2012-01-01

For health scientists, knowledge translation refers to the process of facilitating uptake of knowledge into clinical practice or decision making. Since high-quality clinical research that is not applied cannot improve outcomes, knowledge translation is critical for realizing the value and potential for all types of health research. Knowledge translation is particularly relevant for areas within health care where gaps in care are known to exist, which is the case for some areas of management for people with chronic kidney disease (CKD), including assessment of proteinuria. Given that proteinuria is a key marker of cardiovascular and renal risk, forthcoming international practice guidelines will recommend including proteinuria within staging systems for CKD. While this revised staging system will facilitate identification of patients at higher risk for progression of CKD and mortality who benefit from intervention, strategies to ensure its appropriate uptake will be particularly important. This article describes key elements of effective knowledge translation strategies based on the knowledge-to-action cycle framework and describes options for effective knowledge translation interventions related to the new CKD guidelines, focusing on recommendations related to assessment for proteinuria specifically. The article also presents findings from a multidisciplinary meeting aimed at developing knowledge translation intervention strategies, with input from key stakeholders (researchers, knowledge users, decision makers and collaborators), to facilitate implementation of this guideline. These considerations are relevant for dissemination and implementation of guidelines on other topics and in other clinical settings.

Inflammatory bowel disease biopsies: updated British Society of Gastroenterology reporting guidelines.

PubMed

Feakins, Roger M

2013-12-01

Accurate histopathological assessment of biopsies is important for the diagnosis, subclassification, and management of chronic idiopathic inflammatory bowel disease (IBD). British Society of Gastroenterology (BSG) guidelines for the initial histopathological diagnosis of IBD were published in 1997. Changes since then include: more widespread use of full colonoscopy; greater recognition of the effects of time and treatment; improved documentation of variations in anatomical distribution; better understanding of the mimics of IBD; significant progress in clinical management; and modifications of terminology. Accordingly, an update is required. These revised guidelines aim to optimise the quality and consistency of reporting of biopsies taken for the initial diagnosis of IBD by summarising the literature and making recommendations based on the available evidence. Advice from existing clinical guidelines is also taken into account. Among the subjects discussed are: distinguishing IBD from other colitides, particularly infective colitis; subclassification of IBD (as ulcerative colitis, Crohn's disease, or IBD unclassified); the discriminant value of granulomas; aspects of disease distribution, including discontinuity in ulcerative colitis; time-related changes; differences between paediatric and adult IBD; the role of ileal and upper gastrointestinal biopsies; differential diagnoses such as diverticular colitis and diversion proctocolitis; and dysplasia. The need to correlate the histological features with clinical and endoscopic findings is emphasised. An approach to the conclusion of an IBD biopsy report based on the acronym Pattern, Activity, Interpretation, Dysplasia (PAID) is suggested. The key recommendations are listed at the end of the document.

Advancing Early Detection of Autism Spectrum Disorder by Applying an Integrated Two-Stage Screening Approach

ERIC Educational Resources Information Center

Oosterling, Iris J.; Wensing, Michel; Swinkels, Sophie H.; van der Gaag, Rutger Jan; Visser, Janne C.; Woudenberg, Tim; Minderaa, Ruud; Steenhuis, Mark-Peter; Buitelaar, Jan K.

2010-01-01

Background: Few field trials exist on the impact of implementing guidelines for the early detection of autism spectrum disorders (ASD). The aims of the present study were to develop and evaluate a clinically relevant integrated early detection programme based on the two-stage screening approach of Filipek et al. (1999), and to expand the evidence…

[Disinfecting contact tonometers - a systematic review].

PubMed

Neubauer, A S; Heeg, P; Kampik, A; Hirneiss, C

2009-05-01

The aim of this study is to provide the best available evidence on how to disinfect contact Goldman tonometers. A systematic review of all articles on disinfection of contact tonometers was conducted. Articles published up to July 2008 were identified in Medline, Embase and references from included articles. Two observers participated in the data retrieval and assessment of the studies identified. A total of 89 articles was retrieved, of which 58 could be included. Of those, 18 were clinical studies, 17 experimental microbiological studies, 8 expert assessments or guidelines and 15 reviews, surveys, descriptions of new methods. The clinical studies illustrate the importance of the problem, possible side effects of some disinfection methods but yield inconclusive results regarding efficacy. Experimental studies investigated a variety of bacterial and virological questions as well as material damage by disinfection. Both chlorine-based and hydrogen peroxide-based liquid disinfection were shown to be effective if applied for 5 min. Inconsistent results exist for alcohol wipes and UV disinfection - material damage has been described for both. The US guidelines and most expert recommendations are supported by evidence of the existing data. Chlorine-based and hydrogen peroxide-based liquid disinfections for 5 minutes are effective and relatively safe for disinfecting contact tonometers.

Guideline on cochlear implants.

PubMed

Manrique, Manuel; Ramos, Ángel; de Paula Vernetta, Carlos; Gil-Carcedo, Elisa; Lassaleta, Luis; Sanchez-Cuadrado, Isabel; Espinosa, Juan Manuel; Batuecas, Ángel; Cenjor, Carlos; Lavilla, María José; Núñez, Faustino; Cavalle, Laura; Huarte, Alicia

2018-03-26

In the last decade numerous hospitals have started to work with patients who are candidates for a cochlear implant (CI) and there have been numerous and relevant advances in the treatment of sensorineural hearing loss that extended the indications for cochlear implants. To provide a guideline on cochlear implants to specialists in otorhinolaryngology, other medical specialities, health authorities and society in general. The Scientific Committees of Otology, Otoneurology and Audiology from the Spanish Society of Otolaryngology and Head and Neck Surgery (SEORL-CCC), in a coordinated and agreed way, performed a review of the current state of CI based on the existing regulations and in the scientific publications referenced in the bibliography of the document drafted. The clinical guideline on cochlear implants provides information on: a) Definition and description of Cochlear Implant; b) Indications for cochlear implants; c) Organizational requirements for a cochlear implant programme. A clinical guideline on cochlear implants has been developed by a Committee of Experts of the SEORL-CCC, to help and guide all the health professionals involved in this field of CI in decision-making to treathearing impairment. Copyright © 2018 Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. Publicado por Elsevier España, S.L.U. All rights reserved.

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/

Emergency treatment of a snake bite: Pearls from literature

PubMed Central

Ahmed, Syed Moied; Ahmed, Mohib; Nadeem, Abu; Mahajan, Jyotsna; Choudhary, Adarash; Pal, Jyotishka

2008-01-01

Snake bite is a well-known occupational hazard amongst farmers, plantation workers, and other outdoor workers and results in much morbidity and mortality throughout the world. This occupational hazard is no more an issue restricted to a particular part of the world; it has become a global issue. Accurate statistics of the incidence of snakebite and its morbidity and mortality throughout the world does not exist; however, it is certain to be higher than what is reported. This is because even today most of the victims initially approach traditional healers for treatment and many are not even registered in the hospital. Hence, registering such patients is an important goal if we are to have accurate statistics and reduce the morbidity and mortality due to snakebite. World Health Organization/South East Asian Region Organisation (WHO/SEARO) has published guidelines, specific for the South East Asian region, for the clinical management of snakebites. The same guidelines may be applied for managing snakebite patients in other parts of the world also, since no other professional body has come up with any other evidence-based guidelines. In this article we highlight the incidence and clinical features of different types of snakebite and the management guidelines as per the WHO/SEARO recommendation. PMID:19561988

Implementing evidence-based practices in an emergency department: contradictions exposed when prioritising a flow culture.

PubMed

Kirk, Jeanette W; Nilsen, Per

2016-02-01

An emergency department is typically a place of high activity where practitioners care for unanticipated presentations, which yields a flow culture so that actions that secure available beds are prioritised by the practitioners. How does the flow culture in an emergency department influence nurses' use of a research-based clinical guideline and a nutrition screening routine. Ethnographic fieldwork was carried out over three months. The first author followed nurses, medical secretaries and doctors in the emergency department. Data were also collected by means of semi-structured interviews. An activity system analysis, as described in the Cultural Historical Activity Theory, was conducted to identify various contradictions that could exist between different parts of the activity system. The main contradiction identified was that guidelines and screening routines provided a flow stop. Four associated contradictions were identified: insufficient time to implement guidelines; guilty conscience due to perceived nonadherence to evidence-based practices; newcomers having different priorities; and conflicting views of what constituted being a professional. We found that research-supported guidelines and screening routines were not used if they were perceived to stop the patient flow, suggesting that the practice was not fully evidence based. © 2016 The Authors. Journal of Clinical Nursing Published by John Wiley & Sons Ltd.

Management of juvenile idiopathic arthritis: hitting the target.

PubMed

Hinze, Claas; Gohar, Faekah; Foell, Dirk

2015-05-01

The treatment of juvenile idiopathic arthritis (JIA) is evolving. The growing number of effective drugs has led to successful treatment and prevention of long-term sequelae in most patients. Although patients with JIA frequently achieve lasting clinical remission, sustained remission off medication is still elusive for most. Treatment approaches vary substantially among paediatric rheumatologists owing to the inherent heterogeneity of JIA and, until recently, to the lack of accepted and well-evidenced guidelines. Furthermore, many pertinent questions related to patient management remain unanswered, in particular regarding treatment targets, and selection, intensity and sequence of initiation or withdrawal of therapy. Existing JIA guidelines and recommendations do not specify treat-to-target or tight control strategies, in contrast to adult rheumatology in which these approaches have been successful. The concepts of window of opportunity (early treatment to improve long-term outcomes) and immunological remission (abrogation of subclinical disease activity) are also fundamental when defining treatment methodologies. This Review explores the application of these concepts to JIA and their possible contribution to the development of future clinical guidelines or consensus treatment protocols. The article also discusses how diverse forms of standardized, guideline-led care and personalized treatment can be combined into a targeted, patient-centred approach to optimize management strategies for patients with JIA.

Recommendations for Premature Ovarian Insufficiency Surveillance for Female Survivors of Childhood, Adolescent, and Young Adult Cancer: A Report From the International Late Effects of Childhood Cancer Guideline Harmonization Group in Collaboration With the PanCareSurFup Consortium.

PubMed

van Dorp, Wendy; Mulder, Renée L; Kremer, Leontien C M; Hudson, Melissa M; van den Heuvel-Eibrink, Marry M; van den Berg, Marleen H; Levine, Jennifer M; van Dulmen-den Broeder, Eline; di Iorgi, Natascia; Albanese, Assunta; Armenian, Saro H; Bhatia, Smita; Constine, Louis S; Corrias, Andreas; Deans, Rebecca; Dirksen, Uta; Gracia, Clarisa R; Hjorth, Lars; Kroon, Leah; Lambalk, Cornelis B; Landier, Wendy; Levitt, Gill; Leiper, Alison; Meacham, Lillian; Mussa, Alesandro; Neggers, Sebastian J; Oeffinger, Kevin C; Revelli, Alberto; van Santen, Hanneke M; Skinner, Roderick; Toogood, Andrew; Wallace, William H; Haupt, Riccardo

2016-10-01

Female survivors of childhood, adolescent, and young adult (CAYA) cancer who were treated with alkylating agents and/or radiation, with potential exposure of the ovaries, have an increased risk of premature ovarian insufficiency (POI). Clinical practice guidelines can facilitate these survivors' access to optimal treatment of late effects that may improve health and quality of survival; however, surveillance recommendations vary among the existing long-term follow-up guidelines, which impedes the implementation of screening. The present guideline was developed by using an evidence-based approach and summarizes harmonized POI surveillance recommendations for female survivors of CAYA cancer who were diagnosed at age < 25 years. The recommendations were formulated by an international multidisciplinary panel and graded according to the strength of the evidence and the potential benefit gained from early detection and intervention. The harmonized POI surveillance recommendations were developed by using a transparent process and are intended to facilitate care for survivors of CAYA cancer. The harmonized set of POI surveillance recommendations is intended to be scientifically rigorous, to positively influence health outcomes, and to facilitate the care for female survivors of CAYA cancer. © 2016 by American Society of Clinical Oncology.

Attempted salvage of infected cardiovascular implantable electronic devices: Are there clinical factors that predict success?

PubMed

Peacock, James E; Stafford, Jeanette M; Le, Katherine; Sohail, Muhammad Rizwan; Baddour, Larry M; Prutkin, Jordan M; Danik, Stephan B; Vikram, Holenarasipur R; Hernandez-Meneses, Marta; Miró, José M; Blank, Elisabeth; Naber, Christoph K; Carrillo, Roger G; Greenspon, Arnold J; Tseng, Chi-Hong; Uslan, Daniel Z

2018-03-08

Published guidelines mandate complete device removal in cases of cardiovascular implantable electronic device (CIED) infection. Clinical predictors of successful salvage of infected CIEDs have not been defined. Data from the Multicenter Electrophysiologic Device Infection Collaboration, a prospective, observational, multinational cohort study of CIED infection, were used to investigate whether clinical predictors of successful salvage of infected devices could be identified. Of 433 adult patients with CIED infections, 306 (71%) underwent immediate device explantation. Medical management with device retention and antimicrobial therapy was initially attempted in 127 patients (29%). "Early failure" of attempted salvage occurred in 74 patients (58%) who subsequently underwent device explantation during the index hospitalization. The remaining 53 patients (42%) in the attempted salvage group retained their CIED. Twenty-six (49%) had resolution of CIED infection (successful salvage group) whereas 27 patients (51%) experienced "late" salvage failure. Upon comparing the salvage failure group, early and late (N = 101), to the group experiencing successful salvage of an infected CIED (N = 26), no clinical or laboratory predictors of successful salvage were identified. However, by univariate analysis, coagulase-negative staphylococci as infecting pathogens (P = 0.0439) and the presence of a lead vegetation (P = 0.024) were associated with overall failed salvage. In patients with definite CIED infections, clinical and laboratory variables cannot predict successful device salvage. Until new data are forthcoming, device explantation should remain a mandatory and early management intervention in patients with CIED infection in keeping with existing expert guidelines unless medical contraindications exist or patients refuse device removal. © 2018 Wiley Periodicals, Inc.

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

PubMed

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

2014-01-01

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

2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary

PubMed Central

Gerhard-Herman, Marie D.; Gornik, Heather L.; Barrett, Coletta; Barshes, Neal R.; Corriere, Matthew A.; Drachman, Douglas E.; Fleisher, Lee A.; Fowkes, Francis Gerry R.; Hamburg, Naomi M.; Kinlay, Scott; Lookstein, Robert; Misra, Sanjay; Mureebe, Leila; Olin, Jeffrey W.; Patel, Rajan A.G.; Regensteiner, Judith G.; Schanzer, Andres; Shishehbor, Mehdi H.; Stewart, Kerry J.; Treat-Jacobson, Diane; Walsh, M. Eileen; Halperin, Jonathan L.

2017-01-01

Preamble Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines with recommendations to improve cardiovascular health. These guidelines, based on systematic methods to evaluate and classify evidence, provide a cornerstone of quality cardiovascular care. In response to reports from the Institute of Medicine1,2 and a mandate to evaluate new knowledge and maintain relevance at the point of care, the ACC/AHA Task Force on Clinical Practice Guidelines (Task Force) modified its methodology.3–5 The relationships among guidelines, data standards, appropriate use criteria, and performance measures are addressed elsewhere.5 Intended Use Practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organizations may have a broader target. Although guidelines may be used to inform regulatory or payer decisions, the intent is to improve quality of care and align with patients' interests. Guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances, and should not replace clinical judgment. Guidelines are reviewed annually by the Task Force and are official policy of the ACC and AHA. Each guideline is considered current until it is updated, revised, or superseded by published addenda, statements of clarification, focused updates, or revised full-text guidelines. To ensure that guidelines remain current, new data are reviewed biannually to determine whether recommendations should be modified. In general, full revisions are posted in 5-year cycles.3–6 Modernization Processes have evolved to support the evolution of guidelines as “living documents” that can be dynamically updated. This process delineates a recommendation to address a specific clinical question, followed by concise text (ideally <250 words) and hyperlinked to supportive evidence. This approach accommodates time constraints on busy clinicians and facilitates easier access to recommendations via electronic search engines and other evolving technology. Evidence Review Writing committee members review the literature; weigh the quality of evidence for or against particular tests, treatments, or procedures; and estimate expected health outcomes. In developing recommendations, the writing committee uses evidence-based methodologies that are based on all available data.3–7 Literature searches focus on randomized controlled trials (RCTs) but also include registries, nonrandomized comparative and descriptive studies, case series, cohort studies, systematic reviews, and expert opinion. Only selected references are cited. The Task Force recognizes the need for objective, independent Evidence Review Committees (ERCs) that include methodologists, epidemiologists, clinicians, and biostatisticians who systematically survey, abstract, and assess the evidence to address systematic review questions posed in the PICOTS format (P=population, I=intervention, C=comparator, O=outcome, T=timing, S=setting).2,4–6 Practical considerations, including time and resource constraints, limit the ERCs to evidence that is relevant to key clinical questions and lends itself to systematic review and analysis that could affect the strength of corresponding recommendations. Guideline-Directed Management and Treatment The term “guideline-directed management and therapy” (GDMT) refers to care defined mainly by ACC/AHA Class I recommendations. For these and all recommended drug treatment regimens, the reader should confirm dosage with product insert material and carefully evaluate for contraindications and interactions. Recommendations are limited to treatments, drugs, and devices approved for clinical use in the United States. Class of Recommendation and Level of Evidence The Class of Recommendation (COR; ie, the strength of the recommendation) encompasses the anticipated magnitude and certainty of benefit in proportion to risk. The Level of Evidence (LOE) rates evidence supporting the effect of the intervention on the basis of the type, quality, quantity, and consistency of data from clinical trials and other reports (Table 1).3–5 Unless otherwise stated, recommendations are sequenced by COR and then by LOE. Where comparative data exist, preferred strategies take precedence. When >1 drug, strategy, or therapy exists within the same COR and LOE and no comparative data are available, options are listed alphabetically. Relationships With Industry and Other Entities The ACC and AHA sponsor the guidelines without commercial support, and members volunteer their time. The Task Force zealously avoids actual, potential, or perceived conflicts of interest that might arise through relationships with industry or other entities (RWI). All writing committee members and reviewers are required to disclose current industry relationships or personal interests, from 12 months before initiation of the writing effort. Management of RWI involves selecting a balanced writing committee and assuring that the chair and a majority of committee members have no relevant RWI (Appendix 1). Members are restricted with regard to writing or voting on sections to which their RWI apply. For transparency, members' comprehensive disclosure information is available online. Comprehensive disclosure information for the Task Force is also available online. The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic regions, sexes, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators. Individualizing Care in Patients With Associated Conditions and Comorbidities Managing patients with multiple conditions can be complex, especially when recommendations applicable to coexisting illnesses are discordant or interacting.8 The guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances. The recommendations should not replace clinical judgment. Clinical Implementation Management in accordance with guideline recommendations is effective only when followed. Adherence to recommendations can be enhanced by shared decision making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated conditions and comorbidities. Consequently, circumstances may arise in which deviations from these guidelines are appropriate. The reader is encouraged to consult the full-text guideline9 for additional guidance and details with regard to lower extremity peripheral artery disease (PAD) because the executive summary contains limited information. PMID:27840332

Comorbidities and Chronic Obstructive Pulmonary Disease: Prevalence, Influence on Outcomes, and Management

PubMed Central

Putcha, Nirupama; Drummond, M. Bradley; Wise, Robert A.; Hansel, Nadia N.

2016-01-01

Comorbidities impact a large proportion of patients with chronic obstructive pulmonary disease (COPD), with over 80% of patients with COPD estimated to have at least one comorbid chronic condition. Guidelines for the treatment of COPD are just now incorporating comorbidities to their management recommendations of COPD, and it is becoming increasingly clear that multimorbidity as well as specific comorbidities have strong associations with mortality and clinical outcomes in COPD, including dyspnea, exercise capacity, quality of life, healthcare utilization, and exacerbation risk. Appropriately, there has been an increased focus upon describing the burden of comorbidity in the COPD population and incorporating this information into existing efforts to better understand the clinical and phenotypic heterogeneity of this group. In this article, we summarize existing knowledge about comorbidity burden and specific comorbidities in COPD, focusing on prevalence estimates, association with outcomes, and existing knowledge about treatment strategies. PMID:26238643

Barriers and facilitators to development of standard treatment guidelines in India.

PubMed

Sharma, Sangeeta; Sethi, Gulshan R; Gupta, Usha; Chaudhury, Ranjit Roy

2015-01-01

This paper describes 15 years' experience of the development process of the first set of comprehensive standard treatment guidelines (STGs) for India and their adoption or adaptation by various state governments. The aim is to shorten the learning curve for those embarking on a similar exercise, given the key role of high-quality STGs that are accepted by the clinical community in furthering universal health coverage. The main overall obstacles to STG development are: (i) weak understanding of the concept; (ii) lack of time, enthusiasm and availability of local expertise; and (iii) managing consensus between specialists and generalists. Major concerns to prescribers are: encroachment on professional autonomy, loss of treating the patient as an individual and applying the same standards at all levels of health care. Processes to address these challenges are described. At the policy level, major threats to successful completion and focused implementation are: frequent changes in governance, shifts in priorities and discontinuity. In the authors' experience, compared with each state developing their own STGs afresh, adaptation of pre-existing valid guidelines after an active adaptation process involving local clinical leaders is not only simpler and quicker but also establishes local ownership and facilitates acceptance of a quality document. Executive orders and in-service sensitization programmes to introduce STGs further enhance their adoption in clinical practice.

How Many Orthopaedic Surgeons Does It Take to Write a Manuscript? A Vignette-Based Discussion of Authorship in Orthopaedic Surgery.

PubMed

Agel, Julie; DeCoster, Thomas A; Swiontkowski, Marc F; Roberts, Craig S

2016-11-02

The issue of appropriate authorship designation continues to be a topic of importance because authorship of scholarly work plays an important role in the academic community. It is a recognition of an individual's scholarly work and a factor in academic promotion. The Orthopaedic Trauma Association (OTA) sponsored a minisymposium in 2014 to encourage discussion of the issues that arise in authorship decisions. A residency program director/department chair, a journal editor, a clinical trials coordinator, and a promotions committee member provided viewpoints. In the pages that follow, vignettes are presented along with discussion points to encourage conversation on this topic. Authorship criteria are clearly defined. Authorship based simply on seniority or contribution of cases to clinical trials is inappropriate. Discussion of authorship criteria prior to the initiation of clinical research investigations is a standard that must be met. The International Committee of Medical Journal Editors (ICMJE) guidelines provide a framework for this discussion and should be reviewed by all authors prior to publication. Modifications to published authorship guidelines may be necessary to address some of the scenarios identified here that are not adequately addressed by the existing guidelines. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

Guidelines for the diagnosis and management of migraine in clinical practice

PubMed Central

Pryse-Phillips, W E; Dodick, D W; Edmeads, J G; Gawel, M J; Nelson, R F; Purdy, R A; Robinson, G; Stirling, D; Worthington, I

1997-01-01

OBJECTIVE: To provide physicians and allied health care professionals with guidelines for the diagnosis and management of migraine in clinical practice. OPTIONS: The full range and quality of diagnostic and therapeutic methods available for the management of migraine. OUTCOMES: Improvement in the diagnosis and treatment of migraine, which will lead to a reduction in suffering, increased productivity and decreased economic burden. EVIDENCE AND VALUES: The creation of the guidelines followed a needs assessment by members of the Canadian Headache Society and included a statement of objectives; development of guidelines by multidisciplinary working groups using information from literature reviews and other resources; comparison of alternative clinical pathways and description of how published data were analysed; definition of the level of evidence for data in each case; evaluation and revision of the guidelines at a consensus conference held in Ottawa on Oct. 27-29, 1995; redrafting and insertion of tables showing key variables and data from various studies and tables of data with recommendations; and reassessment by all conference participants. BENEFITS, HARMS AND COSTS: Accuracy in diagnosis is a major factor in improving therapeutic effectiveness. Improvement in the precise diagnosis of migraine, coupled with a rational plan for the treatment of acute attacks and for prophylactic therapy, is likely to lead to substantial benefits in both human and economic terms. RECOMMENDATIONS: The diagnosis of migraine can be improved by using modified criteria of the International Headache Society as well as a semistructured patient interview technique. Appropriate treatment of symptoms should take into account the severity of the migraine attack, since most patients will have attacks of differing severity and can learn to use medication appropriate for each attack. When headaches are frequent or particularly severe, prophylactic therapy should be considered. Both the avoidance of migraine trigger factors and the application of nonpharmacological therapies play important roles in overall migraine management and will be addressed at a later date. VALIDATION: The guidelines are based on consensus of Canadian experts in neurology, emergency medicine, psychiatry, psychology, family medicine and pharmacology, and consumers. Previous guidelines did not exist. Field testing of the guidelines is in progress. PMID:9145054

Improvement of Physical Therapist Assessment of Risk of Falls in the Hospital and Discharge Handover Through an Intervention to Modify Clinical Behavior.

PubMed

Thomas, Susie; Mackintosh, Shylie

2016-06-01

Discharge from the hospital is a high risk transition period for older adults at risk of falls. Guidelines relevant to physical therapists for managing this risk are well documented, but commonly not implemented. This project implemented an intervention to improve physical therapists' adherence to key guideline recommendations for managing risk of falls on discharge from one hospital. A pretest-posttest study design was undertaken and was underpinned by the Theoretical Domains Framework (TDF) to aid in the design of interventions to increase physical therapists' adherence to guideline recommendations and to identify barriers to these interventions. A multifaceted intervention was implemented, including the establishment of a governance committee, education sessions, development of a "pathway" to guide practice, modification of an existing standardized assessment proforma, development of standardized processes and indicators for handover, increasing availability of educational handouts, audit and feedback processes, and allocation of dedicated staffing to oversee falls prevention within the physical therapy department. There were significant improvements in physical therapist behavior leading to key guideline recommendations being met, including: the proportion of patients who were identified to be at risk of falls (6.3% preintervention versus 94.8% postintervention) prior to discharge, an increase in documentation of clinical handover at discharge (68.6% preintervention versus 90.9% postintervention), and improvement in the quality of this documented clinical handover (34.9% of case notes met 5 criteria preintervention versus 92.9% postintervention). The approach was resource intensive and consequently may be difficult to replicate at other sites. A multifaceted intervention underpinned by the TDF, designed to modify physical therapists' behavior to improve adherence to guideline recommendations for managing risk of falls on discharge from one hospital, was successful. © 2016 American Physical Therapy Association.

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

PubMed

Wood, Sylvia K; Payne, Judith K

2012-06-01

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

Clinical guidelines: proliferation and medicolegal significance.

PubMed Central

Hurwitz, B

1994-01-01

Guidelines seeking to influence and regulate clinical activity are currently gaining a new cultural ascendancy on both sides of the Atlantic. Statutory agencies may be charged with developing clinical guidelines, and civil courts, in deciding actions in negligence, could be influenced by standards of care expressed in guideline statements. Clinical guidelines are not accorded unchallengeable status: they have been subject to careful scrutiny by British and American courts to establish their authenticity and relevance. In the United States, compliance with clinical guidelines cannot be used as a defence against liability if a physician's conduct is held to have been negligent, and third party organisations can be held liable if their clinical guidelines are found to be a contributory cause of patient harm. Guidelines have not usurped the role of the expert witness in court. The importance the law attaches to customary practice means that atypical or bizarre guidelines are unlikely to be accepted as embodying a legally required standard of clinical care. PMID:10136259

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

PubMed

Beckwith, Bruce; Schwartz, Robert; Pantanowitz, Liron

2004-04-01

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

RESIDENT IMPLEMENTATION OF THE 2007 ACC/AHA GUIDELINES ON PREOPERATIVE CARDIAC EVALUATION IN NON-CARDIAC SURGERY PATIENTS: IS CLINICAL EXPERIENCE ENOUGH?

PubMed

Amhaz, Hassan H; Kuo, Ruth; Chidiac, Elie J; Pallekonda, Vinay; Fuleihan, Samir F; McKelvey, George; Kaddoum, Romeo N

2015-06-01

Preoperative evaluation of surgical patients is important, as perioperative complications are associated with increased mortality. Specialties including anesthesiology, internal medicine, cardiology, and surgery are involved in the evaluation and management of these patients. This institutional study investigated the residents' knowledge of the 2007 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on perioperative evaluation of patients undergoing non-cardiac surgery. This pilot study used a web-based survey questionnaire to assess resident's knowledge of the 2007 ACC/AHA guidelines through individual steps and corresponding branch point(s) in twelve clinical scenarios. Additionally, residents were asked if they were aware of, or if they had received lectures on ACC/AHA guidelines. Staff anesthesiologists with training in cardiac and intensive care medicine validated the scenarios. A total of 104 resident participants were surveyed including 35 anesthesiology residents, 41 internal medicine residents, 20 surgery residents, and 8 cardiology fellows. Awareness of the 2007 ACC/AHA guidelines by specialty was: anesthesiology (85%), internal medicine (97.6%), cardiology (100%), and surgery (70%). Only 54.3% of anesthesiology, 31.7% of internal medicine, 100% of cardiology, and 10% of surgery residents stated they received lectures. The overall mean score achieved on the eleven scenarios was 50.4% for anesthesiology, 47.0% for internal medicine, 55.7% for cardiology, and 42.3% for surgery. Although the majority of residents were aware of the 2007 ACC/AHA guidelines, fewer received lectures and regardless of specialty, implementation of these guidelines was poor. There exists significant room for improvement in the understanding of preoperative assessment of non-cardiac surgery patients.

Australasian Gastrointestinal Trials Group (AGITG) Contouring Atlas and Planning Guidelines for Intensity-Modulated Radiotherapy in Anal Cancer

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

Ng, Michael, E-mail: mng@radoncvic.com.au; Leong, Trevor; University of Melbourne

2012-08-01

Purpose: To develop a high-resolution target volume atlas with intensity-modulated radiotherapy (IMRT) planning guidelines for the conformal treatment of anal cancer. Methods and Materials: A draft contouring atlas and planning guidelines for anal cancer IMRT were prepared at the Australasian Gastrointestinal Trials Group (AGITG) annual meeting in September 2010. An expert panel of radiation oncologists contoured an anal cancer case to generate discussion on recommendations regarding target definition for gross disease, elective nodal volumes, and organs at risk (OARs). Clinical target volume (CTV) and planning target volume (PTV) margins, dose fractionation, and other IMRT-specific issues were also addressed. A steeringmore » committee produced the final consensus guidelines. Results: Detailed contouring and planning guidelines and a high-resolution atlas are provided. Gross tumor and elective target volumes are described and pictorially depicted. All elective regions should be routinely contoured for all disease stages, with the possible exception of the inguinal and high pelvic nodes for select, early-stage T1N0. A 20-mm CTV margin for the primary, 10- to 20-mm CTV margin for involved nodes and a 7-mm CTV margin for the elective pelvic nodal groups are recommended, while respecting anatomical boundaries. A 5- to 10-mm PTV margin is suggested. When using a simultaneous integrated boost technique, a dose of 54 Gy in 30 fractions to gross disease and 45 Gy to elective nodes with chemotherapy is appropriate. Guidelines are provided for OAR delineation. Conclusion: These consensus planning guidelines and high-resolution atlas complement the existing Radiation Therapy Oncology Group (RTOG) elective nodal ano-rectal atlas and provide additional anatomic, clinical, and technical instructions to guide radiation oncologists in the planning and delivery of IMRT for anal cancer.« less

National guidelines for evaluating pain-Patients' legal right to prioritised health care at multidisciplinary pain clinics in Norway implemented 2009.

PubMed

Hara, Karen Walseth; Borchgrevink, Petter

2017-12-29

Background All nations are posed with the challenge of deciding how to allocate limited health care resources. A Patients' Rights Law from 1999 gives patients in Norway with a serious health condition, for which there is efficacious and cost-effective treatment, a legal right to receive health care from the National Health Care system. Methods Recently national guidelines have been produced for implementing these legal rights within 32 fields of specialist health care. One of these fields deals with serious chronic pain conditions. A task force established by the Directorate of Health, comprising pain specialists, primary care and patient representatives, have produced guidelines for pain conditions. The newly published guidelines seek to answer the difficult questions of which patients should be prioritised at pain clinics and what is a medically acceptable waiting time. Results The guidelines deal with non-acute pain conditions that are too complex for primary care and organ- or disease-specific fields of specialist care. The guidelines state that if health-related quality of life is severely affected by the pain condition and efficacious and cost-effective treatment is available, then patients have a legal right to receive prioritised specialist health care in multidisciplinary pain clinics. The guidelines describe 5 categories of complex pain disorders that as a main rule should be given the right to prioritised health care in pain clinics. The 5 categories are Category 1 Sub-acute (≤6 months) pain conditions with reason to fear chronification. Maximum waiting time 2 weeks, e.g., progressing complex regional pain syndrome (CRPS) 5 months after an ankle-fracture. Category 2 Chronic complex pain condition, with or without known initiating cause, combined with substance abuse and/or psychiatric illness. These patients need concomitant follow-up by psychiatric and/or addiction medicine department(s) and a multidisciplinary pain clinic approach. Maximum waiting time 16 weeks, e.g., CRPS of an arm combined with depression and addiction to heroin. Category 3 Chronic complex pain condition WITH known initiating cause (that can no longer be treated with a curative approach). Maximum waiting time 16 weeks, e.g., Post-herpetic neuralgia. Category 4 Chronic complex pain condition WITHOUT known initiating cause. Maximum waiting time 16 weeks, e.g., chronic muscle pain syndrome. Category 5 Severe and difficult to treat pain condition in patients suffering from a known serious and advanced illness. Maximum waiting time 2 weeks, e.g., advanced cancer, COLD, heart failure, end stage multiple sclerosis. The maximum medically accepted waiting time is set at either 2 or 16 weeks depending on the condition. The full version of the guidelines describes pain categories in detail and gives information on cases that do not qualify to be prioritised for care in a pain clinic. Conclusions Norwegian national guidelines for prioritising among pain conditions are in the process of being implemented. Epidemiologic data and expert opinion suggest that in order to meet the chronic pain patient's legal claim to prioritised specialist health care, the national health care system in Norway will have to establish new pain clinics and increase capacity at existing pain clinics.

[SmartCare: automatizing clinical guidelines].

PubMed

Mersmann, Stefan

2009-10-01

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

Systematic review of recent dementia practice guidelines.

