Development and evaluation of online evidence based guideline bank system.

PubMed

Park, Myonghwa

2006-01-01

The purpose of this study was to develop and evaluate the online evidence-based nursing practice guideline bank system to support the best evidence-based decision in the clinical and community practice settings. The main homepage consisted of seven modules for introduction of site, EBN, guideline bank, guideline development, guideline review, related sites, and community. The major contents in the guidelines were purpose, developer, intended audience, method of development, target population, testing, knowledge components, and evaluation. Electronic versions of the guidelines were displayed by XML, PDF, and PDA versions. The system usability were evaluated by general users, guideline developers, and guideline reviewers on the web and the results showed high scores of satisfaction. This online evidence-based guideline bank system could support nurses' best and cost-effective clinical decision using the sharable standardized guidelines with education module of evidence based nursing.

[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.

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.

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

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

PubMed Central

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

2007-01-01

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

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

PubMed

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

2007-11-23

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

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

ERIC Educational Resources Information Center

Crall, James J.

1990-01-01

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

Rapid Development and Distribution of Mobile Media-Rich Clinical Practice Guidelines Nationwide in Colombia.

PubMed

Flórez-Arango, José F; Sriram Iyengar, M; Caicedo, Indira T; Escobar, German

2017-01-01

Development and electronic distribution of Clinical Practice Guidelines production is costly and challenging. This poster presents a rapid method to represent existing guidelines in auditable, computer executable multimedia format. We used a technology that enables a small number of clinicians to, in a short period of time, develop a substantial amount of computer executable guidelines without programming.

[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.

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

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.

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.

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.

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

PubMed

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

2012-12-01

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

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.

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

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

PubMed

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

2017-10-01

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

Evaluation of evidence-based literature and formulation of recommendations for the clinical preventive guidelines for immigrants and refugees in Canada

PubMed Central

Tugwell, Peter; Pottie, Kevin; Welch, Vivian; Ueffing, Erin; Chambers, Andrea; Feightner, John

2011-01-01

Background: This article describes the evidence review and guideline development method developed for the Clinical Preventive Guidelines for Immigrants and Refugees in Canada by the Canadian Collaboration for Immigrant and Refugee Health Guideline Committee. Methods: The Appraisal of Guidelines for Research and Evaluation (AGREE) best-practice framework was combined with the recently developed Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to produce evidence-based clinical guidelines for immigrants and refugees in Canada. Results: A systematic approach was designed to produce the evidence reviews and apply the GRADE approach, including building on evidence from previous systematic reviews, searching for and comparing evidence between general and specific immigrant populations, and applying the GRADE criteria for making recommendations. This method was used for priority health conditions that had been selected by practitioners caring for immigrants and refugees in Canada. Interpretation: This article outlines the 14-step method that was defined to standardize the guideline development process for each priority health condition. PMID:20573711

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.

Personalized Guideline-Based Treatment Recommendations Using Natural Language Processing Techniques.

PubMed

Becker, Matthias; Böckmann, Britta

2017-01-01

Clinical guidelines and clinical pathways are accepted and proven instruments for quality assurance and process optimization. Today, electronic representation of clinical guidelines exists as unstructured text, but is not well-integrated with patient-specific information from electronic health records. Consequently, generic content of the clinical guidelines is accessible, but it is not possible to visualize the position of the patient on the clinical pathway, decision support cannot be provided by personalized guidelines for the next treatment step. The Systematized Nomenclature of Medicine - Clinical Terms (SNOMED CT) provides common reference terminology as well as the semantic link for combining the pathways and the patient-specific information. This paper proposes a model-based approach to support the development of guideline-compliant pathways combined with patient-specific structured and unstructured information using SNOMED CT. To identify SNOMED CT concepts, a software was developed to extract SNOMED CT codes out of structured and unstructured German data to map these with clinical pathways annotated in accordance with the systematized nomenclature.

Reaching beyond the review of research evidence: a qualitative study of decision making during the development of clinical practice guidelines for disease prevention in healthcare.

PubMed

Richter Sundberg, Linda; Garvare, Rickard; Nyström, Monica Elisabeth

2017-05-11

The judgment and decision making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We have studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. The NBHW formal guideline development model states that guideline recommendations should be based on five decision-criteria: research evidence; curative/preventive effect size, severity of the condition; cost-effectiveness; and ethical considerations. A group of health profession representatives (i.e. a prioritization group) was assigned the task of ranking condition-intervention pairs for guideline recommendations, taking into consideration the multiple decision criteria. The aim of this study was to investigate the decision making process during the two-year development of national guidelines for methods of preventing disease. A qualitative inductive longitudinal case study approach was used to investigate the decision making process. Questionnaires, non-participant observations of nine two-day group meetings, and documents provided data for the analysis. Conventional and summative qualitative content analysis was used to analyse data. The guideline development model was modified ad-hoc as the group encountered three main types of dilemmas: high quality evidence vs. low adoptability of recommendation; insufficient evidence vs. high urgency to act; and incoherence in assessment and prioritization within and between four different lifestyle areas. The formal guideline development model guided the decision-criteria used, but three new or revised criteria were added by the group: 'clinical knowledge and experience', 'potential guideline consequences' and 'needs of vulnerable groups'. The frequency of the use of various criteria in discussions varied over time. Gender, professional status, and interpersonal skills were perceived to affect individuals' relative influence on group discussions. The study shows that guideline development groups make compromises between rigour and pragmatism. The formal guideline development model incorporated multiple aspects, but offered few details on how the different criteria should be handled. The guideline development model devoted little attention to the role of the decision-model and group-related factors. Guideline development models could benefit from clarifying the role of the group-related factors and non-research evidence, such as clinical experience and ethical considerations, in decision-processes during guideline development.

Clinical algorithms to aid osteoarthritis guideline dissemination.

PubMed

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

2016-09-01

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

Clinical guidelines in the European Union: mapping the regulatory basis, development, quality control, implementation and evaluation across member states.

PubMed

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

2012-10-01

Clinical guidelines are advocated to improve the quality of care, especially for chronic diseases. However, the regulatory basis of clinical guidelines, their development, quality control, implementation and use as well as evaluation within countries across the European Union is not systematically known. Using information collected from key informants in each country by means of a structured questionnaire, this mapping exercise illustrates the varied status of guideline production in European Union countries. Most European Union countries have an established national, regional or local clinical guideline programme, and a substantial proportion have developed guidelines on the prevention and management of chronic diseases. Several countries have mechanisms in place to ensure the quality of scientific evidence used for the development of guidelines is high and that the process is consistent and transparent. Others are only now taking an interest in guideline development and are taking the first steps towards establishing ways of implementing them. The majority of countries have no legal basis for the development of guidelines and those that have well established systems mostly implement them on a voluntary basis. The process of guideline development varies in its degrees of decentralisation across countries with many different types of organisations taking on this responsibility. There is general acceptance of the value of the instrument developed by the AGREE collaboration for evaluating the methodological robustness of guidelines. However, the extent to which guidelines are implemented in Europe is unknown, as there is no systematic data collection and, in most countries, no structure to enable it. There are few examples of formal evaluations of the development, quality, implementation and use of guidelines. Our findings call for renewed efforts to respond to the severe lack of standardized guideline terminology and accessibility as well as rigorous studies to evaluate the relationship between different ways to develop guidelines and their methodological quality, between their quality and the actual implementation and usage, and finally between implementation and health outcomes. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

2003-01-01

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

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.

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

Considering health equity when moving from evidence-based guideline recommendations to implementation: a case study from an upper-middle income country on the GRADE approach

PubMed Central

Mosquera, Paola; Alzate, Juan Pablo; Pottie, Kevin; Welch, Vivian; Akl, Elie A; Jull, Janet; Lang, Eddy; Katikireddi, Srinivasa Vittal; Morton, Rachel; Thabane, Lehana; Shea, Bev; Stein, Airton T; Singh, Jasvinder; Florez, Ivan D; Guyatt, Gordon; Schünemann, Holger; Tugwell, Peter

2017-01-01

Abstract The availability of evidence-based guidelines does not ensure their implementation and use in clinical practice or policy making. Inequities in health have been defined as those inequalities within or between populations that are avoidable, unnecessary and also unjust and unfair. Evidence-based clinical practice and public health guidelines (‘guidelines’) can be used to target health inequities experienced by disadvantaged populations, although guidelines may unintentionally increase health inequities. For this reason, there is a need for evidence-based clinical practice and public health guidelines to intentionally target health inequities experienced by disadvantaged populations. Current guideline development processes do not include steps for planned implementation of equity-focused guidelines. This article describes nine steps that provide guidance for consideration of equity during guideline implementation. A critical appraisal of the literature followed by a process to build expert consensus was undertaken to define how to include consideration of equity issues during the specific GRADE guideline development process. Using a case study from Colombia we describe nine steps that were used to implement equity-focused GRADE recommendations: (1) identification of disadvantaged groups, (2) quantification of current health inequities, (3) development of equity-sensitive recommendations, (4) identification of key actors for implementation of equity-focused recommendations, (5) identification of barriers and facilitators to the implementation of equity-focused recommendations, (6) development of an equity strategy to be included in the implementation plan, (7) assessment of resources and incentives, (8) development of a communication strategy to support an equity focus and (9) development of monitoring and evaluation strategies. This case study can be used as model for implementing clinical practice guidelines, taking into account equity issues during guideline development and implementation. PMID:29029068

Surfing the best practice guidelines: national clinical guideline clearinghouse in development.

PubMed

1997-08-01

The growth in development and usage of clinical guidelines during the last five years has been remarkable. Not only are health care practitioners reaching for what's deemed to be the best in protocols and practice, consumers, too, are looking toward standards and guidelines as they become more educated about the quality and quantity of health care services they should be receiving.

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

PubMed

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

2015-04-01

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

Evaluation of clinical practice guidelines.

PubMed Central

Basinski, A S

1995-01-01

Compared with the current focus on the development of clinical practice guidelines the effort devoted to their evaluation is meagre. Yet the ultimate success of guidelines depends on routine evaluation. Three types of evaluation are identified: evaluation of guidelines under development and before dissemination and implementation, evaluation of health care programs in which guidelines play a central role, and scientific evaluation, through studies that provide the scientific knowledge base for further evolution of guidelines. Identification of evaluation and program goals, evaluation design and a framework for evaluation planning are discussed. PMID:7489550

[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.

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.

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

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.

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.

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

The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: screening and diagnosis recommendations.

PubMed

Mehta, S; Guy, S D; Bryce, T N; Craven, B C; Finnerup, N B; Hitzig, S L; Orenczuk, S; Siddall, P J; Widerström-Noga, E; Casalino, A; Côté, I; Harvey, D; Kras-Dupuis, A; Lau, B; Middleton, J W; Moulin, D E; O'Connell, C; Parrent, A G; Potter, P; Short, C; Teasell, R; Townson, A; Truchon, C; Wolfe, D; Bradbury, C L; Loh, E

2016-08-01

Clinical practice guidelines. To develop the first Canadian clinical practice guidelines for screening and diagnosis of neuropathic pain in people with spinal cord injury (SCI). The guidelines are relevant for inpatient and outpatient SCI rehabilitation settings in Canada. The CanPainSCI Working Group reviewed evidence to address clinical questions regarding screening and diagnosis of neuropathic pain after SCI. A consensus process was followed to achieve agreement on recommendations and clinical considerations. Twelve recommendations, based on expert consensus, were developed for the screening and diagnosis of neuropathic pain after SCI. The recommendations address methods for assessment, documentation tools, team member accountability, frequency of screening and considerations for diagnostic investigation. Important clinical considerations accompany each recommendation. The expert Working Group developed recommendations for the screening and diagnosis of neuropathic pain after SCI that should be used to inform practice.

The appraisal of clinical guidelines in dentistry.

PubMed

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

2009-01-01

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

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.

Appraising the methodological quality of the clinical practice guideline for diabetes mellitus using the AGREE II instrument: a methodological evaluation.

PubMed

Radwan, Mahmoud; Akbari Sari, Ali; Rashidian, Arash; Takian, Amirhossein; Abou-Dagga, Sanaa; Elsous, Aymen

2017-02-01

To evaluate the methodological quality of the Palestinian Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological evaluation. A cross-cultural adaptation framework was followed to translate and develop a standardised Translated Arabic Version of the AGREE II. Palestinian Primary Healthcare Centres. Sixteen appraisers independently evaluated the Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological quality of diabetic guideline. The Translated Arabic Version of the AGREE II showed an acceptable reliability and validity. Internal consistency ranged between 0.67 and 0.88 (Cronbach's α). Intra-class coefficient among appraisers ranged between 0.56 and 0.88. The quality of this guideline is low. Both domains 'Scope and Purpose' and 'Clarity of Presentation' had the highest quality scores (66.7% and 61.5%, respectively), whereas the scores for 'Applicability', 'Stakeholder Involvement', 'Rigour of Development' and 'Editorial Independence' were the lowest (27%, 35%, 36.5%, and 40%, respectively). The findings suggest that the quality of this Clinical Practice Guideline is disappointingly low. To improve the quality of current and future guidelines, the AGREE II instrument is extremely recommended to be incorporated as a gold standard for developing, evaluating or updating the Palestinian Clinical Practice Guidelines. Future guidelines can be improved by setting specific strategies to overcome implementation barriers with respect to economic considerations, engaging of all relevant end-users and patients, ensuring a rigorous methodology for searching, selecting and synthesising the evidences and recommendations, and addressing potential conflict of interests within the development group.

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.

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

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.

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.

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

Attitudes and Perceptions about Clinical Guidelines: A Qualitative Study with Spanish Physicians

PubMed Central

Solà, Ivan; Carrasco, José Miguel; Díaz del Campo, Petra; Gracia, Javier; Orrego, Carola; Martínez, Flora; Kotzeva, Anna; Guillamón, Imma; Calderón, Enrique; de Gaminde, Idoia; Louro, Arturo; Rotaeche, Rafael; Salcedo, Flavia; Velázquez, Paola; Alonso-Coello, Pablo

2014-01-01

Background Clinical guidelines (CGs) are popular for healthcare decision making but their acceptability and use by healthcare providers is influenced by numerous factors. Some of these factors are professional-related, such as knowledge and perceptions of and attitudes toward CGs in general. The aim of our study was to evaluate attitudes and perceptions of Spanish physicians towards CGs. Methods We coordinated six discussion groups with a total of 46 physicians. The participants were drawn from 12 medical specialties from both specialized and primary care. We recorded the sessions and transcribed the content verbatim. We analyzed the data using an approach based on the grounded theory. Results We identified two main constructs that defined the physicians' perceptions towards guidelines: knowledge and usefulness. “Knowledge” defined the theoretical meanings of guidelines, while “Usefulness” referred to the pragmatic approach to guidelines. These constructs were interrelated through a series of categories such as confidence, usability, accessibility, dissemination and formats. Conclusions In our study, the constructs that impacted most on physician's attitudes to clinical guidelines were knowledge and usefulness. The tension between the theoretical and the pragmatic constructs determined the attitudes and how physicians use guidelines. Groups developing guidelines should ask relevant clinical questions and develop implementable and context specific recommendations. Developers should be explicit and consistent in the development and presentation of recommendations. PMID:24505253

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…

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.

Singapore Cancer Network (SCAN) Guidelines for Adjuvant Chemotherapy in Resected Non-Small Cell Lung Cancer.

PubMed

2015-10-01

The SCAN lung cancer workgroup aimed to develop Singapore Cancer Network (SCAN) clinical practice guidelines for the use of adjuvant systemic therapy for non-small cell lung cancer in Singapore. The workgroup utilised a modified ADAPTE process to calibrate high quality international evidence-based clinical practice guidelines to our local setting. Five international guidelines were evaluated- those developed by the National Comprehensive Cancer Network (2014), European Society of Medical Oncology (2014), National Institute of Clinical Excellence (2012), Scottish Intercollegiate Guidelines Network (2014), and the Cancer Care Council Australia (2012). Recommendations on the selection of patients, chemotherapy regimen, treatment for stage I disease, treatment for positive margins and treatment options for pN2 disease with negative margins were produced. These adapted guidelines form the SCAN Guidelines 2015 for adjuvant systemic therapy of non-small cell lung cancer.

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.

Report on the RCDS-CDHSRU workshop on developing clinical guidelines/standards of practice.

PubMed

Leake, J L; Main, P A; Woodward, G L

1996-07-01

Investigators from the Community Dental Health Services Research Unit (CDHSRU) held a workshop to test a model for developing clinical guidelines/standards of practice, which are required under the Regulated Health Professions Legislation. Forty-two individuals from Ontario and Canada, including dentists, representatives of the public, and professionals, participated in the three-day workshop, held under the auspices of the quality assurance committee of the Royal College of Dental Surgeons of Ontario (RCDS). Through direct experience, workshop participants sought to learn each of the steps, as defined by the literature, involved in clinical guideline development. Ultimately, they hoped to recommend steps for RCDS to follow in developing standards of practice. To ensure that a realistic and valid model emerged from the workshop, a real topic, namely the management of smooth surface enamel lesions in permanent teeth, was used to develop and test clinical guidelines. Prior to the workshop, participants were sent literature on one of five aspects of the topic, as well as papers describing the methodology of critically appraising the literature, and partially-completed templates outlining the basic steps to be followed. During the first evening and first morning of the workshop, participants listened to presentations on the development of clinical guidelines, the prevalence of smooth surface lesions, the role of economics in guideline development, and the necessary considerations in writing clinical guidelines. Under the leadership of trained facilitators, they then worked in small groups to write evidence-based recommendations and report them to the other workshop participants for feedback. Using this feedback, they returned to their groups to revise their recommendations and work on the workshop's overall recommendations to the RCDS. The day concluded in the evening, when the workshop facilitators and coordinators met to edit the groups' recommendations into a consistent format for presentation to all participants. On the second morning, the participants attended a plenary session to review the evidence-based recommendations developed by the groups, as well as their overall recommendations on the steps to be followed by the RCDS. Ultimately, workshop participants partially completed the templates and developed preliminary evidence-based recommendations on the management of enamel smooth-surface caries. Based on their experiences, they recommended a seven-step process for the future development of clinical practice guidelines/standards of practice in Ontario. These steps are recommendations only, and are not RCDS policy.

Evaluation of Internet-Based Clinical Decision Support Systems

PubMed Central

Thomas, Karl W; Dayton, Charles S

1999-01-01

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

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.

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

PubMed

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

2016-06-01

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

"More bang for the buck": exploring optimal approaches for guideline implementation through interviews with international developers.

PubMed

Gagliardi, Anna R

2012-11-15

Population based studies show that guidelines are underused. Surveys of international guideline developers found that many do not implement their guidelines. The purpose of this research was to interview guideline developers about implementation approaches and resources. Semi-structured telephone interviews were conducted with representatives of guideline development agencies identified in the National Guideline Clearinghouse and sampled by country, type of developer, and guideline clinical indication. Participants were asked to comment on the benefits and resource implications of three approaches for guideline implementation that varied by responsibility: developers, intermediaries, or users. Thirty individuals from seven countries were interviewed, representing government (n = 12) and professional (n = 18) organizations that produced guidelines for a variety of clinical indications. Organizations with an implementation mandate featured widely inconsistent funding and staffing models, variable approaches for choosing promotional strategies, and an array of dissemination activities. When asked to choose a preferred approach, most participants selected the option of including information within guidelines that would help users to implement them. Given variable mandate and resources for implementation, it was considered the most feasible approach, and therefore most likely to have impact due to potentially broad use. While implementation approaches and strategies need not be standardized across organizations, the findings may be used by health care policy makers and managers, and guideline developers to generate strategic and operational plans that optimize implementation capacity. Further research is needed to examine how to optimize implementation capacity by guideline developers, intermediaries and users.

Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease.

PubMed

Cameron, Daniel J; Johnson, Lorraine B; Maloney, Elizabeth L

2014-09-01

Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions - the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1-13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols.

Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease

PubMed Central

Cameron, Daniel J; Johnson, Lorraine B; Maloney, Elizabeth L

2014-01-01

Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions – the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1–13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols. PMID:25077519

When to invest in clinical guidelines for children? A practice oriented tool to facilitate decision-making.

PubMed

Schalkers, Inge; Enthoven, Clair; Bunders, Joske; Dedding, Christine

2017-02-01

Children are not just small adults; they need to be diagnosed and treated in the context of their rapid growth and development. However, in guideline development, children's needs and interests are still overlooked. This study aims (1) to develop a tool that could stimulate guideline developers to take children into account on a more structural basis and (2) to explore how to facilitate children's participation in the process of guideline development. The method used was a three-phase multimethod sequential design. Professionals involved in guideline development participated in interviews (n = 12), filled in a questionnaire (n = 60) and/or participated in the focus group meeting (n = 11). This study results in a comprehensive understanding of the considerations that professionals take into account when deciding whether guidelines need to apply to children specifically. This resulted in a tool that assists guideline developers to make this assessment more accurately. It takes the form of a flowchart that guides users through a series of critical questions. The flowchart reminds guideline developers to consider children as a particular patient population when prioritizing and demarcating new guideline topics. It will help to ensure that clinical guidelines address children's unique health care needs and perspectives. Facilitating children's and parents' participation in the process of guideline development is perceived as challenging; nevertheless, it should be the next step in making paediatric guidelines more child-centred and family-centred. © 2016 John Wiley & Sons, Ltd.

Singapore Cancer Network (SCAN) Guidelines for Systemic Therapy of Pancreatic Adenocarcinoma.

PubMed

2015-10-01

The SCAN pancreatic cancer workgroup aimed to develop Singapore Cancer Network (SCAN) clinical practice guidelines for systemic therapy for pancreatic adenocarcinoma in Singapore. The workgroup utilised a modified ADAPTE process to calibrate high quality international evidence-based clinical practice guidelines to our local setting. Five international guidelines were evaluated- those developed by the National Cancer Comprehensive Network (2014), the European Society of Medical Oncology (2012), Cancer Care Ontario (2013), the Japan Pancreas Society (2013) and the British Society of Gastroenterology, Pancreatic Society of Great Britain and Ireland, and the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland (2005). Recommendations on the management of resected, borderline resectable, locally advanced and metastatic pancreatic adenocarcinoma were developed. These adapted guidelines form the SCAN Guidelines for systemic therapy for pancreatic adenocarcinoma in Singapore.

Utilization of the American Telemedicine Association's Clinical Practice Guidelines

PubMed Central

Antoniotti, Nina; Bernard, Jordana

2013-01-01

Abstract Background: The American Telemedicine Association (ATA) Standards and Guidelines Committee develops practice standards and guidelines. Key to the Committee's mission is dissemination so the standards can be used in the practice of telemedicine. Over a 2-year period, when a standards document was accessed from the ATA Web site, a short survey was completed, but it did not assess how the documents were used once downloaded. A more formal survey was conducted to determine the impact ATA standards and guidelines are having on healthcare delivery via telemedicine. Materials and Methods: A survey was developed and distributed via SurveyMonkey to 13,177 ATA members and nonmembers in November 2011. Results were compiled and analyzed after a 90-day open period for responses to be submitted. Results: The majority of respondents (96%) believe the practice of telemedicine/telehealth should have standards and guidelines and that the ATA and other professional societies/associations should be responsible for developing them. The top uses of guidelines include guidance for clinical practice, training, gaining reimbursement, and research. Respondents indicating a need for standards and guidelines said the ATA (78.7%) and other professional societies/associations (74.5%) should be responsible for development. When asked to list specific practice guidelines or standards they are using for telehealth, the majority (21.5%) are using in-house (e.g., hospital, company)-developed guidelines, followed by those from professional associations/societies (20.4%) and those developed by the ATA (18.2%). Conclusions: Overall, the survey results indicate guidelines documents developed by the ATA and other professional societies and those developed in-house are being regularly accessed and used in both public and private sectors. Practitioners of telemedicine believe that standards and guidelines are needed for guidance for clinical practice, training, gaining reimbursement, and research, and they are to use those developed by professional organization such as the ATA as well as those developed by their own institutions. PMID:24050615

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

PubMed

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

2015-10-01

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

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.

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

Development of an evidence-based review with recommendations using an online iterative process.

PubMed

Rudmik, Luke; Smith, Timothy L

2011-01-01

The practice of modern medicine is governed by evidence-based principles. Due to the plethora of medical literature, clinicians often rely on systematic reviews and clinical guidelines to summarize the evidence and provide best practices. Implementation of an evidence-based clinical approach can minimize variation in health care delivery and optimize the quality of patient care. This article reports a method for developing an "Evidence-based Review with Recommendations" using an online iterative process. The manuscript describes the following steps involved in this process: Clinical topic selection, Evidence-hased review assignment, Literature review and initial manuscript preparation, Iterative review process with author selection, and Manuscript finalization. The goal of this article is to improve efficiency and increase the production of evidence-based reviews while maintaining the high quality and transparency associated with the rigorous methodology utilized for clinical guideline development. With the rise of evidence-based medicine, most medical and surgical specialties have an abundance of clinical topics which would benefit from a formal evidence-based review. Although clinical guideline development is an important methodology, the associated challenges limit development to only the absolute highest priority clinical topics. As outlined in this article, the online iterative approach to the development of an Evidence-based Review with Recommendations may improve productivity without compromising the quality associated with formal guideline development methodology. Copyright © 2011 American Rhinologic Society-American Academy of Otolaryngic Allergy, LLC.

Guidelines for clinical use of CBCT: a review.

PubMed

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

2015-01-01

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

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.

Clinical guideline for nurse-led early extubation after coronary artery bypass: an evaluation.

PubMed

Hawkes, Claire; Foxcroft, David R; Yerrell, Paul

2010-09-01

This paper is a report of an investigation of the development, implementation and outcomes of a clinical guideline for nurse-led early extubation of adult coronary artery bypass graft patients. Healthcare knowledge translation and utilization is an emerging but under-developed research area. The complex context for guideline development and use is methodologically challenging for robust and rigorous evaluation. This study contributes one such evaluation. This was a mixed methods evaluation, with a dominant quantitative study with a secondary qualitative study in a single UK cardiac surgery centre. An interrupted time series study (N = 567 elective coronary artery bypass graft patients) with concurrent within person controls was used to measure the impact of the guideline on the primary outcome: time to extubation. Semi-structured interviews with 11 clinical staff, informed by applied practitioner ethnography, explored the process of guideline development and implementation. The data were collected between January 2001 and January 2003. There was no change in the interrupted time series study primary outcome as a consequence of the guideline implementation. The qualitative study identified three themes: context, process and tensions highlighting that the guideline did not require clinicians to change their practice, although it may have helped maintain practice through its educative role. Further investigation and development of appropriate methods to capture the dynamism in healthcare contexts and its impact on guideline implementation seems warranted. Multi-site mixed methods investigations and programmes of research exploring knowledge translation and utilization initiatives, such as guideline implementation, are needed.

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

PubMed

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

2016-01-01

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

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.

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

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

PubMed

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

2016-08-12

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

Development of the Champlain primary care cardiovascular disease prevention and management guideline

PubMed Central

Montoya, Lorraine; Liddy, Clare; Hogg, William; Papadakis, Sophia; Dojeiji, Laurie; Russell, Grant; Akbari, Ayub; Pipe, Andrew; Higginson, Lyall

2011-01-01

Abstract Problem addressed A well documented gap remains between evidence and practice for clinical practice guidelines in cardiovascular disease (CVD) care. Objective of program As part of the Champlain CVD Prevention Strategy, practitioners in the Champlain District of Ontario launched a large quality-improvement initiative that focused on increasing the uptake in primary care practice settings of clinical guidelines for heart disease, stroke, diabetes, and CVD risk factors. Program description The Champlain Primary Care CVD Prevention and Management Guideline is a desktop resource for primary care clinicians working in the Champlain District. The guideline was developed by more than 45 local experts to summarize the latest evidence-based strategies for CVD prevention and management, as well as to increase awareness of local community-based programs and services. Conclusion Evidence suggests that tailored strategies are important when implementing specific practice guidelines. This article describes the process of creating an integrated clinical guideline for improvement in the delivery of cardiovascular care. PMID:21673196

Framework for enhancing clinical practice guidelines through continuous patient engagement.

PubMed

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

2017-02-01

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

Current challenges in adherence to clinical guidelines for antibiotic prophylaxis in surgery.

PubMed

Khan, Sohail Ahmad; Rodrigues, Gabrial; Kumar, Pramod; Rao, Padma G M

2006-06-01

To study the impact of guidelines on surgical antibiotic prophylaxis in clinical practice, barriers involved in adherence to guidelines and how to overcome the same. Literature pertaining to prophylactic antibiotic usage was searched. Medscape, Medline, Cochrane, Surgical Infection Prevention (SIP) project databases were reviewed. Recent articles from relevant journals, texts, and standard guidelines were also studied. Local guidelines seem more likely to be accepted and followed than those developed nationally. Major barriers involved in adherence to guidelines include lack of awareness about the guidelines, general perception of guideline as a bureaucratic rather than educational tool. Some practitioners perceive guidelines as "cookbook medicine" that does not permit them to make their own medical decisions. Other barriers are complex, multi-step systems that create confusion, decrease accountability. Methods for guideline adherence include surveillance and data analysis, new systems to facilitate documentation and improving workflow, education regarding current evidence-based guidelines and promoting the development of local guidelines or protocol, development and implementation of reminders to facilitate adherence to the local guidelines. A multidisciplinary steering team of surgeons, infectious disease specialists, pharmacists, anesthesiologists, microbiologists and nurses should develop local guidelines suitable to their institution and methods for adherence to prevent the surgical site infections. The gap between evidence-based guidelines and practice must be addressed in order to achieve optimal practice in this domain.

“More bang for the buck”: exploring optimal approaches for guideline implementation through interviews with international developers

PubMed Central

2012-01-01

Background Population based studies show that guidelines are underused. Surveys of international guideline developers found that many do not implement their guidelines. The purpose of this research was to interview guideline developers about implementation approaches and resources. Methods Semi-structured telephone interviews were conducted with representatives of guideline development agencies identified in the National Guideline Clearinghouse and sampled by country, type of developer, and guideline clinical indication. Participants were asked to comment on the benefits and resource implications of three approaches for guideline implementation that varied by responsibility: developers, intermediaries, or users. Results Thirty individuals from seven countries were interviewed, representing government (n = 12) and professional (n = 18) organizations that produced guidelines for a variety of clinical indications. Organizations with an implementation mandate featured widely inconsistent funding and staffing models, variable approaches for choosing promotional strategies, and an array of dissemination activities. When asked to choose a preferred approach, most participants selected the option of including information within guidelines that would help users to implement them. Given variable mandate and resources for implementation, it was considered the most feasible approach, and therefore most likely to have impact due to potentially broad use. Conclusions While implementation approaches and strategies need not be standardized across organizations, the findings may be used by health care policy makers and managers, and guideline developers to generate strategic and operational plans that optimize implementation capacity. Further research is needed to examine how to optimize implementation capacity by guideline developers, intermediaries and users. PMID:23153052

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.

The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review.

PubMed

Sadeghi-Demneh, Ebrahim; Forghany, Saeed; Onmanee, Pornsuree; Trinler, Ursula; Dillon, Michael P; Baker, Richard

2017-06-20

Standards and guidelines are an integral part of prosthetic and orthotic service delivery in the developed world underpinned by an assumption that they lead to improved services. Implementing them has a cost, however, and that cost needs to be justified, particularly in resource-limited environments. This scoping review thus asks the question, "What is the evidence of the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics?" A structured search of three electronic databases (Medline, Scopus and Web of Science) followed by manual searching of title, abstract and full text, yielded 29 articles. Four categories of papers were identified: Descriptions and Commentaries (17 papers), Guideline Development (7), Guideline Testing (2) and Standards implementation (3). No articles were explicitly designed to assess the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics. Studies tended to be commentaries on or descriptions of guideline development, testing or implementation of standards. The literature is not sufficiently well developed to warrant the cost and effort of a systematic review. Future primary research should seek to demonstrate whether and how guidelines and standards improve the outcomes for people that require prostheses, orthoses and other assistive devices. Implications for Rehabilitation International Standards and Clinical Guidelines are now an integral part of clinical service provision in prosthetics and orthotics in the developed world. Complying with standards and guidelines has a cost and, particularly in resource-limited environments, it should be possible to justify this in terms of the resulting benefits. This scoping review concludes that there have been no previous studies designed to directly quantify the effects of implementing standards and guidelines on service delivery.

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

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

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

PubMed

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

2014-01-01

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

Development, Validation, and Implementation of a Clinic Nurse Staffing Guideline.

PubMed

Deeken, Debra Jean; Wakefield, Douglas; Kite, Cora; Linebaugh, Jeanette; Mitchell, Blair; Parkinson, Deidre; Misra, Madhukar

2017-10-01

Ensuring that the level of nurse staffing used to care for patients is appropriate to the setting and service intensity is essential for high-quality and cost-effective care. This article describes the development, validation, and implementation of the clinic technical skills permission list developed specifically to guide nurse staffing decisions in physician clinics of an academic medical center. Results and lessons learned in using this staffing guideline are presented.

Clinical practice guidelines in complementary and alternative medicine. An analysis of opportunities and obstacles. Practice and Policy Guidelines Panel, National Institutes of Health Office of Alternative Medicine.

PubMed

1997-01-01

An estimated 1 of 3 Americans uses some form of complementary and alternative medicine (CAM), such as acupuncture, homeopathy, or herbal medicine. In 1995, the National Institutes of Health Office of Alternative Medicine convened an expert panel to examine the role of clinical practice guidelines in CAM. The panel concluded that CAM practices currently are unsuitable for the development of evidence-based practice guidelines, in part because of the lack of relevant outcomes data from well-designed clinical trials. Moreover, the notions of standardization and appropriateness, inherent in guideline development, face challenging methodologic problems when applied to CAM, which considers many different treatment practices appropriate and encourages highly individualized care. Due to different belief systems and divergent theories about the nature of health and illness, CAM disciplines have fundamental differences in how they define target conditions, causes of disease, interventions, and outcome measures of effectiveness. These differences are even more striking when compared with those used by Western medicine. The panel made a series of recommendations on strategies to strengthen the evidence base for future guideline development in CAM and to meet better the current information needs of clinicians, patients, and guideline developers who seek information about CAM treatments.

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

PubMed

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

2016-11-01

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

Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines.

PubMed

Jefferson, Akilah A; Pearson, Steven D

2017-03-01

Little is known regarding whether Institute of Medicine (IOM) standards for managing conflicts of interest (COI) have been met in the development of recent important clinical guidelines. To evaluate adherence to the IOM standards for limits on commercial COI, guideline development, and evaluation of evidence by the 2013 American College of Cardiology and American Heart Association cholesterol management guideline and the 2014 American Association for the Study of Liver Diseases and Infectious Diseases Society of America hepatitis C virus management guideline. This study was a retrospective document review of the June 2014 print version of the cholesterol guideline and the final September 2015 print version of the hepatitis C virus guideline. Each guideline was assessed for adherence to the IOM standards for commercial COI published in the 2011 special report Clinical Practice Guidelines We Can Trust. The IOM standards call for no commercial COI among guideline committee chairs and cochairs and for less than 50% of committee members to have commercial COI. Guideline and contemporaneous article disclosure statements were used to evaluate adherence to these standards. Each guideline was also reviewed for adherence to other IOM standards for guideline development and evidence review. Among the 16 cholesterol guideline committee members, 7 (44%) disclosed commercial COI, all 7 reported industry-sponsored research, and 6 (38%) also reported consultancy. Of 3 guideline chairs and cochairs, 1 (33%) disclosed commercial COI. Review of contemporaneous articles identified additional commercial COI. Among the 29 hepatitis C virus guideline committee members, 21 (72%) reported commercial COI. Eighteen (62%) disclosed industry-sponsored research, 10 (34%) served on advisory boards, 5 (17%) served on data safety monitoring boards, 3 (10%) were consultants, and 3 (10%) reported other honoraria. Of 6 guideline cochairs, 4 (67%) disclosed commercial COI. All 4 disclosed additional COI in other publications that were not listed in their guideline disclosures. Contemporaneous literature review revealed an additional cochair with commercial COI. Of the 9 IOM guideline development and evidence standards, the cholesterol guideline met 5 (56%), and the hepatitis C virus guideline met them all. Neither the cholesterol guideline nor the hepatitis C virus guideline fully met the IOM standards for commercial COI management, and discordance between committee leader guideline disclosures and those in contemporaneous articles was common. Adherence to additional IOM standards for guideline development and evidence review was mixed. Adoption of consistent COI frameworks across specialty societies may help ensure that clinical guidelines are developed in a transparent and trustworthy manner.

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

PubMed

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

2018-05-17

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

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

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

PubMed

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

2014-01-01

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

Guidelines for clinical use of CBCT: a review

PubMed Central

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

2015-01-01

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

Clinical decision guidelines for NHS cosmetic surgery: analysis of current limitations and recommendations for future development.

PubMed

Cook, S A; Rosser, R; Meah, S; James, M I; Salmon, P

2003-07-01

Because of increasing demand for publicly funded elective cosmetic surgery, clinical decision guidelines have been developed to select those patients who should receive it. The aims of this study were to identify: the main characteristics of such guidelines; whether and how they influence clinical decision making; and ways in which they should be improved. UK health authorities were asked for their current guidelines for elective cosmetic surgery and, in a single plastic surgery unit, we examined the impact of its guidelines by observing consultations and interviewing surgeons and managers. Of 115 authorities approached, 32 reported using guidelines and provided sufficient information for analysis. Guidelines mostly concerned arbitrary sets of cosmetic procedures and lacked reference to an evidence base. They allowed surgery for specified anatomical, functional or symptomatic reasons, but these indications varied between guidelines. Most guidelines also permitted surgery 'exceptionally' for psychological reasons. The guidelines that were studied in detail did not appreciably influence surgeons' decisions, which reflected criteria that were not cited in the guidelines, including cost of the procedure and whether patients sought restoration or improvement of their appearance. Decision guidelines in this area have several limitations. Future guidelines should: include all cosmetic procedures; be informed by a broad range of evidence; and, arguably, include several nonclinical criteria that currently inform surgeons' decision-making.

The Infectious Diseases Society of America Lyme guidelines: a cautionary tale about the development of clinical practice guidelines

PubMed Central

2010-01-01

Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future. PMID:20529367

Child neurology practice guidelines: past, present, and future.

PubMed

Hurwitz, Benjamin A; Hurwitz, Kathleen Bretzius; Ashwal, Stephen

2015-03-01

Practice guidelines have been developed in child neurology during the last fifteen years to address important clinical questions and provide evidence-based recommendations for patient care. This review describes the guideline development process and how it has evolved to meet the needs of child neurologists. Several current child neurology guidelines are reviewed and the advantages and disadvantages of guidelines, as well as the legal consequences of using them to determine a standard of care are discussed. The future of guidelines and of their influence on integrated support systems also is considered. Child neurology practice guidelines are a helpful resource for clinicians, families and institutions as they provide evidence-based recommendations concerning the diagnosis and management of common neurological conditions affecting children. Incorporating consensus processes has allowed expansion of clinically relevant recommendations that has increased the utility of guidelines. Copyright © 2015 Elsevier Inc. All rights reserved.

[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.

Diagnostic criteria, severity classification and guidelines of systemic sclerosis.

PubMed

Asano, Yoshihide; Jinnin, Masatoshi; Kawaguchi, Yasushi; Kuwana, Masataka; Goto, Daisuke; Sato, Shinichi; Takehara, Kazuhiko; Hatano, Masaru; Fujimoto, Manabu; Mugii, Naoki; Ihn, Hironobu

2018-06-01

Several effective drugs have been identified for the treatment of systemic sclerosis (SSc). However, in advanced cases, not only their effectiveness is reduced but they may be also harmful due to their side-effects. Therefore, early diagnosis and early treatment is most important for the treatment of SSc. We established diagnostic criteria for SSc in 2003 and early diagnostic criteria for SSc in 2011, for the purpose of developing evaluation of each organ in SSc. Moreover, in November 2013, the American College of Rheumatology and the European Rheumatology Association jointly developed new diagnostic criteria for increasing their sensitivity and specificity, so we revised our diagnostic criteria and severity classification of SSc. Furthermore, we have revised the clinical guideline based on the newest evidence. 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 SSc. © 2018 Japanese Dermatological Association.

Developing Practice Guidelines for Psychoanalysis

PubMed Central

GRAY, SHEILA HAFTER

1996-01-01

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

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

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

PubMed Central

2012-01-01

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

Barriers to ESC guideline implementation: results of a survey from the European Council on Cardiovascular Nursing and Allied Professions (CCNAP).

PubMed

McKee, Gabrielle; Kerins, Mary; Hamilton, Glenys; Hansen, Tina; Hendriks, Jeroen; Kletsiou, Eleni; Lambrinou, Ekaterini; Jennings, Catriona; Fitzsimons, Donna

2017-12-01

The European Society of Cardiology (ESC) has a comprehensive clinical guideline development programme, relevant for all clinicians. However, implementation of guidelines is not always optimal. The aim of this study was to determine nurses' and allied professionals' awareness and barriers regarding clinical guideline implementation. A cross-sectional survey was administrated online and in print at EuroHeartCare 2015. A questionnaire was developed which examined awareness and barriers to implementation of ESC guidelines on cardiovascular disease prevention in clinical practice (2012) and ESC guidelines in general. Of the 298 respondents, 12% reported that the prevention guidelines were used in their practice area. Respondents identified, in order of magnitude, that lack of leadership, workload, time, resources and a perception that they were unable to influence current practice were barriers to the use of the prevention guidelines. When asked to rank barriers to use of any ESC guidelines, time (22%) and leadership (23%) were ranked highest. Implementation of ESC guidelines by nurses, the majority responders in this survey, is a serious problem, requiring urgent improvement to ensure patients receive optimal evidence based care. Issues of leadership, workload, time and resources are significant barriers to guideline implementation. It is of concern that these professionals perceive both that they have little influence on implementation decisions and lack of leadership regarding guideline implementation. Educational and organisational strategies to improve leadership skills are imperative. These will build self-efficacy and empower nurses and allied professionals to advocate for evidence-based care in the clinical environment.

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.

[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.

Conflict of Interest Policies and Industry Relationships of Guideline Development Group Members: A Cross-Sectional Study of Clinical Practice Guidelines for Depression.

