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

Science.gov (United States)

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

2017-09-01

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

A survey of Australian chiropractors' attitudes and beliefs about evidence-based practice and their use of research literature and clinical practice guidelines.

Science.gov (United States)

Walker, Bruce F; Stomski, Norman J; Hebert, Jeff J; French, Simon D

2013-12-17

Research into chiropractors' use of evidence in clinical practice appears limited to a single small qualitative study. The paucity of research in this area suggests that it is timely to undertake a more extensive study to build a more detailed understanding of the factors that influence chiropractors' adoption of evidence-based practice (EBP) principles. This study aimed to identify Australian chiropractors' attitudes and beliefs towards EBP in clinical practice, and also examine their use of research literature and clinical practice guidelines. We used an online questionnaire about attitudes, beliefs and behaviours towards the use of EBP in clinical practice that had been developed to survey physiotherapists and modified it to ensure that it was relevant to chiropractic practice. We endeavoured to survey all registered Australian chiropractors (n = 4378) via email invitation distributed by Australian chiropractic professional organisations and the Chiropractic Board of Australia. Logistic regression analyses were conducted to examine univariate associations between responses to items measuring attitudes and beliefs with items measuring: age; years since registration; attention to literature; and use of clinical practice guidelines. Questionnaires were returned by 584 respondents (response rate approximately 13%). The respondents' perceptions of EBP were generally positive: most agreed that the application of EBP is necessary (77.9%), literature and research findings are useful (80.2%), EBP helps them make decisions about patient care (66.5%), and expressed an interest in learning or improving EBP skills (74.9%). Almost half of the respondents (45.1%) read between two to five articles a month. Close to half of the respondents (44.7%) used literature in the process of clinical decision making two to five times each month. About half of the respondents (52.4%) agreed that they used clinical practice guidelines, and around half (54.4%) agreed that they were able

Clinical practice guidelines in patient management

Directory of Open Access Journals (Sweden)

Santosh Kumar

2001-01-01

Full Text Available Efforts have always been made to evolve certain prin-ciples to reduce the variability in the management of patients and make medical care more appropriate. These efforts have become almost a movement since 1980s as evidenced in the development of clinical practice guide-lines in all medical disciplines. This article describes the need for clinical practice guidelines and their de-velopment methods and qualities. Advantages and limi-tations of clinical practice guidelines are enumerated. The salient features of various available clinical prac-tice guidelines in urology are also described.

How GPs implement clinical guidelines in everyday clinical practice

DEFF Research Database (Denmark)

Videbæk Le, Jette; Hansen, Helle P; Riisgaard, Helle

2015-01-01

BACKGROUND: Clinical guidelines are considered to be essential for improving quality and safety of health care. However, interventions to promote implementation of guidelines have demonstrated only partial effectiveness and the reasons for this apparent failure are not yet fully understood....... OBJECTIVE: To investigate how GPs implement clinical guidelines in everyday clinical practice and how implementation approaches differ between practices. METHODS: Individual semi-structured open-ended interviews with seven GPs who were purposefully sampled with regard to gender, age and practice form....... Interviews were recorded, transcribed verbatim and then analysed using systematic text condensation. RESULTS: Analysis of the interviews revealed three different approaches to the implementation of guidelines in clinical practice. In some practices the GPs prioritized time and resources on collective...

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

Science.gov (United States)

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.

Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors.

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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

Application of radiotherapy for hepatocellular carcinoma in current clinical practice guidelines

Energy Technology Data Exchange (ETDEWEB)

Rim, Chai Hong; Seong, Jin Sil [Dept. of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of)

2016-09-15

In oncologic practice, treatment guidelines provide appropriate treatment strategies based on evidence. Currently, many guidelines are used, including those of the European Association for the Study of the Liver and European Organization for Research and Treatment of Cancer (EASL-EORTC), National Comprehensive Cancer Network (NCCN), Asia-Pacific Primary Liver Cancer Expert (APPLE), and Korean Liver Cancer Study Group and National Cancer Centre (KLCSG-NCC). Although radiotherapy is commonly used in clinical practice, some guidelines do not accept it as a standard treatment modality. In this review, we will investigate the clinical practice guidelines currently used, and discuss the application of radiotherapy.

Application of radiotherapy for hepatocellular carcinoma in current clinical practice guidelines

International Nuclear Information System (INIS)

Rim, Chai Hong; Seong, Jin Sil

2016-01-01

In oncologic practice, treatment guidelines provide appropriate treatment strategies based on evidence. Currently, many guidelines are used, including those of the European Association for the Study of the Liver and European Organization for Research and Treatment of Cancer (EASL-EORTC), National Comprehensive Cancer Network (NCCN), Asia-Pacific Primary Liver Cancer Expert (APPLE), and Korean Liver Cancer Study Group and National Cancer Centre (KLCSG-NCC). Although radiotherapy is commonly used in clinical practice, some guidelines do not accept it as a standard treatment modality. In this review, we will investigate the clinical practice guidelines currently used, and discuss the application of radiotherapy

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

Science.gov (United States)

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.

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

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

2016-10-06

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

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

Directory of Open Access Journals (Sweden)

Carmel Jacobs

Full Text Available Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents.Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored

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

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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

Guidelines for enhancing clinical supervision: research ...

African Journals Online (AJOL)

... toesighouding behels, maar dat hulle nie die noodsaaklikheid om reflektiewe leer toe te pas tydens die proses van kliniese toesighouding aangedui het nie. Keywords: Clinical supervision, Reflective thinking and learning, Support, Guidance (Health SA Gesondheid: interdisciplinary research journal: 2003 8(4): 12-23) ...

Towards a traceable clinical guidelines application. A model-driven approach.

Science.gov (United States)

Domínguez, E; Pérez, B; Zapata, M

2010-01-01

The goal of this research is to provide an overall framework to enable model-based development of clinical guideline-based decision support systems (GBDSSs). The automatically generated GBDSSs are aimed at providing guided support to the physician during the application of guidelines and automatically storing guideline application data for traceability purposes. The development process of a GBDSS for a guideline is based on model-driven development (MDD) techniques which allow us to carry out such a process automatically, making development more agile and saving on human resource costs. We use UML Statecharts to represent the dynamics of guidelines and, based on this model, we use a MDD-based tool chain to generate the guideline-dependent components of each GBDSS in an automatic way. In particular, as for the traceability capabilities of each GBDSS, MDD techniques are combined with database schema mappings for metadata management in order to automatically generate the GBDSS-persistent component as one of the main contributions of this paper. The complete framework has been implemented as an Eclipse plug-in named GBDSSGenerator which, starting from the statechart representing a guideline, allows the development process to be carried out automatically by only selecting different menu options the plug-in provides. We have successfully validated our overall approach by generating the GBDSS for different types of clinical guidelines, even for laboratory guidelines. The proposed framework allows the development of clinical guideline-based decision support systems in an automatic way making this process more agile and saving on human resource costs.

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.

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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

Ethics in clinical research: the Indian perspective.

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Sanmukhani, J; Tripathi, C B

2011-03-01

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

Utilization of the American Telemedicine Association's Clinical Practice Guidelines

Science.gov (United States)

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

Development of Guidelines for the Conduct of HIV Research ...

African Journals Online (AJOL)

AJRH Managing Editor

Guidelines for HIV Research Monitoring by Ethics Committees. African Journal of Reproductive Health September 2014 (Special Edition); 18(3):66 ... Health and Community Medicine, UNSW Australia; 2Department of Child Dental Health and the Institute of .... International .... review clinical research protocols to ensure both.

Development of clinical practice guidelines.

Science.gov (United States)

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.

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

Science.gov (United States)

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

Science.gov (United States)

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)

Introducing guidelines into clinical practice.

Science.gov (United States)

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

Clinical Practice Guidelines for Irritable Bowel Syndrome in Korea, 2017 Revised Edition

Science.gov (United States)

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

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest.

Science.gov (United States)

Eccles, Martin P; Grimshaw, Jeremy M; Shekelle, Paul; Schünemann, Holger J; Woolf, Steven

2012-07-04

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development.

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

Science.gov (United States)

2012-01-01

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422

Xeroderma pigmentosum clinical practice guidelines.

Science.gov (United States)

Moriwaki, Shinichi; Kanda, Fumio; Hayashi, Masaharu; Yamashita, Daisuke; Sakai, Yoshitada; Nishigori, Chikako

2017-10-01

Xeroderma pigmentosum (XP) is a genetic photosensitive disorder in which patients are highly susceptibe to skin cancers on the sun-exposed body sites. In Japan, more than half of patients (30% worldwide) with XP show complications of idiopathic progressive, intractable neurological symptoms with poor prognoses. Therefore, this disease does not merely present with dermatological symptoms, such as photosensitivity, pigmentary change and skin cancers, but is "an intractable neurological and dermatological disease". For this reason, in March 2007, the Japanese Ministry of Health, Labor and Welfare added XP to the neurocutaneous syndromes that are subject to government research initiatives for overcoming intractable diseases. XP is one of the extremely serious photosensitive disorders in which patients easily develop multiple skin cancers if they are not completely protected from ultraviolet radiation. XP patients thus need to be strictly shielded from sunlight throughout their lives, and they often experience idiopathic neurodegenerative complications that markedly reduce the quality of life for both the patients and their families. Hospitals in Japan often see cases of XP as severely photosensitive in children, and as advanced pigmentary disorders of the sun-exposed area with multiple skin cancers in adults (aged in their 20-40s), making XP an important disease to differentiate in everyday clinical practice. It was thus decided that there was a strong need for clinical practice guidelines dedicated to XP. This process led to the creation of new clinical practice guidelines for XP. © 2017 Japanese Dermatological Association.

Use of clinical practice guidelines to promote best practice when managing clinical interventions for liver transplant candidates.

Science.gov (United States)

Jarrett, Maree

2009-06-01

Limited organ availability and an increasing demand for organ transplantation has extended transplant waiting times and thus increased morbidity and mortality for potential recipients on waiting lists. The Queensland Liver Transplant Service identified use of clinical practice guidelines developed from evidence-based practice as a strategic clinical management/workflow tool that could improve clinical outcomes for patients awaiting liver transplant. An extensive review of publications related to the management of advanced liver disease in potential transplant recipients was undertaken and the supporting evidence was identified. In all stages of development of the guidelines, the multidisciplinary collaborative team of clinicians used recommended principles from The Appraisal of Guidelines, Research and Evaluation collaboration. The liver transplant recipient coordinator acted as facilitator for the project, identifying positive factors and resolving obstacles. Key focus areas in optimizing medical management before liver transplant were identified with the aim of preventing disease progression and complications that would jeopardize patients' outcome. Clinical practice guidelines were developed for each key area to optimize care by promoting appropriate timing of clinical interventions. Practices that required change to comply with identified best practice were investigated, and clinical practice for the outpatient medical management of potential liver transplant recipients with chronic liver disease were developed collaboratively. These guidelines have been accepted and are being implemented within the gastroenterology and hepatology department at the Princess Alexandra Hospital.

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

Science.gov (United States)

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

2017-06-01

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

Ethics in clinical research: The Indian perspective

OpenAIRE

J Sanmukhani; C B Tripathi

2011-01-01

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organiza...

Thyroid nodule guidelines: agreement, disagreement and need for future research

DEFF Research Database (Denmark)

Paschke, Ralf; Hegedüs, Laszlo; Alexander, Erik

2011-01-01

, clinically very relevant areas of uncertainty need to be addressed by further research. This situation applies, for instance, to better definition of ultrasound malignancy criteria and the evaluation of emerging new diagnostic and therapeutic techniques, including molecular markers. For clinicians who advise......This article reviews agreement, disagreement and need for future research of the thyroid nodule guidelines published by the British Thyroid Association, National Cancer Institute, American Thyroid Association and the joint, transatlantic effort of three large societies, the American Society...... of Clinical Endocrinologists, Associazione Medici Endocrinologi and the European Thyroid Association, published in 2010. Consensus exists for most topics in the various guidelines. A few areas of disagreement, such as the use of scintigraphy, are mostly due to differences in disease prevalence in different...

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

Science.gov (United States)

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

Development of evidence-based clinical practice guidelines (CPGs: comparing approaches

Directory of Open Access Journals (Sweden)

Harris Claire

2008-10-01

Full Text Available Abstract Background While the potential of clinical practice guidelines (CPGs to support implementation of evidence has been demonstrated, it is not currently being achieved. CPGs are both poorly developed and ineffectively implemented. To improve clinical practice and health outcomes, both well-developed CPGs and effective methods of CPG implementation are needed. We sought to establish whether there is agreement on the fundamental characteristics of an evidence-based CPG development process and to explore whether the level of guidance provided in CPG development handbooks is sufficient for people using these handbooks to be able to apply it. Methods CPG development handbooks were identified through a broad search of published and grey literature. Documents published in English produced by national or international organisations purporting to support development of evidence-based CPGs were included. A list of 14 key elements of a CPG development process was developed. Two authors read each handbook. For each handbook a judgement was made as to how it addressed each element; assigned as: 'mentioned and clear guidance provided', 'mentioned but limited practical detail provided ', or 'not mentioned'. Results Six CPG development handbooks were included. These were produced by the Council of Europe, the National Health and Medical Research Council of Australia, the National Institute for Health and Clinical Excellence in the UK, the New Zealand Guidelines Group, the Scottish Intercollegiate Guideline Network, and the World Health Organization (WHO. There was strong concordance between the handbooks on the key elements of an evidence-based CPG development process. All six of the handbooks require and provide guidance on establishment of a multidisciplinary guideline development group, involvement of consumers, identification of clinical questions or problems, systematic searches for and appraisal of research evidence, a process for drafting

[Elaboration and critical evaluation of clinical guidelines].

Science.gov (United States)

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.

PROPOSAL OF GUIDELINE FOR CLINICAL TRIAL PROTOCOLS WITH HERBAL DRUGS

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Migdacelys Arboláez Estrada.

2007-04-01

Full Text Available SUMMARYCuba has extensive experience about herbal drugs, however only a few products get to the clinical phase of drug development. Our objective was to design new guidelines for clinical trials with herbal drugs.A detailed bibliographic search about regulatory aspects about clinical trials in Cuba and the world was done for development of the guideline. The guideline's proposed format includes: 1 Index, including the classification of the content. 2 Summary, 3 Fifteen chapters, related to the clinical trials. The guideline also propose the inclusion of annexes.A new guideline containing 15 chapters allows for writing more clear and detailed clinical trial protocols. The guideline contains the information required to guide the research staff who is interested in the validation of herbal drugs pharmacological activations from the perspective of clinical trials. RESUMEN Cuba tiene experiencia extensa sobre plantas medicinales, aunque solo algunos productos llegan a una fase clínica del desarrollo. Nuestro objetivo fué diseñar una nueva guía para ensayos clínicos con plantas medicinales.Hemos realizado una detallada búsqueda bibliográfica sobre aspectos reguladores de ensayos clínicos en Cuba y el resto del mundo para el desarrollo de la guía. El formato propuesto de la guia incluye: 1 Índice, incluyendo la clasificación de los contenidos. 2 Resumen, 3 Quince capítulos, relacionados con los ensayos clínicos. La guía también propone la inclusión de anexos.La nueva guía que contiene 15 capítulos que orientan la redacción de protocolos de ensayos clínicos más claros y más detallados. La guía contiene la información requerida para orientar al personal investigador interesado en la validación de la actividad farmacológica de las plantas medicinales desde la perspectiva de los ensayos clínicos.

Guidelines for Reporting Medical Research

DEFF Research Database (Denmark)

Johansen, Mathilde; Thomsen, Simon Francis

2016-01-01

As a response to a low quality of reporting of medical research, guidelines for several different types of study design have been developed to secure accurate reporting and transparency for reviewers and readers from the scientific community. Herein, we review and discuss the six most widely...... accepted and used guidelines: PRISMA, CONSORT, STROBE, MOOSE, STARD, and SPIRIT. It is concluded that the implementation of these guidelines has led to only a moderate improvement in the quality of the reporting of medical research. There is still much work to be done to achieve accurate and transparent...... reporting of medical research findings....

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

Science.gov (United States)

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

A survey of physical therapists' clinical practice patterns and adherence to clinical guidelines in the management of patients with whiplash associated disorders (WAD).

Science.gov (United States)

Corkery, Marie B; Edgar, Kristen L; Smith, Christine E

2014-05-01

To explore the clinical practice of physical therapists and examine adherence to clinical guidelines for treating patients with whiplash associated disorders (WAD). A cross-sectional electronic survey was sent to 1484 licensed physical therapists from the Orthopedic Section of the American Physical Therapy Association and the American Academy of Orthopedic Manual Physical Therapists. The survey included demographic data and two clinical vignettes describing patients with acute and chronic WAD. The chi-square test was used to analyze responses. There were 291(19.6%) responses to the survey. Of those, 237 (81.4%) provided data for vignette 1 and 204 (70.1%) for vignette 2. One hundred and eighty (76.6%) respondents reported familiarity with evidence-based or clinical practice guidelines for treating patients with WAD. Of those, 71.5% (n = 128) indicated that they followed them more than 50% of the time. Therapists with an advanced certification were more likely to be familiar with clinical guidelines than those who were not certified (Ppsychological distress and some outcome measures. Significant differences in clinical practice (P<0.01) were found between therapists who were and were not familiar with guidelines and those with and without an advanced certification. Advanced certification and knowledge of guidelines appeared to play a role in the clinical practice of physical therapists treating patients with WAD. Further research is needed to explore factors affecting knowledge translation from research to clinical practice and to evaluate the outcomes of patients with WAD when clinical guidelines are applied in practice.

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

Science.gov (United States)

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

2014-01-01

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

European clinical guidelines for hyperkinetic disorder -- first upgrade

NARCIS (Netherlands)

Taylor, E.; Dopfner, M.; Sergeant, J.A.; Asherson, P.; Banaschewski, T.; Coghill, D.; Danckaerts, M.; Rothenberger, A.; Sonuga-Barke, E.; Steinhausen, H.C.; Zuddas, A.

2004-01-01

BACKGROUND: The validity of clinical guidelines changes over time, because new evidence-based knowledge and experience develop. OBJECTIVE: Hence, the European clinical guidelines on hyperkinetic disorder from 1998 had to be evaluated and modified. METHOD: Discussions at the European Network for

European clinical guidelines for hyperkinetic disorder-first upgrade

NARCIS (Netherlands)

Taylor, E.; Döpfner, M.; Sergeant, J.A.; Asherson, P.; Banaschewski, T.; Buitelaar, J.; Coghill, D.; Danckaerts, M.; Rothenberger, A.; Sonuga-Barke, E.; Steinhausen, H.C.; Zuddas, A.

2004-01-01

Background: The validity of clinical guidelines changes over time, because new evidence-based knowledge and experience develop. Objective: Hence, the European clinical guidelines on hyperkinetic disorder from 1998 had to be evaluated and modified. Method Discussions at the European Network for

Annotating Evidence Based Clinical Guidelines : A Lightweight Ontology

NARCIS (Netherlands)

Hoekstra, R.; de Waard, A.; Vdovjak, R.; Paschke, A.; Burger, A.; Romano, P.; Marshall, M.S.; Splendiani, A.

2012-01-01

This paper describes a lightweight ontology for representing annotations of declarative evidence based clinical guidelines. We present the motivation and requirements for this representation, based on an analysis of several guidelines. The ontology provides the means to connect clinical questions

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

Directory of Open Access Journals (Sweden)

Burgers Jako S

2007-11-01

Full Text Available Abstract 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

National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice

DEFF Research Database (Denmark)

Sturgeon, Catharine M; Hoffman, Barry R; Chan, Daniel W

2008-01-01

BACKGROUND: This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. METHODS: One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor...... questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence...... records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical...

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

Science.gov (United States)

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

2015-12-01

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

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

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Paola Frati

2017-01-01

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

An Evaluation of Industry Relationships Among Contributors to AAOS Clinical Practice Guidelines and Appropriate Use Criteria.

Science.gov (United States)

Checketts, Jake X; Cook, Courtney; Vassar, Matt

2018-01-17

A long-standing relationship between orthopaedic surgeons and industry has made financial conflicts of interest a concerning issue. Research supports that financial conflicts of interest can influence both medical research and clinical practice. Financial conflicts of interest may also influence clinical practice guideline recommendations and their corresponding appropriate use criteria. Because of the influential nature of these guidelines, it is imperative that care be taken to minimize bias during guideline development. We retrieved clinical practice guidelines and their corresponding appropriate use criteria from the American Academy of Orthopaedic Surgery that were published or revised between 2013 and 2016. We extracted industry payments received by physicians using the Centers for Medicare & Medicaid Services Open Payments database. We then evaluated the value and types of these payments. We also used these data to determine whether disclosure statements were accurate and whether guideline development was in adherence with the Institute of Medicine's (IOM's) standards. Of the 106 physicians that were evaluated, 85 (80%) received at least 1 industry payment, 56 (53%) accepted >$1,000, and 35 (33%) accepted >$10,000. Financial payments amounted to a mean of $93,512 per physician. Total reimbursement for the 85 clinical practice guideline and appropriate use criteria contributors was $9,912,309. We found that disclosure statements disagreed with the Open Payments data and that the IOM standards were not completely enforced. Clinical practice guideline and appropriate use criteria contributors received substantial payments from industry, many disclosure statements were inaccurate, and the IOM standards were not completely met. Clinical practice guidelines and appropriate use criteria are critical for practicing evidence-based medicine. If financial conflicts of interest are present during their development, it is possible that patient care may be compromised.

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

Science.gov (United States)

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.

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

Directory of Open Access Journals (Sweden)

James D. Chalmers

2017-09-01

To understand the different ways in which patients can contribute to clinical guidelines, research projects and educational activities. To understand the barriers and potential solutions to these barriers from a physician’s perspective, in order to ensure meaningful patient involvement in clinical projects. To understand the barriers and potential solutions from a patient’s perspective, in order to meaningfully involve patients in clinical projects.