PubMed

Ngo, Jennifer; Holroyd-Leduc, Jayna M

2015-01-01

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

Guidelines on the management of atrial fibrillation in the emergency department: a critical appraisal.

PubMed

Costantino, Giorgio; Podda, Gian Marco; Falsetti, Lorenzo; Iannone, Primiano; Lages, Ana; Marra, Alberto M; Masala, Maristella; Reiakvam, Olaug Marie; Savva, Florentia; Schovanek, Jan; van Bree, Sjoerd; da Silva Chora, Inês João; Privitera, Graziella; Ragozzino, Silvio; von Rotz, Matthias; Woittiez, Lycke; Davidson, Christopher; Montano, Nicola

2017-08-01

Several guidelines often exist on the same topic, sometimes offering divergent recommendations. For the clinician, it can be difficult to understand the reasons for this divergence and how to select the right recommendations. The aim of this study is to compare different guidelines on the management of atrial fibrillation (AF), and provide practical and affordable advice on its management in the acute setting. A PubMed search was performed in May 2014 to identify the three most recent and cited published guidelines on AF. During the 1-week school of the European School of Internal Medicine, the attending residents were divided in five working groups. The three selected guidelines were compared with five specific questions. The guidelines identified were: the European Society of Cardiology guidelines on AF, the Canadian guidelines on emergency department management of AF, and the American Heart Association guidelines on AF. Twenty-one relevant sub-questions were identified. For five of these, there was no agreement between guidelines; for three, there was partial agreement; for three data were not available (issue not covered by one of the guidelines), while for ten, there was complete agreement. Evidence on the management of AF in the acute setting is largely based on expert opinion rather than clinical trials. While there is broad agreement on the management of the haemodynamically unstable patient and the use of drugs for rate-control strategy, there is less agreement on drug therapy for rhythm control and no agreement on several other topics.

SU-F-BRA-14: Optimization of Dosimetric Guidelines for Accelerated Partial Breast Irradiation (APBI) Using the Strut-Adjusted Volume Implant (SAVI)

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

Mooney, K; Altman, M; Garcia-Ramirez, J

Purpose: Treatment planning guidelines for accelerated partial breast irradiation (ABPI) using the strut-adjusted volume implant (SAVI) are inconsistent between the manufacturer and NSABP B-39/RTOG 0413 protocol. Furthermore neither set of guidelines accounts for different applicator sizes. The purpose of this work is to establish guidelines specific to the SAVI that are based on clinically achievable dose distributions. Methods: Sixty-two consecutive patients were implanted with a SAVI and prescribed to receive 34 Gy in 10 fractions twice daily using high dose-rate (HDR) Ir-192 brachytherapy. The target (PTV-EVAL) was defined per NSABP. The treatments were planned and evaluated using a combination ofmore » dosimetric planning goals provided by the NSABP, the manufacturer, and our prior clinical experience. Parameters evaluated included maximum doses to skin and ribs, and volumes of PTV-EVAL receiving 90%, 95%, 100%, 150%, and 200% of the prescription (V90, etc). All target parameters were evaluated for correlation with device size using the Pearson correlation coefficient. Revised dosimetric guidelines for target coverage and heterogeneity were determined from this population. Results: Revised guidelines for minimum target coverage (ideal in parentheses): V90≥95%(97%), V95≥90%(95%), V100≥88%(91%). The only dosimetric parameters that were significantly correlated (p<0.05) with device size were V150 and V200. Heterogeneity criteria were revised for the 6–1 Mini/6-1 applicators to V150≤30cc and V200≤15cc, and unchanged for the other sizes. Re-evaluation of patient plans showed 90% (56/62) met the revised minimum guidelines and 76% (47/62) met the ideal guidelines. All and 56/62 patients met our institutional guidelines for maximum skin and rib dose, respectively. Conclusions: We have optimized dosimetric guidelines for the SAVI applicators, and found that implementation of these revised guidelines for SAVI treatment planning yielded target coverage exceeding that required by existing guidelines while preserving heterogeneity constraints and minimizing dose to organs at risk.« less

Middle East Consensus Statement on the Prevention, Diagnosis, and Management of Cow's Milk Protein Allergy

PubMed Central

Abuabat, Ahmed; Al-Hammadi, Suleiman; Aly, Gamal Samy; Miqdady, Mohamad S; Shaaban, Sanaa Youssef; Torbey, Paul-Henri

2014-01-01

Presented are guidelines for the prevention, diagnosis, and treatment of cow's milk protein allergy (CMPA) which is the most common food allergy in infants. It manifests through a variety of symptoms that place a burden on both the infant and their caregivers. The guidelines were formulated by evaluation of existing evidence-based guidelines, literature evidence and expert clinical experience. The guidelines set out practical recommendations and include algorithms for the prevention and treatment of CMPA. For infants at risk of allergy, appropriate prevention diets are suggested. Breastfeeding is the best method for prevention; however, a partially hydrolyzed formula should be used in infants unable to be breastfed. In infants with suspected CMPA, guidelines are presented for the appropriate diagnostic workup and subsequent appropriate elimination diet for treatment. Exclusive breastfeeding and maternal dietary allergen avoidance are the best treatment. In infants not exclusively breastfed, an extensively hydrolyzed formula should be used with amino acid formula recommended if the symptoms are life-threatening or do not resolve after extensively hydrolyzed formula. Adherence to these guidelines should assist healthcare practitioners in optimizing their approach to the management of CMPA and decrease the burden on infants and their caregivers. PMID:25061580

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

PubMed Central

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice. PMID:28182155

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study.

PubMed

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. This is an observational study with prospective recruitment (May 2014-May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice.

[Study on blood pressure standard in children using the automatic sphygmomanometer].

PubMed

Niida, Mami; Hataya, Hiroshi; Honda, Masataka

2015-01-01

In Japan, two treatment guidelines exist for pediatric patients with hypertension. The Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases (JCS2012), by the Japanese Circulation Society, cite the stethoscopy-based American guidelines. The Guidelines for the Management of Hypertension (JSH2009), by the Japanese Society of Hypertension, focus on Japanese data obtained from automated sphygmomanometry. The frequent use of automated sphygmomanometers in clinical practice implies that the JSH2009 guidelines might be better; however with strict low reference values for the diastolic phase, overtreatment may result. Only the Japanese Circulation Society's guidelines include a therapeutic strategy, and the Chronic Kidney Disease (CKD) Guide, CKD Guidelines, and school urinary screening tests all cite these guidelines on stethoscopy-based blood pressure determination. Stethoscopy should be conducted during a medical examination; however, due to limited time in clinical practice, most physicians use automated sphygmomanometers while nevertheless relying on the Japanese Circulation Society reference values--which are stethoscopy-based. To find a compromise, we compared reference values in Japan with those from South Korea (automated sphygmomanometer-based) and those from the United States (stethoscopy-based). Moreover, we examined the results of recent accuracy tests for automated sphygmomanometers. Although the JSH2009 reference values for the systolic phase were consistent with those in the United States (stethoscopy-based), the reference values for the diastolic phase were lower. We observed the same tendency when comparing JSH2009 reference values with those in South Korea (automated sphygmomanometer-based). Conversely, there were only small differences between automated sphygmomanometry and mercury measurement, and we found it was possible to substitute the values from automated sphygmomanometry for stethoscopy. A large-scale study that takes into account patient height, measurement method, and treatment criteria is required to establish appropriate reference values. Even if automated sphygmomanometry is used until appropriate values are established, we consider the criteria provided in the American guidelines as appropriate.

Relating UMLS semantic types and task-based ontology to computer-interpretable clinical practice guidelines.

PubMed

Kumar, Anand; Ciccarese, Paolo; Quaglini, Silvana; Stefanelli, Mario; Caffi, Ezio; Boiocchi, Lorenzo

2003-01-01

Medical knowledge in clinical practice guideline (GL) texts is the source of task-based computer-interpretable clinical guideline models (CIGMs). We have used Unified Medical Language System (UMLS) semantic types (STs) to understand the percentage of GL text which belongs to a particular ST. We also use UMLS semantic network together with the CIGM-specific ontology to derive a semantic meaning behind the GL text. In order to achieve this objective, we took nine GL texts from the National Guideline Clearinghouse (NGC) and marked up the text dealing with a particular ST. The STs we took into consideration were restricted taking into account the requirements of a task-based CIGM. We used DARPA Agent Markup Language and Ontology Inference Layer (DAML + OIL) to create the UMLS and CIGM specific semantic network. For the latter, as a bench test, we used the 1999 WHO-International Society of Hypertension Guidelines for the Management of Hypertension. We took into consideration the UMLS STs closest to the clinical tasks. The percentage of the GL text dealing with the ST "Health Care Activity" and subtypes "Laboratory Procedure", "Diagnostic Procedure" and "Therapeutic or Preventive Procedure" were measured. The parts of text belonging to other STs or comments were separated. A mapping of terms belonging to other STs was done to the STs under "HCA" for representation in DAML + OIL. As a result, we found that the three STs under "HCA" were the predominant STs present in the GL text. In cases where the terms of related STs existed, they were mapped into one of the three STs. The DAML + OIL representation was able to describe the hierarchy in task-based CIGMs. To conclude, we understood that the three STs could be used to represent the semantic network of the task-bases CIGMs. We identified some mapping operators which could be used for the mapping of other STs into these.

Anticipating issues related to increasing preimplantation genetic diagnosis use: a research agenda.

PubMed

Klitzman, Robert; Appelbaum, Paul S; Chung, Wendy; Sauer, Mark

2008-01-01

Increasing use of preimplantation genetic diagnosis (PGD) poses numerous clinical, social, psychological, ethical, legal and policy dilemmas, many of which have received little attention. Patients and providers are now considering and using PGD for a widening array of genetic disorders, and patients may increasingly seek 'designer babies.' In the USA, although governmental oversight policies have been discussed, few specific guidelines exist. Hence, increasingly, patients and providers will face challenging ethical and policy questions of when and for whom to use PGD, and how it should be financed. These issues should be better clarified and addressed through collection of data concerning the current use of PGD in the USA, including factors involved in decision making about PGD use, as well as the education of the various communities that are, and should be, involved in its implementation. Improved understanding of these issues will ultimately enhance the development and implementation of future clinical guidelines and policies.

Quality Primary Care and Family Planning Services for LGBT Clients: A Comprehensive Review of Clinical Guidelines.

PubMed

Klein, David A; Malcolm, Nikita M; Berry-Bibee, Erin N; Paradise, Scott L; Coulter, Jessica S; Keglovitz Baker, Kristin; Schvey, Natasha A; Rollison, Julia M; Frederiksen, Brittni N

2018-04-01

LGBT clients have unique healthcare needs but experience a wide range of quality in the care that they receive. This study provides a summary of clinical guideline recommendations related to the provision of primary care and family planning services for LGBT clients. In addition, we identify gaps in current guidelines, and inform future recommendations and guidance for clinical practice and research. PubMed, Cochrane, and Agency for Healthcare Research and Quality electronic bibliographic databases, and relevant professional organizations' websites, were searched to identify clinical guidelines related to the provision of primary care and family planning services for LGBT clients. Information obtained from a technical expert panel was used to inform the review. Clinical guidelines meeting the inclusion criteria were assessed to determine their alignment with Institute of Medicine (IOM) standards for the development of clinical practice guidelines and content relevant to the identified themes. The search parameters identified 2,006 clinical practice guidelines. Seventeen clinical guidelines met the inclusion criteria. Two of the guidelines met all eight IOM criteria. However, many recommendations were consistent regarding provision of services to LGBT clients within the following themes: clinic environment, provider cultural sensitivity and awareness, communication, confidentiality, coordination of care, general clinical principles, mental health considerations, and reproductive health. Guidelines for the primary and family planning care of LGBT clients are evolving. The themes identified in this review may guide professional organizations during guideline development, clinicians when providing care, and researchers conducting LGBT-related studies.

Developing a guideline for clinical trial protocol content: Delphi consensus survey

PubMed Central

2012-01-01

Background Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the objective of this study was to conduct a three-round Delphi consensus survey to develop and refine minimum content for RCT protocols. Methods Panellists were identified using a multistep iterative approach, met prespecified minimum criteria and represented key stakeholders who develop or use clinical trial protocols. They were asked to rate concepts for importance in a minimum set of items for RCT protocols. The main outcome measures were degree of importance (scale of 1 to 10; higher scores indicating higher importance) and level of consensus for items. Results were presented as medians, interquartile ranges, counts and percentages. Results Ninety-six expert panellists participated in the Delphi consensus survey including trial investigators, methodologists, research ethics board members, funders, industry, regulators and journal editors. Response rates were between 88 and 93% per round. Overall, panellists rated 63 of 88 concepts of high importance (of which 50 had a 25th percentile rating of 8 or greater), 13 of moderate importance (median 6 or 7) and 12 of low importance (median less than or equal to 5) for minimum trial protocol content. General and item-specific comments and subgroup results provided valuable insight for further discussions. Conclusions This Delphi process achieved consensus from a large panel of experts from diverse stakeholder groups on essential content for RCT protocols. It also highlights areas of divergence. These results, complemented by other empirical research and consensus meetings, are helping guide the development of a guideline for protocol content. PMID:23006145

International guideline for the delineation of the clinical target volumes (CTV) for nasopharyngeal carcinoma.

PubMed

Lee, Anne W; Ng, Wai Tong; Pan, Jian Ji; Poh, Sharon S; Ahn, Yong Chan; AlHussain, Hussain; Corry, June; Grau, Cai; Grégoire, Vincent; Harrington, Kevin J; Hu, Chao Su; Kwong, Dora L; Langendijk, Johannes A; Le, Quynh Thu; Lee, Nancy Y; Lin, Jin Ching; Lu, Tai Xiang; Mendenhall, William M; O'Sullivan, Brian; Ozyar, Enis; Peters, Lester J; Rosenthal, David I; Soong, Yoke Lim; Tao, Yungan; Yom, Sue S; Wee, Joseph T

2018-01-01

Target delineation in nasopharyngeal carcinoma (NPC) often proves challenging because of the notoriously narrow therapeutic margin. High doses are needed to achieve optimal levels of tumour control, and dosimetric inadequacy remains one of the most important independent factors affecting treatment outcome. A review of the available literature addressing the natural behaviour of NPC and correlation between clinical and pathological aspects of the disease was conducted. Existing international guidelines as well as published protocols specified by clinical trials on contouring of clinical target volumes (CTV) were compared. This information was then summarized into a preliminary draft guideline which was then circulated to international experts in the field for exchange of opinions and subsequent voting on areas with the greatest controversies. Common areas of uncertainty and variation in practices among experts experienced in radiation therapy for NPC were elucidated. Iterative revisions were made based on extensive discussion and final voting on controversial areas by the expert panel, to formulate the recommendations on contouring of CTV based on optimal geometric expansion and anatomical editing for those structures with substantial risk of microscopic infiltration. Through this comprehensive review of available evidence and best practices at major institutions, as well as interactive exchange of vast experience by international experts, this set of consensus guidelines has been developed to provide a practical reference for appropriate contouring to ensure optimal target coverage. However, the final decision on the treatment volumes should be based on full consideration of individual patients' factors and facilities of an individual centre (including the quality of imaging methods and the precision of treatment delivery). Copyright © 2017 Elsevier B.V. All rights reserved.

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.

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

ERIC Educational Resources Information Center

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

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

Clinicians guide for cue‐based transition to oral feeding in preterm infants: An easy‐to‐use clinical guide

PubMed Central

2017-01-01

Abstract Rationale, aims and objectives This article aims to provide evidence to guide multidisciplinary clinical practitioners towards successful initiation and long‐term maintenance of oral feeding in preterm infants, directed by the individual infant maturity. Method A comprehensive review of primary research, explorative work, existing guidelines, and evidence‐based opinions regarding the transition to oral feeding in preterm infants was studied to compile this document. Results Current clinical hospital practices are described and challenged and the principles of cue‐based feeding are explored. “Traditional” feeding regimes use criteria, such as the infant's weight, gestational age and being free of illness, and even caregiver intuition to initiate or delay oral feeding. However, these criteria could compromise the infant and increase anxiety levels and frustration for parents and caregivers. Cue‐based feeding, opposed to volume‐driven feeding, lead to improved feeding success, including increased weight gain, shorter hospital stay, fewer adverse events, without increasing staff workload while simultaneously improving parents' skills regarding infant feeding. Although research is available on cue‐based feeding, an easy‐to‐use clinical guide for practitioners could not be found. A cue‐based infant feeding regime, for clinical decision making on providing opportunities to support feeding success in preterm infants, is provided in this article as a framework for clinical reasoning. Conclusions Cue‐based feeding of preterm infants requires care providers who are trained in and sensitive to infant cues, to ensure optimal feeding success. An easy‐to‐use clinical guideline is presented for implementation by multidisciplinary team members. This evidence‐based guideline aims to improve feeding outcomes for the newborn infant and to facilitate the tasks of nurses and caregivers. PMID:28251754

ClinGen Pathogenicity Calculator: a configurable system for assessing pathogenicity of genetic variants.

PubMed

Patel, Ronak Y; Shah, Neethu; Jackson, Andrew R; Ghosh, Rajarshi; Pawliczek, Piotr; Paithankar, Sameer; Baker, Aaron; Riehle, Kevin; Chen, Hailin; Milosavljevic, Sofia; Bizon, Chris; Rynearson, Shawn; Nelson, Tristan; Jarvik, Gail P; Rehm, Heidi L; Harrison, Steven M; Azzariti, Danielle; Powell, Bradford; Babb, Larry; Plon, Sharon E; Milosavljevic, Aleksandar

2017-01-12

The success of the clinical use of sequencing based tests (from single gene to genomes) depends on the accuracy and consistency of variant interpretation. Aiming to improve the interpretation process through practice guidelines, the American College of Medical Genetics and Genomics (ACMG) and the Association for Molecular Pathology (AMP) have published standards and guidelines for the interpretation of sequence variants. However, manual application of the guidelines is tedious and prone to human error. Web-based tools and software systems may not only address this problem but also document reasoning and supporting evidence, thus enabling transparency of evidence-based reasoning and resolution of discordant interpretations. In this report, we describe the design, implementation, and initial testing of the Clinical Genome Resource (ClinGen) Pathogenicity Calculator, a configurable system and web service for the assessment of pathogenicity of Mendelian germline sequence variants. The system allows users to enter the applicable ACMG/AMP-style evidence tags for a specific allele with links to supporting data for each tag and generate guideline-based pathogenicity assessment for the allele. Through automation and comprehensive documentation of evidence codes, the system facilitates more accurate application of the ACMG/AMP guidelines, improves standardization in variant classification, and facilitates collaborative resolution of discordances. The rules of reasoning are configurable with gene-specific or disease-specific guideline variations (e.g. cardiomyopathy-specific frequency thresholds and functional assays). The software is modular, equipped with robust application program interfaces (APIs), and available under a free open source license and as a cloud-hosted web service, thus facilitating both stand-alone use and integration with existing variant curation and interpretation systems. The Pathogenicity Calculator is accessible at http://calculator.clinicalgenome.org . By enabling evidence-based reasoning about the pathogenicity of genetic variants and by documenting supporting evidence, the Calculator contributes toward the creation of a knowledge commons and more accurate interpretation of sequence variants in research and clinical care.

Citation of prior research has increased in introduction and discussion sections with time: A survey of clinical trials in physiotherapy.

PubMed

Hoderlein, Xenia; Moseley, Anne M; Elkins, Mark R

2017-08-01

Many clinical trials are reported without reference to the existing relevant high-quality research. This study aimed to investigate the extent to which authors of reports of clinical trials of physiotherapy interventions try to use high-quality clinical research to (1) help justify the need for the trial in the introduction and (2) help interpret the trial's results in the discussion. Data were extracted from 221 clinical trials that were randomly selected from the Physiotherapy Evidence Database: 70 published in 2001 (10% sample) and 151 published in 2015 (10% sample). The Physiotherapy Evidence Database score (which rates methodological quality and completeness of reporting) for each trial was also downloaded. Overall 41% of trial reports cited a systematic review or the results of a search for other evidence in the introduction section: 20% for 2001 and 50% for 2015 (relative risk = 2.3, 95% confidence interval = 1.5-3.8). For the discussion section, only 1 of 221 trials integrated the results of the trial into an existing meta-analysis, but citation of a relevant systematic review did increase from 17% in 2001 to 34% in 2015. There was no relationship between citation of existing research and the total Physiotherapy Evidence Database score. Published reports of clinical trials of physiotherapy interventions increasingly cite a systematic review or the results of a search for other evidence in the introduction, but integration with existing research in the discussion section is very rare. To encourage the use of existing research, stronger recommendations to refer to existing systematic reviews (where available) could be incorporated into reporting checklists and journal editorial guidelines.

Canadian Headache Society guideline for migraine prophylaxis.

PubMed

Pringsheim, Tamara; Davenport, W Jeptha; Mackie, Gordon; Worthington, Irene; Aubé, Michel; Christie, Suzanne N; Gladstone, Jonathan; Becker, Werner J

2012-03-01

The primary objective of this guideline is to assist the practitioner in choosing an appropriate prophylactic medication for an individual with migraine, based on current evidence in the medical literature and expert consensus. This guideline is focused on patients with episodic migraine (headache on ≤ 14 days a month). Through a comprehensive search strategy, randomized, double blind, controlled trials of drug treatments for migraine prophylaxis and relevant Cochrane reviews were identified. Studies were graded according to criteria developed by the US Preventive Services Task Force. Recommendations were graded according to the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group. In addition, a general literature review and expert consensus were used for aspects of prophylactic therapy for which randomized controlled trials are not available. Prophylactic drug choice should be based on evidence for efficacy, side-effect profile, migraine clinical features, and co-existing disorders. Based on our review, 11 prophylactic drugs received a strong recommendation for use (topiramate, propranolol, nadolol, metoprolol, amitriptyline, gabapentin, candesartan, butterbur, riboflavin, coenzyme Q10, and magnesium citrate) and 6 received a weak recommendation (divalproex sodium, flunarizine, pizotifen, venlafaxine, verapamil, and lisinopril). Quality of evidence for different medications varied from high to low. Prophylactic treatment strategies were developed to assist the practitioner in selecting a prophylactic drug for specific clinical situations. These strategies included: first time strategies for patients who have not had prophylaxis before (a beta-blocker and a tricyclic strategy), low side effect strategies (including both drug and herbal/vitamin/mineral strategies), a strategy for patients with high body mass index, strategies for patients with co-existent hypertension or with co-existent depression and /or anxiety, and additional monotherapy drug strategies for patients who have failed previous prophylactic trials. Further strategies included a refractory migraine strategy and strategies for prophylaxis during pregnancy and lactation. There is good evidence from randomized controlled trials for use of a number of different prophylactic medications in patients with migraine. Medication choice for an individual patient requires careful consideration of patient clinical features.

Diagnostic criteria, severity classification and guidelines of localized scleroderma.

PubMed

Asano, Yoshihide; Fujimoto, Manabu; Ishikawa, Osamu; Sato, Shinichi; Jinnin, Masatoshi; Takehara, Kazuhiko; Hasegawa, Minoru; Yamamoto, Toshiyuki; Ihn, Hironobu

2018-04-23

We established diagnostic criteria and severity classification of localized scleroderma because there is no established diagnostic criteria or widely accepted severity classification of the disease. Also, there has been no clinical guideline for localized scleroderma, so we established its clinical guideline ahead of all over the world. In particular, the clinical guideline was established by clinical questions based on evidence-based medicine according to the New Minds Clinical Practice Guideline Creation Manual (version 1.0). We aimed to make the guideline easy to use and reliable based on the newest evidence, and to present guidance as specific as possible for various clinical problems in treatment of localized scleroderma. © 2018 Japanese Dermatological Association.

Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis.

PubMed

Matz, Paul G; Meagher, R J; Lamer, Tim; Tontz, William L; Annaswamy, Thiru M; Cassidy, R Carter; Cho, Charles H; Dougherty, Paul; Easa, John E; Enix, Dennis E; Gunnoe, Bryan A; Jallo, Jack; Julien, Terrence D; Maserati, Matthew B; Nucci, Robert C; O'Toole, John E; Rosolowski, Karie; Sembrano, Jonathan N; Villavicencio, Alan T; Witt, Jens-Peter

2016-03-01

The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis features evidence-based recommendations for diagnosing and treating degenerative lumbar spondylolisthesis. The guideline updates the 2008 guideline on this topic and is intended to reflect contemporary treatment concepts for symptomatic degenerative lumbar spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of May 2013. The NASS guideline on this topic is the only guideline on degenerative lumbar spondylolisthesis included in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse (NGC). The purpose of this guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for patients with degenerative lumbar spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. A systematic review of clinical studies relevant to degenerative spondylolisthesis was carried out. This NASS spondyolisthesis guideline is the product of the Degenerative Lumbar Spondylolisthesis Work Group of NASS' Evidence-Based Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members used the NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Degenerative Lumbar Spondylolisthesis guideline was accepted into the NGC and will be updated approximately every 5 years. Twenty-seven clinical questions were addressed in this guideline update, including 15 clinical questions from the original guideline and 12 new clinical questions. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. Twenty-one new or updated recommendations or consensus statements were issued and 13 recommendations or consensus statements were maintained from the original guideline. The clinical guideline was created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with degenerative lumbar spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flow chart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/Pages/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical practice guidelines in hypertension: a review.

PubMed

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

2015-10-23

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

Depressive disorders co-existing with Addison-Biermer anemia - case report.

PubMed

Just, Mark Jean; Kozakiewicz, Mariusz

2015-01-01

Anemia is a disease that can co-exist with depression, other mental disorders, or somatic diseases. Anemia can imitate symptoms of depression, while depression symptoms can mask concurring symptoms of anemia. I am presenting a case of a 48-year-old woman with Addison-Biermer anemia, with co-existing mood disorders. The clinical analysis of the presented patient's history indicates diagnostic problems and a need for a detailed analysis of drug-related complications that occurred during previous treatment, eg, in the form of neuroleptic malignant syndrome. The presented case report contains valuable guidelines that can be of assistance in diagnostics and treatment of patients treated for mental disorders, who are also diagnosed with somatic diseases.

The experience of hepatitis C treatment for people with a history of mental health problems: An interpretative phenomenological analysis.

PubMed

Ware, K; Davies, J; Rowse, G; Whittaker, S

2015-07-01

This qualitative study explores the experience of hepatitis C virus treatment for people with pre-existing mental health problems within a large city hospital. Four men and four women with pre-existing mental health problems who had received hepatitis C virus treatment took part in semi-structured interviews which were analysed using interpretative phenomenological analysis. A central theme of 'Self, stigma and change' was identified which interlinked with three other main themes of 'Coping and responding to treatment', 'Connectedness to others' and 'The impact of information'. These themes and their sub-themes are discussed in relation to existing literature and clinical practice guidelines. © The Author(s) 2013.

[Interdisciplinary clinical pathway for colorectal cancer].

PubMed

Fischbach, W; Engemann, R

2006-07-01

Limited financial resources in public health care have led to the introduction of clinical pathways as a means to a better effectivity and efficacy. Colorectal cancer met the requirements for establishing such a pathway in a distinguished way: high patient volume, high costs, interdisciplinary multi-modal treatment concepts in a relevant frequency, and existing evidence based guidelines. This article gives an example of a clinical pathway for colorectal cancer as established in our hospital. The potential of such pathways to save costs as well as their implications on treatment results and patients' satisfaction will have to be critically analyzed in the future before their value can be definitely estimated.

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of adult isthmic spondylolisthesis.

PubMed

Kreiner, D Scott; Baisden, Jamie; Mazanec, Daniel J; Patel, Rakesh D; Bess, Robert S; Burton, Douglas; Chutkan, Norman B; Cohen, Bernard A; Crawford, Charles H; Ghiselli, Gary; Hanna, Amgad S; Hwang, Steven W; Kilincer, Cumhur; Myers, Mark E; Park, Paul; Rosolowski, Karie A; Sharma, Anil K; Taleghani, Christopher K; Trammell, Terry R; Vo, Andrew N; Williams, Keith D

2016-12-01

The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Adult Isthmic Spondylolisthesis features evidence-based recommendations for diagnosing and treating adult patients with isthmic spondylolisthesis. The guideline is intended to reflect contemporary treatment concepts for symptomatic isthmic spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of June 2013. NASS' guideline on this topic is the only guideline on adult isthmic spondylolisthesis accepted in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse. The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with isthmic spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. This is a guideline summary review. This guideline is the product of the Adult Isthmic Spondylolisthesis Work Group of NASS' Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questionsto address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Adult Isthmic Spondylolisthesis guideline was accepted into the National Guideline Clearinghouse and will be updated approximately every 5 years. Thirty-one clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with isthmic spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical guidelines contribute to the health inequities experienced by individuals with intellectual disabilities

PubMed Central

2012-01-01

Background Clinical practice guidelines are developed to improve the quality of healthcare. However, clinical guidelines may contribute to health inequities experienced by disadvantaged groups. This study uses an equity lens developed by the International Clinical Epidemiology Network (INCLEN) to examine how well clinical guidelines address inequities experienced by individuals with intellectual disabilities. Methods Nine health problems relevant to the health inequities experienced by persons with intellectual disabilities were selected. Clinical guidelines on these disorders were identified from across the world. The INCLEN equity lens was used as the basis for a purpose-designed, semistructured data collection tool. Two raters independently examined each guideline and completed the data collection tool. The data extracted by each rater were discussed at a research group consensus conference and agreement was reached on a final equity lens rating for each guideline. Results Thirty-six guidelines were identified, one of which (2.8%) explicitly excluded persons with intellectual disabilities. Of the remaining 35, six (17.1%) met the first criterion of the equity lens, identifying persons with intellectual disabilities at high risk for the specific health problem. Eight guidelines (22.9%) contained any content on intellectual disabilities. Six guidelines addressed the fourth equity lens criterion, by giving specific consideration to the barriers to implementation of the guideline in disadvantaged populations. There were no guidelines that addressed the second, third, and fifth equity lens criteria. Conclusions The equity lens is a useful tool to systematically examine whether clinical guidelines address the health needs and inequities experienced by disadvantaged groups. Clinical guidelines are likely to further widen the health inequities experienced by persons with intellectual disabilities, and other disadvantaged groups, by being preferentially advantageous to the general population. There is a need to systematically incorporate methods to consider disadvantaged population groups into the processes used to develop clinical guidelines. PMID:22578137

[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.

199 Development of a National Guideline on Skin Testing and Immunotherapy

PubMed Central

Linnemann, Désirée Larenas; Ortega Martell, José Antonio; del Rio, Blanca; Rodriguez-Perez, Noel; Arias-Cruz, Alfredo; Estrada, Alan

2012-01-01

Background Several international guidelines exist on allergen immunotherapy (AIT) –eg American, European, British, Spanish, Italian- but local conditions that reign in each country limit their applicability. We present the steps we followed to develop a National Guideline on AIT, taking into account local legislation, extracts available, costs and patient preference. Methods Firstly a Nation-wide survey on the practice of skin testing and AIT was undertaken among all members of Mexican Allergist Societies. Secondly, based on the replies obtained with the survey clinical questions were formulated on critical points and issues susceptible for improvement, as diagnosed by the survey. Thirdly, all 6 Regional Allergist Societies were visited to obtain the opinion of their members on the clinical questions concerning how immunotherapy could best be practiced under local Mexican conditions. This led to the Consensed experience. Fourthly, 6 experts looked for the replies to the clinical questions reviewing the literature and assigning quality of evidence to the articles on the specific issues treated by each clinical question. Results To develop the final document the GRADE approach was used. For each clinical question both, knowledge from the local consensed experience and the evidence-based replies were taken into account, as well as cost, patient preference and safety to make a set of recommendations and suggestions on the most crucial aspects of skin testing and AIT. Forming centers of allergists in Mexico corrected the final draft. The final document came out as the January issue of Revista Mexicana Alergia and was presented by the authors in a National Course on Immunotherapy (May 2011), with—apart from the lectures—a more workshop-like part to allow for practical exercising and discussion. The updated questions on allergen immunotherapy for the final board exam are based on the Guideline. Allergy-residents developed a slide-show. In 2012 Regional Allergist Societies shall be visited again. Conclusions We present a democratic way of how a National Guideline can be developed, supported by evidence-based medicine and local experience in a country where little is legislated on this respect and quality improvement has to be stimulated by the professional community. We show how implementation can be enhanced.

Toward a clinical practice guide in pharmacogenomics testing for functional polymorphisms of drug-metabolizing enzymes. Gene/drug pairs and barriers perceived in Spain

PubMed Central

Agúndez, José A. G.; Abad-Santos, Francisco; Aldea, Ana; Alonso-Navarro, Hortensia; Bernal, María L.; Borobia, Alberto M.; Borrás, Emma; Carballo, Miguel; Carvajal, Alfonso; García-Muñiz, José D.; Gervasini, Guillermo; Jiménez-Jiménez, Félix J.; Lucena, María I.; Martínez, Carmen; Sacristán, José A.; Salado, Inés; Sinués, Blanca; Vicente, Jorge; García-Martín, Elena

2012-01-01

The development of clinical practice recommendations or guidelines for the clinical use of biomarkers is an issue of great importance with regard to adverse drug reactions. The potential of pharmacogenomic biomarkers has been extensively investigated in recent years. However, several barriers to implementing the use of pharmacogenomics testing exist. We conducted a survey among members of the Spanish Societies of Pharmacology and Clinical Pharmacology to obtain information about the perception of such barriers and to compare the perceptions of participants about the relative importance of major gene/drug pairs. Of 11 potential barriers, the highest importance was attributed to lack of institutional support for pharmacogenomics testing, and to the issues related to the lack of guidelines. Of the proposed gene/drug pairs the highest importance was assigned to HLA-B/abacavir, UGT1A1/irinotecan, and CYP2D6/tamoxifen. In this perspective article, we compare the relative importance of 29 gene/drug pairs in the Spanish study with that of the same pairs in the American Society for Clinical Pharmacology and Therapeutics study, and we provide suggestions and areas of focus to develop a guide for clinical practice in pharmacogenomics testing. PMID:23233861

Improving Practice Guideline Adherence Through Peer Feedback: Impact of an Ambulatory Cardiology Curriculum.