PubMed

Cosgrove, Lisa; Krimsky, Sheldon; Wheeler, Emily E; Peters, Shannon M; Brodt, Madeline; Shaughnessy, Allen F

2017-01-01

Because of increased attention to the issue of trustworthiness of clinical practice guidelines, it may be that both transparency and management of industry associations of guideline development groups (GDGs) have improved. The purpose of the present study was to assess a) the disclosure requirements of GDGs in a cross-section of guidelines for major depression; and, b) the extent and type of conflicts of panel members. Treatment guidelines for major depression were identified and searched for conflict of interest policies and disclosure statements. Multi-modal screens for undeclared conflicts were also conducted. Fourteen guidelines with a total of 172 panel members were included in the analysis. Eleven of the 14 guidelines (78%) had a stated conflict of interest policy or disclosure statement, although the policies varied widely. Most (57%) of the guidelines were developed by panels that had members with industry financial ties to drug companies that manufacture antidepressant medication. However, only a minority of total panel members (18%) had such conflicts of interest. Drug company speakers bureau participation was the most common type of conflict. Although some progress has been made, organizations that develop guidelines should continue to work toward greater transparency and minimization of financial conflicts of interest.

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

PubMed Central

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

2016-01-01

Background Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. There is a limited number of studies on guidelines in Turkey. The quality of Ministry of Health guidelines have formerly been assessed whereas there is no information on the other guidelines developed in the country. Aim This study aims to assess the quality of CPGs that are developed by professional societies that work for the health sector in Turkey, and compare the findings with international guidelines. Methodology Professional societies that work for the health sector were determined by using the data obtained from the Ministry of Internal Affairs. Inclusion and exclusion criteria were defined for selecting the CPGs. Guidelines containing recommendations about disease management to the doctors, accessible online, developed within the past 5 years, citing references for recommendations, about the diseases over 1% prevalence according to the “Statistical Yearbook of Turkey 2012” were included in the study. The quality of CPGs were assessed with the AGREE II instrument, which is an internationally recognized tool for this purpose. Four independent reviewers, who did not participate in the development of the selected guidelines and were trained in CPG appraisal, used the AGREE instrument for assessment of the selected guidelines. Findings 47 professional societies were defined which provided access to CPGs in their websites; 3 of them were only open to members so these could not be reached. 8 CPGs from 7 societies were selected from a total of 401 CPGs from 44 societies. The mean scores of the domains of the guidelines which were assessed by the AGREE II tool were; Scope and purpose: 64%, stakeholder involvement: 37.9%, rigour of development: 35.3%, clarity and presentation: 77.9%, applicability: 49.0% and editorial independence: 46.0%. Conclusion This is the first study in Turkey regarding quality appraisal of guidelines developed by the local professional societies. It adds to the limited amount of information in the literature that comes from Turkey as well as other developing countries. PMID:27295303

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

PubMed

Mercuri, Mathew

2018-04-17

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

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

PubMed

Esteves, Sandro C; Chan, Peter

2015-09-01

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

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

PubMed Central

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

2013-01-01

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

An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy.

PubMed

Kreiner, D Scott; Hwang, Steven W; Easa, John E; Resnick, Daniel K; Baisden, Jamie L; Bess, Shay; Cho, Charles H; DePalma, Michael J; Dougherty, Paul; Fernand, Robert; Ghiselli, Gary; Hanna, Amgad S; Lamer, Tim; Lisi, Anthony J; Mazanec, Daniel J; Meagher, Richard J; Nucci, Robert C; Patel, Rakesh D; Sembrano, Jonathan N; Sharma, Anil K; Summers, Jeffrey T; Taleghani, Christopher K; Tontz, William L; Toton, John F

2014-01-01

The objective of the North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy is to provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of lumbar disc herniation with radiculopathy. The guideline is intended to reflect contemporary treatment concepts for symptomatic lumbar disc herniation with radiculopathy as reflected in the highest quality clinical literature available on this subject as of July 2011. The goals of the guideline recommendations are to assist in delivering optimum efficacious treatment and functional recovery from this spinal disorder. To provide an evidence-based educational tool to assist spine specialists in the diagnosis and treatment of lumbar disc herniation with radiculopathy. Systematic review and evidence-based clinical guideline. This guideline is a product of the Lumbar Disc Herniation with Radiculopathy Work Group of NASS' Evidence-Based Guideline Development Committee. The work group consisted of multidisciplinary spine care specialists trained in the principles of evidence-based analysis. A literature search addressing each question and using a specific search protocol was performed on English-language references found in Medline, Embase (Drugs and Pharmacology), and four additional evidence-based databases to identify articles. The relevant literature was then independently rated using the NASS-adopted standardized levels of evidence. An evidentiary table was created for each of the questions. Final recommendations to answer each clinical question were developed via work group discussion, and grades were assigned to the recommendations using standardized grades of recommendation. In the absence of Level I to IV evidence, work group consensus statements have been developed using a modified nominal group technique, and these statements are clearly identified as such in the guideline. Twenty-nine clinical questions were formulated and addressed, and the answers are summarized in this article. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. The clinical guideline has been created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with symptomatic lumbar disc herniation with radiculopathy. The entire guideline document, including the evidentiary tables, suggestions for future research, and all the references, is available electronically on the NASS Web site at http://www.spine.org/Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx and will remain updated on a timely schedule. Copyright © 2014 Elsevier Inc. All rights reserved.

Development of clinical practice guidelines.

PubMed

Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard

2014-01-01

Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.

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.

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

Critical appraisal of clinical practice guidelines in pediatric infectious diseases.

PubMed

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

2015-10-01

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

Methodological Quality of Consensus Guidelines in Implant Dentistry.

PubMed

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

2017-01-01

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

Methodological Quality of Consensus Guidelines in Implant Dentistry

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-05-01

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

Publishing web-based guidelines using interactive decision models.

PubMed

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

2001-05-01

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

[Elaboration and critical evaluation of clinical guidelines].

PubMed

García Villar, C

2015-11-01

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

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.

A guideline for adults with an indwelling urinary catheter in different health care Settings - methodological procedures

PubMed

Barbezat, Isabelle; Willener, Rita; Jenni, Giovanna; Hürlimann, Barbara; Geese, Franziska; Spichiger, Elisabeth

2017-07-01

Background: People with an indwelling urinary catheter often suffer from complications and health care professionals are regularly confronted with questions about catheter management. Clinical guidelines are widely accepted to promote evidence-based practice. In the literature, the adaptation of a guideline is described as a valid alternative to the development of a new one. Aim: To translate a guideline for the care for adults with an indwelling urinary catheter in the acute and long term care setting as well as for home care. To adapt the guideline to the Swiss context. Method: In a systematic and pragmatic process, clinical questions were identified, guidelines were searched and evaluated regarding clinical relevance and quality. After each step, the next steps were defined. Results: An English guideline was translated, adapted to the local context and supplemented. The adapted guideline was reviewed by experts, adapted again and approved. After 34 months and an investment of a total of 145 man working days, a guideline for the care for people with an indwelling urinary catheter is available for both institutions. Conclusions: Translation and adaptation of a guideline was a valuable alternative to the development of a new one; nevertheless, the efforts necessary should not be underestimated. For such a project, sufficient professional and methodological resources should be made available to achieve efficient guideline work by a constant team.

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

PubMed

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

2016-07-01

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

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

PubMed

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

2017-07-01

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

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

PubMed Central

2014-01-01

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

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.

Developing prehospital clinical practice guidelines for resource limited settings: why re-invent the wheel?

PubMed

McCaul, Michael; de Waal, Ben; Hodkinson, Peter; Pigoga, Jennifer L; Young, Taryn; Wallis, Lee A

2018-02-05

Methods on developing new (de novo) clinical practice guidelines (CPGs) have received substantial attention. However, the volume of literature is not matched by research into alternative methods of CPG development using existing CPG documents-a specific issue for guideline development groups in low- and middle-income countries. We report on how we developed a context specific prehospital CPG using an alternative guideline development method. Difficulties experienced and lessons learnt in applying existing global guidelines' recommendations to a national context are highlighted. The project produced the first emergency care CPG for prehospital providers in Africa. It included > 270 CPGs and produced over 1000 recommendations for prehospital emergency care. We encountered various difficulties, including (1) applicability issues: few pre-hospital CPGs applicable to Africa, (2) evidence synthesis: heterogeneous levels of evidence classifications and (3) guideline quality. Learning points included (1) focusing on key CPGs and evidence mapping, (2) searching other resources for CPGs, (3) broad representation on CPG advisory boards and (4) transparency and knowledge translation. Re-inventing the wheel to produce CPGs is not always feasible. We hope this paper will encourage further projects to use existing CPGs in developing guidance to improve patient care in resource-limited settings.

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

PubMed

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

2018-03-05

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

Creating Shareable Clinical Decision Support Rules for a Pharmacogenomics Clinical Guideline Using Structured Knowledge Representation.

PubMed

Linan, Margaret K; Sottara, Davide; Freimuth, Robert R

2015-01-01

Pharmacogenomics (PGx) guidelines contain drug-gene relationships, therapeutic and clinical recommendations from which clinical decision support (CDS) rules can be extracted, rendered and then delivered through clinical decision support systems (CDSS) to provide clinicians with just-in-time information at the point of care. Several tools exist that can be used to generate CDS rules that are based on computer interpretable guidelines (CIG), but none have been previously applied to the PGx domain. We utilized the Unified Modeling Language (UML), the Health Level 7 virtual medical record (HL7 vMR) model, and standard terminologies to represent the semantics and decision logic derived from a PGx guideline, which were then mapped to the Health eDecisions (HeD) schema. The modeling and extraction processes developed here demonstrate how structured knowledge representations can be used to support the creation of shareable CDS rules from PGx guidelines.

[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.

Tools developed and disseminated by guideline producers to promote the uptake of their guidelines.

PubMed

Flodgren, Gerd; Hall, Amanda M; Goulding, Lucy; Eccles, Martin P; Grimshaw, Jeremy M; Leng, Gillian C; Shepperd, Sasha

2016-08-22

The uptake of clinical practice guidelines (CPGs) is inconsistent, despite their potential to improve the quality of health care and patient outcomes. Some guideline producers have addressed this problem by developing tools to encourage faster adoption of new guidelines. This review focuses on the effectiveness of tools developed and disseminated by guideline producers to improve the uptake of their CPGs. To evaluate the effectiveness of implementation tools developed and disseminated by guideline producers, which accompany or follow the publication of a CPG, to promote uptake. A secondary objective is to determine which approaches to guideline implementation are most effective. We searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL); NHS Economic Evaluation Database, HTA Database; MEDLINE and MEDLINE In-Process and other non-indexed citations; Embase; PsycINFO; CINAHL; Dissertations and Theses, ProQuest; Index to Theses; Science Citation Index Expanded, ISI Web of Knowledge; Conference Proceedings Citation Index - Science, ISI Web of Knowledge; Health Management Information Consortium (HMIC), and NHS Evidence up to February 2016. We also searched trials registers, reference lists of included studies and relevant websites. We included randomised controlled trials (RCTs) and cluster-RCTs, controlled before-and-after studies (CBAs) and interrupted time series (ITS) studies evaluating the effects of guideline implementation tools developed by recognised guideline producers to improve the uptake of their own guidelines. The guideline could target any clinical area. Two review authors independently extracted data and assessed the risk of bias of each included study using the Cochrane 'Risk of bias' criteria. We graded our confidence in the evidence using the approach recommended by the GRADE working group. The clinical conditions targeted and the implementation tools used were too heterogenous to combine data for meta-analysis. We report the median absolute risk difference (ARD) and interquartile range (IQR) for the main outcome of adherence to guidelines. We included four cluster-RCTs that were conducted in the Netherlands, France, the USA and Canada. These studies evaluated the effects of tools developed by national guideline producers to implement their CPGs. The implementation tools evaluated targeted healthcare professionals; none targeted healthcare organisations or patients.One study used two short educational workshops tailored to barriers. In three studies the intervention consisted of the provision of paper-based educational materials, order forms or reminders, or both. The clinical condition, type of healthcare professional, and behaviour targeted by the CPG varied across studies.Two of the four included studies reported data on healthcare professionals' adherence to guidelines. A guideline tool developed by the producers of a guideline probably leads to increased adherence to the guidelines; median ARD (IQR) was 0.135 (0.115 and 0.159 for the two studies respectively) at an average four-week follow-up (moderate certainty evidence), which indicates a median 13.5% greater adherence to guidelines in the intervention group. Providing healthcare professionals with a tool to improve implementation of a guideline may lead to little or no difference in costs to the health service. Implementation tools developed by recognised guideline producers probably lead to improved healthcare professionals' adherence to guidelines in the management of non-specific low back pain and ordering thyroid-function tests. There are limited data on the relative costs of implementing these interventions.There are no studies evaluating the effectiveness of interventions targeting the organisation of care (e.g. benchmarking tools, costing templates, etc.), or for mass media interventions. We could not draw any conclusions about our second objective, the comparative effectiveness of implementation tools, due to the small number of studies, the heterogeneity between interventions, and the clinical conditions that were targeted.

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

PubMed

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

2011-02-01

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

[The guideline for the treatment of mood disorders in USA and Japan].

PubMed

Higuchi, T

2001-08-01

Recently, the number of available antidepressants has increased dramatically and psychopharmacological treatment is becoming complex. It is important to present some guideline for supporting clinical decision making. Three different kinds of guideline for the treatment of mood disorders, that is, the APA style guideline, the algorithm and the consensus guideline, have been developed in our country. The APA style guideline and the algorithm are basically evidence based and the consensus guideline is developed through the consensus panel format. These guidelines should be used as 'a starting point' for specifying decisions that will be modified occasionally.

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.

Different Teams, Same Conclusions? A Systematic Review of Existing Clinical Guidelines for the Assessment and Treatment of Tinnitus in Adults

PubMed Central

Fuller, Thomas E.; Haider, Haula F.; Kikidis, Dimitris; Lapira, Alec; Mazurek, Birgit; Norena, Arnaud; Rabau, Sarah; Lardinois, Rachelle; Cederroth, Christopher R.; Edvall, Niklas K.; Brueggemann, Petra G.; Rosing, Susanne N.; Kapandais, Anestis; Lungaard, Dorte; Hoare, Derek J.; Cima, Rilana F. F

2017-01-01

Background: Though clinical guidelines for assessment and treatment of chronic subjective tinnitus do exist, a comprehensive review of those guidelines has not been performed. The objective of this review was to identify current clinical guidelines, and compare their recommendations for the assessment and treatment of subjective tinnitus in adults. Method: We systematically searched a range of sources for clinical guidelines (as defined by the Institute of Medicine, United States) for the assessment and/or treatment of subjective tinnitus in adults. No restrictions on language or year of publication were applied to guidelines. Results: Clinical guidelines from Denmark, Germany, Sweden, The Netherlands, and the United States were included in the review. There was a high level of consistency across the guidelines with regard to recommendations for audiometric assessment, physical examination, use of a validated questionnaire(s) to assess tinnitus related distress, and referral to a psychologist when required. Cognitive behavioral treatment for tinnitus related distress, use of hearing aids in instances of hearing loss and recommendations against the use of medicines were consistent across the included guidelines. Differences between the guidelines centered on the use of imaging in assessment procedures and sound therapy as a form of treatment for tinnitus distress respectively. Conclusion: Given the level of commonality across tinnitus guidelines from different countries the development of a European guideline for the assessment and treatment of subjective tinnitus in adults seems feasible. This guideline would have the potential to benefit the large number of clinicians in countries where clinical guidelines do not yet exist, and would support standardization of treatment for patients across Europe. PMID:28275357

Different Teams, Same Conclusions? A Systematic Review of Existing Clinical Guidelines for the Assessment and Treatment of Tinnitus in Adults.

PubMed

Fuller, Thomas E; Haider, Haula F; Kikidis, Dimitris; Lapira, Alec; Mazurek, Birgit; Norena, Arnaud; Rabau, Sarah; Lardinois, Rachelle; Cederroth, Christopher R; Edvall, Niklas K; Brueggemann, Petra G; Rosing, Susanne N; Kapandais, Anestis; Lungaard, Dorte; Hoare, Derek J; Cima, Rilana F F

2017-01-01

Background: Though clinical guidelines for assessment and treatment of chronic subjective tinnitus do exist, a comprehensive review of those guidelines has not been performed. The objective of this review was to identify current clinical guidelines, and compare their recommendations for the assessment and treatment of subjective tinnitus in adults. Method: We systematically searched a range of sources for clinical guidelines (as defined by the Institute of Medicine, United States) for the assessment and/or treatment of subjective tinnitus in adults. No restrictions on language or year of publication were applied to guidelines. Results: Clinical guidelines from Denmark, Germany, Sweden, The Netherlands, and the United States were included in the review. There was a high level of consistency across the guidelines with regard to recommendations for audiometric assessment, physical examination, use of a validated questionnaire(s) to assess tinnitus related distress, and referral to a psychologist when required. Cognitive behavioral treatment for tinnitus related distress, use of hearing aids in instances of hearing loss and recommendations against the use of medicines were consistent across the included guidelines. Differences between the guidelines centered on the use of imaging in assessment procedures and sound therapy as a form of treatment for tinnitus distress respectively. Conclusion: Given the level of commonality across tinnitus guidelines from different countries the development of a European guideline for the assessment and treatment of subjective tinnitus in adults seems feasible. This guideline would have the potential to benefit the large number of clinicians in countries where clinical guidelines do not yet exist, and would support standardization of treatment for patients across Europe.

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

PubMed

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

2017-01-03

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

Developing evidence-based physical therapy clinical practice guidelines.

PubMed

Kaplan, Sandra L; Coulter, Colleen; Fetters, Linda

2013-01-01

Recommended strategies for developing evidence-based clinical practice guidelines (CPGs) are provided. The intent is that future CPGs developed with the support of the Section on Pediatrics of the American Physical Therapy Association would consistently follow similar developmental processes to yield consistent quality and presentation. Steps in the process of developing CPGs are outlined and resources are provided to assist CPG developers in carrying out their task. These recommended processes may also be useful to CPG developers representing organizations with similar structures, objectives, and resources.

Methodological quality of guidelines in gastroenterology.

PubMed

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

2014-06-01

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

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.

A computerized clinical decision support system as a means of implementing depression guidelines.

PubMed

Trivedi, Madhukar H; Kern, Janet K; Grannemann, Bruce D; Altshuler, Kenneth Z; Sunderajan, Prabha

2004-08-01

The authors describe the history and current use of computerized systems for implementing treatment guidelines in general medicine as well as the development, testing, and early use of a computerized decision support system for depression treatment among "real-world" clinical settings in Texas. In 1999 health care experts from Europe and the United States met to confront the well-documented challenges of implementing treatment guidelines and to identify strategies for improvement. They suggested the integration of guidelines into computer systems that is incorporated into clinical workflow. Several studies have demonstrated improvements in physicians' adherence to guidelines when such guidelines are provided in a computerized format. Although computerized decision support systems are being used in many areas of medicine and have demonstrated improved patient outcomes, their use in psychiatric illness is limited. The authors designed and developed a computerized decision support system for the treatment of major depressive disorder by using evidence-based guidelines, transferring the knowledge gained from the Texas Medication Algorithm Project (TMAP). This computerized decision support system (CompTMAP) provides support in diagnosis, treatment, follow-up, and preventive care and can be incorporated into the clinical setting. CompTMAP has gone through extensive testing to ensure accuracy and reliability. Physician surveys have indicated a positive response to CompTMAP, although the sample was insufficient for statistical testing. CompTMAP is part of a new era of comprehensive computerized decision support systems that take advantage of advances in automation and provide more complete clinical support to physicians in clinical practice.

Clinical practice guidelines for the management of acute limb compartment syndrome following trauma.

PubMed

Wall, Christopher J; Lynch, Joan; Harris, Ian A; Richardson, Martin D; Brand, Caroline; Lowe, Adrian J; Sugrue, Michael

2010-03-01

Acute compartment syndrome is a serious and not uncommon complication of limb trauma. The condition is a surgical emergency, and is associated with significant morbidity if not managed appropriately. There is variation in management of acute limb compartment syndrome in Australia. Clinical practice guidelines for the management of acute limb compartment syndrome following trauma were developed in accordance with Australian National Health and Medical Research Council recommendations. The guidelines were based on critically appraised literature evidence and the consensus opinion of a multidisciplinary team involved in trauma management who met in a nominal panel process. Recommendations were developed for key decision nodes in the patient care pathway, including methods of diagnosis in alert and unconscious patients, appropriate assessment of compartment pressure, timing and technique of fasciotomy, fasciotomy wound management, and prevention of compartment syndrome in patients with limb injuries. The recommendations were largely consensus based in the absence of well-designed clinical trial evidence. Clinical practice guidelines for the management of acute limb compartment syndrome following trauma have been developed that will support consistency in management and optimize patient health outcomes.

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.

Oncology nurses' use of National Comprehensive Cancer Network clinical practice guidelines for chemotherapy-induced and febrile neutropenia.

PubMed

Nirenberg, Anita; Reame, Nancy K; Cato, Kenrick D; Larson, Elaine L

2010-11-01

To describe oncology nurses' use of National Comprehensive Cancer Network (NCCN) clinical practice guidelines for chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Cross-sectional survey design; descriptive, correlational analysis. E-mail invitation to Web-based survey. Random sample of 309 Oncology Nursing Society (ONS) members with e-mail addresses who provide care to adult patients receiving chemotherapy. The investigator-developed Neutropenia Oncology Nurses Survey was used. Descriptive tests compared respondents' personal and professional characteristics to those of general ONS members; nonparametric chi-square and Kruskal-Wallis tests were used to correlate respondents' survey subscale scores with demographic data. Significant associations were entered into multiple logistic regression models. The Neutropenia Oncology Nurses Survey's subscales measured subjective norm, attitude, perceived competence and confidence, perceived barriers, and use of NCCN clinical practice guidelines for CIN and FN. Response rate of nurses who opened the survey was 50%. Most practiced in community versus academic centers. Eighty percent reported using the NCCN clinical practice guidelines for CIN and FN. Respondents were more likely to use clinical practice guidelines when they were expected to by physician and nurse colleagues, they perceived fewer barriers, or they held advanced oncology certification. This study was the first to assess oncology nurses' reported use of NCCN clinical practice guidelines for CIN and FN. It also demonstrated the feasibility of partnering with ONS for Web-based survey research. The findings give insight into work-place barriers to evidence-based practice in various settings. Expanding dissemination and implementation of clinical practice guideline recommendations will support the development of oncology nursing standards for risk assessment, management, and patient and family education in CIN and FN.

Development of Guidelines Related to Riverside Community College Nursing Student Mandatory Assignment to AIDS Patients in the Clinical Setting.

ERIC Educational Resources Information Center

Kross, Carolyn Sue

The purpose of this study was to develop Associate Degree nursing program guidelines for Riverside Community College (RCC), in California, regarding mandatory nursing student assignment to Acquired Immune Deficiency Syndrome (AIDS) patients, and student refusal of such assignments in a clinical setting. During the 1990 fall semester, RCC's Nursing…

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

PubMed

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

2015-01-01

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

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

PubMed

Rosenfeld, Richard M; Shiffman, Richard N

2009-06-01

Guidelines translate best evidence into best practice. A well-crafted guideline promotes quality by reducing health-care variations, improving diagnostic accuracy, promoting effective therapy, and discouraging ineffective-or potentially harmful-interventions. Despite a plethora of published guidelines, methodology is often poorly defined and varies greatly within and among organizations. This manual describes the principles and practices used successfully by the American Academy of Otolaryngology-Head and Neck Surgery to produce quality-driven, evidence-based guidelines using efficient and transparent methodology for action-ready recommendations with multidisciplinary applicability. The development process, which allows moving from conception to completion in 12 months, emphasizes a logical sequence of key action statements supported by amplifying text, evidence profiles, and recommendation grades that link action to evidence. As clinical practice guidelines become more prominent as a key metric of quality health care, organizations must develop efficient production strategies that balance rigor and pragmatism. Equally important, clinicians must become savvy in understanding what guidelines are-and are not-and how they are best utilized to improve care. The information in this manual should help clinicians and organizations achieve these goals.

Guideline validation in multiple trauma care through business process modeling.

PubMed

Stausberg, Jürgen; Bilir, Hüseyin; Waydhas, Christian; Ruchholtz, Steffen

2003-07-01

Clinical guidelines can improve the quality of care in multiple trauma. In our Department of Trauma Surgery a specific guideline is available paper-based as a set of flowcharts. This format is appropriate for the use by experienced physicians but insufficient for electronic support of learning, workflow and process optimization. A formal and logically consistent version represented with a standardized meta-model is necessary for automatic processing. In our project we transferred the paper-based into an electronic format and analyzed the structure with respect to formal errors. Several errors were detected in seven error categories. The errors were corrected to reach a formally and logically consistent process model. In a second step the clinical content of the guideline was revised interactively using a process-modeling tool. Our study reveals that guideline development should be assisted by process modeling tools, which check the content in comparison to a meta-model. The meta-model itself could support the domain experts in formulating their knowledge systematically. To assure sustainability of guideline development a representation independent of specific applications or specific provider is necessary. Then, clinical guidelines could be used for eLearning, process optimization and workflow management additionally.

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

PubMed

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

2018-04-30

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

Opioid Therapy for Chronic Pain: Overview of the 2017 US Department of Veterans Affairs and US Department of Defense Clinical Practice Guideline.

PubMed

Rosenberg, Jack M; Bilka, Brandon M; Wilson, Sara M; Spevak, Christopher

2018-05-01

The US Department of Veterans Affairs (VA) and US Department of Defense (DoD) revised the 2010 clinical practice guideline (CPG) for the management of opioid therapy for chronic pain, considering the specific needs of the VA and DoD and new evidence regarding prescribing opioid medication for non-end-of-life-related chronic pain. This paper summarizes the major recommendations and compares them with the US Centers for Disease Control and Prevention (CDC) guideline for prescribing opioids. This Opioid Therapy CPG was developed for VA-DoD service members, veterans, and their families. The VA/DoD Evidence-Based Practice Work Group convened a VA/DoD guideline renewal development effort and conformed to the guidelines established by the VA/DoD Joint Executive Council (JEC) and VA/DoD Health Executive Council (HEC). The panel developed questions, searched and evaluated the literature, developed recommendations using GRADE methodology, and developed algorithms. Passage of the CARA Act by Congress compelled consideration and comparison with the CDC opioid therapy guideline mid-development. There were 18 recommendations made. This article focuses on guideline development and key recommendations with CDC comparisons taken from four major areas, including: initiation and continuation of opioids;type, dose, follow-up, and taper of opioids;risk mitigation;acute pain. Guideline development and recommendations are presented. There was substantial overlap with the CDC opioid guideline. Additionally, there were items particularly relevant to the VA-DoD, including risk mitigation, suicide prevention, and preventing opioid use disorder in young patients. Our guideline highlights avoiding opioid therapy longer than 90 days as a critical juncture.

A Systematic Review of Smartphone Applications for Plastic Surgery Providers: Target Audience, Uses, and Cost.

PubMed

Reusche, Ryan; Buchanan, Patrick J; Kozlow, Jeffrey H; Vercler, Christian J

2016-01-01

The growth and acceptance of smartphones among clinicians has been remarkable over the last decade. Over 87% of doctors use a smartphone or tablet capable of running third-party software known as applications (apps). In the field of plastic surgery, apps have been designed for personal practice development, education, clinical tools and guidelines, and entertainment. This study reviews the literature on apps related to plastic surgery and determines the number and types of apps available. A systematic review of the literature was performed to find articles written about plastic surgery applications. Queries were run in the Apple iPhone iOS App store and Google Play using the term "plastic surgery." Apps were reviewed for ratings, downloads, and cost. In addition, apps were categorized based on purpose. Categories include practice development, media/literature, clinical tool and guideline apps, or recreation. The literature search yielded 8 articles for review, 2 articles focused on categorizing apps and 6 articles focused on describing useful apps. Searching Apple's iTunes (iOS) store identified 273 and Google Play identified 250 apps related to plastic surgery; since 2013, a 62%, and 580% increase, respectively. The iOS store included practice development (46%), recreation (26%), media/literature (14%), and clinical tool and guideline (11%). Google Play store included recreation apps (44%), practice development (24%), clinical tools and guidelines (11%), and media and literature (9%). Apps related to the field of plastic surgery are increasing in prevalence. The content of these apps are variable, and the majority are intended for marketing and development of private practices. Apps linking to literature, texts, study materials, and clinical tools and guidelines are developed for both practicing plastic surgeons and surgical trainees. Finding "useful" apps takes time because searches are often complicated by a variety of apps.

Guideline on anterior cruciate ligament injury

PubMed Central

2012-01-01

The Dutch Orthopaedic Association has a long tradition of development of practical clinical guidelines. Here we present the recommendations from the multidisciplinary clinical guideline working group for anterior cruciate ligament injury. The following 8 clinical questions were formulated by a steering group of the Dutch Orthopaedic Association. What is the role of physical examination and additional diagnostic tools? Which patient-related outcome measures should be used? What are the relevant parameters that influence the indication for an ACL reconstruction? Which findings or complaints are predictive of a bad result of an ACL injury treatment? What is the optimal timing for surgery for an ACL injury? What is the outcome of different conservative treatment modalities? Which kind of graft gives the best result in an ACL reconstruction? What is the optimal postoperative treatment concerning rehabilitation, resumption of sports, and physiotherapy? These 8 questions were answered and recommendations were made, using the “Appraisal of Guidelines for Research and Evaluation” instrument. This instrument seeks to improve the quality and effectiveness of clinical practical guidelines by establishing a shared framework to develop, report, and assess. The steering group has also developed 7 internal indicators to aid in measuring and enhancing the quality of the treatment of patients with an ACL injury, for use in a hospital or practice. PMID:22900914

Guidelines: the do's, don'ts and don't knows of feedback for clinical education.

PubMed

Lefroy, Janet; Watling, Chris; Teunissen, Pim W; Brand, Paul

2015-12-01

The guidelines offered in this paper aim to amalgamate the literature on formative feedback into practical Do's, Don'ts and Don't Knows for individual clinical supervisors and for the institutions that support clinical learning. The authors built consensus by an iterative process. Do's and Don'ts were proposed based on authors' individual teaching experience and awareness of the literature, and the amalgamated set of guidelines were then refined by all authors and the evidence was summarized for each guideline. Don't Knows were identified as being important questions to this international group of educators which if answered would change practice. The criteria for inclusion of evidence for these guidelines were not those of a systematic review, so indicators of strength of these recommendations were developed which combine the evidence with the authors' consensus. A set of 32 Do and Don't guidelines with the important Don't Knows was compiled along with a summary of the evidence for each. These are divided into guidelines for the individual clinical supervisor giving feedback to their trainee (recommendations about both the process and the content of feedback) and guidelines for the learning culture (what elements of learning culture support the exchange of meaningful feedback, and what elements constrain it?) Feedback is not easy to get right, but it is essential to learning in medicine, and there is a wealth of evidence supporting the Do's and warning against the Don'ts. Further research into the critical Don't Knows of feedback is required. A new definition is offered: Helpful feedback is a supportive conversation that clarifies the trainee's awareness of their developing competencies, enhances their self-efficacy for making progress, challenges them to set objectives for improvement, and facilitates their development of strategies to enable that improvement to occur.

Using spiritual interventions in practice: developing some guidelines from evidence-based practice.

PubMed

Hodge, David R

2011-04-01

Research indicates that many social work practitioners are interested in using spiritual interventions in clinical settings. Unfortunately, studies also indicate that practitioners have frequently received minimal training on the topic during their graduate education. Drawing from the evidence-based practice movement, this article develops some guidelines to assist practitioners in using spiritual interventions in an ethical, professional manner that fosters client well-being. These guidelines can be summarized under the following four rubrics: (1) client preference, (2) evaluation of relevant research, (3) clinical expertise, and (4) cultural competency. The article concludes by emphasizing that these overlapping guidelines should be considered concurrently, in a manner that privileges clients' needs and desires in the decision-making process.

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

PubMed

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

2017-04-01

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

Method to integrate clinical guidelines into the electronic health record (EHR) by applying the archetypes approach.

PubMed

Garcia, Diego; Moro, Claudia Maria Cabral; Cicogna, Paulo Eduardo; Carvalho, Deborah Ribeiro

2013-01-01

Clinical guidelines are documents that assist healthcare professionals, facilitating and standardizing diagnosis, management, and treatment in specific areas. Computerized guidelines as decision support systems (DSS) attempt to increase the performance of tasks and facilitate the use of guidelines. Most DSS are not integrated into the electronic health record (EHR), ordering some degree of rework especially related to data collection. This study's objective was to present a method for integrating clinical guidelines into the EHR. The study developed first a way to identify data and rules contained in the guidelines, and then incorporate rules into an archetype-based EHR. The proposed method tested was anemia treatment in the Chronic Kidney Disease Guideline. The phases of the method are: data and rules identification; archetypes elaboration; rules definition and inclusion in inference engine; and DSS-EHR integration and validation. The main feature of the proposed method is that it is generic and can be applied toany type of guideline.

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

PubMed

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

2015-03-01

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

Adopting Health Behavior Change Theory throughout the Clinical Practice Guideline Process

ERIC Educational Resources Information Center

Ceccato, Natalie E.; Ferris, Lorraine E.; Manuel, Douglas; Grimshaw, Jeremy M.

2007-01-01

Adopting a theoretical framework throughout the clinical practice guideline (CPG) process (development, dissemination, implementation, and evaluation) can be useful in systematically identifying, addressing, and explaining behavioral influences impacting CPG uptake and effectiveness. This article argues that using a theoretical framework should…

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

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.

Physiotherapy in asthma--seeking consensus.

PubMed

Nowobilski, Roman; Plaszewski, Maciej; Wloch, Tomasz; Mika, Piotr; Gajewski, Piotr; Brożek, Jan L

2013-08-01

The evidence base for or against physiotherapy interventions in asthmatic adults remains ambiguous, and there are discrepancies between different clinical practice guidelines. We evaluated the level of agreement between the recommendations about physiotherapy for adults with asthma in two major clinical practice guidelines: the Global Initiative for Asthma (GINA 2011) and the British Thoracic Society and the Association of Chartered Physiotherapists in Respiratory Care (BTS/ACPRC 2009). We used the Appraisal of Guidelines for Research & Evaluation (AGREE II) instrument to assess the methodological rigor of the guideline development, the Assessment of Multiple Systematic Reviews (AMSTAR) tool and the Physiotherapy Evidence Database (PEDro) scale to assess the methodological quality of systematic reviews and clinical trials included in the analyzed documents. Additionally, we compared the reference lists of the analyzed sections to establish the overlap in included primary and secondary studies. We observed no agreement between the two guidelines in the choice of source research articles. Only two studies out of 18 used in BTS guidelines were used in the GINA. The reason why GINA developers did not use the body of evidence included in BTS is that it is not clear. Three independent investigators indicated higher scores in all domains of the AGREE II in the BTS/ACPRC document in comparison with the GINA guidelines. The significant differences in the content and in the development processes of the examined sections of the two guidelines suggest the need for more frequent and careful updating or directing the readers of the GINA to the BTS/ACPRC, a guideline addressing specifically and more comprehensively physiotherapy interventions in asthma.

Towards computerizing intensive care sedation guidelines: design of a rule-based architecture for automated execution of clinical guidelines

PubMed Central

2010-01-01

Background Computerized ICUs rely on software services to convey the medical condition of their patients as well as assisting the staff in taking treatment decisions. Such services are useful for following clinical guidelines quickly and accurately. However, the development of services is often time-consuming and error-prone. Consequently, many care-related activities are still conducted based on manually constructed guidelines. These are often ambiguous, which leads to unnecessary variations in treatments and costs. The goal of this paper is to present a semi-automatic verification and translation framework capable of turning manually constructed diagrams into ready-to-use programs. This framework combines the strengths of the manual and service-oriented approaches while decreasing their disadvantages. The aim is to close the gap in communication between the IT and the medical domain. This leads to a less time-consuming and error-prone development phase and a shorter clinical evaluation phase. Methods A framework is proposed that semi-automatically translates a clinical guideline, expressed as an XML-based flow chart, into a Drools Rule Flow by employing semantic technologies such as ontologies and SWRL. An overview of the architecture is given and all the technology choices are thoroughly motivated. Finally, it is shown how this framework can be integrated into a service-oriented architecture (SOA). Results The applicability of the Drools Rule language to express clinical guidelines is evaluated by translating an example guideline, namely the sedation protocol used for the anaesthetization of patients, to a Drools Rule Flow and executing and deploying this Rule-based application as a part of a SOA. The results show that the performance of Drools is comparable to other technologies such as Web Services and increases with the number of decision nodes present in the Rule Flow. Most delays are introduced by loading the Rule Flows. Conclusions The framework is an effective solution for computerizing clinical guidelines as it allows for quick development, evaluation and human-readable visualization of the Rules and has a good performance. By monitoring the parameters of the patient to automatically detect exceptional situations and problems and by notifying the medical staff of tasks that need to be performed, the computerized sedation guideline improves the execution of the guideline. PMID:20082700

Towards computerizing intensive care sedation guidelines: design of a rule-based architecture for automated execution of clinical guidelines.

PubMed

Ongenae, Femke; De Backere, Femke; Steurbaut, Kristof; Colpaert, Kirsten; Kerckhove, Wannes; Decruyenaere, Johan; De Turck, Filip

2010-01-18

Computerized ICUs rely on software services to convey the medical condition of their patients as well as assisting the staff in taking treatment decisions. Such services are useful for following clinical guidelines quickly and accurately. However, the development of services is often time-consuming and error-prone. Consequently, many care-related activities are still conducted based on manually constructed guidelines. These are often ambiguous, which leads to unnecessary variations in treatments and costs.The goal of this paper is to present a semi-automatic verification and translation framework capable of turning manually constructed diagrams into ready-to-use programs. This framework combines the strengths of the manual and service-oriented approaches while decreasing their disadvantages. The aim is to close the gap in communication between the IT and the medical domain. This leads to a less time-consuming and error-prone development phase and a shorter clinical evaluation phase. A framework is proposed that semi-automatically translates a clinical guideline, expressed as an XML-based flow chart, into a Drools Rule Flow by employing semantic technologies such as ontologies and SWRL. An overview of the architecture is given and all the technology choices are thoroughly motivated. Finally, it is shown how this framework can be integrated into a service-oriented architecture (SOA). The applicability of the Drools Rule language to express clinical guidelines is evaluated by translating an example guideline, namely the sedation protocol used for the anaesthetization of patients, to a Drools Rule Flow and executing and deploying this Rule-based application as a part of a SOA. The results show that the performance of Drools is comparable to other technologies such as Web Services and increases with the number of decision nodes present in the Rule Flow. Most delays are introduced by loading the Rule Flows. The framework is an effective solution for computerizing clinical guidelines as it allows for quick development, evaluation and human-readable visualization of the Rules and has a good performance. By monitoring the parameters of the patient to automatically detect exceptional situations and problems and by notifying the medical staff of tasks that need to be performed, the computerized sedation guideline improves the execution of the guideline.

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

PubMed

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

2009-09-15

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

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

PubMed

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

1997-06-15

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

The 2014 International Pressure Ulcer Guideline: methods and development.

PubMed

Haesler, Emily; Kottner, Jan; Cuddigan, Janet

2017-06-01

A discussion of the methodology used to develop the Prevention and Treatment of Pressure Ulcers: Clinical Practice Guideline. (2014). International experts representing National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance developed the second edition of this clinical guideline. Discussion paper - methodology. A comprehensive search for papers published up to July 2013 was conducted in 11 databases and identified 4286 studies. After critical appraisal, 356 studies were included and assigned a level of evidence. Guideline recommendations provide guidance on best practice in pressure ulcer prevention and treatment. Understanding the development process of a guideline increases the meaningfulness of recommendations to clinicians. Five hundred and seventy five recommendations arose from the research and its interpretation. The body of evidence supporting each recommendation was assigned a strength of evidence. A strength of recommendation was assigned to recommendation statements using the GRADE system. Recommendations are primarily supported by a body of evidence rated as C (87% of recommendations), representing low quality and/or indirect evidence (30%) and expert opinion (57%). Two hundred and forty seven recommendations (43%) received a strong recommendation ('Do it'). Recommendations were developed with consideration to research of the highest methodological quality evidence and studies that add to clinical insight and provide guidance for areas of care where minimal research has been conducted. Recommendations in the guideline reflect best practice and should be implemented with consideration to local context and resources and the individual's preferences and needs. © 2016 John Wiley & Sons Ltd.

Clinical Practice Guideline Selection, Development, Implementation, and Evaluation

DTIC Science & Technology

2000-02-01

interventions for a particular diagnosis” (Henning, 1997) developed by members of the hospital staff. They can be Clinical Practice Guidelines6 conceptualized...health care environment , it is more important than ever for health care organizations to select the most cost-effective procedures, and to continuously...of the studies regarding the targeted illness/injury will enable this team to identify those interventions strongly supported by significant

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

PubMed

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

2016-03-15

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

Implementation of a next-generation electronic nursing records system based on detailed clinical models and integration of clinical practice guidelines.

PubMed

Min, Yul Ha; Park, Hyeoun-Ae; Chung, Eunja; Lee, Hyunsook

2013-12-01

The purpose of this paper is to describe the components of a next-generation electronic nursing records system ensuring full semantic interoperability and integrating evidence into the nursing records system. A next-generation electronic nursing records system based on detailed clinical models and clinical practice guidelines was developed at Seoul National University Bundang Hospital in 2013. This system has two components, a terminology server and a nursing documentation system. The terminology server manages nursing narratives generated from entity-attribute-value triplets of detailed clinical models using a natural language generation system. The nursing documentation system provides nurses with a set of nursing narratives arranged around the recommendations extracted from clinical practice guidelines. An electronic nursing records system based on detailed clinical models and clinical practice guidelines was successfully implemented in a hospital in Korea. The next-generation electronic nursing records system can support nursing practice and nursing documentation, which in turn will improve data quality.

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

PubMed

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

2012-08-01

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

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

PubMed

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

2015-11-04

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

MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy.