Clinical cell therapy guidelines for neurorestoration (China version 2016

Directory of Open Access Journals (Sweden)

Huang H

2017-02-01

Full Text Available Hongyun Huang,1 Lin Chen,2 Qingyan Zou,3 Fabin Han,4 Tiansheng Sun,5 Gengsheng Mao,1 Xijing He6 1Institute of Neurorestoratology, General Hospital of Armed Police Forces, 2Department of Neurosurgery, Yuquan Hospital, Tsinghua University, Beijing, 3Guangdong 999 Brain Hospital, Guangzhou, 4Centre for Stem Cells and Regenerative Medicine, Affiliated Hospital of Taishan Medical University, Liaocheng, Shandong, 5Department of Orthopedics, Beijing Army General Hospital, Beijing, 6Second Department of Orthopedics, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China On behalf of the Chinese Association of Neurorestoratology and Chinese Branch of the International Association of Neurorestoratology Abstract: Cell therapy has been shown to be a key clinical therapeutic option for central ­nervous system disease or damage, and >30 types of cells have been identified through preclinical studies as having the capacity for neurorestoration. To standardize the clinical procedures of cell therapy as one of the strategies for treating neurological disorders, the first set of guidelines governing the clinical application of neurorestoration was completed in 2011 by the Chinese Branch of the International Association of Neurorestoratology. Given the rapidly advancing state of the field, the Neurorestoratology Professional Committee of Chinese Medical Doctor Association (Chinese Association of Neurorestoratology and the Chinese Branch of the International Association of Neurorestoratology have approved the current version known as the “Clinical Cell Therapy Guidelines for Neurorestoration (China Version 2016”. We hope this guideline will reflect the most recent results demonstrated in preclinical research, transnational studies, and evidence-based clinical studies, as well as guide clinical practice in applying cell therapy for neurorestoration. Keywords: cell therapy, neurorestoration, China, clinical

Design and implementation of a decision support system for breast cancer treatment based on clinical practice guidelines

International Nuclear Information System (INIS)

Skevofilakas, M.T.; Nikita, K.S.; Templaleksis, P.H.; Birbas, K.N.; Kaklamanos, I.G.; Bonatsos, G.N.

2007-01-01

Evidence based medicine is the clinical practice that uses medical data and proof in order to make efficient clinical decisions. Information technology (IT) can play a crucial role in exploiting the huge size of raw medical data involved. In an attempt to improve clinical efficacy, health care society nowadays also utilizes a new assistant, clinical guidelines. Our research concerns the medical domain of the breast cancer disease. Our research's focus is twofold; our primary goal is to ensure consistency in clinical practice by importing clinical guidelines in an IT driven decision support system (DSS). Furthermore, we seek to improve visualization of disease specific, clinical data, providing for it's faster and more efficient use. (orig.)

A method for developing standardised interactive education for complex clinical guidelines

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Vaughan Janet I

2012-11-01

Full Text Available Abstract 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

In Defense of a Social Value Requirement for Clinical Research.

Science.gov (United States)

Wendler, David; Rid, Annette

2017-02-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

Implementing clinical guidelines in stroke: a qualitative study of perceived facilitators and barriers.

Science.gov (United States)

Donnellan, Claire; Sweetman, S; Shelley, E

2013-08-01

Clinical guidelines are frequently used as a mechanism for implementing evidence-based practice. However research indicates that health professionals vary in the extent to which they adhere to these guidelines. This study aimed to study the perceptions of stakeholders and health professionals on the facilitators and barriers to implementing national stroke guidelines in Ireland. Qualitative interviews using focus groups were conducted with stakeholders (n=3) and multidisciplinary team members from hospitals involved in stroke care (n=7). All focus group interviews were semi-structured, using open-ended questions. Data was managed and analysed using NVivo 9 software. The main themes to emerge from the focus groups with stakeholders and hospital multidisciplinary teams were very similar in terms of topics discussed. These were resources, national stroke guidelines as a tool for change, characteristics of national stroke guidelines, advocacy at local level and community stroke care challenges. Facilitators perceived by stakeholders and health professionals included having dedicated resources, user-friendly guidelines relevant at local level and having supportive advocates on the ground. Barriers were inadequate resources, poor guideline characteristics and insufficient training and education. This study highlights health professionals' perspectives regarding many key concepts which may affect the implementation of stroke care guidelines. The introduction of stroke clinical guidelines at a national level is not sufficient to improve health care quality as they should be incorporated in a quality assurance cycle with education programmes and feedback from surveys of clinical practice. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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

Science.gov (United States)

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

Guideline Formalization and Knowledge Representation for Clinical Decision Support

Directory of Open Access Journals (Sweden)

Tiago OLIVEIRA

2012-09-01

Full Text Available Normal 0 21 false false false EN-US JA X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Tabla normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-hansi-font-family:Cambria; mso-hansi-theme-font:minor-latin; mso-ansi-language:EN-US;} The prevalence of situations of medical error and defensive medicine in healthcare institutions is a great concern of the medical community. Clinical Practice Guidelines are regarded by most researchers as a way to mitigate theseoccurrences; however, there is a need to make them interactive, easier to update and to deploy. This paper provides a model for Computer-Interpretable Guidelines based on the generic tasks of the clinical process, devised to be included in the framework of a Clinical Decision Support System. Aiming to represent medical recommendations in a simple and intuitive way. Hence, this work proposes a knowledge representation formalism that uses an Extension to Logic Programming to handle incomplete information. This model is used to represent different cases of missing, conflicting and inexact information with the aid of a method to quantify its quality. The integration of the guideline model with the knowledge representation formalism yields a clinical decision model that relies on the development of multiple information scenarios and the exploration of different clinical hypotheses.

Guideline Formalization and Knowledge Representation for Clinical Decision Support

Directory of Open Access Journals (Sweden)

Paulo NOVAIS

2013-07-01

Full Text Available Normal 0 21 false false false EN-US JA X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Tabla normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-hansi-font-family:Cambria; mso-hansi-theme-font:minor-latin; mso-ansi-language:EN-US;} The prevalence of situations of medical error and defensive medicine in healthcare institutions is a great concern of the medical community. Clinical Practice Guidelines are regarded by most researchers as a way to mitigate these occurrences; however, there is a need to make them interactive, easier to update and to deploy. This paper provides a model for Computer-Interpretable Guidelines based on the generic tasks of the clinical process, devised to be included in the framework of a Clinical Decision Support System. Aiming to represent medical recommendations in a simple and intuitive way. Hence, this work proposes a knowledge representation formalism that uses an Extension to Logic Programming to handle incomplete information. This model is used to represent different cases of missing, conflicting and inexact information with the aid of a method to quantify its quality. The integration of the guideline model with the knowledge representation formalism yields a clinical decision model that relies on the development of multiple information scenarios and the exploration of different clinical hypotheses.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

Evidence-based clinical guidelines for eating disorders : International comparison

NARCIS (Netherlands)

Hilbert, Anja; Hoek, Hans W.; Schmidt, Ricarda

2017-01-01

Purpose of review: The current systematic review sought to compare available evidence-based clinical treatment guidelines for all specific eating disorders. Recent findings: Nine evidence-based clinical treatment guidelines for eating disorders were located through a systematic search. The

Computerizing clinical practice guidelines

DEFF Research Database (Denmark)

Lyng, Karen Marie

It is well described that hospitals have problems with sustaining high quality of care and expedient introduction of new medical knowledge. Clinical practice guidelines (CPGs) have been promoted as a remedy to deal with these problems. It is, however, also well described that application and comp......It is well described that hospitals have problems with sustaining high quality of care and expedient introduction of new medical knowledge. Clinical practice guidelines (CPGs) have been promoted as a remedy to deal with these problems. It is, however, also well described that application...... is comprised by fieldwork in three oncology departments and a case study of advanced life support. Although close to all patients within oncology are treated according to a CPG, I found limited application of physical CPGs and web-based CPG portals. However, I found comprehensive application of activity...... of the business strategic aims, and 3) analysis and formalization of CPGs. This will imply orchestration of design teams with competencies from a wide array of disciplines such as health practice, business management, knowledge management and information systems....

Exploiting Temporal Constraints of Clinical Guidelines by Applying OpenEHR Archetypes.

Science.gov (United States)

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

2017-01-01

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

Updated clinical practice guidelines for the prevention and treatment of mucositis

NARCIS (Netherlands)

Keefe, Dorothy M.; Schubert, Mark M.; Elting, Linda S.; Sonis, Stephen T.; Epstein, Joel B.; Raber-Durlacher, Judith E.; Migliorati, Cesar A.; McGuire, Deborah B.; Hutchins, Ronald D.; Peterson, Douglas E.

2007-01-01

Considerable progress in research and clinical application has been made since the original guidelines for managing mucositis in cancer patients were published in 2004, and the first active drug for the prevention and treatment of this condition has been approved by the United States Food and Drug

Quality appraisal of clinical practice guidelines on the use of physiotherapy in rheumatoid arthritis: a systematic review.

Science.gov (United States)

Hurkmans, Emalie J; Jones, Anamaria; Li, Linda C; Vliet Vlieland, Theodora P M

2011-10-01

To assess the quality of guidelines published in peer-reviewed literature concerning the role of physiotherapy in the management of patients with RA. A systematic literature search for clinical practice guidelines that included physiotherapy interventions was performed in four electronic databases. We assessed the quality of the selected guidelines using the appraisal of guidelines for research and evaluation (AGREE) instrument. In addition, the recommendations of guidelines with the highest quality scores were summarized. Eight clinical practice guidelines fulfilled the inclusion criteria. Scope/purpose was the most often adequately addressed AGREE domain (in seven of the eight guidelines) and applicability the least (in two of the eight guidelines). Based on the AGREE domain scores, six guidelines could be recommended or strongly recommended for clinical use. Five out of these six (strongly) recommended guidelines included a recommendation on exercise therapy and/or patient education, with these interventions being recommended in every case. Transcutaneous electrical nerve stimulation and thermotherapy were recommended in four of these six guidelines. US, thermotherapy, low-level laser therapy, massage, passive mobilization and balneotherapy were addressed in one or two of these six guidelines. Six of eight clinical practice guidelines addressing physiotherapy interventions were recommended or strongly recommended according to the AGREE instrument. In general, guideline recommendations on physiotherapy intervention, from both the recommended guidelines as well as from the not recommended guidelines, lacked detail concerning mode of delivery, intensity, frequency and duration.

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

Science.gov (United States)

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

2017-09-01

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

ESPEN guideline clinical nutrition in neurology.

Science.gov (United States)

Burgos, Rosa; Bretón, Irene; Cereda, Emanuele; Desport, Jean Claude; Dziewas, Rainer; Genton, Laurence; Gomes, Filomena; Jésus, Pierre; Leischker, Andreas; Muscaritoli, Maurizio; Poulia, Kalliopi-Anna; Preiser, Jean Charles; Van der Marck, Marjolein; Wirth, Rainer; Singer, Pierre; Bischoff, Stephan C

2018-02-01

Neurological diseases are frequently associated with swallowing disorders and malnutrition. Moreover, patients with neurological diseases are at increased risk of micronutrient deficiency and dehydration. On the other hand, nutritional factors may be involved in the pathogenesis of neurological diseases. Multiple causes for the development of malnutrition in patients with neurological diseases are known including oropharyngeal dysphagia, impaired consciousness, perception deficits, cognitive dysfunction, and increased needs. The present evidence- and consensus-based guideline addresses clinical questions on best medical nutrition therapy in patients with neurological diseases. Among them, management of oropharyngeal dysphagia plays a pivotal role. The guideline has been written by a multidisciplinary team and offers 88 recommendations for use in clinical practice for amyotrophic lateral sclerosis, Parkinson's disease, stroke and multiple sclerosis. Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

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

Science.gov (United States)

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

2015-12-30

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

Research ethics for clinical researchers.

Science.gov (United States)

Harnett, John D; Neuman, Richard

2015-01-01

This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.

Evidence-based clinical practice guidelines for chronic pancreatitis 2015.

Science.gov (United States)

Ito, Tetsuhide; Ishiguro, Hiroshi; Ohara, Hirotaka; Kamisawa, Terumi; Sakagami, Junichi; Sata, Naohiro; Takeyama, Yoshifumi; Hirota, Morihisa; Miyakawa, Hiroyuki; Igarashi, Hisato; Lee, Lingaku; Fujiyama, Takashi; Hijioka, Masayuki; Ueda, Keijiro; Tachibana, Yuichi; Sogame, Yoshio; Yasuda, Hiroaki; Kato, Ryusuke; Kataoka, Keisho; Shiratori, Keiko; Sugiyama, Masanori; Okazaki, Kazuichi; Kawa, Shigeyuki; Tando, Yusuke; Kinoshita, Yoshikazu; Watanabe, Mamoru; Shimosegawa, Tooru

2016-02-01

Chronic pancreatitis is considered to be an irreversible progressive chronic inflammatory disease. The etiology and pathology of chronic pancreatitis are complex; therefore, it is important to correctly understand the stage and pathology and provide appropriate treatment accordingly. The newly revised Clinical Practice Guidelines of Chronic Pancreatitis 2015 consist of four chapters, i.e., diagnosis, staging, treatment, and prognosis, and includes a total of 65 clinical questions. These guidelines have aimed at providing certain directions and clinically practical contents for the management of chronic pancreatitis, preferentially adopting clinically useful articles. These revised guidelines also refer to early chronic pancreatitis based on the Criteria for the Diagnosis of Chronic Pancreatitis 2009. They include such items as health insurance coverage of high-titer lipase preparations and extracorporeal shock wave lithotripsy, new antidiabetic drugs, and the definition of and treatment approach to pancreatic pseudocyst. The accuracy of these guidelines has been improved by examining and adopting new evidence obtained after the publication of the first edition.

Evidence-based clinical guidelines in Kyrgyz Republic.

Science.gov (United States)

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

Clinical Research Environment in India: Challenges and Proposed Solutions.

Science.gov (United States)

Burt, Tal; Sharma, Pooja; Dhillon, Savita; Manchanda, Mukul; Mittal, Sanjay; Trehan, Naresh

2014-11-01

India has compelling need and keen aspirations for indigenous clinical research. Notwithstanding this need and previously reported growth the expected expansion of Indian clinical research has not materialized. We reviewed the scientific literature, lay press reports, and ClinicalTrials.gov data for information and commentary on projections, progress, and impediments associated with clinical trials in India. We also propose targeted solutions to identified challenges. The Indian clinical trial sector grew by (+) 20.3% CAGR (compound annual growth rate) between 2005 and 2010 and contracted by (-) 14.6% CAGR between 2010 and 2013. Phase-1 trials grew by (+) 43.5% CAGR from 2005-2013, phase-2 trials grew by (+) 19.8% CAGR from 2005-2009 and contracted by (-) 12.6% CAGR from 2009-2013, and phase-3 trials grew by (+) 13.0% CAGR from 2005-2010 and contracted by (-) 28.8% CAGR from 2010-2013. This was associated with a slowing of the regulatory approval process, increased media coverage and activist engagement, and accelerated development of regulatory guidelines and recuperative initiatives. We propose the following as potential targets for restorative interventions: Regulatory overhaul (leadership and enforcement of regulations, resolution of ambiguity in regulations, staffing, training, guidelines, and ethical principles [e.g., compensation]).Education and training of research professionals, clinicians, and regulators.Public awareness and empowerment. After a peak in 2009-2010, the clinical research sector in India appears to be experiencing a contraction. There are indications of challenges in regulatory enforcement of guidelines; training of clinical research professionals; and awareness, participation, partnership, and the general image amongst the non-professional media and public. Preventative and corrective principles and interventions are outlined with the goal of realizing the clinical research potential in India.

Medical Malpractice Implications of Clinical Practice Guidelines.

Science.gov (United States)

Ruhl, Douglas S; Siegal, Gil

2017-08-01

Clinical practice guidelines aim to improve medical care by clarifying and making useful recommendations to providers. Although providers should account for patients' unique characteristics when determining a treatment plan, it is generally perceived as good practice to follow guidelines when applicable. This is of interest in malpractice litigation, where it is essential to establish a standard of care to evaluate the performances of providers. Although the opinions of expert witnesses are used to determine standards of care, guidelines are expected to play a leading role. Guidelines alone should not establish a legal standard but may help inform this discussion in the courtroom. Therefore, it is incumbent that excellent, practical, and timely guidelines are continually created and updated in a transparent way. These guidelines must be very clear and underscore the various strengths of recommendation based on the quality of available evidence.

Report on the International Society for Laboratory Hematology Survey on guidelines to support clinical hematology laboratory practice.

Science.gov (United States)

Hayward, C P M; Moffat, K A; George, T I; Proytcheva, M; Iorio, A

2016-05-01

Given the importance of evidence-based guidelines in health care, we surveyed the laboratory hematology community to determine their opinions on guideline development and their experience and interest in developing clinical hematology laboratory practice guidelines. The study was conducted using an online survey, distributed to members of the International Society for Laboratory Hematology (ISLH) in 2015, with analysis of collected, anonymized responses. A total of 245 individuals participated. Most worked in clinical and/or research laboratories (83%) or industry (11%). 42% felt there were gaps in current guidelines. The majority (58%) recommended that ISLH engages its membership in guideline development. Participants differed in their familiarity with, and use of, different organizations' guidelines. Participants felt it was important to follow best practice recommendations on guideline development, including engagement of experts, statement about conflict of interests and how they were managed, systematic review and grading evidence for recommendations, identifying recommendations lacking evidence or consensus, and public input and peer review of the guideline. Moreover, it was considered important to provide guidelines free of charge. Industry involvement in guidelines was considered less important. The clinical laboratory hematology community has high expectations of laboratory practice guidelines that are consistent with recent recommendations on evidence-based guideline development. © 2016 John Wiley & Sons Ltd.

Inconsistencies in clinical guidelines for obstetric anaesthesia for Caesarean section

DEFF Research Database (Denmark)

Winther, Lars; Mitchell, A U; Møller, Ann

2013-01-01

Anaesthetists need evidence-based clinical guidelines, also in obstetric anaesthesia. We compared the Danish, English, American, and German national guidelines for anaesthesia for Caesarean section. We focused on assessing the quality of guideline development and evaluation of the guidelines...

Neck Pain: Clinical Practice Guidelines Help Ensure Quality Care.

Science.gov (United States)

2017-07-01

In 2008, physical therapists published the first neck pain clinical practice guidelines. These guidelines have been updated and are now available in the July 2017 issue of JOSPT. To update these guidelines, physical therapists teamed with the International Collaboration on Neck Pain to identify leading practices. These revised guidelines provide direction to clinicians as they screen, evaluate, diagnose, and make treatment-based classifications of neck pain. They also outline the best nonsurgical treatment options based on the published literature. At the end of the day, the best care is a combination of the leading science, the clinical expertise of your health care provider, and your input as the patient. These guidelines help inform the first step in this process. J Orthop Sports Phys Ther 2017;47(7):513. doi:10.2519/jospt.2017.0508.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

2016-12-01

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

Clinical inertia, uncertainty and individualized guidelines.

Science.gov (United States)

Reach, G

2014-09-01

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

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

Science.gov (United States)

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…

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

Science.gov (United States)

Duftschmid, G; Miksch, S

2001-04-01

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

Diabetes guidelines and clinical practice: is there a gap? The South ...

African Journals Online (AJOL)

2012-01-03

Jan 3, 2012 ... Original Research: Diabetes guidelines and clinical practice. 85. 2012 Volume 17 No 2 ... endorsed by The Society of Endocrinology Metabolism and Diabetes of ... do not reach the target HbA1c value of < 7%.8-10 In striving to achieve ..... reflected the worst glycaemic control, as assessed by HbA1c levels.

The Database of the Catalogue of Clinical Practice Guidelines Published via Internet in the Czech Language -The Current State

Czech Academy of Sciences Publication Activity Database

Zvolský, Miroslav

2010-01-01

Roč. 6, č. 1 (2010), s. 83-89 ISSN 1801-5603 R&D Projects: GA MŠk(CZ) 1M06014 Institutional research plan: CEZ:AV0Z10300504 Keywords : internet * World Wide Web * database * clinical practice guideline * clinical practice * evidence-based medicine * formalisation * GLIF (Guideline Inerchange Format) * doctor of medicine, * decision support systems Subject RIV: IN - Informatics, Computer Science http://www.ejbi.org/en/ejbi/article/63-en-the-database-of-the-catalogue-of-clinical- practice -guidelines-published-via-internet-in-the-czech-language-the-current-state.html

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

Science.gov (United States)

Löpprich, Martin; Knaup, Petra

2016-01-01

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

Designing an automated clinical decision support system to match clinical practice guidelines for opioid therapy for chronic pain

Directory of Open Access Journals (Sweden)

Clark Michael E

2010-04-01

Full Text Available Abstract Background Opioid prescribing for chronic pain is common and controversial, but recommended clinical practices are followed inconsistently in many clinical settings. Strategies for increasing adherence to clinical practice guideline recommendations are needed to increase effectiveness and reduce negative consequences of opioid prescribing in chronic pain patients. Methods Here we describe the process and outcomes of a project to operationalize the 2003 VA/DOD Clinical Practice Guideline for Opioid Therapy for Chronic Non-Cancer Pain into a computerized decision support system (DSS to encourage good opioid prescribing practices during primary care visits. We based the DSS on the existing ATHENA-DSS. We used an iterative process of design, testing, and revision of the DSS by a diverse team including guideline authors, medical informatics experts, clinical content experts, and end-users to convert the written clinical practice guideline into a computable algorithm to generate patient-specific recommendations for care based upon existing information in the electronic medical record (EMR, and a set of clinical tools. Results The iterative revision process identified numerous and varied problems with the initially designed system despite diverse expert participation in the design process. The process of operationalizing the guideline identified areas in which the guideline was vague, left decisions to clinical judgment, or required clarification of detail to insure safe clinical implementation. The revisions led to workable solutions to problems, defined the limits of the DSS and its utility in clinical practice, improved integration into clinical workflow, and improved the clarity and accuracy of system recommendations and tools. Conclusions Use of this iterative process led to development of a multifunctional DSS that met the approval of the clinical practice guideline authors, content experts, and clinicians involved in testing. The

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

Science.gov (United States)

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

Science.gov (United States)

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

2017-09-01

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

3 CFR - Guidelines for Human Stem Cell Research

Science.gov (United States)

2010-01-01

... 3 The President 1 2010-01-01 2010-01-01 false Guidelines for Human Stem Cell Research Presidential Documents Other Presidential Documents Memorandum of July 30, 2009 Guidelines for Human Stem Cell Research..., scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent...

Developing clinical guidelines: how much rigour is required?