PubMed

Richardson, Karl M; Singh, Jai; Muñoz, Dan; Damp, Julie B; Mendes, Lisa A

2018-01-01

Graduate medical trainees must be prepared to practice in a quality-driven system that values adherence to and documentation of evidence-based care. Few validated approaches exist to teach these skills. Our objective was to develop, implement, and evaluate an ambulatory practice improvement curriculum capitalizing on peer feedback aimed at improving cardiology fellow guideline knowledge, adherence, and chart documentation. Four outpatient topics were reviewed in dedicated 1-hour sessions: stable ischemic heart disease, heart failure, atrial fibrillation, and aortic valvular disease. Each session began with peer review, critique, and guideline adherence discussion of deidentified outpatient fellow clinic charts, followed by discussion of clinical guidelines. The open discussion of real clinic notes provided a forum for peer feedback exchange. Before each session and after the final session, participants completed a multiple-choice knowledge assessment and self-assessment of comfort with the guidelines. To evaluate the potential effect on patient care, random clinic chart audits were conducted before and after the curriculum using a chart scoring system. Although the format is broadly applicable, the specific curriculum content was designed for a cardiology fellowship cohort in a large academic medical center. It was organized and implemented by 2 cardiology fellows under the direction and supervision of program directors. The curriculum was implemented during prescheduled noon conference hours. The intention was to carry forward this ambulatory curriculum in subsequent years and to use the first 4 sessions to study its potential successes and opportunities for improvement. All 22 general cardiology fellows attended at least two sessions (M = 3.1). Knowledge test scores rose from 52.6% to 73.0% (20.4% increase, p < .001), 95% confidence interval (CI) [13.6%, 27.2%]. Self-reported guidelines knowledge improved by 15.1% (p = .002), 95% CI [6.2%, 24.0%], and self-reported documentation improved by 12.5% (p = .008), 95% CI [3.8%, 21.7%]. Chart audit scores improved by 17.8% (p < .001), 95% CI [10.6%, 25.0%], driven in part by 16.4% improvement in adherence to Class I therapies (p = .001). A targeted curriculum combining peer chart review, feedback, and guideline discussion was associated with significant improvement in fellows' knowledge and adherence to evidence-based therapies. Peer assessment and group-based education and feedback can be leveraged to improve trainee education and impact patient care.

Variability in Pediatric Infectious Disease Consultants' Recommendations for Management of Community-Acquired Pneumonia

PubMed Central

Hersh, Adam L.; Shapiro, Daniel J.; Newland, Jason G.; Polgreen, Philip M.; Beekmann, Susan E.; Shah, Samir S.

2011-01-01

Background Community-acquired pneumonia (CAP) is a common childhood infection. CAP complications, such as parapneumonic empyema (PPE), are increasing and are frequently caused by antibiotic-resistant organisms. No clinical guidelines currently exist for management of pediatric CAP and no published data exist about variations in antibiotic prescribing patterns. Our objectives were to describe variation in CAP clinical management for hospitalized children by pediatric infectious disease consultants and to examine associations between recommended antibiotic regimens and local antibiotic resistance levels. Methods We surveyed pediatric members of the Emerging Infections Network, which consists of 259 pediatric infectious disease physicians. Participants responded regarding their recommended empiric antibiotic regimens for hospitalized children with CAP with and without PPE and their recommendations for duration of therapy. Participants also provided information about the prevalence of penicillin non-susceptible S. pneumoniae and methicillin-resistant S. aureus (MRSA) in their community. Results We received 148 responses (57%). For uncomplicated CAP, respondents were divided between recommending beta-lactams alone (55%) versus beta-lactams in combination with another class (40%). For PPE, most recommended a combination of a beta-lactam plus an anti-MRSA agent, however, they were divided between clindamycin (44%) and vancomycin (57%). The relationship between reported antibiotic resistance and empiric regimen was mixed. We found no relationship between aminopenicillin use and prevalence of penicillin non-suscepetible S. pneumoniae or clindamycin use and clindamycin resistance, however, respondents were more likely to recommend an anti-MRSA agent when MRSA prevalence increased. Conclusions Substantial variability exists in recommendations for CAP management. Development of clinical guidelines via antimicrobial stewardship programs and dissemination of data about local antibiotic resistance patterns represent opportunities to improve care. PMID:21655259

Exploiting Temporal Constraints of Clinical Guidelines by Applying OpenEHR Archetypes.

PubMed

Cintho, Lilian Mie Mukai; Garcia, Diego; da Silva Santos, Bruno Henrique; Sacchi, Lucia; Quaglini, Silvana; Moro, Claudia Maria Cabral

2017-01-01

Studies describing Computer-Interpretable Clinical Guidelines (CIG) with temporal constrains (TC) generally have not addressed issues related to their integration into Electronic Health Record (EHR) systems. This study aimed to represent TCs contained in clinical guidelines by applying archetypes and Guideline Definition Language (GDL) to incorporate decision support into EHRs. An example of each TC class in the clinical guideline for management of Atrial Fibrillation was represented using archetypes and GDL.

Clinical guidelines in primary care: a survey of general practitioners' attitudes and behaviour.

PubMed Central

Siriwardena, A N

1995-01-01

BACKGROUND: In the United Kingdom little is known about general practitioners' attitudes to and behaviour concerning clinical guidelines. AIM: A study was performed to investigate these two under-researched areas. METHOD: In 1994 a postal questionnaire on clinical guidelines was sent to all 326 general practitioner principals on the list of Lincolnshire Family Health Services Authority. The questionnaire consisted of 20 attitude statements and an open question on clinical guidelines, as well as surveying characteristics and behaviour of respondents. RESULTS: Of the 326 general practitioners sent questionnaires, 213 (65%) replied. Most respondents (78%) reported having been involved in writing inhouse guidelines. An even greater proportion (92%) reported having participated in clinical audit. Respondents were generally in favour of clinical guidelines, with mean response scores indicating a positive attitude to guidelines in 15 of the 20 statements, a negative attitude in four and equivocation in one. The majority of respondents felt that guidelines were effective in improving patient care (69%). Members (or fellows) of the Royal College of General Practitioners had a more positive attitude than non-members towards guidelines. They were also significantly more likely than non-members to have written inhouse guidelines, as were those who had participated in audit compared with those who had not participated in audit. A substantial minority (over a quarter) of general practitioners were concerned that guidelines may be used for setting performance-related pay, or that they may lead to 'cookbook' medicine, reduce clinical freedom or stifle innovation. There was also concern that guidelines should be scientifically valid. CONCLUSION: This study suggests that many general practitioners in the Lincolnshire Family Health Services Authority area have produced written inhouse guidelines. This is largely sustained by positive attitudes about the effectiveness and benefits of clinical guidelines. The positive attitude of RCGP members supports it in its continuing role in developing, implementing and evaluating guidelines in primary care. The question of whether incorporation of guidelines into clinical audit is an effective means to disseminate systematic research-based guidelines warrants further study. PMID:8745861

Guidelines for innovation in pediatric surgery.

PubMed

Kastenberg, Zachary; Dutta, Sanjeev

2011-05-01

Surgical innovation involves the conceptualization, research, and translation of a novel idea into a viable procedure or device. The technological advancements made within the field of pediatric surgery over the last century have led to major improvements in patient care and outcomes. There has, however, been a parallel increase in the complexity of the regulatory bodies governing research and device implementation. This article briefly outlines the history of innovation in pediatric surgery, describes the existing regulatory bodies governing surgical research and device development (i.e., Department of Health and Human Services, Food and Drug Administration), and offers a set of guidelines for the pediatric surgeon planning to incorporate a new procedure or device into clinical practice.

Chemotherapy dosing in achondroplastic dwarfism: a case report and review of literature.

PubMed

Elsoueidi, R; Gresham, C; Michael, L; Chaney, D; Mourad, H

2016-12-01

CASE DESCRIPTION: A 74-year-old female with achondroplastic dwarfism was diagnosed with ER-, BR- and HER2- breast cancer. No guideline currently exists to direct chemotherapy dosing in this population. She received neoadjuvant chemotherapy based on body surface area utilizing actual height and weight with dose-dense doxorubicin and cyclophosphamide followed by paclitaxel with the use of granulocyte colony-stimulating factor. Satisfactory clinical response and remission were achieved, and treatment proceeded without any significant toxicity or delays. In the absence of guideline recommendations, dosing chemotherapy based on actual height and weight in patients with achondroplastic dwarfism may be safe and appropriate. © 2016 John Wiley & Sons Ltd.

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

PubMed

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

2012-08-01

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

Peyronie’s Disease: AUA Guideline

PubMed Central

Nehra, Ajay; Alterowitz, Ralph; Culkin, Daniel J.; Faraday, Martha M.; Hakim, Lawrence S.; Heidelbaugh, Joel J.; Khera, Mohit; Kirkby, Erin; McVary, Kevin T.; Miner, Martin M.; Nelson, Christian J.; Sadeghi-Nejad, Hossein; Seftel, Allen D.; Shindel, Alan W.; Burnett, Arthur L.

2016-01-01

Purpose The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of Peyronie’s disease. Materials and Methods A systematic review of the literature using the PubMed®, EMBASE® and Cochrane databases (search dates 1/1/1965 to 1/26/15) was conducted to identify peer-reviewed publications relevant to the diagnosis and treatment of PD. The review yielded an evidence base of 303 articles after application of inclusion/exclusion criteria. Results The systematic review was used to create guideline statements regarding treatment of PD. When sufficient evidence existed, the body of evidence for a particular treatment was assigned a strength rating of A (high quality evidence; high certainty), B (moderate quality evidence; moderate certainty), or C (low quality evidence; low certainty). Evidence-based statements of Strong, Moderate, or Conditional Recommendation were developed based on benefits and risks/burdens to patients. Additional consensus statements related to the diagnosis of PD are provided as Clinical Principles and Expert Opinions due to insufficient published evidence. Conclusions There is a continually expanding literature on PD; the Panel notes that this document constitutes a clinical strategy and is not intended to be interpreted rigidly. The most effective approach for a particular patient is best determined by the individual clinician and patient in the context of that patient’s history, values, and goals for treatment. As the science relevant to PD evolves and improves, the strategies presented here will be amended to remain consistent with the highest standards of clinical care. PMID:26066402

Recommendations on disease management for patients with advanced human epidermal growth factor receptor 2-positive breast cancer and brain metastases: American Society of Clinical Oncology clinical practice guideline.

PubMed

Ramakrishna, Naren; Temin, Sarah; Chandarlapaty, Sarat; Crews, Jennie R; Davidson, Nancy E; Esteva, Francisco J; Giordano, Sharon H; Gonzalez-Angulo, Ana M; Kirshner, Jeffrey J; Krop, Ian; Levinson, Jennifer; Modi, Shanu; Patt, Debra A; Perez, Edith A; Perlmutter, Jane; Winer, Eric P; Lin, Nancy U

2014-07-01

To provide formal expert consensus-based recommendations to practicing oncologists and others on the management of brain metastases for patients with human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. The American Society of Clinical Oncology (ASCO) convened a panel of medical oncology, radiation oncology, guideline implementation, and advocacy experts and conducted a systematic review of the literature. When that failed to yield sufficiently strong quality evidence, the Expert Panel undertook a formal expert consensus-based process to produce these recommendations. ASCO used a modified Delphi process. The panel members drafted recommendations, and a group of other experts joined them for two rounds of formal ratings of the recommendations. No studies or existing guidelines met the systematic review criteria; therefore, ASCO conducted a formal expert consensus-based process. Patients with brain metastases should receive appropriate local therapy and systemic therapy, if indicated. Local therapies include surgery, whole-brain radiotherapy, and stereotactic radiosurgery. Treatments depend on factors such as patient prognosis, presence of symptoms, resectability, number and size of metastases, prior therapy, and whether metastases are diffuse. Other options include systemic therapy, best supportive care, enrollment onto a clinical trial, and/or palliative care. Clinicians should not perform routine magnetic resonance imaging (MRI) to screen for brain metastases, but rather should have a low threshold for MRI of the brain because of the high incidence of brain metastases among patients with HER2-positive advanced breast cancer. © 2014 by American Society of Clinical Oncology.

Diagnosis and management of moderate to severe adult atopic dermatitis: a Consensus by the Italian Society of Dermatology and Venereology (SIDeMaST), the Italian Association of Hospital Dermatologists (ADOI), the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC), and the Italian Society of Allergological, Environmental and Occupational Dermatology (SIDAPA).

PubMed

Calzavara Pinton, Piergiacomo; Cristaudo, Antonio; Foti, Caterina; Canonica, Giorgio W; Balato, Nicola; Costanzo, Antonio; DE Pità, Ornella; DE Simone, Clara; Patruno, Cataldo; Pellacani, Giovanni; Peris, Ketty; Girolomoni, Giampiero

2018-04-01

Atopic dermatitis (AD) is a chronic immune-mediated inflammatory skin disease, currently recognized as a systemic disease possibly burdened by various comorbidities, including, but not limited to, other allergic conditions. Management guidelines issued by American and European dermatology and allergy scientific societies are available. However, some discrepancies exist in these guidelines, and some aspects of the management process, including diagnosis and severity assessment, as well as therapy duration and switch criteria, are not fully clarified by existing guidelines. Moreover, biologics such as dupilumab have now entered the therapeutic scenario of moderate-to-severe AD, offering a great opportunity to treat effectively and safely in need AD patients. For all these reasons, four Italian dermatology and allergy scientific societies joined to provide practical guidance for the management of moderate-to-severe adult AD suitable for the Italian clinical practice. Through a modified Delphi procedure, consensus was reached by 63 Italian dermatologists and allergists experienced in the management of adult AD on 14 statements covering five AD areas of interest, i.e. diagnosis, severity definition, current systemic therapies, eligibility criteria to biologic treatments, and comorbidities, with the aim to define treatment goals and improve adult AD management. The potential usefulness of a multidisciplinary approach is also underlined, given the complexity of AD and its comorbidities.

Pregnancy-related acute aortic dissection in Marfan syndrome: A review of the literature.

PubMed

Smith, Katherine; Gros, Bernard

2017-05-01

A well-established association exists between acute aortic dissection and pregnancy, particularly in women with Marfan syndrome. However, there is debate regarding appropriate management guidelines. In particular, there are differing opinions regarding when prophylactic aortic root repair should be recommended as well as the efficacy of beta blockers in this clinical scenario. The current study evaluated 10 years of published literature (2005-2015) in the PubMed/Medline database. Fifty articles, describing 72 cases of women who presented with aortic dissection in the antepartum or postpartum period were identified. Comparisons on demographic variables and clinical outcomes between cases of women with Marfan syndrome (n = 36) and without Marfan syndrome (n = 36) were conducted. There were no significant differences in demographics (age, gravidity, parity) between the Marfan and non-Marfan cases. Marfan patients presented with antepartum dissections significantly earlier in pregnancy than those without Marfan syndrome (P = .002). However, there were no significant difference between the 2 groups in maternal mortality, fetal mortality, or obstetric outcomes (mode of delivery and gestational age at delivery). Eight cases described events in Marfan women with an aortic root diameter ≤40 mm. Six events occurred in Marfan women who were managed with beta blockers. Current guidelines rely on aortic root diameter for stratification of Marfan women into risk categories, but we identified several cases that would be missed by these guidelines. Specifically, the existing literature suggest that women with Marfan syndrome should take precautions throughout pregnancy, rather than the third trimester. © 2017 Wiley Periodicals, Inc.

Management of exercise-induced bronchospasm in NCAA athletic programs

PubMed Central

Parsons, Jonathan P.; Pestritto, Vincent; Phillips, Gary; Kaeding, Christopher; Best, Thomas M.; Wadley, Gail; Mastronarde, John G.

2009-01-01

Purpose The prevalence of exercise-induced bronchospasm (EIB) is significantly higher in athletes than the general population, and can result in significant morbidity in young, competitive athletes. Guidelines emphasize that education and written treatment protocols improve clinical outcomes for asthmatics. Evidence also supports objective testing when exercise-induced bronchospasm is suspected, immediate availability of rescue inhalers, and involvement of asthma specialists in the care of asthmatic athletes. We sought to determine how EIB is managed at National Collegiate Athletic Association (NCAA) sports medicine programs. Methods A survey consisting of multiple-choice questions related to exercise-induced bronchospasm in athletes was sent electronically to 3200 athletic trainers affiliated with NCAA sports medicine programs. Results 541 athletic trainers responded. A minority of athletic trainers surveyed (21%) indicated an asthma management protocol exists at their institution. 22% indicated that pulmonologists are on staff in or consultants to the sports medicine department. Many indicated a short-acting beta-agonist is not required to be available at all practices (39%) and games (41%) and few athletic trainers indicated their programs utilize objective testing to diagnose EIB (17%). Regression modeling demonstrated education about EIB and involvement of pulmonologists significantly improved adherence to current consensus guidelines. Conclusions Based on our data, many NCAA sports medicine programs do not manage athletes with EIB according to current consensus guidelines. This may result in inaccurate diagnoses and may be detrimental to clinical outcomes and the overall health of student athletes. Providing education about EIB and involvement of pulmonologists significantly increase adherence to guidelines which likely improves clinical care of athletes and potentially athletic performance. PMID:19276862

Regulating trust in pediatric clinical trials.

PubMed

Pinxten, Wim; Nys, Herman; Dierickx, Kris

2008-12-01

The participation of minors in clinical trials is essential to provide safe and effective medical care to children. Because few drugs have been tested in children, pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In this article, we analyze how the enrollment of minors in clinical trials is negotiated within relationships of mutual trust between clinicians, minors, and their parents. After a brief description of the problems associated with involving minors in clinical research, we consider how existing "relationships of trust" can be used as a place where the concerns of research subjects can be more fully discussed and addressed. Building on the tacit recognition of trust found in The European Clinical Trials Directive we make policy recommendations that allow for clearer, more ethically informed guidelines for enrolling minors in clinical research.

Pharmacogenomic Testing for Neuropsychiatric Drugs: Current Status of Drug Labeling, Guidelines for Using Genetic Information, and Test Options

PubMed Central

Drozda, Katarzyna; Müller, Daniel J.; Bishop, Jeffrey R.

2014-01-01

Advancements in pharmacogenomics have introduced an increasing number of opportunities to bring personalized medicine into clinical practice. Understanding how and when to use this technology to help guide pharmacotherapy used to treat neuropsychiatric conditions remains a challenge for many clinicians. Currently, guidelines exist to assist clinicians in the use of genetic information for drug selection and/or dosing for the tricyclic antidepressants, carbamazepine, and phenytoin. Additional language in the product labeling suggests that genetic information may also be useful for assessing the starting and target doses, as well as drug interaction potential, for a number of other medications used to treat psychiatric and neurological conditions. In this review, we outline the current status of pharmacogenomic testing for neuropsychiatric drugs as it pertains to information contained in drug labeling, consensus guidelines, and test panels, as well as considerations related to obtaining tests for patients. PMID:24523097

Automated recommendation for cervical cancer screening and surveillance.

PubMed

Wagholikar, Kavishwar B; MacLaughlin, Kathy L; Casey, Petra M; Kastner, Thomas M; Henry, Michael R; Hankey, Ronald A; Peters, Steve G; Greenes, Robert A; Chute, Christopher G; Liu, Hongfang; Chaudhry, Rajeev

2014-01-01

Because of the complexity of cervical cancer prevention guidelines, clinicians often fail to follow best-practice recommendations. Moreover, existing clinical decision support (CDS) systems generally recommend a cervical cytology every three years for all female patients, which is inappropriate for patients with abnormal findings that require surveillance at shorter intervals. To address this problem, we developed a decision tree-based CDS system that integrates national guidelines to provide comprehensive guidance to clinicians. Validation was performed in several iterations by comparing recommendations generated by the system with those of clinicians for 333 patients. The CDS system extracted relevant patient information from the electronic health record and applied the guideline model with an overall accuracy of 87%. Providers without CDS assistance needed an average of 1 minute 39 seconds to decide on recommendations for management of abnormal findings. Overall, our work demonstrates the feasibility and potential utility of automated recommendation system for cervical cancer screening and surveillance.

[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.

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

PubMed Central

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

2005-01-01

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

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

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

NONE

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

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.

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

PubMed Central

2012-01-01

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

Clinical practice guideline: Bell's Palsy executive summary.

PubMed

Baugh, Reginald F; Basura, Gregory J; Ishii, Lisa E; Schwartz, Seth R; Drumheller, Caitlin Murray; Burkholder, Rebecca; Deckard, Nathan A; Dawson, Cindy; Driscoll, Colin; Gillespie, M Boyd; Gurgel, Richard K; Halperin, John; Khalid, Ayesha N; Kumar, Kaparaboyna Ashok; Micco, Alan; Munsell, Debra; Rosenbaum, Steven; Vaughan, William

2013-11-01

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: Bell's Palsy. To assist in implementing the guideline recommendations, this article summarizes the rationale, purpose, and key action statements. The 11 recommendations developed encourage accurate and efficient diagnosis and treatment and, when applicable, facilitate patient follow-up to address the management of long-term sequelae or evaluation of new or worsening symptoms not indicative of Bell's palsy. There are myriad treatment options for Bell's palsy; some controversy exists regarding the effectiveness of several of these options, and there are consequent variations in care. In addition, there are numerous diagnostic tests available that are used in the evaluation of patients with Bell's palsy. Many of these tests are of questionable benefit in Bell's palsy. Furthermore, while patients with Bell's palsy enter the health care system with facial paresis/paralysis as a primary complaint, not all patients with facial paresis/paralysis have Bell's palsy. It is a concern that patients with alternative underlying etiologies may be misdiagnosed or have an unnecessary delay in diagnosis. All of these quality concerns provide an important opportunity for improvement in the diagnosis and management of patients with Bell's palsy.

Towards a Framework for Evaluating Mobile Mental Health Apps.

PubMed

Chan, Steven; Torous, John; Hinton, Ladson; Yellowlees, Peter

2015-12-01

Mobile phones are ubiquitous in society and owned by a majority of psychiatric patients, including those with severe mental illness. Their versatility as a platform can extend mental health services in the areas of communication, self-monitoring, self-management, diagnosis, and treatment. However, the efficacy and reliability of publicly available applications (apps) have yet to be demonstrated. Numerous articles have noted the need for rigorous evaluation of the efficacy and clinical utility of smartphone apps, which are largely unregulated. Professional clinical organizations do not provide guidelines for evaluating mobile apps. Guidelines and frameworks are needed to evaluate medical apps. Numerous frameworks and evaluation criteria exist from the engineering and informatics literature, as well as interdisciplinary organizations in similar fields such as telemedicine and healthcare informatics. We propose criteria for both patients and providers to use in assessing not just smartphone apps, but also wearable devices and smartwatch apps for mental health. Apps can be evaluated by their usefulness, usability, and integration and infrastructure. Apps can be categorized by their usability in one or more stages of a mental health provider's workflow. Ultimately, leadership is needed to develop a framework for describing apps, and guidelines are needed for both patients and mental health providers.

Physiotherapy for cystic fibrosis in Australia and New Zealand: A clinical practice guideline.

PubMed

Button, Brenda M; Wilson, Christine; Dentice, Ruth; Cox, Narelle S; Middleton, Anna; Tannenbaum, Esta; Bishop, Jennifer; Cobb, Robyn; Burton, Kate; Wood, Michelle; Moran, Fiona; Black, Ryan; Bowen, Summar; Day, Rosemary; Depiazzi, Julie; Doiron, Katherine; Doumit, Michael; Dwyer, Tiffany; Elliot, Alison; Fuller, Louise; Hall, Kathleen; Hutchins, Matthew; Kerr, Melinda; Lee, Annemarie L; Mans, Christina; O'Connor, Lauren; Steward, Ranjana; Potter, Angela; Rasekaba, Tshepo; Scoones, Rebecca; Tarrant, Ben; Ward, Nathan; West, Samantha; White, Dianne; Wilson, Lisa; Wood, Jamie; Holland, Anne E

2016-05-01

Physiotherapy management is a key element of care for people with cystic fibrosis (CF) throughout the lifespan. Although considerable evidence exists to support physiotherapy management of CF, there is documented variation in practice. The aim of this guideline is to optimize the physiotherapy management of people with CF in Australia and New Zealand. A systematic review of the literature in key areas of physiotherapy practice for CF was undertaken. Recommendations were formulated based on National Health and Medical Research Council (Australia) guidelines and considered the quality, quantity and level of the evidence; the consistency of the body of evidence; the likely clinical impact; and applicability to physiotherapy practice in Australia and New Zealand. A total of 30 recommendations were made for airway clearance therapy, inhalation therapy, exercise assessment and training, musculoskeletal management, management of urinary incontinence, managing the newly diagnosed patient with CF, delivery of non-invasive ventilation, and physiotherapy management before and after lung transplantation. These recommendations can be used to underpin the provision of evidence-based physiotherapy care to people with CF in Australia and New Zealand. © 2016 The Authors Respirology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Respirology.

Resident use of the Internet, e-mail, and personal electronics in the care of surgical patients.

PubMed

Plant, Mathew A; Fish, Joel S

2015-01-01

The use of smartphones, e-mail, and the Internet has affected virtually all areas of patient care. Current university and hospital policies concerning the use of devices may be incongruent with day-to-day patient care. The goal was to assess the current usage patterns of the Internet, e-mail, and personal electronics for clinical purposes by surgical residents as well as their communication habits and preferences. Also assessed was residents' knowledge regarding the institutional policies surrounding these issues. Surgical residents (n = 294) at a large teaching institution were surveyed regarding their knowledge of university policies as well as daily use of various communication technologies. Communication preferences were determined using theoretical clinical scenarios. Our survey with a response rate of 54.7% (n = 161) revealed that 93.8% of participants indicated daily Internet use for clinical duties. Most respondents (72%) were either completely unaware of the existence of guidelines for its use or aware but had no familiarity with their content. Use of e-mail for clinical duties was common (85%), and 74% of the respondents rated e-mail as "very important" or "extremely important" for patient care. Everyone who responded had a mobile phone with 98.7% being "smartphones," which the majority (82.9%) stated was "very important" or "extremely important" for patient care. Text messaging was the primary communication method for 57.8% of respondents. The traditional paging system was the primary communication method for only 1.3% of respondents and the preferred method for none. Daily use of technology is the norm among residents; however, knowledge of university guidelines was exceedingly low. Residents need better education regarding current guidelines. Current guidelines do not reflect current clinical practice. Hospitals should consider abandoning the traditional paging system and consider facilitating better use of residents' mobile phones.

Using a cost-benefit analysis to estimate outcomes of a clinical treatment guideline: testing theBrain Trauma Foundation guidelines for the treatment of severe traumatic brain injury.

PubMed

Faul, Mark; Wald, Marlena M; Rutland-Brown, Wesley; Sullivent, Ernest E; Sattin, Richard W

2007-12-01

A decade after promulgation of treatment guidelines by the Brain Trauma Foundation (BTF), few studies exist that examine the application of these guidelines for severe traumatic brain injury (TBI) patients. These studies have reported both cost savings and reduced mortality. We projected the results of previous studies of BTF guideline adoption to estimate the impact of widespread adoption across the United States. We used surveillance systems and national surveys to estimate the number of severely injured TBI patients and compared the lifetime costs of BTF adoption to the current state of treatment. After examining the health outcomes and costs, we estimated that a substantial savings in annual medical costs ($262 million), annual rehabilitation costs ($43 million) and lifetime societal costs ($3.84 billion) would be achieved if treatment guidelines were used more routinely. Implementation costs were estimated to be $61 million. The net savings were primarily because of better health outcomes and a decreased burden on lifetime social support systems. We also estimate that mortality would be reduced by 3,607 lives if the guidelines were followed. Widespread adoption of the BTF guidelines for the treatment of severe TBI would result in substantial savings in costs and lives. The majority of cost savings are societal costs. Further validation work to identify the most effective aspects of the BTF guidelines is warranted.

Agreement between student dietitians' identification of refeeding syndrome risk with refeeding guidelines, electrolytes and other dietitians: a pilot study.

PubMed

Matthews, K; Owers, E; Palmer, M

2015-12-01

Limited research exists concerning how consistently and accurately student and newly-graduated dietitians are identifying refeeding syndrome risk in hospitalised patients. The present study aimed to determine the consistency of students' and newly-graduated dietitians' classification of refeeding syndrome risk, as well as agreement with the application of comparison tools such as the National Institute for Health and Care Excellence guidelines, patients' electrolytes and supplementation, and clinical dietitians previously surveyed. Recently-graduated and final-year Griffith University dietetics students were invited to complete an online survey. The survey questioned demographics and asked respondents to classify the level of refeeding syndrome risk (i.e. none, some, high, unsure) in 13 case studies. Electrolytes and supplementation data were sourced from electronic patient records. Chi-squared tests, t-tests and linear regression analyses were conducted. Fifty-three eligible people responded [n = 53 of 112, mean (SD) age 26 (4) years, 89% female, 34% graduates]. Respondents' answers were generally more consistent and more likely to agree with comparison tools when two tools showed the same level of refeeding syndrome risk (49-98%, β = 0.626-1.0994, P < 0.001) than when they differed (11-49%). Respondents' level of agreement with refeeding identification guidelines, electrolyte levels, supplementation and dietitians previously surveyed did not differ by graduate status, degree level, clinical placement status or having read refeeding syndrome guidelines recently (P > 0.05). Students' and new graduates' identification of refeeding syndrome risk improved when there was consistency between guidelines, electrolytes and dietitians' responses. More research is needed to improve the evidence behind refeeding guidelines, with the aim of enhancing the accuracy and consistency of assessment. © 2014 The British Dietetic Association Ltd.

Factors affecting general practitioners' decisions about plain radiography for back pain: implications for classification of guideline barriers--a qualitative study.

PubMed

Espeland, Ansgar; Baerheim, Anders

2003-03-24

General practitioners often diverge from clinical guidelines regarding spine radiography. This study aimed to identify and describe A) factors general practitioners consider may affect their decisions about ordering plain radiography for back pain and B) barriers to guideline adherence suggested by such factors. Focus group interviews regarding factors affecting ordering decisions were carried out on a diverse sample of Norwegian general practitioners and were analysed qualitatively. Results of this study and two qualitative studies from the Netherlands and USA on use of spine radiography were interpreted for barriers to guideline adherence. These were compared with an existing barrier classification system described by Dr Cabana's group. The factors which Norwegian general practitioners considered might affect their decisions about ordering plain radiography for back pain concerned the following broader issues: clinical ordering criteria, patients' wishes for radiography and the general practitioner's response, uncertainty, professional dignity, access to radiology services, perception of whether the patient really was ill, sense of pressure from other health care providers/social security, and expectations about the consequences of ordering radiography. The three studies suggested several attitude-related and external barriers as classified in a previously reported system described by Dr Cabana in another study. Identified barriers not listed in this system were: lack of expectancy that guideline adherence will lead to desired health care process, emotional difficulty with adherence, improper access to actual/alternative health care services, and pressure from health care providers/organisations. Our findings may help implement spine radiography guidelines. They also indicate that Cabana et al.'s barrier classification system needs extending. A revised system is proposed.

Factors affecting general practitioners' decisions about plain radiography for back pain: implications for classification of guideline barriers – a qualitative study

PubMed Central

Espeland, Ansgar; Baerheim, Anders

2003-01-01

Background General practitioners often diverge from clinical guidelines regarding spine radiography. This study aimed to identify and describe A) factors general practitioners consider may affect their decisions about ordering plain radiography for back pain and B) barriers to guideline adherence suggested by such factors. Methods Focus group interviews regarding factors affecting ordering decisions were carried out on a diverse sample of Norwegian general practitioners and were analysed qualitatively. Results of this study and two qualitative studies from the Netherlands and USA on use of spine radiography were interpreted for barriers to guideline adherence. These were compared with an existing barrier classification system described by Dr Cabana's group. Results The factors which Norwegian general practitioners considered might affect their decisions about ordering plain radiography for back pain concerned the following broader issues: clinical ordering criteria, patients' wishes for radiography and the general practitioner's response, uncertainty, professional dignity, access to radiology services, perception of whether the patient really was ill, sense of pressure from other health care providers/social security, and expectations about the consequences of ordering radiography. The three studies suggested several attitude-related and external barriers as classified in a previously reported system described by Dr Cabana in another study. Identified barriers not listed in this system were: lack of expectancy that guideline adherence will lead to desired health care process, emotional difficulty with adherence, improper access to actual/alternative health care services, and pressure from health care providers/organisations. Conclusions Our findings may help implement spine radiography guidelines. They also indicate that Cabana et al.'s barrier classification system needs extending. A revised system is proposed. PMID:12659640

A review of clinical practice guidelines for lung cancer

PubMed Central

Ball, David; Silvestri, Gerard A.

2013-01-01

Clinical practice guidelines are important evidence-based resources to guide complex clinical decision making. However, it is challenging for health professionals to keep abreast available guidelines and to know how and where to access relevant guidelines. This review examines currently available guidelines for lung cancer published in the English language. Important key features are listed for each identified guideline. The methodology, approaches to dissemination and implementation, and associated resources are summarised. General challenges in the area of guideline development are highlighted. The potential to collaborate more widely across lung cancer guideline developers by sharing literature searches and assessments is discussed. PMID:24163752

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.

Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa.

PubMed

Chingarande, George Rugare; Moodley, Keymanthri

2018-02-17

Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa (BRICS). A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration (2007). The search focused on three main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings (MeSH) and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis. The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees. It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence.

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

PubMed

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

2017-09-01

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

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.

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.

Implementing clinical protocols in oncology: quality gaps and the learning curve phenomenon.

PubMed

Kedikoglou, Simos; Syrigos, Konstantinos; Skalkidis, Yannis; Ploiarchopoulou, Fani; Dessypris, Nick; Petridou, Eleni

2005-08-01

The quality improvement effort in clinical practice has focused mostly on 'performance quality', i.e. on the development of comprehensive, evidence-based guidelines. This study aimed to assess the 'conformance quality', i.e. the extent to which guidelines once developed are correctly and consistently applied. It also aimed to assess the existence of quality gaps in the treatment of certain patient segments as defined by age or gender and to investigate methods to improve overall conformance quality. A retrospective audit of clinical practice in a well-defined oncology setting was undertaken and the results compared to those obtained from prospectively applying an internally developed clinical protocol in the same setting and using specific tools to increase conformance quality. All indicators showed improvement after the implementation of the protocol that in many cases reached statistical significance, while in the entire cohort advanced age was associated (although not significantly) with sub-optimal delivery of care. A 'learning curve' phenomenon in the implementation of quality initiatives was detected, with all indicators improving substantially in the second part of the prospective study. Clinicians should pay separate attention to the implementation of chosen protocols and employ specific tools to increase conformance quality in patient care.