PubMed

Lalla, Rajesh V; Bowen, Joanne; Barasch, Andrei; Elting, Linda; Epstein, Joel; Keefe, Dorothy M; McGuire, Deborah B; Migliorati, Cesar; Nicolatou-Galitis, Ourania; Peterson, Douglas E; Raber-Durlacher, Judith E; Sonis, Stephen T; Elad, Sharon

2014-05-15

Mucositis is a highly significant, and sometimes dose-limiting, toxicity of cancer therapy. The goal of this systematic review was to update the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) Clinical Practice Guidelines for mucositis. A literature search was conducted to identify eligible published articles, based on predefined inclusion/exclusion criteria. Each article was independently reviewed by 2 reviewers. Studies were rated according to the presence of major and minor flaws as per previously published criteria. The body of evidence for each intervention, in each treatment setting, was assigned a level of evidence, based on previously published criteria. Guidelines were developed based on the level of evidence, with 3 possible guideline determinations: recommendation, suggestion, or no guideline possible. The literature search identified 8279 papers, 1032 of which were retrieved for detailed evaluation based on titles and abstracts. Of these, 570 qualified for final inclusion in the systematic reviews. Sixteen new guidelines were developed for or against the use of various interventions in specific treatment settings. In total, the MASCC/ISOO Mucositis Guidelines now include 32 guidelines: 22 for oral mucositis and 10 for gastrointestinal mucositis. This article describes these updated guidelines. The updated MASCC/ISOO Clinical Practice Guidelines for mucositis will help clinicians provide evidence-based management of mucositis secondary to cancer therapy. © 2014 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

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.

A patient workflow management system built on guidelines.

PubMed Central

Dazzi, L.; Fassino, C.; Saracco, R.; Quaglini, S.; Stefanelli, M.

1997-01-01

To provide high quality, shared, and distributed medical care, clinical and organizational issues need to be integrated. This work describes a methodology for developing a Patient Workflow Management System, based on a detailed model of both the medical work process and the organizational structure. We assume that the medical work process is represented through clinical practice guidelines, and that an ontological description of the organization is available. Thus, we developed tools 1) for acquiring the medical knowledge contained into a guideline, 2) to translate the derived formalized guideline into a computational formalism, precisely a Petri Net, 3) to maintain different representation levels. The high level representation guarantees that the Patient Workflow follows the guideline prescriptions, while the low level takes into account the specific organization characteristics and allow allocating resources for managing a specific patient in daily practice. PMID:9357606

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.

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.

Librarian contributions to clinical practice guidelines.

PubMed

Cruse, Peggy; Protzko, Shandra

2014-01-01

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

A JAVA-based multimedia tool for clinical practice guidelines.

PubMed

Maojo, V; Herrero, C; Valenzuela, F; Crespo, J; Lazaro, P; Pazos, A

1997-01-01

We have developed a specific language for the representation of Clinical Practice Guidelines (CPGs) and Windows C++ and platform independent JAVA applications for multimedia presentation and edition of electronically stored CPGs. This approach facilitates translation of guidelines and protocols from paper to computer-based flowchart representations. Users can navigate through the algorithm with a friendly user interface and access related multimedia information within the context of each clinical problem. CPGs can be stored in a computer server and distributed over the World Wide Web, facilitating dissemination, local adaptation, and use as a reference element in medical care. We have chosen the Agency for Health Care and Policy Research's heart failure guideline to demonstrate the capabilities of our tool.

Guidelines for the management of people with foot health problems related to rheumatoid arthritis: a survey of their use in podiatry practice.

PubMed

Williams, Anita E; Graham, Andrea S; Davies, Samantha; Bowen, Catherine J

2013-06-18

In the last decade there has been a significant expansion in the body of knowledge on the effects of rheumatoid arthritis (RA) on the foot and the management of these problems. Aligned with this has been the development of specialist clinical roles for podiatrists. However, despite being recommended by national guidelines, specialist podiatrists are scarce. In order to inform non-specialist podiatrists of the appropriate interventions for these foot problems, management guidelines have been developed and disseminated by a group of specialist podiatrists. The aim of this survey was to investigate the use of these guidelines in clinical practice. Following ethical approval an online questionnaire survey was carried out. The questions were formulated from a focus group and comprised fixed response and open response questions. The survey underwent cognitive testing with two podiatrists before being finalised. An inductive approach using thematic analysis was used with the qualitative data. 245 questionnaires were completed (128-non-specialist working in the private sector, 101 non-specialists working in the NHS and 16 specialist podiatrists). Overall, 97% of the non-specialists (n = 222) had not heard of the guidelines. The non-specialists identified other influences on their management of people with RA, such as their undergraduate training and professional body branch meetings. Three main themes emerged from the qualitative data: (i) the benefits of the foot health management guidelines, (ii) the barriers to the use of guidelines generally and (iii) the features of useable clinical guidelines. This study has revealed some crucial information about podiatrists' level of engagement with the foot health management guidelines and the use of guidelines in general. Specifically, the non-specialist podiatrists were less likely to use the foot health management guidelines than the specialist podiatrists. The positive aspects were that for the specialist practitioners, the guidelines helped them to identify their professional development needs and for the few non-specialists that did use them, they enabled appropriate referral to the rheumatology team for foot health management. The barriers to their use included a lack of understanding of the risk associated with managing people with RA and that guidelines can be too long and detailed for use in clinical practice. Suggestions are made for improving the implementation of foot health guidelines.

Selecting relevant and feasible measurement instruments for the revised Dutch clinical practice guideline for physical therapy in patients after stroke.

PubMed

Otterman, Nicoline; Veerbeek, Janne; Schiemanck, Sven; van der Wees, Philip; Nollet, Frans; Kwakkel, Gert

2017-07-01

To select relevant and feasible instruments for the revision of the Dutch clinical practice guideline for physical therapy in patients with stroke. In this implementation study a comprehensive proposal for ICF categories and matching instruments was developed, based on reliability and validity. Relevant instruments were then selected in a consensus round by 11 knowledge brokers who were responsible for the implementation of the selected instruments. The feasibility of the selected instruments was tested by 36 physical therapists at different work settings within stroke services. Finally, instruments that were deemed relevant and feasible were included in the revised guideline. A total of 28 instruments were recommended for inclusion in the revised guideline. Nineteen instruments were retained from the previous guideline. Ten new instruments were tested in clinical practice, seven of which were found feasible. Two more instruments were added after critical appraisal of the set of the measurement instruments. The revised guideline contains 28 relevant and feasible instrument selected and tested in clinical practice by physical therapists. Further education and implementation is needed to integrate instruments in clinical practice. Further research is proposed for developing and implementing a core set of measurement instruments to be used at fixed time points to establish data registries that allow for continuous improvement of rehabilitation for stroke patients. Implications for Rehabilitation The revised Dutch Stroke Physical Therapy Guideline recommends a total of 28 instruments, that are relevant and feasible for clinical practice of physical therapist in the different settings of stroke rehabilitation. The selection of instrument in daily practice should be part of the clinical reasoning process of PTs and be tailored to individual patients' needs and the degree of priority of the affected ICF category. Suggested education strategies for further integration of instruments in of the daily practice of PTs in Stroke Rehabilitation are: 'Training on the job' and 'peer assessment in clinical situations'.

SU-E-I-97: Smart Auto-Planning Framework in An EMR Environment (SAFEE)

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

Zhang, B; Chen, S; Mutaf, Y

2014-06-01

Purpose: Our Radiation Oncology Department uses clinical practice guidelines for patient treatment, including normal tissue sparing and other dosimetric constraints. These practice guidelines were adapted from national guidelines, clinical trials, literature reviews, and practitioner's own experience. Modern treatment planning systems (TPS) have the capability of incorporating these practice guidelines to automatically create radiation therapy treatment plans with little human intervention. We are developing a software infrastructure to integrate clinical practice guidelines and radiation oncology electronic medical record (EMR) system into radiation therapy treatment planning system (TPS) for auto planning. Methods: Our Smart Auto-Planning Framework in an EMR environment (SAFEE) usesmore » a software pipeline framework to integrate practice guidelines,EMR, and TPS together. The SAFEE system starts with retrieving diagnosis information and physician's prescription from the EMR system. After approval of contouring, SAFEE will automatically create plans according to our guidelines. Based on clinical objectives, SAFEE will automatically select treatment delivery techniques (such as, 3DRT/IMRT/VMAT) and optimize plans. When necessary, SAFEE will create multiple treatment plans with different combinations of parameters. SAFEE's pipeline structure makes it very flexible to integrate various techniques, such as, Model-Base Segmentation (MBS) and plan optimization algorithms, e.g., Multi-Criteria Optimization (MCO). In addition, SAFEE uses machine learning, data mining techniques, and an integrated database to create clinical knowledgebase and then answer clinical questions, such as, how to score plan quality or how volume overlap affects physicians' decision in beam and treatment technique selection. Results: In our institution, we use Varian Aria EMR system and RayStation TPS from RaySearch, whose ScriptService API allows control by external programs. These applications are the building blocks of our SAFEE system. Conclusion: SAFEE is a feasible method of integrating clinical information to develop an auto-planning paradigm to improve clinical workflow in cancer patient care.« less

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

PubMed

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

2011-08-01

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

An official American thoracic society workshop report: developing performance measures from clinical practice guidelines.

PubMed

Kahn, Jeremy M; Gould, Michael K; Krishnan, Jerry A; Wilson, Kevin C; Au, David H; Cooke, Colin R; Douglas, Ivor S; Feemster, Laura C; Mularski, Richard A; Slatore, Christopher G; Wiener, Renda Soylemez

2014-05-01

Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care.

Best practice guidelines for the molecular genetic diagnosis of Type 1 (HFE-related) hereditary haemochromatosis

PubMed Central

King, Caitriona; Barton, David E

2006-01-01

Background Hereditary haemochromatosis (HH) is a recessively-inherited disorder of iron over-absorption prevalent in Caucasian populations. Affected individuals for Type 1 HH are usually either homozygous for a cysteine to tyrosine amino acid substitution at position 282 (C282Y) of the HFE gene, or compound heterozygotes for C282Y and for a histidine to aspartic acid change at position 63 (H63D). Molecular genetic testing for these two mutations has become widespread in recent years. With diverse testing methods and reporting practices in use, there was a clear need for agreed guidelines for haemochromatosis genetic testing. The UK Clinical Molecular Genetics Society has elaborated a consensus process for the development of disease-specific best practice guidelines for genetic testing. Methods A survey of current practice in the molecular diagnosis of haemochromatosis was conducted. Based on the results of this survey, draft guidelines were prepared using the template developed by UK Clinical Molecular Genetics Society. A workshop was held to develop the draft into a consensus document. The consensus document was then posted on the Clinical Molecular Genetics Society website for broader consultation and amendment. Results Consensus or near-consensus was achieved on all points in the draft guidelines. The consensus and consultation processes worked well, and outstanding issues were documented in an appendix to the guidelines. Conclusion An agreed set of best practice guidelines were developed for diagnostic, predictive and carrier testing for hereditary haemochromatosis and for reporting the results of such testing. PMID:17134494

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

PubMed

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

2015-03-01

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

Recommendations for the Pharmacological Management of Neuropathic Pain: An Overview and Literature Update

PubMed Central

Dworkin, Robert H.; O'Connor, Alec B.; Audette, Joseph; Baron, Ralf; Gourlay, Geoffrey K.; Haanpää, Maija L.; Kent, Joel L.; Krane, Elliot J.; LeBel, Alyssa A.; Levy, Robert M.; Mackey, Sean C.; Mayer, John; Miaskowski, Christine; Raja, Srinivasa N.; Rice, Andrew S. C.; Schmader, Kenneth E.; Stacey, Brett; Stanos, Steven; Treede, Rolf-Detlef; Turk, Dennis C.; Walco, Gary A.; Wells, Christopher D.

2010-01-01

The Neuropathic Pain Special Interest Group of the International Association for the Study of Pain recently sponsored the development of evidence-based guidelines for the pharmacological treatment of neuropathic pain. Tricyclic antidepressants, dual reuptake inhibitors of serotonin and norepinephrine, calcium channel α2-δ ligands (ie, gabapentin and pregabalin), and topical lidocaine were recommended as first-line treatment options on the basis of the results of randomized clinical trials. Opioid analgesics and tramadol were recommended as second-line treatments that can be considered for first-line use in certain clinical circumstances. Results of several recent clinical trials have become available since the development of these guidelines. These studies have examined botulinum toxin, high-concentration capsaicin patch, lacosamide, selective serotonin reuptake inhibitors, and combination therapies in various neuropathic pain conditions. The increasing number of negative clinical trials of pharmacological treatments for neuropathic pain and ambiguities in the interpretation of these negative trials must also be considered in developing treatment guidelines. The objectives of the current article are to review the Neuropathic Pain Special Interest Group guidelines for the pharmacological management of neuropathic pain and to provide a brief overview of these recent studies. PMID:20194146

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

PubMed Central

Rosenfeld, Richard M.; Shiffman, Richard N.

2010-01-01

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

Curricular Guidelines for Clinical Competency by Dental Auxiliaries in Dental Radiography.

ERIC Educational Resources Information Center

Journal of Dental Education, 1984

1984-01-01

Guidelines developed for educational institutions as curriculum development aids are presented. They are the result of efforts within the American Association of Dental Schools (AADS) by the Section on Oral Radiology. Their use as course development aids is suggested by AADS policy. (MLW)

[Suicide Risk Assessment in the Clinical Practice Guidelines for the Diagnosis and Management of Depression in Colombia].

PubMed

Gómez Restrepo, Carlos; Bohórquez Peñaranda, Adriana Patricia; Gil Lemus, Laura Marcela; Jaramillo, Luis Eduardo; García Valencia, Jenny; Bravo Narváez, Eliana; de la Hoz Bradford, Ana María; Palacio, Carlos

2013-01-01

Suicide is the most serious complications of depression. It has high associated health costs and causes millions of deaths worldwide per year. Given its implications, it is important to know the factors that increase the risk of its occurrence and the most useful tools for addressing it. To identify the signs and symptoms that indicate an increased risk of suicide, and factors that increase the risk in patients diagnosed with depression. To establish the tools best fitted to identify suicide risk in people with depression. Clinical practice guidelines were developed, following those of the methodmethodological guidelines of the Ministry of Social Protection, to collect evidence and to adjust recommendations. Recommendations from the NICE90 and CANMAT guidelines were adopted and updated for questions found in these guidelines, while new recommendations were developed for questions not found in them. Basic points and recommendations are presented from a chapter of the clinical practice guidelines on depressive episodes and recurrent depressive disorder related to suicide risk assessment. Their corresponding recommendation levels are included. Copyright © 2013 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

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

PubMed

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

2017-12-05

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

Deprescribing benzodiazepine receptor agonists: Evidence-based clinical practice guideline.

PubMed

Pottie, Kevin; Thompson, Wade; Davies, Simon; Grenier, Jean; Sadowski, Cheryl A; Welch, Vivian; Holbrook, Anne; Boyd, Cynthia; Swenson, Robert; Ma, Andy; Farrell, Barbara

2018-05-01

To develop an evidence-based guideline to help clinicians make decisions about when and how to safely taper and stop benzodiazepine receptor agonists (BZRAs); to focus on the highest level of evidence available and seek input from primary care professionals in the guideline development, review, and endorsement processes. The overall team comprised 8 clinicians (1 family physician, 2 psychiatrists, 1 clinical psychologist, 1 clinical pharmacologist, 2 clinical pharmacists, and 1 geriatrician) and a methodologist; members disclosed conflicts of interest. For guideline development, a systematic process was used, including the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Evidence was generated by conducting a systematic review of BZRA deprescribing trials for insomnia, as well as performing a review of reviews of the harms of continued BZRA use and narrative syntheses of patient preferences and resource implications. This evidence and GRADE quality of evidence ratings were used to generate recommendations. The team refined guideline content and recommendations through consensus and synthesized clinical considerations to address front-line clinician questions. The draft guideline was reviewed by clinicians and stakeholders. We recommend that deprescribing (tapering slowly) of BZRAs be offered to elderly adults (≥ 65 years) who take BZRAs, regardless of duration of use, and suggest that deprescribing (tapering slowly) be offered to adults aged 18 to 64 who have used BZRAs for more than 4 weeks. These recommendations apply to patients who use BZRAs to treat insomnia on its own (primary insomnia) or comorbid insomnia where potential underlying comorbidities are effectively managed. This guideline does not apply to those with other sleep disorders or untreated anxiety, depression, or other physical or mental health conditions that might be causing or aggravating insomnia. Benzodiazepine receptor agonists are associated with harms, and therapeutic effects might be short term. Tapering BZRAs improves cessation rates compared with usual care without serious harms. Patients might be more amenable to deprescribing conversations if they understand the rationale (potential for harm), are involved in developing the tapering plan, and are offered behavioural advice. This guideline provides recommendations for making decisions about when and how to reduce and stop BZRAs. Recommendations are meant to assist with, not dictate, decision making in conjunction with patients. Copyright© the College of Family Physicians of Canada.

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

Standardization of search methods for guideline development: an international survey of evidence-based guideline development groups.

PubMed

Deurenberg, Rikie; Vlayen, Joan; Guillo, Sylvie; Oliver, Thomas K; Fervers, Beatrice; Burgers, Jako

2008-03-01

Effective literature searching is particularly important for clinical practice guideline development. Sophisticated searching and filtering mechanisms are needed to help ensure that all relevant research is reviewed. To assess the methods used for the selection of evidence for guideline development by evidence-based guideline development organizations. A semistructured questionnaire assessing the databases, search filters and evaluation methods used for literature retrieval was distributed to eight major organizations involved in evidence-based guideline development. All of the organizations used search filters as part of guideline development. The medline database was the primary source accessed for literature retrieval. The OVID or SilverPlatter interfaces were used in preference to the freely accessed PubMed interface. The Cochrane Library, embase, cinahl and psycinfo databases were also frequently used by the organizations. All organizations reported the intention to improve and validate their filters for finding literature specifically relevant for guidelines. In the first international survey of its kind, eight major guideline development organizations indicated a strong interest in identifying, improving and standardizing search filters to improve guideline development. It is to be hoped that this will result in the standardization of, and open access to, search filters, an improvement in literature searching outcomes and greater collaboration among guideline development organizations.

How to adapt existing evidence-based clinical practice guidelines: a case example with smoking cessation guidelines in Canada

PubMed Central

Selby, Peter; Hunter, Katie; Rogers, Jess; Lang-Robertson, Kelly; Soklaridis, Sophie; Chow, Virginia; Tremblay, Michèle; Koubanioudakis, Denise; Dragonetti, Rosa; Hussain, Sarwar; Zawertailo, Laurie

2017-01-01

Objective To develop and encourage the adoption of clinical practice guidelines (CPGs) for smoking cessation in Canada by engaging stakeholders in the adaptation of existing high-quality CPGs using principles of the ADAPTE framework. Methods An independent expert body in guideline review conducted a review and identified six existing CPGs, which met a priori criteria for quality and potential applicability to the local context. Summary statements were extracted and assigned a grade of recommendation and level of evidence by a second expert panel. Regional knowledge exchange brokers recruited additional stakeholders to build a multidisciplinary network of over 800 clinicians, researchers and decision-makers from across Canada. This interprofessional network and other stakeholders were offered various opportunities to provide input on the guideline both online and in person. We actively encouraged end-user input into the development and adaptation of the guidelines to ensure applicability to various practice settings and to promote adoption. Results The final guideline contained 24 summary statements along with supporting clinical considerations, across six topic area sections. The guideline was adopted by various provincial/territorial and national government and non-governmental organisations. Conclusions This method can be applied in other jurisdictions to adapt existing high-quality smoking cessation CPGs to the local context and to facilitate subsequent adoption by various stakeholders. PMID:29102984

A critical review of recent clinical practice guidelines on the diagnosis and treatment of non-neurogenic male lower urinary tract symptoms

PubMed Central

Chua, Michael Erlano; Mendoza, Jonathan; See, Manuel; Esmena, Ednalyn; Aguila, Dean; Silangcruz, Jan Michael; Reyes, Buenaventura Jose; Luna, Saturnino; Morales, Marcelino

2015-01-01

Introduction: We provide an overview of the quality of recent clinical clinical practice guidelines (CPGs) for non-neurogenic male lower urinary tract symptoms (LUTS) and summarize the recommendations for their diagnosis, assessment, and treatment. Methods: We systematically searched recent (2008–2013) CPGs for non-neurogenic male LUTS. Eligible CPGs were assessed and appraised using Appraisal of Guidelines, Research and Evaluation II (AGREE II) tool by a CPG-appraisal group. The appraisal scores for each guideline were summarized according to each domain and in total. A recommendation summary was made across the guidelines for diagnostics, conservative management, medical, minimally invasive therapy, and surgical management. Results: A total of 8 guidelines were considered. According to AGREE II appraisal of guidelines, the National Institute for Health and Clinical Excellence (NICE), American Urological Association (AUA) and European Association of Urology (EAU) consistently scored high on the guideline domains assessed. Recommendations on diagnostics, conservative management, medical, and surgical management were consistent among the top 3 guidelines. However, we noted a discrepancy in recommending minimally invasive therapy as an alternative management of moderate to severe or bothersome non-neurogenic male LUTS secondary to benign prostatic enlargement (BPE); the NICE guideline, in particular, does not recommend using minimally invasive therapy. Conclusion: The quality of recent CPGs on non-neurogenic male LUTS was appraised and summarized. The guidelines from NICE, AUA and EAU were considered highly compliant to the AGREE II proposition for guideline formation and development. PMID:26279717

A critical review of recent clinical practice guidelines on the diagnosis and treatment of non-neurogenic male lower urinary tract symptoms.

PubMed

Chua, Michael Erlano; Mendoza, Jonathan; See, Manuel; Esmena, Ednalyn; Aguila, Dean; Silangcruz, Jan Michael; Reyes, Buenaventura Jose; Luna, Saturnino; Morales, Marcelino

2015-01-01

We provide an overview of the quality of recent clinical clinical practice guidelines (CPGs) for non-neurogenic male lower urinary tract symptoms (LUTS) and summarize the recommendations for their diagnosis, assessment, and treatment. We systematically searched recent (2008-2013) CPGs for non-neurogenic male LUTS. Eligible CPGs were assessed and appraised using Appraisal of Guidelines, Research and Evaluation II (AGREE II) tool by a CPG-appraisal group. The appraisal scores for each guideline were summarized according to each domain and in total. A recommendation summary was made across the guidelines for diagnostics, conservative management, medical, minimally invasive therapy, and surgical management. A total of 8 guidelines were considered. According to AGREE II appraisal of guidelines, the National Institute for Health and Clinical Excellence (NICE), American Urological Association (AUA) and European Association of Urology (EAU) consistently scored high on the guideline domains assessed. Recommendations on diagnostics, conservative management, medical, and surgical management were consistent among the top 3 guidelines. However, we noted a discrepancy in recommending minimally invasive therapy as an alternative management of moderate to severe or bothersome non-neurogenic male LUTS secondary to benign prostatic enlargement (BPE); the NICE guideline, in particular, does not recommend using minimally invasive therapy. The quality of recent CPGs on non-neurogenic male LUTS was appraised and summarized. The guidelines from NICE, AUA and EAU were considered highly compliant to the AGREE II proposition for guideline formation and development.

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

PubMed

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

2017-03-01

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

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

PubMed

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

2017-11-01

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

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

PubMed

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

2015-02-01

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

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.

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

PubMed

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

2012-12-01

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

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

PubMed

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

2012-01-01

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

No. 354-Canadian HIV Pregnancy Planning Guidelines.

PubMed

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

2018-01-01

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

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.

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.

Practice guidelines for management of uterine corpus cancer in Korea: a Korean Society of Gynecologic Oncology Consensus Statement

PubMed Central

Hong, Dae Gy; Shin, So-Jin; Ju, Woong; Cho, Hanbyoul; Lee, Chulmin; Kim, Hyun-Jung; Bae, Duk-Soo

2017-01-01

Clinical practice guidelines for gynecologic cancers have been developed by many organizations. Although these guidelines have much in common in terms of the practice of standard of care for uterine corpus cancer, practice guidelines that reflect the characteristics of patients and healthcare and insurance systems are needed for each country. The Korean Society of Gynecologic Oncology (KSGO) published the first edition of practice guidelines for gynecologic cancer treatment in late 2006; the second edition was released in July 2010 as an evidence-based recommendation. The Guidelines Revision Committee was established in 2015 and decided to produce the third edition of the guidelines as an advanced form based on evidence-based medicine, considering up-to-date clinical trials and abundant qualified Korean data. These guidelines cover screening, surgery, adjuvant treatment, and advanced and recurrent disease with respect to endometrial carcinoma and uterine sarcoma. The committee members and many gynecologic oncologists derived key questions from the discussion, and a number of relevant scientific literatures were reviewed in advance. Recommendations for each specific question were developed by the consensus conference, and they are summarized here, together with other details. The objective of these practice guidelines is to establish standard policies on issues in clinical areas related to the management of uterine corpus cancer based on the findings in published papers to date and the consensus of experts as a KSGO Consensus Statement. PMID:27894165

Clinical 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

An education and motivation intervention to change clinical management of the third stage of labor - the GIRMMAHP Initiative.

PubMed

Figueras, Albert; Narváez, Edgar; Valsecia, Mabel; Vásquez, Susana; Rojas, Germán; Camilo, Angiolina; del Valle, José-María; Aguilera, Cristina

2008-12-01

Hemorrhage and hypertensive disorders are major contributors to death after delivery in developing countries. The GIRMMAHP Initiative was designed to describe the actual delivery care in five Latin American countries and to educate and motivate clinical staff at 17 hospitals with the purpose of implementing their own clinical practice guidelines to prevent postpartum hemorrhage. A multicountry education intervention was developed in four consecutive stages, using two analyses: (a) an observational study of the clinical records in eight teaching and nine nonteaching hospitals and (b) a study of the long-term changes measured 12 months after completion of an education intervention and writing a local clinical guideline. Data from 2,247 pregnant women showed that only 23.3 percent had an active management of the third stage of labor and that 22.7 percent received no prenatal care visit. These data were used to prepare local clinical practice guidelines in each participant hospital. The proportion of active management increased to 72.6 percent of deliveries at 3 months and 58.7 percent 1 year later. Use of oxytocin during the third stage of labor increased to 85.9 percent of included deliveries. The proportion of women who had postpartum hemorrhage decreased from 12.7 percent at baseline to 5 percent at 1 year after the intervention. An education intervention and discussion of actual clinical practice problems with health professionals and their involvement in drafting clinical guidelines helped improve health care quality and practitioners' adherence to these guidelines.

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.

Plain Language Summary: Earwax (Cerumen Impaction)

PubMed

Krouse, Helene J; Magit, Anthony E; O'Connor, Sarah; Schwarz, Seth R; Walsh, Sandra A

2017-01-01

This plain language summary serves as an overview in explaining earwax (cerumen). The summary applies to patients older than 6 months with a clinical diagnosis of earwax impaction and is based on the 2017 update of the Clinical Practice Guideline: Earwax (Cerumen Impaction). The evidence-based guideline includes research that supports diagnosis and treatment of earwax impaction. The guideline was developed to improve care by health care providers for managing earwax impaction by creating clear recommendations to use in medical practice.

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.

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

PubMed

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

2014-07-01

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

Developing Guidelines for HIV Antibody Testing among Victims of Pediatric Sexual Abuse.

ERIC Educational Resources Information Center

Gellert, George A.; And Others

1990-01-01

An interim set of human immunodeficiency virus (HIV) testing guidelines for victims of pediatric sexual abuse (PSA) is proposed. Guidelines are based on responses of 63 practitioners of PSA assessment to 7 hypothetical clinical profiles with 12 testing criteria. (Author/DB)

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

PubMed

Knezevic, Ivana; Moorthy, Vasee; Sheets, Rebecca

2015-04-21

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

Monitoring and evaluation of patient involvement in clinical practice guideline development: lessons from the Multidisciplinary Guideline for Employment and Severe Mental Illness, the Netherlands.

PubMed

van der Ham, Alida J; van Erp, Nicole; Broerse, Jacqueline E W

2016-04-01

The aim of this study was to gain better insight into the quality of patient participation in the development of clinical practice guidelines and to contribute to approaches for the monitoring and evaluation of such initiatives. In addition, we explore the potential of a dialogue-based approach for reconciliation of preferences of patients and professionals in the guideline development processes. The development of the Multidisciplinary Guideline for Employment and Severe Mental Illness in the Netherlands served as a case study. Methods for patient involvement in guideline development included the following: four patient representatives in the development group and advisory committee, two focus group discussions with patients, a dialogue session and eight case studies. To evaluate the quality of patient involvement, we developed a monitoring and evaluation framework including both process and outcome criteria. Data collection included observations, document analysis and semi-structured interviews (n = 26). The quality of patient involvement was enhanced using different methods, reflection of patient input in the guideline text, a supportive attitude among professionals and attention to patient involvement throughout the process. The quality was lower with respect to representing the diversity of the target group, articulation of the patient perspective in the GDG, and clarity and transparency concerning methods of involvement. The monitoring and evaluation framework was useful in providing detailed insights into patient involvement in guideline development. Patient involvement was evaluated as being of good quality. The dialogue-based approach appears to be a promising method for obtaining integrated stakeholder input in a multidisciplinary setting. © 2015 John Wiley & Sons Ltd.

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

PubMed

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

2016-10-01

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

The Lebanese Society for Infectious Diseases and Clinical Microbiology (LSIDCM) guidelines for adult community-acquired pneumonia (Cap) in Lebanon.

PubMed

Moghnieh, Rima; Yared Sakr, Nadine; Kanj, Souha S; Musharrafieh, Umayya; Husni, Rula; Jradeh, Mona; Al-Awar, Ghassan; Matar, Madona; Jureij, Wafa; Antoine, Saad; Azar, Eid; Abi Hanna, Pierre; Minari, Afaf; Hammoud, Jamale; Kfoury, Joumana; Mahfouz, Tahsin; Abou Chakra, Diaa; Zaatari, Mohamad; Tabbarah, Zuhayr A

2014-01-01

Adult community-acquired pneumonia (CAP) is a common cause of morbidity and mortality which is managed by different disciplines in a heterogeneous fashion. Development of consensus guidelines to standardize these wide variations in care has become a prime objective. The Lebanese Society of Infectious Diseases and Clinical Microbiology (LSIDCM) convened to set Lebanese national guidelines for the management of CAP since it is a major and a prevalent disease affecting the Lebanese population. These guidelines, besides being helpful in direct clinical practice, play a major role in establishing stewardship programs in hospitals in an effort to contain antimicrobial resistance on the national level. These guidelines are intended for primary care practitioners and emergency medicine physicians. They constitute an appropriate starting point for specialists' consultation being based on the available local epidemiological and resistance data. This document includes the following: 1/ Rationale and scope of the guidelines; 2/ Microbiology of CAP based on Lebanese data; 3/ Clinical presentation and diagnostic workup of CAP; 4/ Management and prevention strategies based on the IDSA/ATS Consensus Guidelines, 2007, and the ESCMID Guidelines, 2011, and tailored to the microbiological data in Lebanon; 5/ Comparison to regional guidelines. The recommendations made in this document were graded based on the strength of the evidence as in the 2007 IDSA/ATS Consensus Guidelines. Hopefully, these guidelines will be an important step towards standardization of CAP care in Lebanon and set the agenda for further research in this area.

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

Adapting clinical practice guidelines for diabetic retinopathy in Kenya: process and outputs.

PubMed

Mwangi, Nyawira; Gachago, Muchai; Gichangi, Michael; Gichuhi, Stephen; Githeko, Kibata; Jalango, Atieno; Karimurio, Jefitha; Kibachio, Joseph; Muthami, Lawrence; Ngugi, Nancy; Nduri, Carmichael; Nyaga, Patrick; Nyamori, Joseph; Zindamoyen, Alain Nazaire Mbongo; Bascaran, Covadonga; Foster, Allen

2018-06-15

The use of clinical practice guidelines envisages augmenting quality and best practice in clinical outcomes. Generic guidelines that are not adapted for local use often fail to produce these outcomes. Adaptation is a systematic and rigorous process that should maintain the quality and validity of the guideline, while making it more usable by the targeted users. Diverse skills are required for the task of adaptation. Although adapting a guideline is not a guarantee that it will be implemented, adaptation may improve acceptance and adherence to its recommendations. We describe the process used to adapt clinical guidelines for diabetic retinopathy in Kenya, using validated tools and manuals. A technical working group consisting of volunteers provided leadership. The process was intensive and required more time than anticipated. Flexibility in the process and concurrent health system activities contributed to the success of the adaptation. The outputs from the adaptation include the guidelines in different formats, point of care instruments, as well as tools for training, monitoring, quality assurance and patient education. Guideline adaptation is applicable and feasible at the national level in Kenya. However, it is labor- and time -intensive. It presents a valuable opportunity to develop several additional outputs that are useful at the point of care.

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

PubMed

Moreno-Pérez, Oscar; Esteva De Antonio, Isabel

2012-01-01

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

Evidence-based clinical guidelines in Kyrgyz Republic.

PubMed

Zurdinova, A A

2015-01-01

Improving quality of care in many countries is one of the priorities of health systems. At the same time one of the most important methods of improving quality of care is the widespread use of methods and principles of evidence-based medicine (EBM) [1]. The implementation of EBM in public health practice provides for the optimization of quality of care in terms of safety, efficacy and cost, one way of which is the use of clinical guidelines. Clinical guidelines developed with the use of EBM, provide an opportunity to use the latest and accurate information to optimize or neutralize impact on physician decision-making of subjective factors such as intuition, expertise, opinion of respected colleagues, recommendations of popular manuals and handbooks, etc. To assess and analyze the developed clinical guidelines (CG) and protocols (CP) in the Kyrgyz Republic in the period from 2008 to 2014 and evaluate their implementation in practical healthcare. Retrospective analysis of the developed clinical guidelines and protocols according to the approved methodology, interviewing leaders, questioning doctors and patients for their implementation. All participants gave informed consent for voluntary participation in the study. Within the framework of the National Program "Manas Taalimi" "Strategy for development of evidence-based medicine in the Kyrgyz Republic for 2006-2010" (MOH Order №490 from 09.04.06) was developed and approved for use. Its main purpose was to create a sustainable system of development, deployment and monitoring of the CG and CP and further promotion of EBM into practical health care, education and science. As a result, a number of documents ("Expert Council for assessing the quality of clinical guidelines/protocols", "AGREE instrument to assess the methodological content of clinical guidelines" [2], "The methodology of development and adaptation of clinical guidelines based on evidence-based medicine") were approved by the Order of the Ministry of Health from 31.12.2008 №704.This methodology was based on the international guideline SIGN-50 [3], as part of the strategy, it was decided to adapt clinical guidelines of the advanced countries of the world to the organizational characteristics of health care in the Kyrgyz Republic. According to the adopted methodology, the development of clinical guidelines should include the following steps: choose a theme, create a multidisciplinary group to conduct a search of existing clinical guidelines and assess their quality, if necessary, conduct an additional search of evidence, make recommendations and draw up the text of clinical guidelines, conduct peer review and consultations, approve clinical guidelines in the pilot, approve the clinical management of the Ministry of Health, publish and distribute, put into practice, monitor the effectiveness of implementation, provide for the revision and updating of clinical guidelines as new credible information appears. In the future, these CGs will be considered as a basis for the development of the CP in accordance with the possibilities of health care organizations of the country. Figuratively speaking, the CG answers the question - "What can be done in an ideal situation? ', And CP -" What should be done in a country?".The Ministry of Health over the period 2008-2014 years approved 41 CGs and 118 CPs for common diseases. It should be noted that only 31.7% of them were represented by the corresponding CGs. Among the approved CPs only 15.3% were based on the corresponding CGs. All of the CGs and CPs (100%) identified experts who prepared the documents and to whom they are addressed. The search strategy information was available only in 24.3% of cases, and only 18.1% used the criteria for selection of international guidelines, which were found in the CGs. 100% of the CGs and CPs indicated no conflict of interest of their developers, but it should be noted that 89% of the CG and CP were developed with the financial assistance of donor organizations supporting the Kyrgyz health reform. The degree of evidence of the recommendations was presented in 100% of the documents, but grading scales were different: in one CG manual grading was used with 3 levels of evidence (A, B, C), in the other - 4 levels (A, B, C, D ), and in the third - tier 5-6 (I, II, III, IV, V), which is not the approved methodology, which was based on gradation - A, B, C, D. In the process of approval of CGs and CPs, 100% did not specify points of methodological quality evaluation.To assess the implementation of approved CG in the practice (training, availability of the CG and CP for each doctor, informing patients about the CG and CP, monitoring use) we interviewed the leaders of health care organizations (20), surveyed 200 doctors and 100 patients. Only 10% of leaders said that they participated in the training on the CG and CP. 5% of them confirmed that every doctor had the corresponding copies of CGs and CPs, 100% of the leaders conduct internal audits on the use of the CG and CP, in 95% of cases the developed CGs and CPs do not take into account local health systems conditions (drugs, equipments etc.). 100% of respondents followed the CGs and CPs, as penalties were introduces by the Ministry of Health, Health Insurance Fund for violation of these recommendations. 25% of respondents reported improved clinical outcomes. To the question "How to improve the practice of medicine with the use of CGs and CPs?" 100% of the managers answered that they needed trainings: trainings for physicians, trainings for the developers of these documents. The survey of doctors showed that only 5% of them were trained in the use of CGs and CPs, 100% of them had the copies of CGs and CPs, 100% of doctors answered that the CGs and CPs not always were suitable for their practice. Questioning patients revealed the following: 100% of them never heard of the CGs and CPs, 2% of patients noted some improvement in healthcare delivery, and 20% of patients were referred to private laboratories for diagnostic tests, and 100% of the patients-respondents bought their drugs for their own pocket money. It is very important to ensure equal opportunities in access to medical interventions designed accordingly to the CGs and CPs at all health facilities that will prevent discrimination, depending on territorial distribution, administrative subordination, and other factors in the provision of health care. Implementation of CG and CP recommendations depends not only on the level of health care, knowledge and judgment of a clinician, but also on affordability of a particular diagnostic or therapeutic technologies for a patient. Cases when effective services are not unaffordable for patients should be considered from ethical perspective.

Texas Medication Algorithm Project: development and feasibility testing of a treatment algorithm for patients with bipolar disorder.

PubMed

Suppes, T; Swann, A C; Dennehy, E B; Habermacher, E D; Mason, M; Crismon, M L; Toprac, M G; Rush, A J; Shon, S P; Altshuler, K Z

2001-06-01

Use of treatment guidelines for treatment of major psychiatric illnesses has increased in recent years. The Texas Medication Algorithm Project (TMAP) was developed to study the feasibility and process of developing and implementing guidelines for bipolar disorder, major depressive disorder, and schizophrenia in the public mental health system of Texas. This article describes the consensus process used to develop the first set of TMAP algorithms for the Bipolar Disorder Module (Phase 1) and the trial testing the feasibility of their implementation in inpatient and outpatient psychiatric settings across Texas (Phase 2). The feasibility trial answered core questions regarding implementation of treatment guidelines for bipolar disorder. A total of 69 patients were treated with the original algorithms for bipolar disorder developed in Phase 1 of TMAP. Results support that physicians accepted the guidelines, followed recommendations to see patients at certain intervals, and utilized sequenced treatment steps differentially over the course of treatment. While improvements in clinical symptoms (24-item Brief Psychiatric Rating Scale) were observed over the course of enrollment in the trial, these conclusions are limited by the fact that physician volunteers were utilized for both treatment and ratings. and there was no control group. Results from Phases 1 and 2 indicate that it is possible to develop and implement a treatment guideline for patients with a history of mania in public mental health clinics in Texas. TMAP Phase 3, a recently completed larger and controlled trial assessing the clinical and economic impact of treatment guidelines and patient and family education in the public mental health system of Texas, improves upon this methodology.

Guidelines on Chemotherapy in Advanced Stage Gynecological Malignancies: An Evaluation of 224 Professional Societies and Organizations

PubMed Central

Polyzos, Nikolaos P.; Mauri, Davide; Ioannidis, John P. A.

2011-01-01

Background Clinical practice guidelines are important for guiding practice, but it is unclear if they are commensurate with the available evidence. Methods We examined guidelines produced by cancer and gynecological societies and organizations and evaluated their coverage of and stance towards chemotherapy for advanced stage disease among 4 gynecological malignancies (breast, ovarian, cervical, endometrial cancer) where the evidence for the use of chemotherapy is very different (substantial and conclusive for breast and ovarian cancer, limited and suggesting no major benefit for cervical and endometrial cancer). Eligible societies and organizations were identified through systematic internet searches (last update June 2009). Pertinent websites were scrutinized for presence of clinical practice guidelines, and relative guidelines were analyzed. Results Among 224 identified eligible societies and organizations, 69 (31%) provided any sort of guidelines, while recommendations for chemotherapy on advanced stage gynecological malignancies were available in 20 of them. Only 14 had developed their own guideline, and only 5 had developed guidelines for all 4 malignancies. Use of levels of evidence and grades of recommendations, and aspects of the production, implementation, and timeliness of the guidelines did not differ significantly across malignancies. Guidelines on breast and ovarian cancer utilized significantly more randomized trials and meta-analyses. Guidelines differed across malignancies on their coverage of disease-free survival (p = 0.033), response rates (p = 0.024), symptoms relief (p = 0.005), quality of life (p = 0.001) and toxicity (p = 0.039), with breast and ovarian cancer guidelines typically covering more frequently these outcomes. All guidelines explicitly or implicitly endorsed the use of chemotherapy. Conclusions Clinical practice guidelines are provided by the minority of professional societies and organizations. Available guidelines tend to recommend chemotherapy even for diseases where the effect of chemotherapy is controversial and recommendations are based on scant evidence. PMID:21611154

Does GEM-encoding clinical practice guidelines improve the quality of knowledge bases? A study with the rule-based formalism.