Science.gov (United States)

Haroon, Munib; Ranmal, Rita; McElroy, Helen; Dudley, Jan

2015-04-01

Clinical guidelines that are rigorously developed play a fundamental role in improving healthcare and reducing unnecessary variations in practice. National guidelines are increasingly used by healthcare professionals, patients and commissioners; however, national bodies are unable to meet the demand for guidance on all topics. There are fewer resources available for guidance produced locally or by specialty groups, and it is necessary to achieve a balance between pragmatism and rigour while conforming to the widely accepted norms of what constitutes a good guideline. This paper introduces the key concepts around this topic with suggestions for those interested in developing their own guideline. An example of challenges encountered in generating high-quality clinical guidance is given in box 1. Box 1 Challenges in guideline development Professor Johnson runs a local developmental paediatrics service with eight other colleagues. All have different ways of managing children with PAVING syndrome. This was difficult for patients and staff and has led to disagreements on how certain patients should be managed. As a result, Professor Johnson developed a Guideline Development Group to look at the management of PAVING syndrome. The group identified 12 clinical questions (including diagnosis, exclusion of comorbidities, treatment modalities), searched the PubMed database and found some useful evidence that they used to formulate key recommendations. For one question about behavioural therapy, PubMed did not suggest any evidence so they informally arrived at a consensus among themselves and wrote up their guideline. On the back of this success, they applied for the guideline to be endorsed or supported by the Royal College of Paediatrics and Child Health (RCPCH). To their frustration, it was turned down on methodological grounds. Professor Johnson wrote to the RCPCH saying that he was "pretty peeved that the PAVING syndrome guideline had been rejected" for the College

Guidelines for use of fishes in research

Science.gov (United States)

Use of Fishes in Research Committee (joint committee of the American Fisheries Society, the American Institute of Fishery Research Biologists

2014-01-01

The 2004 and 2014 Guidelines were developed to provide a structure that advances appropriate attention toward valid experimental designs and procedures with aquatic animals while ensuring humane treatment of the experimental subjects. At a practical level, the Guidelines are intended to provide general recommendations on field and laboratory endeavors, such as sampling, holding, and handling fishes; to offer information on administrative matters, including regulations and permits; and to address typical ethical concerns, such as perceptions of pain or discomfort experienced by experimental subjects. These Guidelines must be recognized as guidelines. They are not intended to provide detailed instructions but rather to alert investigators to a broad array of topics and concerns to consider prior to initiating study. At a comprehensive level, the principles upon which these Guidelines are based are broadly applicable, and many of the described practices and approaches can be adapted to situations involving other aquatic animal species and conditions. Understanding the differences between fishes and other vertebrates, especially mammals, is critically important to conducting scientifically sound research with fishes. Disparities in life histories and mortality rates in fishes versus other vertebrates are critical in designing sustainable sampling levels in fish populations. The UFR Committee points out that (1) compared to mammalian populations, adult populations of many fish species persist despite very high natural mortality rates in juvenile stages by virtue of the fact that most species lay thousands or tens of thousands of eggs; (2) because of these mortality patterns, research on fishes, especially field research or research on early life stages, can involve, and often requires, much larger numbers of research subjects than does research on mammals; and (3) the animal handling and husbandry requirements for fishes are fundamentally different from those for

Curriculum Guidelines for Clinical Dental Hygiene.

Science.gov (United States)

Journal of Dental Education, 1985

1985-01-01

The American Association of Dental Schools curriculum guidelines for clinical dental hygiene include definitions, notes on the interrelationship of courses, an overview of course objectives, and suggested primary educational goals, prerequisites, core content, specific objectives, sequencing, faculty, and facilities. (MSE)

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

Science.gov (United States)

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

2018-01-01

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

Professional impact of clinical research

Energy Technology Data Exchange (ETDEWEB)

Nelhans, G.

2016-07-01

In this study, professional impact is defined as the academic literature that is cited in the literature that is used by professions in order to pursue skilled activities that are specific to their expertise. Specifically, we are focusing on the clinical guidelines that are used in the many health and medical professions that are issued by government bodies at national and international levels to ensure a certain quality level and to make results comparable at the national level. To date, more than 50.000 references have been identified in about 500 Swedish clinical guidelines issued by the above mentioned governmental bodies in Sweden. Of these, 73 % of the references have been matched to a PubMed id. The goal of this project is to develop a conceptual and theoretical contribution to the development of indicators for measuring the impact of research outside of the specifically academic literature. (Author)

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

Science.gov (United States)

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

How nurses seek and evaluate clinical guidelines on the Internet

NARCIS (Netherlands)

Verhoeven, F.; Steehouder, M.F.; Hendrix, Ron M.G.; van Gemert-Pijnen, Julia E.W.C.

2010-01-01

Aim: This paper is a report of a study conducted to assess nurses’ information-seeking strategies and problems encountered when seeking clinical guidelines on the Internet, and to investigate the criteria they apply when evaluating the guidelines and the websites communicating the guidelines. -

Value and limitations of clinical practice guidelines in neonatology.

Science.gov (United States)

Polin, Richard A; Lorenz, John M

2015-12-01

Given the overwhelming size of the neonatal literature, clinicians must rely upon expert panels such as the Committee on Fetus and Newborn in the USA and the National Institute for Healthcare and Excellence in the UK for guidance. Guidelines developed by expert panels are not equivalent to evidence-based medicine and are not rules, but do provide evidence-based recommendations (when possible) and at minimum expert consensus reports. The standards used to develop evidence-based guidelines differ among expert panels. Clinicians must be able judge the quality of evidence from an expert panel, and decide whether a recommendation applies to their neonatal intensive care unit or infant under their care. Furthermore, guidelines become outdated within a few years and must be revised or discarded. Clinical practice guidelines should not always be equated with standard of care. However, they do provide a framework for determining acceptable care. Clinicians do not need to follow guidelines if the recommendations are not applicable to their population or infant. However, if a plan of care is not consistent with apparently applicable clinical practice guidelines, the medical record should include an explanation for the deviation from the relevant practice guideline. Copyright © 2015 Elsevier Ltd. All rights reserved.

Unmet needs in obesity management: From guidelines to clinic.

Science.gov (United States)

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.

Critical Appraisal of Clinical Practice Guidelines for Age-Related Macular Degeneration

Directory of Open Access Journals (Sweden)

Annie M. Wu

2015-01-01

Full Text Available Purpose. To evaluate the methodological quality of age-related macular degeneration (AMD clinical practice guidelines (CPGs. Methods. AMD CPGs published by the American Academy of Ophthalmology (AAO and Royal College of Ophthalmologists (RCO were appraised by independent reviewers using the Appraisal of Guidelines for Research and Evaluation (AGREE II instrument, which comprises six domains (Scope and Purpose, Stakeholder Involvement, Rigor of Development, Clarity of Presentation, Applicability, and Editorial Independence, and an Overall Assessment score summarizing methodological quality across all domains. Results. Average domain scores ranged from 35% to 83% for the AAO CPG and from 17% to 83% for the RCO CPG. Intraclass correlation coefficients for the reliability of mean scores for the AAO and RCO CPGs were 0.74 and 0.88, respectively. The strongest domains were Scope and Purpose and Clarity of Presentation. The weakest were Stakeholder Involvement (AAO and Editorial Independence (RCO. Conclusions. Future AMD CPGs can be improved by involving all relevant stakeholders in guideline development, ensuring transparency of guideline development and review methodology, improving guideline applicability with respect to economic considerations, and addressing potential conflict of interests within the development group.

Head injury: audit of a clinical guideline to justify head CT

International Nuclear Information System (INIS)

Haydon, Nicholas B.

2013-01-01

Head injury causes significant morbidity and mortality, and there is contention about which patients to scan. The UK National Health Service Clinical Guideline (CG) 56 provides criteria for selecting patients with clinically important brain injury who may benefit from a head CT scan, while minimising the radiation and economic burden of scanning patients without significant injury. This study aims to audit the documentation of the use of these guidelines in a busy UK trauma hospital and discusses the comparison with an Australian (New South Wales (NSW) ) head injury guideline. A retrospective cohort study of 480 patients presenting with head injury to the emergency department over 2 months was performed. The patient notes were assessed for documentation of each aspect of the clinical guidelines. Criteria were established to assess the utilisation of the CG 56. A database of clinical data was amalgamated with the head CT scan results for each patient. For the UK CG 56, 73% of the criteria were documented, with the least documented being 'signs of basal skull fracture' and 'amnesia of events'. Thirty-two per cent of patients received head CT and of these, 24% (37 patients) were reported to have pathology. Twenty-four patients underwent head CT without clinical justification being documented, none of which had reported pathology on CT. The study shows that the head injury guidelines are not being fully utilised at a major UK trauma hospital, resulting in 5% of patients being exposed to ionising radiation without apparent documented clinical justification. The NSW guideline has distinct differences to the CG 56, with a more complex algorithm and an absence of specific time frames for head CT completion. The results suggest a need for further education and awareness of head injury clinical guidelines.

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.

Science.gov (United States)

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

Barriers to implementing evidence-based clinical guidelines: A survey of early adopters

Science.gov (United States)

Spallek, Heiko; Song, Mei; Polk, Deborah E; Bekhuis, Tanja; Frantsve-Hawley, Julie; Aravamudhan, Krishna

2010-01-01

Objective The purpose of this study is to identify barriers that early-adopting dentists perceive as common and challenging when implementing recommendations from evidence-based (EB) clinical guidelines. Method This is a cross-sectional study. Dentists who attended the 2008 Evidence-based Dentistry Champion Conference were eligible for inclusion. Forty-three dentists (34%) responded to a 22-item questionnaire administered online. Two investigators independently coded and categorized responses to open-ended items. Descriptive statistics were computed to assess the frequency of barriers and perceived challenges. Results The most common barriers to implementation are difficulty in changing current practice model, resistance and criticism from colleagues, and lack of trust in evidence or research. Barriers perceived as serious problems have to do with lack of up-to-date evidence, lack of clear answers to clinical questions, and contradictory information in the scientific literature. Conclusions Knowledge of barriers will help improve translation of biomedical research for dentists. Information in guidelines needs to be current, clear, and simplified for use at chairside; dentists’ fears need to be addressed. PMID:21093800

Evaluation and treatment of hypertriglyceridemia: an endocrine society clinical practice guideline.

NARCIS (Netherlands)

Berglund, L.; Brunzell, J.D.; Goldberg, A.C.; Goldberg, I.J.; Sacks, F.M.; Murad, M.H.; Stalenhoef, A.F.H.

2012-01-01

Objective: The aim was to develop clinical practice guidelines on hypertriglyceridemia. Participants: The Task Force included a chair selected by The Endocrine Society Clinical Guidelines Subcommittee (CGS), five additional experts in the field, and a methodologist. The authors received no corporate

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

Science.gov (United States)

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.

Critical Appraisal of International Clinical Practice Guidelines in Kidney Transplantation Using the Appraisal of Guidelines for Research and Education (AGREE) II Tool: A Systematic Review.

Science.gov (United States)

OʼDonoghue, Katriona Jane Marie; Reed, Rhiannon D; Knight, Simon R; O'Callaghan, John M; Ayaz-Shah, Anam A; Hassan, Sevda; Weissenbacher, Annemarie; Morris, Peter J; Pengel, Liset H M

2018-05-22

Whilst Clinical Practice Guidelines (CPGs) are used for the development of local protocols in kidney transplantation (Ktx), the quality of their methodology is variable. This systematic review aimed to critically appraise international CPGs in all aspects of Ktx using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. CPGs in Ktx and donation published between 2010 and 2017 were identified from MEDLINE, Embase, National Guideline Clearinghouse, NHS and NICE Evidence Searches, and the websites of transplant societies. Using AGREE II, 3 appraisers assessed the quality of CPGs. Interrater reliability was measured using the intraclass correlation coefficient (ICC). Searches identified 3,168 records and 115 CPGs were included. The highest scoring AGREE II domain was 'Scope and Purpose' (80%; Range 30-100%), followed by 'Clarity of Presentation' (77%; Range 43-98%), 'Editorial independence' (52%; Range 0-94%), 'Rigour of Development' (47%; Range 6-97%) and 'Stakeholder Involvement' (41%; Range 11-85%). The poorest scoring domain was 'Applicability' (31%; Range 3-74%). Most CPGs were recommended for future use either with (63%) or without modifications (18%). A small number were not recommended for future use (14%) or reviewers did not agree on recommending the CPG (5%). The overall mean CPG quality score was 4 out of 7 (Range 2-7). The mean ICC of 0.74 indicated substantial agreement between reviewers. The quality of international CPGs in Ktx was variable, and most CPGs lacked key aspects of methodological robustness and transparency. Improvements in methodology, patient involvement and strategies for implementation are required.

American Clinical Neurophysiology Society Guideline 2: Guidelines for Standard Electrode Position Nomenclature.

Science.gov (United States)

Acharya, Jayant N; Hani, Abeer; Cheek, Janna; Thirumala, Partha; Tsuchida, Tammy N

2016-08-01

This revision to the EEG Guidelines is an update incorporating current electroencephalography technology and practice and was previously published as Guideline 5. While the 10-10 system of electrode position nomenclature has been accepted internationally for almost two decades, it has not been used universally. The reasons for this and clinical scenarios when the 10-10 system provides additional localizing information are discussed in this revision. In addition, situations in which AF1/2, AF5/6, PO1/2 and PO5/6 electrode positions may be utilized for EEG recording are discussed.

An evidence-based clinical guideline for the use of antithrombotic therapies in spine surgery.

Science.gov (United States)

Bono, Christopher M; Watters, William C; Heggeness, Michael H; Resnick, Daniel K; Shaffer, William O; Baisden, Jamie; Ben-Galim, Peleg; Easa, John E; Fernand, Robert; Lamer, Tim; Matz, Paul G; Mendel, Richard C; Patel, Rajeev K; Reitman, Charles A; Toton, John F

2009-12-01

the work group through the modified nominal group technique and is clearly identified as such in the guideline. Fourteen clinical questions were formulated, addressing issues of incidence of DVT and PE in spine surgery and recommendations regarding utilization of mechanical prophylaxis and chemoprophylaxis in spine surgery. The answers to these 14 clinical questions are summarized in this article. The respective recommendations were graded by the strength of the supporting literature that was stratified by levels of evidence. A clinical guideline addressing the use of antithrombotic therapies in spine surgery has been created using the techniques of evidence-based medicine and using the best available evidence as a tool to assist spine surgeons in minimizing the risk of DVT and PE. The entire guideline document, including the evidentiary tables, suggestions for future research, and all references, is available electronically at the NASS Web site (www.spine.org) and will remain updated on a timely schedule.

Clinical practice guideline: Allergic rhinitis.

Science.gov (United States)

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

2015-02-01

Allergic rhinitis (AR) is one of the most common diseases affecting adults. It is the most common chronic disease in children in the United States today and the fifth most common chronic disease in the United States overall. AR is estimated to affect nearly 1 in every 6 Americans and generates $2 to $5 billion in direct health expenditures annually. It can impair quality of life and, through loss of work and school attendance, is responsible for as much as $2 to $4 billion in lost productivity annually. Not surprisingly, myriad diagnostic tests and treatments are used in managing this disorder, yet there is considerable variation in their use. This clinical practice guideline was undertaken to optimize the care of patients with AR by addressing quality improvement opportunities through an evaluation of the available evidence and an assessment of the harm-benefit balance of various diagnostic and management options. The primary purpose of this guideline is to address quality improvement opportunities for all clinicians, in any setting, who are likely to manage patients with AR as well as to optimize patient care, promote effective diagnosis and therapy, and reduce harmful or unnecessary variations in care. The guideline is intended to be applicable for both pediatric and adult patients with AR. Children under the age of 2 years were excluded from the clinical practice guideline because rhinitis in this population may be different than in older patients and is not informed by the same evidence base. The guideline is intended to focus on a limited number of quality improvement opportunities deemed most important by the working group and is not intended to be a comprehensive reference for diagnosing and managing AR. The recommendations outlined in the guideline are not intended to represent the standard of care for patient management, nor are the recommendations intended to limit treatment or care provided to individual patients. The development group made a strong

[How to assess clinical practice guidelines with AGREE II: The example of neonatal jaundice].

Science.gov (United States)

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.

Performance of ACMG-AMP Variant-Interpretation Guidelines among Nine Laboratories in the Clinical Sequencing Exploratory Research Consortium.

Science.gov (United States)

Amendola, Laura M; Jarvik, Gail P; Leo, Michael C; McLaughlin, Heather M; Akkari, Yassmine; Amaral, Michelle D; Berg, Jonathan S; Biswas, Sawona; Bowling, Kevin M; Conlin, Laura K; Cooper, Greg M; Dorschner, Michael O; Dulik, Matthew C; Ghazani, Arezou A; Ghosh, Rajarshi; Green, Robert C; Hart, Ragan; Horton, Carrie; Johnston, Jennifer J; Lebo, Matthew S; Milosavljevic, Aleksandar; Ou, Jeffrey; Pak, Christine M; Patel, Ronak Y; Punj, Sumit; Richards, Carolyn Sue; Salama, Joseph; Strande, Natasha T; Yang, Yaping; Plon, Sharon E; Biesecker, Leslie G; Rehm, Heidi L

2016-06-02

Evaluating the pathogenicity of a variant is challenging given the plethora of types of genetic evidence that laboratories consider. Deciding how to weigh each type of evidence is difficult, and standards have been needed. In 2015, the American College of Medical Genetics and Genomics (ACMG) and the Association for Molecular Pathology (AMP) published guidelines for the assessment of variants in genes associated with Mendelian diseases. Nine molecular diagnostic laboratories involved in the Clinical Sequencing Exploratory Research (CSER) consortium piloted these guidelines on 99 variants spanning all categories (pathogenic, likely pathogenic, uncertain significance, likely benign, and benign). Nine variants were distributed to all laboratories, and the remaining 90 were evaluated by three laboratories. The laboratories classified each variant by using both the laboratory's own method and the ACMG-AMP criteria. The agreement between the two methods used within laboratories was high (K-alpha = 0.91) with 79% concordance. However, there was only 34% concordance for either classification system across laboratories. After consensus discussions and detailed review of the ACMG-AMP criteria, concordance increased to 71%. Causes of initial discordance in ACMG-AMP classifications were identified, and recommendations on clarification and increased specification of the ACMG-AMP criteria were made. In summary, although an initial pilot of the ACMG-AMP guidelines did not lead to increased concordance in variant interpretation, comparing variant interpretations to identify differences and having a common framework to facilitate resolution of those differences were beneficial for improving agreement, allowing iterative movement toward increased reporting consistency for variants in genes associated with monogenic disease. Copyright © 2016 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

[Clinical practice guidelines and knowledge management in healthcare].

Science.gov (United States)

Ollenschläger, Günter

2013-10-01

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

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

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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.

Implementing clinical guidelines in psychiatry: a qualitative study of perceived facilitators and barriers

Directory of Open Access Journals (Sweden)

Wistedt Anna

2010-01-01

Full Text Available Abstract Background Translating scientific evidence into daily practice is complex. Clinical guidelines can improve health care delivery, but there are a number of challenges in guideline adoption and implementation. Factors influencing the effective implementation of guidelines remain poorly understood. Understanding of barriers and facilitators is important for development of effective implementation strategies. The aim of this study was to determine perceived facilitators and barriers to guideline implementation and clinical compliance to guidelines for depression in psychiatric care. Methods This qualitative study was conducted at two psychiatric clinics in Stockholm, Sweden. The implementation activities at one of the clinics included local implementation teams, seminars, regular feedback and academic detailing. The other clinic served as a control and only received guidelines by post. Data were collected from three focus groups and 28 individual, semi-structured interviews. Content analysis was used to identify themes emerging from the interview data. Results The identified barriers to, and facilitators of, the implementation of guidelines could be classified into three major categories: (1 organizational resources, (2 health care professionals' individual characteristics and (3 perception of guidelines and implementation strategies. The practitioners in the implementation team and at control clinics differed in three main areas: (1 concerns about control over professional practice, (2 beliefs about evidence-based practice and (3 suspicions about financial motives for guideline introduction. Conclusions Identifying the barriers to, and facilitators of, the adoption of recommendations is an important way of achieving efficient implementation strategies. The findings of this study suggest that the adoption of guidelines may be improved if local health professionals actively participate in an ongoing implementation process and identify

A service oriented approach for guidelines-based clinical decision support using BPMN.

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Rodriguez-Loya, Salvador; Aziz, Ayesha; Chatwin, Chris

2014-01-01

Evidence-based medical practice requires that clinical guidelines need to be documented in such a way that they represent a clinical workflow in its most accessible form. In order to optimize clinical processes to improve clinical outcomes, we propose a Service Oriented Architecture (SOA) based approach for implementing clinical guidelines that can be accessed from an Electronic Health Record (EHR) application with a Web Services enabled communication mechanism with the Enterprise Service Bus. We have used Business Process Modelling Notation (BPMN) for modelling and presenting the clinical pathway in the form of a workflow. The aim of this study is to produce spontaneous alerts in the healthcare workflow in the diagnosis of Chronic Obstructive Pulmonary Disease (COPD). The use of BPMN as a tool to automate clinical guidelines has not been previously employed for providing Clinical Decision Support (CDS).

Do Clinical Practice Guidelines Improve Quality?

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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.

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

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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.

Inside guidelines: comparative analysis of recommendations and evidence in diabetes guidelines from 13 countries

NARCIS (Netherlands)

Burgers, Jako S.; Bailey, Julia V.; Klazinga, Niek S.; van der Bij, Akke K.; Grol, Richard; Feder, Gene

2002-01-01

OBJECTIVE: To compare guidelines on diabetes from different countries in order to examine whether differences in recommendations could be explained by use of different research evidence. RESEARCH DESIGN AND METHODS: We analyzed 15 clinical guidelines on type 2 diabetes from 13 countries using

Effects of Direct-to-Consumer Advertising and Clinical Guidelines on Appropriate Use of Human Papillomavirus DNA Tests

Science.gov (United States)

2011-01-01

Background Both clinical guidelines and direct-to-consumer (DTC) advertising influence use of new health care technologies, but little is known about their relative effects. The introduction of a cervical cancer screening test in 2000 offered a unique opportunity to assess the two strategies. Objective To evaluate the effects of clinical guidelines and a targeted DTC advertising campaign on overall and appropriate use of human papillomavirus (HPV) DNA tests. Research Design Quasi-experimental study using difference-in-differences analysis. Data were MarketScan private insurance claims for 500,000 women ages 21 to 64 enrolled at least 12 consecutive months from January 2001 through December 2005. Results Both clinical guidelines and DTC advertising were associated with increases in overall HPV DNA test use. DTC advertising was associated with a statistically significant increase in HPV DNA test use in two groups of DTC cities (+5.57 percent, padvertising was associated with comparable increases in the probability of appropriate and inappropriate use of the HPV DNA test in primary screening. Clinical guideline releases from the American College of Obstetricians and Gynecologists, and by a co-sponsored panel, were associated with greater increases in HPV DNA tests for appropriate primary screening than for inappropriate primary screening (β=0.3347, padvertising was associated with increased overall use of a cervical cancer screening test, while clinical guidelines were differentially associated with increased appropriate use. These findings suggest distinct influences of consumer marketing and professional guidelines on the use of health care products and services. PMID:21150798

Systematic evaluation of clinical practice guidelines for pharmacogenomics.