Guidelines for Reporting Case Studies on Extracorporeal Treatments in Poisonings: Methodology

PubMed Central

Lavergne, Valéry; Ouellet, Georges; Bouchard, Josée; Galvao, Tais; Kielstein, Jan T; Roberts, Darren M; Kanji, Salmaan; Mowry, James B; Calello, Diane P; Hoffman, Robert S; Gosselin, Sophie; Nolin, Thomas D; Goldfarb, David S; Burdmann, Emmanuel A; Dargan, Paul I; Decker, Brian Scott; Hoegberg, Lotte C; Maclaren, Robert; Megarbane, Bruno; Sowinski, Kevin M; Yates, Christopher; Mactier, Robert; Wiegand, Timothy; Ghannoum, Marc

2014-01-01

A literature review performed by the EXtracorporeal TReatments In Poisoning (EXTRIP) workgroup highlighted deficiencies in the existing literature, especially the reporting of case studies. Although general reporting guidelines exist for case studies, there are none in the specific field of extracorporeal treatments in toxicology. Our goal was to construct and propose a checklist that systematically outlines the minimum essential items to be reported in a case study of poisoned patients undergoing extracorporeal treatments. Through a modified two-round Delphi technique, panelists (mostly chosen from the EXTRIP workgroup) were asked to vote on the pertinence of a set of items to identify those considered minimally essential for reporting complete and accurate case reports. Furthermore, independent raters validated the clarity of each selected items between each round of voting. All case reports containing data on extracorporeal treatments in poisoning published in Medline in 2011 were reviewed during the external validation rounds. Twenty-one panelists (20 from the EXTRIP workgroup and an invited expert on pharmacology reporting guidelines) participated in the modified Delphi technique. This group included journal editors and experts in nephrology, clinical toxicology, critical care medicine, emergency medicine, and clinical pharmacology. Three independent raters participated in the validation rounds. Panelists voted on a total of 144 items in the first round and 137 items in the second round, with response rates of 96.3% and 98.3%, respectively. Twenty case reports were evaluated at each validation round and the independent raters' response rate was 99.6% and 98.8% per validation round. The final checklist consists of 114 items considered essential for case study reporting. This methodology of alternate voting and external validation rounds was useful in developing the first reporting guideline for case studies in the field of extracorporeal treatments in poisoning. We believe that this guideline will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports may provide early signals of effectiveness and/or harm, thereby improving healthcare decision-making. PMID:24890576

The effect of interventions aiming to optimise the prescription of antibiotics in dental care—A systematic review

PubMed Central

Böhmer, Femke

2017-01-01

Background Abundant evidence in dentistry suggests that antibiotics are prescribed despite the existence of guidelines aiming to reduce the development of antibiotic resistance. This review investigated (1) which type of interventions aiming to optimise prescription of antibiotics exist in dentistry, (2) the effect of these interventions and (3) the specific strengths and limitations of the studies reporting on these interventions. Method Literature search was based on Medline, Embase, Global Health, Cochrane CENTRAL, ClinicalTrials.gov and Current Controlled Trials. Studies with one of the two primary outcomes were included: (1) The number of antibiotics prescribed and/or (2) the accuracy of the prescription, commonly measured as a percentage of adherence to local clinical guidelines. Results Nine studies met these inclusion criteria. Five studies reported on the prescription of antibiotics in primary dental care and four studies focused on outpatient dental care. Interventions used in primary dental care included a combination of audit, feedback, education, local consensus, dissemination of guidelines and/or academic detailing. Trials in the outpatient setting made use of expert panel discussions, educational feedback on previous acts of prescribing, the dissemination of guidelines and the establishment of internal guidelines. All studies successfully reduced the number of antibiotics prescribed and/or increased the accuracy of the prescription. However, most studies were confounded by a high risk of selection bias, selective outcome reporting and high variance across study groups. In particular, information relating to study design and methodology was insufficient. Only three studies related the prescriptions to the number of patients treated with antibiotics. Conclusions This systematic review was able to offer conclusions which took the limitations of the investigated studies into account. Unfortunately, few studies could be included and many of these studies were confounded by a low quality of scientific reporting and lack of information regarding study methodology. High-quality research with objective and standardised outcome reporting, longer periods of follow-up, rigorous methodology and adequate standard of study reporting is urgently needed. PMID:29136646

Email recruitment to use web decision support tools for pneumonia.

PubMed

Flanagan, James R; Peterson, Michael; Dayton, Charles; Strommer Pace, Lori; Plank, Andrew; Walker, Kristy; Carlson, William S

2002-01-01

Application of guidelines to improve clinical decisions for Community Acquired Pneumonia (CAP) patients depends on accurate information about specific facts of each case and on presenting guideline support at the time decisions are being made. We report here on a system designed to solicit information from physicians about their CAP patients in order to classify CAP and present appropriate guidelines for type of care, length of stay, and use of antibiotics. We used elements of three existing information systems to create a achieve these goals: professionals coding diagnoses captured by the existing clinical information system (CIS), email, and web-based decision support tools including a pneumonia severity evaluation tool (SET). The non-secure IS components (email and web) were able to link to information in the CIS using tokens that do not reveal confidential patient-identifiable information. We examined their response to this strategy and the accuracy of pneumonia classification using this approach compared to chart review as a gold standard. On average physicians responded to email solicitations 50% of the time over the 14 month study. Also using this standard, we examined various information triggers for case finding. Professional coding of the primary reason for admission as pneumonia was fairly sensitive as an indicator of CAP. Physician use of the web SET was insensitive but fairly specific. Pneumonia classification using the SET was very reliable compared to experts' chart review using the same algorithm. We examined the distribution of severity of pneumonia for cases of pneumonia found by the various information triggers and for each severity the average length of stay. The distribution found by both chart review and by SET has demonstrated a shift toward more severe cases being admitted compared to only 3 years ago. The length of stay for level of severity is above expectations published by guidelines even for cases of true CAP by chart review. We suggest that the Fine classification system may not adequately describe patients in this setting. Physicians frequently responded that the guidelines presented did not fit their patients.

Skin care practices in newborn nurseries and mother-baby units in Maryland.

PubMed

Khalifian, S; Golden, W C; Cohen, B A

2017-06-01

Skin provides several important homeostatic functions to the developing neonate. However, no consensus guidelines exist in the United States for skin care in the healthy term newborn. We performed a study of skin and umbilical cord care (including bathing practices, vernix removal and antiseptic cord application) in newborn nurseries and mother-baby units throughout the state of Maryland to determine practices in a variety of clinical settings and assess if uniformity in skin care exists. These data were then assessed in the context of a review of the current literature. We received responses from over 90% of nurseries across the state. In our cohort, practices varied widely between institutions and specific populations, and often were not evidence-based or were contrary to best practices discussed in the scientific literature. The frequent departures from evidence that occur regarding the aforementioned practices are likely due to a lack of consensus on these issues as well as limited data on such practices, further highlighting the need for data-driven guidelines on newborn skin care.

Practical Recommendations of the Obesity Management Task Force of the European Association for the Study of Obesity for the Post-Bariatric Surgery Medical Management

PubMed Central

Busetto, Luca; Dicker, Dror; Azran, Carmil; Batterham, Rachel L.; Farpour-Lambert, Nathalie; Fried, Martin; Hjelmesæth, Jøran; Kinzl, Johann; Leitner, Deborah R.; Makaronidis, Janine M.; Schindler, Karin; Toplak, Hermann; Yumuk, Volkan

2018-01-01

Bariatric surgery is today the most effective long-term therapy for the management of patients with severe obesity, and its use is recommended by the relevant guidelines of the management of obesity in adults. Bariatric surgery is in general safe and effective, but it can cause new clinical problems and is associated with specific diagnostic, preventive and therapeutic needs. For clinicians, the acquisition of special knowledge and skills is required in order to deliver appropriate and effective care to the post-bariatric patient. In the present recommendations, the basic notions needed to provide first-level adequate medical care to post-bariatric patients are summarised. Basic information about nutrition, management of co-morbidities, pregnancy, psychological issues as well as weight regain prevention and management is derived from current evidences and existing guidelines. A short list of clinical practical recommendations is included for each item. It remains clear that referral to a bariatric multidisciplinary centre, preferably the one performing the original procedure, should be considered in case of more complex clinical situations. PMID:29207379

The implementation of a community-based aerobic walking program for mild to moderate knee osteoarthritis (OA): a knowledge translation (KT) randomized controlled trial (RCT): Part I: The Uptake of the Ottawa Panel clinical practice guidelines (CPGs)

PubMed Central

2012-01-01

Background The implementation of evidence based clinical practice guidelines on self-management interventions to patients with chronic diseases is a complex process. A multifaceted strategy may offer an effective knowledge translation (KT) intervention to promote knowledge uptake and improve adherence in an effective walking program based on the Ottawa Panel Evidence Based Clinical Practice Guidelines among individuals with moderate osteoarthritis (OA). Methods A single-blind, randomized control trial was conducted. Patients with mild to moderate (OA) of the knee (n=222) were randomized to one of three KT groups: 1) Walking and Behavioural intervention (WB) (18 males, 57 females) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking for OA; 2) Walking intervention (W) (24 males, 57 females) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet; 3) Self-directed control (C) (32 males, 52 females) wherein participants only received the educational pamphlet. One-way analyses of variance were used to test for differences in quality of life, adherence, confidence, and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period. Results Short-term program adherence was greater in WB compared to C (p<0.012) after 3 months. No statistical significance (p> 0.05) was observed for long-term adherence (6 to 12 months), and total adherence between the three groups. The three knowledge translation strategies demonstrated equivalent long-term results for the implementation of a walking program for older individuals with moderate OA. Lower dropout rates as well as higher retention rates were observed for WB at 12 and 18 months. Conclusion The additional knowledge translation behavioural component facilitated the implementation of clinical practice guidelines on walking over a short-term period. More studies are needed to improve the long-term walking adherence or longer guidelines uptake on walking among participants with OA. Particular attention should be taken into account related to patient’s characteristic and preference. OA can be managed through the implementation of a walking program based on clinical practice guidelines in existing community-based walking clubs as well as at home with the minimal support of an exercise therapist or a trained volunteer. Trial Registration Current Controlled Trials IRSCTNO9193542 PMID:23061875

Efficacy and Safety of a Colistin Loading Dose, High-Dose Maintenance Regimen in Critically Ill Patients With Multidrug-Resistant Gram-Negative Pneumonia.

PubMed

Elefritz, Jessica L; Bauer, Karri A; Jones, Christian; Mangino, Julie E; Porter, Kyle; Murphy, Claire V

2017-09-01

Emergence of multidrug-resistant (MDR) gram-negative (GN) pathogens and lack of novel antibiotics have increased the use of colistin, despite unknown optimal dosing. This study aimed to evaluate the safety and efficacy of a colistin loading dose, high-dose (LDHD) maintenance regimen in patients with MDR-GN pneumonia. A retrospective cohort analysis was performed comparing critically ill patients with MDR-GN pneumonia pre- and postimplementation of a colistin LDHD guideline with a primary outcome of clinical cure. Safety was assessed using incidence of acute kidney injury (AKI) based on RIFLE (risk, injury, failure, loss, end-stage renal disease) criteria. Seventy-two patients met the inclusion criteria (42 preimplementation and 30 postimplementation). Clinical cure was achieved in 23 (55%) patients in the preimplementation group and 20 (67%) patients in the postimplementation group ( P = .31). AKI occurred in 50% of the patients during the preimplementation period and 58% during the postimplementation period ( P = .59) with no difference in initiation rates of renal replacement therapy. The increased clinical cure rate after implementation of the colistin LDHD guideline did not reach statistical significance. The LDHD guideline, however, was not associated with an increased incidence of AKI, despite higher intravenous colistin doses. Opportunity exists to optimize colistin dosage while balancing toxicity, but larger studies are warranted.

Puzzle test: A tool for non-analytical clinical reasoning assessment.

PubMed

Monajemi, Alireza; Yaghmaei, Minoo

2016-01-01

Most contemporary clinical reasoning tests typically assess non-automatic thinking. Therefore, a test is needed to measure automatic reasoning or pattern recognition, which has been largely neglected in clinical reasoning tests. The Puzzle Test (PT) is dedicated to assess automatic clinical reasoning in routine situations. This test has been introduced first in 2009 by Monajemi et al in the Olympiad for Medical Sciences Students.PT is an item format that has gained acceptance in medical education, but no detailed guidelines exist for this test's format, construction and scoring. In this article, a format is described and the steps to prepare and administer valid and reliable PTs are presented. PT examines a specific clinical reasoning task: Pattern recognition. PT does not replace other clinical reasoning assessment tools. However, it complements them in strategies for assessing comprehensive clinical reasoning.

Chiropractic quality assurance: standards and guidelines

PubMed Central

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

2001-01-01

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

Increased risk of RSV infection in children with Down's syndrome: clinical implementation of prophylaxis in the European Union.

PubMed

van Beek, Dianne; Paes, Bosco; Bont, Louis

2013-01-01

Prospective cohort studies show that Down's syndrome (DS) is an independent risk factor for hospitalization for RSV bronchiolitis. It is unknown whether this observation has been translated into specific management for DS children. The primary goal was to assess the knowledge of healthcare providers in the European Union about RSV infection in DS children and to determine whether it influenced the implementation of prophylaxis. DS caregivers were surveyed using a standardized questionnaire, and country-specific guidelines were obtained. Fifty-three caregivers participated. Thirty-nine (86.7%) had knowledge of the increased risk of severe RSV infection in DS children, and 30 (71.4%) graded that it was important to have a statement on the use of RSV prophylaxis in existing guidelines. Twenty-eight participants had a local DS guideline; hard copies of twelve unique guidelines were obtained. Only one (8.3%) contained a statement on RSV prophylaxis for DS, and five considered such a statement for the next version. Conclusion. Most pediatricians had knowledge that DS children have an increased risk of severe RSV infection. Despite the lack of a specific RSV prophylaxis trial in DS, they felt that a statement on RSV prophylaxis in DS guidelines was important, but this was rarely present in current guidelines.

The International College of Neuropsychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 1: Background and Methods of the Development of Guidelines

PubMed Central

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

2017-01-01

Abstract Background: This paper includes a short description of the important clinical aspects of Bipolar Disorder with emphasis on issues that are important for the therapeutic considerations, including mixed and psychotic features, predominant polarity, and rapid cycling as well as comorbidity. Methods: The workgroup performed a review and critical analysis of the literature concerning grading methods and methods for the development of guidelines. Results: The workgroup arrived at a consensus to base the development of the guideline on randomized controlled trials and related meta-analyses alone in order to follow a strict evidence-based approach. A critical analysis of the existing methods for the grading of treatment options was followed by the development of a new grading method to arrive at efficacy and recommendation levels after the analysis of 32 distinct scenarios of available data for a given treatment option. Conclusion: The current paper reports details on the design, method, and process for the development of CINP guidelines for the treatment of Bipolar Disorder. The rationale and the method with which all data and opinions are combined in order to produce an evidence-based operationalized but also user-friendly guideline and a specific algorithm are described in detail in this paper. PMID:27815414

Increased Risk of RSV Infection in Children with Down's Syndrome: Clinical Implementation of Prophylaxis in the European Union

PubMed Central

Paes, Bosco; Bont, Louis

2013-01-01

Prospective cohort studies show that Down's syndrome (DS) is an independent risk factor for hospitalization for RSV bronchiolitis. It is unknown whether this observation has been translated into specific management for DS children. The primary goal was to assess the knowledge of healthcare providers in the European Union about RSV infection in DS children and to determine whether it influenced the implementation of prophylaxis. DS caregivers were surveyed using a standardized questionnaire, and country-specific guidelines were obtained. Fifty-three caregivers participated. Thirty-nine (86.7%) had knowledge of the increased risk of severe RSV infection in DS children, and 30 (71.4%) graded that it was important to have a statement on the use of RSV prophylaxis in existing guidelines. Twenty-eight participants had a local DS guideline; hard copies of twelve unique guidelines were obtained. Only one (8.3%) contained a statement on RSV prophylaxis for DS, and five considered such a statement for the next version. Conclusion. Most pediatricians had knowledge that DS children have an increased risk of severe RSV infection. Despite the lack of a specific RSV prophylaxis trial in DS, they felt that a statement on RSV prophylaxis in DS guidelines was important, but this was rarely present in current guidelines. PMID:23878586

Secondary Prevention of Cervical Cancer: ASCO Resource-Stratified Clinical Practice Guideline.

PubMed

Jeronimo, Jose; Castle, Philip E; Temin, Sarah; Denny, Lynette; Gupta, Vandana; Kim, Jane J; Luciani, Silvana; Murokora, Daniel; Ngoma, Twalib; Qiao, Youlin; Quinn, Michael; Sankaranarayanan, Rengaswamy; Sasieni, Peter; Schmeler, Kathleen M; Shastri, Surendra S

2017-10-01

To provide resource-stratified, evidence-based recommendations on the secondary prevention of cervical cancer globally. ASCO convened a multidisciplinary, multinational panel of oncology, primary care, epidemiology, health economic, cancer control, public health, and patient advocacy experts to produce recommendations reflecting four resource-tiered settings. A review of existing guidelines, a formal consensus-based process, and a modified ADAPTE process to adapt existing guidelines were conducted. Other experts participated in formal consensus. Seven existing guidelines were identified and reviewed, and adapted recommendations form the evidence base. Four systematic reviews plus cost-effectiveness analyses provided indirect evidence to inform consensus, which resulted in ≥ 75% agreement. Human papillomavirus (HPV) DNA testing is recommended in all resource settings; visual inspection with acetic acid may be used in basic settings. Recommended age ranges and frequencies by setting are as follows: maximal: ages 25 to 65, every 5 years; enhanced: ages 30 to 65, if two consecutive negative tests at 5-year intervals, then every 10 years; limited: ages 30 to 49, every 10 years; and basic: ages 30 to 49, one to three times per lifetime. For basic settings, visual assessment is recommended as triage; in other settings, genotyping and/or cytology are recommended. For basic settings, treatment is recommended if abnormal triage results are present; in other settings, colposcopy is recommended for abnormal triage results. For basic settings, treatment options are cryotherapy or loop electrosurgical excision procedure; for other settings, loop electrosurgical excision procedure (or ablation) is recommended. Twelve-month post-treatment follow-up is recommended in all settings. Women who are HIV positive should be screened with HPV testing after diagnosis and screened twice as many times per lifetime as the general population. Screening is recommended at 6 weeks postpartum in basic settings; in other settings, screening is recommended at 6 months. In basic settings without mass screening, infrastructure for HPV testing, diagnosis, and treatment should be developed.Additional information can be found at www.asco.org/rs-cervical-cancer-secondary-prev-guideline and www.asco.org/guidelineswiki.It is the view of of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement, but not replace, local guidelines.

Secondary Prevention of Cervical Cancer: ASCO Resource-Stratified Clinical Practice Guideline

PubMed Central

Jeronimo, Jose; Castle, Philip E.; Temin, Sarah; Denny, Lynette; Gupta, Vandana; Kim, Jane J.; Luciani, Silvana; Murokora, Daniel; Ngoma, Twalib; Qiao, Youlin; Quinn, Michael; Sankaranarayanan, Rengaswamy; Sasieni, Peter; Schmeler, Kathleen M.; Shastri, Surendra S.

2017-01-01

Purpose To provide resource-stratified, evidence-based recommendations on the secondary prevention of cervical cancer globally. Methods ASCO convened a multidisciplinary, multinational panel of oncology, primary care, epidemiology, health economic, cancer control, public health, and patient advocacy experts to produce recommendations reflecting four resource-tiered settings. A review of existing guidelines, a formal consensus-based process, and a modified ADAPTE process to adapt existing guidelines were conducted. Other experts participated in formal consensus. Results Seven existing guidelines were identified and reviewed, and adapted recommendations form the evidence base. Four systematic reviews plus cost-effectiveness analyses provided indirect evidence to inform consensus, which resulted in ≥ 75% agreement. Recommendations Human papillomavirus (HPV) DNA testing is recommended in all resource settings; visual inspection with acetic acid may be used in basic settings. Recommended age ranges and frequencies by setting are as follows: maximal: ages 25 to 65, every 5 years; enhanced: ages 30 to 65, if two consecutive negative tests at 5-year intervals, then every 10 years; limited: ages 30 to 49, every 10 years; and basic: ages 30 to 49, one to three times per lifetime. For basic settings, visual assessment is recommended as triage; in other settings, genotyping and/or cytology are recommended. For basic settings, treatment is recommended if abnormal triage results are present; in other settings, colposcopy is recommended for abnormal triage results. For basic settings, treatment options are cryotherapy or loop electrosurgical excision procedure; for other settings, loop electrosurgical excision procedure (or ablation) is recommended. Twelve-month post-treatment follow-up is recommended in all settings. Women who are HIV positive should be screened with HPV testing after diagnosis and screened twice as many times per lifetime as the general population. Screening is recommended at 6 weeks postpartum in basic settings; in other settings, screening is recommended at 6 months. In basic settings without mass screening, infrastructure for HPV testing, diagnosis, and treatment should be developed. Additional information can be found at www.asco.org/rs-cervical-cancer-secondary-prev-guideline and www.asco.org/guidelineswiki. It is the view of of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement, but not replace, local guidelines. PMID:29094101

Differential diagnosis of common tremor syndromes

PubMed Central

Bhidayasiri, R

2005-01-01

Tremor is one of the most common involuntary movement disorders seen in clinical practice. In addition to the detailed history, the differential diagnosis is mainly clinical based on the distinction at rest, postural and intention, activation condition, frequency, and topographical distribution. The causes of tremor are heterogeneous and it can present alone (for example, essential tremor) or as a part of a neurological syndrome (for example, multiple sclerosis). Essential tremor and the tremor of Parkinson's disease are the most common tremors encountered in clinical practice. This article focuses on a practical approach to these different forms of tremor and how to distinguish them clinically. Evidence supporting various strategies used in the differentiation is then presented, followed by a review of formal guidelines or recommendations when they exist. PMID:16344298

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.

MO-A-BRC-02: TG167 Report - Detailed Description

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

Rivard, M.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

MO-A-BRC-01: TG167 Report - Introduction

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

Nath, R.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1)more » dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

Knowledge Translation in Audiology

PubMed Central

Kothari, Anita; Bagatto, Marlene P.; Seewald, Richard; Miller, Linda T.; Scollie, Susan D.

2011-01-01

The impetus for evidence-based practice (EBP) has grown out of widespread concern with the quality, effectiveness (including cost-effectiveness), and efficiency of medical care received by the public. Although initially focused on medicine, EBP principles have been adopted by many of the health care professions and are often represented in practice through the development and use of clinical practice guidelines (CPGs). Audiology has been working on incorporating EBP principles into its mandate for professional practice since the mid-1990s. Despite widespread efforts to implement EBP and guidelines into audiology practice, gaps still exist between the best evidence based on research and what is being done in clinical practice. A collaborative dynamic and iterative integrated knowledge translation (KT) framework rather than a researcher-driven hierarchical approach to EBP and the development of CPGs has been shown to reduce the knowledge-to-clinical action gaps. This article provides a brief overview of EBP and CPGs, including a discussion of the barriers to implementing CPGs into clinical practice. It then offers a discussion of how an integrated KT process combined with a community of practice (CoP) might facilitate the development and dissemination of evidence for clinical audiology practice. Finally, a project that uses the knowledge-to-action (KTA) framework for the development of outcome measures in pediatric audiology is introduced. PMID:22194314

Implementing practice guidelines: lessons from public mental health settings.

PubMed

Parks, Joseph J

2007-01-01

There is evidence that state-of-the-art psychiatric treatments are not being translated into community settings, resulting in the de facto denial of up-to-date psychiatric care for many Americans with mental illness. Although multiple models of evidence-based care exist, little is known about how to disseminate information regarding these models to clinicians in real-world practice. Suggested solutions have included the use of published practice guidelines, such as the American Psychiatric Association Practice Guidelines and the Expert Consensus Guidelines, or algorithm-based programs, such as the Texas Medication Algorithm Project. Unfortunately, the real-world utility of practice guidelines tends to be limited, because their implementation depends entirely on practitioner self-motivation. Similarly, the use of algorithm-based programs may be limited by their pervasive high specificity, practitioner resistance, and various patient misperceptions. Another solution is the implementation of evidence-based practices (EBPs), such as the Substance Abuse and Mental Health Services Administration (SAMHSA) EBPs. However, states' use of the SAMHSA EBPs has been hampered by misalignment of the funding structure, lack of information regarding EBPs, high costs to train and supervise staff, staff turnover, and a lack of resources. As a result, federal and clinical/professional agencies have called for a change in the nation's mental health care delivery system, supplying persuasive arguments for the economic and clinical superiority of integrated care models. One such model, the Missouri Medical Risk Management (MRM) Program for Medicaid Recipients with Schizophrenia, currently assists patients identified as being at high risk for adverse medical and behavioral outcomes. Preliminary results from the Missouri MRM Program are described.

Adjuvant and Salvage Radiation Therapy After Prostatectomy: American Society for Radiation Oncology/American Urological Association Guidelines

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

Valicenti, Richard K., E-mail: Richard.valicenti@ucdmc.ucdavis.edu; Thompson, Ian; Albertsen, Peter

Purpose: The purpose of this guideline was to provide a clinical framework for the use of radiation therapy after radical prostatectomy as adjuvant or salvage therapy. Methods and Materials: A systematic literature review using PubMed, Embase, and Cochrane database was conducted to identify peer-reviewed publications relevant to the use of radiation therapy after prostatectomy. The review yielded 294 articles; these publications were used to create the evidence-based guideline statements. Additional guidance is provided as Clinical Principles when insufficient evidence existed. Results: Guideline statements are provided for patient counseling, use of radiation therapy in the adjuvant and salvage contexts, defining biochemicalmore » recurrence, and conducting a restaging evaluation. Conclusions: Physicians should offer adjuvant radiation therapy to patients with adverse pathologic findings at prostatectomy (ie, seminal vesicle invastion, positive surgical margins, extraprostatic extension) and salvage radiation therapy to patients with prostate-specific antigen (PSA) or local recurrence after prostatectomy in whom there is no evidence of distant metastatic disease. The offer of radiation therapy should be made in the context of a thoughtful discussion of possible short- and long-term side effects of radiation therapy as well as the potential benefits of preventing recurrence. The decision to administer radiation therapy should be made by the patient and the multidisciplinary treatment team with full consideration of the patient's history, values, preferences, quality of life, and functional status. The American Society for Radiation Oncology and American Urological Association websites show this guideline in its entirety, including the full literature review.« less

Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline.

PubMed

Foster, Harris E; Barry, Michael J; Dahm, Philipp; Gandhi, Manhar C; Kaplan, Steven A; Kohler, Tobias S; Lerner, Lori B; Lightner, Deborah J; Parsons, J Kellogg; Roehrborn, Claus G; Welliver, Charles; Wilt, Timothy J; McVary, Kevin T

2018-06-11

Male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is common in men and can have negative effects on quality of life (QOL). It is the hope that this Guideline becomes a reference on the effective evidence-based surgical management of LUTS/BPH. The evidence team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies indexed between January 2007 and September 2017. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions (table 1 in supplementary unabridged guideline, http://jurology.com/). This Guideline provides updated, evidence-based recommendations regarding management of LUTS/BPH utilizing surgery and minimally invasive surgical therapies; additional statements are made regarding diagnostic and pre-operative tests. Clinical statements are made in comparison to what is generally accepted as the gold standard (i.e. transurethral resection of the prostate [TURP]- monopolar and/or bipolar). This guideline is designed to be used in conjunction with the associated treatment algorithm. The prevalence and the severity of LUTS increases as men age and is an important diagnosis in the healthcare of patients and the welfare of society. This document will undergo additional literature reviews and updating as the knowledge regarding current treatments and future surgical options continues to expand. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

International Continence Society supported pelvic physiotherapy education guideline.

PubMed

Bakker, Els; Shelly, Beth; Esch, Fetske H; Frawley, Helena; McClurg, Doreen; Meyers, Peter

2018-02-01

To provide a guideline of desired knowledge, clinical skills and education levels in Pelvic Physiotherapy (PT). Physiotherapy (PT) involves "using knowledge and skills unique to physiotherapists" and, "is the service only provided by, or under the direction and supervision of a physiotherapist." 1 METHODS: The PT Committee, within the body of the International Continence Society (ICS), collected information regarding existing educational levels for pelvic floor PT. Through face to face and on on-line discussion consensus was reached which was summarized in three progressive educational levels based on knowledge and skills and brought together in a guideline. The guideline was submitted to all physiotherapists and the Educational Committee of the ICS, and after approval, submitted to the Executive Board of the ICS. The guideline lists, in a progressive way, knowledge areas and skills to be achieved by education. It is broad and allows for individual interpretation based on local situations regarding education and healthcare possibilities. It is intended to be dynamic and updated on a regular basis. The proposed Pelvic PT education guideline is a dynamic document that allows course creators to plan topics for continuing course work and to recognize educational level of a therapist in the field of Pelvic PT. This education guideline can be used to set minimum worldwide standards resulting in higher skill levels for local pelvic physiotherapists and thereby better patient care outcome. © 2018 Wiley Periodicals, Inc.

Developing clinical practice guidelines: reviewing, reporting, and publishing guidelines; updating guidelines; and the emerging issues of enhancing guideline implementability and accounting for comorbid conditions in guideline development

PubMed Central

2012-01-01

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this third paper we discuss the issues of: reviewing, reporting, and publishing guidelines; updating guidelines; and the two emerging issues of enhancing guideline implementability and how guideline developers should approach dealing with the issue of patients who will be the subject of guidelines having co-morbid conditions. PMID:22762242

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

PubMed Central

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

2014-01-01

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

Authoring and verification of clinical guidelines: a model driven approach.

PubMed

Pérez, Beatriz; Porres, Ivan

2010-08-01

The goal of this research is to provide a framework to enable authoring and verification of clinical guidelines. The framework is part of a larger research project aimed at improving the representation, quality and application of clinical guidelines in daily clinical practice. The verification process of a guideline is based on (1) model checking techniques to verify guidelines against semantic errors and inconsistencies in their definition, (2) combined with Model Driven Development (MDD) techniques, which enable us to automatically process manually created guideline specifications and temporal-logic statements to be checked and verified regarding these specifications, making the verification process faster and cost-effective. Particularly, we use UML statecharts to represent the dynamics of guidelines and, based on this manually defined guideline specifications, we use a MDD-based tool chain to automatically process them to generate the input model of a model checker. The model checker takes the resulted model together with the specific guideline requirements, and verifies whether the guideline fulfils such properties. The overall framework has been implemented as an Eclipse plug-in named GBDSSGenerator which, particularly, starting from the UML statechart representing a guideline, allows the verification of the guideline against specific requirements. Additionally, we have established a pattern-based approach for defining commonly occurring types of requirements in guidelines. We have successfully validated our overall approach by verifying properties in different clinical guidelines resulting in the detection of some inconsistencies in their definition. The proposed framework allows (1) the authoring and (2) the verification of clinical guidelines against specific requirements defined based on a set of property specification patterns, enabling non-experts to easily write formal specifications and thus easing the verification process. Copyright 2010 Elsevier Inc. All rights reserved.

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

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY PROTOCOL FOR STANDARDIZED PRODUCTION OF CLINICAL PRACTICE GUIDELINES, ALGORITHMS, AND CHECKLISTS - 2017 UPDATE.

PubMed

Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Camacho, Pauline; Correa, Ricardo; Figaro, M Kathleen; Garber, Jeffrey R; Jasim, Sina; Pantalone, Kevin M; Trence, Dace; Upala, Sikarin

2017-08-01

Clinical practice guideline (CPG), clinical practice algorithm (CPA), and clinical checklist (CC, collectively CPGAC) development is a high priority of the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE). This 2017 update in CPG development consists of (1) a paradigm change wherein first, environmental scans identify important clinical issues and needs, second, CPA construction focuses on these clinical issues and needs, and third, CPG provide CPA node/edge-specific scientific substantiation and appended CC; (2) inclusion of new technical semantic and numerical descriptors for evidence types, subjective factors, and qualifiers; and (3) incorporation of patient-centered care components such as economics and transcultural adaptations, as well as implementation, validation, and evaluation strategies. This third point highlights the dominating factors of personal finances, governmental influences, and third-party payer dictates on CPGAC implementation, which ultimately impact CPGAC development. The AACE/ACE guidelines for the CPGAC program is a successful and ongoing iterative exercise to optimize endocrine care in a changing and challenging healthcare environment. AACE = American Association of Clinical Endocrinologists ACC = American College of Cardiology ACE = American College of Endocrinology ASeRT = ACE Scientific Referencing Team BEL = best evidence level CC = clinical checklist CPA = clinical practice algorithm CPG = clinical practice guideline CPGAC = clinical practice guideline, algorithm, and checklist EBM = evidence-based medicine EHR = electronic health record EL = evidence level G4GAC = Guidelines for Guidelines, Algorithms, and Checklists GAC = guidelines, algorithms, and checklists HCP = healthcare professional(s) POEMS = patient-oriented evidence that matters PRCT = prospective randomized controlled trial.

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

Orbital infections: a complete cycle 7-year audit and a management guideline.

PubMed

Atfeh, Mihiar Sami; Singh, Kathryn; Khalil, Hisham Saleh

2018-06-04

Orbital infections are regularly encountered and are managed by various healthcare disciplines. Sepsis of the orbit and adjacent tissues can be associated with considerable acute complication and long-term sequelae. Therefore, prompt recognition and management of this condition are crucial. This article presents the outcomes of a 7-year complete cycle audit project and describes the development of the new local guideline on the management of orbital infections in our tertiary centre. (1) A retrospective 5-year audit cycle on patients with orbital infections. (2) A review of available evidence on the management of orbital infections. (3) A new local multidisciplinary guideline on the management of orbital infections. (4) A retrospective 2-year second audit cycle to assess the clinical outcomes. Various disciplines intersect in the management of orbital infections. Standardising the management of this condition proved to be achievable through the developed guideline. However, room for improvement in practice exists in areas such as the promptness in referring patients to specialist care, the multidisciplinary assessment of patients on admission, and the improvement of scanning requests of patients.