PubMed

Georg, Georg; Séroussi, Brigitte; Bouaud, Jacques

2003-01-01

The aim of this work was to determine whether the GEM-encoding step could improve the representation of clinical practice guidelines as formalized knowledge bases. We used the 1999 Canadian recommendations for the management of hypertension, chosen as the knowledge source in the ASTI project. We first clarified semantic ambiguities of therapeutic sequences recommended in the guideline by proposing an interpretative framework of therapeutic strategies. Then, after a formalization step to standardize the terms used to characterize clinical situations, we created the GEM-encoded instance of the guideline. We developed a module for the automatic derivation of a rule base, BR-GEM, from the instance. BR-GEM was then compared to the rule base, BR-ASTI, embedded within the critic mode of ASTI, and manually built by two physicians from the same Canadian guideline. As compared to BR-ASTI, BR-GEM is more specific and covers more clinical situations. When evaluated on 10 patient cases, the GEM-based approach led to promising results.

An Official American Thoracic Society Workshop Report. A Framework for Addressing Multimorbidity in Clinical Practice Guidelines for Pulmonary Disease, Critical Illness, and Sleep Disorders.

PubMed

Wilson, Kevin C; Gould, Michael K; Krishnan, Jerry A; Boyd, Cynthia M; Brozek, Jan L; Cooke, Colin R; Douglas, Ivor S; Goodman, Richard A; Joo, Min J; Lareau, Suzanne; Mularski, Richard A; Patel, Minal R; Rosenfeld, Richard M; Shanawani, Hasan; Slatore, Christopher; Sockrider, Marianna; Sufian, Beth; Thomson, Carey C; Wiener, Renda Soylemez

2016-03-01

Coexistence of multiple chronic conditions (i.e., multimorbidity) is the most common chronic health problem in adults. However, clinical practice guidelines have primarily focused on patients with a single disease, resulting in uncertainty about the care of patients with multimorbidity. The American Thoracic Society convened a workshop with the goal of establishing a strategy to address multimorbidity within clinical practice guidelines. In this Workshop Report, we describe a framework that addresses multimorbidity in each of the key steps of guideline development: topic selection, panel composition, identifying clinical questions, searching for and synthesizing evidence, rating the quality of that evidence, summarizing benefits and harms, formulating recommendations, and rating the strength of the recommendations. For the consideration of multimorbidity in guidelines to be successful and sustainable, the process must be both feasible and pragmatic. It is likely that this will be achieved best by the step-wise addition and refinement of the various components of the framework.

The development of a guideline implementability tool (GUIDE-IT): a qualitative study of family physician perspectives

PubMed Central

2014-01-01

Background The potential of clinical practice guidelines has not been realized due to inconsistent adoption in clinical practice. Optimising intrinsic characteristics of guidelines (e.g., its wording and format) that are associated with uptake (as perceived by their end users) may have potential. Using findings from a realist review on guideline uptake and consultation with experts in guideline development, we designed a conceptual version of a future tool called Guideline Implementability Tool (GUIDE-IT). The tool will aim to involve family physicians in the guideline development process by providing a process to assess draft guideline recommendations. This feedback will then be given back to developers to consider when finalizing the recommendations. As guideline characteristics are best assessed by end-users, the objectives of the current study were to explore how family physicians perceive guideline implementability, and to determine what components should comprise the final GUIDE-IT prototype. Methods We conducted a qualitative study with family physicians inToronto, Ontario. Two experienced investigators conducted one-hour interviews with family physicians using a semi-structured interview guide to 1) elicit feedback on perceptions on guideline implementability; 2) to generate a discussion in response to three draft recommendations; and 3) to provide feedback on the conceptual GUIDE-IT. Sessions were audio taped and transcribed verbatim. Data collection and analysis were guided by content analyses. Results 20 family physicians participated. They perceived guideline uptake according to facilitators and barriers across 6 categories of guideline implementability (format, content, language, usability, development, and the practice environment). Participants’ feedback on 3 draft guideline recommendations were grouped according to guideline perception, cognition, and agreement. When asked to comment on GUIDE-IT, most respondents believed that the tool would be useful, but urged to involve “regular” or community family physicians in the process, and suggested that an online system would be the most efficient way to deliver it. Conclusions Our study identified facilitators and barriers of guideline implementability from the perspective of community and academic family physicians that will be used to build our GUIDE-IT prototype. Our findings build on current knowledge by showing that family physicians perceive guideline uptake mostly according to factors that are in the control of guideline developers. PMID:24476491

Canadian physicians' attitudes about and preferences regarding clinical practice guidelines

PubMed Central

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

1997-01-01

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

Integration of Evidence into a Detailed Clinical Model-based Electronic Nursing Record System

PubMed Central

Park, Hyeoun-Ae; Jeon, Eunjoo; Chung, Eunja

2012-01-01

Objectives The purpose of this study was to test the feasibility of an electronic nursing record system for perinatal care that is based on detailed clinical models and clinical practice guidelines in perinatal care. Methods This study was carried out in five phases: 1) generating nursing statements using detailed clinical models; 2) identifying the relevant evidence; 3) linking nursing statements with the evidence; 4) developing a prototype electronic nursing record system based on detailed clinical models and clinical practice guidelines; and 5) evaluating the prototype system. Results We first generated 799 nursing statements describing nursing assessments, diagnoses, interventions, and outcomes using entities, attributes, and value sets of detailed clinical models for perinatal care which we developed in a previous study. We then extracted 506 recommendations from nine clinical practice guidelines and created sets of nursing statements to be used for nursing documentation by grouping nursing statements according to these recommendations. Finally, we developed and evaluated a prototype electronic nursing record system that can provide nurses with recommendations for nursing practice and sets of nursing statements based on the recommendations for guiding nursing documentation. Conclusions The prototype system was found to be sufficiently complete, relevant, useful, and applicable in terms of content, and easy to use and useful in terms of system user interface. This study has revealed the feasibility of developing such an ENR system. PMID:22844649

Legal issues in the development and use of clinical practice guidelines.

PubMed

Gevers, S

2001-01-01

Over the last ten years, the development and dissemination of practice guidelines has increased at a rapid pace. From a legal point of view, it should always be made clear whether a guideline has been developed to improve the quality of care and is based on medical evidence and professional experience, or whether other concerns and considerations (organisational, financial) did prevail. Guidelines should not simply be imposed on health professionals; that would result in a standardisation of care that does no justice to individual patient needs and preferences. Patients have the right to be informed about reasonable and realistic treatment alternatives, even if they are not included in the guideline. Using cost effectiveness analysis in guideline development can help to reduce care of dubious effectiveness. But if cost considerations are used as a reason to limit effective medical care, the guidelines in question need political legitimation.

Conceptual Models and Guidelines for Clinical Assessment of Financial Capacity

PubMed Central

Marson, Daniel

2016-01-01

The ability to manage financial affairs is a life skill of critical importance, and neuropsychologists are increasingly asked to assess financial capacity across a variety of settings. Sound clinical assessment of financial capacity requires knowledge and appreciation of applicable clinical conceptual models and principles. However, the literature has presented relatively little conceptual guidance for clinicians concerning financial capacity and its assessment. This article seeks to address this gap. The article presents six clinical models of financial capacity : (1) the early gerontological IADL model of Lawton, (2) the clinical skills model and (3) related cognitive psychological model developed by Marson and colleagues, (4) a financial decision-making model adapting earlier decisional capacity work of Appelbaum and Grisso, (5) a person-centered model of financial decision-making developed by Lichtenberg and colleagues, and (6) a recent model of financial capacity in the real world developed through the Institute of Medicine. Accompanying presentation of the models is discussion of conceptual and practical perspectives they represent for clinician assessment. Based on the models, the article concludes by presenting a series of conceptually oriented guidelines for clinical assessment of financial capacity. In summary, sound assessment of financial capacity requires knowledge and appreciation of clinical conceptual models and principles. Awareness of such models, principles and guidelines will strengthen and advance clinical assessment of financial capacity. PMID:27506235

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.

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

PubMed

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

2016-10-01

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

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

PubMed

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

2016-01-01

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

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

PubMed

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

2018-02-01

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

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

PubMed

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

2016-01-01

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

Improving the 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

Online consensus conferences for clinical guidelines development - a survey among participants from the International Guidelines for the Treatment of Actinic Keratosis.

PubMed

Werner, Ricardo N; Jacobs, Anja; Rosumeck, Stefanie; Nast, Alexander

2014-12-01

Guideline development requires considerable time and financial resources. New technical devices such as software for online conferences may help to reduce time and financial efforts of guidelines development. The present survey may serve as an explorative pilot for a future study to determine the technical feasibility, acceptability and possible weaknesses of online consensus conferences for clinical guidelines development. An anonymous online survey was conducted among participants in the online consensus conference of the International League of Dermatological Societies (ILDS) Guidelines for the Treatment of Actinic Keratosis. The majority of participants reported no technical problems with the participation in the online consensus conference; one participant had substantial technical problems accountable to a regional telephone breakdown. The majority of participants would not have preferred a traditional face-to-face conference, and all participants rated online consensus conferences for international guidelines as absolutely acceptable. Rates of acceptance were particularly high among those participants with prior experience with consensus conferences. Certain aspects, particularly the possibilities of debating, were rated as possibly superior in face-to-face conferences by some participants. The data from the online survey indicate that online consensus conferences may be an appropriate alternative to traditional face-to-face consensus conferences, especially within the frame of international guidelines that would require high travel costs and time. Further research is necessary to confirm the data from this explorative pilot study. © 2014 John Wiley & Sons, Ltd.

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

Quality Assessment of Clinical Practice Guidelines for Respiratory Diseases in China: A Systematic Appraisal.

PubMed

Jiang, Mei; Liao, Li-Yue; Liu, Xiao-Qing; He, Wei-Qun; Guan, Wei-Jie; Chen, Hao; Li, Yi-Min

2015-09-01

There has been a significant increase in the publication of clinical practice guidelines (CPGs) for respiratory diseases in China. However, little is known about the quality and potential impacts of these CPGs. Our objective was to critically evaluate the quality of Chinese CPGs for respiratory diseases that were published in peer-reviewed medical journals. A systematic search of scientific literature published between 1979 and 2013 was undertaken to identify and select CPGs that were related to respiratory diseases. Four Chinese databases (the Chinese Biomedical Literature database [CBM], the China National Knowledge Infrastructure [CNKI], the VIP database, and the WANFANG database) were used. The quality of eligible guidelines was assessed independently by four reviewers using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. The overall agreement among reviewers was evaluated using an intraclass correlation coefficient. A total of 109 guidelines published in 27 medical journals from 1979 to 2013 were evaluated. The overall agreement among reviewers was considered good (intraclass correlation coefficient, 0.838; 95% CI, 0.812-0.862). The scores of the six AGREE domains were low: 57.3% for scope and purpose (range, 4.2%-80.5%), 23.8% for stakeholder involvement (range, 2.8%-54.2%), 7.7% for rigor of development (range, 0%-27.1%), 59.8% for clarity and presentation (range, 22.2%-80.6%), 10.9% for applicability (range, 0%-22.9%), and 0.6% for editorial independence (range, 0%-16.7%). Scores for all guidelines were below 60%, and only three guidelines (2.8%) were recommended for clinical practice with modifications. The quality of the guidelines was low, and stakeholder involvement, rigor of development, applicability, and editorial independence should be considered in the future development of CPGs for respiratory diseases in China.

A method for developing standardised interactive education for complex clinical guidelines

PubMed Central

2012-01-01

Background Although systematic use of the Perinatal Society of Australia and New Zealand internationally endorsed Clinical Practice Guideline for Perinatal Mortality (PSANZ-CPG) improves health outcomes, implementation is inadequate. Its complexity is a feature known to be associated with non-compliance. Interactive education is effective as a guideline implementation strategy, but lacks an agreed definition. SCORPIO is an educational framework containing interactive and didactic teaching, but has not previously been used to implement guidelines. Our aim was to transform the PSANZ-CPG into an education workshop to develop quality standardised interactive education acceptable to participants for learning skills in collaborative interprofessional care. Methods The workshop was developed using the construct of an educational framework (SCORPIO), the PSANZ-CPG, a transformation process and tutor training. After a pilot workshop with key target and stakeholder groups, modifications were made to this and subsequent workshops based on multisource written observations from interprofessional participants, tutors and an independent educator. This participatory action research process was used to monitor acceptability and educational standards. Standardised interactive education was defined as the attainment of content and teaching standards. Quantitative analysis of positive expressed as a percentage of total feedback was used to derive a total quality score. Results Eight workshops were held with 181 participants and 15 different tutors. Five versions resulted from the action research methodology. Thematic analysis of multisource observations identified eight recurring education themes or quality domains used for standardisation. The two content domains were curriculum and alignment with the guideline and the six teaching domains; overload, timing, didacticism, relevance, reproducibility and participant engagement. Engagement was the most challenging theme to resolve. Tutors identified all themes for revision whilst participants identified a number of teaching but no content themes. From version 1 to 5, a significant increasing trend in total quality score was obtained; participants: 55%, p=0.0001; educator: 42%, p=0.0004; tutor peers: 57%, p=0.0001. Conclusions Complex clinical guidelines can be developed into a workshop acceptable to interprofessional participants. Eight quality domains provide a framework to standardise interactive teaching for complex clinical guidelines. Tutor peer review is important for content validity. This methodology may be useful for other guideline implementation. PMID:23131137

A method for developing standardised interactive education for complex clinical guidelines.

PubMed

Vaughan, Janet I; Jeffery, Heather E; Raynes-Greenow, Camille; Gordon, Adrienne; Hirst, Jane; Hill, David A; Arbuckle, Susan

2012-11-06

Although systematic use of the Perinatal Society of Australia and New Zealand internationally endorsed Clinical Practice Guideline for Perinatal Mortality (PSANZ-CPG) improves health outcomes, implementation is inadequate. Its complexity is a feature known to be associated with non-compliance. Interactive education is effective as a guideline implementation strategy, but lacks an agreed definition. SCORPIO is an educational framework containing interactive and didactic teaching, but has not previously been used to implement guidelines. Our aim was to transform the PSANZ-CPG into an education workshop to develop quality standardised interactive education acceptable to participants for learning skills in collaborative interprofessional care. The workshop was developed using the construct of an educational framework (SCORPIO), the PSANZ-CPG, a transformation process and tutor training. After a pilot workshop with key target and stakeholder groups, modifications were made to this and subsequent workshops based on multisource written observations from interprofessional participants, tutors and an independent educator. This participatory action research process was used to monitor acceptability and educational standards. Standardised interactive education was defined as the attainment of content and teaching standards. Quantitative analysis of positive expressed as a percentage of total feedback was used to derive a total quality score. Eight workshops were held with 181 participants and 15 different tutors. Five versions resulted from the action research methodology. Thematic analysis of multisource observations identified eight recurring education themes or quality domains used for standardisation. The two content domains were curriculum and alignment with the guideline and the six teaching domains; overload, timing, didacticism, relevance, reproducibility and participant engagement. Engagement was the most challenging theme to resolve. Tutors identified all themes for revision whilst participants identified a number of teaching but no content themes. From version 1 to 5, a significant increasing trend in total quality score was obtained; participants: 55%, p=0.0001; educator: 42%, p=0.0004; tutor peers: 57%, p=0.0001. Complex clinical guidelines can be developed into a workshop acceptable to interprofessional participants. Eight quality domains provide a framework to standardise interactive teaching for complex clinical guidelines. Tutor peer review is important for content validity. This methodology may be useful for other guideline implementation.

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines

PubMed Central

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-01-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association’s governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research;Improving patient care provided by members by providing focus on quality and evidence;Creating legislative environments that favour effective clinical practice;Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; andIdentifying areas that require further information or research to improve clinical care.The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement. PMID:25314352

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines.

PubMed

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-10-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association's governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research; Improving patient care provided by members by providing focus on quality and evidence; Creating legislative environments that favour effective clinical practice; Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; and Identifying areas that require further information or research to improve clinical care. The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement.

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

PubMed

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

2017-11-01

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

[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.

Ottawa Panel Evidence-Based Clinical Practice Guidelines for Patient Education Programmes in the Management of Osteoarthritis

ERIC Educational Resources Information Center

Health Education Journal, 2011

2011-01-01

Objective: The purpose of this study was to develop guidelines and recommendations on patient education programmes of any type, targeted specially to individuals with OA and which were designed to improve the clinical effectiveness of managing OA. Methods: The Ottawa Methods Group contacted specialized organizations that focus on management for…

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

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

PubMed

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

2017-05-01

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

A new framing approach in guideline development to manage different sources of knowledge.

PubMed

Lukersmith, Sue; Hopman, Katherine; Vine, Kristina; Krahe, Lee; McColl, Alexander

2017-02-01

Contemporary guideline methodology struggles to consider context and information from different sources of knowledge besides quantitative research. Return to work programmes involve multiple components and stakeholders. If the guideline is to be relevant and practical for a complex intervention such as return to work, it is essential to use broad sources of knowledge. This paper reports on a new method in guideline development to manage different sources of knowledge. The method used framing for the return-to-work guidance within the Clinical Practice Guidelines for the Management of Rotator Cuff Syndrome in the Workplace. The development involved was a multi-disciplinary working party of experts including consumers. The researchers considered a broad range of research, expert (practice and experience) knowledge, the individual's and workplace contexts, and used framing with the International Classification of Functioning, Disability and Health. Following a systematic database search on four clinical questions, there were seven stages of knowledge management to extract, unpack, map and pack information to the ICF domains framework. Companion graded recommendations were developed. The results include practical examples, user and consumer guides, flow charts and six graded or consensus recommendations on best practice for return to work intervention. Our findings suggest using framing in guideline methodology with internationally accepted frames such as the ICF is a reliable and transparent framework to manage different sources of knowledge. Future research might examine other examples and methods for managing complexity and using different sources of knowledge in guideline development. © 2016 John Wiley & Sons, Ltd.

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.

Introducing guidelines into clinical practice.

PubMed

Fowkes, F G; Roberts, C J

1984-04-01

The impetus for guidelines of practice has been accelerated by a worldwide trend towards insurance based systems of health care. In the past it has been the tradition for the clinician to order all the diagnostic procedures that conceivably might help to clarify what is wrong with a patient, or what course of treatment should be followed. This traditional view ignores the stubborn economic reality that resources are finite and that it is no longer possible to be both endlessly generous and continually fair. Making judgements about the need for, and value of, services now forms an important part of coping with this problem. Clinical practice has to strive to be as safe as possible and to produce a given benefit at a socially acceptable cost. Guidelines are recommendations, preferably developed by clinicians themselves, which describe how and when individual clinical activities should be offered in order to achieve these objectives. Utilisation review of current practice is a valuable source of information for the development of guidelines. In the United Kingdom the Royal College of Radiologists attempted to do this in connection with the use of pre-operative chest X-rays. In 1979 they published the findings of a multicentre review of 10,619 consecutive cases of elective non-cardiopulmonary surgery undertaken in 8 centres throughout the United Kingdom. Substantial variations were found in national practice. Use of pre-operative chest X-rays varied from 11.5% of patients in one centre to 54.2% of patients in another centre. The study also found that the chest X-ray report did not seem to have much influence on the decision to operate nor on the decision to use inhalation anaesthesia. The College study failed to find "any evidence at all for the effectiveness of pre-operative chest X-ray when used routinely" and it was estimated that even if the procedure was 10% effective the costs of avoiding one death would be approximately 1 million pounds. These findings provided the impetus for the College to develop guidelines for the use of pre-operative chest X-rays in hospitals in the United Kingdom. Creating a change in clinical practice through the introduction of guidelines is a three stage process: Stage I: introducing the idea of a change in practice. Stage II: introduction of guidelines into clinical practice. Stage III: sustained implementation of guidelines in clinical practice.(ABSTRACT TRUNCATED AT 400 WORDS)

Unmet needs in obesity management: From guidelines to clinic.

PubMed

Ritten, Angela; LaManna, Jacqueline

2017-10-01

Despite the rather slow acceptance of obesity as a disease state, several obesity staging systems and weight-management guidelines have been developed and are in use, along with an ever-growing number of treatment options. Many primary care clinicians, including nurse practitioners (NPs), are at the forefront of clinical efforts to assist individuals with obesity, but face challenges due to lack of alignment and consensus among the various staging systems and guidelines. This is further complicated by shortfalls in clinical training related to obesity management and increasing complexities in reimbursement for obesity-related services. Unmet needs in the management of obesity thus stretch from guidelines to clinic. This article examines the principal barriers to effective management of individuals with obesity and considers how concerns might be overcome, with particular emphasis on the role of the NP. ©2017 American Association of Nurse Practitioners.

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

PubMed

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

2013-01-01

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

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

PubMed

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

2010-09-01

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

The clinical development process for a novel preventive vaccine: An overview.

PubMed

Singh, K; Mehta, S

2016-01-01

Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.

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

PubMed

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

2013-01-01

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

Driving out waste: a framework to enhance value in clinical care.

PubMed

Burton, David A

2013-06-01

Many healthcare providers today are seeking to improve the value of the care they deliver by implementing standardized clinical practice guidelines aimed at reducing variations in care, avoiding complications, and lowering costs. To succeed, such an initiative requires the full support and participation of the clinicians who will use the guidelines. Providers also should have a fully developed infrastructure consisting of a clinical content system, an analytics system, and a deployment system.

Management of Carpal Tunnel Syndrome.

PubMed

Mooar, Pekka A; Doherty, William J; Murray, Jayson N; Pezold, Ryan; Sevarino, Kaitlyn S

2018-03-15

The American Academy of Orthopaedic Surgeons (AAOS) has developed Appropriate Use Criteria (AUC) for Management of Carpal Tunnel Syndrome. Evidence-based information, in conjunction with the clinical expertise of physicians, was used to develop the criteria to improve patient care and obtain best outcomes while considering the subtleties and distinctions necessary in making clinical decisions. To provide the evidence foundation for this AUC, the AAOS Evidence-Based Medicine Unit provided the writing panel and voting panel with the 2016 AAOS Clinical Practice Guideline titled Management of Carpal Tunnel Syndrome Evidence-Based Clinical Practice Guideline. The Management of Carpal Tunnel Syndrome AUC clinical patient scenarios were derived from indications typical of patients with suspected carpal tunnel syndrome in clinical practice, as well as from current evidence-based clinical practice guidelines and supporting literature to identify the appropriateness of treatments. The 135 patient scenarios and 6 treatments were developed by the writing panel, a group of clinicians who are specialists in this AUC topic. Next, a separate, multidisciplinary, voting panel (made up of specialists and nonspecialists) rated the appropriateness of treatment of each patient scenario using a 9-point scale to designate a treatment as Appropriate (median rating, 7 to 9), May Be Appropriate (median rating, 4 to 6), or Rarely Appropriate (median rating, 1 to 3).

Adaptation, evaluation, and updating of guidelines: article 14 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Burgers, Jako S; Anzueto, Antonio; Black, Peter N; Cruz, Alvaro A; Fervers, Béatrice; Graham, Ian D; Metersky, Mark; Woodhead, Mark; Yawn, Barbara P

2012-12-01

Professional societies, like many other organizations, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the last of a series of 14 articles that methodologists and researchers from around the world have prepared to advise guideline developers in respiratory and other diseases on how to achieve this. We updated a review of the literature on guideline adaptation, evaluation, and updating, focusing on four key questions. In this review we addressed the following questions. (1) Which high-quality guidelines on chronic obstructive pulmonary disease (COPD) are available? (2) How should guidelines be adapted to the user's context and culture? (3) How should the use of guidelines be evaluated in clinical practice? and (4) How should guidelines be efficiently kept up-to-date? We did not conduct systematic reviews ourselves. We relied on a literature review published in 2006 and on a manual produced by the ADAPTE Collaboration to inform our judgments, as well as our collective experience and workshop discussions. Guideline adaptation can be seen as an alternative to de novo development and as part of an implementation process, taking into consideration the user's own context. A systematic approach should be followed to ensure high quality of the resulting guidance. On the topic of COPD, many guidelines are available. Guidelines of the Global Initiative for Chronic Obstructive Lung Disease and of the American Thoracic Society and European Respiratory Society are particularly well-suited for adaptation. The adaptation process includes (1) definition of specific questions that need to be answered by the guideline; (2) assessment of guideline quality; (3) assessment of the clinical content, validity, acceptability, applicability, and transferability of the recommendations; and (4) decisions about adoption or adaptation of the recommendations. The use of the guidelines in practice can be measured with performance indicators. Adverse effects of strict adherence to guideline recommendations should be prevented, in particular when the improvement of patient outcomes is unclear. COPD guidelines should be updated at least every 2 years. Collaboration between COPD guideline developers is recommended to prevent duplication of effort.

Using patient values and preferences to inform the importance of health outcomes in practice guideline development following the GRADE approach.

PubMed

Zhang, Yuan; Coello, Pablo Alonso; Brożek, Jan; Wiercioch, Wojtek; Etxeandia-Ikobaltzeta, Itziar; Akl, Elie A; Meerpohl, Joerg J; Alhazzani, Waleed; Carrasco-Labra, Alonso; Morgan, Rebecca L; Mustafa, Reem A; Riva, John J; Moore, Ainsley; Yepes-Nuñez, Juan José; Cuello-Garcia, Carlos; AlRayees, Zulfa; Manja, Veena; Falavigna, Maicon; Neumann, Ignacio; Brignardello-Petersen, Romina; Santesso, Nancy; Rochwerg, Bram; Darzi, Andrea; Rojas, Maria Ximena; Adi, Yaser; Bollig, Claudia; Waziry, Reem; Schünemann, Holger J

2017-05-02

There are diverse opinions and confusion about defining and including patient values and preferences (i.e. the importance people place on the health outcomes) in the guideline development processes. This article aims to provide an overview of a process for systematically incorporating values and preferences in guideline development. In 2013 and 2014, we followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to adopt, adapt and develop 226 recommendations in 22 guidelines for the Ministry of Health of the Kingdom of Saudi Arabia. To collect context-specific values and preferences for each recommendation, we performed systematic reviews, asked clinical experts to provide feedback according to their clinical experience, and consulted patient representatives. We found several types of studies addressing the importance of outcomes, including those reporting utilities, non-utility measures of health states based on structured questionnaires or scales, and qualitative studies. Guideline panels used the relative importance of outcomes based on values and preferences to weigh the balance of desirable and undesirable consequences of alternative intervention options. However, we found few studies addressing local values and preferences. Currently there are different but no firmly established processes for integrating patient values and preferences in healthcare decision-making of practice guideline development. With GRADE Evidence-to-Decision (EtD) frameworks, we provide an empirical strategy to find and incorporate values and preferences in guidelines by performing systematic reviews and eliciting information from guideline panel members and patient representatives. However, more research and practical guidance are needed on how to search for relevant studies and grey literature, assess the certainty of this evidence, and best summarize and present the findings.

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

PubMed

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

2016-08-01

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

AAFP and ISFM Guidelines for diagnosing and solving house-soiling behavior in cats.

PubMed

Carney, Hazel C; Sadek, Tammy P; Curtis, Terry M; Halls, Vicky; Heath, Sarah; Hutchison, Pippa; Mundschenk, Kari; Westropp, Jodi L

2014-07-01

These Guidelines have been developed by the American Association of Feline Practitioners (AAFP) and the International Society of Feline Medicine (ISFM) as a resource for veterinary practitioners who want to better understand and manage the important clinical condition of house-soiling in their feline patients. The Guidelines offer straightforward, practical solutions that, in most cases, will help veterinarians and cat owners prevent, manage or entirely remediate feline house-soiling behavior. The Guidelines include scientifically documented information when it is available. However, because research is often lacking, some recommendations reflect the accumulated clinical experience of the authors. © ISFM and AAFP 2014.

Using whole disease modeling to inform resource allocation decisions: economic evaluation of a clinical guideline for colorectal cancer using a single model.

PubMed

Tappenden, Paul; Chilcott, Jim; Brennan, Alan; Squires, Hazel; Glynne-Jones, Rob; Tappenden, Janine

2013-06-01

To assess the feasibility and value of simulating whole disease and treatment pathways within a single model to provide a common economic basis for informing resource allocation decisions. A patient-level simulation model was developed with the intention of being capable of evaluating multiple topics within National Institute for Health and Clinical Excellence's colorectal cancer clinical guideline. The model simulates disease and treatment pathways from preclinical disease through to detection, diagnosis, adjuvant/neoadjuvant treatments, follow-up, curative/palliative treatments for metastases, supportive care, and eventual death. The model parameters were informed by meta-analyses, randomized trials, observational studies, health utility studies, audit data, costing sources, and expert opinion. Unobservable natural history parameters were calibrated against external data using Bayesian Markov chain Monte Carlo methods. Economic analysis was undertaken using conventional cost-utility decision rules within each guideline topic and constrained maximization rules across multiple topics. Under usual processes for guideline development, piecewise economic modeling would have been used to evaluate between one and three topics. The Whole Disease Model was capable of evaluating 11 of 15 guideline topics, ranging from alternative diagnostic technologies through to treatments for metastatic disease. The constrained maximization analysis identified a configuration of colorectal services that is expected to maximize quality-adjusted life-year gains without exceeding current expenditure levels. This study indicates that Whole Disease Model development is feasible and can allow for the economic analysis of most interventions across a disease service within a consistent conceptual and mathematical infrastructure. This disease-level modeling approach may be of particular value in providing an economic basis to support other clinical guidelines. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Singapore Cancer Network (SCAN) Guidelines for Referral for Genetic Evaluation of Common Hereditary Cancer Syndromes.

PubMed

2015-10-01

The SCAN cancer genetics workgroup aimed to develop Singapore Cancer Network (SCAN) clinical practice guidelines for referral for genetic evaluation of common hereditary cancer syndromes. The workgroup utilised a modified ADAPTE process to calibrate high quality international evidence-based clinical practice guidelines to our local setting. To formulate referral guidelines for the 3 most commonly encountered hereditary cancer syndromes to guide healthcare providers in Singapore who care for cancer patients and/or their family members, 7, 5, and 3 sets of international guidelines respectively for hereditary breast and ovarian cancer (HBOC) syndrome, Lynch syndrome (LS), and familial adenomatous polyposis (FAP) were evaluated. For each syndrome, the most applicable one was selected, with modifications made such that they would be appropriate to the local context. These adapted guidelines form the SCAN Guidelines 2015 for referral for genetic evaluation of common hereditary cancer syndromes.

GEM at 10: a decade's experience with the Guideline Elements Model.

PubMed

Hajizadeh, Negin; Kashyap, Nitu; Michel, George; Shiffman, Richard N

2011-01-01

The Guideline Elements Model (GEM) was developed in 2000 to organize the information contained in clinical practice guidelines using XML and to represent guideline content in a form that can be understood by human readers and processed by computers. In this work, we systematically reviewed the literature to better understand how GEM was being used, potential barriers to its use, and suggestions for improvement. Fifty external and twelve internally produced publications were identified and analyzed. GEM was used most commonly for modeling and ontology creation. Other investigators applied GEM for knowledge extraction and data mining, for clinical decision support for guideline generation. The GEM Cutter software-used to markup guidelines for translation into XML- has been downloaded 563 times since 2000. Although many investigators found GEM to be valuable, others critiqued its failure to clarify guideline semantics, difficulties in markup, and the fact that GEM files are not usually executable.

Addressing implementation challenges during guideline development - a case study of Swedish national guidelines for methods of preventing disease.

PubMed

Richter-Sundberg, Linda; Kardakis, Therese; Weinehall, Lars; Garvare, Rickard; Nyström, Monica E

2015-01-22

Many of the world's life threatening diseases (e.g. cancer, heart disease, stroke) could be prevented by eliminating life-style habits such as tobacco use, unhealthy diet, physical inactivity and excessive alcohol use. Incorporating evidence-based research on methods to change unhealthy lifestyle habits in clinical practice would be equally valuable. However gaps between guideline development and implementation are well documented, with implications for health care quality, safety and effectiveness. The development phase of guidelines has been shown to be important both for the quality in guideline content and for the success of implementation. There are, however, indications that guidelines related to general disease prevention methods encounter specific barriers compared to guidelines that are diagnosis-specific. In 2011 the Swedish National board for Health and Welfare launched guidelines with a preventive scope. The aim of this study was to investigate how implementation challenges were addressed during the development process of these disease preventive guidelines. Seven semi-structured interviews were conducted with members of the guideline development management group. Archival data detailing the guideline development process were also collected and used in the analysis. Qualitative data were analysed using content analysis as the analytical framework. The study identified several strategies and approaches that were used to address implementation challenges during guideline development. Four themes emerged from the analysis: broad agreements and consensus about scope and purpose; a formalized and structured development procedure; systematic and active involvement of stakeholders; and openness and transparency in the specific guideline development procedure. Additional factors concerning the scope of prevention and the work environment of guideline developers were perceived to influence the possibilities to address implementation issues. This case study provides examples of how guideline developers perceive and approach the issue of implementation during the development and early launch of prevention guidelines. Models for guideline development could benefit from an initial assessment of how the guideline topic, its target context and stakeholders will affect the upcoming implementation.

Guidelines proposal for clinical recognition of mouth breathing children.

PubMed

Pacheco, Maria Christina Thomé; Casagrande, Camila Ferreira; Teixeira, Lícia Pacheco; Finck, Nathalia Silveira; de Araújo, Maria Teresa Martins

2015-01-01

Mouth breathing (MB) is an etiological factor for sleep-disordered breathing (SDB) during childhood. The habit of breathing through the mouth may be perpetuated even after airway clearance. Both habit and obstruction may cause facial muscle imbalance and craniofacial changes. The aim of this paper is to propose and test guidelines for clinical recognition of MB and some predisposing factors for SDB in children. Semi-structured interviews were conducted with 110 orthodontists regarding their procedures for clinical evaluation of MB and their knowledge about SDB during childhood. Thereafter, based on their answers, guidelines were developed and tested in 687 children aged between 6 and 12 years old and attending elementary schools. There was no standardization for clinical recognition of MB among orthodontists. The most common procedures performed were inefficient to recognize differences between MB by habit or obstruction. The guidelines proposed herein facilitate clinical recognition of MB, help clinicians to differentiate between habit and obstruction, suggest the most appropriate treatment for each case, and avoid maintenance of mouth breathing patterns during adulthood.

[A computerised clinical decision-support system for the management of depression in Primary Care].

PubMed

Aragonès, Enric; Comín, Eva; Cavero, Myriam; Pérez, Víctor; Molina, Cristina; Palao, Diego

Despite its clinical relevance and its importance as a public health problem, there are major gaps in the management of depression. Evidence-based clinical guidelines are useful to improve processes and clinical outcomes. In order to make their implementation easier these guidelines have been transformed into computerised clinical decision support systems. In this article, a description is presented on the basics and characteristics of a new computerised clinical guideline for the management of major depression, developed in the public health system in Catalonia. This tool helps the clinician to establish reliable and accurate diagnoses of depression, to choose the best treatment a priori according to the disease and the patient characteristics. It also emphasises the importance of systematic monitoring to assess the clinical course, and to adjust therapeutic interventions to the patient's needs at all times. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

Development of Quality Management Systems for Clinical Practice Guidelines in Korea.

PubMed

Jo, Heui-Sug; Kim, Dong Ik; Chang, Sung-Goo; Shin, Ein-Soon; Oh, Moo-Kyung

2015-11-01

This study introduces the Clinical practice guidelines (CPGs) appraisal system by the Korean Academy of Medical Sciences (KAMS). Quality management policies for CPGs vary among different countries, which have their own cultures and health care systems. However, supporting developers in guideline development and appraisals using standardized tools are common practices. KAMS, an organization representing the various medical societies of Korea, has been striving to establish a quality management system for CPGs, and has established a CPGs quality management system that reflects the characteristics of the Korean healthcare environment and the needs of its users. KAMS created a foundation for the development of CPGs, set up an independent appraisal organization, enacted regulations related to the appraisals, and trained appraisers. These efforts could enhance the ability of each individual medical society to develop CPGs, to increase the quality of the CPGs, and to ultimately improve the quality of the information available to decision-makers.

2018 AAHA Diabetes Management Guidelines for Dogs and Cats.

PubMed

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

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

Clinical guideline representation in a CDS: a human information processing method.

PubMed

Kilsdonk, Ellen; Riezebos, Rinke; Kremer, Leontien; Peute, Linda; Jaspers, Monique

2012-01-01

The Dutch Childhood Oncology Group (DCOG) has developed evidence-based guidelines for screening childhood cancer survivors for possible late complications of treatment. These paper-based guidelines appeared to not suit clinicians' information retrieval strategies; it was thus decided to communicate the guidelines through a Computerized Decision Support (CDS) tool. To ensure high usability of this tool, an analysis of clinicians' cognitive strategies in retrieving information from the paper-based guidelines was used as requirements elicitation method. An information processing model was developed through an analysis of think aloud protocols and used as input for the design of the CDS user interface. Usability analysis of the user interface showed that the navigational structure of the CDS tool fitted well with the clinicians' mental strategies employed in deciding on survivors screening protocols. Clinicians were more efficient and more complete in deciding on patient-tailored screening procedures when supported by the CDS tool than by the paper-based guideline booklet. The think-aloud method provided detailed insight into users' clinical work patterns that supported the design of a highly usable CDS system.

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

PubMed

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

2017-02-01

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

A new impetus for guideline development and implementation: construction and evaluation of a toolbox.

PubMed

Hilbink, Mirrian A H W; Ouwens, Marielle M T J; Burgers, Jako S; Kool, Rudolf B

2014-03-19

In the last decade, guideline organizations faced a number of problems, including a lack of standardization in guideline development methods and suboptimal guideline implementation. To contribute to the solution of these problems, we produced a toolbox for guideline development, implementation, revision, and evaluation. All relevant guideline organizations in the Netherlands were approached to prioritize the topics. We sent out a questionnaire and discussed the results at an invitational conference. Based on consensus, twelve topics were selected for the development of new tools. Subsequently, working groups were composed for the development of the tools. After development of the tools, their draft versions were pilot tested in 40 guideline projects. Based on the results of the pilot tests, the tools were refined and their final versions were presented. The vast majority of organizations involved in pilot testing of the tools reported satisfaction with using the tools. Guideline experts involved in pilot testing of the tools proposed a variety of suggestions for the implementation of the tools. The tools are available in Dutch and in English at a web-based platform on guideline development and implementation (http://www.ha-ring.nl). A collaborative approach was used for the development and evaluation of a toolbox for development, implementation, revision, and evaluation of guidelines. This approach yielded a potentially powerful toolbox for improving the quality and implementation of Dutch clinical guidelines. Collaboration between guideline organizations within this project led to stronger linkages, which is useful for enhancing coordination of guideline development and implementation and preventing duplication of efforts. Use of the toolbox could improve quality standards in the Netherlands, and might facilitate the development of high-quality guidelines in other countries as well.

Use of Global initiative for asthma (GINA) guidelines in asthma management among paediatric residents in a Sub Saharan African country: a cross-sectional descriptive study.

PubMed

Chikaodinaka Ayuk, Adaeze; Ubesie, Agozie; Laura Odimegwu, Chioma; Iloh, Kenechukwu

2017-01-01

Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. Despite abundance of asthma guidelines, prevalence has continued to increase globally. There is need to assess how the contents of asthma guidelines are put to clinical use by doctors in the management of children with asthma. This study aims at evaluating the clinical practice of paediatric residents in applying GINA guidelines. Cross-sectional descriptive study of paediatric residents from 23 university teaching hospitals in Nigeria using structured questionnaire. Data analyses were with Statistical Package for Social Sciences (SPSS) version 19 (Chicago IL). Chi square was used to assess for any significant associations between categorical variables. A p < 0.05 was regarded to be statistically significant. Sixty-six paediatric residents aged 27- 40 years were enrolled into the study (37 females and 29 males). One-third had spent more than three years in residency training. Fifty-eight residents (87.9%) were aware of the GINA guidelines while 46 (69.7%) were familiar with its contents. Only 39 (59.1%) residents adhered to the GINA guidelines. Twenty of the 35 junior residents (57.1%) compared to 26 of 31 (83.9%) senior residents were familiar with the GINA guidelines (p=0.031) while 15 of 35 junior residents (42.9%) compared to 24 of 31 senior residents (77.4%) consistently follow the GINA guidelines (p=0.006). Adherence to GINA guidelines was not influenced significantly by years of graduation or training (p>0.05). The use of the GINA guidelines was poor among paediatric residents. Application of contents rather than just availability of asthma guidelines may partly account for increasing asthma prevalence globally.

The Instrument for Measuring the Implementation Situation of Traditional Chinese Medicine Guideline: Evaluation and Application

PubMed Central

Wang, Yangyang; Chen, Yaolong; Wang, Xiaoyun; Deng, Jingwen

2017-01-01

Clinical practice guidelines play an important role in reducing the variations in clinical practices and improving the quality of care. To assess the real effect, measuring its implementation situation is needed. The implementation situation can be reflected by testing the consistency between the actual clinical practice and the guideline. We constructed an instrument to measure the implementation situation of Traditional Chinese Medicine (TCM) guideline through consistency testing. The main objectives of our study were to validate the instrument and evaluate the implementation situation of menopause syndrome guideline of TCM, using the data from the consistency test of comparing the medical records with the guideline. A total of 621 cases were included for data analysis. Cronbach's Alpha coefficient is 0.73. The model fit of 7 items in four dimensions was good (SRMR = 0.04; GFI = 0.97; NFI = 0.97; TLI = 0.96; CFI = 0.98; AGFI = 0.90). This instrument is of good reliability and validity. It can help the guideline developers to measure the implementation situation, find the reasons affecting the implementation, and revise the guideline. The method of using consistency test to measure the implementation situation may provide a sample for evaluating the guideline implementation in other fields. PMID:29234379

Designing for Clinical Change: Creating an Intervention to Implement New Statin Guidelines in a Primary Care Clinic.