Science.gov (United States)

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

2018-06-01

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

[Possible relation between clinical guidelines and legal standard of medicine].

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Furukawa, Toshiharu; Kitagawa, Yuko

2010-10-01

Legal standard of medicine is not equal across the all kinds of medical institutions. Each medical institution is required its respective standard of medicine in which its doctors are expected to have studied medical informations, which have been spread among medical institutions with similar characteristics. Therefore, in principle, clinical guidelines for the treatment of a disease formed by public committees do not directly become the medical standards of respective disease treatment. However, doctors would be legally required to practice medicine with reference to the clinical guidelines because medical informations, mediated by internet or many kinds of media, have been spread very fast to all medical institutions these days. Moreover, doctors would be required to inform their patients of non-standardized new treatments, even if such treatments are not listed in clinical guidelines in case patients have special concern about new treat-

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC): experiences from a successful ERS Clinical Research Collaboration.

Science.gov (United States)

Chalmers, James D; Crichton, Megan; Goeminne, Pieter C; Loebinger, Michael R; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

2017-09-01

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areasTo understand some of the key features of successful disease registriesTo review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 yearsTo understand the key research priorities identified by EMBARC for the next 5 years.

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

Science.gov (United States)

Motte, Anne-France; Diallo, Stéphanie; van den Brink, Hélène; Châteauvieux, Constance; Serrano, Carole; Naud, Carole; Steelandt, Julie; Alsac, Jean-Marc; Aubry, Pierre; Cour, Florence; Pellerin, Olivier; Pineau, Judith; Prognon, Patrice; Borget, Isabelle; Bonan, Brigitte; Martelli, Nicolas

2017-11-01

The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices. Copyright © 2017 Elsevier Inc. All rights reserved.

Toward Improving Quality of End-of-Life Care: Encoding Clinical Guidelines and Standing Orders Using the Omaha System.

Science.gov (United States)

Slipka, Allison F; Monsen, Karen A

2018-02-01

End-of-life care (EOLC) relieves the suffering of millions of people around the globe each year. A growing body of hospice care research has led to the creation of several evidence-based clinical guidelines for EOLC. As evidence for the effectiveness of timely EOLC swells, so does the increased need for efficient information exchange between disciplines and across the care continuum. The purpose of this study was to investigate the feasibility of using the Omaha System as a framework for encoding interoperable evidence-based EOL interventions with specified temporality for use across disciplines and settings. Four evidence-based clinical guidelines and one current set of hospice standing orders were encoded using the Omaha System Problem Classification Scheme and Intervention Scheme, as well as Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT). The resulting encoded guideline was entered on a Microsoft Excel spreadsheet and made available for public use on the Omaha System Guidelines website. The resulting EOLC guideline consisted of 153 interventions that may enable patients and their surrogates, clinicians, and ancillary providers to communicate interventions in a universally comprehensible way. Evidence-based interventions from diverse disciplines involved in EOLC are described within this guideline using the Omaha System. Because the Omaha System and clinical guidelines are maintained in the public domain, encoding interventions is achievable by anyone with access to the Internet and basic Excel skills. Using the guideline as a documentation template customized for unique patient needs, clinicians can quantify and track patient care across the care continuum to ensure timely evidence-based interventions. Clinical guidelines coded in the Omaha System can support the use of multidisciplinary evidence-based interventions to improve quality of EOLC across settings and professions. © 2017 Sigma Theta Tau International.

Clinical Practice Guidelines for Rare Diseases: The Orphanet Database.

Directory of Open Access Journals (Sweden)

Sonia Pavan

Full Text Available Clinical practice guidelines (CPGs for rare diseases (RDs are scarce, may be difficult to identify through Internet searches and may vary in quality depending on the source and methodology used. In order to contribute to the improvement of the diagnosis, treatment and care of patients, Orphanet (www.orpha.net has set up a procedure for the selection, quality evaluation and dissemination of CPGs, with the aim to provide easy access to relevant, accurate and specific recommendations for the management of RDs. This article provides an analysis of selected CPGs by medical domain coverage, prevalence of diseases, languages and type of producer, and addresses the variability in CPG quality and availability. CPGs are identified via bibliographic databases, websites of research networks, expert centres or medical societies. They are assessed according to quality criteria derived from the Appraisal of Guidelines, REsearch and Evaluation (AGREE II Instrument. Only open access CPGs and documents for which permission from the copyright holders has been obtained are disseminated on the Orphanet website. From January 2012 to July 2015, 277 CPGs were disseminated, representing coverage of 1,122 groups of diseases, diseases or subtypes in the Orphanet database. No language restriction is applied, and so far 10 languages are represented, with a predominance of CPGs in English, French and German (92% of all CPGs. A large proportion of diseases with identified CPGs belong to rare oncologic, neurologic, hematologic diseases or developmental anomalies. The Orphanet project on CPG collection, evaluation and dissemination is a continuous process, with regular addition of new guidelines, and updates. CPGs meeting the quality criteria are integrated to the Orphanet database of rare diseases, together with other types of textual information and the appropriate services for patients, researchers and healthcare professionals in 40 countries.

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

Science.gov (United States)

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.

[Sex and gender equity in research: rationale for the SAGER guidelines and recommended use].

Science.gov (United States)

Heidari, Shirin; Babor, Thomas F; De Castro, Paola; Tort, Sera; Curno, Mirjam

2018-05-03

Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literatura search on sex and gender policies in scientific publishing. The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

Brief Introduction of NCCN Clinical Practice Guidelines for Adolescent and Young Adult Oncology

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HUANG Xin-en

2014-09-01

Full Text Available Cancer is always a main factor threatening human’s health and life, and its incidence and mortality are gradually increasing in recent years. However, some advances have been made with the unremitting efforts and exploration human made and the improvement is mainly made in cancer treatment of young children and older adults, while little in adolescent and young adult (AYA patients, who are generally defined as individuals of 15 to 39 years old at the time of initial cancer diagnosis due to many factors. To highlight the issues of this unique population, National Comprehensive Cancer Network (NCCN absorbs a large amount of information and previous researches and develops a set of clinical practice guidelines. Though the guidelines are more supportive care guidelines than treatment guidelines, they give us the opportunity to learn the latest international developments in AYA treatment and more survival chance for the treatment of AYA patients.

Guidelines for use of fishes in research: revised and expanded

Science.gov (United States)

Jenkins, Jill A.; Bart, Henry L.; Bowker, James D.; Bowser, Paul R.; MacMillan, J. Randy; Nickum, John G.; Rachlin, Joseph W.; Rose, James D.; Sorensen, Peter W.; Warkentine, Barbara E.; Whitledge, Greg W.

2014-01-01

The Guidelines for the Use of Fishes in Research (2014; 2014 Guidelines), now available through the American fisheries Society (AFS) website and in print from the AFS bookstore, is a resource to aid researchers and regulatory authorities regarding responsible, scientifically valid research on fish and aquatic wildlife. The Guidelines for the Use of Fishes in Field Research (American Society of Ichthyologists and Herpetologists [ASIH] et al. 1987, 1988) emphasized field research and was followed by the 2004 Guidelines including laboratory research topics. Each version of the Guidelines has been jointly endorsed and/or published by the ASIH, the American Institute of Fishery Research Biologists (AIFRB), and AFS--each focusing on the scientific understanding, global conservation, and sustainability of aquatic animals, fisheries, and ecosystems. Changes with time necessitate revisions to make the Guidelines consistent with contemporary practices and scientific literature so to remain relevant as a technical resource. This document provides not only general principles relevant for field and laboratory research endeavors but includes specific requirements for researchers working within the United States and outside of the country. Within the scope of their expertise, the 2014 Uses of Fishers in Research (UFR) Committee members updated and revised sections, resulting in a 90-page 2014 Guidelines having undergone through peer review. As before, topical areas were addressed (see Table of Contents on page 416). Expanded coverage was provided on U.S. and international agencies and programs relevant to research with fishes. The Surgical Procedures and the Marking and Tagging section received special focus by a UFR Subcommittee. Feeds and Feeding and the Administration of Drugs, Biologics and Other Chemicals are just some of the newly added topics. The 2014 Guidelines is user-friendly by way of hyperlinks to external Internet sites, intradocument sections, and tables of

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

Science.gov (United States)

Chabeli, M M

2002-08-01

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

Korean Clinical Practice Guidelines for Aneurysmal Subarachnoid Hemorrhage

Science.gov (United States)

Cho, Won-Sang; Park, Sukh Que; Ko, Jun Kyeung; Kim, Dae-Won; Park, Jung Cheol; Yeon, Je Young; Chung, Seung Young; Chung, Joonho; Joo, Sung-Pil; Hwang, Gyojun; Kim, Deog Young; Chang, Won Hyuk; Choi, Kyu-Sun; Lee, Sung Ho; Sheen, Seung Hun; Kang, Hyun-Seung; Kim, Byung Moon; Bae, Hee-Joon; Oh, Chang Wan; Park, Hyeon Seon

2018-01-01

Despite advancements in treating ruptured cerebral aneurysms, an aneurysmal subarachnoid hemorrhage (aSAH) is still a grave cerebrovascular disease associated with a high rate of morbidity and mortality. Based on the literature published to date, worldwide academic and governmental committees have developed clinical practice guidelines (CPGs) to propose standards for disease management in order to achieve the best treatment outcomes for aSAHs. In 2013, the Korean Society of Cerebrovascular Surgeons issued a Korean version of the CPGs for aSAHs. The group researched all articles and major foreign CPGs published in English until December 2015 using several search engines. Based on these articles, levels of evidence and grades of recommendations were determined by our society as well as by other related Quality Control Committees from neurointervention, neurology and rehabilitation medicine. The Korean version of the CPGs for aSAHs includes risk factors, diagnosis, initial management, medical and surgical management to prevent rebleeding, management of delayed cerebral ischemia and vasospasm, treatment of hydrocephalus, treatment of medical complications and early rehabilitation. The CPGs are not the absolute standard but are the present reference as the evidence is still incomplete, each environment of clinical practice is different, and there is a high probability of variation in the current recommendations. The CPGs will be useful in the fields of clinical practice and research. PMID:29526058

Practical guidelines for qualitative research using online forums.

Science.gov (United States)

Im, Eun-Ok; Chee, Wonshik

2012-11-01

With an increasing number of Internet research in general, the number of qualitative Internet studies has recently increased. Online forums are one of the most frequently used qualitative Internet research methods. Despite an increasing number of online forum studies, very few articles have been written to provide practical guidelines to conduct an online forum as a qualitative research method. In this article, practical guidelines in using an online forum as a qualitative research method are proposed based on three previous online forum studies. First, the three studies are concisely described. Practical guidelines are proposed based on nine idea categories related to issues in the three studies: (a) a fit with research purpose and questions, (b) logistics, (c) electronic versus conventional informed consent process, (d) structure and functionality of online forums, (e) interdisciplinary team, (f) screening methods, (g) languages, (h) data analysis methods, and (i) getting participants' feedback.

Patient attributes warranting consideration in clinical practice guidelines, health workforce planning and policy

Directory of Open Access Journals (Sweden)

Segal Leonie

2011-09-01

Full Text Available Abstract Background In order for clinical practice guidelines (CPGs to meet their broad objective of enhancing the quality of care and supporting improved patient outcomes, they must address the needs of diverse patient populations. We set out to explore the patient attributes that are likely to demand a unique approach to the management of chronic disease, and which are crucial if evidence or services planning is to reflect clinic populations. These were incorporated into a new conceptual framework; using diabetes mellitus as an exemplar. Methods The patient attributes that informed the framework were identified from CPGs, the diabetes literature, an expert academic panel, and two cross-disciplinary panels; and agreed upon using a modified nominal group technique. Results Full consensus was reached on twenty-four attributes. These factors fell into one of three themes: (1 type/stage of disease, (2 morbid events, and (3 factors impacting on capacity to self-care. These three themes were incorporated in a convenient way in the workforce evidence-based (WEB model. Conclusions While biomedical factors are frequently recognised in published clinical practice guidelines, little attention is given to attributes influencing a person's capacity to self-care. Paying explicit attention to predictable threats to effective self-care in clinical practice guidelines, by drawing on the WEB model, may assist in refinements that would address observed disparities in health outcomes across socio-economic groups. The WEB model also provides a framework to inform clinical training, and health services and workforce planning and research; including the assessment of healthcare needs, and the allocation of healthcare resources.

Sewage epidemiology and illicit drug research: the development of ethical research guidelines.

Science.gov (United States)

Prichard, Jeremy; Hall, Wayne; de Voogt, Pim; Zuccato, Ettore

2014-02-15

To discuss the need to develop ethical guidelines for researchers using sewage epidemiology to monitor drug use in the general population and specific precincts, including prisons, schools and workplaces. Describe current applications of sewage epidemiology, identify potential ethical risks associated with this science, and identify key means by which these risks may be mitigated through proportionate ethical guidance that allows this science to be fully developed. A rapidly advancing field of research is sewage epidemiology (SE) - the analysis of wastewater samples to monitor illicit drug use and other substances. Typically this research involves low ethical risks because individual participants cannot be identified and, consequently, review has been waived by human research ethics committees. In the absence of such oversight, ethical research guidelines are recommended for SE teams, peer reviewers and journal editors; guidelines will assist them to mitigate any risks in general population studies and studies of prisons, schools and workplaces. Potential harms include the stigmatisation of participants and, in the prison setting, austere policy responses to SE data that impact negatively upon inmate-participants. The risk of harm can be managed through research planning, awareness of the socio-political context in which results will be interpreted (or, in the case of media, sensationalised) and careful relations with industry partners. Ethical guidelines should be developed in consultation with SE scholars and be periodically amended. They should include publication processes that safeguard scientific rigour and be promulgated through existing research governance structures. Guidelines will assist to promote an ethical research culture among SE teams and scholars involved in the publication process and this will work to protect the reputation of the field. Copyright © 2014 Elsevier B.V. All rights reserved.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

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

Science.gov (United States)

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

2016-01-01

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

The Menopausal Transition: Guidelines for Researchers.

Science.gov (United States)

Mansfield, Phyllis Kernoff; And Others

1989-01-01

Research guidelines are presented to encourage sound research on the menopausal transition. Included is a review of current literature covering three aspects of menopausal transition: age span, changes in menstrual bleeding during the transition, and other psychological and somatic changes during premenopausal stages. (IAH)

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

knowledge and adherence to clinical practice guidelines amongst ...

African Journals Online (AJOL)

ABEOLUGBENGAS

Objective: The therapeutic management of patients with Low Back Pain (LBP) has long been characterized ... Keywords: Low back pain, Clinical practice Guidelines, Knowledge, Adherence ..... discourage the use of modalities such as TENS,.

Using mixed methods research in medical education: basic guidelines for researchers.

Science.gov (United States)

Schifferdecker, Karen E; Reed, Virginia A

2009-07-01

Mixed methods research involves the collection, analysis and integration of both qualitative and quantitative data in a single study. The benefits of a mixed methods approach are particularly evident when studying new questions or complex initiatives and interactions, which is often the case in medical education research. Basic guidelines for when to use mixed methods research and how to design a mixed methods study in medical education research are not readily available. The purpose of this paper is to remedy that situation by providing an overview of mixed methods research, research design models relevant for medical education research, examples of each research design model in medical education research, and basic guidelines for medical education researchers interested in mixed methods research. Mixed methods may prove superior in increasing the integrity and applicability of findings when studying new or complex initiatives and interactions in medical education research. They deserve an increased presence and recognition in medical education research.

Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors

Directory of Open Access Journals (Sweden)

Puppalwar G

2015-03-01

Full Text Available Gaurav Puppalwar, Meenakshi Mourya, Ganesh Kadhe, Amey Mane Medical Affairs, Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Mumbai, India Abstract: Clinical trials provide a foundation for new drug development processes, as well as for product license extensions for existing therapies. The reduction in the amount of time and cost to conduct a clinical trial becomes important, as competition to bring a new drug to the market is increasing, and so is the search for new markets. Kenya, Nigeria, Tanzania, Uganda, and Zambia offer a diverse patient population, as well as a comparatively research-friendly and ambitious government to develop these countries as pharmaceutical and health sectors of excellence. All these countries have their own guidelines to conduct clinical trials that feature some similarities and some subtle differences. Over the last decade, the guidelines have been evolving to provide a good ground to foreign sponsors, which carry out clinical trials while keeping the interest of patients as a priority. In the advent of these evolving guidelines, it becomes important for a foreign sponsor to understand and be aware of these guidelines before carrying out clinical trials. The present paper attempts to collect and compile all information available regarding the guidelines on the conduct of trials by a foreign sponsor in these five countries, which are available at government websites and search engines. The information gathered was organized into simplified flowcharts for easy understanding and usage. A clear understanding of the guidelines can effectively reduce the challenges faced for conducting clinical trials in these countries. Keywords: informed consent, ethics, drug development, emerging markets

Do evidence-based guidelines change clinical practice patterns?

DEFF Research Database (Denmark)

Kessel, Line; Erngaard, Ditte; Flesner, Per

2017-01-01

In 2013, the Danish Health and Medicines Authorities published a National Clinical Guideline on the treatment of age-related cataracts. The guideline provided evidence-based recommendations on the indication for cataract surgery, cataract surgery in patients with age-related macular degeneration......, on the use of toric intraocular lenses (IOLs) to correct preoperative corneal astigmatism, the use of intracameral and topical antibiotics to prevent endophthalmitis, choice of anti-inflammatory medication to control postoperative inflammation and prevent cystoid macular oedema, the use of immediate...

PREPARE: guidelines for planning animal research and testing.

Science.gov (United States)

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

2018-04-01

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

European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of HIV-infected adults

DEFF Research Database (Denmark)

Clumeck, N; Pozniak, A; Raffi, F

2008-01-01

A working group of the European AIDS Clinical Society (EACS) have developed these guidelines for European clinicians to help them in the treatment of adults with HIV infection. This third version of the guidelines includes, as new topics, the assessment of patients at initial and subsequent clinic...... virological failure and the treatment of HIV during pregnancy. In Europe, there is a wide range of clinical practices in antiretroviral therapy depending on various factors such as drug registration, national policies, local availability, reimbursement and access to treatment. These can vary greatly from one...

Implementing tobacco use treatment guidelines in public health dental clinics in New York City.

Science.gov (United States)

Shelley, Donna; Anno, Jaime; Tseng, Tuo-Yen; Calip, Greg; Wedeles, John; Lloyd, Madeleine; Wolff, Mark S

2011-04-01

In this study we evaluated the effect of a multicomponent intervention to implement the Public Health Service (PHS) guideline Treating Tobacco Use and Dependence in six randomly selected dental clinics in New York University's College of Dentistry. The main outcome measure-provider adherence to tobacco use treatment guidelines-was assessed by auditing a random selection of patient charts pre (698) and post (641) intervention. The intervention components included a chart reminder and referral system, free nicotine replacement therapy (NRT), and provider training and feedback. The results showed that rates of screening for tobacco use did not change between pre and post test chart audits. However, providers were significantly more likely to offer advice (28.4 percent pre, 49 percent post), assess readiness to quit (17.8 percent pre, 29.9 percent post), and offer assistance (6.5 percent pre and 15.6 percent post) in the post test period. Increases in NRT distribution were associated with booster training sessions but declined in the time periods between those trainings. Research is needed to further define sustainable strategies for implementing tobacco use treatment in dental clinics. The results of this study suggest the feasibility and effectiveness of using a tailored multicomponent approach to implement tobacco use treatment guidelines in dental clinics.

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

Science.gov (United States)

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 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.

Nurse awareness of clinical research: a survey in a Japanese University Hospital

Science.gov (United States)

2014-01-01

Background Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research. Methods As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed. Results Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse

Clinical practice guidelines for translating pharmacogenomic knowledge to bedside. Focus on anticancer drugs.

Directory of Open Access Journals (Sweden)

José A G Agúndez

2014-08-01

Full Text Available The development of clinical practice recommendations or guidelines for the clinical use of pharmacogenomics data is an essential issue for improving drug therapy, particularly for drugs with high toxicity and/or narrow therapeutic index such as anticancer drugs. Although pharmacogenomic-based recommendations have been formulated for over 40 anticancer drugs, the number of clinical practice guidelines available is very low. The guidelines already published indicate that pharmacogenomic testing is useful for patient selection, but final dosing adjustment should be carried out on the basis of clinical or analytical parameters rather than on pharmacogenomic information.Patient selection may seem a modest objective, but it constitutes a crucial improvement with regard to the pre-pharmacogenomics situation and it saves patients’ lives. However we should not overstate the current power of pharmacogenomics. At present the pharmacogenomics of anticancer drugs is not sufficiently developed for dose adjustments based on pharmacogenomics only, and no current guidelines recommend such adjustments without considering clinical and/or analytical parameters.