Integrating values and consumer involvement in guidelines with the patient at the center: article 8 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Kelson, Marcia; Akl, Elie A; Bastian, Hilda; Cluzeau, Françoise; Curtis, J Randall; Guyatt, Gordon; Montori, Victor M; Oliver, Sandy; Schünemann, Holger J

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence. They are also realizing the need to involve consumers of healthcare (patients, caregivers, and the public) and integrate their values and preferences in clinical guideline development. This is the eighth of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases. It focuses on where to find information about consumer values and preferences, at what points in the guideline development process to integrate their values and preferences, and why. In this review, we addressed the following questions: (1) What do we mean by "consumers"? (2) Why integrate the values and preferences of consumers of healthcare (patients, caregivers, and the public) into clinical practice guidelines? (3) What are the sources of information on consumer values? (4) When and how should consumer values and preferences be integrated into chronic obstructive pulmonary disease guideline recommendations? We defined consumers as patients, caregivers, and members of the public, excluding groups that may also be identified as consumers of guidelines including health professionals, providers, and commissioners of services. We searched PubMed and other databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on available evidence, supplemented by a rapid appraisal of a selection of qualitative studies, experience of what guideline developers are doing, and workshop discussions. A clear distinction needs to be made between the use of information on consumer values and preferences by guideline developers, and the direct involvement of consumers in guideline development processes. Sources of information on consumer values include the research literature and direct elicitation of values both from organizations representing consumer interests and from individuals. To complement the identification of consumer values, there are a range of methods for involving consumers at all stages of guideline development, from consultation to direct membership of guideline development groups. Evidence-based guidelines need to consider explicitly the values and preferences of all relevant stakeholders (including those of consumers) and to provide opportunities for patients, caregivers, and the public to engage in the processes that consider and integrate those values into the development of guideline recommendations.

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

Development of a South African integrated syndromic respiratory disease guideline for primary care.

PubMed

English, René G; Bateman, Eric D; Zwarenstein, Merrick F; Fairall, Lara R; Bheekie, Angeni; Bachmann, Max O; Majara, Bosielo; Ottmani, Salah-Eddine; Scherpbier, Robert W

2008-09-01

The Practical Approach to Lung Health in South Africa (PALSA) initiative aimed to develop an integrated symptom- and sign-based (syndromic) respiratory disease guideline for nurse care practitioners working in primary care in a developing country. A multidisciplinary team developed the guideline after reviewing local barriers to respiratory health care provision, relevant health care policies, existing respiratory guidelines, and literature. Guideline drafts were evaluated by means of focus group discussions. Existing evidence-based guideline development methodologies were tailored for development of the guideline. A locally-applicable guideline based on syndromic diagnostic algorithms was developed for the management of patients 15 years and older who presented to primary care facilities with cough or difficulty breathing. PALSA has developed a guideline that integrates and presents diagnostic and management recommendations for priority respiratory diseases in adults using a symptom- and sign-based algorithmic guideline for nurses in developing countries.

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

PubMed

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

2015-05-08

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

Guideline.gov: A Database of Clinical Specialty Guidelines.

PubMed

El-Khayat, Yamila M; Forbes, Carrie S; Coghill, Jeffrey G

2017-01-01

The National Guidelines Clearinghouse (NGC), also known as Guideline.gov, is a database of resources to assist health care providers with a central depository of guidelines for clinical specialty areas in medicine. The database is provided free of charge and is sponsored by the U.S. Department of Health and Human Services and the Agency for Healthcare Research and Quality. The guidelines for treatment are updated regularly, with new guidelines replacing older guidelines every five years. There are hundreds of current guidelines with more added each week. The purpose and goal of NGC is to provide physicians, nurses, and other health care providers, insurance companies, and others in the field of health care with a unified database of the most current, detailed, relevant, and objective clinical practice guidelines.

Semantic Clinical Guideline Documents

PubMed Central

Eriksson, Henrik; Tu, Samson W.; Musen, Mark

2005-01-01

Decision-support systems based on clinical practice guidelines can support physicians and other health-care personnel in the process of following best practice consistently. A knowledge-based approach to represent guidelines makes it possible to encode computer-interpretable guidelines in a formal manner, perform consistency checks, and use the guidelines directly in decision-support systems. Decision-support authors and guideline users require guidelines in human-readable formats in addition to computer-interpretable ones (e.g., for guideline review and quality assurance). We propose a new document-oriented information architecture that combines knowledge-representation models with electronic and paper documents. The approach integrates decision-support modes with standard document formats to create a combined clinical-guideline model that supports on-line viewing, printing, and decision support. PMID:16779037

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.

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

PubMed

Dogra, Nisha

2007-03-01

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

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: V. The 2014 Ancillary Therapy and Supportive Care Working Group Report

PubMed Central

Carpenter, Paul A.; Kitko, Carrie L.; Elad, Sharon; Flowers, Mary E.D.; Gea-Banacloche, Juan C.; Halter, Jörg P.; Hoodin, Flora; Johnston, Laura; Lawitschka, Anita; McDonald, George B.; Opipari, Anthony W.; Savani, Bipin N.; Schultz, Kirk R.; Smith, Sean R.; Syrjala, Karen L.; Treister, Nathaniel; Vogelsang, Georgia B.; Williams, Kirsten M.; Pavletic, Steven Z.; Martin, Paul J.; Lee, Stephanie J.; Couriel, Daniel R.

2016-01-01

The 2006 National Institutes of Health (NIH) Consensus paper presented recommendations by the Ancillary Therapy and Supportive Care Working Group to support clinical research trials in chronic graft-versus-host disease (GVHD). Topics covered in that inaugural effort included the prevention and management of infections and common complications of chronic GVHD, as well as recommendations for patient education and appropriate follow-up. Given the new literature that has emerged during the past 8 years, we made further organ-specific refinements to these guidelines. Minimum frequencies are suggested for monitoring key parameters relevant to chronic GVHD during systemic immunosuppressive therapy and, thereafter, referral to existing late effects consensus guidelines is advised. Using the framework of the prior consensus, the 2014 NIH recommendations are organized by organ or other relevant systems and graded according to the strength and quality of supporting evidence. PMID:25838185

Distribution and determinants of pneumonia diagnosis using Integrated Management of Childhood Illness guidelines: a nationally representative study in Malawi.

PubMed

Uwemedimo, Omolara T; Lewis, Todd P; Essien, Elsie A; Chan, Grace J; Nsona, Humphreys; Kruk, Margaret E; Leslie, Hannah H

2018-01-01

Pneumonia remains the leading cause of child mortality in sub-Saharan Africa. The Integrated Management of Childhood Illness (IMCI) strategy was developed to standardise care in low-income and middle-income countries for major childhood illnesses and can effectively improve healthcare worker performance. Suboptimal clinical evaluation can result in missed diagnoses and excess morbidity and mortality. We estimate the sensitivity of pneumonia diagnosis and investigate its determinants among children in Malawi. Data were obtained from the 2013-2014 Service Provision Assessment survey, a census of health facilities in Malawi that included direct observation of care and re-examination of children by trained observers. We calculated sensitivity of pneumonia diagnosis and used multilevel log-binomial regression to assess factors associated with diagnostic sensitivity. 3136 clinical visits for children 2-59 months old were observed at 742 health facilities. Healthcare workers completed an average of 30% (SD 13%) of IMCI guidelines in each encounter. 573 children met the IMCI criteria for pneumonia; 118 (21%) were correctly diagnosed. Advanced practice clinicians were more likely than other providers to diagnose pneumonia correctly (adjusted relative risk 2.00, 95% CI 1.21 to 3.29). Clinical quality was strongly associated with correct diagnosis: sensitivity was 23% in providers at the 75th percentile for guideline adherence compared with 14% for those at the 25th percentile. Contextual factors, facility structural readiness, and training or supervision were not associated with sensitivity. Care quality for Malawian children is poor, with low guideline adherence and missed diagnosis for four of five children with pneumonia. Better sensitivity is associated with provider type and higher adherence to IMCI. Existing interventions such as training and supportive supervision are associated with higher guideline adherence, but are insufficient to meaningfully improve sensitivity. Innovative and scalable quality improvement interventions are needed to strengthen health systems and reduce avoidable child mortality.

Development of clinical practice guidelines for supportive care in childhood cancer--prioritization of topics using a Delphi approach.

PubMed

Loeffen, E A H; Mulder, R L; Kremer, L C M; Michiels, E M C; Abbink, F C H; Ball, L M; Segers, H; Mavinkurve-Groothuis, A M C; Smit, F J; Vonk, I J M; Vd Wetering, M D; Tissing, W J E

2015-07-01

Currently, very few guidelines for supportive care for children with cancer exist. In the Netherlands, nationwide guidelines are over 10 years old and mostly based on expert opinion. Consequently, there is growing support and need for clinical practice guidelines (CPGs), which ought to be developed with a well-defined methodology and include a systematic search of literature, evidence summaries, and a transparent description of the decision process for the final recommendations. Development of CPGs is time consuming; therefore, it is important to prioritize topics for which there is the greatest clinical demand. This study aims to prioritize childhood cancer supportive care topics for development of CPGs. A Delphi survey consisting of two rounds was conducted to prioritize relevant childhood cancer supportive care topics for the development of CPGs. A group of experts comprising 15 pediatric oncologists, 15 pediatric oncology nurses, and 15 general pediatricians involved in care for childhood cancer patients were invited to participate. All relevant supportive care topics in childhood cancer were rated. In both rounds, 36 panellists (82%) responded. Agreement between panellists was very good, with an intraclass correlation coefficient of 0.918 (95% confidence interval (CI) = 0.849-0.966, p < 0.001) in round 2. The ten topics with the highest score in the final round were infection, sepsis, febrile neutropenia, pain, nausea/vomiting, restrictions in daily life and activities, palliative care, procedural sedation, terminal care, and oral mucositis. We successfully used a Delphi survey to prioritize childhood cancer supportive care topics for the development of CPGs. This is a first step towards uniform and evidence-based Dutch guidelines in supportive care in childhood cancer. Even though performed nationally, we believe that this study can also be regarded as an example starting point for international development of CPGs in the field of supportive care in cancer or any other field for that matter.

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

PubMed Central

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

2017-01-01

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

The challenge of defining and treating anemia and iron deficiency in pregnancy: A study of New Zealand midwives' management of iron status in pregnancy and the postpartum period.

PubMed

Calje, Esther; Skinner, Joan

2017-06-01

Early recognition and management of low maternal iron status is associated with improved maternal, fetal, and neonatal outcomes. However, existing international guidelines for the testing and management of maternal iron-deficiency anemia are variable, with no national guideline for New Zealand midwives. Clinical management is complicated by normal physiological hemodilution, and complicated further by the effects of inflammation on iron metabolism, especially in populations with a high prevalence of obesity or infection. This study describes how midwives in one New Zealand area diagnose and treat anemia and iron deficiency, in the absence of established guidelines. Data on demographics, laboratory results, and documented clinical management were retrospectively collected from midwives (n=21) and women (n=189), from September to December 2013. Analysis was predominantly descriptive. A secondary analysis of iron status and body mass index (BMI) was undertaken. A total of 46% of 186 women, with hemoglobin testing at booking, did not have ferritin tested; 86% (of 385) of ferritin tests were not concurrently tested with C-reactive protein. Despite midwives prescribing iron for 48.7% of second trimester women, 47.1% still had low iron status before birth. Only 22.8% of women had hemoglobin testing postpartum. There was a significant difference between third trimester median ferritin levels in women with BMI ≥25.00 (14 μg/L) and BMI <25.00 (18 μg/L) (P=.05). There was a wide range in the midwives' practice. Maternal iron status was difficult to categorize, because of inconsistent testing. This study indicates the need for an evidence-based clinical guideline for New Zealand midwives and maternity care providers. © 2017 Wiley Periodicals, Inc.

40 CFR 401.12 - Law authorizing establishment of effluent limitations guidelines for existing sources, standards...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 29 2011-07-01 2009-07-01 true Law authorizing establishment of effluent limitations guidelines for existing sources, standards of performance for new sources and pretreatment standards of new and existing sources. 401.12 Section 401.12 Protection of Environment...

Is electroconvulsive therapy during pregnancy safe?

PubMed

Jiménez-Cornejo, Magdalena; Zamorano-Levi, Natalia; Jeria, Álvaro

2016-12-07

Therapeutic options for psychiatric conditions are limited during pregnancy because many drugs are restricted or contraindicated. Electroconvulsive therapy constitutes an alternative, however there is controversy over its safety. Using the Epistemonikos database, which is maintained by searching multiple databases, we found five systematic reviews, including 81 studies overall describing case series or individual cases. Data were extracted from the identified reviews and summary tables of the results were prepared using the GRADE method. We concluded it is not clear what are the risks associated with electroconvulsive therapy during pregnancy because the certainty of the existing evidence is very low. Likewise, existing systematic reviews and international clinical guidelines differ in their conclusions and recommendations.

Extending an evidence hierarchy to include topics other than treatment: revising the Australian 'levels of evidence'

PubMed Central

2009-01-01

Background In 1999 a four-level hierarchy of evidence was promoted by the National Health and Medical Research Council in Australia. The primary purpose of this hierarchy was to assist with clinical practice guideline development, although it was co-opted for use in systematic literature reviews and health technology assessments. In this hierarchy interventional study designs were ranked according to the likelihood that bias had been eliminated and thus it was not ideal to assess studies that addressed other types of clinical questions. This paper reports on the revision and extension of this evidence hierarchy to enable broader use within existing evidence assessment systems. Methods A working party identified and assessed empirical evidence, and used a commissioned review of existing evidence assessment schema, to support decision-making regarding revision of the hierarchy. The aim was to retain the existing evidence levels I-IV but increase their relevance for assessing the quality of individual diagnostic accuracy, prognostic, aetiologic and screening studies. Comprehensive public consultation was undertaken and the revised hierarchy was piloted by individual health technology assessment agencies and clinical practice guideline developers. After two and a half years, the hierarchy was again revised and commenced a further 18 month pilot period. Results A suitable framework was identified upon which to model the revision. Consistency was maintained in the hierarchy of "levels of evidence" across all types of clinical questions; empirical evidence was used to support the relationship between study design and ranking in the hierarchy wherever possible; and systematic reviews of lower level studies were themselves ascribed a ranking. The impact of ethics on the hierarchy of study designs was acknowledged in the framework, along with a consideration of how harms should be assessed. Conclusion The revised evidence hierarchy is now widely used and provides a common standard against which to initially judge the likelihood of bias in individual studies evaluating interventional, diagnostic accuracy, prognostic, aetiologic or screening topics. Detailed quality appraisal of these individual studies, as well as grading of the body of evidence to answer each clinical, research or policy question, can then be undertaken as required. PMID:19519887

Development of a Curriculum on the Child With Medical Complexity: Filling a Gap When Few Practice Guidelines Exist.

PubMed

Shah, Neha H; Anspacher, Melanie; Davis, Aisha; Bhansali, Priti

2015-01-01

Pediatric hospitalists are increasingly involved in the clinical management of children with medical complexity (CMC), specifically those with neurologic impairment and technology dependence. Clinical care guidelines and educational resources on management of the diseases and devices prevalent in CMC are scarce. The objective of this study was to develop and evaluate a web-based curriculum on care of CMC for hospitalists at our institution using a novel approach to validate educational content. Junior faculty collaborated with senior hospitalist peer mentors to create multimedia learning modules on highly-desired topics as determined by needs assessment. Module authors were encouraged to work with subspecialty experts from within the institution and to submit their modules for external peer review. Pilot study participants were asked to complete all modules, associated knowledge tests, and evaluations over a 4-month period. Sixteen of 33 eligible hospitalists completed the curriculum and associated assessments. High scores with respect to satisfaction were seen across all modules. There was a significant increase in posttest knowledge scores (P < 0.001) with sustained retention at 6 months posttest (P < 0.013). Participants were most likely to make changes to their teaching and clinical practice based on participation in this curriculum. We used a novel approach for content development in this curriculum that incorporated consultation with experts and external peer review, resulting in improved knowledge, high satisfaction, and behavior change. Our approach may be a useful method to improve content validity for educational resources on topics that do not have established clinical care guidelines.

Management of acute ischaemic stroke at Nasser Hospital, Gaza Strip: a clinical audit.

PubMed

Alkhatib, Mohammed N; Abd-Alghafoor, Tamer; Elmassry, AlaaEldeen; Albarqouni, Loai; Böttcher, Bettina; Alfaqawi, Maha

2018-02-21

Stroke is a leading cause of morbidity and mortality worldwide. The aim of this study was to assess the standard of care for patients with acute ischaemic stroke at the internal medicine department of Nasser Hospital, Gaza Strip. For this retrospective clinical audit, we selected a random sample of 100 medical records for patients with stroke who were admitted to Nasser Hospital between January and August, 2016. Clinical practice was compared with the recommendations in the 2013 American Heart Association and American Stroke Association guidelines. Patient confidentiality was maintained, and ethical approval was obtained from the Palestinian Ministry of Health. Five patient records were not coded and therefore excluded. Of the remaining 95 patients, 51 (54%) were men with a mean age of 67 years (SD 14). 53 patients presented with dysarthria. The duration of stroke symptoms before admission was not reported in 86 (91%) records. A complete blood count and renal function tests were done for all patients, lipid profiling for 87 (92%) patients, electrocardiography for 85 (89%) patients, carotid duplex ultrasound for 32 (34%) patients, and CT scan for all patients. None of the patients had continuous cardiac monitoring or an assessment of swallowing function, and 70 (74%) patients received immediate anti-platelet therapy (325 mg aspirin). 80 (85%) patients received venous thromboembolism prophylaxis. 41 (43%) patients were given antibiotics without a recorded indication. None of the patients received thrombolytic therapy. As recommended in the guidelines, 41 (43%) patients did not receive anti-hypertensive agents on the first day of hospitalisation. 46 (48%) patients had diabetes, and glycaemic control was achieved by day 3 in 26 (57%) patients. No Palestinian guidelines exist for the management of patients with acute ischaemic stroke, and in most cases management was based on personal experience rather than evidence. The development of evidence-based guidelines is mandatory to improve management of ischaemic stroke. Furthermore, implementing staff education activities, regular clinical audit, and team feedback would encourage adherence to such guidelines. Combined with the establishment of a specialised stroke unit and development of a multidisciplinary team approach, patient outcome could be improved further. None. Copyright © 2018 Elsevier Ltd. All rights reserved.

Reporting results from whole-genome and whole-exome sequencing in clinical practice: a proposal for Canada?

PubMed

Zawati, Ma'n H; Parry, David; Thorogood, Adrian; Nguyen, Minh Thu; Boycott, Kym M; Rosenblatt, David; Knoppers, Bartha Maria

2014-01-01

This article proposes recommendations for the use of whole-genome and whole-exome (WGS/WES) sequencing in clinical practice, endorsed by the board of directors of the Canadian College of Medical Geneticists. The publication of statements and recommendations by several international and national organisations on clinical WGS/WES has prompted a need for Canadian-specific guidance. A multi-disciplinary group consisting of lawyers, ethicists, genetic researchers, and clinical geneticists was assembled to review existing guidelines on WGS/WES and identify provisions relevant to the Canadian context. Definitions were provided to orient the recommendations and to minimize confusion with other recommendations. Recommendations include the following: WGS/WES should be used in a judicious and cost-efficient manner; WGS/WES should be used to answer a clinical question; and physicians need to explain to adult patients the nature of the results that could arise, so as to allow them to make informed choices over whether to take the test and which results they wish to receive. Recommendations are also provided for WGS/WES in the pediatric context, and for when results implicate patients' family members. These recommendations are only a proposal to be developed into comprehensive Canadian-based guidelines. They aim to promote discussion about the reporting of WGS/WES results, and to encourage the ethical implementation of these new technologies in the clinical setting.

Indications for MARS-MRI in Patients Treated With Articular Surface Replacement XL Total Hip Arthroplasty.

PubMed

Connelly, James W; Galea, Vincent P; Laaksonen, Inari; Matuszak, Sean J; Madanat, Rami; Muratoglu, Orhun; Malchau, Henrik

2018-04-19

The purpose of this study was to identify which patient and clinical factors are predictive of adverse local tissue reaction (ALTR) and to use these factors to create a highly sensitive algorithm for indicating metal artifact reduction sequence magnetic resonance imaging (MARS-MRI) in Articular Surface Replacement (ASR) XL total hip arthroplasty patients. Our secondary aim was to compare our algorithm to existing national guidelines on when to take MARS-MRI in metal-on-metal total hip arthroplasty patients. The study consisted of 137 patients treated with unilateral ASR XL implants from a prospective, multicenter study. Patients underwent MARS-MRI regardless of clinical presentation at a mean of 6.2 (range, 3.3-10.4) years from surgery. Univariate and multivariate analyses were conducted to determine which variables were predictive of ALTR. Predictors were used to create an algorithm to indicate MARS-MRI. Finally, we compared our algorithm's ability to detect ALTR to existing guidelines. We found a visual analog scale pain score ≥2 (odds ratio [OR] = 2.53; P = .023), high blood cobalt (OR = 1.05; P = .023), and male gender (OR = 2.37; P = .034) to be significant predictors of ALTR presence in our cohort. The resultant algorithm achieved 86.4% sensitivity and 60.2% specificity in detecting ALTR within our cohort. Our algorithm had the highest area under the curve and was the only guideline that was significantly predictive of ALTR (P = .014). Our algorithm including patient-reported pain and sex-specific cutoffs for blood cobalt levels could predict ALTR and indicate MARS-MRI in our cohort of ASR XL metal-on-metal patients with high sensitivity. Level II, diagnostic study. Copyright © 2018 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2018-01-01

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

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

PubMed

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

2018-04-01

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

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.

Guidelines for the selection and application of tantalum electrolytic capacitors in highly reliable equipment

NASA Technical Reports Server (NTRS)

Holladay, A. M.

1978-01-01

Guidelines are given for the selection and application of three types of tantalum electrolytic capacitors in current use in the design of electrical and electronic circuits for space flight missions. In addition, the guidelines supplement requirements of existing military specifications used in the procurement of capacitors. A need exists for these guidelines to assist designers in preventing some of the recurring, serious problems experienced with tantalum electrolytic capacitors in the recent past. The three types of capacitors covered by these guidelines are; solid, wet foil, and tantalum cased wet slug.

Clinical Guidelines and Implementation into Daily Dental Practice.

PubMed

Guncu, Guliz Nigar; Nemli, Secil Karakoca; Carrilho, Eunice; Yamalık, Nermin; Volodina, Elena; Melo, Paulo; Margvelashvili, Vladimer; Rossi, Alessandra

2018-01-31

The purpose of this study is to assess the extent of the familiarity, attitude and perceptions of dental professionals regarding clinical dental guidelines and their implementation into daily dental practice. For this purpose, a questionnaire which was developed by the members of the World Dental Federation, European Regional Organization Working Group - 'Relation Between Dental Practitioner and Universities', was implemented by the National Dental Associations of six European Regional Organization-zone countries (Georgian Stomatological Association - Georgia, Associazione Nazionale Dentisti Italiani - Italy, Portuguese Dental Association - Portugal, Russian Dental Association - Russia, Swiss Dental Association - Switzerland, and Turkish Dental Association - Turkey. The questionnaire was filled by a total of 910 dental professionals who are members of one of these national dental associations and who voluntarily wanted to participate to this survey. Most of the survey participants were familiar with clinical dental guidelines (68%), claimed that they implemented them into daily practice (61.7%), and generally acknowledged their benefits (81.8%). Many participants believed that clinical dental guidelines could help to improve the clinical treatment plan (50.6 %) and the accuracy of diagnosis (39.4%); which increased with age and years of practice (p < 0.05). The most frequently perceived barrier to the effective implementation of clinical dental guidelines was expressed as 'lack of awareness', while participants suggested a role for national dental associations in spreading clinical dental guidelines. A better understanding of the perceptions and attitudes of dentists towards clinical dental guidelines and the potential impact of factors affecting such perceptions and attitudes may be of particular importance for attempts aiming at overcoming the barriers for effective implementation of clinical dental guidelines into daily practice. Despite a significant familiarity and a common positive attitude, dental professionals are likely to have different perceptions towards clinical dental guidelines, especially regarding their effective implementation into daily practice, benefits and barriers.

The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.

PubMed

Zeng, Xiantao; Zhang, Yonggang; Kwong, Joey S W; Zhang, Chao; Li, Sheng; Sun, Feng; Niu, Yuming; Du, Liang

2015-02-01

To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline. We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools. We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines. We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

A Systematic Review of Clinical Practice Guidelines' Recommendations on Levothyroxine Therapy Alone versus Combination Therapy (LT4 plus LT3) for Hypothyroidism.

PubMed

Kraut, Eyal; Farahani, Pendar

2015-12-04

Patients with hypothyroidism are increasingly enquiring about the benefit of using combination therapy of levothyroxine (LT4) and liothyronine (LT3) as a potential treatment for hypothyroidism. Combination therapy, however, remains controversial. The purpose of this study was to systematically review available hypothyroidism treatment recommendations from clinical practice guidelines from around the world to identify the consensus regarding combination therapy. Clinical practice guidelines were obtained from searches of PubMed, EMBASE, and MEDLINE, using several combinations of MeSH terms. The search was limited to clinical guidelines in English-language publications, published between January 1, 1990 and May 1, 2015. A quantitative approach was utilized for data synthesis. Thirteen guidelines were identified, including three regarding pregnancy, two regarding pediatric populations and eight regarding adult populations. There were six guidelines from North America, four guidelines from Europe and three guidelines from South America. Twelve of the guidelines were published after 2010. Nine guidelines addressed combination therapy of LT4 plus LT3, and all nine concluded that LT4 therapy alone is the standard of care, with insufficient evidence to recommend widespread combination therapy. Only the 2012 ETA Guidelines and the 2015 BTA Guidelines concluded that combination therapy could be used, although only in certain circumstances and as an experimental treatment. This systematic review illustrates that clinical practice guidelines worldwide do not recommend and do not support routine use of combination LT4 and LT3 therapy to treat hypothyroidism.

A framework for assessing Health Economic Evaluation (HEE) quality appraisal instruments.

PubMed

Langer, Astrid

2012-08-16

Health economic evaluations support the health care decision-making process by providing information on costs and consequences of health interventions. The quality of such studies is assessed by health economic evaluation (HEE) quality appraisal instruments. At present, there is no instrument for measuring and improving the quality of such HEE quality appraisal instruments. Therefore, the objectives of this study are to establish a framework for assessing the quality of HEE quality appraisal instruments to support and improve their quality, and to apply this framework to those HEE quality appraisal instruments which have been subject to more scrutiny than others, in order to test the framework and to demonstrate the shortcomings of existing HEE quality appraisal instruments. To develop the quality assessment framework for HEE quality appraisal instruments, the experiences of using appraisal tools for clinical guidelines are used. Based on a deductive iterative process, clinical guideline appraisal instruments identified through literature search are reviewed, consolidated, and adapted to produce the final quality assessment framework for HEE quality appraisal instruments. The final quality assessment framework for HEE quality appraisal instruments consists of 36 items organized within 7 dimensions, each of which captures a specific domain of quality. Applying the quality assessment framework to four existing HEE quality appraisal instruments, it is found that these four quality appraisal instruments are of variable quality. The framework described in this study should be regarded as a starting point for appraising the quality of HEE quality appraisal instruments. This framework can be used by HEE quality appraisal instrument producers to support and improve the quality and acceptance of existing and future HEE quality appraisal instruments. By applying this framework, users of HEE quality appraisal instruments can become aware of methodological deficiencies inherent in existing HEE quality appraisal instruments. These shortcomings of existing HEE quality appraisal instruments are illustrated by the pilot test.

A framework for assessing Health Economic Evaluation (HEE) quality appraisal instruments

PubMed Central

2012-01-01

Background Health economic evaluations support the health care decision-making process by providing information on costs and consequences of health interventions. The quality of such studies is assessed by health economic evaluation (HEE) quality appraisal instruments. At present, there is no instrument for measuring and improving the quality of such HEE quality appraisal instruments. Therefore, the objectives of this study are to establish a framework for assessing the quality of HEE quality appraisal instruments to support and improve their quality, and to apply this framework to those HEE quality appraisal instruments which have been subject to more scrutiny than others, in order to test the framework and to demonstrate the shortcomings of existing HEE quality appraisal instruments. Methods To develop the quality assessment framework for HEE quality appraisal instruments, the experiences of using appraisal tools for clinical guidelines are used. Based on a deductive iterative process, clinical guideline appraisal instruments identified through literature search are reviewed, consolidated, and adapted to produce the final quality assessment framework for HEE quality appraisal instruments. Results The final quality assessment framework for HEE quality appraisal instruments consists of 36 items organized within 7 dimensions, each of which captures a specific domain of quality. Applying the quality assessment framework to four existing HEE quality appraisal instruments, it is found that these four quality appraisal instruments are of variable quality. Conclusions The framework described in this study should be regarded as a starting point for appraising the quality of HEE quality appraisal instruments. This framework can be used by HEE quality appraisal instrument producers to support and improve the quality and acceptance of existing and future HEE quality appraisal instruments. By applying this framework, users of HEE quality appraisal instruments can become aware of methodological deficiencies inherent in existing HEE quality appraisal instruments. These shortcomings of existing HEE quality appraisal instruments are illustrated by the pilot test. PMID:22894708

Safe working practices and HIV infection: knowledge, attitudes, perception of risk, and policy in hospital.

PubMed Central

Davidson, G; Gillies, P

1993-01-01

OBJECTIVES--To assess the knowledge, attitudes, and perceptions of risk of occupational HIV transmission in hospital in relation to existing guidelines. DESIGN--Cross sectional anonymous questionnaire survey of all occupational groups. SETTING--One large inner city teaching hospital. SUBJECTS--All 1530 staff working in the hospital in October 1991 and 22 managers. MAIN MEASURES--Knowledge of safe working practices and hospital guidelines; attitudes towards patients with AIDS; perception of risk of occupational transmission of HIV; availability of guidelines. RESULTS--The response rate in the questionnaire survey was 63% (958/1530). Although staff across all occupational groups knew of the potential risk of infection from needlestick injury (98%, 904/922), significantly more non-clinical staff (ambulance, catering, and domestic staff) than clinical staff (doctors, nurses, and paramedics) thought HIV could be transmitted by giving blood (38%, 153/404 v 12%, 40/346; chi 2 = 66.1 p < 0.001); one in ten clinical staff believed this. Except for midwives, half of staff in most occupational groups and 19% (17/91) of doctors and 22% (28/125) of nurses thought gloves should be worn in all contacts with people with AIDS. Most staff (62%, 593/958), including 38% (36/94) of doctors and 52% (67/128) of nurses thought patients should be routinely tested on admission, 17% of doctors and 19% of nurses thought they should be isolated in hospital. One in three staff perceived themselves at risk of HIV. Midwives, nurses, and theatre technicians were most aware of guidelines for safe working compared with only half of doctors, ambulance, and paramedical staff and no incinerator staff. CONCLUSIONS--Policy guidelines for safe working practices for patients with HIV infection and AIDS need to be disseminated across all occupational groups to reduce negative staff attitudes, improve knowledge of occupational transmission, establish an appropriate perception of risk, and create a supportive and caring hospital environment for people with HIV. IMPLICATIONS--Managers need to disseminate policy guidelines and information to all staff on an ongoing basis. PMID:10132073

Proposal of quality indicators for cardiac rehabilitation after acute coronary syndrome in Japan: a modified Delphi method and practice test.

PubMed

Ohtera, Shosuke; Kanazawa, Natsuko; Ozasa, Neiko; Ueshima, Kenji; Nakayama, Takeo

2017-01-27

Cardiac rehabilitation is underused and its quality in practice is unclear. A quality indicator is a measurable element of clinical practice performance. This study aimed to propose a set of quality indicators for cardiac rehabilitation following an acute coronary event in the Japanese population and conduct a small-size practice test to confirm feasibility and applicability of the indicators in real-world clinical practice. This study used a modified Delphi technique (the RAND/UCLA appropriateness method), a consensus method which involves an evidence review, a face-to-face multidisciplinary panel meeting and repeated anonymous rating. Evidence to be reviewed included clinical practice guidelines available in English or Japanese and existing quality indicators. Performance of each indicator was assessed retrospectively using medical records at a university hospital in Japan. 10 professionals in cardiac rehabilitation for the consensus panel. In the literature review, 23 clinical practice guidelines and 16 existing indicators were identified to generate potential indicators. Through the consensus-building process, a total of 30 indicators were assessed and finally 13 indicators were accepted. The practice test (n=39) revealed that 74% of patients underwent cardiac rehabilitation. Median performance of process measures was 93% (IQR 46-100%). 'Communication with the doctor who referred the patient to cardiac rehabilitation' and 'continuous participation in cardiac rehabilitation' had low performance (32% and 38%, respectively). A modified Delphi technique identified a comprehensive set of quality indicators for cardiac rehabilitation. The single-site, small-size practice test confirmed that most of the proposed indicators were measurable in real-world clinical practice. However, some clinical processes which are not covered by national health insurance in Japan had low performance. Further studies will be needed to clarify and improve the quality of care in cardiac rehabilitation. 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/.

Evaluation of Guidelines for Subgrade Treatments

DOT National Transportation Integrated Search

2005-02-01

ODOT has recently developed guidelines for subgrade treatments to be used during plan : development and construction. This study evaluates these guidelines by comparing them with : existing guidelines developed elsewhere and validating them through c...

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.

Ethical considerations in design of a study to evaluate a US Food and Drug Administration-approved indication: antivenom versus placebo for copperhead envenomation.