PubMed

DeJonckheere, Melissa; Robinson, Claire H; Evans, Lindsey; Lowery, Julie; Youles, Bradley; Tremblay, Adam; Kelley, Caitlin; Sussman, Jeremy B

2018-04-24

Recent clinical practice guidelines from major national organizations, including a joint United States Department of Veterans Affairs (VA) and Department of Defense (DoD) committee, have substantially changed recommendations for the use of the cholesterol-lowering statin medications after years of relative stability. Because statin medications are among the most commonly prescribed treatments in the United States, any change in their use may have significant implications for patients and providers alike. Prior research has shown that effective implementation interventions should be both user centered and specifically chosen to address identified barriers. The objectives of this study were to identify potential determinants of provider uptake of the new statin guidelines and to use that information to tailor a coordinated and streamlined local quality improvement intervention focused on prescribing appropriate statins. We employed user-centered design principles to guide the development and testing of a multicomponent guideline implementation intervention to improve statin prescribing. This paper describes the intervention development process whereby semistructured qualitative interviews with providers were conducted to (1) illuminate the knowledge, attitudes, and behaviors of providers and (2) elicit feedback on intervention prototypes developed to align with and support the use of the VA/DoD guidelines. Our aim was to use this information to design a local quality improvement intervention focused on statin prescribing that was tailored to the needs of primary care providers at our facility. Cabana's Clinical Practice Guidelines Framework for Improvement and Nielsen's Usability Heuristics were used to guide the analysis of data obtained in the intervention development process. Semistructured qualitative interviews were conducted with 15 primary care Patient Aligned Care Team professionals (13 physicians and 2 clinical pharmacists) at a single VA medical center. Findings highlight that providers were generally comfortable with the paradigm shift to risk-based guidelines but less clear on the need for the VA/DoD guidelines in specific. Providers preferred a clinical decision support tool that helped them calculate patient risk and guide their care without limiting autonomy. They were less comfortable with risk communication and performance measurement systems that do not account for shared decision making. When possible, we incorporated their recommendations into the intervention. By combining qualitative methods and user-centered design principles, we could inform the design of a multicomponent guideline implementation intervention to better address the needs and preferences of providers, including clear and direct language, logical decision prompts with an option to dismiss a clinical decision support tool, and logical ordering of feedback information. Additionally, this process allowed us to identify future design considerations for quality improvement interventions. ©Melissa DeJonckheere, Claire H Robinson, Lindsey Evans, Julie Lowery, Bradley Youles, Adam Tremblay, Caitlin Kelley, Jeremy B Sussman. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 24.04.2018.

Evidence synthesis and guideline development in genomic medicine: current status and future prospects.

PubMed

Schully, Sheri D; Lam, Tram Kim; Dotson, W David; Chang, Christine Q; Aronson, Naomi; Birkeland, Marian L; Brewster, Stephanie Jo; Boccia, Stefania; Buchanan, Adam H; Calonge, Ned; Calzone, Kathleen; Djulbegovic, Benjamin; Goddard, Katrina A B; Klein, Roger D; Klein, Teri E; Lau, Joseph; Long, Rochelle; Lyman, Gary H; Morgan, Rebecca L; Palmer, Christina G S; Relling, Mary V; Rubinstein, Wendy S; Swen, Jesse J; Terry, Sharon F; Williams, Marc S; Khoury, Muin J

2015-01-01

With the accelerated implementation of genomic medicine, health-care providers will depend heavily on professional guidelines and recommendations. Because genomics affects many diseases across the life span, no single professional group covers the entirety of this rapidly developing field. To pursue a discussion of the minimal elements needed to develop evidence-based guidelines in genomics, the Centers for Disease Control and Prevention and the National Cancer Institute jointly held a workshop to engage representatives from 35 organizations with interest in genomics (13 of which make recommendations). The workshop explored methods used in evidence synthesis and guideline development and initiated a dialogue to compare these methods and to assess whether they are consistent with the Institute of Medicine report "Clinical Practice Guidelines We Can Trust." The participating organizations that develop guidelines or recommendations all had policies to manage guideline development and group membership, and processes to address conflicts of interests. However, there was wide variation in the reliance on external reviews, regular updating of recommendations, and use of systematic reviews to assess the strength of scientific evidence. Ongoing efforts are required to establish criteria for guideline development in genomic medicine as proposed by the Institute of Medicine.

Ancestral assumptions and the clinical uncertainty of evolutionary medicine.

PubMed

Cournoyea, Michael

2013-01-01

Evolutionary medicine is an emerging field of medical studies that uses evolutionary theory to explain the ultimate causes of health and disease. Educational tools, online courses, and medical school modules are being developed to help clinicians and students reconceptualize health and illness in light of our evolutionary past. Yet clinical guidelines based on our ancient life histories are epistemically weak, relying on the controversial assumptions of adaptationism and advocating a strictly biophysical account of health. To fulfill the interventionist goals of clinical practice, it seems that proximate explanations are all we need to develop successful diagnostic and therapeutic guidelines. Considering these epistemic concerns, this article argues that the clinical relevance of evolutionary medicine remains uncertain at best.

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

Rigour of development does not AGREE with recommendations in practice guidelines on the use of ice for acute ankle sprains.

PubMed

Van de Velde, S; Heselmans, A; Donceel, P; Vandekerckhove, P; Ramaekers, D; Aertgeerts, B

2011-09-01

OBJECTIVE This study evaluated whether the Appraisal of Guidelines Research and Evaluation (AGREE) rigour of development score of practice guidelines on ice for acute ankle sprains is related to the convergence between recommendations. DESIGN The authors systematically reviewed guidelines on ice for acute ankle sprains. Four appraisers independently used the AGREE instrument to evaluate the rigour of development of selected guidelines. For each guideline, one reviewer listed the cited evidence on ice and calculated a cited evidence score. The authors plotted the recommended durations and numbers of ice applications over the standardised rigour of development score to explore the relationships. DATA SOURCES Three reviewers searched for guidelines in Medline, Embase, Sportdiscus, PEDro, G-I-N Guideline Library, Trip Database, SumSearch, National Guideline Clearinghouse and the Health Technology Assessment database, and conducted a web-based search for guideline development organisations. ELIGIBILITY CRITERIA Eligible guidelines had a development methodology that included a process to search or use results from scientific studies and the participation of an expert group to formulate recommendations. RESULTS The authors identified 21 guidelines, containing clinically significant variations in recommended durations and numbers of ice applications. The median standardised rigour of development score was 57% (IQR 18 to 77). Variations occurred evenly among guidelines with low moderate or high rigour scores. The median evidence citation score in the guidelines was 7% (IQR 0 to 61). CONCLUSIONS There is no relationship between the rigour of development score and the recommendations in guidelines on ice for acute ankle sprains. The guidelines suffered from methodological problems which were not captured by the AGREE instrument.

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

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

Does GEM-Encoding Clinical Practice Guidelines Improve the Quality of Knowledge Bases? A Study with the Rule-Based Formalism

PubMed Central

Georg, Gersende; Séroussi, Brigitte; Bouaud, Jacques

2003-01-01

The aim of this work was to determine whether the GEM-encoding step could improve the representation of clinical practice guidelines as formalized knowledge bases. We used the 1999 Canadian recommendations for the management of hypertension, chosen as the knowledge source in the ASTI project. We first clarified semantic ambiguities of therapeutic sequences recommended in the guideline by proposing an interpretative framework of therapeutic strategies. Then, after a formalization step to standardize the terms used to characterize clinical situations, we created the GEM-encoded instance of the guideline. We developed a module for the automatic derivation of a rule base, BR-GEM, from the instance. BR-GEM was then compared to the rule base, BR-ASTI, embedded within the critic mode of ASTI, and manually built by two physicians from the same Canadian guideline. As compared to BR-ASTI, BR-GEM is more specific and covers more clinical situations. When evaluated on 10 patient cases, the GEM-based approach led to promising results. PMID:14728173

Identifying the effective evidence sources to use in developing Clinical Guidelines for Acute Stroke Management: lived experiences of the search specialist and project manager.

PubMed

Parkhill, Anne; Hill, Kelvin

2009-03-01

The Australian National Stroke Foundation appointed a search specialist to find the best available evidence for the second edition of its Clinical Guidelines for Acute Stroke Management. To identify the relative effectiveness of differing evidence sources for the guideline update. We searched and reviewed references from five valid evidence sources for clinical and economic questions: (i) electronic databases; (ii) reference lists of relevant systematic reviews, guidelines, and/or primary studies; (iii) table of contents of a number of key journals for the last 6 months; (iv) internet/grey literature; and (v) experts. Reference sources were recorded, quantified, and analysed. In the clinical portion of the guidelines document, there was a greater use of previous knowledge and sources other than electronic databases for evidence, while there was a greater use of electronic databases for the economic section. The results confirmed that searchers need to be aware of the context and range of sources for evidence searches. For best available evidence, searchers cannot rely solely on electronic databases and need to encompass many different media and sources.

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

PubMed

Prabhu, Malavika; Eckert, Linda O

2016-12-01

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

Clinical practice guidelines in breast cancer

PubMed Central

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

2018-01-01

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

Implementing change in primary care practices using electronic medical records: a conceptual framework.

PubMed

Nemeth, Lynne S; Feifer, Chris; Stuart, Gail W; Ornstein, Steven M

2008-01-16

Implementing change in primary care is difficult, and little practical guidance is available to assist small primary care practices. Methods to structure care and develop new roles are often needed to implement an evidence-based practice that improves care. This study explored the process of change used to implement clinical guidelines for primary and secondary prevention of cardiovascular disease in primary care practices that used a common electronic medical record (EMR). Multiple conceptual frameworks informed the design of this study designed to explain the complex phenomena of implementing change in primary care practice. Qualitative methods were used to examine the processes of change that practice members used to implement the guidelines. Purposive sampling in eight primary care practices within the Practice Partner Research Network-Translating Researching into Practice (PPRNet-TRIP II) clinical trial yielded 28 staff members and clinicians who were interviewed regarding how change in practice occurred while implementing clinical guidelines for primary and secondary prevention of cardiovascular disease and strokes. A conceptual framework for implementing clinical guidelines into primary care practice was developed through this research. Seven concepts and their relationships were modelled within this framework: leaders setting a vision with clear goals for staff to embrace; involving the team to enable the goals and vision for the practice to be achieved; enhancing communication systems to reinforce goals for patient care; developing the team to enable the staff to contribute toward practice improvement; taking small steps, encouraging practices' tests of small changes in practice; assimilating the electronic medical record to maximize clinical effectiveness, enhancing practices' use of the electronic tool they have invested in for patient care improvement; and providing feedback within a culture of improvement, leading to an iterative cycle of goal setting by leaders. This conceptual framework provides a mental model which can serve as a guide for practice leaders implementing clinical guidelines in primary care practice using electronic medical records. Using the concepts as implementation and evaluation criteria, program developers and teams can stimulate improvements in their practice settings. Investing in collaborative team development of clinicians and staff may enable the practice environment to be more adaptive to change and improvement.

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

PubMed

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

2007-08-01

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

Guidelines for prevention of venous thromboembolism in immobile patients secondary to neurological impairment.

PubMed

Gaber, Tarek A-Z K

2007-10-15

Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalized patients and 7% of these cases are due to immobility secondary to a neurological impairment. Many guidelines are available to guide clinicians dealing with medical or surgical patients. However, and with the exception of spinal injuries, no guidelines are available to deal with other neurologically impaired patients at risk of VTE. Our study aimed at gathering evidence from the literature to enable us to deal with the main controversial issues of VTE prevention. Guidelines will be formulated. A Clinical Standards Group is responsible for the development of clinical guidelines for the Greater Manchester Neurorehabilitation network with services covering a population of around 3 million. The development of VTE prevention guidelines started with the formulation of the main questions, then gathering evidence from the literature to address these questions. Wide consultation then took place. The guidelines were then put before the group for endorsement. Answers for the main questions such as duration of thromboprophylaxis, TEDS and antiplatelets drugs use were suggested. The resulting document was summarized as a flow chart for use. We feel that the proposed guidelines are a useful tool for clinicians as they reflect the evidence available from the literature at the moment.

Transforming clinical practice guidelines and clinical pathways into fast-and-frugal decision trees to improve clinical care strategies.

PubMed

Djulbegovic, Benjamin; Hozo, Iztok; Dale, William

2018-02-27

Contemporary delivery of health care is inappropriate in many ways, largely due to suboptimal Q5 decision-making. A typical approach to improve practitioners' decision-making is to develop evidence-based clinical practice guidelines (CPG) by guidelines panels, who are instructed to use their judgments to derive practice recommendations. However, mechanisms for the formulation of guideline judgments remains a "black-box" operation-a process with defined inputs and outputs but without sufficient knowledge of its internal workings. Increased explicitness and transparency in the process can be achieved by implementing CPG as clinical pathways (CPs) (also known as clinical algorithms or flow-charts). However, clinical recommendations thus derived are typically ad hoc and developed by experts in a theory-free environment. As any recommendation can be right (true positive or negative), or wrong (false positive or negative), the lack of theoretical structure precludes the quantitative assessment of the management strategies recommended by CPGs/CPs. To realize the full potential of CPGs/CPs, they need to be placed on more solid theoretical grounds. We believe this potential can be best realized by converting CPGs/CPs within the heuristic theory of decision-making, often implemented as fast-and-frugal (FFT) decision trees. This is possible because FFT heuristic strategy of decision-making can be linked to signal detection theory, evidence accumulation theory, and a threshold model of decision-making, which, in turn, allows quantitative analysis of the accuracy of clinical management strategies. Fast-and-frugal provides a simple and transparent, yet solid and robust, methodological framework connecting decision science to clinical care, a sorely needed missing link between CPGs/CPs and patient outcomes. We therefore advocate that all guidelines panels express their recommendations as CPs, which in turn should be converted into FFTs to guide clinical care. © 2018 John Wiley & Sons, Ltd.

Identifying target audiences: who are the guidelines for? : article 1 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Yawn, Barbara P; Akl, Elie A; Qaseem, Amir; Black, Peter; Campos-Outcalt, Doug

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use rigorous processes to ensure that health care recommendations are informed by the best available research evidence. Different clinical practice guidelines addressing the management of the same disease may vary widely in the evidence used and the format of the recommendations, with the result that not all are appropriate for all audiences. This is the first of a series of 14 articles that clinicians, methodologists, and researchers from around the world prepared to advise those developing guidelines in respiratory and other diseases about the potential impact of identifying the target audiences for their clinical practice guidelines. In this review we address the following questions. (1) Which audiences are interested in a chronic obstructive pulmonary disease (COPD) guideline? (2) How many audiences can be addressed in a single COPD guideline? (3) What is the purpose of the guidelines? (4) Who should be included on the guideline panel? We collected information by searching PubMed and reviewing information from groups that are currently making and using respiratory disease guidelines, as well as from workshop discussions. Our conclusions are based on available evidence, consideration of what guideline developers are doing, and the opinions of those who attended the workshop. Clinicians desire COPD and other guidelines that are concise, use evidence from practices similar to theirs, and whose authors have expertise in providing care in similar settings and with similar patients. In the case of COPD, barriers to generalists' use of guidelines include lack of awareness of the guidelines, failure to embrace the diagnostic methods as capable of providing definitive confirmation of COPD, and, most importantly, failure of previous guidelines to address the treatment of COPD in the context of the broad range of multiple morbidities that affect most people with COPD. COPD specialists may require guidelines with more details regarding complex COPD management. The purpose of the guidelines may determine the appropriate audience. Guidelines developed to improve care by enhancing education may have a very different audience than guidelines designed to improve care by limiting the scope of practice, punishing noncompliance, or saving money. The purpose will drive dissemination and implementation strategies, but should not influence the methods used to develop a guideline. Clinicians desire guidelines, but data suggest that the current development systems, content, format, and dissemination strategies may need to be altered to fit these audiences. After the purpose and audience are determined, the guideline committee must decide how to fairly address these audiences, which will usually require seeking their input.

How equity is addressed in clinical practice guidelines: a content analysis

PubMed Central

Shi, Chunhu; Tian, Jinhui; Wang, Quan; Petkovic, Jennifer; Ren, Dan; Yang, Kehu; Yang, Yang

2014-01-01

Objectives Considering equity into guidelines presents methodological challenges. This study aims to qualitatively synthesise the methods for incorporating equity in clinical practice guidelines (CPGs). Setting Content analysis of methodological publications. Eligibility criteria for selecting studies Methodological publications were included if they provided checklists/frameworks on when, how and to what extent equity should be incorporated in CPGs. Data sources We electronically searched MEDLINE, retrieved references, and browsed guideline development organisation websites from inception to January 2013. After study selection by two authors, general characteristics and checklists items/framework components from included studies were extracted. Based on the questions or items from checklists/frameworks (unit of analysis), content analysis was conducted to identify themes and questions/items were grouped into these themes. Primary outcomes The primary outcomes were methodological themes and processes on how to address equity issues in guideline development. Results 8 studies with 10 publications were included from 3405 citations. In total, a list of 87 questions/items was generated from 17 checklists/frameworks. After content analysis, questions were grouped into eight themes (‘scoping questions’, ‘searching relevant evidence’, ‘appraising evidence and recommendations’, ‘formulating recommendations’, ‘monitoring implementation’, ‘providing a flow chart to include equity in CPGs’, and ‘others: reporting of guidelines and comments from stakeholders’ for CPG developers and ‘assessing the quality of CPGs’ for CPG users). Four included studies covered more than five of these themes. We also summarised the process of guideline development based on the themes mentioned above. Conclusions For disadvantaged population-specific CPGs, eight important methodological issues identified in this review should be considered when including equity in CPGs under the guidance of a scientific guideline development manual. PMID:25479795

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

PubMed

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

2013-12-01

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

Utilizing a Collaborative Learning Model to Promote Early Extubation Following Infant Heart Surgery.

PubMed

Mahle, William T; Nicolson, Susan C; Hollenbeck-Pringle, Danielle; Gaies, Michael G; Witte, Madolin K; Lee, Eva K; Goldsworthy, Michelle; Stark, Paul C; Burns, Kristin M; Scheurer, Mark A; Cooper, David S; Thiagarajan, Ravi; Sivarajan, V Ben; Colan, Steven D; Schamberger, Marcus S; Shekerdemian, Lara S

2016-10-01

To determine whether a collaborative learning strategy-derived clinical practice guideline can reduce the duration of endotracheal intubation following infant heart surgery. Prospective and retrospective data collected from the Pediatric Heart Network in the 12 months pre- and post-clinical practice guideline implementation at the four sites participating in the collaborative (active sites) compared with data from five Pediatric Heart Network centers not participating in collaborative learning (control sites). Ten children's hospitals. Data were collected for infants following two-index operations: 1) repair of isolated coarctation of the aorta (birth to 365 d) and 2) repair of tetralogy of Fallot (29-365 d). There were 240 subjects eligible for the clinical practice guideline at active sites and 259 subjects at control sites. Development and application of early extubation clinical practice guideline. After clinical practice guideline implementation, the rate of early extubation at active sites increased significantly from 11.7% to 66.9% (p < 0.001) with no increase in reintubation rate. The median duration of postoperative intubation among active sites decreased from 21.2 to 4.5 hours (p < 0.001). No statistically significant change in early extubation rates was found in the control sites 11.7% to 13.7% (p = 0.63). At active sites, clinical practice guideline implementation had no statistically significant impact on median ICU length of stay (71.9 hr pre- vs 69.2 hr postimplementation; p = 0.29) for the entire cohort. There was a trend toward shorter ICU length of stay in the tetralogy of Fallot subgroup (71.6 hr pre- vs 54.2 hr postimplementation, p = 0.068). A collaborative learning strategy designed clinical practice guideline significantly increased the rate of early extubation with no change in the rate of reintubation. The early extubation clinical practice guideline did not significantly change postoperative ICU length of stay.

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

PubMed

Wang, Yue-Xi; Liu, Meng-Yu; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Xue-Yao; Liu, Yu-Qi; Wang, Yan-Ping; Han, Xue-Jie

2017-09-01

To assess the quality and application effect of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine(Guidelines) through the applicability and applicability evaluation respectively. The questionnaire survey was adopted to evaluate the applicability of the Guidelines, including the utilization, quality, and clinical application conditions. The results showed that the familiarity rate and utilization rate of the Guidelines were 85.37%, 48.78%, respectively. The data showed that the familiarity and the utilization rates were different in the working staff with different professional titles. The evaluation level was the lowest given by the staff with junior professional title (70.97%, 29.03%) in comparison. The assessment showed the overall quality of the Guideline was good and slightly low level for the rationality scores of the other therapeutic methods as well as for the recuperation and prevention (80.49%, 85.37%), which was in line with the clinical compliance of the Guideline. The perspective observation of clinical cases was used for the applicability evaluation, including clinical compliance of the Guideline, effect evaluation, and comprehensive assessment, et al. The results showed that the safety score was the highest, followed by the economic issue and efficacy. For the comprehensive evaluation of the applicability, complete applicability accounted for 29.27%, and the general applicability accounted for 87.80%. It was showed in the three index scores of the applicability evaluation that the accumulative score 7-9 scores were 75.65%, 73.89%, 71.12%. Through the applicability and applicability evaluation, the Guideline was satisfactory in the overall quality, high in the safety of clinical application and good in efficacy and economic issues. There are some limits on the development method and technical issues in the Guideline, which is required to be supplemented in the revision. Additionally, the strategy study on the promotion of the Guideline should be enhanced so as to expedite the recognition and utilization of the Guideline. Copyright© by the Chinese Pharmaceutical Association.

Changing Provider Behavior in the Context of Chronic Disease Management: Focus on Clinical Inertia.

PubMed

Lavoie, Kim L; Rash, Joshua A; Campbell, Tavis S

2017-01-06

Widespread acceptance of evidence-based medicine has led to the proliferation of clinical practice guidelines as the primary mode of communicating current best practices across a range of chronic diseases. Despite overwhelming evidence supporting the benefits of their use, there is a long history of poor uptake by providers. Nonadherence to clinical practice guidelines is referred to as clinical inertia and represents provider failure to initiate or intensify treatment despite a clear indication to do so. Here we review evidence for the ubiquity of clinical inertia across a variety of chronic health conditions, as well as the organizational and system, patient, and provider factors that serve to maintain it. Limitations are highlighted in the emerging literature examining interventions to reduce clinical inertia. An evidence-based framework to address these limitations is proposed that uses behavior change theory and advocates for shared decision making and enhanced guideline development and dissemination.

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

PubMed

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

2013-01-01

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

Clinical Practice Guidelines for Prevention, Diagnosis and Management of Early and Delayed-onset Ocular Injuries Due to Mustard Gas Exposure

PubMed Central

Rajavi, Zhale; Safi, Sare; Javadi, Mohammad Ali; Jafarinasab, Mohammad Reza; Feizi, Sepehr; Moghadam, Mohammadreza Sedighi; Jadidi, Khosrow; Babaei, Mahmoud; Shirvani, Armin; Baradaran-Rafii, Alireza; Mohammad-Rabei, Hossein; Ziaei, Hossein; Ghassemi-Broumand, Mohammad; Baher, Siamak Delfaza; Naderi, Mostafa; Panahi-Bazaz, Mahmoodreza; Zarei-Ghanavati, Siamak; Hanjani, Shahriar; Ghasemi, Hassan; Salouti, Ramin; Pakbin, Mojgan; Kheiri, Bahareh

2017-01-01

Purpose: To develop clinical practice guidelines (CPGs) for prevention, diagnosis, treatment and follow-up of ocular injuries caused by exposure to mustard gas. Methods: The clinical questions were designed by the guideline team. Websites and databases including National Guidelines Clearinghouse, National Institute for Clinical Excellence, Cochrane, and PubMed were searched to find related CPGs and explore possible answers to the clinical questions. Since there were no relevant CPGs in the literature, related articles in Persian and English languages were extracted. Each article along with its level of evidence was summarized. Additionally, hand search was performed by looking the reference list of each article. Consequently, recommendations were developed considering the clinical benefits and side effects of each therapeutic modality. The recommendations were re-evaluated in terms of customization criteria. All recommendations along with the related evidence were scored from 1 to 9 by experts from all medical universities of Iran. The level of agreement among the experts was evaluated by analyzing the given scores. Results: The agreement was achieved for all recommendations. The experts suggested a number of minor modifications which were applied to the recommendations. Finally, CPGs were developed with 98 recommendations under three major domains including prevention of injury, diagnosis and management of the acute and delayed-onset mustard gas ocular injuries. Conclusion: Considering the lack of CPGs for the prevention, diagnosis, and management of mustard gas-induced keratitis, these recommendations would be useful to prevent the serious ocular complications of mustard gas and standardize eye care services to the affected individuals. PMID:28299009

Clinical Practice Guidelines for Prevention, Diagnosis and Management of Early and Delayed-onset Ocular Injuries Due to Mustard Gas Exposure.

PubMed

Rajavi, Zhale; Safi, Sare; Javadi, Mohammad Ali; Jafarinasab, Mohammad Reza; Feizi, Sepehr; Moghadam, Mohammadreza Sedighi; Jadidi, Khosrow; Babaei, Mahmoud; Shirvani, Armin; Baradaran-Rafii, Alireza; Mohammad-Rabei, Hossein; Ziaei, Hossein; Ghassemi-Broumand, Mohammad; Baher, Siamak Delfaza; Naderi, Mostafa; Panahi-Bazaz, Mahmoodreza; Zarei-Ghanavati, Siamak; Hanjani, Shahriar; Ghasemi, Hassan; Salouti, Ramin; Pakbin, Mojgan; Kheiri, Bahareh

2017-01-01

To develop clinical practice guidelines (CPGs) for prevention, diagnosis, treatment and follow-up of ocular injuries caused by exposure to mustard gas. The clinical questions were designed by the guideline team. Websites and databases including National Guidelines Clearinghouse, National Institute for Clinical Excellence, Cochrane, and PubMed were searched to find related CPGs and explore possible answers to the clinical questions. Since there were no relevant CPGs in the literature, related articles in Persian and English languages were extracted. Each article along with its level of evidence was summarized. Additionally, hand search was performed by looking the reference list of each article. Consequently, recommendations were developed considering the clinical benefits and side effects of each therapeutic modality. The recommendations were re-evaluated in terms of customization criteria. All recommendations along with the related evidence were scored from 1 to 9 by experts from all medical universities of Iran. The level of agreement among the experts was evaluated by analyzing the given scores. The agreement was achieved for all recommendations. The experts suggested a number of minor modifications which were applied to the recommendations. Finally, CPGs were developed with 98 recommendations under three major domains including prevention of injury, diagnosis and management of the acute and delayed-onset mustard gas ocular injuries. Considering the lack of CPGs for the prevention, diagnosis, and management of mustard gas-induced keratitis, these recommendations would be useful to prevent the serious ocular complications of mustard gas and standardize eye care services to the affected individuals.

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.

Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines.

PubMed

Dumbreck, Siobhan; Flynn, Angela; Nairn, Moray; Wilson, Martin; Treweek, Shaun; Mercer, Stewart W; Alderson, Phil; Thompson, Alex; Payne, Katherine; Guthrie, Bruce

2015-03-11

To identify the number of drug-disease and drug-drug interactions for exemplar index conditions within National Institute of Health and Care Excellence (NICE) clinical guidelines. Systematic identification, quantification, and classification of potentially serious drug-disease and drug-drug interactions for drugs recommended by NICE clinical guidelines for type 2 diabetes, heart failure, and depression in relation to 11 other common conditions and drugs recommended by NICE guidelines for those conditions. NICE clinical guidelines for type 2 diabetes, heart failure, and depression Potentially serious drug-disease and drug-drug interactions. Following recommendations for prescription in 12 national clinical guidelines would result in several potentially serious drug interactions. There were 32 potentially serious drug-disease interactions between drugs recommended in the guideline for type 2 diabetes and the 11 other conditions compared with six for drugs recommended in the guideline for depression and 10 for drugs recommended in the guideline for heart failure. Of these drug-disease interactions, 27 (84%) in the type 2 diabetes guideline and all of those in the two other guidelines were between the recommended drug and chronic kidney disease. More potentially serious drug-drug interactions were identified between drugs recommended by guidelines for each of the three index conditions and drugs recommended by the guidelines for the 11 other conditions: 133 drug-drug interactions for drugs recommended in the type 2 diabetes guideline, 89 for depression, and 111 for heart failure. Few of these drug-disease or drug-drug interactions were highlighted in the guidelines for the three index conditions. Drug-disease interactions were relatively uncommon with the exception of interactions when a patient also has chronic kidney disease. Guideline developers could consider a more systematic approach regarding the potential for drug-disease interactions, based on epidemiological knowledge of the comorbidities of people with the disease the guideline is focused on, and should particularly consider whether chronic kidney disease is common in the target population. In contrast, potentially serious drug-drug interactions between recommended drugs for different conditions were common. The extensive number of potentially serious interactions requires innovative interactive approaches to the production and dissemination of guidelines to allow clinicians and patients with multimorbidity to make informed decisions about drug selection. © Dumbreck et al 2015.

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.

International CPR guidelines - perspectives in CPR.

PubMed

Nolan, Jerry P

2013-09-01

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

Royal College of Physicians Intercollegiate Stroke Working Party evidence-based guidelines for the secondary prevention of stroke through nutritional or dietary modification.

PubMed

Hookway, C; Gomes, F; Weekes, C E

2015-04-01

Each year, 15 million people worldwide and 110,000 people in England have a stroke. Having a stroke increases the risk of having another. There are a number of additional known risk factors that can be modified by diet. The present study aimed to systematically review key nutrients and diets and their role in secondary prevention, as well as provide evidence-based guidelines for use in clinical practice. The work was conducted as part of the process to develop the 4th edition of the Royal College of Physicians' (RCP) National Clinical Guideline (NCG) for Stroke. Questions were generated by the research team, in consultation with the Virtual Stroke Group, an online professional interest group, and the RCP Intercollegiate Stroke Working Party Guideline Development Group. Nine questions covering several individual nutrients and diet combinations were defined and searches conducted up until 31 October 2011 using five electronic databases (Embase, Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library and Web of Science). All included studies were assessed for quality and risk of bias using van Tulder criteria for randomised controlled trials (RCTs) and Quality of Reporting of Meta-analyses (QUORUM) criteria for systematic reviews. Of 4287 abstracts were identified, 79 papers were reviewed and 29 systematic reviews and RCTs were included to provide evidence for the secondary prevention components of the guidelines. For each question, evidence statements, recommendations and practical considerations were developed. This systematic review process has resulted in the development of evidence-based guidelines for use in clinical practice and has identified areas for further research. © 2014 The British Dietetic Association Ltd.

Use of declarative statements in creating and maintaining computer-interpretable knowledge bases for guideline-based care.

PubMed

Tu, Samson W; Hrabak, Karen M; Campbell, James R; Glasgow, Julie; Nyman, Mark A; McClure, Robert; McClay, James; Abarbanel, Robert; Mansfield, James G; Martins, Susana M; Goldstein, Mary K; Musen, Mark A

2006-01-01

Developing computer-interpretable clinical practice guidelines (CPGs) to provide decision support for guideline-based care is an extremely labor-intensive task. In the EON/ATHENA and SAGE projects, we formulated substantial portions of CPGs as computable statements that express declarative relationships between patient conditions and possible interventions. We developed query and expression languages that allow a decision-support system (DSS) to evaluate these statements in specific patient situations. A DSS can use these guideline statements in multiple ways, including: (1) as inputs for determining preferred alternatives in decision-making, and (2) as a way to provide targeted commentaries in the clinical information system. The use of these declarative statements significantly reduces the modeling expertise and effort required to create and maintain computer-interpretable knowledge bases for decision-support purpose. We discuss possible implications for sharing of such knowledge bases.

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

PubMed

Walker, Jackie; Lane, Pauline; McKenzie, Clare

2010-10-01

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

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

PubMed

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

2018-05-01

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

Addendum Guidelines for the Prevention of Peanut Allergy in the United States

PubMed Central

Togias, Alkis; Cooper, Susan F.; Acebal, Maria L.; Assa’ad, Amal; Baker, James R.; Beck, Lisa A.; Block, Julie; Byrd-Bredbenner, Carol; Chan, Edmond S.; Eichenfield, Lawrence F.; Fleischer, David M.; Fuchs, George J.; Furuta, Glenn T.; Greenhawt, Matthew J.; Gupta, Ruchi S.; Habich, Michele; Jones, Stacie M.; Keaton, Kari; Muraro, Antonella; Plaut, Marshall; Rosenwasser, Lanny J.; Rotrosen, Daniel; Sampson, Hugh A.; Schneider, Lynda C.; Sicherer, Scott H.; Sidbury, Robert; Spergel, Jonathan; Stukus, David R.; Venter, Carina; Boyce, Joshua A.

2016-01-01

Background Food allergy is an important public health problem because it affects children and adults, it may be severe and even life-threatening, and it may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases (NIAID), working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. Objectives Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, NIAID facilitated development of Addendum Guidelines to specifically address the prevention of peanut allergy. Results The Addendum provides three separate guidelines for infants at various risk levels for development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE, skin prick testing, and oral food challenge) and the timing and approaches for introduction of peanut-containing foods in the health care provider’s office or at home. The Addendum Guidelines provide the background, rationale, and strength of evidence for each recommendation. Conclusions Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy. PMID:28065278

Impact of electronic clinical decision support on adherence to guideline-recommended treatment for hyperlipidaemia, atrial fibrillation and heart failure: protocol for a cluster randomised trial

PubMed Central

Kessler, Maya Elizabeth; Cook, David A; Kor, Daryl Jon; McKie, Paul M; Pencille, Laurie J; Scheitel, Marianne R; Chaudhry, Rajeev

2017-01-01

Introduction Clinical practice guidelines facilitate optimal clinical practice. Point of care access, interpretation and application of such guidelines, however, is inconsistent. Informatics-based tools may help clinicians apply guidelines more consistently. We have developed a novel clinical decision support tool that presents guideline-relevant information and actionable items to clinicians at the point of care. We aim to test whether this tool improves the management of hyperlipidaemia, atrial fibrillation and heart failure by primary care clinicians. Methods/analysis Clinician care teams were cluster randomised to receive access to the clinical decision support tool or passive access to institutional guidelines on 16 May 2016. The trial began on 1 June 2016 when access to the tool was granted to the intervention clinicians. The trial will be run for 6 months to ensure a sufficient number of patient encounters to achieve 80% power to detect a twofold increase in the primary outcome at the 0.05 level of significance. The primary outcome measure will be the percentage of guideline-based recommendations acted on by clinicians for hyperlipidaemia, atrial fibrillation and heart failure. We hypothesise care teams with access to the clinical decision support tool will act on recommendations at a higher rate than care teams in the standard of care arm. Ethics and dissemination The Mayo Clinic Institutional Review Board approved all study procedures. Informed consent was obtained from clinicians. A waiver of informed consent and of Health Insurance Portability and Accountability Act (HIPAA) authorisation for patients managed by clinicians in the study was granted. In addition to publication, results will be disseminated via meetings and newsletters. Trial registration number NCT02742545. PMID:29208620

Salient Features and Outline of the Joint Japanese Guidelines for Safe Handling of Cancer Chemotherapy Drugs

PubMed Central

Kanda, Kiyoko; Hirai, Kazue; Iino, Keiko; Nomura, Hisanaga; Yasui, Hisateru; Kano, Taro; Ichikawa, Chisato; Hiura, Sumiko; Morita, Tomoko; Mitsuma, Ayako; Komatsu, Hiroko

2017-01-01

The purpose of this paper is to introduce the outline and describe the salient features of the “Joint Guidelines for Safe Handling of Cancer Chemotherapy Drugs” (hereinafter, “Guideline”), which were published in July 2015. The purpose of this Guideline is to provide guidance to protect against occupational exposure to hazardous drugs (HDs) to all medical personnel involved in cancer chemotherapy, including physicians, pharmacists, and nurses and home health-care providers. The Guideline was developed according to the Medical Information Network Distribution Service guidance for developing clinical practice guidelines, with reference to five authoritative guidelines used worldwide. PubMed, Cumulative Index to Nursing and Allied Health Literature, Ichushi-Web, and Cochrane Central Register of Controlled Trials were used for a systematic search of the literature. Eight clinical questions (CQs) were eventually established, and the strength of recommendation for each CQ is presented based on 867 references. The salient features of the Guideline are that it was jointly developed by three societies (Japanese Society of Cancer Nursing, Japanese Society of Medical Oncology, and Japanese Society of Pharmaceutical Oncology), contains descriptions including the definition of HDs and the concept of hierarchy of controls, and addresses exposure control measures during handling of chemotherapy drugs. Our future task is to collect additional evidence for the recommended exposure control measures and to assess whether publication of the Guideline has led to adherence of measures to prevent occupational exposure. PMID:28966958

UK guidelines on oesophageal dilatation in clinical practice

PubMed Central

Sami, Sarmed S; Haboubi, Hasan N; Ang, Yeng; Boger, Philip; Bhandari, Pradeep; de Caestecker, John; Griffiths, Helen; Haidry, Rehan; Patel, Praful; Paterson, Stuart; Ragunath, Krish; Watson, Peter; Siersema, Peter D; Attwood, Stephen E

2018-01-01

These are updated guidelines which supersede the original version published in 2004. This work has been endorsed by the Clinical Services and Standards Committee of the British Society of Gastroenterology (BSG) under the auspices of the oesophageal section of the BSG. The original guidelines have undergone extensive revision by the 16 members of the Guideline Development Group with representation from individuals across all relevant disciplines, including the Heartburn Cancer UK charity, a nursing representative and a patient representative. The methodological rigour and transparency of the guideline development processes were appraised using the revised Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. Dilatation of the oesophagus is a relatively high-risk intervention, and is required by an increasing range of disease states. Moreover, there is scarcity of evidence in the literature to guide clinicians on how to safely perform this procedure. These guidelines deal specifically with the dilatation procedure using balloon or bougie devices as a primary treatment strategy for non-malignant narrowing of the oesophagus. The use of stents is outside the remit of this paper; however, for cases of dilatation failure, alternative techniques—including stents—will be listed. The guideline is divided into the following subheadings: (1) patient preparation; (2) the dilatation procedure; (3) aftercare and (4) disease-specific considerations. A systematic literature search was performed. The Grading of Recommendations Assessment, Develop­ment and Evaluation (GRADE) tool was used to evaluate the quality of evidence and decide on the strength of recommendations made. PMID:29478034

Reporting of financial conflicts of interest in clinical practice guidelines: a case study analysis of guidelines from the Canadian Medical Association Infobase.

PubMed

Shnier, Adrienne; Lexchin, Joel; Romero, Mirna; Brown, Kevin

2016-08-15

Clinical practice guidelines are widely distributed by medical associations and relied upon by physicians for the best available clinical evidence. International findings report that financial conflicts of interest (FCOI) with drug companies may influence drug recommendations and are common among guideline authors. There is no comparable study on exclusively Canadian guidelines; therefore, we provide a case study of authors' FCOI declarations in guidelines from the Canadian Medical Association (CMA) Infobase. We also assess the financial relationships between guideline-affiliated organizations and drug companies. Using a population approach, we extracted first-line drug recommendations and authors' FCOI disclosures in guidelines from the CMA Infobase. We contacted the corresponding authors on guidelines when FCOI disclosures were missing for some or all authors. We also extracted guideline-affiliated organizations and searched each of their websites to determine if they had financial relationships with drug companies. We analyzed 350 authors from 28 guidelines. Authors were named on one, two, or three guidelines, yielding 400 FCOI statements. In 75.0 % of guidelines at least one author, and in 21.4 % of guidelines all authors, disclosed FCOI with drug companies. In 54.0 % of guidelines at least one author, and in 28.6 % of guidelines over half of the authors, disclosed FCOI with manufacturers of drugs that they recommended. Twenty of 48 authors on multiple guidelines reported different FCOI in their disclosures. Eight guidelines identified affiliated organizations with financial relationships with manufacturers of drugs recommended in those guidelines. This is the first study to systematically describe FCOI disclosures by authors of Canadian guidelines and financial relationships between guideline-affiliated organizations and pharmaceutical companies. These financial relationships are common. Because authoritative value is assigned to guidelines distributed by medical associations, we encourage them to develop formal policies to limit the potential influence of FCOI on guideline recommendations.

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

PubMed

Macrae, Duncan J

2007-05-01

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

Prevention, diagnosis, therapy and follow-up care of sepsis: 1st revision of S-2k guidelines of the German Sepsis Society (Deutsche Sepsis-Gesellschaft e.V. (DSG)) and the German Interdisciplinary Association of Intensive Care and Emergency Medicine (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin (DIVI))

PubMed Central

Reinhart, K.; Brunkhorst, F. M.; Bone, H.-G.; Bardutzky, J.; Dempfle, C.-E.; Forst, H.; Gastmeier, P.; Gerlach, H.; Gründling, M.; John, S.; Kern, W.; Kreymann, G.; Krüger, W.; Kujath, P.; Marggraf, G.; Martin, J.; Mayer, K.; Meier-Hellmann, A.; Oppert, M.; Putensen, C.; Quintel, M.; Ragaller, M.; Rossaint, R.; Seifert, H.; Spies, C.; Stüber, F.; Weiler, N.; Weimann, A.; Werdan, K.; Welte, T.

2010-01-01

Practice guidelines are systematically developed statements and recommendations that assist the physicians and patients in making decisions about appropriate health care measures for specific clinical circumstances taking into account specific national health care structures. The 1st revision of the S-2k guideline of the German Sepsis Society in collaboration with 17 German medical scientific societies and one self-help group provides state-of-the-art information (results of controlled clinical trials and expert knowledge) on the effective and appropriate medical care (prevention, diagnosis, therapy and follow-up care) of critically ill patients with severe sepsis or septic shock. The guideline had been developed according to the “German Instrument for Methodological Guideline Appraisal” of the Association of the Scientific Medical Societies (AWMF). In view of the inevitable advancements in scientific knowledge and technical expertise, revisions, updates and amendments must be periodically initiated. The guideline recommendations may not be applied under all circumstances. It rests with the clinician to decide whether a certain recommendation should be adopted or not, taking into consideration the unique set of clinical facts presented in connection with each individual patient as well as the available resources. PMID:20628653

Challenges and opportunities for pediatric severe TBI-review of the evidence and exploring a way forward.

PubMed

Bell, Michael J; Adelson, P David; Wisniewski, Stephen R

2017-10-01

Traumatic brain injury (TBI) is a leading killer of children in the developed and developing world. Despite evidence-based guidelines and several recent clinical trials, the progress in developing best practices for children with severe TBI has been slow. This article describes (i) the burden of the disease, (ii) the inadequacies of the evidence-based guidelines, (iii) the failure of the largest clinical trials to prove their primary hypotheses, and (iv) possible advances from an observational cohort study called the Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial that has recently completed enrollment.