Clinical Practice Guidelines for the Antibiotic Treatment of Community-Acquired Urinary Tract Infections

Science.gov (United States)

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

Guidelines for Self-assessment of Research Reactor Safety

International Nuclear Information System (INIS)

2018-01-01

Self-assessment is an organization’s internal process to review its current status, processes and performance against predefined criteria and thereby to provide key elements for the organization’s continual development and improvement. Self-assessment helps the organization to think through what it is expected to do, how it is performing in relation to these expectations, and what it needs to do to improve performance, fulfil the expectations and achieve better compliance with the predefined criteria. This publication provides guidelines for a research reactor operating organization to perform a self-assessment of the safety management and the safety of the facility and to identify gaps between the current situation and the IAEA safety requirements for research reactors. These guidelines also provide a methodology for Member States, regulatory bodies and operating organizations to perform a self-assessment of their application of the provisions of the Code of Conduct on the Safety of Research Reactors. This publication also addresses planning, implementation and follow-up of actions to enhance safety and strengthen application of the Code. The guidelines are applicable to all types of research reactor and critical and subcritical assemblies, at all stages in their lifetimes, and to States, regulatory bodies and operating organizations throughout all phases of research reactor programmes. Research reactor operating organizations can use these guidelines at any time to support self-assessments conducted in accordance with the organization’s integrated management system. These guidelines also serve as a tool for an organization to prepare to receive an IAEA Integrated Safety Assessment of Research Reactors (INSARR) mission. An important result of this is the opportunity for an operating organization to identify focus areas and make safety improvements in advance of an INSARR mission, thereby increasing the effectiveness of the mission and efficiency of the

A Critical Review of Low Back Pain Guidelines.

Science.gov (United States)

Chetty, Laran

2017-09-01

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

Developing evidence-based clinical practice guidelines in hospitals in Australia, Indonesia, Malaysia, the Philippines and Thailand: values, requirements and barriers

Directory of Open Access Journals (Sweden)

Turner Tari J

2009-12-01

Full Text Available Abstract Background Evidence-based clinical practice guidelines support clinical decision-making by making recommendations to guide clinical practice. These recommendations are developed by integrating the expertise of a multidisciplinary group of clinicians with the perspectives of consumers and the best available research evidence. However studies have raised concerns about the quality of guideline development, and particularly the link between research and recommendations. The reasons why guideline developers are not following the established development methods are not clear. We aimed to explore the barriers to developing evidence-based guidelines in eleven hospitals in Australia, Indonesia, Malaysia, the Philippines and Thailand, so as to better understand how evidence-based guideline development could be facilitated in these settings. The research aimed to identify the value clinicians place on guidelines, what clinicians want in guidelines developed in hospital settings and what factors limit rigorous evidence-based guideline development in these settings. Methods Semi-structured, face-to-face interviews were undertaken with senior and junior healthcare providers (nurses, midwives, doctors, allied health from the maternal and neonatal services of the eleven participating hospitals. Interviews were audio-recorded, transcribed and a thematic analysis undertaken. Results Ninety-three individual, 25 pair and eleven group interviews were conducted. Participants were clear that they want guidelines that are based on evidence and updated regularly. They were also clear that there are major barriers to this. Most of the barriers were shared across countries, and included lack of time, lack of skills in finding, appraising and interpreting evidence, lack of access to relevant evidence and difficulty arranging meetings and achieving consensus. Barriers that were primarily identified in Australian hospitals include cumbersome organisational

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

Science.gov (United States)

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.

[Formula: see text]Official Position of the American Academy of Clinical Neuropsychology (AACN): Guidelines for Practicum Training in Clinical Neuropsychology.

Science.gov (United States)

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.

Rational pharmacotherapy and clinical practice guidelines - Theories and perspectives on implementing pharmacotherapeutic treatment guidelines

NARCIS (Netherlands)

Fijn, R; Brouwers, JRBJ; Timmer, JW; de Jong-van den Berg, LTW

Several theories behind implementing clinical guidelines have been described within the literature. At first sight, these may seem different. However, there are similarities and eventually they are rather complementary than mutually exclusive. This article integrates several theoretical views on

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

Science.gov (United States)

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

2011-09-06

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. 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. 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. This article outlines the 14-step method that was defined to standardize the guideline development process for each priority health condition.

Methodological Guidelines for Advertising Research

DEFF Research Database (Denmark)

Rossiter, John R.; Percy, Larry

2017-01-01

In this article, highly experienced advertising academics and advertising research consultants John R. Rossiter and Larry Percy present and discuss what they believe to be the seven most important methodological guidelines that need to be implemented to improve the practice of advertising research....... Their focus is on methodology, defined as first choosing a suitable theoretical framework to guide the research study and then identifying the advertising responses that need to be studied. Measurement of those responses is covered elsewhere in this special issue in the article by Bergkvist and Langner. Most...

Information and Communication Technologies for the Dissemination of Clinical Practice Guidelines to Health Professionals: A Systematic Review.

Science.gov (United States)

De Angelis, Gino; Davies, Barbara; King, Judy; McEwan, Jessica; Cavallo, Sabrina; Loew, Laurianne; Wells, George A; Brosseau, Lucie

2016-11-30

The transfer of research knowledge into clinical practice can be a continuous challenge for researchers. Information and communication technologies, such as websites and email, have emerged as popular tools for the dissemination of evidence to health professionals. The objective of this systematic review was to identify research on health professionals' perceived usability and practice behavior change of information and communication technologies for the dissemination of clinical practice guidelines. We used a systematic approach to retrieve and extract data about relevant studies. We identified 2248 citations, of which 21 studies met criteria for inclusion; 20 studies were randomized controlled trials, and 1 was a controlled clinical trial. The following information and communication technologies were evaluated: websites (5 studies), computer software (3 studies), Web-based workshops (2 studies), computerized decision support systems (2 studies), electronic educational game (1 study), email (2 studies), and multifaceted interventions that consisted of at least one information and communication technology component (6 studies). Website studies demonstrated significant improvements in perceived usefulness and perceived ease of use, but not for knowledge, reducing barriers, and intention to use clinical practice guidelines. Computer software studies demonstrated significant improvements in perceived usefulness, but not for knowledge and skills. Web-based workshop and email studies demonstrated significant improvements in knowledge, perceived usefulness, and skills. An electronic educational game intervention demonstrated a significant improvement from baseline in knowledge after 12 and 24 weeks. Computerized decision support system studies demonstrated variable findings for improvement in skills. Multifaceted interventions demonstrated significant improvements in beliefs about capabilities, perceived usefulness, and intention to use clinical practice guidelines, but

Challenges of implementing fibromyalgia treatment guidelines in current clinical practice.

Science.gov (United States)

Arnold, Lesley M; Clauw, Daniel J

2017-09-01

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

Systematic review of clinical practice guidelines related to multiple sclerosis.

Directory of Open Access Journals (Sweden)

Jia Guo

Full Text Available BACKGROUND: High quality clinical practice guidelines (CPGs can provide clinicians with explicit recommendations on how to manage health conditions and bridge the gap between research and clinical practice. Unfortunately, the quality of CPGs for multiple sclerosis (MS has not been evaluated. OBJECTIVE: To evaluate the methodological quality of CPGs on MS using the AGREE II instrument. METHODS: According to the inclusion and exclusion criteria, we searched four databases and two websites related to CPGs, including the Cochrane library, PubMed, EMBASE, DynaMed, the National Guideline Clearinghouse (NGC, and Chinese Biomedical Literature database (CBM. The searches were performed on September 20th 2013. All CPGs on MS were evaluated by the AGREE II instrument. The software used for analysis was SPSS 17.0. RESULTS: A total of 27 CPGs on MS met inclusion criteria. The overall agreement among reviews was good or substantial (ICC was above 0.70. The mean scores for each of all six domains were presented as follows: scope and purpose (mean ± SD: 59.05 ± 16.13, stakeholder involvement (mean ± SD: 29.53 ± 17.67, rigor of development (mean ± SD: 31.52 ± 21.50, clarity of presentation (mean ± SD: 60.39 ± 13.73, applicability (mean ± SD: 27.08 ± 17.66, editorial independence (mean ± SD: 28.70 ± 22.03. CONCLUSIONS: The methodological quality of CPGs for MS was acceptable for scope, purpose and clarity of presentation. The developers of CPGs need to pay more attention to editorial independence, applicability, rigor of development and stakeholder involvement during the development process. The AGREE II instrument should be adopted by guideline developers.

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

Science.gov (United States)

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.

Guidelines for Conducting Mixed-methods Research: An Extension and Illustration.

OpenAIRE

Venkatesh, Viswanath

2016-01-01

In this paper, we extend the guidelines of Venkatesh et al. (2013) for mixed-methods research by identifying and integrating variations in mixed-methods research. By considering 14 properties of mixed-methods research (e.g., purposes, research questions, epistemological assumptions), our guidelines demonstrate how researchers can flexibly identify the existing variations in mixed-methods research and proceed accordingly with a study design that suits their needs. To make the guide...

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

Science.gov (United States)

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

2018-03-01

prior to visualization of the larynx. (2) Clinicians should not prescribe antireflux medications to treat isolated dysphonia, based on symptoms alone attributed to suspected gastroesophageal reflux disease (GERD) or laryngopharyngeal reflux (LPR), without visualization of the larynx. (3) Clinicians should not routinely prescribe corticosteroids for patients with dysphonia prior to visualization of the larynx. The policy level for the following recommendation about laryngoscopy at any time was an option: (1) Clinicians may perform diagnostic laryngoscopy at any time in a patient with dysphonia. Disclaimer This clinical practice guideline is not intended as an exhaustive source of guidance for managing dysphonia (hoarseness). Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. The guideline is not intended to replace clinical judgment or establish a protocol for all individuals with this condition, and it may not provide the only appropriate approach to diagnosing and managing this problem. Differences from Prior Guideline (1) Incorporation of new evidence profiles to include the role of patient preferences, confidence in the evidence, differences of opinion, quality improvement opportunities, and any exclusion to which the action statement does not apply (2) Inclusion of 3 new guidelines, 16 new systematic reviews, and 4 new randomized controlled trials (3) Inclusion of a consumer advocate on the guideline update group (4) Changes to 9 KASs from the original guideline (5) New KAS 3 (escalation of care) and KAS 13 (outcomes) (6) Addition of an algorithm outlining KASs for patients with dysphonia.

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

Science.gov (United States)

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.

Common data elements for spinal cord injury clinical research

DEFF Research Database (Denmark)

Biering-Sørensen, F; Alai, S; Anderson, K.

2015-01-01

Institutes of Health. SETTING: International Working Groups. METHODS: Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed and provided recommendations for SCI clinical research. The project was carried out in collaboration...... of CDEs can facilitate SCI clinical research and trial design, data sharing and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence......OBJECTIVES: To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National...

A critical appraisal of clinical practice guidelines for the treatment of lower-limb osteoarthritis

Science.gov (United States)

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

A review of multidisciplinary clinical practice guidelines in suicide prevention: toward an emerging standard in suicide risk assessment and management, training and practice.

Science.gov (United States)

Bernert, Rebecca A; Hom, Melanie A; Roberts, Laura Weiss

2014-10-01

The current paper aims to: (1) examine clinical practice guidelines in suicide prevention across fields, organizations, and clinical specialties and (2) inform emerging standards in clinical practice, research, and training. The authors conducted a systematic literature review to identify clinical practice guidelines and resource documents in suicide prevention and risk management. The authors used PubMed, Google Scholar, and Google Search, and keywords included: clinical practice guideline, practice guideline, practice parameters, suicide, suicidality, suicidal behaviors, assessment, and management. To assess for commonalities, the authors reviewed guidelines and resource documents across 13 key content categories and assessed whether each document suggested validated assessment measures. The search generated 101 source documents, which included N = 10 clinical practice guidelines and N = 12 additional resource documents (e.g., non-formalized guidelines, tool-kits). All guidelines (100 %) provided detailed recommendations for the use of evidence-based risk factors and protective factors, 80 % provided brief (but not detailed) recommendations for the assessment of suicidal intent, and 70 % recommended risk management strategies. By comparison, only 30 % discussed standardization of risk-level categorizations and other content areas considered central to best practices in suicide prevention (e.g., restricting access to means, ethical considerations, confidentiality/legal issues, training, and postvention practices). Resource documents were largely consistent with these findings. Current guidelines address similar aspects of suicide risk assessment and management, but significant discrepancies exist. A lack of consensus was evident in recommendations across core competencies, which may be improved by increased standardization in practice and training. Additional resources appear useful for supplemental use.

A Typology for Modeling Processes in Clinical Guidelines and Protocols

Science.gov (United States)

Tu, Samson W.; Musen, Mark A.

We analyzed the graphical representations that are used by various guideline-modeling methods to express process information embodied in clinical guidelines and protocols. From this analysis, we distilled four modeling formalisms and the processes they typically model: (1) flowcharts for capturing problem-solving processes, (2) disease-state maps that link decision points in managing patient problems over time, (3) plans that specify sequences of activities that contribute toward a goal, (4) workflow specifications that model care processes in an organization. We characterized the four approaches and showed that each captures some aspect of what a guideline may specify. We believe that a general guideline-modeling system must provide explicit representation for each type of process.

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

Science.gov (United States)

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

2017-09-01

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

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

Science.gov (United States)

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.

Japanese Society of Medical Oncology Clinical Guidelines: Molecular Testing for Colorectal Cancer Treatment, Third Edition.

Science.gov (United States)

Yamazaki, Kentaro; Taniguchi, Hiroya; Yoshino, Takayuki; Akagi, Kiwamu; Ishida, Hideyuki; Ebi, Hiromichi; Nakatani, Kaname; Muro, Kei; Yatabe, Yasushi; Yamaguchi, Kensei; Tsuchihara, Katsuya

2018-06-01

The Japanese Society of Medical Oncology (JSMO) previously published 2 editions of the clinical guidelines: "Japanese guidelines for testing of KRAS gene mutation in colorectal cancer" in 2008 and "Japanese Society of Medical Oncology Clinical Guidelines: RAS (KRAS/NRAS) mutation testing in colorectal cancer patients" in 2014. These guidelines have contributed to the proper use of KRAS and RAS mutation testing, respectively. Recently, clinical utility, particularly for colorectal cancer (CRC) patients with BRAF V600E mutation or DNA mismatch-repair (MMR) deficiency, has been established. Therefore, the guideline members decided these genetic alterations should also be involved. The aim of this revision is to properly carry out testing for BRAF V600E mutation and MMR deficiency in addition to RAS mutation. The revised guidelines include the basic requirements for testing for these genetic alterations based on recent scientific evidence. Furthermore, because clinical utility of comprehensive genetic testing using next-generation sequencing and somatic gene testing of analyzing circulating tumor DNA has increasingly evolved with recent advancements in testing technology, we noted the current situation and prospects for these testing technologies and their clinical implementation in the revised guidelines. © 2018 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

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

Science.gov (United States)

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

2001-01-01

The purpose of guidelines in clinical practice is to improve the effectiveness and efficiency of clinical care. It is known that nationally or internationally produced guidelines which, in particular, do not involve medical processes at the time of consultation, do not take local factors into account, and have no consistent implementation strategy, have limited impact in changing either the behaviour of physicians, or patterns of care. The literature provides evidence for the effectiveness of computerization of CPGs for increasing compliance and improving patient outcomes. Probably the most effective concepts are knowledge-based functions for decision support or monitoring that are integrated in clinical information systems. This approach is mostly restricted by the effort required for development and maintenance of the information systems and the limited number of implemented medical rules. Most of the guidelines are text-based, and are primarily published in medical journals and posted on the internet. However, internet-published guidelines have little impact on the behaviour of physicians. It can be difficult and time-consuming to browse the internet to find (a) the correct guidelines to an existing diagnosis and (b) and adequate recommendation for a specific clinical problem. Our objective is to provide a web-based guideline service that takes as input clinical data on a particular patient and returns as output a customizable set of recommendations regarding diagnosis and treatment. Information in healthcare is to a very large extent transmitted and stored as unstructured or slightly structured text such as discharge letters, reports, forms, etc. The same applies for facilities containing medical information resources for clinical purposes and research such as text books, articles, guidelines, etc. Physicians are used to obtaining information from text-based sources. Since most guidelines are text-based, it would be practical to use a document-based solution

National clinical guidelines for management of the palatally ectopic maxillary canine.

Science.gov (United States)

Husain, J; Burden, D; McSherry, P; Morris, D; Allen, M

2012-08-01

This review summarises updated clinical guidelines produced by the Clinical Standards Committee of the Faculty of Dental Surgery, Royal College of Surgeons of England (FDSRCS). This guideline on the management of the palatally ectopic maxillary canine illustrates the information contained in the recently updated online version. The timely recognition of ectopic canines is important for the overall management of the dentition. This review illustrates five management strategies for ectopic permanent canines: interceptive treatment by extraction of the deciduous canine, surgical exposure and orthodontic alignment, surgical removal of the palatally ectopic permanent canine, auto-transplantation and no active treatment/leave and observe. The current available evidence for each of these management options has been evaluated and awarded a grade used by the Scottish Intercollegiate Guidelines Network.

Investigation of barriers to clinical practice guideline-recommended pharmacotherapy in the treatment of COPD.

Directory of Open Access Journals (Sweden)

Price L

2007-06-01

Full Text Available Background: The adoption of clinical practice guideline recommendations for COPD is suboptimal. Determining the barriers to the implementation of these practice guidelines may help improve patient care.Objective: To determine whether barriers to the use of pharmacotherapy according to practice guidelines are related primarily to patient or prescriber factors.Methods: Retrospective cohort study. Members of a health maintenance organization identified as having spirometry-defined COPD ranging from stage II to IV. Electronic medical records were reviewed for documentation of the following: 1 patient affordability issues, 2 history of an adverse drug reaction, 3 history of inefficacy to therapy, and 4 prescription history.Results: A total of 111 medical records were reviewed. There were 51% of patients who had not filled medications that had been prescribed in accordance with guidelines and 43% did not have the guideline recommended medications prescribed in the previous year. Only 4% and 2% of patients had documented inefficacy and affordability issues, respectively. There were no reported cases of adverse drug reactions. Conclusions: This study provides insight to the acceptance of COPD treatment recommendations by patients and providers. Further research is needed to design interventions to reduce barriers and optimize COPD treatment.

[The development of clinical guidelines for the diagnosis and treatment of chronic periodontitis in Belgium].

Science.gov (United States)

Cosyn, Jan; De Bruyn, Hugo

2008-01-01

In many disciplines of medicine guidelines are developed for the diagnosis and treatment of disease. These are essentially intended to standardize care and to optimize communication between the general practitioner and the specialist. Guidelines have already been described in the literature for chronic periodontitis. However, given the unique conditions in Belgium, these may not be appropriate for the average dental practice. In this manuscript the development of Belgian clinical guidelines for the diagnosis and treatment of chronic periodontitis is described. Basically, ten clinical questions were used as a basis for a thorough literature search. Evidence-based clinical guidelines were developed and adapted during three peer review sessions. In the final session Belgian specialists, who had all been invited, participated. This made sure that the scientific input was sufficiently transformed into clinical guidelines which are actually feasible today in Belgium.

The 2016 CIOMS guidelines and public-health research ethics

African Journals Online (AJOL)

2017-12-01

Dec 1, 2017 ... CIOMS International Ethical Guidelines for Biomedical Research Involving ... mention of public health in relation to social value. • The new guideline 7, .... reports, can be obtained from conventional media sources such as.

Integration of clinical research documentation in electronic health records.

Science.gov (United States)

Broach, Debra

2015-04-01

Clinical trials of investigational drugs and devices are often conducted within healthcare facilities concurrently with clinical care. With implementation of electronic health records, new communication methods are required to notify nonresearch clinicians of research participation. This article reviews clinical research source documentation, the electronic health record and the medical record, areas in which the research record and electronic health record overlap, and implications for the research nurse coordinator in documentation of the care of the patient/subject. Incorporation of clinical research documentation in the electronic health record will lead to a more complete patient/subject medical record in compliance with both research and medical records regulations. A literature search provided little information about the inclusion of clinical research documentation within the electronic health record. Although regulations and guidelines define both source documentation and the medical record, integration of research documentation in the electronic health record is not clearly defined. At minimum, the signed informed consent(s), investigational drug or device usage, and research team contact information should be documented within the electronic health record. Institutional policies should define a standardized process for this integration in the absence federal guidance. Nurses coordinating clinical trials are in an ideal position to define this integration.

Appraisal tools for clinical practice guidelines: a systematic review.

Directory of Open Access Journals (Sweden)

Ulrich Siering

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

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

Science.gov (United States)

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.

Determination of Guidelines Complience: Comparison of Clinical Guidelines with the Patient’s Record

Czech Academy of Sciences Publication Activity Database

Veselý, A.; Zvárová, Jana

2012-01-01

Roč. 8, č. 1 (2012), s. 16-28 ISSN 1801-5603 R&D Projects: GA MŠk(CZ) 1M06014 Institutional support: RVO:67985807 Keywords : clinical guidelines * GLIF model * Electronic Health Record * reminder facility * execution engine algorithm Subject RIV: IN - Informatics, Computer Science http://www.ejbi.org/img/ejbi/2012/1/Vesely_en.pdf

General practitioner's reported use of clinical guidelines for hypertension and ambulatory blood pressure.

LENUS (Irish Health Repository)

Flynn, E

2012-03-01

ABPM is an invaluable clinical tool, as it has been shown to improve blood pressure control in primary care. Many clinical guidelines for hypertension advocate ambulatory blood pressure monitoring. This study aims to quantify the use of clinical guidelines for hypertension and to explore the role of ABPM in Primary Care. A questionnaire survey was sent to GPs working in the West of Ireland. 88% (n=139) of GPs use clinical guidelines that recommend the use of ABPM. 82% (n=130) of GPs find use of clinic blood pressure monitoring insufficient for the diagnosis and monitoring of hypertension. Despite good access to ABPM, GPs report lack of remuneration, 72% (n=116), cost 68% (n=108), and lack of time, 51% (n=83) as the main limiting factors to use of ABPM. GPs recognise the clinical value of ABPM, but this study identifies definite barriers to the use of ABPM in Primary Care.

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

Science.gov (United States)

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

The significance of clinical practice guidelines on adult varicocele detection and management

Directory of Open Access Journals (Sweden)

Anand Shridharani

2016-01-01

Full Text Available Varicoceles are the most common correctable etiology of male factor infertility. However, the detection and management of varicoceles have not been standardized. This has led to decades of debate regarding the effect of varicocele on male infertility and subsequently whether repair leads to an improved fertility status. The current body of evidence investigating the role of varicocele and varicocelectomy is weak and conflicting. The stance taken by the AUA and ASRM suggests that there is insufficient outcomes data to support evidenced-based guidelines, citing evidence used to provide current recommendations are generally of a low quality level. On the other hand, the EAU Guidelines give a level 1a of evidence for management of varicoceles that are clinically palpable, associated with subnormal semen analyses and having otherwise unexplained fertility. Besides aiding with clinical varicocele detection and management, clinical practice opinion statements and guidelines aim to direct and strengthen the infrastructure of future studies. We review the current status of opinion statements and guidelines in varicocele and management detection with focus on their application in practice.