PubMed

Gerardo, Charles J; Lavonas, Eric J; McKinney, Ross E

2014-10-01

In 2000, the US Food and Drug Administration approved CroFab(®) Crotalidae Polyvalent Immune Fab, ovine (FabAV), which had received orphan drug designation, for use in patients with minimal to moderate North American crotaline envenomations including copperhead snakes. As existing evidence on the effectiveness of FabAV for this indication is limited, wide practice variation in its use exists. In order to provide more definitive clinical evidence as to the role of this treatment, a new randomized, placebo-controlled trial of FabAV specifically for copperhead bites was initiated. In light of the existing US Food and Drug Administration approval, ethical considerations of participation in this trial have been raised. We discuss the ethical principles pertinent to this randomized, placebo-controlled trial with placebo arm. We apply an accepted framework for ethical research to this trial. Due to the evidence gap in the literature, wide-ranging treatment recommendations by medical experts, and broad practice variation, clinical equipoise exists in the treatment of copperhead envenomation with FabAV. The impact of this clinical equipoise on the value and scientific validity of the trial is discussed. The trial's risk-benefit ratio is also considered. Potential risks to the patients are minimized as the protocol includes a plan for rescue therapy in the event that patients progress to severe envenomation symptoms. Overall, risks are further minimized by the inclusion of an interim analysis with stopping rules based on demonstrated efficacy should the therapy clearly prove to be beneficial. Although a post-marketing clinical study of this nature is unusual for an approved indication, this trial adheres to all ethical preconditions found in existing guidelines for clinical research involving human subjects. © The Author(s) 2014.

The Development of Human Factor Guidelines for Unmanned Aircraft System Control Stations

NASA Technical Reports Server (NTRS)

Hobbs, Alan

2014-01-01

Despite being referred to as unmanned some of the major challenges confronting unmanned aircraft systems (UAS) relate to human factors. NASA is conducting research to address the human factors relevant to UAS access to non-segregated airspace. This work covers the issues of pilot performance, interaction with ATC, and control station design. A major outcome of this research will be recommendations for human factors design guidelines for UAS control stations to support routine beyond-line-of-sight operations in the US national airspace system (NAS). To be effective, guidelines must be relevant to a wide range of systems, must not be overly prescriptive, and must not impose premature standardization on evolving technologies. In developing guidelines, we recognize that existing regulatory and guidance material may already provide adequate coverage of certain issues. In other cases suitable guidelines may be found in existing military or industry human factors standards. In cases where appropriate existing standards cannot be identified, original guidelines will be proposed.

Modelling outcomes of complex treatment strategies following a clinical guideline for treatment decisions in patients with rheumatoid arthritis.

PubMed

Tran-Duy, An; Boonen, Annelies; Kievit, Wietske; van Riel, Piet L C M; van de Laar, Mart A F J; Severens, Johan L

2014-10-01

Management of rheumatoid arthritis (RA) is characterised by a sequence of disease-modifying antirheumatic drugs (DMARDs) and biological response modifiers (BRMs). In most of the Western countries, the drug sequences are determined based on disease activity and treatment history of the patients. A model for realistic patient outcomes should reflect the treatment pathways relevant for patients with specific characteristics. This study aimed at developing a model that could simulate long-term patient outcomes and cost effectiveness of treatment strategies with and without inclusion of BRMs following a clinical guideline for treatment decisions. Discrete event simulation taking into account patient characteristics and treatment history was used for model development. Treatment effect on disease activity, costs, health utilities and times to events were estimated using Dutch observational studies. Long-term progression of physical functioning was quantified using a linear mixed-effects model. Costs and health utilities were estimated using two-part models. The treatment strategy recommended by the Dutch Society for Rheumatology where both DMARDs and BRMs were available (Strategy 2) was compared with the treatment strategy without BRMs (Strategy 1). Ten thousand theoretical patients were tracked individually until death. In the probabilistic sensitivity analysis, Monte Carlo simulations were performed with 1,000 sets of parameters sampled from appropriate probability distributions. The simulated changes over time in disease activity and physical functioning were plausible. The incremental cost per quality-adjusted life-year gained of Strategy 2 compared with Strategy 1 was 124,011. At a willingness-to-pay threshold higher than 119,167, Strategy 2 dominated Strategy 1 in terms of cost effectiveness but the probability that the Strategy 2 is cost effective never exceeded 0.87. It is possible to model the outcomes of complex treatment strategies based on a clinical guideline for the management of RA. Following the Dutch guideline and using real-life data, inclusion of BRMs in the treatment strategy for RA appeared to be less favourable in our model than in most of the existing models that compared drug sequences independent of patient characteristics and used data from randomised controlled clinical trials. Despite complexity and demand for extensive data, our modelling approach can help to identify the knowledge gaps in clinical guidelines for RA management and priorities for future research.

Clinical Management of ADHD in a Family Medicine Residency Program: Comparison with AAP Guidelines.

PubMed

Skelley, Jessica W; Carpenter, P Chase; Morehead, M Shawn; Murphy, Patrick L

2016-06-01

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder. Research has shown that even with the growing incidence of children diagnosed as having ADHD, physicians may find providing optimal care to these patients challenging. Our objective was to contrast existing clinical management of ADHD in a family medicine setting with published American Academy of Pediatrics guidelines and review the literature pertinent to differences. A report was generated for all visits with "ADHD" or "ADD" (attention-deficit disorder) as a current or past medical problem that had been addressed at the family medicine clinic from July 2012 to June 2014. A total of 60 pediatric patients were identified. A retrospective chart review of clinical practice and management patterns for these patients was completed using a standardized data collection form based on the 2011 ADHD treatment guidelines set by the American Academy of Pediatrics. Fifty-seven (95%) patients had documentation of at least one core symptom of ADHD, and 27 (45%) patients had documentation of these symptoms in more than one setting (clinic/school/home). Only 30 (50%) patients were assessed at the initial ADHD visit for coexisting conditions. Coexisting conditions were found to be present in 20 (33.3%) patients. Of these 20 patients, coexisting conditions were not addressed during the visit in 12 (60%) patients before drug therapy for ADHD was initially prescribed. Behavioral therapy was initiated as first-line monotherapy in one of the nine preschool-age patients (4-5 years old). Fifty-two (86.7%) patients received a preferred initial medication as identified by guidelines, and 41 (78.8%) of those patients received an appropriate initial dose. Fifty-one (85%) patients were assessed for improvement of symptoms, and 39 (65%) were assessed for adverse events. Of 62 documented medication adjustments, 54 (87.1%) adjustments coincided with current practice guidelines. Sixteen (26.7%) patients were referred to mental health specialists. This retrospective review identified areas of strength and weakness for attending physicians and medical residents in the diagnosis, evaluation, and treatment of children with ADHD. A significant need was identified for more physician-focused education on the evaluation of coexisting conditions and long-term management associated with ADHD therapy. Further training in the initiation of behavioral therapy as a first-line treatment above drug therapy and proper medication selection in children aged 4 to 5 years also are recommended.

Human Factors Guidelines for UAS in the National Airspace System

NASA Technical Reports Server (NTRS)

Hobbs, Alan; Shively, R. Jay

2013-01-01

The ground control stations (GCS) of some UAS have been characterized by less-than-adequate human-system interfaces. In some cases this may reflect a failure to apply an existing regulation or human factors standard. In other cases, the problem may indicate a lack of suitable guidance material. NASA is leading a community effort to develop recommendations for human factors guidelines for GCS to support routine beyond-line-of-sight UAS operations in the national airspace system (NAS). In contrast to regulations, guidelines are not mandatory requirements. However, by encapsulating solutions to identified problems or areas of risk, guidelines can provide assistance to system developers, users and regulatory agencies. To be effective, guidelines must be relevant to a wide range of systems, must not be overly prescriptive, and must not impose premature standardization on evolving technologies. By assuming that a pilot will be responsible for each UAS operating in the NAS, and that the aircraft will be required to operate in a manner comparable to conventionally piloted aircraft, it is possible to identify a generic set of pilot tasks and the information, control and communication requirements needed to support these tasks. Areas where guidelines will be useful can then be identified, utilizing information from simulations, operational experience and the human factors literature. In developing guidelines, we recognize that existing regulatory and guidance material will, at times, provide adequate coverage of an area. In other cases suitable guidelines may be found in existing military or industry human factors standards. In cases where appropriate existing standards cannot be identified, original guidelines will be proposed.

A benchmarking project on the quality of previous guidelines about the management of malignant pleural effusion from the European Society of Thoracic Surgeons (ESTS) Pleural Diseases Working Group.

PubMed

Bertolaccini, Luca; Bedetti, Benedetta; Brunelli, Alessandro; Marinova, Katerina; Raveglia, Federico; Rocco, Gaetano; Shargall, Yaron; Solli, Piergiorgio; Varela, Gonzalo; Papagiannopoulos, Kostas; Kuzdzal, Jaroslaw; Massard, Gilbert; Ruffini, Enrico; Falcoz, Pierre-Emmanuel; Martinez-Barenys, Carlos; Opitz, Isabelle; Batirel, Hasan F; Toker, Alper; Scarci, Marco

2017-08-01

In the European Society of Thoracic Surgeons (ESTS) survey about management of malignant pleural effusions (MPE), 56% of respondents are not informed of any relevant clinical guidelines and 52%, who are aware of the existence of guidelines, declared that they are in need of updating or revision. The ESTS Pleural Diseases Working Group developed a benchmarking project on quality of previous guidelines on the management of MPE. The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument was used to assess each guideline. Each item was scored on a 7-point scale. Scores for each domain were calculated. Economic data for the nations which have issued the guidelines were collected from the Organisation for Economic Cooperation and Development health statistics database. Six guidelines fitted the inclusion criteria and were assessed. Five out of 6 guidelines were produced by a multinational collaboration. Observers would recommend only 2 guidelines with minimal modification. Two areas that received the best score were clarity of presentation and scope and purpose (objectives and health questions target population). The applicability of guideline domain had the lowest score. Multivariate analysis demonstrated that clarity of presentation, international guidelines and publication through medical journal were related to improved scores. A strong correlation was observed between the measures of economic status. The quality of guidelines assessed by the AGREE II criteria was found to be extremely variable. Guidelines achieving higher AGREE II scores were more likely to come from the European Union with the direct involvement of scientific societies in their development. It was also recognized that some fundamental unanswered questions remain about the management of MPE. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Guidelines by the AAPM and GEC-ESTRO on the use of innovative brachytherapy devices and applications: Report of Task Group 167

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

Nath, Ravinder; Rivard, Mark J., E-mail: mark.j.rivard@gmail.com; DeWerd, Larry A.

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used in the evaluation of innovative devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining the equivalence of the innovative treatment modality to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of innovative radiotherapy devices or applications is a critical part in which physicists should be actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative brachytherapy devices and applications andmore » includes evaluation of (1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, (2) risks and benefits from a regulatory and safety perspective, and (3) resource assessment and preparedness. Further, it is suggested that any developed calibration methods be traceable to a primary standards dosimetry laboratory (PSDL) such as the National Institute of Standards and Technology in the U.S. or to other PSDLs located elsewhere such as in Europe. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the Accredited Dosimetry Calibration Laboratories in the U.S. is encouraged before a source is introduced into widespread routine clinical use. The American Association of Physicists in Medicine and the Groupe Européen de Curiethérapie-European Society for Radiotherapy and Oncology (GEC-ESTRO) have developed guidelines for the safe and consistent application of brachytherapy using innovative devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. Nuclear Regulatory Commission, U.S. Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, U.S. Food and Drug Administration, European Commission for CE Marking (Conformité Européenne), and institutional review boards and radiation safety committees.« less

TDM in psychiatry and neurology: A comprehensive summary of the consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology, update 2017; a tool for clinicians^.

PubMed

Schoretsanitis, Georgios; Paulzen, Michael; Unterecker, Stefan; Schwarz, Markus; Conca, Andreas; Zernig, Gerald; Gründer, Gerhard; Haen, Ekkerhard; Baumann, Pierre; Bergemann, Niels; Clement, Hans Willi; Domschke, Katharina; Eckermann, Gabriel; Egberts, Karin; Gerlach, Manfred; Greiner, Christine; Havemann-Reinecke, Ursula; Hefner, Gudrun; Helmer, Renate; Janssen, Ger; Jaquenoud-Sirot, Eveline; Laux, Gerd; Messer, Thomas; Mössner, Rainald; Müller, Matthias J; Pfuhlmann, Bruno; Riederer, Peter; Saria, Alois; Schoppek, Bernd; Silva Gracia, Margarete; Stegmann, Benedikt; Steimer, Werner; Stingl, Julia C; Uhr, Manfred; Ulrich, Sven; Waschgler, Roland; Zurek, Gabriela; Hiemke, Christoph

2018-04-01

Therapeutic drug monitoring (TDM) combines the quantification of drug concentrations in blood, pharmacological interpretation and treatment guidance. TDM introduces a precision medicine tool in times of increasing awareness of the need for personalized treatment. In neurology and psychiatry, TDM can guide pharmacotherapy for patient subgroups such as children, adolescents, pregnant women, elderly patients, patients with intellectual disabilities, patients with substance use disorders, individuals with pharmacokinetic peculiarities and forensic patients. Clear indications for TDM include lack of clinical response in the therapeutic dose range, assessment of drug adherence, tolerability issues and drug-drug interactions. Based upon existing literature, recommended therapeutic reference ranges, laboratory alert levels, and levels of recommendation to use TDM for dosage optimization without specific indications, conversion factors, factors for calculation of dose-related drug concentrations and metabolite-to-parent ratios were calculated. This summary of the updated consensus guidelines by the TDM task force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie offers the practical and theoretical knowledge for the integration of TDM as part of pharmacotherapy with neuropsychiatric agents into clinical routine. The present guidelines for TDM application for neuropsychiatric agents aim to assist clinicians in enhancing safety and efficacy of treatment.

Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

PubMed

Roehle, Robert; Wieske, Viktoria; Schuetz, Georg M; Gueret, Pascal; Andreini, Daniele; Meijboom, Willem Bob; Pontone, Gianluca; Garcia, Mario; Alkadhi, Hatem; Honoris, Lily; Hausleiter, Jörg; Bettencourt, Nuno; Zimmermann, Elke; Leschka, Sebastian; Gerber, Bernhard; Rochitte, Carlos; Schoepf, U Joseph; Shabestari, Abbas Arjmand; Nørgaard, Bjarne; Sato, Akira; Knuuti, Juhani; Meijs, Matthijs F L; Brodoefel, Harald; Jenkins, Shona M M; Øvrehus, Kristian Altern; Diederichsen, Axel Cosmus Pyndt; Hamdan, Ashraf; Halvorsen, Bjørn Arild; Mendoza Rodriguez, Vladimir; Wan, Yung Liang; Rixe, Johannes; Sheikh, Mehraj; Langer, Christoph; Ghostine, Said; Martuscelli, Eugenio; Niinuma, Hiroyuki; Scholte, Arthur; Nikolaou, Konstantin; Ulimoen, Geir; Zhang, Zhaoqi; Mickley, Hans; Nieman, Koen; Kaufmann, Philipp A; Buechel, Ronny Ralf; Herzog, Bernhard A; Clouse, Melvin; Halon, David A; Leipsic, Jonathan; Bush, David; Jakamy, Reda; Sun, Kai; Yang, Lin; Johnson, Thorsten; Laissy, Jean-Pierre; Marcus, Roy; Muraglia, Simone; Tardif, Jean-Claude; Chow, Benjamin; Paul, Narinder; Maintz, David; Hoe, John; de Roos, Albert; Haase, Robert; Laule, Michael; Schlattmann, Peter; Dewey, Marc

2018-03-19

To analyse the implementation, applicability and accuracy of the pretest probability calculation provided by NICE clinical guideline 95 for decision making about imaging in patients with chest pain of recent onset. The definitions for pretest probability calculation in the original Duke clinical score and the NICE guideline were compared. We also calculated the agreement and disagreement in pretest probability and the resulting imaging and management groups based on individual patient data from the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT). 4,673 individual patient data from the CoMe-CCT Consortium were analysed. Major differences in definitions in the Duke clinical score and NICE guideline were found for the predictors age and number of risk factors. Pretest probability calculation using guideline criteria was only possible for 30.8 % (1,439/4,673) of patients despite availability of all required data due to ambiguity in guideline definitions for risk factors and age groups. Agreement regarding patient management groups was found in only 70 % (366/523) of patients in whom pretest probability calculation was possible according to both models. Our results suggest that pretest probability calculation for clinical decision making about cardiac imaging as implemented in the NICE clinical guideline for patients has relevant limitations. • Duke clinical score is not implemented correctly in NICE guideline 95. • Pretest probability assessment in NICE guideline 95 is impossible for most patients. • Improved clinical decision making requires accurate pretest probability calculation. • These refinements are essential for appropriate use of cardiac CT.

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

PubMed

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

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

Antihypertensive prescribing--a survey of general practice supervisors and registrars.

PubMed

Eastman, Peter

2008-11-01

Hypertension is a common problem in general practice. Prescribing guidelines vary, but generally favour thiazide diuretics as first line treatment for uncomplicated essential hypertension. This study looks at antihypertensive prescribing habits of primary care practitioners and their knowledge of prescribing guideline recommendations. General practitioner supervisors and registrars from the Sydney Institute of General Practice Education and Training completed an online survey between April and July 2007. In response to a clinical vignette, participants indicated which agent they would use as first line therapy. In addition, they described what they knew about existing prescribing guidelines for essential hypertension. One hundred and thirty-eight surveys were sent and 31 were returned completed. Angiotensin converting enzyme inhibitors were favoured as first line agents. Most believed current guidelines recommend more than one class of antihypertensive agent as appropriate for the initiation of single agent therapy. Angiotensin converting enzyme inhibitors were nominated most often as first line treatments recommended by guidelines. The study is limited by a small sample size, a low response rate and the fact that participants all came from a similar location. Prescribing habits in the study group were not consistent with two out of three Australian guidelines on management of hypertension. Further research may allow generalisation to the wider Australian general practice community and indicate underlying reasons for this inconsistency. Hypertension management is an important educational topic for general practice registrars and GPs.

The International College of Neuropsychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 1: Background and Methods of the Development of Guidelines.

PubMed

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

2017-02-01

This paper includes a short description of the important clinical aspects of Bipolar Disorder with emphasis on issues that are important for the therapeutic considerations, including mixed and psychotic features, predominant polarity, and rapid cycling as well as comorbidity. The workgroup performed a review and critical analysis of the literature concerning grading methods and methods for the development of guidelines. The workgroup arrived at a consensus to base the development of the guideline on randomized controlled trials and related meta-analyses alone in order to follow a strict evidence-based approach. A critical analysis of the existing methods for the grading of treatment options was followed by the development of a new grading method to arrive at efficacy and recommendation levels after the analysis of 32 distinct scenarios of available data for a given treatment option. The current paper reports details on the design, method, and process for the development of CINP guidelines for the treatment of Bipolar Disorder. The rationale and the method with which all data and opinions are combined in order to produce an evidence-based operationalized but also user-friendly guideline and a specific algorithm are described in detail in this paper. © The Author 2016. Published by Oxford University Press on behalf of CINP.

Smartphone Application of Primary Care Guidelines used in Education of Medical Students

PubMed Central

Waldmann, Uta-Maria; Weckbecker, Klaus

2013-01-01

Background and Objective: The guidelines of the German College of General Practitioners and Family Physicians (DEGAM) on frequent and important reasons for encounter in Primary Care play a central role in the teaching of Family Medicine. They were edited by the authors into an app for mobile phones, making them available at all times to General Practitioners and medical students. This study examines the issue: how useful do students consider this application within their learning process in Family Medicine? Method: The short versions of the 15 DEGAM guidelines were processed as a web app (for all smartphone software systems) including offline utilisation, and offered to students in the Family Medicine course, during clinical attachments in General Practice, on elective compulsory courses or for their final year rotation in General Practice. The evaluation was made with a structured survey using the feedback function of the Moodle learning management system [http://www.elearning-allgemeinmedizin.de] with Likert scales and free-text comments. Results: Feedback for evaluation came from 14 (25%) of the student testers from the Family Medicine course (9), the clinical attachment in General Practice (1), the final year rotation in General Practice (1) and elective compulsory courses (4). Students rated the app as an additional benefit to the printed/pdf-form. They use it frequently and successfully during waiting periods and before, during, or after lectures. In addition to general interest and a desire to become acquainted with the guidelines and to learn, the app is consulted with regard to general (theoretical) questions, rather than in connection with contact with patients. Interest in and knowledge of the guidelines is stimulated by the app, and on the whole the application can be said to be well suited to the needs of this user group. Discussion: The students evaluated the guidelines app positively: as a modern way of familiarising them with the guidelines and expanding their knowledge, particularly through its use in waiting periods and the attractive medium smartphone. However, the latter prevents a mandatory curricular use in compulsory courses, since not all students use smartphones. It is a meaningful addition to existing teaching materials and supports evidence-based teaching in Family Medicine and is suitable for use not only in university course teaching but also during clinical training. PMID:23467657

Smartphone application of primary care guidelines used in education of medical students.

PubMed

Waldmann, Uta-Maria; Weckbecker, Klaus

2013-01-01

The guidelines of the German College of General Practitioners and Family Physicians (DEGAM) on frequent and important reasons for encounter in Primary Care play a central role in the teaching of Family Medicine. They were edited by the authors into an app for mobile phones, making them available at all times to General Practitioners and medical students. This study examines the issue: how useful do students consider this application within their learning process in Family Medicine? The short versions of the 15 DEGAM guidelines were processed as a web app (for all smartphone software systems) including offline utilisation, and offered to students in the Family Medicine course, during clinical attachments in General Practice, on elective compulsory courses or for their final year rotation in General Practice. The evaluation was made with a structured survey using the feedback function of the Moodle learning management system [http://www.elearning-allgemeinmedizin.de] with Likert scales and free-text comments. Feedback for evaluation came from 14 (25%) of the student testers from the Family Medicine course (9), the clinical attachment in General Practice (1), the final year rotation in General Practice (1) and elective compulsory courses (4). Students rated the app as an additional benefit to the printed/pdf-form. They use it frequently and successfully during waiting periods and before, during, or after lectures. In addition to general interest and a desire to become acquainted with the guidelines and to learn, the app is consulted with regard to general (theoretical) questions, rather than in connection with contact with patients. Interest in and knowledge of the guidelines is stimulated by the app, and on the whole the application can be said to be well suited to the needs of this user group. The students evaluated the guidelines app positively: as a modern way of familiarising them with the guidelines and expanding their knowledge, particularly through its use in waiting periods and the attractive medium smartphone. However, the latter prevents a mandatory curricular use in compulsory courses, since not all students use smartphones. It is a meaningful addition to existing teaching materials and supports evidence-based teaching in Family Medicine and is suitable for use not only in university course teaching but also during clinical training.

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

PubMed

Saunders, Hannele

2015-07-01

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

[The development of clinical guidelines for the diagnosis and treatment of chronic periodontitis in Belgium].

PubMed

Cosyn, Jan; De Bruyn, Hugo

2008-01-01

In many disciplines of medicine guidelines are developed for the diagnosis and treatment of disease. These are essentially intended to standardize care and to optimize communication between the general practitioner and the specialist. Guidelines have already been described in the literature for chronic periodontitis. However, given the unique conditions in Belgium, these may not be appropriate for the average dental practice. In this manuscript the development of Belgian clinical guidelines for the diagnosis and treatment of chronic periodontitis is described. Basically, ten clinical questions were used as a basis for a thorough literature search. Evidence-based clinical guidelines were developed and adapted during three peer review sessions. In the final session Belgian specialists, who had all been invited, participated. This made sure that the scientific input was sufficiently transformed into clinical guidelines which are actually feasible today in Belgium.

Anterior Cruciate Ligament Reconstruction Rehabilitation

PubMed Central

Wright, Rick W.; Haas, Amanda K.; Anderson, Joy; Calabrese, Gary; Cavanaugh, John; Hewett, Timothy E.; Lorring, Dawn; McKenzie, Christopher; Preston, Emily; Williams, Glenn; Amendola, Annunziato

2015-01-01

Context: Anterior cruciate ligament (ACL) reconstruction rehabilitation has evolved over the past 20 years. This evolution has been driven by a variety of level 1 and level 2 studies. Evidence Acquisition: The MOON Group is a collection of orthopaedic surgeons who have developed a prospective longitudinal cohort of the ACL reconstruction patients. To standardize the management of these patients, we developed, in conjunction with our physical therapy committee, an evidence-based rehabilitation guideline. Study Design: Clinical review. Level of Evidence: Level 2. Results: This review was based on 2 systematic reviews of level 1 and level 2 studies. Recently, the guideline was updated by a new review. Continuous passive motion did not improve ultimate motion. Early weightbearing decreases patellofemoral pain. Postoperative rehabilitative bracing did not improve swelling, pain range of motion, or safety. Open chain quadriceps activity can begin at 6 weeks. Conclusion: High-level evidence exists to determine appropriate ACL rehabilitation guidelines. Utilizing this protocol follows the best available evidence. PMID:26131301

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

PubMed

Henry, Blair

2016-09-01

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

Under-treatment of type 2 diabetes: Causes and outcomes of clinical inertia.

PubMed

Bailey, Clifford J

2016-12-01

To assess the impact of clinical inertia on type 2 diabetes (T2D) care. PubMed database search from January 2000 until December 2015. Clinical inertia, defined as resistance to initiate or intensify treatment in a patient not at the evidence-based glycated haemoglobin goal, is conservatively estimated to occur in at least 25% of patients with T2D. Consequently, many patients with diagnosed and treated T2D experience extended periods, in some cases years, of ineffectively controlled hyperglycaemia, potentially causing serious microvascular and macrovascular harm. Delayed treatment does not appear to be specific to primary care, but also occurs in the specialist setting. The causes of clinical inertia appear to be complex, involving both reasonable and unacceptable delays on the part of the clinician and poor compliance with treatment regimens on the part of the patient. Evidence suggests that the clinical and organisational context may be particularly important in reinforcing clinical inertia, notably the increasingly severe time constraints for diagnosis and management of multiple morbidities, consideration of complex guidelines, assessment of cost and appreciation of patient concerns, all of which may hamper prioritisation of the important issue of under-treatment. Since the pharmacotherapeutic tools for good control of blood glucose exist in all advanced healthcare systems, initiatives to address the important and widespread problem of clinical inertia may require focused campaigns that encourage attention to guideline recommendations and their adaptation for individualised care. © 2016 John Wiley & Sons Ltd.

Anesthetic neuroprotection: antecedents and an appraisal of preclinical and clinical data quality.

PubMed

Ishida, Kazuyoshi; Berger, Miles; Nadler, Jacob; Warner, David S

2014-01-01

Anesthetics have been studied for nearly fifty years as potential neuroprotective compounds in both perioperative and resuscitation medicine. Although anesthetics present pharmacologic properties consistent with preservation of brain viability in the context of an ischemic insult, no anesthetic has been proven efficacious for neuroprotection in humans. After such effort, it could be concluded that anesthetics are simply not neuroprotective in humans. Moreover, pharmacologic neuroprotection with non-anesthetic drugs has also repeatedly failed to be demonstrated in human acute brain injury. Recent focus has been on rectification of promising preclinical neuroprotection data and subsequent failed clinical trials. This has led to consensus guidelines for the process of transferring purported therapeutics from bench to bedside. In this review we first examined the history of anesthetic neuroprotection research. Then, a systematic review was performed to identify major clinical trials of anesthetic neuroprotection. Both the preclinical neuroprotection portfolio cited to justify a clinical trial and the design and conduct of that clinical trial were evaluated using modern standards that include the Stroke Therapy Academic Industry Roundtable (STAIR) and Consolidated Standards of Reporting Trials (CONSORT) guidelines. In publications intended to define anesthetic neuroprotection, we found overall poor quality of both preclinical efficacy analysis portfolios and clinical trial designs and conduct. Hence, using current translational research standards, it was not possible to conclude from existing data whether anesthetics ameliorate perioperative ischemic brain injury. Incorporation of advances in translational neuroprotection research conduct may provide a basis for more definitive and potentially successful clinical trials of anesthetics as neuroprotectants.

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.

Methodological quality of systematic reviews referenced in clinical practice guidelines for the treatment of opioid use disorder.

PubMed

Ross, Andrew; Rankin, Justin; Beaman, Jason; Murray, Kelly; Sinnett, Philip; Riddle, Ross; Haskins, Jordan; Vassar, Matt

2017-01-01

With efforts to combat opioid use disorder, there is an increased interest in clinical practice guidelines (CPGs) for opioid use disorder treatments. No literature exists examining the quality of systematic reviews used in opioid use disorder CPGs. This study aims to describe the methodological quality and reporting clarity of systematic reviews (SRs) used to create CPGs for opioid use disorder. From June to July 2016 guideline clearinghouses and medical literature databases were searched for relevant CPGs used in the treatment of opioid use disorder. Included CPGs must have been recognized by a national organization. SRs from the reference section of each CPG was scored by using AMSTAR (a measurement tool to assess the methodological quality of systematic reviews) tool and PRISMA (preferred reporting items for systematic reviews and meta-analyses) checklist. Seventeen CPGs from 2006-2016 were included in the review. From these, 57 unique SRs were extracted. SRS comprised 0.28% to 17.92% of all references found in the CPGs. All SRs obtained moderate or high methodological quality score on the AMSTAR tool. All reviews met at least 70% of PRISMA criteria. In PRISMA, underperforming areas included accurate title labeling, protocol registration, and risk of bias. Underperforming areas in AMSTAR included conflicts of interest, funding, and publication bias. A positive correlation was found between AMSTAR and PRISMA scores (r = .79). Although the SRs in the CPGs were of good quality, there are still areas for improvement. Systematic reviewers should consult PRISMA and AMSTAR when conducting and reporting reviews. It is important for CPG developers to consider methodological quality as a factor when developing CPG recommendations, recognizing that the quality of systematic reviews underpinning guidelines does not necessarily correspond to the quality of the guideline itself.

The Dose That Works: Low Level Laser Treatment of Tendinopathy

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

Tumilty, Steve; Munn, Joanne; David Baxter, G.

2010-05-31

Background: Low Level Laser Therapy (LLLT) is used in the treatment of tendon injuries. However, the clinical effectiveness of this modality remains controversial with limited agreement on the most efficacious dosage and parameter choices. Purpose: To assess the clinical effectiveness of LLLT in the treatment of tendinopathy and the validity of current dosage recommendations for treatment. Method: Medical databases were searched from inception to 1st August 2008. Controlled clinical trials evaluating LLLT as a primary intervention for any tendinopathy were included in the review. Methodological quality was classified using the PEDro scale. Appropriateness of treatment parameters were assessed using establishedmore » guidelines. Results: Twenty five trials met the inclusion criteria. There was conflicting findings from multiple trials: 12 showed positive effects and 13 were inconclusive or showed no effect. Dosages used in the 12 positive studies support the existence of an effective dosage window that closely resembled current guidelines. Where pooling of data was possible, LLLT showed a positive effect size; in high quality studies of lateral epicondylitis, participants' grip strength was 9.59 Kg higher than the control group; for participants with Achilles tendinopathy, the effect was 13.6 mm less pain on a 100 mm visual analogue scale. Conclusion: This study found conflicting evidence as to the effectiveness of LLLT in the treatment of tendinopathy. However, an effective dosage window emerged showing benefit in the treatment of tendinopathy. Strong evidence exists from the 12 positive studies that positive outcomes are associated with the use of current dosage recommendations for the treatment of tendinopathy.« less

The Dose That Works: Low Level Laser Treatment of Tendinopathy

NASA Astrophysics Data System (ADS)

Tumilty, Steve; Munn, Joanne; McDonough, Suzanne; Hurley, Deirdre A.; Basford, Jeffrey R.; David Baxter, G.

2010-05-01

Background: Low Level Laser Therapy (LLLT) is used in the treatment of tendon injuries. However, the clinical effectiveness of this modality remains controversial with limited agreement on the most efficacious dosage and parameter choices. Purpose: To assess the clinical effectiveness of LLLT in the treatment of tendinopathy and the validity of current dosage recommendations for treatment. Method: Medical databases were searched from inception to 1st August 2008. Controlled clinical trials evaluating LLLT as a primary intervention for any tendinopathy were included in the review. Methodological quality was classified using the PEDro scale. Appropriateness of treatment parameters were assessed using established guidelines. Results: Twenty five trials met the inclusion criteria. There was conflicting findings from multiple trials: 12 showed positive effects and 13 were inconclusive or showed no effect. Dosages used in the 12 positive studies support the existence of an effective dosage window that closely resembled current guidelines. Where pooling of data was possible, LLLT showed a positive effect size; in high quality studies of lateral epicondylitis, participants' grip strength was 9.59 Kg higher than the control group; for participants with Achilles tendinopathy, the effect was 13.6 mm less pain on a 100 mm visual analogue scale. Conclusion: This study found conflicting evidence as to the effectiveness of LLLT in the treatment of tendinopathy. However, an effective dosage window emerged showing benefit in the treatment of tendinopathy. Strong evidence exists from the 12 positive studies that positive outcomes are associated with the use of current dosage recommendations for the treatment of tendinopathy.

Adaptation of international guidelines for metastatic colorectal cancer: an asian consensus.

PubMed

Cheng, Ann-Lii; Li, Jin; Vaid, Ashok K; Ma, Brigette Buig Yue; Teh, Catherine; Ahn, Joong B; Bello, Maximino; Charoentum, Chaiyut; Chen, Li-Tzong; de Lima Lopes, Gilberto; Ho, Gwo F; Kong, Hwai L; Lam, Ka O; Liu, Tian S; Park, Young S; Sriuranpong, Virote; Sudoyo, Aru W; Wang, Jaw-Yuan; Zhang, Jun; Zhang, Su Z; Ciardiello, Fortunato; Köhne, Clause-Henning; Shaw, Michael; Kim, Tae Won

2014-09-01

Colorectal cancer (CRC) is among the most common cancers worldwide, but marked epidemiological differences exist between Asian and non-Asian populations. Hence, a consensus meeting was held in Hong Kong in December 2012 to develop Asia-specific guidelines for the management of metastatic CRC (mCRC). A multidisciplinary expert panel, consisting of 23 participants from 10 Asian and 2 European countries, discussed current guidelines for colon or rectal cancer and developed recommendations for adapting these guidelines to Asian clinical practice. Participants agreed that mCRC management in Asia largely follows international guidelines, but they proposed a number of recommendations based on regional 'real-world' experience. In general, participants agreed that 5-fluorouracil (5-FU) infusion regimens in doublets can be substituted with UFT (capecitabine, tegafur-uracil) and S1 (tegafur, 5-chloro-2,4-dihydroxypyridine and oxonic acid), and that the monoclonal antibodies cetuximab and panitumumab are recommended for KRAS wild type tumors. For KRAS mutant tumors, bevacizumab is the preferred biological therapy. FOLFOX (folinic acid, 5-FU, and oxaliplatin) is preferred for initial therapy in Asian patients. The management of mCRC is evolving, and it must be emphasized that the recommendations presented here reflect current treatment practices and thus might change as more data become available. Copyright © 2014 Elsevier Inc. All rights reserved.