Guideline on terminology and definitions of updating clinical guidelines: The Updating Glossary.

PubMed

Martínez García, Laura; Pardo-Hernández, Hector; Sanabria, Andrea Juliana; Alonso-Coello, Pablo; Penman, Katrina; McFarlane, Emma

2018-03-01

The Guidelines International Network (G-I-N) Updating Guidelines Working Group launched an initiative to develop a glossary (the Updating Glossary) with domains, terms, definitions, and synonyms related to updating of clinical guidelines (CGs). The steering committee developed an initial list of domains, terms, definitions, and synonyms through brainstorming and discussion. The panel members participated in three rounds of feedback to discuss, refine, and clarify the proposed terms, definitions, and synonyms. Finally, the panel members were surveyed to assess their level of agreement regarding the glossary. Eighteen terms were identified and defined: (1) continuous updating, (2) decision to update, (3) fixed updating, (4) full updating, (5) impact of the new evidence, (6) partial updating, (7) prioritization process, (8) reporting process, (9) signal for an update, (10) surveillance process, (11) time of validity, (12) timeframe, (13) tools and resources, (14) up to date, (15) update cycle, (16) update unit, (17) updated version, and (18) updating strategy. Consensus was reached for all terms, definitions, and synonyms (median agreement scores ≥ 6); except for one term. The G-I-N Updating Guidelines Working Group assembled the Updating Glossary to facilitate and improve the knowledge exchange among CGs developers, researchers, and users. Copyright © 2017 Elsevier Inc. All rights reserved.

Using Qualitative Research to Inform Development of Professional Guidelines: A Case Study of the Society of Critical Care Medicine Family-Centered Care Guidelines.

PubMed

Coombs, Maureen A; Davidson, Judy E; Nunnally, Mark E; Wickline, Mary A; Curtis, J Randall

2017-08-01

To explore the importance, challenges, and opportunities using qualitative research to enhance development of clinical practice guidelines, using recent guidelines for family-centered care in the ICU as an example. In developing the Society of Critical Care Medicine guidelines for family-centered care in the neonatal ICU, PICU, and adult ICU, we developed an innovative adaptation of the Grading of Recommendations, Assessments, Development and Evaluations approach to explicitly incorporate qualitative research. Using Grading of Recommendations, Assessments, Development and Evaluations and the Council of Medical Specialty Societies principles, we conducted a systematic review of qualitative research to establish family-centered domains and outcomes. Thematic analyses were undertaken on study findings and used to support Population, Intervention, Comparison, Outcome question development. We identified and employed three approaches using qualitative research in these guidelines. First, previously published qualitative research was used to identify important domains for the Population, Intervention, Comparison, Outcome questions. Second, this qualitative research was used to identify and prioritize key outcomes to be evaluated. Finally, we used qualitative methods, member checking with patients and families, to validate the process and outcome of the guideline development. In this, a novel report, we provide direction for standardizing the use of qualitative evidence in future guidelines. Recommendations are made to incorporate qualitative literature review and appraisal, include qualitative methodologists in guideline taskforce teams, and develop training for evaluation of qualitative research into guideline development procedures. Effective methods of involving patients and families as members of guideline development represent opportunities for future work.

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

PubMed

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

2013-01-01

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

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

PubMed

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

2013-12-01

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

National Priority Setting of Clinical Practice Guidelines Development for Chronic Disease Management.

PubMed

Jo, Heui-Sug; Kim, Dong Ik; Oh, Moo-Kyung

2015-12-01

By November 2013, a total of 125 clinical practice guidelines (CPGs) have been developed in Korea. However, despite the high burden of diseases and the clinical importance of CPGs, most chronic diseases do not have available CPGs. Merely 83 CPGs are related to chronic diseases, and only 40 guidelines had been developed in the last 5 yr. Considering the rate of the production of new evidence in medicine and the worsening burden from chronic diseases, the need for developing CPGs for more chronic diseases is becoming increasingly pressing. Since 2011, the Korean Academy of Medical Sciences and the Korea Centers for Disease Control and Prevention have been jointly developing CPGs for chronic diseases. However, priorities have to be set and resources need to be allocated within the constraint of a limited funding. This study identifies the chronic diseases that should be prioritized for the development of CPGs in Korea. Through an objective assessment by using the analytic hierarchy process and a subjective assessment with a survey of expert opinion, high priorities were placed on ischemic heart disease, cerebrovascular diseases, Alzheimer's disease and other dementias, osteoarthritis, neck pain, chronic kidney disease, and cirrhosis of the liver.

Regulatory considerations for clinical development of cancer vaccines.

PubMed

Heelan, Bridget Theresa

2014-01-01

Cancer vaccines are aimed at stimulating an immune response to tumor tissue. There is a high level of clinical activity in this rapidly advancing field with over 1,400 trials registered on Clincaltrials.gov. The recent approval of Sipuleucel-T which is the first cancer vaccine approved in the US and EU has encouraged developers in this field. In contrast to more established approaches for treating cancer such as chemotherapy, regulatory guidelines have been developed relatively recently for cancer vaccines. These guidelines advise on general clinical requirements. As there is an increase in innovative strategies with novel products, a 2-way dialog with regulators is recommended on a case-by-case basis to justify the clinical development plan, taking into account specific quality issues related to the product(s) in development. It is important that the rationale, background and justification for the planned development is convincing when interacting with the regulatory authorities, to enable drug developers and regulators to reach agreement.

Clinical guidelines for endoscopic mucosal resection of non-pedunculated colorectal lesions.

PubMed

Albéniz, Eduardo; Pellisé, María; Gimeno García, Antonio Z; Lucendo, Alfredo José; Alonso Aguirre, Pedro A; Herreros de Tejada, Alberto; Álvarez, Marco Antonio; Fraile, María; Herráiz Bayod, Maite; López Rosés, Leopoldo; Martínez Ares, David; Ono, Akiko; Parra Blanco, Adolfo; Redondo, Eduardo; Sánchez Yagüe, Andrés; Soto, Santiago; Díaz Tasende, José; Montes Díaz, Marta; Téllez, Manuel Rodríguez; García, Orlando; Zuñiga Ripa, Alba; Hernández Conde, Marta; Alberca de Las Parras, Fernando; Gargallo, Carla; Saperas, Esteban; Navas, Miguel Muñoz; Gordillo, Javier; Ramos Zabala, Felipe; Echevarría, José Manuel; Bustamante, Marco; González Haba, Mariano; González Huix, Ferrán; González Suárez, Begoña; Vila Costas, Juan José; Guarner Argente, Carlos; Múgica, Fernando; Cobián, Julyssa; Rodríguez Sánchez, Joaquín; López Viedma, Bartolomé; Pin, Noel; Marín Gabriel, José Carlos; Nogales, Óscar; de la Peña, Joaquín; Navajas León, Francisco Javier; León Brito, Helena; Remedios, David; Esteban, José Miguel; Barquero, David; Martínez Cara, Juan Gabriel; Martínez Alcalá, Felipe; Fernández Urién, Ignacio; Valdivielso, Eduardo

2018-03-01

This document summarizes the contents of the Clinical Guidelines for the Endoscopic Mucosal Resection of Non-Pedunculated Colorectal Lesions that was developed by the working group of the Spanish Society of Digestive Endoscopy (GSEED of Endoscopic Resection). This document presents recommendations for the endoscopic management of superficial colorectal neoplastic lesions. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

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

PubMed

Davies, Jonathan

2009-12-01

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

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

PubMed

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

2018-04-27

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

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

PubMed

Siering, Ulrich; Rüther, Alric

2014-01-01

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

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.

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.

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

Applying the knowledge to action framework to plan a strategy for implementing breast cancer screening guidelines: an interprofessional perspective.

PubMed

Munce, Sarah; Kastner, Monika; Cramm, Heidi; Lal, Shalini; Deschêne, Sarah-Maude; Auais, Mohammad; Stacey, Dawn; Brouwers, Melissa

2013-09-01

Integrated knowledge translation (IKT) interventions may be one solution to improving the uptake of clinical guidelines. IKT research initiatives are particularly relevant for breast cancer research and initiatives targeting the implementation of clinical guidelines and guideline implementation initiatives, where collaboration with an interdisciplinary team of practitioners, patients, caregivers, and policy makers is needed for producing optimum patient outcomes. The objective of this paper was to describe the process of developing an IKT strategy that could be used by guideline developers to improve the uptake of their new clinical practice guidelines on breast cancer screening. An interprofessional group of students as well as two faculty members met six times over three days at the KT Canada Summer Institute in 2011. The team used all of the phases of the action cycle in the Knowledge to Action Framework as an organizing framework. While the entire framework was used, the step involving assessing barriers to knowledge use was judged to be particularly relevant in anticipating implementation problems and being able to inform the specific KT interventions that would be appropriate to mitigate these challenges and to accomplish goals and outcomes. This activity also underscored the importance of group process and teamwork in IKT. We propose that an a priori assessment of barriers to knowledge use (i.e., level and corresponding barriers), along with the other phases of the Knowledge to Action Framework, is a strategic approach for KT strategy development, implementation, and evaluation planning and could be used in the future planning of KT strategies.

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

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

PubMed

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

2014-02-01

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

Developing clinical practice guidelines for Chinese herbal treatment of polycystic ovary syndrome: A mixed-methods modified Delphi study.

PubMed

Lai, Lily; Flower, Andrew; Moore, Michael; Lewith, George

2015-06-01

Preliminary evidence suggests Chinese herbal medicine (CHM) could be a viable treatment option for polycystic ovary syndrome (PCOS). Prior to conducting a clinical trial it is important to consider the characteristics of good clinical practice. This study aims to use professional consensus to establish good clinical practice guidelines for the CHM treatment of PCOS. CHM practitioners participated in a mixed-methods modified Delphi study involving three rounds of structured group communication. Round 1 involved qualitative interviews with practitioners to generate statements regarding good clinical practice. In round 2, these statements were distributed online to the same practitioners to rate their agreement using a 7-point Likert scale, where group consensus was defined as a median rating of ≥5. Statements reaching consensus were accepted for consideration onto the guideline whilst those not reaching consensus were re-distributed for consideration in round 3. Statements presented in the guidelines were graded from A (strong consensus) to D (no consensus) determined by median score and interquartile range. 11 CHM practitioners in the UK were recruited. After three Delphi rounds, 91 statement items in total had been considered, of which 89 (97.8%) reached consensus and 2 (2.2%) did not. The concluding set of guidelines consists of 85 items representing key features of CHM prescribing for PCOS. These guidelines can be viewed as an initial framework that captures fundamental principles of good clinical practice for CHM. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2016-01-01

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

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

PubMed

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

2011-10-11

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

Development of tuberculosis infection control guidelines in a pediatric HIV clinic in sub-Saharan Africa.

PubMed

Carlucci, J G; Jin, L; Sanders, J E; Mohapi, E Q; Mandalakas, A M

2015-03-21

A well-established pediatric human immunodeficiency virus (HIV) clinic in Lesotho with initial infection control (IC) measures prioritizing blood-borne disease. In line with international recommendations, services have been expanded to include the management of patients with tuberculosis (TB). The creation of comprehensive IC guidelines with an emphasis on TB has become a priority. To provide a model for developing and implementing IC guidelines in ambulatory care facilities in limited-resource settings with high HIV and TB prevalence. Activities: An IC plan that includes guidance covering both general IC measures and TB-specific guidelines was created by integrating local and international recommendations and emphasizing the importance of administrative measures, environmental controls, and disease-specific precautions. An interdisciplinary committee was established to oversee its implementation, monitoring, and evaluation. Development and implementation of IC guidelines in resource-limited settings are feasible and should be a priority in high HIV and TB prevalence areas. Education should be the cornerstone of such endeavors. Many interventions can be implemented with minimal expertise and material resources. Administrative support and institutional investment are essential to the sustainability of an effective IC program.

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

PubMed

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

2017-01-01

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

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

PubMed

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

2015-11-01

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

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2012-01-01

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

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

PubMed

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

2017-02-01

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

Development of a computerized assessment of clinician adherence to a treatment guideline for patients with bipolar disorder.

PubMed

Dennehy, Ellen B; Suppes, Trisha; John Rush, A; Lynn Crismon, M; Witte, B; Webster, J

2004-01-01

The adoption of treatment guidelines for complex psychiatric illness is increasing. Treatment decisions in psychiatry depend on a number of variables, including severity of symptoms, past treatment history, patient preferences, medication tolerability, and clinical response. While patient outcomes may be improved by the use of treatment guidelines, there is no agreed upon standard by which to assess the degree to which clinician behavior corresponds to those recommendations. This report presents a method to assess clinician adherence to the complex multidimensional treatment guideline for bipolar disorder utilized in the Texas Medication Algorithm Project. The steps involved in the development of this system are presented, including the reliance on standardized documentation, defining core variables of interest, selecting criteria for operationalization of those variables, and computerization of the assessment of adherence. The computerized assessment represents an improvement over other assessment methods, which have relied on laborious and costly chart reviews to extract clinical information and to analyze provider behavior. However, it is limited by the specificity of decisions that guided the adherence scoring process. Preliminary findings using this system with 2035 clinical visits conducted for the bipolar disorder module of TMAP Phase 3 are presented. These data indicate that this system of guideline adherence monitoring is feasible.

Audit, guidelines and standards: clinical governance for hip fracture care in Scotland.

PubMed

Currie, Colin T; Hutchison, James D

To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland. Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004. Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met. Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.

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

PubMed

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

2012-08-01

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

Assessing the effectiveness of strategies to implement clinical guidelines for the management of chronic diseases at primary care level in EU Member States: a systematic review.

PubMed

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

2012-10-01

This review aimed to evaluate the effectiveness of strategies to implement clinical guidelines for chronic disease management in primary care in EU Member States. We conducted a systematic review of interventional studies assessing the implementation of clinical guidelines. We searched five databases (EMBASE, MEDLINE, CENTRAL, Eppi-Centre and Clinicaltrials.gov) following a strict Cochrane methodology. We included studies focusing on the management of chronic diseases in adults in primary care. A total of 21 studies were found. The implementation strategy was fully effective in only four (19%), partially effective in eight (38%), and not effective in nine (43%). The probability that an intervention would be effective was only slightly higher with multifaceted strategies, compared to single interventions. However, effect size varied across studies; therefore it was not possible to determine the most successful strategy. Only eight studies evaluated the impact on patients' health and only two of those showed significant improvement, while in five there was an improvement in the process of care which did not translate into an improvement in health outcomes. Only four studies reported any data on the cost of the implementation but none undertook a cost-effectiveness analysis. Only one study presented data on the barriers to the implementation of guidelines, noting a lack of awareness and agreement about clinical guidelines. Our results reveal that there are only a few rigorous studies which assess the effectiveness of a strategy to implement clinical guidelines in Europe. Moreover, the results are not consistent in showing which strategy is the most appropriate to facilitate their implementation. Therefore, further research is needed to develop more rigorous studies to evaluate health outcomes associated with the implementation of clinical guidelines; to assess the cost-effectiveness of implementing clinical guidelines; and to investigate the perspective of service users and health service staff. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Japanese Clinical Guidelines for Endoscopic Treatment of Pancreatolithiasis.

PubMed

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

2015-10-01

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

Guidelines for the management of hepatitis C in general practice: a semi-qualitative interview survey of GPs' views regarding content and implementation.

PubMed

Cullen, W; O'Leary, M; Langton, D; Stanley, J; Kelly, Y; Bury, G

2005-01-01

Hepatitis C is a common infection among people who attend GPs for methadone maintenance treatment. To determine the views of GPs towards clinical guidelines for the management of hepatitis C among current or former injecting drug users in advance of their implementation. A purposive sample of 14 GPs (10% of the total prescribing methadone at the time the guidelines were developed) was invited to review a pre-publication draft of the guidelines and interviewed regarding content, presentation, perceived barriers to implementation and suggested interventions to facilitate effective implementation of the guidelines. GPs indicated the guidelines were useful but suggested aspects of presentation should be clarified. Organisational issues were identified as the principal barriers to effective implementation, with the provision of additional nursing support the principal intervention suggested to facilitate implementation. Interviewing intended recipients may be an important step in ensuring clinical practice guidelines are effectively implemented.

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

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.

Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines

PubMed Central

Norris, Susan L.; Schulman, Sam; Hirsh, Jack; Eckman, Mark H.; Akl, Elie A.; Crowther, Mark; Vandvik, Per Olav; Eikelboom, John W.; McDonagh, Marian S.; Lewis, Sandra Zelman; Gutterman, David D.; Cook, Deborah J.; Schünemann, Holger J.

2012-01-01

Background: To develop the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: ACCP Evidence-Based Clinical Practice Guidelines (AT9), the American College of Chest Physicians (ACCP) assembled a panel of clinical experts, information scientists, decision scientists, and systematic review and guideline methodologists. Methods: Clinical areas were designated as articles, and a methodologist without important intellectual or financial conflicts of interest led a panel for each article. Only panel members without significant conflicts of interest participated in making recommendations. Panelists specified the population, intervention and alternative, and outcomes for each clinical question and defined criteria for eligible studies. Panelists and an independent evidence-based practice center executed systematic searches for relevant studies and evaluated the evidence, and where resources and evidence permitted, they created standardized tables that present the quality of the evidence and key results in a transparent fashion. Results: One or more recommendations relate to each specific clinical question, and each recommendation is clearly linked to the underlying body of evidence. Judgments regarding the quality of evidence and strength of recommendations were based on approaches developed by the Grades of Recommendations, Assessment, Development, and Evaluation Working Group. Panel members constructed scenarios describing relevant health states and rated the disutility associated with these states based on an additional systematic review of evidence regarding patient values and preferences for antithrombotic therapy. These ratings guided value and preference decisions underlying the recommendations. Each topic panel identified questions in which resource allocation issues were particularly important and, for these issues, experts in economic analysis provided additional searches and guidance. Conclusions: AT9 methodology reflects the current science of evidence-based clinical practice guideline development, with reliance on high-quality systematic reviews, a standardized process for quality assessment of individual studies and the body of evidence, an explicit process for translating the evidence into recommendations, disclosure of financial as well as intellectual conflicts of interest followed by management of disclosed conflicts, and extensive peer review. PMID:22315256

Erratum to: Circulating tumor markers: a guide to their appropriate clinical use | Comparative summary of recommendations from clinical practice guidelines (PART 1), (PART 2), (PART 3).

PubMed

2017-10-31

Erratum To: Circulating tumor markers: a guide to their appropriate clinical use | Comparative summary of recommendations from clinical practice guidelines (PART 1) Gion M, Trevisiol C, Rutjes AW, Rainato G, Fabricio AS. Int J Biol Markers. 2016 Dec 23;31(4):e332-e367. doi: 10.5301/jbm.5000251. Circulating tumor markers: a guide to their appropriate clinical use | Comparative summary of recommendations from clinical practice guidelines (PART 2).Gion M, Trevisiol C, Rutjes AWS, Rainato G, Fabricio ASC. Int J Biol Markers. 2017 Mar 2;32(1):e1-e52. doi: 10.5301/ijbm.5000259. Circulating tumor markers: a guide to their appropriate clinical use | Comparative summary of recommendations from clinical practice guidelines (PART 3).Gion M, Trevisiol C, Rutjes AWS, Rainato G, Fabricio ASC. Int J Biol Markers. 2017 May 4;32(2):e147-e181. doi: 10.5301/ijbm.5000272. We report an amendment in the Detailed summary tables pages of the three parts of the guidelines above. The correct definition of detailed summary tables is reported below. Definition and target audience Detailed summary tables are tables prepared for every tumor type which report recommendations and supplementary information from different guidance documents with enough details to be useful for health care providers, policy makers (for potential adaptation to specific settings) and staff developing educational material informed by available evidence.

An Official American Thoracic Society Workshop Report

PubMed Central

Wilson, Kevin C.; Gould, Michael K.; Krishnan, Jerry A.; Boyd, Cynthia M.; Brozek, Jan L.; Cooke, Colin R.; Douglas, Ivor S.; Goodman, Richard A.; Joo, Min J.; Lareau, Suzanne; Mularski, Richard A.; Patel, Minal R.; Rosenfeld, Richard M.; Shanawani, Hasan; Slatore, Christopher; Sockrider, Marianna; Sufian, Beth; Thomson, Carey C.; Wiener, Renda Soylemez

2018-01-01

Coexistence of multiple chronic conditions (i.e., multimorbidity) is the most common chronic health problem in adults. However, clinical practice guidelines have primarily focused on patients with a single disease, resulting in uncertainty about the care of patients with multimorbidity. The American Thoracic Society convened a workshop with the goal of establishing a strategy to address multimorbidity within clinical practice guidelines. In this Workshop Report, we describe a framework that addresses multimorbidity in each of the key steps of guideline development: topic selection, panel composition, identifying clinical questions, searching for and synthesizing evidence, rating the quality of that evidence, summarizing benefits and harms, formulating recommendations, and rating the strength of the recommendations. For the consideration of multimorbidity in guidelines to be successful and sustainable, the process must be both feasible and pragmatic. It is likely that this will be achieved best by the step-wise addition and refinement of the various components of the framework. PMID:26963362

How to report a research study.

PubMed

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

2014-09-01

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

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

Evaluation of Industry Relationships Among Authors of Otolaryngology Clinical Practice Guidelines.

PubMed

Horn, Jarryd; Checketts, Jake Xavier; Jawhar, Omar; Vassar, Matt

2018-03-01

Financial relationships between physicians and industry have influence on patient care. Therefore, organizations producing clinical practice guidelines (CPGs) must have policies limiting financial conflicts during guideline development. To evaluate payments received by physician authors of otolaryngology CPGs, compare disclosure statements for accuracy, and investigate the extent to which the American Academy of Otolaryngology-Head and Neck Surgery complied with standards for guideline development from the Institute of Medicine (IOM). This cross-sectional analysis retrieved CPGs from the American Academy of Otolaryngology-Head and Neck Surgery Foundation that were published or revised from January 1, 2013, through December 31, 2015, by 49 authors. Data were retrieved from December 1 through 31, 2016. Industry payments received by authors were extracted using the Centers for Medicare & Medicaid Services Open Payments database. The values and types of these payments were then evaluated and used to determine whether self-reported disclosure statements were accurate and whether guidelines adhered to applicable IOM standards. The monetary amounts and types of payments received by physicians who author otolaryngology guidelines and the accuracy of disclosure statements. Of the 49 physicians in this sample, 39 (80%) received an industry payment. Twenty-one authors (43%) accepted more than $1000; 12 (24%), more than $10 000; 7 (14%), more than $50 000; and 2 (4%), more than $100 000. Mean (SD) financial payments amounted to $18 431 ($53 459) per physician. Total reimbursement for all authors was $995 282. Disclosure statements disagreed with the Open Payments database for 3 authors, amounting to approximately $20 000 among them. Of the 3 IOM standards assessed, only 1 was consistently enforced. Some CPG authors failed to fully disclose all financial conflicts of interest, and most guideline development panels and chairpersons had conflicts. In addition, adherence to IOM standards for guideline development was lacking. This study is relevant to CPG panels authoring recommendations, physicians implementing CPGs to guide patient care, and the organizations establishing policies for guideline development.

Curriculum Guidelines & Regulatory Criteria for Family Nurse Practitioners Seeking Prescriptive Authority To Manage Pharmacotherapeutics in Primary Care. Summary Report 1998.

ERIC Educational Resources Information Center

National Council of State Boards of Nursing, Chicago, IL.

This report describes a multi-organizational project to accomplish two goals: (1) to develop pharmacology/pharmacotherapeutics curriculum guidelines designed to prepare family nurse practitioners (FNPs) for full prescriptive authority; and (2) to develop regulatory criteria for evaluating the academic preparation and clinical competencies of FNPs…

[Interpretation of 2018 guidelines for the early management of patients with acute ischemic stroke].

PubMed

Wang, Gang; Fang, Bangjiang; Yu, Xuezhong; Li, Zhijun

2018-04-01

In 2018, the American Heart Association/American Stroke Association (AHA/ASA) has developed the latest 2018 guidelines for the early management of patients with acute ischemic stroke (AIS), based on the latest evidences. The 2018 guidelines including recommendations on pre-hospital and in-hospital management treatment, has revised and add new recommendations from 2013 guideline. The major changes in 2018 guideline involve applications of brain imaging in early stage, intravenous thrombolysis and mechanical thrombectomy, et al. This review interprets the 2018 guidelines for clinicians to improve the clinical diagnosis, treatment and outcome of patients with AIS.

Evidence-based practice guideline of Chinese herbal medicine for primary open-angle glaucoma (qingfeng -neizhang).

PubMed

Yang, Yingxin; Ma, Qiu-Yan; Yang, Yue; He, Yu-Peng; Ma, Chao-Ting; Li, Qiang; Jin, Ming; Chen, Wei

2018-03-01

Primary open angle glaucoma (POAG) is a chronic, progressive optic neuropathy. The aim was to develop an evidence-based clinical practice guideline of Chinese herbal medicine (CHM) for POAG with focus on Chinese medicine pattern differentiation and treatment as well as approved herbal proprietary medicine. The guideline development group involved in various pieces of expertise in contents and methods. Authors searched electronic databases include CNKI, VIP, Sino-Med, Wanfang data, PubMed, the Cochrane Library, EMBASE, as well as checked China State Food and Drug Administration (SFDA) from the inception of these databases to June 30, 2015. Systematic reviews and randomized controlled trials of Chinese herbal medicine treating adults with POAG were evaluated. Risk of bias tool in the Cochrane Handbook and evidence strength developed by the GRADE group were applied for the evaluation, and recommendations were based on the findings incorporating evidence strength. After several rounds of Expert consensus, the final guideline was endorsed by relevant professional committees. CHM treatment principle and formulae based on pattern differentiation together with approved patent herbal medicines are the main treatments for POAG, and the diagnosis and treatment focusing on blood related patterns is the major domain. CHM therapy alone or combined with other conventional treatment reported in clinical studies together with Expert consensus were recommended for clinical practice.

Consensus clinical management guidelines for Niemann-Pick disease type C.

PubMed

Geberhiwot, Tarekegn; Moro, Alessandro; Dardis, Andrea; Ramaswami, Uma; Sirrs, Sandra; Marfa, Mercedes Pineda; Vanier, Marie T; Walterfang, Mark; Bolton, Shaun; Dawson, Charlotte; Héron, Bénédicte; Stampfer, Miriam; Imrie, Jackie; Hendriksz, Christian; Gissen, Paul; Crushell, Ellen; Coll, Maria J; Nadjar, Yann; Klünemann, Hans; Mengel, Eugen; Hrebicek, Martin; Jones, Simon A; Ory, Daniel; Bembi, Bruno; Patterson, Marc

2018-04-06

Niemann-Pick Type C (NPC) is a progressive and life limiting autosomal recessive disorder caused by mutations in either the NPC1 or NPC2 gene. Mutations in these genes are associated with abnormal endosomal-lysosomal trafficking, resulting in the accumulation of multiple tissue specific lipids in the lysosomes. The clinical spectrum of NPC disease ranges from a neonatal rapidly progressive fatal disorder to an adult-onset chronic neurodegenerative disease. The age of onset of the first (beyond 3 months of life) neurological symptom may predict the severity of the disease and determines life expectancy.NPC has an estimated incidence of ~ 1: 100,000 and the rarity of the disease translate into misdiagnosis, delayed diagnosis and barriers to good care. For these reasons, we have developed clinical guidelines that define standard of care for NPC patients, foster shared care arrangements between expert centres and family physicians, and empower patients. The information contained in these guidelines was obtained through a systematic review of the literature and the experiences of the authors in their care of patients with NPC. We adopted the Appraisal of Guidelines for Research & Evaluation (AGREE II) system as method of choice for the guideline development process. We made a series of conclusive statements and scored them according to level of evidence, strengths of recommendations and expert opinions. These guidelines can inform care providers, care funders, patients and their carers of best practice of care for patients with NPC. In addition, these guidelines have identified gaps in the knowledge that must be filled by future research. It is anticipated that the implementation of these guidelines will lead to a step change in the quality of care for patients with NPC irrespective of their geographical location.

Commentary on recent therapeutic guidelines for osteoarthritis.

PubMed

Cutolo, Maurizio; Berenbaum, Francis; Hochberg, Marc; Punzi, Leonardo; Reginster, Jean-Yves

2015-06-01

Despite availability of international evidence-based guidelines for osteoarthritis (OA) management, agreement on the different treatment modalities is lacking. A symposium of European and US OA experts was held within the framework of the Annual European Congress of Rheumatology to discuss and compare guidelines and recommendations for the treatment of knee OA and to reach a consensus for management, particularly for areas in which there is no clear consensus: non-pharmacological therapy; efficacy and safety of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs); intra-articular (i.a.) hyaluronates (HA); and the role of chondroitin sulfate (CS) and/or glucosamine sulfate (GS). All guidelines reviewed agree that knee OA is a progressive disease of the joint whose management requires non-pharmacological and pharmacological approaches. Discrepancies between guidelines are few and mostly reflect heterogeneity of expert panels involved, geographical differences in the availability of pharmacotherapies, and heterogeneity of the studies included. Panels chosen for guideline development should include experts with real clinical experience in drug use and patient management. Implementation of agreed guidelines can be thwarted by drug availability and reimbursement plans, resulting in optimal OA treatment being jeopardized, HA and symptomatic slow-acting drugs for osteoarthritis (SySADOAs) being clear examples of drugs whose availability and prescription can greatly vary geographically. In addition, primary care providers, often responsible for OA management (at least in early disease), may not adhere to clinical care guidelines, particularly for non-pharmacological OA treatment. Harmonization of the recommendations for knee OA treatment is challenging but feasible, as shown by the step-by-step therapeutic algorithm developed by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). More easily disseminated and implemented guidance for OA treatment in the primary care setting is key to improved management of OA. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparison of global versus Asian clinical trial strategies supportive of registration of drugs in Japan.

PubMed

Shirotani, Mari; Kurokawa, Tatsuo; Chiba, Koji

2014-07-01

The number of worldwide and Asian multiregional clinical trials (MRCTs) submitted for Japanese New Drug Applications increased markedly between 2009 and 2013, with an increasing number performed for simultaneously submission in the USA, EU, and Japan. Asian studies accounted for 32% of MRCTs (14/44 studies) and had comparatively small sample sizes (<500 subjects). Moreover, the number of Japanese subjects in Asian studies was 2.1- to 13.4-fold larger than the sample size estimated using the method described in Japanese MRCT guidelines, whereas the ratio for worldwide studies was 0.05- to 4.9-fold. Before the introduction of this guidelines, bridging or domestic clinical development strategies were used as the regional development strategy in accordance with ICH E5 guidelines. The results presented herein suggest that Asian studies were conducted when the drug had already been approved in the US/EU, when phase 3 clinical trials were not be planned in the USA/EU, when there was insufficient knowledge of ethnic differences in drug efficacy and safety, or when Caucasian data could not be extrapolated to the Japanese population. New strategies with Asian studies including the Japanese population could be conducted instead of Japanese domestic development strategy. © 2014, The American College of Clinical Pharmacology.

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.

Conceptual Models and Guidelines for Clinical Assessment of Financial Capacity.

PubMed

Marson, Daniel

2016-09-01

The ability to manage financial affairs is a life skill of critical importance, and neuropsychologists are increasingly asked to assess financial capacity across a variety of settings. Sound clinical assessment of financial capacity requires knowledge and appreciation of applicable clinical conceptual models and principles. However, the literature has presented relatively little conceptual guidance for clinicians concerning financial capacity and its assessment. This article seeks to address this gap. The article presents six clinical models of financial capacity : (1) the early gerontological IADL model of Lawton, (2) the clinical skills model and (3) related cognitive psychological model developed by Marson and colleagues, (4) a financial decision-making model adapting earlier decisional capacity work of Appelbaum and Grisso, (5) a person-centered model of financial decision-making developed by Lichtenberg and colleagues, and (6) a recent model of financial capacity in the real world developed through the Institute of Medicine. Accompanying presentation of the models is discussion of conceptual and practical perspectives they represent for clinician assessment. Based on the models, the article concludes by presenting a series of conceptually oriented guidelines for clinical assessment of financial capacity. In summary, sound assessment of financial capacity requires knowledge and appreciation of clinical conceptual models and principles. Awareness of such models, principles and guidelines will strengthen and advance clinical assessment of financial capacity. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Guidelines for wise utilization of knee imaging].

PubMed

Finestone, Aharon S; Eshed, Iris; Freedman, Yehuda; Beer, Yiftah; Bar-Sever, Zvi; Kots, Yavvgeni; Adar, Eliyahu; Mann, Gideon

2012-02-01

The knee is a complex structure afflicted with diverse pathologies. Correct management of knee complaints demands wise utilization of imaging modalities, considering their accuracy in the specific clinical situation, the patient's safety and availability and financial issues. Some of these considerations are universal, while others are local, depending on medical and insurance systems. There is controversy and unclearness regarding the best imaging modality in different clinical situations. To develop clinical guidelines for utilizing knee imaging. Leading physicians in specialties associated with knee disease and imaging were invited to participate in a panel on the guidelines. Controversies were settled in the main panel or in sub-panels. The panel agreed on the principles in choosing from the various modalities, primarily medical accuracy, followed by patient safety, availability and cost. There was agreement that the physician is responsible to choose the most appropriate diagnostic tool, consulting, when necessary, on the advantages, limitations and risks of the various imaging modalities. A comprehensive table was compiled with the importance of the different imaging modalities in various clinical situations. For the first time, Israeli guidelines on wise utilization of knee imaging are presented. They take into consideration the clinical situations and also availability and financial issues specific to Israel. These guidelines will serve physicians of several disciplines and medical insurers to improve patient management efficiently.

Estimation of Direct Melanoma-related Costs by Disease Stage and by Phase of Diagnosis and Treatment According to Clinical Guidelines.

PubMed

Buja, Alessandra; Sartor, Gino; Scioni, Manuela; Vecchiato, Antonella; Bolzan, Mario; Rebba, Vincenzo; Sileni, Vanna Chiarion; Palozzo, Angelo Claudio; Montesco, Maria; Del Fiore, Paolo; Baldo, Vincenzo; Rossi, Carlo Riccardo

2018-02-07

Cutaneous melanoma is a major concern in terms of healthcare systems and economics. The aim of this study was to estimate the direct costs of melanoma by disease stage, phase of diagnosis, and treatment according to the pre-set clinical guidelines drafted by the AIOM (Italian Medical Oncological Association). Based on the AIOM guidelines for malignant cutaneous melanoma, a highly detailed decision-making model was developed describing the patient's pathway from diagnosis through the subsequent phases of disease staging, surgical and medical treatment, and follow-up. The model associates each phase potentially involving medical procedures with a likelihood measure and a cost, thus enabling an estimation of the expected costs by disease stage and clinical phase of melanoma diagnosis and treatment according to the clinical guidelines. The mean per-patient cost of the whole melanoma pathway (including one year of follow-up) ranged from €149 for stage 0 disease to €66,950 for stage IV disease. The costs relating to each phase of the disease's diagnosis and treatment depended on disease stage. It is essential to calculate the direct costs of managing malignant cutaneous melanoma according to clinical guidelines in order to estimate the economic burden of this disease and to enable policy-makers to allocate appropriate resources.

[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.

Recommendations for patient engagement in guideline development panels: A qualitative focus group study of guideline-naïve patients.

PubMed

Armstrong, Melissa J; Mullins, C Daniel; Gronseth, Gary S; Gagliardi, Anna R

2017-01-01

Patient and consumer engagement in clinical practice guideline development is internationally advocated, but limited research explores mechanisms for successful engagement. To investigate the perspectives of potential patient/consumer guideline representatives on topics pertaining to engagement including guideline development group composition and barriers to and facilitators of engagement. Participants were guideline-naïve volunteers for programs designed to link community members to academic research with diverse ages, gender, race, and degrees of experience interacting with health care professionals. Three focus groups and one key informant interview were conducted and analyzed using a qualitative descriptive approach. Participants recommended small, diverse guideline development groups engaging multiple patient/consumer stakeholders with no prior relationships with each other or professional panel members. No consensus was achieved on the ideal balance of patient/consumer and professional stakeholders. Pre-meeting reading/training and an identified contact person were described as keys to successful early engagement; skilled facilitators, understandable speech and language, and established mechanisms for soliciting patient opinions were suggested to enhance engagement at meetings. Most suggestions for effective patient/consumer engagement in guidelines require forethought and planning but little additional expense, making these strategies easily accessible to guideline developers desiring to achieve more meaningful patient and consumer engagement.

Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer.

PubMed

Watanabe, Toshiaki; Muro, Kei; Ajioka, Yoichi; Hashiguchi, Yojiro; Ito, Yoshinori; Saito, Yutaka; Hamaguchi, Tetsuya; Ishida, Hideyuki; Ishiguro, Megumi; Ishihara, Soichiro; Kanemitsu, Yukihide; Kawano, Hiroshi; Kinugasa, Yusuke; Kokudo, Norihiro; Murofushi, Keiko; Nakajima, Takako; Oka, Shiro; Sakai, Yoshiharu; Tsuji, Akihito; Uehara, Keisuke; Ueno, Hideki; Yamazaki, Kentaro; Yoshida, Masahiro; Yoshino, Takayuki; Boku, Narikazu; Fujimori, Takahiro; Itabashi, Michio; Koinuma, Nobuo; Morita, Takayuki; Nishimura, Genichi; Sakata, Yuh; Shimada, Yasuhiro; Takahashi, Keiichi; Tanaka, Shinji; Tsuruta, Osamu; Yamaguchi, Toshiharu; Yamaguchi, Naohiko; Tanaka, Toshiaki; Kotake, Kenjiro; Sugihara, Kenichi

2018-02-01

Japanese mortality due to colorectal cancer is on the rise, surpassing 49,000 in 2015. Many new treatment methods have been developed during recent decades. The Japanese Society for Cancer of the Colon and Rectum Guidelines 2016 for the treatment of colorectal cancer (JSCCR Guidelines 2016) were prepared to show standard treatment strategies for colorectal cancer, to eliminate disparities among institutions in terms of treatment, to eliminate unnecessary treatment and insufficient treatment, and to deepen mutual understanding between health-care professionals and patients by making these Guidelines available to the general public. These Guidelines were prepared by consensus reached by the JSCCR Guideline Committee, based on a careful review of the evidence retrieved by literature searches, and in view of the medical health insurance system and actual clinical practice settings in Japan. Therefore, these Guidelines can be used as a tool for treating colorectal cancer in actual clinical practice settings. More specifically, they can be used as a guide to obtaining informed consent from patients and choosing the method of treatment for each patient. As a result of the discussions held by the Guideline Committee, controversial issues were selected as Clinical Questions, and recommendations were made. Each recommendation is accompanied by a classification of the evidence and a classification of recommendation categories based on the consensus reached by the Guideline Committee members. Here we present the English version of the JSCCR Guidelines 2016.

Tailoring International Pressure Ulcer Prevention Guidelines for Nigeria: A Knowledge Translation Study Protocol.

PubMed

Ilesanmi, Rose Ekama; Gillespie, Brigid M; Adejumo, Prisca Olabisi; Chaboyer, Wendy

2015-07-28

The 2014 International Pressure Ulcer Prevention (PUP) Clinical Practice Guidelines (CPG) provides the most current evidence based strategies to prevent Pressure Ulcer (PU). The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable. To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. Guided by the Knowledge to Action (KTA) framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle. A PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care. Using KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources.

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.

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

PubMed

Watine, Joseph; Wils, Julien; Augereau, Christine

2017-02-01

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

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

[Correspondence between advances of dental composites and adhesives and clinical guidelines for direct restorations].

PubMed

Wang, X Y; Yue, L

2018-06-09

The longevity of direct adhesive restoration is related to the restorative materials, the patient and the professional. On one hand, dental composites/adhesives have been modified and developed to fulfill the criteria for clinical application. On the other hand, the clinical guidelines for adhesive restorations have been released and updated accordingly, which would prolong the longevity of restorations. In this commentary, the removal of carious tissues, interface preparation for bonding and application of adhesives are emphasized. The administrative measures for registration and clinical evaluation criteria for adhesive restorative material are also introduced.

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

PubMed

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

2016-04-01

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

[Management of Patients on Antithrombotic Agents Undergoing Endoscopy].

PubMed

Kim, Joon Sung; Kim, Byung Wook

2018-05-25

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

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

PubMed

Shiffman, Richard N; Michel, Georges

2004-01-01

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

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.

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.

Patients' Experiences With Vehicle Collision to Inform the Development of Clinical Practice Guidelines: A Narrative Inquiry.