The significance of clinical practice guidelines on adult varicocele detection and management.

Science.gov (United States)

Shridharani, Anand; Owen, Ryan C; Elkelany, Osama O; Kim, Edward D

2016-01-01

Varicoceles are the most common correctable etiology of male factor infertility. However, the detection and management of varicoceles have not been standardized. This has led to decades of debate regarding the effect of varicocele on male infertility and subsequently whether repair leads to an improved fertility status. The current body of evidence investigating the role of varicocele and varicocelectomy is weak and conflicting. The stance taken by the AUA and ASRM suggests that there is insufficient outcomes data to support evidenced-based guidelines, citing evidence used to provide current recommendations are generally of a low quality level. On the other hand, the EAU Guidelines give a level 1a of evidence for management of varicoceles that are clinically palpable, associated with subnormal semen analyses and having otherwise unexplained fertility. Besides aiding with clinical varicocele detection and management, clinical practice opinion statements and guidelines aim to direct and strengthen the infrastructure of future studies. We review the current status of opinion statements and guidelines in varicocele and management detection with focus on their application in practice.

Actinic Keratosis Clinical Practice Guidelines: An Appraisal of Quality

Directory of Open Access Journals (Sweden)

Joslyn S. Kirby

2015-01-01

Full Text Available Actinic keratosis (AK is a common precancerous skin lesion and many AK management guidelines exist, but there has been limited investigation into the quality of these documents. The objective of this study was to assess the strengths and weaknesses of guidelines that address AK management. A systematic search for guidelines with recommendations for AK was performed. The Appraisal of Guidelines for Research and Evaluation (AGREE II was used to appraise the quality of guidelines. Multiple raters independently reviewed each of the guidelines and applied the AGREE II tool and scores were calculated. Overall, 2,307 citations were identified and 7 fulfilled the study criteria. The Cancer Council of Australia/Australian Cancer Network guideline had the highest mean scores and was the only guideline to include a systematic review, include an evidence rating for recommendations, and report conflicts of interest and funding sources. High-quality, effective guidelines are evidence-based with recommendations that are concise and organized, so practical application is facilitated. Features such as concise tables, pictorial diagrams, and explicit links to evidence are helpful. However, the rigor and validity of some guidelines were weak. So, it is important for providers to be aware of the features that contribute to a high-quality, practical document.

[Algorithm for application of the "ethical guidelines for epidemiological research" and taxonomy of public health research].

Science.gov (United States)

Okamoto, Etsuji

2003-11-01

"Ethical Guidelines for Epidemiological Research" took effect in July 2002, with a moral duty of all researchers to comply when conducting epidemiological studies although it is not legally binding. Public health research entails various forms of studies including not only epidemiological studies but also attention to psychological, societal and economic aspects, which are outside of the jurisdiction of the guidelines. Hence, confusion may arise among members of Japanese Society of Public Health as to whether the study they conduct falls within the definition of epidemiological research. The author discusses legal interpretations of the guidelines arising in the course of translation work as part of government-funded project, "Dissemination of the 'Ethical Guidelines for Epidemiological Research' via Internet (principal investigator: Toru Doi)" and argues that a case-method approach would be best suited to enhance understanding by researchers with diverse, non-legal backgrounds. The author proposes an algorithm for classification of studies as to whether the guideline applies, and applies it to all original articles published in the Japanese Journal of Public Health (JJPH) in one year (March 2002 thru February 2003). The rationale for classification is discussed from the strict legal viewpoint in each case. Sixteen out of 46 original articles published in JJPH for one year were classified as epidemiological studies to which the guidelines apply. Those classified otherwise were psychological studies (10), epidemiological studies not targeting specific diseases and are exempt form the guidelines (3), purely methodological studies (4), economics studies (3), fact-finding or opinion surveys with no hypothesis testing (2), as well as studies authorized by law (4) or using unlinkable anonymous data only (4), all of which are exempt from the guidelines. Reference to ethical considerations in the methodology section as required by the instructions for authors was generally

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

Directory of Open Access Journals (Sweden)

Johnson Lorraine

2010-06-01

Full Text Available Abstract 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.

Guidelines for Qualitative Research in Organization Studies: Controversy and Possibilities

Directory of Open Access Journals (Sweden)

Maria Fernanda Rios Cavalcanti

2017-09-01

Full Text Available The aim of the present article is to tackle the controversy of establishing guidelines for qualitative research in Organization and Management Theory (OMT and to present a summary of suggestions on how to conduct good qualitative research given by methodologists on top-tier international publications. In order to do so, the article discusses: general guidelines for qualitative research; how to achieve coherence and transparency in a qualitative empirical study; the meaning and importance of the concept of reflexivity; and, finally how to establish a theoretical contribution and transferability of findings in such context. The work presents a valuable contribution because such guidelines, concepts, and approaches can be adopted by students and researchers when conducting a qualitative research proposal, and by periodic reviewers to evaluate the quality of existing empirical studies.

[Clinical guidelines for the prevention of infective endocarditis].

Science.gov (United States)

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.

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

Science.gov (United States)

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

2016-05-01

Financial relationships between organizations that produce clinical practice guidelines and biomedical companies are vulnerable to conflicts of interest. We sought to determine whether organizations that produce clinical practice guidelines have financial relationships with biomedical companies and whether there are associations between organizations' conflict of interest policies and recommendations and disclosures provided in guidelines. We conducted a cross-sectional survey and review of websites of 95 national/international medical organizations that produced 290 clinical practice guidelines published on the National Guideline Clearinghouse website from January 1 to December 31, 2012. Survey responses were available for 68% (65/95) of organizations (167/290 guidelines, 58%), and websites were reviewed for 100% (95/95) of organizations (290/290 guidelines, 100%). In all, 63% (60/95) of organizations producing clinical practice guidelines reported receiving funds from a biomedical company; 80% (76/95) of organizations reported having a policy for managing conflicts of interest. Disclosure statements (disclosing presence or absence of financial relationships with biomedical companies) were available in 65% (188/290) of clinical practice guidelines for direct funding sources to produce the guideline, 51% (147/290) for financial relationships of the guideline committee members, and 1% (4/290) for financial relationships of the organizations producing the guidelines. Among all guidelines, 6% (18/290) disclosed direct funding by biomedical companies, 40% (117/290) disclosed financial relationships between committee members and biomedical companies (38% of guideline committee members, 773/2,043), and 1% (4/290) disclosed financial relationships between the organizations producing the guidelines and biomedical companies. In the survey responses, 60 organizations reported the procedures that they included in their conflict of interest policies (158 guidelines

Alcohol use and pregnancy consensus clinical guidelines.

Science.gov (United States)

Carson, George; Cox, Lori Vitale; Crane, Joan; Croteau, Pascal; Graves, Lisa; Kluka, Sandra; Koren, Gideon; Martel, Marie-Jocelyne; Midmer, Deana; Nulman, Irena; Poole, Nancy; Senikas, Vyta; Wood, Rebecca

2010-08-01

to establish national standards of care for the screening and recording of alcohol use and counselling on alcohol use of women of child-bearing age and pregnant women based on the most up-to-date evidence. published literature was retrieved through searches of PubMed, CINAHL, and the Cochrane Library in May 2009 using appropriate controlled vocabulary (e.g., pregnancy complications, alcohol drinking, prenatal care) and key words (e.g., pregnancy, alcohol consumption, risk reduction). Results were restricted to literature published in the last five years with the following research designs: systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment (HTA) and HTA-related agencies, national and international medical specialty societies, clinical practice guideline collections, and clinical trial registries. Each article was screened for relevance and the full text acquired if determined to be relevant. The evidence obtained was reviewed and evaluated by the members of the Expert Workgroup established by the Society of Obstetricians and Gynaecologists of Canada. The quality of evidence was evaluated and recommendations were made according to guidelines developed by the Canadian Task Force on Preventive Health Care. the quality of evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table 1). the Public Health Agency of Canada and the Society of Obstetricians and Gynaecologists of Canada. these consensus guidelines have been endorsed by the Association of Obstetricians and Gynecologists of Quebec; the Canadian Association of Midwives; the Canadian Association of Perinatal, Women's Health and Neonatal Nurses (CAPWHN); the College of Family Physicians of

Global Imaging referral guidelines

International Nuclear Information System (INIS)

Kawooya, M.; Perez, M.; Lau, L.; Reeed, M.

2010-01-01

The medical imaging specialists called for global referral guidelines which would be made available to referring doctors. These referral guidelines should be:- Applicable in different health care settings, including resource-poor settings; Inclusive in terms of the range of clinical conditions; User-friendly and accessible (format/media); Acceptable to stakeholders, in particular to the referrers as the main target audience. To conceive evidence-based medicine as an integration of best research evidence with clinical expertise and patient values. The Direct recipients of the Referral Guidelines would be:- Referrers: general practitioners / family doctors; paediatricians; emergency department doctors; other specialists and health workers. Providers (medical imaging practitioners): radiologists; nuclear medicine physicians; radiographers; other appropriately qualified practitioners providing diagnostic imaging services. For the Referral Guidelines to be effective there need to be: Credibility evidence-based Practicality end user involvement Context local resources, disease profiles Endorsement, opinion leaders Implementation- policy, education, CPOE - Monitoring of the use clinical audit, report feedback. The aim of the Referral Guidelines Project was to: Produce global referral guidelines that are evidence-based, cost effective and appropriate for the local setting, and include consideration of available equipment and expertise (RGWG; SIGs); Include supporting information about radiation doses, potential risks, protection of children and pregnant women (introductory chapter); Facilitate the implementation of the guidelines through guidance and tools (e.g. implementation guides, checklists, capacity building tools, guides on stakeholders engagement, audit support criteria); Conduct pilot testing in different clinical settings from each of the six WHO regions; Promote the inclusion of the referral guidelines in the curricula of medical schools; Develop and implement

Potential facilitators and barriers to adopting standard treatment guidelines in clinical practice.

Science.gov (United States)

Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia

2017-04-18

Purpose The purpose of this paper is to assess medicines information sources accessed by clinicians, if sources differed in theory and practice and to find out the barriers and facilitators to effective guideline adoption. Design/methodology/approach In all, 183 doctors were surveyed. Barriers and facilitators were classified as: communication; potential adopters; innovation; organization characteristics and environmental/social/economic context. Findings Most of the clinicians accessed multiple information sources including standard treatment guidelines, but also consulted seniors/colleagues in practice. The top three factors influencing clinical practice guideline adoption were innovation characteristics, environmental context and individual characteristics. The respondents differed in the following areas: concerns about flexibility offered by the guideline; denying patients' individuality; professional autonomy; insights into gaps in current practice and evidence-based practice; changing practices with little or no benefit. Barriers included negative staff attitudes/beliefs, guideline integration into organizational structures/processes, time/resource constraints. Fearing third parties (government and insurance companies) restricting medicines reimbursement and poor liability protection offered by the guidelines emerged as the barriers. Facilitators include aligning organizational structures/processes with the innovation; providing leadership support to guide diffusion; increasing awareness and enabling early innovation during pre/in-service training, with regular feedback on outcomes and use. Practical implications Guideline adoption in clinical practice is partly within doctors' control. There are other key prevailing factors in the local context such as environmental, social context, professional and organizational culture affecting its adoption. Organizational policy and accreditation standards necessitating adherence can serve as a driver. Originality

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

Science.gov (United States)

Newcombe, J P; Kerridge, I H

2007-01-01

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Korean clinical practice guidelines: otitis media in children.

Science.gov (United States)

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

2012-08-01

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

Speech pathologists' experiences with stroke clinical practice guidelines and the barriers and facilitators influencing their use: a national descriptive study.

Science.gov (United States)

Hadely, Kathleen A; Power, Emma; O'Halloran, Robyn

2014-03-06

Communication and swallowing disorders are a common consequence of stroke. Clinical practice guidelines (CPGs) have been created to assist health professionals to put research evidence into clinical practice and can improve stroke care outcomes. However, CPGs are often not successfully implemented in clinical practice and research is needed to explore the factors that influence speech pathologists' implementation of stroke CPGs. This study aimed to describe speech pathologists' experiences and current use of guidelines, and to identify what factors influence speech pathologists' implementation of stroke CPGs. Speech pathologists working in stroke rehabilitation who had used a stroke CPG were invited to complete a 39-item online survey. Content analysis and descriptive and inferential statistics were used to analyse the data. 320 participants from all states and territories of Australia were surveyed. Almost all speech pathologists had used a stroke CPG and had found the guideline "somewhat useful" or "very useful". Factors that speech pathologists perceived influenced CPG implementation included the: (a) guideline itself, (b) work environment, (c) aspects related to the speech pathologist themselves, (d) patient characteristics, and (e) types of implementation strategies provided. There are many different factors that can influence speech pathologists' implementation of CPGs. The factors that influenced the implementation of CPGs can be understood in terms of knowledge creation and implementation frameworks. Speech pathologists should continue to adapt the stroke CPG to their local work environment and evaluate their use. To enhance guideline implementation, they may benefit from a combination of educational meetings and resources, outreach visits, support from senior colleagues, and audit and feedback strategies.

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

Science.gov (United States)

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

2016-09-27

Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

Science.gov (United States)

Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

2018-02-06

Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n�

Assessment of clinical practice guideline methodology for the treatment of knee osteoarthritis with intra-articular hyaluronic acid.

Science.gov (United States)

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

Methodological Quality of Consensus Guidelines in Implant Dentistry.

Science.gov (United States)

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 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.

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

Science.gov (United States)

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.

Guidelines for Developing and Reporting Machine Learning Predictive Models in Biomedical Research: A Multidisciplinary View.

Science.gov (United States)

Luo, Wei; Phung, Dinh; Tran, Truyen; Gupta, Sunil; Rana, Santu; Karmakar, Chandan; Shilton, Alistair; Yearwood, John; Dimitrova, Nevenka; Ho, Tu Bao; Venkatesh, Svetha; Berk, Michael

2016-12-16

As more and more researchers are turning to big data for new opportunities of biomedical discoveries, machine learning models, as the backbone of big data analysis, are mentioned more often in biomedical journals. However, owing to the inherent complexity of machine learning methods, they are prone to misuse. Because of the flexibility in specifying machine learning models, the results are often insufficiently reported in research articles, hindering reliable assessment of model validity and consistent interpretation of model outputs. To attain a set of guidelines on the use of machine learning predictive models within clinical settings to make sure the models are correctly applied and sufficiently reported so that true discoveries can be distinguished from random coincidence. A multidisciplinary panel of machine learning experts, clinicians, and traditional statisticians were interviewed, using an iterative process in accordance with the Delphi method. The process produced a set of guidelines that consists of (1) a list of reporting items to be included in a research article and (2) a set of practical sequential steps for developing predictive models. A set of guidelines was generated to enable correct application of machine learning models and consistent reporting of model specifications and results in biomedical research. We believe that such guidelines will accelerate the adoption of big data analysis, particularly with machine learning methods, in the biomedical research community. ©Wei Luo, Dinh Phung, Truyen Tran, Sunil Gupta, Santu Rana, Chandan Karmakar, Alistair Shilton, John Yearwood, Nevenka Dimitrova, Tu Bao Ho, Svetha Venkatesh, Michael Berk. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 16.12.2016.

Guidelines for reporting health economic research.

Science.gov (United States)

Haddad, F S; McLawhorn, A S

2016-02-01

Health economic evaluations potentially provide valuable information to clinicians, health care administrators, and policy makers regarding the financial implications of decisions about the care of patients. The highest quality research should be used to inform decisions that have direct impact on the access to care and the outcome of treatment. However, economic analyses are often complex and use research methods which are relatively unfamiliar to clinicians. Furthermore, health economic data have substantial national, regional, and institutional variability, which can limit the external validity of the results of a study. Therefore, minimum guidelines that aim to standardise the quality and transparency of reporting health economic research have been developed, and instruments are available to assist in the assessment of its quality and the interpretation of results. The purpose of this editorial is to discuss the principal types of health economic studies, to review the most common instruments for judging the quality of these studies and to describe current reporting guidelines. Recommendations for the submission of these types of studies to The Bone & Joint Journal are provided. Cite this article: Bone Joint J 2016;98-B:147-51. ©2016 The British Editorial Society of Bone & Joint Surgery.

Underreporting of conflicts of interest in clinical practice guidelines

DEFF Research Database (Denmark)

Bindslev, Julie Bolette Brix; Schroll, Jeppe; Gøtzsche, Peter C

2013-01-01

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...

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

OpenAIRE

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

2016-01-01

Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients i...

Clinical Practice Guidelines for the Management of Atopic Dermatitis 2016.

Science.gov (United States)

Saeki, Hidehisa; Nakahara, Takeshi; Tanaka, Akio; Kabashima, Kenji; Sugaya, Makoto; Murota, Hiroyuki; Ebihara, Tamotsu; Kataoka, Yoko; Aihara, Michiko; Etoh, Takafumi; Katoh, Norito

2016-10-01

Atopic dermatitis (AD) is a disease characterized by relapsing eczema with pruritus as a primary lesion. Most patients have an atopic predisposition. The definitive diagnosis of AD requires the presence of all three features: (i) pruritus; (ii) typical morphology and distribution of the eczema; and (iii) chronic and chronically relapsing course. The current strategies to treat AD in Japan from the perspective of evidence-based medicine consist of three primary measures: (i) the use of topical corticosteroids and tacrolimus ointment as the main treatment for the inflammation; (ii) topical application of emollients to treat the cutaneous barrier dysfunction; and (iii) avoidance of apparent exacerbating factors, psychological counseling and advice about daily life. The guidelines present recommendations to review clinical research articles, evaluate the balance between the advantages and disadvantages of medical activities, and optimize medical activity-related patient outcomes with respect to several important points requiring decision-making in clinical practice. © 2016 Japanese Dermatological Association.

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

NARCIS (Netherlands)

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

2017-01-01

Rationale, aims and objectives: Most of the clinical guidelines in low-resource countries are adaptations from preexisting international guidelines. This adaptation can be problematic when those international guidelines are not based on current evidence or original evidence-based international

Oxytocin augmentation during labor: how to implement medical guidelines into clinical practice.

Science.gov (United States)

Holmgren, Stina; Silfver, Kristina Gren; Lind, Cecilia; Nordström, Lennart

2011-11-01

To describe an extensive process to implement guidelines for oxytocin use during labor and to report its effects on compliance to clinical practice guidelines after 1 year. A multifaceted strategy was developed to involve all obstetric staff and identify possible local barriers to change in advance. The process lasted for more than 1 year. To describe the implementation of oxytocin use according to the new guidelines, and to compare management in clinical practice with guideline recommendations from audits performed before and after the project. Identification of possible barriers to change, academic detailing, audits with feedback, and local opinion leaders were important factors for a successful process. Documentation of the indication for oxytocin use increased from 54% before, to 86% after the completion of the project (Pcheck list to monitor oxytocin use. However, audits with feedback need to continue for medical safety, and have been planned to take place every 6 months. Copyright © 2011 Elsevier B.V. All rights reserved.

Reconciling pairs of concurrently used clinical practice guidelines using Constraint Logic Programming.

Science.gov (United States)

Wilk, Szymon; Michalowski, Martin; Michalowski, Wojtek; Hing, Marisela Mainegra; Farion, Ken

2011-01-01

This paper describes a new methodological approach to reconciling adverse and contradictory activities (called points of contention) occurring when a patient is managed according to two or more concurrently used clinical practice guidelines (CPGs). The need to address these inconsistencies occurs when a patient with more than one disease, each of which is a comorbid condition, has to be managed according to different treatment regimens. We propose an automatic procedure that constructs a mathematical guideline model using the Constraint Logic Programming (CLP) methodology, uses this model to identify and mitigate encountered points of contention, and revises the considered CPGs accordingly. The proposed procedure is used as an alerting mechanism and coupled with a guideline execution engine warns the physician about potential problems with the concurrent application of two or more guidelines. We illustrate the operation of our procedure in a clinical scenario describing simultaneous use of CPGs for duodenal ulcer and transient ischemic attack.

Workshop presentation: research guidelines for Construction Management

OpenAIRE

Marco Alvise Bragadin

2013-01-01

Nowadays the European economic system challenges the construction sector to take part to industrial recovery of western countries. In co-operation with the Construction Production research group of the Tampere University of of research about construction management tools and methods were detected. Research guidelines: 1) Construction management: tools and methods to manage construction projects 2) environmental impact of construction projects 3) construction management and safety 4) project p...

Comparing the use of SNOMED CT and ICD10 for coding clinical conditions to implement laboratory guidelines.

Science.gov (United States)

Yasini, Mobin; Ebrahiminia, Vahid; Duclos, Catherine; Venot, Alain; Lamy, Jean-Baptiste

2013-01-01

Laboratory medicine is responsible for an important part of hospital expenditure. Providing appropriate decision support to laboratory test requesters at the point of care is one of the main incentives for implementing laboratory guidelines, which can improve medical care. Laboratory guidelines developed by local experts in the Parisian region and two national guidelines for dyslipidemia were analyzed to extract test ordering recommendations. Clinical conditions which can be a trigger to order or not to order laboratory tests were extracted and mapped with ICD10 and SNOMED CT: 43.1% of clinical conditions were matched by ICD10 whereas SNOMED CT covered 80.1% of these conditions. For the non-mapped conditions, the main problem was found to be the ambiguity of the terms used in the guidelines. Ordinal characteristics of some clinical conditions and using terms more specific than SNOMED CT were other causes of mapping failure. Applying consistent and explicit concepts in the development of guidelines would lead to better implementation. By resolving the guideline ambiguity, SNOMED CT is a good choice and covers almost all of the clinical conditions in laboratory guidelines which are needed to implement in a Clinical Decision Support System.