Implementation of pregnancy weight management and obesity guidelines: a meta-synthesis of healthcare professionals' barriers and facilitators using the Theoretical Domains Framework.

PubMed

Heslehurst, N; Newham, J; Maniatopoulos, G; Fleetwood, C; Robalino, S; Rankin, J

2014-06-01

Obesity in pregnancy is rising and is associated with severe health consequences for both the mother and the child. There is an increasing international focus on guidelines to manage the clinical risks of maternal obesity, and for pregnancy weight management. However, passive dissemination of guidelines is not effective and more active strategies are required for effective guideline implementation into practice. Implementation of guidelines is a form of healthcare professional behaviour change, and therefore implementation strategies should be based on appropriate behaviour change theory. This systematic review aimed to identify the determinants of healthcare professionals' behaviours in relation to maternal obesity and weight management. Twenty-five studies were included. Data synthesis of the existing international qualitative and quantitative evidence base used the Theoretical Domains Framework to identify the barriers and facilitators to healthcare professionals' maternal obesity and weight management practice. The domains most frequently identified included 'knowledge', 'beliefs about consequences' and 'environmental context and resources'. Healthcare professionals' weight management practice had the most barriers compared with any other area of maternal obesity practice. The results of this review will be used to inform the development of an intervention to support healthcare professional behaviour change. © 2014 The Authors. obesity reviews © 2014 International Association for the Study of Obesity.

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.

Mild cognitive impairment in Parkinson’s disease: the challenge and the promise

PubMed Central

Fernandez, Hubert H; Crucian, Gregory P; Okun, Michael S; Price, Catherine C; Bowers, Dawn

2005-01-01

This review addresses the literature surrounding Parkinson’s disease (PD) and mild cognitive impairment (MCI). It discusses the neuropsychological, pharmaceutical, and pathological overlap, the socioeconomic impact of PD and MCI, and the value of recognizing, understanding, and treating MCI in PD. It is concluded from this review that MCI in PD does exist and should be considered in clinical and research investigations. Due to the lack of accepted clinical criteria, an inclusive operating definition of MCI in PD is proposed. Research guidelines for studying the presence of MCI in PD and evaluating the efficacy of pharmaceutical interventions are also suggested. PMID:18568128

Safe and pragmatic use of sodium–glucose co-transporter 2 inhibitors in type 2 diabetes mellitus: South Asian Federation of Endocrine Societies consensus statement

PubMed Central

Kalra, Sanjay; Ghosh, Sujoy; Aamir, A. H.; Ahmed, Md. Tofail; Amin, Mohammod Feroz; Bajaj, Sarita; Baruah, Manash P.; Bulugahapitiya, Uditha; Das, A. K.; Giri, Mimi; Gunatilake, Sonali; Mahar, Saeed A.; Pathan, Md. Faruque; Qureshi, Nazmul Kabir; Raza, S. Abbas; Sahay, Rakesh; Shakya, Santosh; Shreshta, Dina; Somasundaram, Noel; Sumanatilleke, Manilka; Unnikrishnan, A. G.; Wijesinghe, Achini Madushani

2017-01-01

Diabetes prevalence shows a continuous increasing trend in South Asia. Although well-established treatment modalities exist for type 2 diabetes mellitus (T2DM) management, they are limited by their side effect profile. Sodium–glucose co-transporter 2 inhibitors (SGLT2i) with their novel insulin-independent renal action provide improved glycemic control, supplemented by reduction in weight and blood pressure, and cardiovascular safety. Based on the clinical outcomes with SGLT2i in patients with T2DM, treatment strategies that make a “good clinical sense” are desirable. Considering the peculiar lifestyle, body types, dietary patterns (long duration religious fasts), and the hot climate of the South Asian population, a unanimous decision was taken to design specific, customized guidelines for T2DM treatment strategies in these regions. The panel met for a discussion three times so as to get a consensus for the guidelines, and only unanimous consensus was included. After careful consideration of the quality and strength of the available evidence, the executive summary of this consensus statement was developed based on the American Association of Clinical Endocrinologists/American College of Endocrinology protocol. PMID:28217523

ALAT-2014 Chronic Obstructive Pulmonary Disease (COPD) Clinical Practice Guidelines: questions and answers.

PubMed

Montes de Oca, María; López Varela, María Victorina; Acuña, Agustín; Schiavi, Eduardo; Rey, María Alejandra; Jardim, José; Casas, Alejandro; Tokumoto, Antonio; Torres Duque, Carlos A; Ramírez-Venegas, Alejandra; García, Gabriel; Stirbulov, Roberto; Camelier, Aquiles; Bergna, Miguel; Cohen, Mark; Guzmán, Santiago; Sánchez, Efraín

2015-08-01

ALAT-2014 COPD Clinical Practice Guidelines used clinical questions in PICO format to compile evidence related to risk factors, COPD screening, disease prognosis, treatment and exacerbations. Evidence reveals the existence of risk factors for COPD other than tobacco, as well as gender differences in disease presentation. It shows the benefit of screening in an at-risk population, and the predictive value use of multidimensional prognostic indexes. In stable COPD, similar benefits in dyspnea, pulmonary function and quality of life are achieved with LAMA or LABA long-acting bronchodilators, whereas LAMA is more effective in preventing exacerbations. Dual bronchodilator therapy has more benefits than monotherapy. LAMA and combination LABA/IC are similarly effective, but there is an increased risk of pneumonia with LABA/IC. Data on the efficacy and safety of triple therapy are scarce. Evidence supports influenza vaccination in all patients and anti-pneumococcal vaccination in patients <65years of age and/or with severe airflow limitation. Antibiotic prophylaxis may decrease exacerbation frequency in patients at risk. The use of systemic corticosteroids and antibiotics are justified in exacerbations requiring hospitalization and in some patients managed in an outpatient setting. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

Japanese Society of Medical Oncology Clinical Guidelines: Molecular Testing for Colorectal Cancer Treatment, Third Edition.

PubMed

Yamazaki, Kentaro; Taniguchi, Hiroya; Yoshino, Takayuki; Akagi, Kiwamu; Ishida, Hideyuki; Ebi, Hiromichi; Nakatani, Kaname; Muro, Kei; Yatabe, Yasushi; Yamaguchi, Kensei; Tsuchihara, Katsuya

2018-06-01

The Japanese Society of Medical Oncology (JSMO) previously published 2 editions of the clinical guidelines: "Japanese guidelines for testing of KRAS gene mutation in colorectal cancer" in 2008 and "Japanese Society of Medical Oncology Clinical Guidelines: RAS (KRAS/NRAS) mutation testing in colorectal cancer patients" in 2014. These guidelines have contributed to the proper use of KRAS and RAS mutation testing, respectively. Recently, clinical utility, particularly for colorectal cancer (CRC) patients with BRAF V600E mutation or DNA mismatch-repair (MMR) deficiency, has been established. Therefore, the guideline members decided these genetic alterations should also be involved. The aim of this revision is to properly carry out testing for BRAF V600E mutation and MMR deficiency in addition to RAS mutation. The revised guidelines include the basic requirements for testing for these genetic alterations based on recent scientific evidence. Furthermore, because clinical utility of comprehensive genetic testing using next-generation sequencing and somatic gene testing of analyzing circulating tumor DNA has increasingly evolved with recent advancements in testing technology, we noted the current situation and prospects for these testing technologies and their clinical implementation in the revised guidelines. © 2018 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

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.

Provider perceptions of barriers to the emergency use of tPA for Acute Ischemic Stroke: A qualitative study

PubMed Central

2011-01-01

Background Only 1-3% of ischemic stroke patients receive thrombolytic therapy. Provider barriers to adhering with guidelines recommending tPA delivery in acute stroke are not well known. The main objective of this study was to describe barriers to thrombolytic use in acute stroke care. Methods Twenty-four hospitals were randomly selected and matched into 12 pairs. Barrier assessment occurred at intervention sites only, and utilized focus groups and structured interviews. A pre-specified taxonomy was employed to characterize barriers. Two investigators independently assigned themes to transcribed responses. Seven facilitators (three emergency physicians, two nurses, and two study coordinators) conducted focus groups and interviews of emergency physicians (65), nurses (62), neurologists (15), radiologists (12), hospital administrators (12), and three others (hospitalists and pharmacist). Results The following themes represented the most important external barriers: environmental and patient factors. Important barriers internal to the clinician included familiarity with and motivation to adhere to the guidelines, lack of self-efficacy and outcome expectancy. The following themes were not substantial barriers: lack of awareness of the existence of acute stroke guidelines, presence of conflicting guidelines, and lack of agreement with the guidelines. Conclusions Healthcare providers perceive environmental and patient-related factors as the primary barriers to adherence with acute stroke treatment guidelines. Interventions focused on increasing physician familiarity with and motivation to follow guidelines may be of highest yield in improving adherence. Improving self-efficacy in performing guideline concordant care may also be useful. Trial Registration ClinicalTrials.gov identifier: NCT00349479 PMID:21548943

Do current national and international guidelines have specific recommendations for older adults with bipolar disorder? A brief report.

PubMed

Dols, Annemiek; Kessing, Lars Vedel; Strejilevich, Sergio A; Rej, Soham; Tsai, Shang-Ying; Gildengers, Ariel G; Almeida, Osvaldo P; Shulman, Kenneth I; Sajatovic, Martha

2016-12-01

Older adults with bipolar disorder (OABD) are a growing segment of patients with bipolar disorder (BD) for which specific guidelines are warranted. Although, OABD are frequently excluded from randomized controlled trials due to their age or somatic comorbidity, more treatment data from a variety of sources have become available in recent years. It is expected that at least some of this emerging information on OABD would be incorporated into treatment guidelines available to clinicians around the world. The International Society of Bipolar Disorders OABD task force compiled and compared recommendations from current national and international guidelines that specifically address geriatric or older individuals with BD (from year 2005 onwards). There were 34 guidelines, representing six continents and 19 countries. The majority of guidelines had no separate section on OABD. General principles for treating OABD with medication are recommended to be similar to those for younger adults, with special caution for side effects due to somatic comorbidity and concomitant medications. Therapeutic lithium serum levels are suggested to be lower but recommendations are very general and mostly not informed by specific research evidence. There is a lack of emphasis of OABD-specific issues in existing guidelines. Given the substantial clinical heterogeneity in BD across the life span, along with the rapidly expanding population of older individuals worldwide, and limited mental health workforce with geriatric expertise, it is critical that additional effort and resources be devoted to studying treatment interventions specific to OABD and that treatment guidelines reflect research findings. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Implementing guidelines: Proposed definitions of neuropsychology services in pediatric oncology.

PubMed

Baum, Katherine T; Powell, Stephanie K; Jacobson, Lisa A; Gragert, Marsha N; Janzen, Laura A; Paltin, Iris; Rey-Casserly, Celiane M; Wilkening, Greta N

2017-08-01

Several organizations have published guidelines for the neuropsychological care of survivors of childhood cancer. However, there is limited consensus in how these guidelines are applied. The model of neuropsychology service delivery is further complicated by the variable terminology used to describe recommended services. In an important first step to translate published guidelines into clinical practice, this paper proposes definitions for specific neuropsychological processes and services, with the goal of facilitating consistency across sites to foster future clinical program development and to clarify clinical practice guidelines. © 2017 Wiley Periodicals, Inc.

Primary prophylaxis of venous thromboembolism in children.

PubMed

Cole, Catherine H

2010-06-01

Venous thromboembolism (VTE) is rare in children and young adolescents, and occurs predominantly in those with congenital heart disease in whom guidelines exist for VTE prophylaxis. For other paediatric patients, the rarity of the event makes writing an evidence-based clinical practice guideline difficult because each of the known risk factors contributes only a small increase in risk. Thrombophilia screening is controversial because few results assist with prediction of likely thrombosis and may not alter recommendations for prophylaxis. Recent publications highlight the importance of non-pharmacological prevention of VTE in children and adolescents undergoing surgery and the importance of liaison among surgeon, anaesthetist and haematologist. This annotation was written with the aim of collating current evidence for VTE prophylaxis and emphasising the need for further research in vulnerable subgroups.

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

PubMed

Senger, Sylvia; Lelgemann, Monika; Kopp, Ina

2006-01-01

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

[Formula: see text]Official Position of the American Academy of Clinical Neuropsychology (AACN): Guidelines for Practicum Training in Clinical Neuropsychology.

PubMed

Nelson, Aaron P; Roper, Brad L; Slomine, Beth S; Morrison, Chris; Greher, Michael R; Janusz, Jennifer; Larson, Jennifer C; Meadows, Mary-Ellen; Ready, Rebecca E; Rivera Mindt, Monica; Whiteside, Doug M; Willment, Kim; Wodushek, Thomas R

2015-01-01

Practical experience is central to the education and training of neuropsychologists, beginning in graduate school and extending through postdoctoral fellowship. However, historically, little attention has been given to the structure and requirements of practicum training in clinical neuropsychology. A working group of senior-level neuropsychologists, as well as a current postdoctoral fellow, all from a diverse range of settings (The AACN Practicum Guidelines Workgroup), was formed to propose guidelines for practicum training in clinical neuropsychology. The Workgroup reviewed relevant literature and sought input from professional organizations involved in education and training in neuropsychology. The proposed guidelines provide a definition of practicum training in clinical neuropsychology, detail entry and exit criteria across competencies relevant to practicum training in clinical neuropsychology, and discuss the relationship between doctoral training programs and practicum training sites. The proposed guidelines also provide a methodology for competency-based evaluation of clinical neuropsychology practicum trainees and outline characteristics and features that are integral to an effective training environment. Although the guidelines discussed below may not be implemented in their entirety across all clinical neuropsychology practicum training sites, they are consistent with the latest developments in competency-based education.

A critical appraisal of clinical practice guidelines for the treatment of lower-limb osteoarthritis

PubMed Central

Pencharz, James N; Grigoriadis, Elizabeth; Jansz, Gwenderlyn F; Bombardier, Claire

2002-01-01

Clinical practice guidelines are important tools to assist clinical decision-making. Recently, several guidelines addressing the management of osteoarthritis (OA) have been published. Clinicians treating patients with OA must ensure that these guidelines are developed with consistency and methodological rigour. We undertook a qualitative summary and critical appraisal of six medical treatment guidelines for the management of lower-limb OA published in the medical literature within the past 5 years. A review of these six guidelines revealed that each possesses strengths and weakness. While most described the scope and intended patient populations, the guidelines varied considerably in the rigour of their development, coverage of implementation issues, and disclosure of conflicts of interest. PMID:11879536

Clinical Practice Guidelines for the Antibiotic Treatment of Community-Acquired Urinary Tract Infections

PubMed Central

Ha, U-Syn; Lee, Seung-Ju; Yeo, Jeong Kyun; Min, Seung Ki; Lee, Heeyoung

2018-01-01

Urinary tract infections (UTIs) are infectious diseases that commonly occur in communities. Although several international guidelines for the management of UTIs have been available, clinical characteristics, etiology and antimicrobial susceptibility patterns may differ from country to country. This work represents an update of the 2011 Korean guideline for UTIs. The current guideline was developed by the update and adaptation method. This clinical practice guideline provides recommendations for the diagnosis and management of UTIs, including asymptomatic bacteriuria, acute uncomplicated cystitis, acute uncomplicated pyelonephritis, complicated pyelonephritis related to urinary tract obstruction, and acute bacterial prostatitis. This guideline targets community-acquired UTIs occurring among adult patients. Healthcare-associated UTIs, catheter-associated UTIs, and infections in immunocompromised patients were not included in this guideline. PMID:29637759

Only One Third of Tehran's Physicians are Familiar with 'Evidence-Based Clinical Guidelines'.

PubMed

Mounesan, Leila; Nedjat, Saharnaz; Majdzadeh, Reza; Rashidian, Arash; Gholami, Jaleh

2013-03-01

Clinical guidelines have increasingly been used as tools for applying new knowledge and research findings. Although, efforts have been made to produce clinical guidelines in Iran, it is not clear whether they have been used by physicians and what factors are associated with them?. Four hundred and forty three practicing physicians in Tehran were selected from private clinics through weighted random sampling. The data collection tool was a questionnaire on familiarity and attitude toward clinical guidelines. The descriptive and analytical findings were analyzed with t-tests, Chi(2), logistic and linear multivariate regression by SPSS, version 16. 31.8% of physicians were familiar with clinical guidelines. Based on the logistic regression model physicians' familiarity with clinical guidelines was positively and significantly associated with 'working experience in a health service delivery point' OR = 2.13 (95% CI, 1.17-3.90), 'familiarity with therapeutic protocols' OR = 2.09 (95% CI, 1.22-3.57) and 'holding a specialty degree' OR = 2.51 (95% CI, 1.24-5.07). The mean overall attitude scores in the 'usefulness', 'reliability', and 'problems and barriers' domains were, respectively, 78.9 (SD = 16.5), 78.9 (SD = 19.7) and 50.4 (SD = 15.9) out of a total of 100 scores in each domain. No significant association was observed between attitude domains and other independent variables using multivariate linear regression. Little familiarity with clinical guidelines may represent weakness in of production and distribution of domestic evidence. Although, physicians considered guidelines as useful and reliable tools, but problems such as difficult access to guidelines and lack of facilities to apply them were stated as well.

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.

[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.

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

[Clinical practice guidelines: juridical and medico legal issues in health care malpractice liability].

PubMed

Moreschi, Carlo; Broi, Ugo Da

2014-01-01

Clinical Practice Guidelines are clinical tools addressed to medical and health professionals and are normally employed to improve quality and safety of diagnostic and therapeutical procedures but may sometimes limit the autonomy of medical and other health care professionals. The adherence to Clinical Practice Guidelines should not be an exclusive step to evaluate the liability and respect of standards of care in case of medico-legal investigations being each clinical case very specific. Medical liability and respect of standards of care should be evaluated with the support of Clinical Practice Guidelines and the extensive examination of all specific features, professional background and experience requested to treat each single patient.

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

PubMed Central

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

2017-01-01

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

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

A service oriented approach for guidelines-based clinical decision support using BPMN.

PubMed

Rodriguez-Loya, Salvador; Aziz, Ayesha; Chatwin, Chris

2014-01-01

Evidence-based medical practice requires that clinical guidelines need to be documented in such a way that they represent a clinical workflow in its most accessible form. In order to optimize clinical processes to improve clinical outcomes, we propose a Service Oriented Architecture (SOA) based approach for implementing clinical guidelines that can be accessed from an Electronic Health Record (EHR) application with a Web Services enabled communication mechanism with the Enterprise Service Bus. We have used Business Process Modelling Notation (BPMN) for modelling and presenting the clinical pathway in the form of a workflow. The aim of this study is to produce spontaneous alerts in the healthcare workflow in the diagnosis of Chronic Obstructive Pulmonary Disease (COPD). The use of BPMN as a tool to automate clinical guidelines has not been previously employed for providing Clinical Decision Support (CDS).

Representation primitives, process models and patient data in computer-interpretable clinical practice guidelines: a literature review of guideline representation models.

PubMed

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

2002-12-18

Representation of clinical practice guidelines in a computer-interpretable format is a critical issue for guideline development, implementation, and evaluation. We studied 11 types of guideline representation models that can be used to encode guidelines in computer-interpretable formats. We have consistently found in all reviewed models that primitives for representation of actions and decisions are necessary components of a guideline representation model. Patient states and execution states are important concepts that closely relate to each other. Scheduling constraints on representation primitives can be modeled as sequences, concurrences, alternatives, and loops in a guideline's application process. Nesting of guidelines provides multiple views to a guideline with different granularities. Integration of guidelines with electronic medical records can be facilitated by the introduction of a formal model for patient data. Data collection, decision, patient state, and intervention constitute four basic types of primitives in a guideline's logic flow. Decisions clarify our understanding on a patient's clinical state, while interventions lead to the change from one patient state to another.

Ministry of Health Clinical Practice Guidelines: Prevention, Diagnosis and Management of Tuberculosis

PubMed Central

Wang, Yee Tang Sonny; Chee, Cynthia Bin Eng; Hsu, Li Yang; Jagadesan, Raghuram; Kaw, Gregory Jon Leng; Kong, Po Marn; Lew, Yii Jen; Lim, Choon Seng; Lim, Ting Ting Jayne; Lu, Kuo Fan Mark; Ooi, Peng Lim; Sng, Li-Hwei; Thoon, Koh Cheng

2016-01-01

The Ministry of Health (MOH) has developed the clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis to provide doctors and patients in Singapore with evidence-based treatment for tuberculosis. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis, for the information of SMJ readers. The chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines. PMID:26996216

Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data--The Influence of Different Parameters in a Routine Clinical Microbiology Laboratory.

PubMed

Kohlmann, Rebekka; Gatermann, Sören G

2016-01-01

Many clinical microbiology laboratories report on cumulative antimicrobial susceptibility testing (cAST) data on a regular basis. Criteria for generation of cAST reports, however, are often obscure and inconsistent. Whereas the CLSI has published a guideline for analysis and presentation of cAST data, national guidelines directed at clinical microbiology laboratories are not available in Europe. Thus, we sought to describe the influence of different parameters in the process of cAST data analysis in the setting of a German routine clinical microbiology laboratory during 2 consecutive years. We developed various program scripts to assess the consequences ensuing from different algorithms for calculation of cumulative antibiograms from the data collected in our clinical microbiology laboratory in 2013 and 2014. One of the most pronounced effects was caused by exclusion of screening cultures for multi-drug resistant organisms which decreased the MRSA rate in some cases to one third. Dependent on the handling of duplicate isolates, i.e. isolates of the same species recovered from successive cultures on the same patient during the time period analyzed, we recorded differences in resistance rates of up to 5 percentage points for S. aureus, E. coli and K. pneumoniae and up to 10 percentage points for P. aeruginosa. Stratification by site of care and specimen type, testing of antimicrobials selectively on resistant isolates, change of interpretation rules and analysis at genus level instead of species level resulted in further changes of calculated antimicrobial resistance rates. The choice of parameters for cAST data analysis may have a substantial influence on calculated antimicrobial resistance rates. Consequently, comparability of cAST reports from different clinical microbiology laboratories may be limited. We suggest that laboratories communicate the strategy used for cAST data analysis as long as national guidelines for standardized cAST data analysis and reporting do not exist in Europe.

Challenges in developing national HIV guidelines: experience from the eastern Mediterranean

PubMed Central

De Weggheleire, Anja; Bortolotti, Veronique; Zolfo, Maria; Crowley, Siobhan; Colebunders, Robert; Riedner, Gabriele

2011-01-01

Abstract Objective To appraise the process of development and clinical content of national human immunodeficiency virus (HIV) clinical practice guidelines of countries in the eastern Mediterranean and to formulate recommendations for future guideline development and adaptation. Methods Twenty-three countries in the World Health Organization (WHO) Eastern Mediterranean and United Nations Children’s Fund Middle East and North Africa regions were invited to submit national HIV clinical practice guidelines for review. The guideline development methodology was assessed using an adaptation of the Appraisal of Guidelines Research and Evaluation (AGREE) instrument and guideline content, using a checklist to evaluate concordance with WHO 2006 generic guidelines. Findings Twelve countries submitted 20 guidelines developed between 2004 and 2009. Median scores were poor (i.e. < 0.6) for the methodological quality domains of rigour of development, stakeholder involvement and applicability and flexibility. Scores were better for the domains of scope and purpose (median: 0.82, interquartile range, IQR: 0.58–0.89) and clarity and presentation (median: 0.67, IQR: 0.50–0.78). Concerning guideline content, recommended first-line treatment and eligibility criteria for antiretroviral therapy (ART) in adults were in line with WHO recommendations in most guidelines. However, recommendations on antiretroviral prophylaxis for the prevention of vertical HIV transmission, diagnosis and treatment of HIV infection in infants, monitoring patients on ART, treatment failure and co-morbidities were often lacking. Conclusion The large majority of national HIV clinical practice guidelines had methodological weaknesses and content inaccuracies. Countries require assistance with the adaptation process to ensure that guidelines are valid and up to date and accurately reflect WHO global clinical care recommendations for patients with HIV. PMID:21673860

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.

An appraisal of the trustworthiness of practice guidelines for depression and anxiety in children and youth.

PubMed

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

2018-04-26

Little is known about the trustworthiness of clinical practice guidelines (PGs) relevant to child and youth depression or anxiety. To address this gap, we used systematic review methods to identify all available relevant PGs, quality appraise them, and make recommendations regarding which PGs are trustworthy and should be used by clinicians. Prespecified inclusion criteria identified eligible PGs. Two independent trained reviewers applied the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. Using three AGREE II domain scores (stakeholder involvement, rigor of development [clinical validity/trustworthiness], and editorial independence), PG quality was designated as (1) minimum (≥50%) and (2) high (≥70%). Of 25 eligible PGs, five met minimum quality criteria (depression, n = 4; anxiety, n = 1); three out of five met high-quality criteria (depression, n = 2; anxiety, n = 1). Among the five minimum quality PGs, developers included government (n = 2), independent expert groups (n = 2), and other (n = 1). No PGs developed by specialty societies achieved minimum or high-quality ratings; eight of 25 PGs were up-to-date. Trustworthy PGs are available to support clinical decisions about depression and anxiety in children and youth, but are few in number. Many existing PGs (up to 80%) may not be clinically valid. Clinicians who implement the high-quality PGs identified here can increase the number of children and youth who receive effective interventions for depression and anxiety, minimize harm, and avoid wasted resources. Clinicians, service planners, youth, and their families should encourage PG developers to increase the pool of high-quality PGs using internationally recognized PG development standards. © 2018 Wiley Periodicals, Inc.

American Society of Clinical Oncology Clinical Practice Guideline Update on the Use of Pharmacologic Interventions Including Tamoxifen, Raloxifene, and Aromatase Inhibition for Breast Cancer Risk Reduction

PubMed Central

Visvanathan, Kala; Chlebowski, Rowan T.; Hurley, Patricia; Col, Nananda F.; Ropka, Mary; Collyar, Deborah; Morrow, Monica; Runowicz, Carolyn; Pritchard, Kathleen I.; Hagerty, Karen; Arun, Banu; Garber, Judy; Vogel, Victor G.; Wade, James L.; Brown, Powel; Cuzick, Jack; Kramer, Barnett S.; Lippman, Scott M.

2009-01-01

Purpose To update the 2002 American Society of Clinical Oncology guideline on pharmacologic interventions for breast cancer (BC) risk reduction. Methods A literature search identified relevant randomized trials published since 2002. Primary outcome of interest was BC incidence (invasive and noninvasive). Secondary outcomes included BC mortality, adverse events, and net health benefits. An expert panel reviewed the literature and developed updated consensus guidelines. Results Seventeen articles met inclusion criteria. In premenopausal women, tamoxifen for 5 years reduces the risk of BC for at least 10 years, particularly estrogen receptor (ER) –positive invasive tumors. Women ≤ 50 years of age experience fewer serious side effects. Vascular and vasomotor events do not persist post-treatment across all ages. In postmenopausal women, raloxifene and tamoxifen reduce the risk of ER-positive invasive BC with equal efficacy. Raloxifene is associated with a lower risk of thromboembolic disease, benign uterine conditions, and cataracts than tamoxifen in postmenopausal women. No evidence exists establishing whether a reduction in BC risk from either agent translates into reduced BC mortality. Recommendations In women at increased risk for BC, tamoxifen (20 mg/d for 5 years) may be offered to reduce the risk of invasive ER-positive BC, with benefits for at least 10 years. In postmenopausal women, raloxifene (60 mg/d for 5 years) may also be considered. Use of aromatase inhibitors, fenretinide, or other selective estrogen receptor modulators to lower BC risk is not recommended outside of a clinical trial. Discussion of risks and benefits of preventive agents by health providers is critical to patient decision making. PMID:19470930

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

Korean Medication Algorithm for Depressive Disorder: Comparisons with Other Treatment Guidelines

PubMed Central

Wang, Hee Ryung; Bahk, Won-Myong; Seo, Jeong Seok; Woo, Young Sup; Park, Young-Min; Jeong, Jong-Hyun; Kim, Won; Shim, Se-Hoon; Lee, Jung Goo; Jon, Duk-In; Min, Kyung Joon

2017-01-01

In this review, we compared recommendations from the Korean Medication Algorithm Project for Depressive Disorder 2017 (KMAP-DD 2017) to other global treatment guidelines for depression. Six global treatment guidelines were reviewed; among the six, 4 were evidence-based guidelines, 1 was an expert consensus-based guideline, and 1 was an amalgamation of both evidence and expert consensus-based recommendations. The recommendations in the KMAP-DD 2017 were generally similar to those in other global treatment guidelines, although there were some differences between the guidelines. The KMAP-DD 2017 appeared to reflect current changes in the psychopharmacology of depression quite well, like other recently published evidence-based guidelines. As an expert consensus-based guideline, the KMAP-DD 2017 had some limitations. However, considering there are situations in which clinical evidence cannot be drawn from planned clinical trials, the KMAP-DD 2017 may be helpful for Korean psychiatrists making decisions in the clinical settings by complementing previously published evidence-based guidelines. PMID:28783928

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

Clinical guidelines and the fate of medical autonomy in Ontario.

PubMed

Rappolt, S G

1997-04-01

Conceptually, clinical guidelines and professional autonomy have a paradoxical relationship. Despite being the quintessence of medical knowledge at the corporate level, guidelines diminish the clinical autonomy of individual practitioners, and therefore threaten medicine's justification for its autonomy. Theorists have argued that professional autonomy will be retained through elite dominance of practitioners, while comparative research suggests that economic autonomy can be traded off to retain clinical autonomy. Under government pressure to regulate the growth of Ontario physicians' fee-for-service public expenditure, the profession's representative organization, the Ontario Medical Association (OMA), promoted voluntary clinical guidelines, hoping to both constrain costs and preserve professional control over the content of medical care. The OMA collaborated with the Ministry of Health in developing guidelines and establishing a provincial centre for health service research. Ontario's practitioners disregarded the OMA's exhortations to implement clinical guidelines, suggesting that in the absence of external constraints, practitioners can subvert elite dominance. However, practitioners' unchecked clinical and economic autonomy, combined with evidence of wide provincial variations in medical care, served to legitimize the government's increasingly unilateral control over the schedule of insured medical services, and, in 1993, their imposition of a global cap on physicians' fee-for-service income pool. When analysed in the context of ongoing Ministry-OMA relations, the failure of the OMA's guidelines strategy to constrain medical service costs has expedited an overall decline in medical autonomy in Ontario. The emergence and course of Ontario's clinical guidelines movement is consistent with the view that medical autonomy is contingent upon broad class forces, and the conceptualization of professional organizations as instruments for mediated occupational control.

Korean guidelines for the diagnosis and management of dry eye: development and validation of clinical efficacy.

PubMed

Hyon, Joon Young; Kim, Hyo-Myung; Lee, Doh; Chung, Eui-Sang; Song, Jong-Suk; Choi, Chul Young; Lee, Jungbok

2014-06-01

To evaluate the clinical efficacy of newly developed guidelines for the diagnosis and management of dry eye. This retrospective, multi-center, non-randomized, observational study included a total of 1,612 patients with dry eye disease who initially visited the clinics from March 2010 to August 2010. Korean guidelines for the diagnosis and management of dry eye were newly developed from concise, expert-consensus recommendations. Severity levels at initial and final visits were determined using the guidelines in patients with 90 ± 7 days of follow-up visits (n = 526). Groups with different clinical outcomes were compared with respect to clinical parameters, treatment modalities, and guideline compliance. Main outcome measures were ocular and visual symptoms, ocular surface disease index, global assessment by patient and physician, tear film break-up time, Schirmer-1 test score, ocular surface staining score at initial and final visits, clinical outcome after three months of treatment, and guideline compliance. Severity level was reduced in 47.37% of patients treated as recommended by the guidelines. Younger age (odd ratio [OR], 0.984; p = 0.044), higher severity level at initial visit, compliance to treatment recommendation (OR, 1.832; p = 0.047), and use of topical cyclosporine (OR, 1.838; p = 0.011) were significantly associated with improved clinical outcomes. Korean guidelines for the diagnosis and management of dry eye can be used as a valid and effective tool for the treatment of dry eye disease.

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

High burden of genetic conditions diagnosed in a cardiac neurodevelopmental clinic.

PubMed

Goldenberg, Paula C; Adler, Betsy J; Parrott, Ashley; Anixt, Julia; Mason, Karen; Phillips, Jannel; Cooper, David S; Ware, Stephanie M; Marino, Bradley S

2017-04-01

There is a known high prevalence of genetic and clinical syndrome diagnoses in the paediatric cardiac population. These disorders often have multisystem effects, which may have an important impact on neurodevelopmental outcomes. Taken together, these facts suggest that patients and families may benefit from consultation by genetic specialists in a cardiac neurodevelopmental clinic. This study assessed the burden of genetic disorders and utility of genetics evaluation in a cardiac neurodevelopmental clinic. A retrospective chart review was conducted of patients evaluated in a cardiac neurodevelopmental clinic from 6 December, 2011 to 16 April, 2013. All patients were seen by a cardiovascular geneticist with genetic counselling support. A total of 214 patients were included in this study; 64 of these patients had a pre-existing genetic or syndromic diagnosis. Following genetics evaluation, an additional 19 were given a new clinical or laboratory-confirmed genetic diagnosis including environmental such as teratogenic exposures, malformation associations, chromosomal disorders, and single-gene disorders. Genetic testing was recommended for 112 patients; radiological imaging to screen for congenital anomalies for 17 patients; subspecialist medical referrals for 73 patients; and non-genetic clinical laboratory testing for 14 patients. Syndrome-specific guidelines were available and followed for 25 patients with known diagnosis. American Academy of Pediatrics Red Book asplenia guideline recommendations were given for five heterotaxy patients, and family-based cardiac screening was recommended for 23 families affected by left ventricular outflow tract obstruction. Genetics involvement in a cardiac neurodevelopmental clinic is helpful in identifying new unifying diagnoses and providing syndrome-specific care, which may impact the patient's overall health status and neurodevelopmental outcome.

A method for assessing the cost-effectiveness and the break-even point of clinical practice guidelines.