PubMed

Lindsay, Gail M; Mior, Silvano A; Côté, Pierre; Carroll, Linda J; Shearer, Heather M

2016-01-01

The purpose of this narrative inquiry was to explore the experiences of persons who were injured in traffic collisions and seek their recommendations for the development of clinical practice guideline (CPG) for the management of minor traffic injuries. Patients receiving care for traffic injuries were recruited from 4 clinics in Ontario, Canada resulting in 11 adult participants (5 men, 6 women). Eight were injured while driving cars, 1 was injured on a motorcycle, 2 were pedestrians, and none caused the collision. Using narrative inquiry methodology, initial interviews were audiotaped, and follow-up interviews were held within 2 weeks to extend the story of experience created from the first interview. Narrative plotlines across the 11 stories were identified, and a composite story inclusive of all recommendations was developed by the authors. The research findings and composite narrative were used to inform the CPG Expert Panel in the development of new CPGs. Four recommended directions were identified from the narrative inquiry process and applied. First, terminology that caused stigma was a concern. This resulted in modified language ("injured persons") being adopted by the Expert Panel, and a new nomenclature categorizing layers of injury was identified. Second, participants valued being engaged as partners with health care practitioners. This resulted in inclusion of shared decision-making as a foundational recommendation connecting CPGs and care planning. Third, emotional distress was recognized as a factor in recovery. Therefore, the importance of early detection and the ongoing evaluation of risk factors for delayed recovery were included in all CPGs. Fourth, participants shared that they were unfamiliar with the health care system and insurance industry before their accident. Thus, repeatedly orienting injured persons to the system was advised. A narrative inquiry of 11 patients' experiences with traffic collision and their recommendations for clinical guidelines informed the Ontario Protocol for Traffic Injury Management Collaboration in the development of new Minor Injury Guidelines. The values and findings of the qualitative inquiry were interwoven into each clinical pathway and embedded within the final guideline report submitted to government. Copyright © 2016 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

Lessons learned in detailed clinical modeling at Intermountain Healthcare

PubMed Central

Oniki, Thomas A; Coyle, Joseph F; Parker, Craig G; Huff, Stanley M

2014-01-01

Background and objective Intermountain Healthcare has a long history of using coded terminology and detailed clinical models (DCMs) to govern storage of clinical data to facilitate decision support and semantic interoperability. The latest iteration of DCMs at Intermountain is called the clinical element model (CEM). We describe the lessons learned from our CEM efforts with regard to subjective decisions a modeler frequently needs to make in creating a CEM. We present insights and guidelines, but also describe situations in which use cases conflict with the guidelines. We propose strategies that can help reconcile the conflicts. The hope is that these lessons will be helpful to others who are developing and maintaining DCMs in order to promote sharing and interoperability. Methods We have used the Clinical Element Modeling Language (CEML) to author approximately 5000 CEMs. Results Based on our experience, we have formulated guidelines to lead our modelers through the subjective decisions they need to make when authoring models. Reported here are guidelines regarding precoordination/postcoordination, dividing content between the model and the terminology, modeling logical attributes, and creating iso-semantic models. We place our lessons in context, exploring the potential benefits of an implementation layer, an iso-semantic modeling framework, and ontologic technologies. Conclusions We assert that detailed clinical models can advance interoperability and sharing, and that our guidelines, an implementation layer, and an iso-semantic framework will support our progress toward that goal. PMID:24993546

Development of a meta-algorithm for guiding primary care encounters for patients with multimorbidity using evidence-based and case-based guideline development methodology.

PubMed

Muche-Borowski, Cathleen; Lühmann, Dagmar; Schäfer, Ingmar; Mundt, Rebekka; Wagner, Hans-Otto; Scherer, Martin

2017-06-22

The study aimed to develop a comprehensive algorithm (meta-algorithm) for primary care encounters of patients with multimorbidity. We used a novel, case-based and evidence-based procedure to overcome methodological difficulties in guideline development for patients with complex care needs. Systematic guideline development methodology including systematic evidence retrieval (guideline synopses), expert opinions and informal and formal consensus procedures. Primary care. The meta-algorithm was developed in six steps:1. Designing 10 case vignettes of patients with multimorbidity (common, epidemiologically confirmed disease patterns and/or particularly challenging health care needs) in a multidisciplinary workshop.2. Based on the main diagnoses, a systematic guideline synopsis of evidence-based and consensus-based clinical practice guidelines was prepared. The recommendations were prioritised according to the clinical and psychosocial characteristics of the case vignettes.3. Case vignettes along with the respective guideline recommendations were validated and specifically commented on by an external panel of practicing general practitioners (GPs).4. Guideline recommendations and experts' opinions were summarised as case specific management recommendations (N-of-one guidelines).5. Healthcare preferences of patients with multimorbidity were elicited from a systematic literature review and supplemented with information from qualitative interviews.6. All N-of-one guidelines were analysed using pattern recognition to identify common decision nodes and care elements. These elements were put together to form a generic meta-algorithm. The resulting meta-algorithm reflects the logic of a GP's encounter of a patient with multimorbidity regarding decision-making situations, communication needs and priorities. It can be filled with the complex problems of individual patients and hereby offer guidance to the practitioner. Contrary to simple, symptom-oriented algorithms, the meta-algorithm illustrates a superordinate process that permanently keeps the entire patient in view. The meta-algorithm represents the back bone of the multimorbidity guideline of the German College of General Practitioners and Family Physicians. This article presents solely the development phase; the meta-algorithm needs to be piloted before it can be implemented. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed Central

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

2017-01-01

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

Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel.

PubMed

Togias, Alkis; Cooper, Susan F; Acebal, Maria L; Assa'ad, Amal; Baker, James R; Beck, Lisa A; Block, Julie; Byrd-Bredbenner, Carol; Chan, Edmond S; Eichenfield, Lawrence F; Fleischer, David M; Fuchs, George J; Furuta, Glenn T; Greenhawt, Matthew J; Gupta, Ruchi S; Habich, Michele; Jones, Stacie M; Keaton, Kari; Muraro, Antonella; Plaut, Marshall; Rosenwasser, Lanny J; Rotrosen, Daniel; Sampson, Hugh A; Schneider, Lynda C; Sicherer, Scott H; Sidbury, Robert; Spergel, Jonathan; Stukus, David R; Venter, Carina; Boyce, Joshua A

2017-02-01

Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy. Published by Elsevier Inc.

Addendum Guidelines for the Prevention of Peanut Allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-Sponsored Expert Panel.

PubMed

Togias, Alkis; Cooper, Susan F; Acebal, Maria L; Assa'ad, Amal; Baker, James R; Beck, Lisa A; Block, Julie; Byrd-Bredbenner, Carol; Chan, Edmond S; Eichenfield, Lawrence F; Fleischer, David M; Fuchs, George J; Furuta, Glenn T; Greenhawt, Matthew J; Gupta, Ruchi S; Habich, Michele; Jones, Stacie M; Keaton, Kari; Muraro, Antonella; Plaut, Marshall; Rosenwasser, Lanny J; Rotrosen, Daniel; Sampson, Hugh A; Schneider, Lynda C; Sicherer, Scott H; Sidbury, Robert; Spergel, Jonathan; Stukus, David R; Venter, Carina; Boyce, Joshua A

Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy. Published by Elsevier Inc.

Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel.

PubMed

Togias, Alkis; Cooper, Susan F; Acebal, Maria L; Assa'ad, Amal; Baker, James R; Beck, Lisa A; Block, Julie; Byrd-Bredbenner, Carol; Chan, Edmond S; Eichenfield, Lawrence F; Fleischer, David M; Fuchs, George J; Furuta, Glenn T; Greenhawt, Matthew J; Gupta, Ruchi S; Habich, Michele; Jones, Stacie M; Keaton, Kari; Muraro, Antonella; Plaut, Marshall; Rosenwasser, Lanny J; Rotrosen, Daniel; Sampson, Hugh A; Schneider, Lynda C; Sicherer, Scott H; Sidbury, Robert; Spergel, Jonathan; Stukus, David R; Venter, Carina; Boyce, Joshua A

2017-01-01

Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. The addendum provides 3 separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy. Published by Elsevier Inc.

They're NICE and Neat, but Are They Useful? A Grounded Theory of Clinical Psychologists' Beliefs About and Use of NICE Guidelines.

PubMed

Court, Alex John; Cooke, Anne; Scrivener, Amanda

2017-07-01

Guidelines are ubiquitous but inconsistently used in UK mental health services. Clinical psychologists are often influential in guideline development and implementation, but opinion within the profession is divided. This study utilized grounded theory methodology to examine clinical psychologists' beliefs about and use of NICE guidelines. Eleven clinical psychologists working in the NHS were interviewed. The overall emerging theme was; NICE guidelines are considered to have benefits but to be fraught with dangers. Participants were concerned that guidelines can create an unhelpful illusion of neatness. They managed the tension between the helpful and unhelpful aspects of guidelines by relating to them in a flexible manner. The participants reported drawing on specialist skills such as idiosyncratic formulation and integration. However, due to the pressures and dominant discourses within services they tended to practice in ways that prevent these skills from being recognized. This led to fears that their professional identity was threatened, which impacted upon perceptions of the guidelines. To our knowledge, the theoretical framework presented in this paper is the first that attempts to explain why NICE guidelines are not consistently utilized in UK mental health services. The current need for services to demonstrate 'NICE compliance' may be leading to a perverse incentive for clinical psychologists in particular to do one thing but say another and for specialist skills to be obscured. If borne out by future studies, this represents a threat to continued quality improvement and also to the profession. Copyright © 2016 John Wiley & Sons, Ltd. Guidelines have many benefits, but the current pressure for services to be 'NICE compliant' may be having unintended negative as well as positive effects. Lack of implementation may be partly the result of active choice by clinicians concerned to use the full range of professional skills and to offer flexibility and choice to service users. The current context is creating a perverse incentive for clinicians to say one thing but do another. This is problematic for services and a potential threat to the profession of clinical psychology. Copyright © 2016 John Wiley & Sons, Ltd.

Development of a tailored strategy to improve postpartum hemorrhage guideline adherence.

PubMed

de Visser, Suzan M; Woiski, Mallory D; Grol, Richard P; Vandenbussche, Frank P H A; Hulscher, Marlies E J L; Scheepers, Hubertina C J; Hermens, Rosella P M G

2018-02-08

Despite the introduction of evidence based guidelines and practical courses, the incidence of postpartum hemorrhage shows an increasing trend in developed countries. Substandard care is often found, which implies an inadequate implementation in high resource countries. We aimed to reduce the gap between evidence-based guidelines and clinical application, by developing a strategy, tailored to current barriers for implementation. The development of the implementation strategy consisted of three phases, supervised by a multidisciplinary expert panel. In the first phase a framework of the strategy was created, based on barriers to optimal adherence identified among professionals and patients together with evidence on effectiveness of strategies found in literature. In the second phase, the tools within the framework were developed, leading to a first draft. In the third phase the strategy was evaluated among professionals and patients. The professionals were asked to give written feedback on tool contents, clinical usability and inconsistencies with current evidence care. Patients evaluated the tools on content and usability. Based on the feedback of both professionals and patients the tools were adjusted. We developed a tailored strategy to improve guideline adherence, covering the trajectory of the third trimester of pregnancy till the end of the delivery. The strategy, directed at professionals, comprehending three stop moments includes a risk assessment checklist, care bundle and time-out procedure. As patient empowerment tools, a patient passport and a website with patient information was developed. The evaluation among the expert panel showed all professionals to be satisfied with the content and usability and no discrepancies or inconsistencies with current evidence was found. Patients' evaluation revealed that the information they received through the tools was incomplete. The tools were adjusted accordingly to the missing information. A usable, tailored strategy to implement PPH guidelines and practical courses was developed. The next step is the evaluation of the strategy in a feasibility trial. Clinical trial registration: The Fluxim study, registration number: NCT00928863 .

KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors.

PubMed

Lentine, Krista L; Kasiske, Bertram L; Levey, Andrew S; Adams, Patricia L; Alberú, Josefina; Bakr, Mohamed A; Gallon, Lorenzo; Garvey, Catherine A; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L; Taler, Sandra J; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G; Cheung, Michael; Garg, Amit X

2017-08-01

The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a "proof-in-concept" risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided.In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017;101(Suppl 8S):S1-S109.

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

PubMed

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

2017-11-01

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

South African Guidelines Excellence (SAGE): Adopt, adapt, or contextualise?

PubMed

Dizon, J M; Grimmer, K; Louw, Q; Kredo, T; Young, T; Machingaidze, S

2016-12-01

Clinical practice guideline (CPG) activities must be planned carefully for efficient use of available resources and evidence-based implementation. De novo development of CPGs may sometimes 'recreate the wheel' and delay implementation. Three innovative alternatives to de novo CPG development (adopt, contextualise or adapt) are outlined, which have greater potential than de novo development to best use the limited available resources, personnel and time in settings such as South Africa.

Impact of the Canadian Diabetes Association guideline dissemination strategy on clinician knowledge and behaviour change outcomes.

PubMed

Yu, Catherine H; Lillie, Erin; Mascarenhas-Johnson, Alekhya; Gall Casey, Carolyn; Straus, Sharon E

2018-04-04

Implementation of clinical practice guideline (CPG) into clinical practice remains limited. Using the Knowledge-To-Action framework, a guideline dissemination and implementation strategy for the Canadian Diabetes Association's 2013 CPG was developed and launched to clinicians and people with diabetes. The RE-AIM framework guided evaluation of this strategy clinician; we report here one aspect of the effectiveness dimension using mixed methods. We measured impact of the strategy on clinican knowledge and behaviour change constructs using evaluation forms, national online survey and individual interviews. After attending a lecture, clinician confidence (n = 915) increased (3.7(SD 0.7) to 4.5 (SD 0.6) on a 5-point scale (p < 0.001)), with 55% (n = 505) intending to make a practice change (e.g. clinical management regarding glycemic control). Ninety-four percent of survey respondents (n = 907) were aware of the guidelines, attributed to communications from professional associations, continuing professional development events, and colleagues. Forty to 98% of respondents (total n 462-485) were correct in their interpretation of CPG messages, and 33-65%(total n 351-651) reported that they had made changes to their practice. Interviews with 28 clinicians revealed that organizational credibility, online access to tools, clarity of tool content, and education sessions facilitated uptake; lack of time, team-based consensus, and seamless integration into care and patient complexity were barriers. The complexity of diabetes care requires systemic adoption of organization of care interventions, including interprofessional collaboration and consensus. Augmenting our strategy to include scalable models for professional development, integration of guidelines into electronic medical records, and expansion of our target audience to include health care teams and patients, may optimize guideline uptake. Copyright © 2018 Elsevier B.V. All rights reserved.

Developing a Clinician Friendly Tool to Identify Useful Clinical Practice Guidelines: G-TRUST.

PubMed

Shaughnessy, Allen F; Vaswani, Akansha; Andrews, Bonnie K; Erlich, Deborah R; D'Amico, Frank; Lexchin, Joel; Cosgrove, Lisa

2017-09-01

Clinicians are faced with a plethora of guidelines. To rate guidelines, they can select from a number of evaluation tools, most of which are long and difficult to apply. The goal of this project was to develop a simple, easy-to-use checklist for clinicians to use to identify trustworthy, relevant, and useful practice guidelines, the Guideline Trustworthiness, Relevance, and Utility Scoring Tool (G-TRUST). A modified Delphi process was used to obtain consensus of experts and guideline developers regarding a checklist of items and their relative impact on guideline quality. We conducted 4 rounds of sampling to refine wording, add and subtract items, and develop a scoring system. Multiple attribute utility analysis was used to develop a weighted utility score for each item to determine scoring. Twenty-two experts in evidence-based medicine, 17 developers of high-quality guidelines, and 1 consumer representative participated. In rounds 1 and 2, items were rewritten or dropped, and 2 items were added. In round 3, weighted scores were calculated from rankings and relative weights assigned by the expert panel. In the last round, more than 75% of experts indicated 3 of the 8 checklist items to be major indicators of guideline usefulness and, using the AGREE tool as a reference standard, a scoring system was developed to identify guidelines as useful, may not be useful, and not useful. The 8-item G-TRUST is potentially helpful as a tool for clinicians to identify useful guidelines. Further research will focus on its reliability when used by clinicians. © 2017 Annals of Family Medicine, Inc.

Choice of Insulin in Type 2 Diabetes: A Southeast Asian Perspective.

PubMed

Kalra, Sanjay; Thai, Hong Quang; Deerochanawong, Chaicharn; Su-Yen, Goh; Mohamed, Mafauzy; Latt, Tint Swe; Aye, Than Than; Latif, Zafar Ahmed; Katulanda, Prasad; Khun, Touch; Satha, Sum; Vongvandy, Vadsana

2017-01-01

Southeast Asia faces a diabetes epidemic, which has created significant challenges for health care. The unique Asian diabetes phenotype, coupled with peculiar lifestyle, diet, and healthcare-seeking behavior, makes it imperative to develop clinical pathways and guidelines which address local needs and requirements. From an insulin-centric viewpoint, the preparations prescribed in such pathways should be effective, safe, well tolerated, nonintrusive, and suitable for the use in multiple clinical situations including initiation and intensification. This brief communication describes the utility of premixed or dual action insulin in such clinical pathways and guidelines.

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

The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline.

PubMed

Funder, John W; Carey, Robert M; Mantero, Franco; Murad, M Hassan; Reincke, Martin; Shibata, Hirotaka; Stowasser, Michael; Young, William F

2016-05-01

To develop clinical practice guidelines for the management of patients with primary aldosteronism. The Task Force included a chair, selected by the Clinical Guidelines Subcommittee of the Endocrine Society, six additional experts, a methodologist, and a medical writer. The guideline was cosponsored by American Heart Association, American Association of Endocrine Surgeons, European Society of Endocrinology, European Society of Hypertension, International Association of Endocrine Surgeons, International Society of Endocrinology, International Society of Hypertension, Japan Endocrine Society, and The Japanese Society of Hypertension. The Task Force received no corporate funding or remuneration. We searched for systematic reviews and primary studies to formulate the key treatment and prevention recommendations. We used the Grading of Recommendations, Assessment, Development, and Evaluation group criteria to describe both the quality of evidence and the strength of recommendations. We used "recommend" for strong recommendations and "suggest" for weak recommendations. We achieved consensus by collecting the best available evidence and conducting one group meeting, several conference calls, and multiple e-mail communications. With the help of a medical writer, the Endocrine Society's Clinical Guidelines Subcommittee, Clinical Affairs Core Committee, and Council successfully reviewed the drafts prepared by the Task Force. We placed the version approved by the Clinical Guidelines Subcommittee and Clinical Affairs Core Committee on the Endocrine Society's website for comments by members. At each stage of review, the Task Force received written comments and incorporated necessary changes. For high-risk groups of hypertensive patients and those with hypokalemia, we recommend case detection of primary aldosteronism by determining the aldosterone-renin ratio under standard conditions and recommend that a commonly used confirmatory test should confirm/exclude the condition. We recommend that all patients with primary aldosteronism undergo adrenal computed tomography as the initial study in subtype testing and to exclude adrenocortical carcinoma. We recommend that an experienced radiologist should establish/exclude unilateral primary aldosteronism using bilateral adrenal venous sampling, and if confirmed, this should optimally be treated by laparoscopic adrenalectomy. We recommend that patients with bilateral adrenal hyperplasia or those unsuitable for surgery should be treated primarily with a mineralocorticoid receptor antagonist.

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.

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

PubMed Central

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

2014-01-01

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

Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure

PubMed Central

Brochard, Laurent; Elliott, Mark W.; Hess, Dean; Hill, Nicholas S.; Navalesi, Paolo; Antonelli, Massimo; Brozek, Jan; Conti, Giorgio; Ferrer, Miquel; Guntupalli, Kalpalatha; Jaber, Samir; Keenan, Sean; Mancebo, Jordi; Mehta, Sangeeta; Raoof, Suhail

2017-01-01

Noninvasive mechanical ventilation (NIV) is widely used in the acute care setting for acute respiratory failure (ARF) across a variety of aetiologies. This document provides European Respiratory Society/American Thoracic Society recommendations for the clinical application of NIV based on the most current literature. The guideline committee was composed of clinicians, methodologists and experts in the field of NIV. The committee developed recommendations based on the GRADE (Grading, Recommendation, Assessment, Development and Evaluation) methodology for each actionable question. The GRADE Evidence to Decision framework in the guideline development tool was used to generate recommendations. A number of topics were addressed using technical summaries without recommendations and these are discussed in the supplementary material. This guideline committee developed recommendations for 11 actionable questions in a PICO (population–intervention–comparison–outcome) format, all addressing the use of NIV for various aetiologies of ARF. The specific conditions where recommendations were made include exacerbation of chronic obstructive pulmonary disease, cardiogenic pulmonary oedema, de novo hypoxaemic respiratory failure, immunocompromised patients, chest trauma, palliation, post-operative care, weaning and post-extubation. This document summarises the current state of knowledge regarding the role of NIV in ARF. Evidence-based recommendations provide guidance to relevant stakeholders. PMID:28860265

Building a comprehensive syntactic and semantic corpus of Chinese clinical texts.

PubMed

He, Bin; Dong, Bin; Guan, Yi; Yang, Jinfeng; Jiang, Zhipeng; Yu, Qiubin; Cheng, Jianyi; Qu, Chunyan

2017-05-01

To build a comprehensive corpus covering syntactic and semantic annotations of Chinese clinical texts with corresponding annotation guidelines and methods as well as to develop tools trained on the annotated corpus, which supplies baselines for research on Chinese texts in the clinical domain. An iterative annotation method was proposed to train annotators and to develop annotation guidelines. Then, by using annotation quality assurance measures, a comprehensive corpus was built, containing annotations of part-of-speech (POS) tags, syntactic tags, entities, assertions, and relations. Inter-annotator agreement (IAA) was calculated to evaluate the annotation quality and a Chinese clinical text processing and information extraction system (CCTPIES) was developed based on our annotated corpus. The syntactic corpus consists of 138 Chinese clinical documents with 47,426 tokens and 2612 full parsing trees, while the semantic corpus includes 992 documents that annotated 39,511 entities with their assertions and 7693 relations. IAA evaluation shows that this comprehensive corpus is of good quality, and the system modules are effective. The annotated corpus makes a considerable contribution to natural language processing (NLP) research into Chinese texts in the clinical domain. However, this corpus has a number of limitations. Some additional types of clinical text should be introduced to improve corpus coverage and active learning methods should be utilized to promote annotation efficiency. In this study, several annotation guidelines and an annotation method for Chinese clinical texts were proposed, and a comprehensive corpus with its NLP modules were constructed, providing a foundation for further study of applying NLP techniques to Chinese texts in the clinical domain. Copyright © 2017. Published by Elsevier Inc.

ABM Clinical Protocol #21: Guidelines for Breastfeeding and the Drug-Dependent Woman

PubMed Central

2009-01-01

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. PMID:19835481

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

PubMed Central

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

2016-01-01

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

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

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

PubMed

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

2014-01-01

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

A Mobile App Development Guideline for Hospital Settings: Maximizing the Use of and Minimizing the Security Risks of "Bring Your Own Devices" Policies

PubMed Central

Pelletier, Alexandra; Sunthara, Gajen; Gujral, Nitin; Mittal, Vandna; Bourgeois, Fabienne C

2016-01-01

Background Hospitals today are introducing new mobile apps to improve patient care and workflow processes. Mobile device adoption by hospitals fits with present day technology behavior; however, requires a deeper look into hospital device policies and the impact on patients, staff, and technology development. Should hospitals spend thousands to millions of dollars to equip all personnel with a mobile device that is only used in a hospital environment? Allowing health care professionals to use personal mobile devices at work, known as bring-your-own-device (BYOD), has the potential to support both the hospital and its employees to deliver effective and efficient care. Objective The objectives of this research were to create a mobile app development guideline for a BYOD hospital environment, apply the guideline to the development of an in-house mobile app called TaskList, pilot the TaskList app within Boston Children’s Hospital (BCH), and refine the guideline based on the app pilot. TaskList is an Apple operating system (iOS)-based app designed for medical residents to monitor, create, capture, and share daily collaborative tasks associated with patients. Methods To create the BYOD guidelines, we developed TaskList that required the use of mobile devices among medical resident. The TaskList app was designed in four phases: (1) mobile app guideline development, (2) requirements gathering and developing of TaskList fitting the guideline, (3) deployment of TaskList using BYOD with end-users, and (4) refinement of the guideline based on the TaskList pilot. Phase 1 included understanding the existing hospital BYOD policies and conducting Web searches to find best practices in software development for a BYOD environment. Phase 1 also included gathering subject matter input from the Information Services Department (ISD) at BCH. Phase 2 involved the collaboration between the Innovation Acceleration Program at BCH, the ISD Department and the TaskList Clinical team in understanding what features should be built into the app. Phase 3 involved deployment of TaskList on a clinical floor at BCH. Lastly, Phase 4 gathered the lessons learned from the pilot to refine the guideline. Results Fourteen practical recommendations were identified to create the BCH Mobile Application Development Guideline to safeguard custom applications in hospital BYOD settings. The recommendations were grouped into four categories: (1) authentication and authorization, (2) data management, (3) safeguarding app environment, and (4) remote enforcement. Following the guideline, the TaskList app was developed and then was piloted with an inpatient ward team. Conclusions The Mobile Application Development guideline was created and used in the development of TaskList. The guideline is intended for use by developers when addressing integration with hospital information systems, deploying apps in BYOD health care settings, and meeting compliance standards, such as Health Insurance Portability and Accountability Act (HIPAA) regulations. PMID:27169345

A Mobile App Development Guideline for Hospital Settings: Maximizing the Use of and Minimizing the Security Risks of "Bring Your Own Devices" Policies.

PubMed

Al Ayubi, Soleh U; Pelletier, Alexandra; Sunthara, Gajen; Gujral, Nitin; Mittal, Vandna; Bourgeois, Fabienne C

2016-05-11

Hospitals today are introducing new mobile apps to improve patient care and workflow processes. Mobile device adoption by hospitals fits with present day technology behavior; however, requires a deeper look into hospital device policies and the impact on patients, staff, and technology development. Should hospitals spend thousands to millions of dollars to equip all personnel with a mobile device that is only used in a hospital environment? Allowing health care professionals to use personal mobile devices at work, known as bring-your-own-device (BYOD), has the potential to support both the hospital and its employees to deliver effective and efficient care. The objectives of this research were to create a mobile app development guideline for a BYOD hospital environment, apply the guideline to the development of an in-house mobile app called TaskList, pilot the TaskList app within Boston Children's Hospital (BCH), and refine the guideline based on the app pilot. TaskList is an Apple operating system (iOS)-based app designed for medical residents to monitor, create, capture, and share daily collaborative tasks associated with patients. To create the BYOD guidelines, we developed TaskList that required the use of mobile devices among medical resident. The TaskList app was designed in four phases: (1) mobile app guideline development, (2) requirements gathering and developing of TaskList fitting the guideline, (3) deployment of TaskList using BYOD with end-users, and (4) refinement of the guideline based on the TaskList pilot. Phase 1 included understanding the existing hospital BYOD policies and conducting Web searches to find best practices in software development for a BYOD environment. Phase 1 also included gathering subject matter input from the Information Services Department (ISD) at BCH. Phase 2 involved the collaboration between the Innovation Acceleration Program at BCH, the ISD Department and the TaskList Clinical team in understanding what features should be built into the app. Phase 3 involved deployment of TaskList on a clinical floor at BCH. Lastly, Phase 4 gathered the lessons learned from the pilot to refine the guideline. Fourteen practical recommendations were identified to create the BCH Mobile Application Development Guideline to safeguard custom applications in hospital BYOD settings. The recommendations were grouped into four categories: (1) authentication and authorization, (2) data management, (3) safeguarding app environment, and (4) remote enforcement. Following the guideline, the TaskList app was developed and then was piloted with an inpatient ward team. The Mobile Application Development guideline was created and used in the development of TaskList. The guideline is intended for use by developers when addressing integration with hospital information systems, deploying apps in BYOD health care settings, and meeting compliance standards, such as Health Insurance Portability and Accountability Act (HIPAA) regulations.

American Association of Dental Schools Curricular Guidelines for Orthodontics.

ERIC Educational Resources Information Center

Journal of Dental Education, 1980

1980-01-01

Guidelines reviewed and approved by the American Association of Dental Schools and sent to the Council on Dental Education in June 1979 are outlined. Educational goals and objectives and sequence of instruction (including growth and development, preclinical orthodontics, and clinical experience) are discussed. (MLW)

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

PubMed

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

2013-12-01

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

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

PubMed

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

2001-08-01

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

Guidelines for clinical supervision in health service psychology.

PubMed

2015-01-01

This document outlines guidelines for supervision of students in health service psychology education and training programs. The goal was to capture optimal performance expectations for psychologists who supervise. It is based on the premises that supervisors (a) strive to achieve competence in the provision of supervision and (b) employ a competency-based, meta-theoretical approach to the supervision process. The Guidelines on Supervision were developed as a resource to inform education and training regarding the implementation of competency-based supervision. The Guidelines on Supervision build on the robust literatures on competency-based education and clinical supervision. They are organized around seven domains: supervisor competence; diversity; relationships; professionalism; assessment/evaluation/feedback; problems of professional competence, and ethical, legal, and regulatory considerations. The Guidelines on Supervision represent the collective effort of a task force convened by the American Psychological Association (APA) Board of Educational Affairs (BEA). PsycINFO Database Record (c) 2015 APA, all rights reserved.

Nephrology nurses' perspectives on difficult ethical issues and practice guideline for shared decision making.

PubMed

Rabetoy, Christy Price; Bair, Bradley C

2007-01-01

Nephrologists and nephrology nurses have struggled with the technological, financial, and ethical concerns surrounding the life sustaining treatment of hemodialysis for as long as this treatment as been available. One of the overriding issues for the nephrology community has been appropriate utilization of this technology and the appropriate restraint for prescribing dialysis. Since the inception of dialysis, there has been discussion of guidelines for deciding who should receive and who should not receive this therapy. In 2000, a clinical guideline was developed to assist in directing the care of patients. The knowledge and acceptance of this guideline by nephrologists has been researched in the past. However, there is no data of knowledge and acceptance of the guideline by nephrology clinical nurses or nephrology nurse practitioners. A survey was conducted to begin to ascertain this information in order to better understand the perspectives of nephrology nurses.

Factors affecting speech pathologists' implementation of stroke management guidelines: a thematic analysis.

PubMed

Miao, Melissa; Power, Emma; O'Halloran, Robyn

2015-01-01

Although clinical practice guidelines can facilitate evidence-based practice and improve the health outcomes of stroke patients, they continue to be underutilised. There is limited research into the reasons for this, especially in speech pathology. This study provides the first in-depth, qualitative examination of the barriers and facilitators that speech pathologists perceive and experience when implementing guidelines. A maximum variation sample of eight speech pathologists participated in a semi-structured interview concerning the implementation of the National Stroke Foundation's Clinical Guidelines for Stroke Management 2010. Interviews were transcribed, thematically analysed and member checked before overall themes were identified. Three main themes and ten subthemes were identified. The first main theme, making implementation explicit, reflected the necessity of accessing and understanding guideline recommendations, and focussing specifically on implementation in context. In the second theme, demand versus ability to change, the size of changes required was compared with available resources and collaboration. The final theme, Speech pathologist motivation to implement guidelines, demonstrated the influence of individual perception of the guidelines and personal commitment to improved practice. Factors affecting implementation are complex, and are not exclusively barriers or facilitators. Some potential implementation strategies are suggested. Further research is recommended. In most Western nations, stroke remains the single greatest cause of disability, including communication and swallowing disabilities. Although adherence to stroke clinical practice guidelines improves stroke patient outcomes, guidelines continue to be underutilised, and the reasons for this are not well understood. This is the first in-depth qualitative study identifying the complex barriers and facilitators to guideline implementation as experienced by speech pathologists in stroke care. Suggested implementation strategies include local monitoring of guideline implementation (e.g. team meetings, audits), increasing collaboration on implementation projects (e.g. managerial involvement, networking), and seeking speech pathologist input into guideline development.

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.

[Clinical guidelines for the prevention of infective endocarditis].

PubMed

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

2014-03-01

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

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

PubMed

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

2014-08-01

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

Cost-effectiveness in Clostridium difficile treatment decision-making

PubMed Central

Nuijten, Mark JC; Keller, Josbert J; Visser, Caroline E; Redekop, Ken; Claassen, Eric; Speelman, Peter; Pronk, Marja H

2015-01-01

AIM: To develop a framework for the clinical and health economic assessment for management of Clostridium difficile infection (CDI). METHODS: CDI has vast economic consequences emphasizing the need for innovative and cost effective solutions, which were aim of this study. A guidance model was developed for coverage decisions and guideline development in CDI. The model included pharmacotherapy with oral metronidazole or oral vancomycin, which is the mainstay for pharmacological treatment of CDI and is recommended by most treatment guidelines. RESULTS: A design for a patient-based cost-effectiveness model was developed, which can be used to estimate the cost-effectiveness of current and future treatment strategies in CDI. Patient-based outcomes were extrapolated to the population by including factors like, e.g., person-to-person transmission, isolation precautions and closing and cleaning wards of hospitals. CONCLUSION: The proposed framework for a population-based CDI model may be used for clinical and health economic assessments of CDI guidelines and coverage decisions for emerging treatments for CDI. PMID:26601096

Cost-effectiveness in Clostridium difficile treatment decision-making.

PubMed

Nuijten, Mark Jc; Keller, Josbert J; Visser, Caroline E; Redekop, Ken; Claassen, Eric; Speelman, Peter; Pronk, Marja H

2015-11-16

To develop a framework for the clinical and health economic assessment for management of Clostridium difficile infection (CDI). CDI has vast economic consequences emphasizing the need for innovative and cost effective solutions, which were aim of this study. A guidance model was developed for coverage decisions and guideline development in CDI. The model included pharmacotherapy with oral metronidazole or oral vancomycin, which is the mainstay for pharmacological treatment of CDI and is recommended by most treatment guidelines. A design for a patient-based cost-effectiveness model was developed, which can be used to estimate the cost-effectiveness of current and future treatment strategies in CDI. Patient-based outcomes were extrapolated to the population by including factors like, e.g., person-to-person transmission, isolation precautions and closing and cleaning wards of hospitals. The proposed framework for a population-based CDI model may be used for clinical and health economic assessments of CDI guidelines and coverage decisions for emerging treatments for CDI.

Gastroenterology in developing countries: Issues and advances

PubMed Central

Mandeville, Kate L; Krabshuis, Justus; Ladep, Nimzing Gwamzhi; Mulder, Chris JJ; Quigley, Eamonn MM; Khan, Shahid A

2009-01-01

Developing countries shoulder a considerable burden of gastroenterological disease. Infectious diseases in particular cause enormous morbidity and mortality. Diseases which afflict both western and developing countries are often seen in more florid forms in poorer countries. Innovative techniques continuously improve and update gastroenterological practice. However, advances in diagnosis and treatment which are commonplace in the West, have yet to reach many developing countries. Clinical guidelines, based on these advances and collated in resource-rich environments, lose their relevance outside these settings. In this two-part review, we first highlight the global burden of gastroenterological disease in three major areas: diarrhoeal diseases, hepatitis B, and Helicobacter pylori. Recent progress in their management is explored, with consideration of future solutions. The second part of the review focuses on the delivery of clinical services in developing countries. Inadequate numbers of healthcare workers hamper efforts to combat gastroenterological disease. Reasons for this shortage are examined, along with possibilities for increased specialist training. Endoscopy services, the mainstay of gastroenterology in the West, are in their infancy in many developing countries. The challenges faced by those setting up a service are illustrated by the example of a Nigerian endoscopy unit. Finally, we highlight the limited scope of many clinical guidelines produced in western countries. Guidelines which take account of resource limitations in the form of “cascades” are advocated in order to make these guidelines truly global. Recognition of the different working conditions facing practitioners worldwide is an important step towards narrowing the gap between gastroenterology in rich and poor countries. PMID:19533805

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.

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

PubMed

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

2014-05-01

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

[A general description of the clinical guideline for the management of febrile neutropenia].

PubMed

Takamatsu, Yasushi

2013-06-01

The most serious adverse event in cancer patients who receive anti-neoplastic agents is febrile neutropenia(FN). The clinical guideline for the use of antimicrobial agents in managing patients with FN was published by the Infectious Diseases Society of America. However, the dosage and administration of antimicrobial agents are not completely adapted for Japanese insurance coverage. The Japanese Society of Medical Oncology therefore decided to develop a clinical guideline for the management of FN in Japanese patients. In this study, we provide a general description of the guideline. According to the guideline, fever is defined as a single axillary temperature of B37. 5°C(or an oral temperature of B38°C)and neutropenia is defined as a neutrophil count of <500/mL or <1, 000/mL if the count is expected to decrease to <500/mL within the next 48 h. In patients who develop FN, empirical anti-pseudomonal b-lactam agent monotherapy should be administered promptly at the onset of fever. Antibiotic therapy should continue until patients become afebrile and their neutrophil counts recover to B500/mL. If fever persists for 4-7 days under antibiotic therapy in high-risk patients, empirical antifungal therapy should be considered. Granulocyte colony-stimulating factor prophylaxis should be considered for high-risk patients with an anticipated risk of FN of B20%.

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.

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.

[Clinical guidelines for the management of schizophrenia:Aims and limitations (Ι)].

PubMed

Margariti, M; Hadjulis, M; Lazaridou, M; Angelidis, G F; Fotopoulos, V; Markaki, L; Koulouri, F

2017-01-01

The initiative for the development of national treatment guidelines, dates back to the '90s. In Greece, however, National Clinical Guidelines for the management of schizophrenia were first formulated in 2014 when a Working Group was set up for this purpose by the Greek Ministry of Health. The objective of this Working Group was to provide evidence-based recommendations covering the pharmacological and psychosocial treatment of schizophrenia as well as the development of appropriate treatment services. The Working Group utilized the NICE Guideline (National Institute of Clinical Excellence, 2010, 2014) for the management of Psychosis & Schizophrenia as the main guide to develop the Greek National Guidelines , and in addition the American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Schizophrenia (APA 2004), the Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the treatment of schizophrenia and related disorders (Royal Australian and New Zealand College of Psychiatrists 2005) , as well as other relevant sources. The Working Group also took into consideration the available Greek bibliography as well as the external evaluations of the Greek psychiatric reform programs. A special effort was made to adapt the international experience to the current Greek landscape with the constraints resulting from the uneven dispersion of mental health services, the lack of coordination between services, the incomplete sectorization of mental health services provided as part of the National Health System, the still underdeveloped Primary Care Health Service, and last but not least the difficult economic situation in Greece. After the preparation of the draft guidelines, a thorough consultation followed with the relevant stakeholders, including mental health professionals, user associations and representatives of the Greek Ombudsman. Additionally, the Hellenic Psychiatric Association established an Expert Committee in Spring 2016, that contributed with its observations to the final exercise. This article will be followed by two further publications (incorporating the Hellenic Psychiatric Association comments) which include: (1) the summary recommendations regarding the pharmacological, psychological and psychosocial interventions in the treatment of schizophrenia, and (2) the summary recommendations regarding: (a) the role of primary health care service and the role of the family physician in the treatment of schizophrenia (b) the summary recommendations regarding continuity of care and c) the summary recommendations regarding community interventions with documented effectiveness in the treatment of schizophrenia.

The development of a multidisciplinary, evidence-based guideline for "HIV and employment".

PubMed

Wagener, Marlies N; Roelofs, Pepijin; Miedema, Harold S; Brandjes, Dees P M; Dahmen, Rutger; van Gorp, Eric C M

2015-01-01

The objective of this study was to develop a multidisciplinary guideline that supports the care and vocational rehabilitation of HIV-infected people with employment-related problems. The guideline was developed according to the "evidence-based guideline development" method developed by the Dutch Institute for Health Care Improvement. This method consists of the following steps: forming a multidisciplinary core group and an expert panel, formulating key questions, searching and appraising the available literature, formulating considerations and recommendations, peer reviewing the draft guideline, and authorizing the final guideline. All relevant professional associations were represented in the core group that was assembled to develop the guideline, i.e., HIV doctors, HIV nurses, general practitioners, occupational health physicians, psychologists, social workers, occupational health nurses, vocational experts, and insurance physicians. Five key questions for the guideline were formulated with the following themes: determinants of employment, disclosure and stigma, self-management, interventions, and the organization of care. In the literature review on these topics, 45 studies met the inclusion criteria. The methodological quality of the included articles was poor. Factors such as patient preferences and medical/ethical issues were considered. The recommendations in the guideline are a weighting of the scientific evidence and the considerations of the core group. The guideline, as well as its summary for daily practice, clarifies the most important barriers and facilitators to people with HIV either staying at work or returning to work, and it constitutes a clinical, easy-to-use guideline for health-care providers and how they can support people with HIV who want to work.

[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.

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

PubMed

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

2014-11-01

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

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

PubMed

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

2010-09-01

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

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

PubMed

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

2010-09-01

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

[GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines.

PubMed

Morgano, Gian Paolo; Parmelli, Elena; Amato, Laura; Iannone, Primiano; Marchetti, Marco; Moja, Lorenzo; Davoli, Marina; Schünemann, Holger

2018-05-01

In the first article in this series we described the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision (EtD) frameworks and their rationale for different types of decisions. In this second article, we describe the use of EtD frameworks for clinical recommendations and how it can help clinicians and patients who use those recommendations. EtD frameworks for clinical practice recommendations provide a structured and transparent approach for guideline panels. The framework helps ensure consideration of key criteria that determine whether an intervention should be recommended and that judgments are informed by the best available evidence. Frameworks are also a way for panels to make guideline users aware of the rationale (justification) for their recommendations.

Clinical practice variations in prescribing antipsychotics for patients with schizophrenia.

PubMed

Owen, Richard R; Fischer, Ellen P; Kirchner, JoAnn E; Thrush, Carol R; Williams, D Keith; Cuffel, Brian J; Elliott, Carl E; Booth, Brenda M

2003-01-01

Few studies have examined the variations among individual physicians in prescribing antipsychotics for schizophrenia. This study examined clinical practice variations in the route and dosage of antipsychotic medication prescribed for inpatients with schizophrenia by 11 different psychiatrists. The sample consisted of 130 patients with a DSM-III-R diagnosis of schizophrenia who had received inpatient care at a state hospital or Veterans Affairs medical center in the southeastern United States in 1992-1993. Mixed-effects regression models were developed to explore the influence of individual physicians and hospitals on route of antipsychotic administration (oral or depot) and daily antipsychotic dose, controlling for patient case-mix variables (age, race, sex, duration of illness, symptom severity, and substance-abuse diagnosis). The average daily antipsychotic dose was 1092 +/- 892 chlorpromazine mg equivalents. Almost half of the patients (48%) were prescribed doses above or below the range recommended by current practice guidelines. The proportion of patients prescribed depot antipsychotics was significantly different at the 2 hospitals, as was the antipsychotic dose prescribed at discharge. Individual physicians and patient characteristics were not significantly associated with prescribing practices. These data, which were obtained before clinical practice guidelines were widely disseminated, provide a benchmark against which to examine more current practice variations in antipsychotic prescribing. The results raise several questions about deviations from practice guidelines in the pharmacological treatment of schizophrenia. To adequately assess quality and inform and possibly further develop clinical practice guideline recommendations for schizophrenia, well-designed research studies conducted in routine clinical settings are needed.

Recommendations for patient engagement in guideline development panels: A qualitative focus group study of guideline-naïve patients

PubMed Central

Mullins, C. Daniel; Gronseth, Gary S.; Gagliardi, Anna R.