A consensus-based guideline defining clinical target volume for primary disease in external beam radiotherapy for intact uterine cervical cancer

International Nuclear Information System (INIS)

Toita, Takafumi; Ohno, Tatsuya; Kaneyasu, Yuko

2011-01-01

The objective of this study was to develop a consensus-based guideline to define clinical target volume for primary disease (clinical target volume primary) in external beam radiotherapy for intact uterine cervical cancer. The working subgroup of the Japan Clinical Oncology Group (JCOG) Radiation Therapy Study Group began developing a guideline for primary clinical target volume in November 2009. The group consisted of 10 radiation oncologists and 2 gynecologic oncologists. The process started with comparing the contouring on computed tomographic images of actual cervical cancer cases among the members. This was followed by a comprehensive literature review that included primary research articles and textbooks as well as information on surgical procedures. Extensive discussion occurred in face-to-face meetings (three occasions) and frequent e-mail communications until a consensus was reached. The working subgroup reached a consensus on the definition for the clinical target volume primary. The clinical target volume primary consists of the gross tumor volume, uterine cervix, uterine corpus, parametrium, vagina and ovaries. Definitions for these component structures were determined. Anatomical boundaries in all directions were defined for the parametrium. Examples delineating these boundaries were prepared for the posterior border of the parametrium for various clinical situations (id est (i.e.) central tumor bulk, degree of parametrial involvement). A consensus-based guideline defining the clinical target volume primary was developed for external beam radiotherapy for intact uterine cervical cancer. This guideline will serve as a template for radiotherapy protocols in future clinical trials. It may also be used in actual clinical practice in the setting of highly precise external beam radiotherapy, including intensity-modulated radiotherapy. (author)

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

Science.gov (United States)

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

2015-01-01

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

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

Science.gov (United States)

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

2017-09-01

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

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

Science.gov (United States)

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.

Why consider patients' preferences? A discourse analysis of clinical practice guideline developers.

Science.gov (United States)

Boivin, Antoine; Green, Judith; van der Meulen, Jan; Légaré, France; Nolte, Ellen

2009-08-01

Several organizations are advocating for patients' preferences to be considered in clinical practice guideline development and implementation. However, lack of agreement on the goal and meaning of this policy curtails evaluation and development of patient involvement programs. To describe guideline developers' discourses on the goal of considering patients' preferences. Qualitative study using discourse analysis. 18 participants (patients, health professionals, and public health experts) from 2 groups of British guideline developers. Template analysis of semi-structured individual interviews was strengthened by active search for deviant cases, team debriefing, and member checking. All respondents supported the idea of taking account of patients' preferences in guidelines. Divergences with the goal and meaning of considering preferences were structured in 4 discourses: (1) The Governance discourse constructs guideline development as a rational process of synthesizing population data-including evidence on patients' preferences-to maximize public health within the constraints of available resources; (2) the Informed Decision discourse aims at fostering patients' choice by providing tailored information on the risks and benefits of interventions; (3) the Professional Care discourse insists on basing professionals' recommendations on the individual characteristics of patients; (4) The Consumer Advocacy discourse argues for greater political power and influence over guideline development and clinical decision making. The identified discourses provide a set of hypothesis on how patient involvement programs are expected to work, which could help clarify the goals pursued by guideline organizations and anchor further evaluation efforts.

A survey of Korean medicine doctors' clinical practice patterns for autism spectrum disorder: preliminary research for clinical practice guidelines.

Science.gov (United States)

Lee, Jihong; Lee, Sun Haeng; Lee, Boram; Yang, In Jun; Chang, Gyu Tae

2018-03-13

The aim of this study was to investigate autism spectrum disorder (ASD) clinical practice patterns of Korean medicine doctors (KMDs) through questionnaire survey. Questionnaires on Korean medicine (KM) treatment for ASD were distributed to 255 KMDs on December 5, 2016. The KMDs were psychiatrists, pediatricians, or general practitioners, who treated patients with ASD. The questionnaire covered items on treatment methods, aims of treatment, KM syndrome differentiation, diagnostic tools, and sociodemographic characteristics. Frequency analysis was conducted to describe the participants and their practices. A total 22.4% KMDs (n = 57/255) completed the questionnaires and 54 KMDs (21.2%) matched the inclusion criteria. The KMDs utilized herbal medicine (27.3%), body acupuncture (17.6%), scalp acupuncture (10.7%), moxibustion (6.4%), and Korean medical psychotherapy (5.9%) to treat ASD. The most commonly prescribed herbal medicine was Yukmijihwang-tang. Forty-eight (88.9%) KMDs responded that they used KM syndrome differentiation. 'Organ system, Qi, Blood, Yin, Yang, Fluid and Humor diagnosis' was most frequently used for syndrome differentiation. ASD was mainly diagnosed based on the fourth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) and DSM-5. The present study demonstrated the current status of KMDs' diagnosis and treatment of ASD. In future clinical trials and clinical practice guidelines, these findings will provide meaningful information on the actual practice patterns of KMDs.

Barriers to implementing the clinical guideline on borderline personality disorder in the Netherlands

NARCIS (Netherlands)

Hermens, M.L.M.; van Splunteren, P.T.; van den Bosch, A.; Verheul, R.

2011-01-01

Objective: This study determined the gap between actual care and optimal care (recommended in the clinical guideline) for patients with borderline personality disorder in the Netherlands. Factors that affected guideline implementation were identified. Methods: Ten specialized mental health

The development of evidence-based guidelines in dentistry.

Science.gov (United States)

Faggion, C M

2013-02-01

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

How Qualitative Research Informs Clinical and Policy Decision Making in Transplantation: A Review.

Science.gov (United States)

Tong, Allison; Morton, Rachael L; Webster, Angela C

2016-09-01

Patient-centered care is no longer just a buzzword. It is now widely touted as a cornerstone in delivering quality care across all fields of medicine. However, patient-centered strategies and interventions necessitate evidence about patients' decision-making processes, values, priorities, and needs. Qualitative research is particularly well suited to understanding the experience and perspective of patients, donors, clinicians, and policy makers on a wide range of transplantation-related topics including organ donation and allocation, adherence to prescribed therapy, pretransplant and posttransplant care, implementation of clinical guidelines, and doctor-patient communication. In transplantation, evidence derived from qualitative research has been integrated into strategies for shared decision-making, patient educational resources, process evaluations of trials, clinical guidelines, and policies. The aim of this article is to outline key concepts and methods used in qualitative research, guide the appraisal of qualitative studies, and assist clinicians to understand how qualitative research may inform their practice and policy.

Wiki-Based Clinical Practice Guidelines for the Management of Adult Onset Sarcoma: A New Paradigm in Sarcoma Evidence

Science.gov (United States)

Neuhaus, S. J.; Thomas, D.; Desai, J.; Vuletich, C.; von Dincklage, J.; Olver, I.

2015-01-01

In 2013 Australia introduced Wiki-based Clinical Practice Guidelines for the Management of Adult Onset Sarcoma. These guidelines utilized a customized MediaWiki software application for guideline development and are the first evidence-based guidelines for clinical management of sarcoma. This paper presents our experience with developing and implementing web-based interactive guidelines and reviews some of the challenges and lessons from adopting an evidence-based (rather than consensus-based) approach to clinical sarcoma guidelines. Digital guidelines can be easily updated with new evidence, continuously reviewed and widely disseminated. They provide an accessible method of enabling clinicians and consumers to access evidence-based clinical practice recommendations and, as evidenced by over 2000 views in the first four months after release, with 49% of those visits being from countries outside of Australia. The lessons learned have relevance to other rare cancers in addition to the international sarcoma community. PMID:25784832

A Comparative Analysis of Indigenous Research Guidelines to Inform Genomic Research in Indigenous Communities

Directory of Open Access Journals (Sweden)

Jay Maddock

2012-05-01

Full Text Available BACKGROUND: Genetic research has potential benefits for improving health, such as identifying molecular characteristics of a disease, understanding disease prevalence and treatment, and developing treatments tailored to patients based on individual genetic characteristics of their disease. Indigenous people are often targeted for genetic research because genes are easier to study in communities that practice endogamy. Therefore, populations perceived to be more homogenous, such as Indigenous peoples, are ideal for genetic studies. While Indigenous communities remain the focal point of many genomic studies, some result in harm and unethical practice. Unfortunately, the harms of poorly formulated and unethical research involving Indigenous people have created barriers to participation that prevent critical and lifesaving research. These harms have led a number of Indigenous communities to develop guidelines for engaging with researchers to assist in safely bridging the gap between genetic research and Indigenous peoples.SPECIFIC AIMS: The specific aims of this study were: (1 to conduct an international review and comparison of Indigenous research guidelines that highlight topics regarding genetics and use of biological samples and identify commonalities and differences among ethical principles of concern to Indigenous peoples; and (2 develop policy recommendations for Indigenous populations interested in creating formal policies around the use of genetic information and protection of biological samples using data from specific aim 1.METHODS: A comparative analysis was performed to identify best research practices and recommendations for Indigenous groups from four countries: Canada, New Zealand, Australia, and the United States. The analysis examined commonalities in political relationships, which support self-determination among these Indigenous communities to control their data. Current international Indigenous guidelines were analyzed to review

Advice for acute low back pain: a comparison of what research supports and what guidelines recommend.

Science.gov (United States)

Stevens, Matthew L; Lin, Chung-Wei C; de Carvalho, Flavia A; Phan, Kevin; Koes, Bart; Maher, Chris G

2017-10-01

Advice is widely considered an effective treatment for acute low back pain (LBP); however, details on what and how to deliver this intervention is less clear. We assessed and compared clinical trials that test advice for acute LBP with practice guidelines for their completeness of reporting and concordance on the content, method of delivery, and treatment regimen of advice interventions. Systematic review. Advice randomized controlled trials were identified through a systematic search. Guidelines were taken from recent overviews of guidelines for LBP. Completeness of reporting was assessed using the Template for Intervention Description and Replication checklist. Thematic analysis was used to characterize advice interventions into topics across the aspects of content, method of delivery, and regimen. Concordance between clinical trials and guidelines was assessed by comparing the number of trials that found a statistically significant treatment effect for an intervention that included a specific advice topic with the number of guidelines recommending that topic. The median (interquartile range) completeness of reporting for clinical trials and guidelines was 8 (7-9) and 3 (2-4) out of nine items on the Template for Intervention Description and Replication checklist, respectively. Guideline recommendations were discordant with clinical trials for 50% of the advice topics identified. Completeness of reporting was less than ideal for randomized controlled trials and extremely poor for guidelines. The recommendations made in guidelines of advice for acute LBP were often not concordant with the results of clinical trials. Taken together, these findings mean that the potential clinical value of advice interventions for patients with acute LBP is probably not being realized. Copyright © 2017 Elsevier Inc. All rights reserved.

The role of model checking in critiquing based on clinical guidelines

NARCIS (Netherlands)

Groot, Perry; Hommersom, Arjen; Lucas, Peter; Serban, Radu; Ten Teije, Annette; Van Harmelen, Frank

2007-01-01

Medical critiquing systems criticise clinical actions performed by a physician. In order to provide useful feedback, an important task is to find differences between the actual actions and a set of 'ideal' actions as described by a clinical guideline. In case differences exist, insight to which

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

Science.gov (United States)

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.

Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Science.gov (United States)

Sateia, Michael J.; Buysse, Daniel J.; Krystal, Andrew D.; Neubauer, David N.; Heald, Jonathan L.

2017-01-01

Introduction: The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations: The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of

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

Science.gov (United States)

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.

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

NARCIS (Netherlands)

Wees, P.J. van der; Zagers, C.A.; Die, S.E. de; Hendriks, E.J.; Nijhuis-Van der Sanden, M.W.G.; Bie, R.A. de

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

75 FR 8085 - National Institutes of Health Guidelines for Human Stem Cell Research

Science.gov (United States)

2010-02-23

... Health Guidelines for Human Stem Cell Research SUMMARY: The National Institutes of Health (NIH) is requesting public comment on a revision to the definition of human embryonic stem cells (hESCs) in the ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines). On July 7, 2009, NIH...

75 FR 13137 - National Institutes of Health Guidelines for Human Stem Cell Research

Science.gov (United States)

2010-03-18

... Health Guidelines for Human Stem Cell Research SUMMARY: The National Institutes of Health (NIH) is extending the public comment period on a revision to the definition of human embryonic stem cells (hESCs) in the ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines). Due to a...

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

Science.gov (United States)

Ita, Koichiro

2016-02-01

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

Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the management of schizophrenia and related disorders.

Science.gov (United States)

Galletly, Cherrie; Castle, David; Dark, Frances; Humberstone, Verity; Jablensky, Assen; Killackey, Eóin; Kulkarni, Jayashri; McGorry, Patrick; Nielssen, Olav; Tran, Nga

2016-05-01

This guideline provides recommendations for the clinical management of schizophrenia and related disorders for health professionals working in Australia and New Zealand. It aims to encourage all clinicians to adopt best practice principles. The recommendations represent the consensus of a group of Australian and New Zealand experts in the management of schizophrenia and related disorders. This guideline includes the management of ultra-high risk syndromes, first-episode psychoses and prolonged psychoses, including psychoses associated with substance use. It takes a holistic approach, addressing all aspects of the care of people with schizophrenia and related disorders, not only correct diagnosis and symptom relief but also optimal recovery of social function. The writing group planned the scope and individual members drafted sections according to their area of interest and expertise, with reference to existing systematic reviews and informal literature reviews undertaken for this guideline. In addition, experts in specific areas contributed to the relevant sections. All members of the writing group reviewed the entire document. The writing group also considered relevant international clinical practice guidelines. Evidence-based recommendations were formulated when the writing group judged that there was sufficient evidence on a topic. Where evidence was weak or lacking, consensus-based recommendations were formulated. Consensus-based recommendations are based on the consensus of a group of experts in the field and are informed by their agreement as a group, according to their collective clinical and research knowledge and experience. Key considerations were selected and reviewed by the writing group. To encourage wide community participation, the Royal Australian and New Zealand College of Psychiatrists invited review by its committees and members, an expert advisory committee and key stakeholders including professional bodies and special interest groups. The

Spanish Clinical Guidelines on Vascular Access for Haemodialysis.

Science.gov (United States)

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

2017-11-01

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

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

Science.gov (United States)

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

2018-05-16

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

Service Blueprint for Improving Clinical Guideline Adherence via Mobile Health Technology

OpenAIRE

Y. O'Connor; C. Heavin; S. O' Connor; J. Gallagher; J. Wu; J. O'Donoghue

2015-01-01

Background: To improve the delivery of paediatric healthcare in low resource settings, Community Health Workers (CHW) have been provided with a paper-based set of protocols known as Community Case Management (CCM). Yet research has shown that CHW adherence to CCM guidelines is poor, ultimately impacting health service delivery. Digitising the CCM guidelines via mobile technology is argued in extant literature to improve CHW adherence. However, little research exist which ...

The International Rare Diseases Research Consortium: Policies and Guidelines to maximize impact.

Science.gov (United States)

Lochmüller, Hanns; Torrent I Farnell, Josep; Le Cam, Yann; Jonker, Anneliene H; Lau, Lilian Pl; Baynam, Gareth; Kaufmann, Petra; Dawkins, Hugh Js; Lasko, Paul; Austin, Christopher P; Boycott, Kym M

2017-12-01

The International Rare Diseases Research Consortium (IRDiRC) has agreed on IRDiRC Policies and Guidelines, following extensive deliberations and discussions in 2012 and 2013, as a first step towards improving coordination of research efforts worldwide. The 25 funding members and 3 patient umbrella organizations (as of early 2013) of IRDiRC, a consortium of research funders that focuses on improving diagnosis and therapy for rare disease patients, agreed in Dublin, Ireland in April 2013 on the Policies and Guidelines that emphasize collaboration in rare disease research, the involvement of patients and their representatives in all relevant aspects of research, as well as the sharing of data and resources. The Policies and Guidelines provide guidance on ontologies, diagnostics, biomarkers, patient registries, biobanks, natural history, therapeutics, models, publication, intellectual property, and communication. Most IRDiRC members-currently nearly 50 strong-have since incorporated its policies in their funding calls and some have chosen to exceed the requirements laid out, for instance in relation to data sharing. The IRDiRC Policies and Guidelines are the first, detailed agreement of major public and private funding organizations worldwide to govern rare disease research, and may serve as a template for other areas of international research collaboration. While it is too early to assess their full impact on research productivity and patient benefit, the IRDiRC Policies and Guidelines have already contributed significantly to improving transparency and collaboration in rare disease research.

Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline

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Berglund, Lars; Brunzell, John D.; Goldberg, Anne C.; Goldberg, Ira J.; Sacks, Frank; Murad, Mohammad Hassan; Stalenhoef, Anton F. H.

2012-01-01

Objective: The aim was to develop clinical practice guidelines on hypertriglyceridemia. Participants: The Task Force included a chair selected by The Endocrine Society Clinical Guidelines Subcommittee (CGS), five additional experts in the field, and a methodologist. The authors received no corporate funding or remuneration. Consensus Process: Consensus was guided by systematic reviews of evidence, e-mail discussion, conference calls, and one in-person meeting. The guidelines were reviewed and approved sequentially by The Endocrine Society's CGS and Clinical Affairs Core Committee, members responding to a web posting, and The Endocrine Society Council. At each stage, the Task Force incorporated changes in response to written comments. Conclusions: The Task Force recommends that the diagnosis of hypertriglyceridemia be based on fasting levels, that mild and moderate hypertriglyceridemia (triglycerides of 150–999 mg/dl) be diagnosed to aid in the evaluation of cardiovascular risk, and that severe and very severe hypertriglyceridemia (triglycerides of > 1000 mg/dl) be considered a risk for pancreatitis. The Task Force also recommends that patients with hypertriglyceridemia be evaluated for secondary causes of hyperlipidemia and that subjects with primary hypertriglyceridemia be evaluated for family history of dyslipidemia and cardiovascular disease. The Task Force recommends that the treatment goal in patients with moderate hypertriglyceridemia be a non-high-density lipoprotein cholesterol level in agreement with National Cholesterol Education Program Adult Treatment Panel guidelines. The initial treatment should be lifestyle therapy; a combination of diet modification and drug therapy may also be considered. In patients with severe or very severe hypertriglyceridemia, a fibrate should be used as a first-line agent. PMID:22962670

Workshop presentation: research guidelines for Construction Management

Directory of Open Access Journals (Sweden)

Marco Alvise Bragadin

2013-10-01

Full Text Available Nowadays the European economic system challenges the construction sector to take part to industrial recovery of western countries. In co-operation with the Construction Production research group of the Tampere University of of research about construction management tools and methods were detected. Research guidelines: 1 Construction management: tools and methods to manage construction projects 2 environmental impact of construction projects 3 construction management and safety 4 project procurement 5 construction management for major public works & complex projects

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

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

2008-09-12

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

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

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de Veer Anke JE

2008-09-01

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

Chronic pancreatitis: from guidelines to clinical practice

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Generoso Uomo

2012-10-01

Full Text Available Introduction The paucity of specific standardized criteria leads to uncertainties in clinical practice regarding the management of chronic pancreatitis (CP.Objectives This paper reports some of the systematic guidelines for the diagnosis and treatment of CP recently elaborated by an Italian multicenter study group. We review recommendations on clinical and nutritional aspects of the disease, assessment of pancreatic function, treatment of exocrine pancreatic failure and secondary diabetes, treatment of pain, and prevention of painful relapses. The review also looks at the role of endoscopy in the management of pancreatic pain, pancreatic stones, duct narrowing and dilation, and complications; the appropriate use of various imaging techniques, including endoscopic ultrasound; and the indications for and techniques used in surgical management of CP.

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

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

2017-11-01

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

Research Contributions towards Guidelines for Land Administration

DEFF Research Database (Denmark)

Stubkjær, Erik

. Recently, the issue of the core of the cadastral system was addressed. The presentation will summarise the research outcome, and relate it to development needs in European land administration, as illustrated by the Land Administration Guidelines. Comments on long-term capacity building and on terminology...

Conceptual Models and Guidelines for Clinical Assessment of Financial Capacity.

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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.

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

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Roque, Matheus; Esteves, Sandro C

2016-01-01

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

Appreciative inquiry enhances cardiology nurses’ clinical decision making when using a clinical guideline on delirium

DEFF Research Database (Denmark)

Vedsegaard, Helle; Schrader, Anne-Marie; Rom, Gitte

2016-01-01

The current study responds to implementation challenges with translating evidence-based knowledge into practice. We explore how appreciative inquiry can be used in in-house learning sessions for nurses to enhance their knowledge in using a guideline on delirium as part of clinical decision making...... and axial coding drawing on the principles of grounded theory. The study shows that appreciative inquiry was meaningful to cardiology nurses in providing them with knowledge of using a guideline on delirium in clinical decision making, the main reasons being a) data on a current patient were included, b....... Through 18 sessions with 3–12 nurses, an appreciative inquiry approach was used. Specialist nurses from the Heart Centre of Copenhagen and senior lecturers from the Department of Nursing at Metropolitan University College facilitated the sessions. Field notes from the sessions were analysed using open...

Methodological quality of guidelines in gastroenterology.

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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.

Characteristics of Spanish articles of "scientific quality" cited in clinical practice guidelines on mental health.

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Permanyer-Miralda, Gaietà; Adam, Paula; Guillamón, Imma; Solans-Domènech, Maite; Pons, Joan M V

2013-01-01

The study aims to illustrate the impact of Spanish research in clinical decision making. To this end, we analysed the characteristics of the most significant Spanish publications cited in clinical practice guidelines (CPG) on mental health. We conducted a descriptive qualitative study on the characteristics of ten articles cited in Spanish CPG on mental health, and selected for their "scientific quality". We analysed the content of the articles on the basis of the following characteristics: topics, study design, research centres, scientific and practical relevance, type of funding, and area or influence of the reference to the content of the guidelines. Among the noteworthy studies, some basic science studies, which have examined the establishment of genetic associations in the pathogenesis of mental illness are included, and others on the effectiveness of educational interventions. The content of those latter had more influence on the GPC, because they were cited in the summary of the scientific evidence or in the recommendations. Some of the outstanding features in the selected articles are the sophisticated designs (experimental or analytical), and the number of study centres, especially in international collaborations. Debate or refutation of previous findings on controversial issues may have also contributed to the extensive citation of work. The inclusion of studies in the CPG is not a sufficient condition of "quality", but their description can be instructive for the design of future research or publications. Copyright © 2012 SEP y SEPB. Published by Elsevier Espana. All rights reserved.

A methodology for evaluation of a markup-based specification of clinical guidelines.