PubMed

Gandjour, A; Lauterbach, K W

2001-01-01

Assessing the costs and benefits of developing a clinical practice guideline is important because investments in guidelines compete with investments in other clinical programs. Despite the considerable number of guidelines in many industrialized countries, little is known about their costs and cost-effectiveness. The authors have developed specific measures to determine the cost-effectiveness of guidelines, using a German evidence-based guideline on obesity for the diagnosis and treatment of obese patients as a model. The measures are: the number of people needed to cure, the number of people needed to prevent from developing the disease in question, and the number of people to treat in order to break even.

Recommendations for imaging tumor response in neurofibromatosis clinical trials

PubMed Central

Ardern-Holmes, Simone L.; Babovic-Vuksanovic, Dusica; Barker, Fred G.; Connor, Steve; Evans, D. Gareth; Fisher, Michael J.; Goutagny, Stephane; Harris, Gordon J.; Jaramillo, Diego; Karajannis, Matthias A.; Korf, Bruce R.; Mautner, Victor; Plotkin, Scott R.; Poussaint, Tina Y.; Robertson, Kent; Shih, Chie-Schin; Widemann, Brigitte C.

2013-01-01

Objective: Neurofibromatosis (NF)-related benign tumors such as plexiform neurofibromas (PN) and vestibular schwannomas (VS) can cause substantial morbidity. Clinical trials directed at these tumors have become available. Due to differences in disease manifestations and the natural history of NF-related tumors, response criteria used for solid cancers (1-dimensional/RECIST [Response Evaluation Criteria in Solid Tumors] and bidimensional/World Health Organization) have limited applicability. No standardized response criteria for benign NF tumors exist. The goal of the Tumor Measurement Working Group of the REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) committee is to propose consensus guidelines for the evaluation of imaging response in clinical trials for NF tumors. Methods: Currently used imaging endpoints, designs of NF clinical trials, and knowledge of the natural history of NF-related tumors, in particular PN and VS, were reviewed. Consensus recommendations for response evaluation for future studies were developed based on this review and the expertise of group members. Results: MRI with volumetric analysis is recommended to sensitively and reproducibly evaluate changes in tumor size in clinical trials. Volumetric analysis requires adherence to specific imaging recommendations. A 20% volume change was chosen to indicate a decrease or increase in tumor size. Use of these criteria in future trials will enable meaningful comparison of results across studies. Conclusions: The proposed imaging response evaluation guidelines, along with validated clinical outcome measures, will maximize the ability to identify potentially active agents for patients with NF and benign tumors. PMID:24249804

Recommendations for imaging tumor response in neurofibromatosis clinical trials.

PubMed

Dombi, Eva; Ardern-Holmes, Simone L; Babovic-Vuksanovic, Dusica; Barker, Fred G; Connor, Steve; Evans, D Gareth; Fisher, Michael J; Goutagny, Stephane; Harris, Gordon J; Jaramillo, Diego; Karajannis, Matthias A; Korf, Bruce R; Mautner, Victor; Plotkin, Scott R; Poussaint, Tina Y; Robertson, Kent; Shih, Chie-Schin; Widemann, Brigitte C

2013-11-19

Neurofibromatosis (NF)-related benign tumors such as plexiform neurofibromas (PN) and vestibular schwannomas (VS) can cause substantial morbidity. Clinical trials directed at these tumors have become available. Due to differences in disease manifestations and the natural history of NF-related tumors, response criteria used for solid cancers (1-dimensional/RECIST [Response Evaluation Criteria in Solid Tumors] and bidimensional/World Health Organization) have limited applicability. No standardized response criteria for benign NF tumors exist. The goal of the Tumor Measurement Working Group of the REiNS (Response Evaluation in Neurofibromatosis and Schwannomatosis) committee is to propose consensus guidelines for the evaluation of imaging response in clinical trials for NF tumors. Currently used imaging endpoints, designs of NF clinical trials, and knowledge of the natural history of NF-related tumors, in particular PN and VS, were reviewed. Consensus recommendations for response evaluation for future studies were developed based on this review and the expertise of group members. MRI with volumetric analysis is recommended to sensitively and reproducibly evaluate changes in tumor size in clinical trials. Volumetric analysis requires adherence to specific imaging recommendations. A 20% volume change was chosen to indicate a decrease or increase in tumor size. Use of these criteria in future trials will enable meaningful comparison of results across studies. The proposed imaging response evaluation guidelines, along with validated clinical outcome measures, will maximize the ability to identify potentially active agents for patients with NF and benign tumors.

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.

Funding nutrition research: where's the money?

PubMed

Thomson, Cynthia A

2007-12-01

While a great idea that can be developed into a viable hypothesis is central to the development of a meritorious research proposal, without funding, the evidence base supporting or reputing a hypothesis cannot be advanced. A wide variety of funding sources exist for nutrition research, including governmental, organizational, industrial, and intramural-based funding; however, understanding the "language" of research funding can be challenging. This review provides an overview of funding sources, guidelines for securing funding, and recommendations to support a successful application for clinical nutrition research.

Latin American and Caribbean countries' baseline clinical and policy guidelines for responding to intimate partner violence and sexual violence against women.

PubMed

Stewart, Donna E; Aviles, Raquel; Guedes, Alessandra; Riazantseva, Ekaterina; MacMillan, Harriet

2015-07-15

Violence against women is a global public health problem with negative effects on physical, mental, and reproductive health. The World Health Organization (WHO) has identified intimate partner violence (IPV) and sexual violence (SV) as major targets for prevention and amelioration and recently developed clinical and policy guidelines to assist healthcare providers. This project was undertaken to determine the 2013 baseline national policies and clinical guidelines on IPV and SV within the Latin American and Caribbean (LAC) region to identify strengths and gaps requiring action. Each Pan American Health Organization/World Health Organization Regional Office for the Americas (PAHO/WHO) country focal point was contacted to request their current national policy and clinical guidelines (protocol) on IPV/SV. We augmented this by searching the internet and the United Nations Women website. Each country's policy and clinical guideline (where available) was reviewed and entered into a scoring matrix based on WHO Clinical and Policy Guidelines. A total score for each heading and subheading was developed by adding positive responses to identify LAC regional strengths and gaps. We obtained 15 national policies and 12 national clinical guidelines (protocols) from a total of 18 countries ("response" rate 66.7%). National policies were comprehensive in terms of physical, emotional, and sexual violence and recommended good intersectoral collaboration. The greatest gap was in the training of health-care providers. National Guidelines for women-centered care for IPV/SV survivors were strong in the vital areas of privacy, confidentiality, danger assessment, safety planning, and supportive reactions to disclosure. The largest gaps noted were again in training healthcare professionals and strengthening monitoring and evaluation of services. Baseline measurement of policy and clinical guidelines for IPV/SV in LAC PAHO/WHO member countries at the time of issuing the 2013 WHO Clinical and Policy Guidelines reveals some important strengths, but also serious gaps that need to be addressed. The most pressing needs are for concerted training initiatives for healthcare providers and strengthening multisectoral monitoring and evaluation of services. A future evaluation of national policies, clinical guidelines, monitoring and evaluation will need to be conducted to measure the progress of the required scaling-up process.

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.

Proposed Guidelines for Operating Counselor Education and Supervision Training Clinics

ERIC Educational Resources Information Center

Lauka, Justin D.; McCarthy, Amanda K.

2013-01-01

The purpose of this article is to justify and present a set of guidelines for the effective and ethical administration of counselor education and supervision training clinics. Responding directly to a call for creating guidelines, the authors address core issues surrounding their development. Benefits for clear and accessible guidelines and risks…

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

PubMed Central

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

2012-01-01

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

Acromegaly: an endocrine society clinical practice guideline.

PubMed

Katznelson, Laurence; Laws, Edward R; Melmed, Shlomo; Molitch, Mark E; Murad, Mohammad Hassan; Utz, Andrea; Wass, John A H

2014-11-01

The aim was to formulate clinical practice guidelines for acromegaly. The Task Force included a chair selected by the Endocrine Society Clinical Guidelines Subcommittee (CGS), five experts in the field, and a methodologist. The authors received no corporate funding or remuneration. This guideline is cosponsored by the European Society of Endocrinology. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. The Task Force reviewed primary evidence and commissioned two additional systematic reviews. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society and the European Society of Endocrinology reviewed drafts of the guidelines. Using an evidence-based approach, this acromegaly guideline addresses important clinical issues regarding the evaluation and management of acromegaly, including the appropriate biochemical assessment, a therapeutic algorithm, including use of medical monotherapy or combination therapy, and management during pregnancy.

How can clinical practice guidelines be adapted to facilitate shared decision making? A qualitative key-informant study.

PubMed

van der Weijden, Trudy; Pieterse, Arwen H; Koelewijn-van Loon, Marije S; Knaapen, Loes; Légaré, France; Boivin, Antoine; Burgers, Jako S; Stiggelbout, Anne M; Faber, Marjan; Elwyn, Glyn

2013-10-01

To explore how clinical practice guidelines can be adapted to facilitate shared decision making. This was a qualitative key-informant study with group discussions and semi-structured interviews. First, 75 experts in guideline development or shared decision making participated in group discussions at two international conferences. Next, health professionals known as experts in depression or breast cancer, experts on clinical practice guidelines and/or shared decision making, and patient representatives were interviewed (N=20). Using illustrative treatment decisions on depression or breast cancer, we asked the interviewees to indicate as specifically as they could how guidelines could be used to facilitate shared decision making. Interviewees suggested some generic strategies, namely to include a separate chapter on the importance of shared decision making, to use language that encourages patient involvement, and to develop patient versions of guidelines. Recommendation-specific strategies, related to specific decision points in the guideline, were also suggested: These include structuring the presentation of healthcare options to increase professionals' option awareness; structuring the deliberation process between professionals and patients; and providing relevant patient support tools embedded at important decision points in the guideline. This study resulted in an overview of strategies to adapt clinical practice guidelines to facilitate shared decision making. Some strategies seemed more contentious than others. Future research should assess the feasibility and impact of these strategies to make clinical practice guidelines more conducive to facilitate shared decision making.

Policies and Procedures That Facilitate Implementation of Evidence-Based Clinical Guidelines in U.S. Dental Schools.

PubMed

Polk, Deborah E; Nolan, Beth A D; Shah, Nilesh H; Weyant, Robert J

2016-01-01

The aim of this study was to determine the degree to which dental schools in the United States have policies and procedures in place that facilitate the implementation of evidence-based clinical guidelines. The authors sent surveys to all 65 U.S. dental schools in 2014; responses were obtained from 38 (58%). The results showed that, of the nine policies and procedures examined, only two were fully implemented by 50% or more of the responding schools: guidelines supported through clinical faculty education or available chairside (50%), and students informed of guidelines in both the classroom and clinic (65.8%). Although 92% of the respondents reported having an electronic health record, 80% of those were not using it to track compliance with guidelines. Five schools reported implementing more policies than the rest of the schools. The study found that the approach to implementing guidelines at most of the responding schools did not follow best practices although five schools had an exemplary set of policies and procedures to support guideline implementation. These results suggest that most dental schools are currently not implementing guidelines effectively and efficiently, but that the goal of schools' having a comprehensive implementation program for clinical guidelines is achievable since some are doing so. Future studies should determine whether interventions to improve implementation in dental schools are needed.

[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.

Design and implementation of the GLIF3 guideline execution engine.

PubMed

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

2004-10-01

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

Physicians’ Knowledge and Attitudes Regarding Implantable Cardioverter- Defibrillators

PubMed Central

Sherazi, Saadia; Zareba, Wojciech; Daubert, James P.; McNitt, Scott; Shah, Abrar H.; Aktas, Mehmet K.; Block, Robert C.

2012-01-01

Background Information is limited regarding the knowledge and attitudes of physicians typically involved in the referral of patients for implantable cardioverter defibrillator (ICD) implantation. Methods We conducted a survey of primary care physicians and cardiologists at the University of Rochester Medical Center and the Unity Health System Rochester, NY from December 2008 to February 2009. The survey collected information regarding knowledge and attitudes of physicians towards ICD therapy. Results Of the 332 surveys distributed, 110 (33%) were returned. Over-all 94 (87%) physicians reported referring patients for ICD implantation. Eighteen (17%) physicians reported unawareness of guidelines for ICD use. Sixty-four (59%) physicians recommended ICD in patients with ischemic cardiomyopathy and left ventricular ejection fraction (LVEF) ≤ 35%. Sixty-five (62%) physicians use ≤ 35% as LVEF criteria for ICD referral in patients with non-ischemic cardiomyopathy. Cardiologists were more familiar than primary care physicians with LVEF criteria for implantation of ICD in patients with ischemic and non-ischemic cardiomyopathy (p value 0.005 and 0.002 respectively). Twenty-nine (27%) participants were unsure regarding benefits of ICDs in eligible women and Blacks. Eighty two (76%) physicians believed that an ICD could benefit patients ≥70 years whereas only 53 (49%) indicated that an ICD would benefit patients ≥ 80 years of age. A lack of familiarity with current clinical guidelines regarding ICD implantation exists. Primary care physicians are less aware of clinical guidelines than are cardiologists. This finding highlights the need to improve the dissemination of guidelines to primary care physicians in an effort to improve ICD utilization. PMID:20535717

Critical appraisal of cardiology guidelines on revascularisation: clinical practice.

PubMed

Dobies, David R; Barber, Kimberly R

2018-01-01

Evidence-based medicine (EBM) provides clinicians with beneficial information. Nonetheless, study findings are often arbitrary, speculative or provisional. The current state of misleading evidence exists in all applications, including those for guideline recommendations. We conductedan appraisal of the American College of Cardiologyand European Society of Cardiology Guidelines for revascularisation of complex coronary anatomy to determine the veracity of the evidence that recommendations were based on. Study-specific critical appraisals were conducted by the authors on the 5-year Synergy between percutaneous coronary intervention with Taxus and cardiac surgery (SYNTAX) and future revascularisation evaluation in patients with diabetes mellitus: optimal management of multivessel disease (FREEDOM) Trials. Each appraisal was performed according the standard EBM practices. A thorough design and analytic critique was performed for each study and the results presented and explained. The guideline recommendations were reviewed in terms of the veracity of the evidence cited. The relative difference in major adverse cardiac and cerebrovascular event (MAACE) rates between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are not the 30% level reported by the SYNTAX Trial but closer to 11% difference when study limitations are factored in. Similarly, the 30% effect size in MAACE rates between procedures from the FREEDOM Trial is closer to a non-significant 5% relative difference when limitations are adjusted for. Based on the actual findings of each study, outcomes from procedures by CABG or PCI for multivessel revascularisation are similar and contradict the conclusions of the study authors as well as the recommendations. These recommendations fail to inform current clinical practice.

Delivering Clinical Practice Guideline-Concordant Care for PTSD and Major Depression in Military Treatment Facilities.

PubMed

Hepner, Kimberly A; Farris, Coreen; Farmer, Carrie M; Iyiewuare, Praise O; Tanielian, Terri; Wilks, Asa; Robbins, Michael; Paddock, Susan M; Pincus, Harold Alan

2018-04-01

Providing accessible, high-quality care for psychological health (PH) conditions, such as posttraumatic stress disorder (PTSD) and major depressive disorder (MDD), is important to maintaining a healthy, mission-ready force. It is unclear whether the current system of care meets the needs of service members with PTSD or MDD, and little is known about the barriers to delivering guideline-concordant care. RAND used existing provider workforce data, a provider survey, and key informant interviews to (1) provide an overview of the PH workforce at military treatment facilities (MTFs), (2) examine the extent to which care for PTSD and MDD in military treatment facilities is consistent with Department of Veterans Affairs/Department of Defense clinical practice guidelines, and (3) identify facilitators and barriers to providing this care. This study provides a comprehensive assessment of providers' perspectives on their capacity to deliver PH care within MTFs and presents detailed results by provider type and service branch. Findings suggest that most providers report using guideline-concordant psychotherapies, but use varied by provider type. The majority of providers reported receiving at least minimal training and supervision in at least one recommended psychotherapy for PTSD and for MDD. Still, more than one-quarter of providers reported that limits on travel and lack of protected time in their schedule affected their ability to access additional professional training. Finally, most providers reported routinely screening patients for PTSD and MDD with a validated screening instrument, but fewer providers reported using a validated screening instrument to monitor treatment progress.

Mild traumatic brain injury in children: management practices in the acute care setting.

PubMed

Kool, Bridget; King, Vivienne; Chelimo, Carol; Dalziel, Stuart; Shepherd, Michael; Neutze, Jocelyn; Chambers, Nikki; Wells, Susan

2014-08-01

Accurate diagnosis, treatment and follow up of children suffering mild traumatic brain injury (MTBI) is important as post-concussive symptoms and long-term disability might occur. This research explored the decisions clinicians make in their assessment and management of children with MTBI in acute care settings, and identified barriers and enablers to the delivery of best-practice care. A purposeful sample of 29 clinicians employed in two metropolitan paediatric EDs and one Urgent Care clinic was surveyed using a vignette-based questionnaire that also included domains of guideline awareness, attitudes to MTBI care, use of clinical decision support systems, and knowledge and skills for practising evidence-based healthcare. Overall, the evaluation and management of children presenting acutely with MTBI generally followed best-practice guidelines, particularly in relation to identifying intracranial injuries that might require surgical intervention, observation for potential deterioration, adequate pain management and the provision of written head injury advice on discharge. Larger variation emerged in regard to follow-up care and referral pathways. Potential barriers to best- practice were lack of guideline awareness, attitudes to MTBI, and lack of time or other priorities. Opportunities exist to improve care for children who present in acute care settings following mild traumatic brain injury. These include having up-to-date guidelines that are consistent across acute care settings; providing clearer pathways for referral and follow up; targeting continuing medical education towards potential complications; and providing computerised decision support so that assessment and management are conducted systematically. © 2014 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

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.

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

PubMed

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

2015-03-01

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

A UML approach to process modelling of clinical practice guidelines for enactment.

PubMed

Knape, T; Hederman, L; Wade, V P; Gargan, M; Harris, C; Rahman, Y

2003-01-01

Although clinical practice guidelines (CPGs) have been suggested as a means of encapsulating best practice in evidence-based medical treatment, their usage in clinical environments has been disappointing. Criticisms of guideline representations have been that they are predominantly narrative and are difficult to incorporate into clinical information systems. This paper analyses the use of UML process modelling techniques for guideline representation and proposes the automated generation of executable guidelines using XMI. This hybrid UML-XMI approach provides flexible authoring of guideline decision and control structures whilst integrating appropriate data flow. It also uses an open XMI standard interface to allow the use of authoring tools and process control systems from multiple vendors. The paper first surveys CPG modelling formalisms followed by a brief introduction to process modelling in UMI. Furthermore, the modelling of CPGs in UML is presented leading to a case study of encoding a diabetes mellitus CPG using UML.

The dissemination of clinical practice guidelines over an intranet: an evaluation.

PubMed Central

Stolte, J. J.; Ash, J.; Chin, H.

1999-01-01

This study compares two clinical practice guideline dissemination systems. It was hypothesized that placing guidelines on an intranet would make this information easier to retrieve. Retrieval time, retrieval accuracy, and ease of use were empirically evaluated. Sixteen clinicians from Kaiser Permanente volunteered to complete tasks that measured these variables. Time values were significantly longer for tasks completed with intranet guidelines (Intranet = 6.7 minutes, Paper = 5.7 minutes). Tasks completed with paper guidelines had a significantly higher percentage of perfect scores than those completed with the intranet (Paper = 85%, Intranet = 59%). There was no significant difference in reported ease of use. Simply placing clinical information on an electronic system does not guarantee that the information will be easier to retrieve. Such information needs to be fully integrated into the clinical decision making process. Computerizing guidelines may provide a necessary initial step toward this goal, but it does not represent the final solution. PMID:10566503

Toward Improving Quality of End-of-Life Care: Encoding Clinical Guidelines and Standing Orders Using the Omaha System.

PubMed

Slipka, Allison F; Monsen, Karen A

2018-02-01

End-of-life care (EOLC) relieves the suffering of millions of people around the globe each year. A growing body of hospice care research has led to the creation of several evidence-based clinical guidelines for EOLC. As evidence for the effectiveness of timely EOLC swells, so does the increased need for efficient information exchange between disciplines and across the care continuum. The purpose of this study was to investigate the feasibility of using the Omaha System as a framework for encoding interoperable evidence-based EOL interventions with specified temporality for use across disciplines and settings. Four evidence-based clinical guidelines and one current set of hospice standing orders were encoded using the Omaha System Problem Classification Scheme and Intervention Scheme, as well as Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT). The resulting encoded guideline was entered on a Microsoft Excel spreadsheet and made available for public use on the Omaha System Guidelines website. The resulting EOLC guideline consisted of 153 interventions that may enable patients and their surrogates, clinicians, and ancillary providers to communicate interventions in a universally comprehensible way. Evidence-based interventions from diverse disciplines involved in EOLC are described within this guideline using the Omaha System. Because the Omaha System and clinical guidelines are maintained in the public domain, encoding interventions is achievable by anyone with access to the Internet and basic Excel skills. Using the guideline as a documentation template customized for unique patient needs, clinicians can quantify and track patient care across the care continuum to ensure timely evidence-based interventions. Clinical guidelines coded in the Omaha System can support the use of multidisciplinary evidence-based interventions to improve quality of EOLC across settings and professions. © 2017 Sigma Theta Tau International.

Advice for acute low back pain: a comparison of what research supports and what guidelines recommend.

PubMed

Stevens, Matthew L; Lin, Chung-Wei C; de Carvalho, Flavia A; Phan, Kevin; Koes, Bart; Maher, Chris G

2017-10-01

Advice is widely considered an effective treatment for acute low back pain (LBP); however, details on what and how to deliver this intervention is less clear. We assessed and compared clinical trials that test advice for acute LBP with practice guidelines for their completeness of reporting and concordance on the content, method of delivery, and treatment regimen of advice interventions. Systematic review. Advice randomized controlled trials were identified through a systematic search. Guidelines were taken from recent overviews of guidelines for LBP. Completeness of reporting was assessed using the Template for Intervention Description and Replication checklist. Thematic analysis was used to characterize advice interventions into topics across the aspects of content, method of delivery, and regimen. Concordance between clinical trials and guidelines was assessed by comparing the number of trials that found a statistically significant treatment effect for an intervention that included a specific advice topic with the number of guidelines recommending that topic. The median (interquartile range) completeness of reporting for clinical trials and guidelines was 8 (7-9) and 3 (2-4) out of nine items on the Template for Intervention Description and Replication checklist, respectively. Guideline recommendations were discordant with clinical trials for 50% of the advice topics identified. Completeness of reporting was less than ideal for randomized controlled trials and extremely poor for guidelines. The recommendations made in guidelines of advice for acute LBP were often not concordant with the results of clinical trials. Taken together, these findings mean that the potential clinical value of advice interventions for patients with acute LBP is probably not being realized. Copyright © 2017 Elsevier Inc. All rights reserved.

The importance of Good Clinical Practice guidelines and its role in clinical trials

PubMed Central

Vijayananthan, A; Nawawi, O

2008-01-01

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights. PMID:21614316

Update of guidelines for surgical endodontics - the position after ten years.

PubMed

Evans, G E; Bishop, K; Renton, T

2012-05-25

This is the first of a series of articles, which will summarise new or updated clinical guidelines produced by the Clinical Standards Committee of the Faculty of Dental Surgery, Royal College of Surgeons of England (FDSRCS). Important developments for the dental profession from a number of clinical guidelines will be presented, commencing with the Guidelines for surgical endodontics. The impact of recent evidence relating to the outcome of surgical endodontics and techniques such as cone beam computed tomography and microsurgical techniques are considered.

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

PubMed

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

2015-02-01

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

The role of angiotensin receptor-neprilysin inhibitors in cardiovascular disease-existing evidence, knowledge gaps, and future directions.

PubMed

Ambrosy, Andrew P; Mentz, Robert J; Fiuzat, Mona; Cleland, John G F; Greene, Stephen J; O'Connor, Christopher M; Teerlink, John R; Zannad, Faiez; Solomon, Scott D

2018-02-21

Although traditional renin-angiotensin system antagonists including angiotensin-converting enzyme inhibitors and angiotensin receptor blockers have revolutionized the treatment of cardiovascular disease (CVD), the pivotal PARADIGM-HF trial demonstrated that sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), was superior to an angiotensin-converting enzyme inhibitor in reducing cardiovascular morbidity and mortality in patients with heart failure and reduced ejection fraction. However, despite international regulatory approval and strong recommendations in the guidelines, uptake of sacubitril/valsartan has been disappointing. Sacubitril/valsartan is now the focus of a large programme of clinical trials testing the hypothesis that ARNIs may supplant conventional renin-angiotensin system inhibitors across the spectrum of CVD, including hypertension, secondary prevention after myocardial infarction, and heart failure with preserved ejection fraction. This review summarizes the existing evidence, knowledge gaps, and future directions of ARNIs in CVD based on discussions between clinical trialists, industry representatives, and regulatory authorities at the 2016 Global CardioVascular Clinical Trialists Forum in Washington, D.C. © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.

Presymptomatic ALS genetic counseling and testing

PubMed Central

Stanislaw, Christine; Reyes, Eliana; Hussain, Sumaira; Cooley, Anne; Fernandez, Maria Catalina; Dauphin, Danielle D.; Michon, Sara-Claude; Andersen, Peter M.; Wuu, Joanne

2016-01-01

Remarkable advances in our understanding of the genetic contributions to amyotrophic lateral sclerosis (ALS) have sparked discussion and debate about whether clinical genetic testing should routinely be offered to patients with ALS. A related, but distinct, question is whether presymptomatic genetic testing should be offered to family members who may be at risk for developing ALS. Existing guidelines for presymptomatic counseling and testing are mostly based on small number of individuals, clinical judgment, and experience from other neurodegenerative disorders. Over the course of the last 8 years, we have provided testing and 317 genetic counseling sessions (including predecision, pretest, posttest, and ad hoc counseling) to 161 first-degree family members participating in the Pre-Symptomatic Familial ALS Study (Pre-fALS), as well as testing and 75 posttest counseling sessions to 63 individuals with familial ALS. Based on this experience, and the real-world challenges we have had to overcome in the process, we recommend an updated set of guidelines for providing presymptomatic genetic counseling and testing to people at high genetic risk for developing ALS. These recommendations are especially timely and relevant given the growing interest in studying presymptomatic ALS. PMID:27194384

Behavioral medicine perspectives on the design of health information technology to improve decision-making, guideline adherence, and care coordination in chronic pain management.

PubMed

Midboe, Amanda M; Lewis, Eleanor T; Cronkite, Ruth C; Chambers, Dallas; Goldstein, Mary K; Kerns, Robert D; Trafton, Jodie A

2011-03-01

Development of clinical decision support systems (CDSs) has tended to focus on facilitating medication management. An understanding of behavioral medicine perspectives on the usefulness of a CDS for patient care can expand CDSs to improve management of chronic disease. The purpose of this study is to explore feedback from behavioral medicine providers regarding the potential for CDSs to improve decision-making, care coordination, and guideline adherence in pain management. Qualitative methods were used to analyze semi-structured interview responses from behavioral medicine stakeholders following demonstration of an existing CDS for opioid prescribing, ATHENA-OT. Participants suggested that a CDS could assist with decision-making by educating providers, providing recommendations about behavioral therapy, facilitating risk assessment, and improving referral decisions. They suggested that a CDS could improve care coordination by facilitating division of workload, improving patient education, and increasing consideration and knowledge of options in other disciplines. Clinical decision support systems are promising tools for improving behavioral medicine care for chronic pain.

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: V. The 2014 Ancillary Therapy and Supportive Care Working Group Report.

PubMed

Carpenter, Paul A; Kitko, Carrie L; Elad, Sharon; Flowers, Mary E D; Gea-Banacloche, Juan C; Halter, Jörg P; Hoodin, Flora; Johnston, Laura; Lawitschka, Anita; McDonald, George B; Opipari, Anthony W; Savani, Bipin N; Schultz, Kirk R; Smith, Sean R; Syrjala, Karen L; Treister, Nathaniel; Vogelsang, Georgia B; Williams, Kirsten M; Pavletic, Steven Z; Martin, Paul J; Lee, Stephanie J; Couriel, Daniel R

2015-07-01

The 2006 National Institutes of Health (NIH) Consensus paper presented recommendations by the Ancillary Therapy and Supportive Care Working Group to support clinical research trials in chronic graft-versus-host disease (GVHD). Topics covered in that inaugural effort included the prevention and management of infections and common complications of chronic GVHD, as well as recommendations for patient education and appropriate follow-up. Given the new literature that has emerged during the past 8 years, we made further organ-specific refinements to these guidelines. Minimum frequencies are suggested for monitoring key parameters relevant to chronic GVHD during systemic immunosuppressive therapy and, thereafter, referral to existing late effects consensus guidelines is advised. Using the framework of the prior consensus, the 2014 NIH recommendations are organized by organ or other relevant systems and graded according to the strength and quality of supporting evidence. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Unified treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop

PubMed Central

2011-01-01

Background Envenomation by crotaline snakes (rattlesnake, cottonmouth, copperhead) is a complex, potentially lethal condition affecting thousands of people in the United States each year. Treatment of crotaline envenomation is not standardized, and significant variation in practice exists. Methods A geographically diverse panel of experts was convened for the purpose of deriving an evidence-informed unified treatment algorithm. Research staff analyzed the extant medical literature and performed targeted analyses of existing databases to inform specific clinical decisions. A trained external facilitator used modified Delphi and structured consensus methodology to achieve consensus on the final treatment algorithm. Results A unified treatment algorithm was produced and endorsed by all nine expert panel members. This algorithm provides guidance about clinical and laboratory observations, indications for and dosing of antivenom, adjunctive therapies, post-stabilization care, and management of complications from envenomation and therapy. Conclusions Clinical manifestations and ideal treatment of crotaline snakebite differ greatly, and can result in severe complications. Using a modified Delphi method, we provide evidence-informed treatment guidelines in an attempt to reduce variation in care and possibly improve clinical outcomes. PMID:21291549

Comprehensive review of methicillin-resistant Staphylococcus aureus: screening and preventive recommendations for plastic surgeons and other surgical health care providers.

PubMed

O'Reilly, Eamon B; Johnson, Mark D; Rohrich, Rod J

2014-11-01

Up to 2.3 million people are colonized with methicillin-resistant Staphylococcus aureus in the United States, causing well-documented morbidity and mortality. Although the association of clinical outcomes with community and hospital carriage rates is increasingly defined, less is reported about asymptomatic colonization prevalence among physicians, and specifically plastic surgeons and the subsequent association with the incidence of patient surgical-site infection. A review of the literature using the PubMed and Cochrane databases analyzing provider screening, transmission, and prevalence was undertaken. In addition, a search was completed for current screening and decontamination guidelines and outcomes. The methicillin-resistant S. aureus carriage prevalence of surgical staff is 4.5 percent. No prospective data exist regarding transmission and interventions for plastic surgeons. No studies were found specifically looking at prevalence or treatment of plastic surgeons. Current recommendations by national organizations focus on patient-oriented point-of-care testing and intervention, largely ignoring the role of the health care provider. Excellent guidelines exist regarding screening, transmission prevention, and treatment both in the workplace and in the community. No current such guidelines exist for plastic surgeons. No Level I or II evidence was found regarding physician screening, treatment, or transmission. Current expert opinion, however, indicates that plastic surgeons and their staff should be vigilant for methicillin-resistant S. aureus transmission, and once a sentinel cluster of skin and soft-tissue infections is identified, systematic screening and decontamination should be considered. If positive, topical decolonization therapy should be offered. In refractory cases, oral antibiotic therapy may be required, but this should not be used as a first-line strategy.

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

PubMed Central

2015-01-01

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

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

PubMed

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

2017-02-15

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

[Contribution of Chilean research to the formulation of national clinical guidelines].

PubMed

Núñez, Paulina F; Torres, Adrián C; Armas, Rodolfo M

2014-12-01

In Chile, 80 diseases were included in a health care system called Health Care Guarantees (GES) and clinical guidelines were elaborated for their management. To assess the scientific background of guidelines and if they were based on research financed by the Chilean National Commission for Science and Technology. The references of the 82 guidelines developed for 80 diseases were reviewed, registering their number, authors, country of origin and funding source. The guidelines had a total of 6,604 references. Of these, only 185 were Chilean (2.8%) and five (0.08%) originated from research financed by the National Commission for Science and Technology. The contribution of research funded by national agencies to the formulation of clinical guidelines is minimal.

Clinical Practice Experiences in Diagnosis and Treatment of Traumatic Brain Injury in Children: A Survey among Clinicians at 9 Large Hospitals in China

PubMed Central

Xiang, Joe; Zhang, Di; Shi, Xiuquan; Yan, Xueqiang; Zhu, Huiping

2015-01-01

Proper diagnosis and treatment of traumatic brain injury (TBI) in children is becoming an increasingly problematic issue in China. This study investigated Chinese clinicians to provide information about their knowledge and experiences in diagnosis and treatment of pediatric TBI. We conducted a questionnaire survey among clinicians in the emergency departments and neurosurgery departments at 9 major hospitals in China. The questionnaire included demographic information, and knowledge and experiences regarding the diagnosis and treatment of pediatric TBI. A total of 235 clinicians completed questionnaires. 43.8% of the surveyed clinicians reported children with only scalp hematoma without any other signs and symptoms of concussion as TBI cases. Most clinicians (85.1%) reported no existing uniform diagnostic criteria for children with TBI in China. The majority of clinicians (91.9%) reported that CT scans were performed in all patients with suspected head injury as a routine procedure in their hospitals. Only 20.9% of clinicians believed that radiation from CT scanning may increase cancer risk in children. About 33.6% of the clinicians reported that they ordered CT scans to investigate suspected head injury due to the poor doctor-patient relationship in China, and to protect themselves against any medical lawsuits in the future. About 80% of the clinicians reported that there are no existing pediatric TBI treatment guidelines in China. Instead a senior doctor’s advice is the most reported guidelines regarding treating pediatric TBI (66.0%). All of the surveyed clinicians reported that the lack of diagnosis and/or treatment standard is the biggest problem in effectively diagnosing and treating pediatric TBI in China. Developing guidelines for the diagnosis and treatment of children with TBI is a high priority in China. The extremely high usage of CT for pediatric TBI in China suggests that it is important to establish evidence-based clinical decision rules to help Chinese clinicians make diagnostic and therapeutic decisions during their practice in order to identify children unlikely to have a clinically-important TBI who can be safely discharged without a CT scan. PMID:26565400