2017-01-01

Background Patient and consumer engagement in clinical practice guideline development is internationally advocated, but limited research explores mechanisms for successful engagement. Objective To investigate the perspectives of potential patient/consumer guideline representatives on topics pertaining to engagement including guideline development group composition and barriers to and facilitators of engagement. Setting and participants Participants were guideline-naïve volunteers for programs designed to link community members to academic research with diverse ages, gender, race, and degrees of experience interacting with health care professionals. Methods Three focus groups and one key informant interview were conducted and analyzed using a qualitative descriptive approach. Results Participants recommended small, diverse guideline development groups engaging multiple patient/consumer stakeholders with no prior relationships with each other or professional panel members. No consensus was achieved on the ideal balance of patient/consumer and professional stakeholders. Pre-meeting reading/training and an identified contact person were described as keys to successful early engagement; skilled facilitators, understandable speech and language, and established mechanisms for soliciting patient opinions were suggested to enhance engagement at meetings. Conclusions Most suggestions for effective patient/consumer engagement in guidelines require forethought and planning but little additional expense, making these strategies easily accessible to guideline developers desiring to achieve more meaningful patient and consumer engagement. PMID:28319201

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

PubMed

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

2013-03-02

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

Knowledge translation: a case study on pneumonia research and clinical guidelines in a low- income country.

PubMed

Goyet, Sophie; Barennes, Hubert; Libourel, Therese; van Griensven, Johan; Frutos, Roger; Tarantola, Arnaud

2014-06-26

The process and effectiveness of knowledge translation (KT) interventions targeting policymakers are rarely reported. In Cambodia, a low-income country (LIC), an intervention aiming to provide evidence-based knowledge on pneumonia to health authorities was developed to help update pediatric and adult national clinical guidelines. Through a case study, we assessed the effectiveness of this KT intervention, with the goal of identifying the barriers to KT and suggest strategies to facilitate KT in similar settings. An extensive search for all relevant sources of data documenting the processes of updating adult and pediatric pneumonia guidelines was done. Documents included among others, reports, meeting minutes, and email correspondences. The study was conducted in successive phases: an appraisal of the content of both adult and pediatric pneumonia guidelines; an appraisal of the quality of guidelines by independent experts, using the AGREE-II instrument; a description and modeling of the KT process within the guidelines updating system, using the Unified Modeling Language (UML) tools 2.2; and the listing of the barriers and facilitators to KT we identified during the study. The first appraisal showed that the integration of the KT key messages in pediatric and adult guidelines varied with a better efficiency in the pediatric guidelines. The overall AGREE-II quality assessments scored 37% and 44% for adult and pediatric guidelines, respectively. Scores were lowest for the domains of 'rigor of development' and 'editorial independence.' The UML analysis highlighted that time frames and constraints of the involved stakeholders greatly differed and that there were several missed opportunities to translate on evidence into the adult pneumonia guideline. Seventeen facilitating factors and 18 potential barriers to KT were identified. Main barriers were related to the absence of a clear mandate from the Ministry of Health for the researchers and to a lack of synchronization between knowledge production and policy-making. Study findings suggest that stakeholders, both researchers and policy makers planning to update clinical guidelines in LIC may need methodological support to overcome the expected barriers.

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

PubMed Central

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

2013-01-01

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

Education in the workplace for the physician: clinical management states as an organizing framework.

PubMed

Greenes, R A

2000-01-01

Medical educators are interested in approaches to making selected relevant knowledge available in the context of problem-based care. This is of value both during the process of care and as a means of organizing information for offline self-study. Four trends in health information technology are relevant to achieving the goal and can be expected to play a growing role in the future. First, health care enterprises are developing approaches for access to information resources related to the care of a patient, including clinical data and images but also communication tools, referral and other logistic tools, decision support, and educational materials. Second, information for patients and methods for patient-doctor interaction and decision making are becoming available. Third, computer-based methods for representation of practice guidelines are being developed to support applications that can incorporate their logic. Finally, considering patients as being in particular "clinical management states" (or CMSs) for specific problems, approaches are being developed to use guidelines as a kind of "predictive" framework to enable development of interfaces for problem-based clinical encounters. The guidelines for a CMS can be used to identify the kinds of resources specifically needed for clinical encounters of that type. As the above trends converge to produce problem-specific environments, professional specialty organizations and continuing medical education course designers will need to focus energies on organizing and updating medical knowledge to make it available in CMS-specific contexts.

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

Assessing biocomputational modelling in transforming clinical guidelines for osteoporosis management.

PubMed

Thiel, Rainer; Viceconti, Marco; Stroetmann, Karl

2011-01-01

Biocomputational modelling as developed by the European Virtual Physiological Human (VPH) Initiative is the area of ICT most likely to revolutionise in the longer term the practice of medicine. Using the example of osteoporosis management, a socio-economic assessment framework is presented that captures how the transformation of clinical guidelines through VPH models can be evaluated. Applied to the Osteoporotic Virtual Physiological Human Project, a consequent benefit-cost analysis delivers promising results, both methodologically and substantially.

ABM Clinical Protocol #21: Guidelines for Breastfeeding and Substance Use or Substance Use Disorder, Revised 2015

PubMed Central

2015-01-01

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. PMID:25836677

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

Lim, Karen; Small, William; Portelance, Lorraine

Purpose: Accurate target definition is vitally important for definitive treatment of cervix cancer with intensity-modulated radiotherapy (IMRT), yet a definition of clinical target volume (CTV) remains variable within the literature. The aim of this study was to develop a consensus CTV definition in preparation for a Phase 2 clinical trial being planned by the Radiation Therapy Oncology Group. Methods and Materials: A guidelines consensus working group meeting was convened in June 2008 for the purposes of developing target definition guidelines for IMRT for the intact cervix. A draft document of recommendations for CTV definition was created and used to aidmore » in contouring a clinical case. The clinical case was then analyzed for consistency and clarity of target delineation using an expectation maximization algorithm for simultaneous truth and performance level estimation (STAPLE), with kappa statistics as a measure of agreement between participants. Results: Nineteen experts in gynecological radiation oncology generated contours on axial magnetic resonance images of the pelvis. Substantial STAPLE agreement sensitivity and specificity values were seen for gross tumor volume (GTV) delineation (0.84 and 0.96, respectively) with a kappa statistic of 0.68 (p < 0.0001). Agreement for delineation of cervix, uterus, vagina, and parametria was moderate. Conclusions: This report provides guidelines for CTV definition in the definitive cervix cancer setting for the purposes of IMRT, building on previously published guidelines for IMRT in the postoperative setting.« less

Threats to validity in the design and conduct of preclinical efficacy studies: a systematic review of guidelines for in vivo animal experiments.

PubMed

Henderson, Valerie C; Kimmelman, Jonathan; Fergusson, Dean; Grimshaw, Jeremy M; Hackam, Dan G

2013-01-01

The vast majority of medical interventions introduced into clinical development prove unsafe or ineffective. One prominent explanation for the dismal success rate is flawed preclinical research. We conducted a systematic review of preclinical research guidelines and organized recommendations according to the type of validity threat (internal, construct, or external) or programmatic research activity they primarily address. We searched MEDLINE, Google Scholar, Google, and the EQUATOR Network website for all preclinical guideline documents published up to April 9, 2013 that addressed the design and conduct of in vivo animal experiments aimed at supporting clinical translation. To be eligible, documents had to provide guidance on the design or execution of preclinical animal experiments and represent the aggregated consensus of four or more investigators. Data from included guidelines were independently extracted by two individuals for discrete recommendations on the design and implementation of preclinical efficacy studies. These recommendations were then organized according to the type of validity threat they addressed. A total of 2,029 citations were identified through our search strategy. From these, we identified 26 guidelines that met our eligibility criteria--most of which were directed at neurological or cerebrovascular drug development. Together, these guidelines offered 55 different recommendations. Some of the most common recommendations included performance of a power calculation to determine sample size, randomized treatment allocation, and characterization of disease phenotype in the animal model prior to experimentation. By identifying the most recurrent recommendations among preclinical guidelines, we provide a starting point for developing preclinical guidelines in other disease domains. We also provide a basis for the study and evaluation of preclinical research practice. Please see later in the article for the Editors' Summary.

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

PubMed Central

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

2015-01-01

Background Evidence-based medicine promotes and relies on the use of evidence in developing clinical practice guidelines (CPGs). The Chinese healthcare system includes both traditional Chinese medicine (TCM) and Western medicine, which are expected to be equally reflected in Chinese CPGs. Objective To evaluate the inclusion of TCM-related information in Western medicine CPGs developed in China and the adoption of high level evidence. Methods All CPGs were identified from the China Guideline Clearinghouse (CGC), which is the main Chinese organisation maintaining the guidelines issued by the Ministry of Health of China, the Chinese Medical Association and the Chinese Medical Doctors’ Association. TCM-related contents were extracted from all the CPGs identified. Extracted information comprised the institution issuing the guideline, date of issue, disease, recommendations relating to TCM, evidence level of the recommended content and references supporting the recommendations. Results A total of 604 CPGs were identified, only a small number of which (74/604; 12%) recommended TCM therapy and only five guidelines (7%) had applied evidence grading. The 74 CPGs involved 13 disease systems according to the International Classification of Diseases 10th edition. TCM was mainly recommended in the treatment part of the guidelines (73/74, 99%), and more than half of the recommendations (43/74, 58%) were related to Chinese herbal medicine (single herbs or herbal treatment based on syndrome differentiation). Conclusions Few Chinese Western medicine CPGs recommend TCM therapies and very few provide evidence grading for the TCM recommendation. We suggest that future guideline development should be based on systematic searches for evidence to support CPG recommendations and involve a multidisciplinary approach including TCM expertise. PMID:26041487

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

PubMed

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

2015-06-03

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

Humanistic psychotherapy research 1990-2015: from methodological innovation to evidence-supported treatment outcomes and beyond.

PubMed

Angus, Lynne; Watson, Jeanne Cherry; Elliott, Robert; Schneider, Kirk; Timulak, Ladislav

2015-01-01

Over the past 25 years, humanistic psychotherapy (HP) researchers have actively contributed to the development and implementation of innovative practice-informed research measures and coding systems. Qualitative and quantitative research findings, including meta-analyses, support the identification of HP approaches as evidence-based treatments for a variety of psychological conditions. Implications for future psychotherapy research, training, and practice are discussed in terms of addressing the persistent disjunction between significant HP research productivity and relatively low support for HP approaches in university-based clinical training programs, funding agencies, and government-supported clinical guidelines. Finally, specific recommendations are provided to further enhance and expand the impact of HP research for clinical training programs and the development of treatment guidelines.

Evidence-based practice guideline of Chinese herbal medicine for primary open-angle glaucoma (qingfeng -neizhang)

PubMed Central

Yang, Yingxin; Ma, Qiu-yan; Yang, Yue; He, Yu-peng; Ma, Chao-ting; Li, Qiang; Jin, Ming; Chen, Wei

2018-01-01

Abstract Background: Primary open angle glaucoma (POAG) is a chronic, progressive optic neuropathy. The aim was to develop an evidence-based clinical practice guideline of Chinese herbal medicine (CHM) for POAG with focus on Chinese medicine pattern differentiation and treatment as well as approved herbal proprietary medicine. Methods: The guideline development group involved in various pieces of expertise in contents and methods. Authors searched electronic databases include CNKI, VIP, Sino-Med, Wanfang data, PubMed, the Cochrane Library, EMBASE, as well as checked China State Food and Drug Administration (SFDA) from the inception of these databases to June 30, 2015. Systematic reviews and randomized controlled trials of Chinese herbal medicine treating adults with POAG were evaluated. Risk of bias tool in the Cochrane Handbook and evidence strength developed by the GRADE group were applied for the evaluation, and recommendations were based on the findings incorporating evidence strength. After several rounds of Expert consensus, the final guideline was endorsed by relevant professional committees. Results: CHM treatment principle and formulae based on pattern differentiation together with approved patent herbal medicines are the main treatments for POAG, and the diagnosis and treatment focusing on blood related patterns is the major domain. Conclusion: CHM therapy alone or combined with other conventional treatment reported in clinical studies together with Expert consensus were recommended for clinical practice. PMID:29595636

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.

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

PubMed

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

2018-03-14

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

Clinical practice guidelines for the management of pregnancy in women with autoimmune rheumatic diseases of the Mexican College of Rheumatology. Part I.

PubMed

Saavedra Salinas, Miguel Ángel; Barrera Cruz, Antonio; Cabral Castañeda, Antonio Rafael; Jara Quezada, Luis Javier; Arce-Salinas, C Alejandro; Álvarez Nemegyei, José; Fraga Mouret, Antonio; Orozco Alcalá, Javier; Salazar Páramo, Mario; Cruz Reyes, Claudia Verónica; Andrade Ortega, Lilia; Vera Lastra, Olga Lidia; Mendoza Pinto, Claudia; Sánchez González, Antonio; Cruz Cruz, Polita Del Rocío; Morales Hernández, Sara; Portela Hernández, Margarita; Pérez Cristóbal, Mario; Medina García, Gabriela; Hernández Romero, Noé; Velarde Ochoa, María Del Carmen; Navarro Zarza, José Eduardo; Portillo Díaz, Verónica; Vargas Guerrero, Angélica; Goycochea Robles, María Victoria; García Figueroa, José Luis; Barreira Mercado, Eduardo; Amigo Castañeda, Mary Carmen

2015-01-01

Pregnancy in women with autoimmune rheumatic diseases is associated with several maternal and fetal complications. The development of clinical practice guidelines with the best available scientific evidence may help standardize the care of these patients. To provide recommendations regarding prenatal care, treatment, and a more effective monitoring of pregnancy in women with lupus erythematosus (SLE), rheumatoid arthritis (RA) and antiphospholipid antibody syndrome (APS). Nominal panels were formed for consensus, systematic search of information, development of clinical questions, processing and grading of recommendations, internal validation by peers, and external validation of the final document. The quality criteria of the AGREE II instrument were followed. The various panels answered the 37 questions related to maternal and fetal care in SLE, RA, and APS, as well as to the use of antirheumatic drugs during pregnancy and lactation. The recommendations were discussed and integrated into a final manuscript. Finally, the corresponding algorithms were developed. We present the recommendations for pregnant women with SLE in this first part. We believe that the Mexican clinical practice guidelines for the management of pregnancy in women with SLE integrate the best available evidence for the treatment and follow-up of patients with these conditions. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

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

PubMed

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

2011-09-01

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

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

PubMed Central

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

2017-01-01

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

Radiotherapy for non-malignant disorders: state of the art and update of the evidence-based practice guidelines

PubMed Central

Micke, O; Muecke, R

2015-01-01

Every year in Germany about 50,000 patients are referred and treated by radiotherapy (RT) for “non-malignant disorders”. This highly successful treatment is applied only for specific indications such as preservation or recovery of the quality of life by means of pain reduction or resolution and/or an improvement of formerly impaired physical body function owing to specific disease-related symptoms. Since 1995, German radiation oncologists have treated non-malignant disorders according to national consensus guidelines; these guidelines were updated and further developed over 3 years by implementation of a systematic consensus process to achieve national upgraded and accepted S2e clinical practice guidelines. Throughout this process, international standards of evaluation were implemented. This review summarizes most of the generally accepted indications for the application of RT for non-malignant diseases and presents the special treatment concepts. The following disease groups are addressed: painful degenerative skeletal disorders, hyperproliferative disorders and symptomatic functional disorders. These state of the art guidelines may serve as a platform for daily clinical work; they provide a new starting point for quality assessment, future clinical research, including the design of prospective clinical trials, and outcome research in the underrepresented and less appreciated field of RT for non-malignant disorders. PMID:25955230

Evidence-based emergency medicine. Creating a system to facilitate translation of evidence into standardized clinical practice: a preliminary report.

PubMed

Wright, Stewart W; Trott, Alexander; Lindsell, Christopher J; Smith, Carol; Gibler, W Brian

2008-01-01

The Institute of Medicine, through its landmark report concerning errors in medicine, suggests that standardization of practice through systematic development and implementation of evidence-based clinical pathways is an effective way of reducing errors in emergency systems. The specialty of emergency medicine is well positioned to develop a complete system of innovative quality improvement, incorporating best practice guidelines with performance measures and practitioner feedback mechanisms to reduce errors and therefore improve quality of care. This article reviews the construction, ongoing development, and initial impact of such a system at a large, urban, university teaching hospital and at 2 affiliated community hospitals. The Committee for Procedural Quality and Evidence-Based Practice was formed within the Department of Emergency Medicine to establish evidence-based guidelines for nursing and provider care. The committee measures the effect of such guidelines, along with other quality measures, through pre- and postguideline patient care medical record audits. These measures are fed back to the providers in a provider-specific, peer-matched "scorecard." The Committee for Procedural Quality and Evidence-Based Practice affects practice and performance within our department. Multiple physician and nursing guidelines have been developed and put into use. Using asthma as an example, time to first nebulizer treatment and time to disposition from the emergency department decreased. Initial therapeutic agent changed and documentation improved. A comprehensive, guideline-driven, evidence-based approach to clinical practice is feasible within the structure of a department of emergency medicine. High-level departmental support with dedicated personnel is necessary for the success of such a system. Internet site development (available at http://www.CPQE.com) for product storage has proven valuable. Patient care has been improved in several ways; however, consistent and complete change in provider behavior remains elusive. Physician scorecards may play a role in altering these phenomena. Emergency medicine can play a leadership role in the development of quality improvement, error reduction, and pay-for-performance systems.

Design Recommendations for Pharmacogenomics Clinical Decision Support Systems

PubMed Central

Khelifi, Maher; Tarczy-Hornoch, Peter; Devine, Emily B.; Pratt, Wanda

2017-01-01

The use of pharmacogenomics (PGx) in clinical practice still faces challenges to fully adopt genetic information in targeting drug therapy. To incorporate genetics into clinical practice, many support the use of Pharmacogenomics Clinical Decision Support Systems (PGx-CDS) for medication prescriptions. This support was fueled by new guidelines to incorporate genetics for optimizing drug dosage and reducing adverse events. In addition, the complexity of PGx led to exploring CDS outside the paradigm of the basic CDS tools embedded in commercial electronic health records. Therefore, designing the right CDS is key to unleashing the full potential of pharmacogenomics and making it a part of clinicians’ daily workflow. In this work, we 1) identify challenges and barriers of the implementation of PGx-CDS in clinical settings, 2) develop a new design approach to CDS with functional characteristics that can improve the adoption of pharmacogenomics guidelines and thus patient safety, and 3) create design guidelines and recommendations for such PGx-CDS tools. PMID:28815136

Addendum Guidelines for the Prevention of Peanut Allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-Sponsored Expert Panel.

PubMed

Togias, Alkis; Cooper, Susan F; Acebal, Maria L; Assa'ad, Amal; Baker, James R; Beck, Lisa A; Block, Julie; Byrd-Bredbenner, Carol; Chan, Edmond S; Eichenfield, Lawrence F; Fleischer, David M; Fuchs, George J; Furuta, Glenn T; Greenhawt, Matthew J; Gupta, Ruchi S; Habich, Michele; Jones, Stacie M; Keaton, Kari; Muraro, Antonella; Plaut, Marshall; Rosenwasser, Lanny J; Rotrosen, Daniel; Sampson, Hugh A; Schneider, Lynda C; Sicherer, Scott H; Sidbury, Robert; Spergel, Jonathan; Stukus, David R; Venter, Carina; Boyce, Joshua A

2017-01-01

Food allergy is an important public health problem because it affects children and adults, can be severe and even life-threatening, and may be increasing in prevalence. Beginning in 2008, the National Institute of Allergy and Infectious Diseases, working with other organizations and advocacy groups, led the development of the first clinical guidelines for the diagnosis and management of food allergy. A recent landmark clinical trial and other emerging data suggest that peanut allergy can be prevented through introduction of peanut-containing foods beginning in infancy. Prompted by these findings, along with 25 professional organizations, federal agencies, and patient advocacy groups, the National Institute of Allergy and Infectious Diseases facilitated development of addendum guidelines to specifically address the prevention of peanut allergy. The addendum provides three separate guidelines for infants at various risk levels for the development of peanut allergy and is intended for use by a wide variety of health care providers. Topics addressed include the definition of risk categories, appropriate use of testing (specific IgE measurement, skin prick tests, and oral food challenges), and the timing and approaches for introduction of peanut-containing foods in the health care provider's office or at home. The addendum guidelines provide the background, rationale, and strength of evidence for each recommendation. Guidelines have been developed for early introduction of peanut-containing foods into the diets of infants at various risk levels for peanut allergy. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

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

PubMed

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

2017-03-10

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

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…

Castration-resistant prostate cancer: AUA Guideline.

PubMed

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

2013-08-01

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

Evaluation of Pulmonary Nodules: Clinical Practice Consensus Guidelines for Asia.

PubMed

Bai, Chunxue; Choi, Chang-Min; Chu, Chung Ming; Anantham, Devanand; Chung-Man Ho, James; Khan, Ali Zamir; Lee, Jang-Ming; Li, Shi Yue; Saenghirunvattana, Sawang; Yim, Anthony

2016-10-01

American College of Chest Physicians (CHEST) clinical practice guidelines on the evaluation of pulmonary nodules may have low adoption among clinicians in Asian countries. Unique patient characteristics of Asian patients affect the diagnostic evaluation of pulmonary nodules. The objective of these clinical practice guidelines was to adapt those of CHEST to provide consensus-based recommendations relevant to practitioners in Asia. A modified ADAPTE process was used by a multidisciplinary group of pulmonologists and thoracic surgeons in Asia. An initial panel meeting analyzed all CHEST recommendations to achieve consensus on recommendations and identify areas that required further investigation before consensus could be achieved. Revised recommendations were circulated to panel members for iterative review and redrafting to develop the final guidelines. Evaluation of pulmonary nodules in Asia broadly follows those of the CHEST guidelines with important caveats. Practitioners should be aware of the risk of lung cancer caused by high levels of indoor and outdoor air pollution, as well as the high incidence of adenocarcinoma in female nonsmokers. Furthermore, the high prevalence of granulomatous disease and other infectious causes of pulmonary nodules need to be considered. Therefore, diagnostic risk calculators developed in non-Asian patients may not be applicable. Overall, longer surveillance of nodules than those recommended by CHEST should be considered. TB in Asia favors lesser reliance on PET scanning and greater use of nonsurgical biopsy over surgical diagnosis or surveillance. Practitioners in Asia are encouraged to use these adapted consensus guidelines to facilitate consistent evaluation of pulmonary nodules. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Decision making about healthcare-related tests and diagnostic test strategies. Paper 4: International guidelines show variability in their approaches.

PubMed

Mustafa, Reem A; Wiercioch, Wojtek; Arevalo-Rodriguez, Ingrid; Cheung, Adrienne; Prediger, Barbara; Ivanova, Liudmila; Ventresca, Matthew; Brozek, Jan; Santesso, Nancy; Bossuyt, Patrick; Garg, Amit X; Lloyd, Nancy; Lelgemann, Monika; Bühler, Diedrich; Schünemann, Holger J

2017-12-01

The objective of the study was to describe and compare current practices in developing guidelines about the use of healthcare-related tests and diagnostic strategies (HCTDS). We sampled 37 public health and clinical practice guidelines about HCTDS from various sources without language restrictions. Detailed descriptions of the systems used to assess the quality of evidence and develop recommendations were challenging to find within guidelines. We observed much variability among and within organizations with respect to how they develop recommendations about HCTDS. Twenty-four percent of the guidelines did not consider health benefits and harms but based decisions solely on test accuracy. We did not identify guidelines that described the main potential care pathways involving tests for a healthcare problem. In addition, we did not identify guidelines that systematically assessed, described, and referenced the evidence that linked test accuracy and patient-important outcomes. There is considerable variability among the processes used and factors considered in developing recommendations about the use of tests. This variability may be the cause for the disagreement we observed in recommendations about testing for the same condition. Copyright © 2017 Elsevier Inc. All rights reserved.

Writing about Clients: Developing Composite Case Material and Its Rationale

ERIC Educational Resources Information Center

Duffy, Maureen

2010-01-01

Ethical guidelines of the 4 major professional associations representing counselors and psychotherapists are reviewed. To help clarify thinking about writing up clinical cases, 3 kinds of cases are described. The author concludes that the current guidelines for clinician authors in writing about clients for publication or presentation are…

[Introduction of British guidelines in perinatal mental healthcare--towards enhancing the function of perinatal mental healthcare in Japan].

PubMed

Suzuki, Toshihito

2014-01-01

Professionals in many different occupations, from psychiatrists, obstetricians, and pediatricians to nurses, midwives, pharmacists, clinical psychologists, public health nurses, and psychiatric social workers, are involved in perinatal mental healthcare. In order to enhance the function of such healthcare, it is necessary both to provide specialized training in each occupation and form a system and to smoothly conduct medical collaboration between different occupations. A deficiency in the medical function of perinatal mental healthcare greatly influences the mother and child's health, mental hygiene, and social life later in life. Therefore, a demand is seen for specialized staff and system formation capable of the following: 1) responding with appropriate perinatal management of female patients taking psychotropic drugs; 2) providing support and pregnancy consultation to female patients who wish to have children; and 3) properly handling postpartum mental disorder management, possibility of breastfeeding, and various issues that arise in mother-child relationships during upbringing. In the UK, the clinical guideline (NICE Clinical Guideline 45) for perinatal mental healthcare, which was created by the National Institute for Clinical Excellence (NICE), provides important guidelines on how to handle perinatal mental health. Aside from the NICE guideline, the Maudsley Prescribing Guidelines in Psychiatry indicates basic guidelines on prescribing perinatal drug therapy. In Japan, however, the current situation of perinatal mental healthcare is such that it has yet to be systemically developed. In this paper, we introduce the basic content in these British guidelines that should be noted. In addition, we consider the current status and future disposition of Japan's perinatal mental healthcare, with consideration for the differences in healthcare circumstances between Japan and the UK.

Implementation of clinical guidelines on diabetes and hypertension in urban Mongolia: a qualitative study of primary care providers' perspectives and experiences.

PubMed

Chimeddamba, Oyun; Peeters, Anna; Ayton, Darshini; Tumenjargal, Enkhjargal; Sodov, Sonin; Joyce, Catherine

2015-08-11

Hypertension and diabetes, key risk factors for cardiovascular disease, are significant health problems globally. As cardiovascular disease is one of the leading causes of mortality in Mongolia since 2000, clinical guidelines on arterial hypertension and diabetes were developed and implemented in 2011. This paper explores the barriers and enablers influencing the implementation of these guidelines in the primary care setting. A phenomenological qualitative study with semi-structured interviews was conducted to explore the implementation of the diabetes and hypertension guidelines at the primary care level, as well as to gain insight into how practitioners view the usability and practicality of the guidelines. Ten family health centres were randomly chosen from a list of all the family health centres (n = 136) located in Ulaanbaatar City. In each centre, a focus group discussion with nurses (n = 20) and individual interviews with practice doctors (n = 10) and practice managers (n = 10) were conducted. Data was analysed using a thematic approach utilising the Theoretical Domains Framework. The majority of the study participants reported being aware of the guidelines and that they had incorporated them into their daily practice. They also reported having attended guideline training sessions which were focused on practice skill development. The majority of participants expressed satisfaction with the wide range of resources that had been supplied to them by the Mongolian Government to assist with the implementation of the guidelines. The resources, supplied from 2011 onwards, included screening devices, equipment for blood tests, medications and educational materials. Other enablers were the participants' commitment and passion for guideline implementation and their belief in the simplicity and practicality of the guidelines. Primary care providers reported a number of challenges in implementing the guidelines, including frustration caused by increased workload and long waiting times, time constraints, difficulties with conflicting tasks and low patient health literacy. This study provides evidence that comprehensive and rigorous dissemination and implementation strategies increase the likelihood of successful implementation of new guidelines in low resource primary care settings. It also offers some key lessons that might be carefully considered when other evidence-based clinical guidelines are to be put into effect in low resource settings and elsewhere.

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

PubMed

Rosenfeld, Richard M; Wyer, Peter C

2018-01-01

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

Overview of guidelines on iron chelation therapy in patients with myelodysplastic syndromes and transfusional iron overload.

PubMed

Gattermann, Norbert

2008-07-01

Between 2002 and 2008, a number of consensus statements and guidelines were developed by various groups around the world to educate healthcare professionals on the treatment of myelodysplastic syndromes (MDS), including the management of transfusional iron overload with iron chelation therapy. Guidelines have been developed by The Italian Society of Hematology, The UK MDS Guidelines Group, The Nagasaki Group, The National Comprehensive Cancer Network, and The MDS Foundation. These guidelines show that the approaches to managing iron overload in patients with MDS are region specific, differing in their recommendations for when iron chelation therapy should be initiated and strategies for the ongoing management of iron overload. The guidelines all agree that red blood cell transfusions are clinically beneficial to treat the symptomatic anemia in MDS, and that patients with low-risk MDS receiving transfusions are the most likely to benefit from iron chelation therapy.

Principles for interactions with biopharmaceutical companies: the development of guidelines for patient advocacy organizations in the field of rare diseases.

PubMed

Stein, Susan; Bogard, Elizabeth; Boice, Nicole; Fernandez, Vivian; Field, Tessa; Gilstrap, Alan; Kahn, Susan R; Larkindale, Jane; Mathieson, Toni

2018-01-22

Rare diseases are a global public health concern, affecting an estimated 350 million individuals. Only 5% of approximately 7000 known rare diseases have a treatment, and only about half have a patient advocacy organization. Biopharmaceutical companies face complex challenges in developing treatments for rare diseases. Patient advocacy organizations may play a major role by positively influencing research and development, clinical trials, and regulations. Thus, collaboration among patient advocacy organizations and industry is essential to bring new therapeutics to patients. We identified an unmet need for guidelines on day-to-day decision-making by rare disease patient advocacy organizations when working with biopharmaceutical partners. We convened an Independent Expert Panel experienced in collaborations between patient advocacy organizations and biopharmaceutical companies (April 2017) to develop consensus guidelines for these relationships. The guidelines were based on an original version by the International Fibrodysplasia Ossificans Progressiva Association (IFOPA). The Expert Panel reviewed and broadened these to be applicable to all patient advocacy organizations. Comments on the draft Guidelines were provided first by Panel participants and subsequently by six independent experts from patient advocacy organizations and industry. The Panel comprised four experts from the rare disease community who lead patient advocacy organizations; three leaders who perform advocacy functions within biopharmaceutical companies; and two facilitators, both having leadership experience in rare diseases and industry. The finalized Guidelines consist of four main sections: Identification and Engagement With Companies, Patient Engagement and Patient Privacy, Financial Contributions, and Clinical Trial Communication and Support. The Guidelines address the daily considerations, choices, and consequences of patient advocacy organizations as they engage with biopharmaceutical companies, and offer recommendations for volunteer/paid leaders of the organizations on how to interact in a thoughtful, responsible, ethical way that engenders trust. These Guidelines recommend best practices and standards for interactions between patient advocacy organizations and industry that will ultimately have a positive effect on the development of novel treatments. Patient advocacy organizations will be provided free access to these Guidelines to help bring clarification to day-to-day decision-making around their interactions, and for use as a living document with the potential for regular revisions and updates.

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

PubMed

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

2012-03-01

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

European Fissure Sealant Guidelines: assessment using AGREE II.

PubMed

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

2017-02-01

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

Pressure ulcer guideline development and dissemination in Europe.

PubMed

Meesterberends, Esther; Halfens, Ruud; Lohrmann, Christa; de Wit, Rianne

2010-06-01

To explore the current state of pressure ulcer guideline development and dissemination, from national to local level (i.e. nursing homes) in six European countries: England, Germany, Italy, the Netherlands, Portugal and Sweden. Pressure ulcers are a persistent problem in healthcare institutions. Their prevalence is influenced by many factors, one of them being the development and dissemination of pressure ulcer guidelines. These are difficult and complex processes and it is not clear whether they differ between European countries. Literature review and semi-structured interviews. Interviews were conducted in six countries at national and nursing home level. Four countries had national pressure ulcer prevention and treatment guidelines. Portugal had no national guidelines and Sweden had shifted the responsibility to regional level. All participating nursing homes had pressure ulcer guidelines except those in Portugal. Control and monitoring of guideline dissemination was carried out only in Sweden and England. All countries studied have national or regional pressure ulcer prevention and treatment guidelines, except Portugal. Portugal is also the only country where none of the nursing homes included had pressure ulcer guidelines. Because the dissemination of such guidelines does not imply actual implementation, further research should focus on the implementation process. Clinical guidelines, like pressure ulcer guidelines, are important tools in guiding the care processes in healthcare institutions. Successful dissemination of guidelines from national level to individual healthcare institutions is a first and necessary step in actually applying them. Monitoring of the guideline dissemination process is therefore essential.

Dutch guideline for clinical foetal-neonatal and paediatric post-mortem radiology, including a review of literature.

PubMed

Sonnemans, L J P; Vester, M E M; Kolsteren, E E M; Erwich, J J H M; Nikkels, P G J; Kint, P A M; van Rijn, R R; Klein, W M

2018-06-01

Clinical post-mortem radiology is a relatively new field of expertise and not common practice in most hospitals yet. With the declining numbers of autopsies and increasing demand for quality control of clinical care, post-mortem radiology can offer a solution, or at least be complementary. A working group consisting of radiologists, pathologists and other clinical medical specialists reviewed and evaluated the literature on the diagnostic value of post-mortem conventional radiography (CR), ultrasonography, computed tomography (PMCT), magnetic resonance imaging (PMMRI), and minimally invasive autopsy (MIA). Evidence tables were built and subsequently a Dutch national evidence-based guideline for post-mortem radiology was developed. We present this evaluation of the radiological modalities in a clinical post-mortem setting, including MIA, as well as the recently published Dutch guidelines for post-mortem radiology in foetuses, neonates, and children. In general, for post-mortem radiology modalities, PMMRI is the modality of choice in foetuses, neonates, and infants, whereas PMCT is advised in older children. There is a limited role for post-mortem CR and ultrasonography. In most cases, conventional autopsy will remain the diagnostic method of choice. Based on a literature review and clinical expertise, an evidence-based guideline was developed for post-mortem radiology of foetal, neonatal, and paediatric patients. What is Known: • Post-mortem investigations serve as a quality check for the provided health care and are important for reliable epidemiological registration. • Post-mortem radiology, sometimes combined with minimally invasive techniques, is considered as an adjunct or alternative to autopsy. What is New: • We present the Dutch guidelines for post-mortem radiology in foetuses, neonates and children. • Autopsy remains the reference standard, however minimal invasive autopsy with a skeletal survey, post-mortem computed tomography, or post-mortem magnetic resonance imaging can be complementary thereof.

Choice of Insulin in Type 2 Diabetes: A Southeast Asian Perspective

PubMed Central

Kalra, Sanjay; Thai, Hong Quang; Deerochanawong, Chaicharn; Su-Yen, Goh; Mohamed, Mafauzy; Latt, Tint Swe; Aye, Than Than; Latif, Zafar Ahmed; Katulanda, Prasad; Khun, Touch; Satha, Sum; Vongvandy, Vadsana

2017-01-01

Southeast Asia faces a diabetes epidemic, which has created significant challenges for health care. The unique Asian diabetes phenotype, coupled with peculiar lifestyle, diet, and healthcare-seeking behavior, makes it imperative to develop clinical pathways and guidelines which address local needs and requirements. From an insulin-centric viewpoint, the preparations prescribed in such pathways should be effective, safe, well tolerated, nonintrusive, and suitable for the use in multiple clinical situations including initiation and intensification. This brief communication describes the utility of premixed or dual action insulin in such clinical pathways and guidelines. PMID:28553609

A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care.

PubMed

Quanbeck, Andrew; Brown, Randall T; Zgierska, Aleksandra E; Jacobson, Nora; Robinson, James M; Johnson, Roberta A; Deyo, Brienna M; Madden, Lynn; Tuan, Wen-Jan; Alagoz, Esra

2018-01-25

This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

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.

Proposal for establishing structure and process in the development of implicit chiropractic standards of care and practice guidelines.

PubMed

Hansen, D T; Adams, A H; Meeker, W C; Phillips, R B

1992-09-01

With the advent of health care's "era of accountability", the chiropractic profession is now faced with generating implicit standards and guidelines for care or having it done for us by outside agencies. Already we see chiropractic groups in individual states and provinces being pressured into naive efforts of guideline development. Current knowledge and experience are available through recent health care literature that clearly defines the structure and process of guideline development and offers suggestions on how to measure outcomes of those processes. In addition, the United States Congress has directed a new federal agency to oversee this activity and monitor outcomes of quality improvement programs. The time has come for the chiropractic profession to define its exact role in health care delivery and develop implicit standards of care and practice guidelines. This sentinel effort should be managed by a commissioned body of empaneled experts that generally represent the academic and clinical chiropractic profession. A protocol for selection of these panelists and the panel chairperson needs to be developed and memorialized. Appropriate methodology (with definitions) needs to be developed for the process of standards/guideline development. Adherence to the accepted structure and process of guideline development will ensure the continuity of this dynamic process in the coming generations. This proposal offers a preliminary definition of the structure and process, including a "seed" policy statement and decision flow chart, specific to guideline development. Once the structure and process of guideline development for chiropractic are defined, the profession can then present this product to federal and state agencies, private sector health care purchasers, patient advocacy groups and other stakeholders of chiropractic care.(ABSTRACT TRUNCATED AT 250 WORDS)

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.

Do guidelines influence the implementation of health programs? — Uganda’s experience

PubMed Central

2012-01-01

Background A guideline contains processes and procedures intended to guide health service delivery. However, the presence of guidelines may not guarantee their implementation, which may be a result of weaknesses in the development process. This study was undertaken to describe the processes of developing health planning, services management, and clinical guidelines within the health sector in Uganda, with the goal of understanding how these processes facilitate or abate the utility of guidelines. Methods Qualitative and quantitative research methods were used to collect and analyze data. Data collection was undertaken at the levels of the central Ministry of Health, the district, and service delivery. Qualitative methods included review of documents, observations, and key informant interviews, as well as quantitative aspects included counting guidelines. Quantitative data were analyzed with Microsoft Excel, and qualitative data were analyzed using deductive content thematic analysis. Results There were 137 guidelines in the health sector, with programs related to Millennium Development Goals having the highest number (n = 83). The impetus for guideline development was stated in 78% of cases. Several guidelines duplicated content, and some conflicted with each other. The level of consultation varied, and some guidelines did not consider government-wide policies and circumstances at the service delivery level. Booklets were the main format of presentation, which was not tailored to the service delivery level. There was no framework for systematic dissemination, and target users were defined broadly in most cases. Over 60% of guidelines available at the central level were not available at the service delivery level, but there were good examples in isolated cases. There was no framework for systematic monitoring of use, evaluation, and review of guidelines. Suboptimal performance of the supervision framework that would encourage the use of guidelines, assess their utilization, and provide feedback was noted. Conclusions Guideline effectiveness is compromised by the development process. To ensure the production of high-quality guidelines, efforts must be employed at the country and regional levels. The regional level can facilitate pooling resources and expertise in knowledge generation, methodology development, guideline repositories, and capacity building. Countries should establish and enforce systems and guidance on guideline development. PMID:23068082

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

PubMed

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

2017-05-01

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

[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.

Systems consultation: protocol for a novel implementation strategy designed to promote evidence-based practice in primary care.

PubMed

Quanbeck, Andrew; Brown, Randall T; E Zgierska, Aleksandra; A Johnson, Roberta; Robinson, James M; Jacobson, Nora

2016-01-27

Adoption of evidence-based practices takes place at a glacial place in healthcare. This research will pilot test an innovative implementation strategy - systems consultation -intended to speed the adoption of evidence-based practice in primary care. The strategy is based on tenets of systems engineering and has been extensively tested in addiction treatment. Three innovations have been included in the strategy - translation of a clinical practice guideline into a checklist-based implementation guide, the use of physician peer coaches ('systems consultants') to help clinics implement the guide, and a focus on reducing variation in practices across prescribers and clinics. The implementation strategy will be applied to improving opioid prescribing practices in primary care, which may help ultimately mitigate the increasing prevalence of opioid abuse and addiction. The pilot test will compare four intervention clinics to four control clinics in a matched-pairs design. A leading clinical guideline for opioid prescribing has been translated into a checklist-based implementation guide in a systematic process that involved experts who wrote the guideline in consultation with implementation experts and primary care physicians. Two physicians with expertise in family and addiction medicine are serving as the systems consultants. Each systems consultant will guide two intervention clinics, using two site visits and follow-up communication by phone and email, to implement the translated guideline. Mixed methods will be used to test the feasibility, acceptability, and preliminary effectiveness of the implementation strategy in an evaluation that meets standards for 'fully developed use' of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The clinic will be the primary unit of analysis. The systems consultation implementation strategy is intended to generalize to the adoption of other clinical guidelines. This pilot test is intended to prepare for a large randomized clinical trial that will test the strategy against other implementation strategies, such as audit/feedback and academic detailing, used to close the gap between knowledge and practice. The systems consultation approach has the potential to shorten the famously long time it takes to implement evidence-based practices and clinical guidelines in healthcare.

GUIDELINES OF CARE FOR THE MANAGEMENT OF ATOPIC DERMATITIS

PubMed Central

Eichenfield, Lawrence F.; Tom, Wynnis L.; Chamlin, Sarah L.; Feldman, Steven R.; Hanifin, Jon M.; Simpson, Eric L.; Berger, Timothy G.; Bergman, James N.; Cohen, David E.; Cooper, Kevin D.; Cordoro, Kelly M.; Davis, Dawn M.; Krol, Alfons; Margolis, David J.; Paller, Amy S.; Schwarzenberger, Kathryn; Silverman, Robert A.; Williams, Hywel C.; Elmets, Craig A.; Block, Julie; Harrod, Christopher G.; Begolka, Wendy Smith; Sidbury, Robert

2014-01-01

Atopic dermatitis (AD) is a chronic, pruritic inflammatory dermatosis that affects up to 25% of children and 2–3% of adults. This guideline addresses important clinical questions that arise in AD management and care, providing updated and expanded recommendations based on the available evidence. In this first of four sections, methods for diagnosis and monitoring of disease, outcomes measures for assessment and common clinical associations that affect patients with AD are discussed. Known risk factors for the development of disease are also reviewed. PMID:24290431