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Shalom, Erez; Shahar, Yuval; Taieb-Maimon, Meirav; Lunenfeld, Eitan

2008-11-06

We introduce a three-phase, nine-step methodology for specification of clinical guidelines (GLs) by expert physicians, clinical editors, and knowledge engineers, and for quantitative evaluation of the specification's quality. We applied this methodology to a particular framework for incremental GL structuring (mark-up) and to GLs in three clinical domains with encouraging results.

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

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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.

Classification and Clinical Diagnosis of Fibromyalgia Syndrome: Recommendations of Recent Evidence-Based Interdisciplinary Guidelines

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Mary-Ann Fitzcharles

2013-01-01

Full Text Available Objectives. Fibromyalgia syndrome (FMS, characterized by subjective complaints without physical or biomarker abnormality, courts controversy. Recommendations in recent guidelines addressing classification and diagnosis were examined for consistencies or differences. Methods. Systematic searches from January 2008 to February 2013 of the US-American National Guideline Clearing House, the Scottish Intercollegiate Guidelines Network, Guidelines International Network, and Medline for evidence-based guidelines for the management of FMS were conducted. Results. Three evidence-based interdisciplinary guidelines, independently developed in Canada, Germany, and Israel, recommended that FMS can be clinically diagnosed by a typical cluster of symptoms following a defined evaluation including history, physical examination, and selected laboratory tests, to exclude another somatic disease. Specialist referral is only recommended when some other physical or mental illness is reasonably suspected. The diagnosis can be based on the (modified preliminary American College of Rheumatology (ACR 2010 diagnostic criteria. Discussion. Guidelines from three continents showed remarkable consistency regarding the clinical concept of FMS, acknowledging that FMS is neither a distinct rheumatic nor mental disorder, but rather a cluster of symptoms, not explained by another somatic disease. While FMS remains an integral part of rheumatology, it is not an exclusive rheumatic condition and spans a broad range of medical disciplines.

Adherence to EBM guidelines in clinical practice.

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Khafizianova, R Kh; Burykin, I M

2015-01-01

Adequate and rational pharmacotherapy is an important element of rehabilitation of patients with myocardial infarction. Orders of the Ministry of Health of the Russian Federation, domestic and international guidelines, and scientific publications - all contain a complete algorithm for rational pharmacotherapy [1, 2]. These documents are based on the principles of evidence-based medicine (EBM) and help practicing physicians to carry out individualized and rational pharmacotherapy. However, clinical studies have shown low adherence of physicians to clinical guidelines. In the Russian Federation the death rate from cardiovascular diseases is higher than in developed countries. Thus, studies of the causes of high cardiovascular mortality are needed. To assess adherence of practicing physicians to principles of evidence-based medicine in treating patients after myocardial infarction at the stage of rehabilitation. A retrospective analysis of 157 cases of patients in rehabilitation after myocardial infarction for the years 2006 and 2009 was undertaken.We analyzed the list of drugs, prescribed to patients during the period of rehabilitation, drug combinations, regimens and pharmacoepidemiological parameters. We used the following rehabilitation criteria: blood pressure control, smoking cessation, and weight control. Recommendations of controlled physical activities have also been studied. Patient care was compared with the guideline recommendations. Statistical analysis was performed using the OLAP system. 65 patients with myocardial infarction received rehabilitation therapy in 2006, and 92 - in 2009. It was found, that in 2006 physicians prescribed an average of 4.5 drugs per patient, and in 2009 - 4.6 drugs per patient. The average number of cardiovascular drugs (category C of ATC classification) per patient was 2.9 in 2006, and 2.6 - in 2009. Polypharmacy was found in half of the patients.In terms of evidence-based medicine, an important element in the rehabilitation

Menstrual questionnaires for clinical and research use.

Science.gov (United States)

Matteson, Kristen A

2017-04-01

Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB. Copyright © 2016. Published by Elsevier Ltd.

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

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

2015-12-29

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

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

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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.

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

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

2014-07-15

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

Korean clinical practice guidelines for preventing the transmission of infections in hemodialysis facilities

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Hayne Cho Park

2018-03-01

Full Text Available Patients receiving hemodialysis are vulnerable to infectious diseases due to their impaired immunity and high risk of exposure to pathogens. To protect patients, staff, and visitors from potential infections, each hemodialysis unit should establish and follow standard infection control and prevention measures. Therefore, clinical practice guidelines were developed by a working group of nephrologists and infection control specialists to provide evidence-based guidance for dialysis physicians and nurses, with the aim of preventing infection transmission and controlling infection sources in hemodialysis facilities. The areas of infection control covered by these guidelines include standard precautions, isolation strategies, vascular access, water treatment, cleaning/disinfecting/sterilizing, and vaccination. This special report summarizes the key recommendations from the Korean clinical practice guidelines for preventing the transmission of infections in hemodialysis facilities.

Functional Hypothalamic Amenorrhea: An Endocrine Society Clinical Practice Guideline.

Science.gov (United States)

Gordon, Catherine M; Ackerman, Kathryn E; Berga, Sarah L; Kaplan, Jay R; Mastorakos, George; Misra, Madhusmita; Murad, M Hassan; Santoro, Nanette F; Warren, Michelle P

2017-05-01

The American Society for Reproductive Medicine, the European Society of Endocrinology, and the Pediatric Endocrine Society. This guideline was funded by the Endocrine Society. To formulate clinical practice guidelines for the diagnosis and treatment of functional hypothalamic amenorrhea (FHA). The participants include an Endocrine Society-appointed task force of eight experts, a methodologist, and a medical writer. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Endocrine Society committees and members and cosponsoring organizations reviewed and commented on preliminary drafts of this guideline. FHA is a form of chronic anovulation, not due to identifiable organic causes, but often associated with stress, weight loss, excessive exercise, or a combination thereof. Investigations should include assessment of systemic and endocrinologic etiologies, as FHA is a diagnosis of exclusion. A multidisciplinary treatment approach is necessary, including medical, dietary, and mental health support. Medical complications include, among others, bone loss and infertility, and appropriate therapies are under debate and investigation. Copyright © 2017 Endocrine Society

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

Science.gov (United States)

Noda, Emi; Mifune, Taka; Nakayama, Takeo

2013-01-01

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

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

Science.gov (United States)

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.

The Gap in Knowledge of Clinical Practice Guidelines by Mental Health Residents in Buenos Aires (Argentina

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Javier Fabrissin

2014-05-01

Full Text Available The aim of this pilot study was to evaluate if the residents of psychiatry and clinical psychology from the city of Buenos Aires knew any of the existing mental health Clinical Practice and Treatment Guidelines (CPTGs. We asked residents their opinion about CPTGs and, also, if they followed their recommendations in clinical practice. We asked 59 mental health residents (28 physicians and 29 psychologists with different years of clinical training to fill a questionnaire to know their opinion about CPTGs and also if they follow the CPTG recommendations in their clinical practice. We found that 79.31% of residents did not know any CPTG. Eighty percent of the residents who did know any CPTG have a positive opinion about CPTGs. Finally, the American Psychiatric Association Guidelines were the most known CPTGs. The authors emphasize the need for a clinical guidelines diffusion policy in Buenos Aires city and particularly as a clinical and training resource for mental health residents.

Guidelines for preclinical animal research in ALS/MND: A consensus meeting.

Science.gov (United States)

Ludolph, Albert C; Bendotti, Caterina; Blaugrund, Eran; Chio, Adriano; Greensmith, Linda; Loeffler, Jean-Philippe; Mead, Richard; Niessen, Heiko G; Petri, Susanne; Pradat, Pierre-Francois; Robberecht, Wim; Ruegg, Markus; Schwalenstöcker, Birgit; Stiller, Detlev; van den Berg, Leonard; Vieira, Fernando; von Horsten, Stephan

2010-01-01

The development of therapeutics for ALS/MND is largely based on work in experimental animals carrying human SOD mutations. However, translation of apparent therapeutic successes from in vivo to the human disease has proven difficult and a considerable amount of financial resources has been apparently wasted. Standard operating procedures (SOPs) for preclinical animal research in ALS/MND are urgently required. Such SOPs will help to establish SOPs for translational research for other neurological diseases within the next few years. To identify the challenges and to improve the research methodology, the European ALS/MND group held a meeting in 2006 and published guidelines in 2007 (1). A second international conference to improve the guidelines was held in 2009. These second and improved guidelines are dedicated to the memory of Sean F. Scott.

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

Science.gov (United States)

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.

Clinical guidelines «Rational use of nonsteroidal anti-inflammatory drugs (NSAIDs in clinical practice»

Directory of Open Access Journals (Sweden)

A. E. Karateev

2015-01-01

Full Text Available The paper presents the new version of the clinical guidelines «Rational use of nonsteroidal anti-inflammatory drugs (NSAIDs in clinical practice » prepared by the Association of Rheumatologists of Russia, the Russian Pain Society, the Russian Gastroenterological Association, the Russian Society of Cardiology, the Association of Traumatologists and Orthopedists of Russia, the Association of Interdisciplinary Medicine, and the Russian Association of Palliative Medicine.In our country, NSAIDs are the most important and most popular class of analgesics. Unlike global practice, Russian physicians rather rarely recommend paracetamol as a first-line drug to relieve moderate or severe pain, by giving preference to NSAIDs; the use of opioid analgesics for noncancers is minimized because of tight legal restrictions.NSAIDs are effective and easy-to-use; however, they are far from safe; the administration of these medications may lead to serious gastrointestinal, cardiovascular, renal, and other complications in a number of cases. So the use of NSAIDs should be compulsorily monitored for adverse reactions and the choice of a specific drug for each clinical case should be based on the objective estimation of a ratio of its efficacy to safety.In recent years, there have been fresh data on the use of NSAIDs for different diseases and a few novel representatives of this drug group have appeared on the Russian pharmacological market.This all has necessitated a new version of the guidelines on the rational use of NSAIDs. These are based on the provisions that have high validity and have been confirmed by the results of well-organized clinical and large-scale population-based studies, as well as by their meta-analysis.The guidelines are intended for physicians of all specialties. 

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

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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 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.

IOM and DHHS meeting on making clinical practice guidelines appropriate for patients with multiple chronic conditions.

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Goodman, Richard A; Boyd, Cynthia; Tinetti, Mary E; Von Kohorn, Isabelle; Parekh, Anand K; McGinnis, J Michael

2014-01-01

The increasing prevalence of Americans with multiple (2 or more) chronic conditions raises concerns about the appropriateness and applicability of clinical practice guidelines for patient management. Most guidelines clinicians currently rely on have been designed with a single chronic condition in mind, and many such guidelines are inattentive to issues related to comorbidities. In response to the need for guideline developers to address comorbidities in guidelines, the Department of Health and Human Services convened a meeting in May 2012 in partnership with the Institute of Medicine to identify principles and action options. Eleven principles to improve guidelines' attentiveness to the population with multiple chronic conditions were identified during the meeting. They are grouped into 3 interrelated categories: (1) principles intended to improve the stakeholder technical process for developing guidelines; (2) principles intended to strengthen content of guidelines in terms of multiple chronic conditions; and (3) principles intended to increase focus on patient-centered care. This meeting built upon previously recommended actions by identifying additional principles and options for government, guideline developers, and others to use in strengthening the applicability of clinical practice guidelines to the growing population of people with multiple chronic conditions. The suggested principles are helping professional societies to improve guidelines' attentiveness to persons with multiple chronic conditions.

The updating of clinical practice guidelines: insights from an international survey

Directory of Open Access Journals (Sweden)

Solà Ivan

2011-09-01

Full Text Available Abstract 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

Index-TB Guidelines: Guidelines on extrapulmonary tuberculosis for India

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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

Assembly and evaluation of an inventory of guidelines that are available to support clinical hematology laboratory practice.

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Hayward, C P M; Moffat, K A; George, T I; Proytcheva, M

2015-05-01

Practice guidelines provide helpful support for clinical laboratories. Our goal was to assemble an inventory of publically listed guidelines on hematology laboratory topics, to create a resource for laboratories and for assessing gaps in practice-focused guidelines. PubMed and website searches were conducted to assemble an inventory of hematology laboratory-focused guidelines. Exclusions included annual, technical, or collaborative study reports, clinically focused guidelines, position papers, nomenclature, and calibration documents. Sixty-eight guidelines were identified on hematology laboratory practice topics from 12 organizations, some as joint guidelines. The median year of publication was 2010 and 15% were >10 years old. Coagulation topics had the largest numbers of guidelines, whereas some areas of practice had few guidelines. A minority of guidelines showed evidence of periodic updates, as some organizations did not remove or identify outdated guidelines. This inventory of current practice guidelines will encourage awareness and uptake of guideline recommendations by the worldwide hematology laboratory community, with the International Society for Laboratory Hematology facilitating ongoing updates. There is a need to encourage best guideline development practices, to ensure that hematology laboratory community has current, high-quality, and evidence-based practice guidelines that cover the full scope of hematology laboratory practice. © 2015 John Wiley & Sons Ltd.

What's in a setting?: Influence of organizational culture on provider adherence to clinical guidelines for treating tobacco use.

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Hung, Dorothy Y; Leidig, Robynn; Shelley, Donna R

2014-01-01

Organizational culture is an important but underinvestigated feature of the work environment that can impact provider behavior, including adherence to clinical practice guidelines. There is substantial evidence that physician assistance to smokers can produce significant reductions in tobacco use. However, this evidence has not been well translated into practice, as only a small proportion of smokers receive recommended treatment during medical visits. This study examines organizational culture as a contextual feature of primary care clinics and its impact on adherence to evidence-based guidelines for treating tobacco use. Cross-sectional survey data were collected from 500 primary care providers in 60 community clinics located in New York City. Relationships between provider adherence to "5A" clinical guidelines, as recommended by the U.S. Public Health Service, and both provider and organizational covariates were described. We used hierarchical linear modeling to examine the associations between clinic culture and provider treatment patterns. Providers in clinics with stronger "group/clan," "hierarchical," and "rational" culture types, as compared with a "developmental" culture, reported greater adherence to 5A guidelines (p organizational culture can influence provider adherence to cessation treatment guidelines, even when controlling for other factors known to affect practice patterns. Specifically, cultures that emphasize human resources and performance standards are conducive to integrating 5A guidelines into routine practice. Understanding the role of organizational culture enables healthcare managers and practitioners to be strategic when implementing, and also sustaining, use of evidence-based guidelines.

Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network

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Schulz Kenneth F

2010-04-01

Full Text Available Abstract Although current electronic methods of scientific publishing offer increased opportunities for publishing all research studies and describing them in sufficient detail, health research literature still suffers from many shortcomings. These shortcomings seriously undermine the value and utility of the literature and waste scarce resources invested in the research. In recent years there have been several positive steps aimed at improving this situation, such as a strengthening of journals' policies on research publication and the wide requirement to register clinical trials. The EQUATOR (Enhancing the QUAlity and Transparency Of health Research Network is an international initiative set up to advance high quality reporting of health research studies; it promotes good reporting practices including the wider implementation of reporting guidelines. EQUATOR provides free online resources http://www.equator-network.org supported by education and training activities and assists in the development of robust reporting guidelines. This paper outlines EQUATOR's goals and activities and offers suggestions for organizations and individuals involved in health research on how to strengthen research reporting.

The AGREE Enterprise: a decade of advancing clinical practice guidelines.

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Makarski, Julie; Brouwers, Melissa C

2014-08-15

The original AGREE (Appraisal of Guidelines for REsearch and Evaluation) Instrument was published in 2003, and its revision, the AGREE II, in 2009. Together, they filled an important gap in the guideline and quality of care fields. Ten years later, the AGREE Enterprise reflects on a trajectory of projects and international collaboration that have contributed to advancing the science and quality of practice guidelines and the uptake of AGREE/AGREE II. The AGREE Enterprise has undertaken activities to improve the tool and to develop resources to support its use. Since 2003, the uptake and adoption of AGREE by the international community has been swift and broad. A total of 33 language translations of the original AGREE Instrument and the current AGREE II are available and were initiated by the international community. A recent scan of the published literature identified over 600 articles that referenced the AGREE tools. The AGREE tools have been widely received and applied, with several organizations having incorporated the AGREE as part of their formal practice guideline programs. Since its redevelopment in 2010, the AGREE Enterprise website (www.agreetrust.org) continues to experience steady increases in visitors per month and currently has over 10,000 registered users. The AGREE Enterprise has contributed to the advancements of guidelines through research activities and international participation by scientific and user communities. As we enter a new decade, we look forward to ongoing collaborations and contributing to further advancements to improve quality of care and health care systems.

Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40

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Boone, Margaret; Brown, Nancy J.; Moon, Mary A.; Schuman, Deborah J.; Thomas, Josephine; Wright, Denise L.

2004-01-01

This Treatment Improvement Protocol (TIP) addresses the clinical use of buprenorphine in the treatment of opioid addiction. TIPs are best-practice guidelines for the treatment of substance use disorders that make the latest research in substance abuse treatment available to counselors and educators. The content was generated by a panel of experts…

From Paper Based Clinical Practice Guidelines to Declarative Workflow Management

DEFF Research Database (Denmark)

Lyng, Karen Marie; Hildebrandt, Thomas; Mukkamala, Raghava Rao

2009-01-01

We present a field study of oncology workflow, involving doctors, nurses and pharmacists at Danish hospitals and discuss the obstacles, enablers and challenges for the use of computer based clinical practice guidelines. Related to the CIGDec approach of Pesic and van der Aalst we then describe how...

The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines

DEFF Research Database (Denmark)

Juul, Anne Benedicte; Gluud, Christian; Wetterslev, Jørn

2005-01-01

To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.......To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation....

The challenge of developing ethical guidelines for a research infrastructure

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Kutsch, Werner Leo

2016-04-01

The mission of the Integrated Carbon Observation System (ICOS RI) is to enable research to understand the greenhouse gas (GHG) budgets and perturbations. The ICOS RI provides the long-term observations required to understand the present state and predict future behaviour of the global carbon cycle and GHG emissions. Technological developments and implementations, related to GHGs, will be promoted by the linking of research, education and innovation. In order to provide this data ICOS RI is a distributed research infrastructure. The backbones of ICOS RI are the national measurement stations such as ICOS atmosphere, ecosystem and ocean stations. ICOS Central Facilities are the European level ICOS RI Centres, which have the specific tasks in collecting and processing the data and samples received from the national measurement networks. During the establishment of ICOS RI ethical guidelines were developed. These guidelines describe principles of ethics in the research activities that should be applied within ICOS RI. They should be acknowledged and followed by all researchers affiliated to ICOS RI and should be supported by all participating institutions. The presentation describes (1) the general challenge to develop ethical guidelines in a complex international infrastructure and (2) gives an overview about the content that includes different kinds of conflicts of interests, data ethics and social responsibility.

Research Needed on the Use of CAS Standards and Guidelines.

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Creamer, Don G.

2003-01-01

This article suggests research projects that would extend the knowledge base about the use of Council for the Advancement of Standards in Higher Education (CAS) standards and guidelines in useful ways. Included are five research questions and specific research methodologies to guide researchers. (Contains 20 references.) (Author)

Integrating guideline development and implementation: analysis of guideline development manual instructions for generating implementation advice

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Gagliardi Anna R

2012-07-01

Full Text Available Abstract Background Guidelines are important tools that inform healthcare delivery based on best available research evidence. Guideline use is in part based on quality of the guidelines, which includes advice for implementation and has been shown to vary. Others hypothesized this is due to limited instructions in guideline development manuals. The purpose of this study was to examine manual instructions for implementation advice. Methods We used a directed and summative content analysis approach based on an established framework of guideline implementability. Six manuals identified by another research group were examined to enumerate implementability domains and elements. Results Manuals were similar in content but lacked sufficient detail in particular domains. Most frequently this was Accomodation, which includes information that would help guideline users anticipate and/or overcome organizational and system level barriers. In more than one manual, information was also lacking for Communicability, information that would educate patients or facilitate their involvement in shared decision making, and Applicability, or clinical parameters to help clinicians tailor recommendations for individual patients. Discussion Most manuals that direct guideline development lack complete information about incorporating implementation advice. These findings can be used by those who developed the manuals to consider expanding their content in these domains. It can also be used by guideline developers as they plan the content and implementation of their guidelines so that the two are integrated. New approaches for guideline development and implementation may need to be developed. Use of guidelines might be improved if they included implementation advice, but this must be evaluated through ongoing research.

Diagnostic evaluation and management of chronic thromboembolic pulmonary hypertension: A clinical practice guideline

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Mehta, Sanjay; Helmersen, Doug; Provencher, Steeve; Hirani, Naushad; Rubens, Fraser D; De Perrot, Marc; Blostein, Mark; Boutet, Kim; Chandy, George; Dennie, Carole; Granton, John; Hernandez, Paul; Hirsch, Andrew M; Laframboise, Karen; Levy, Robert D; Lien, Dale; Martel, Simon; Shoemaker, Gerard; Swiston, John; Weinkauf, Justin

2010-01-01

BACKGROUND Pulmonary embolism is a common condition. Some patients subsequently develop chronic thromboembolic pulmonary hypertension (CTEPH). Many care gaps exist in the diagnosis and management of CTEPH patients including lack of awareness, incomplete diagnostic assessment, and inconsistent use of surgical and medical therapies. METHODS A representative interdisciplinary panel of medical experts undertook a formal clinical practice guideline development process. A total of 20 key clinical issues were defined according to the patient population, intervention, comparator, outcome (PICO) approach. The panel performed an evidence-based, systematic, literature review, assessed and graded the relevant evidence, and made 26 recommendations. RESULTS Asymptomatic patients postpulmonary embolism should not be screened for CTEPH. In patients with pulmonary hypertension, the possibility of CTEPH should be routinely evaluated with initial ventilation/ perfusion lung scanning, not computed tomography angiography. Pulmonary endarterectomy surgery is the treatment of choice in patients with surgically accessible CTEPH, and may also be effective in CTEPH patients with disease in more ‘distal’ pulmonary arteries. The anatomical extent of CTEPH for surgical pulmonary endarterectomy is best assessed by contrast pulmonary angiography, although positive computed tomography angiography may be acceptable. Novel medications indicated for the treatment of pulmonary hypertension may be effective for selected CTEPH patients. CONCLUSIONS The present guideline requires formal dissemination to relevant target user groups, the development of tools for implementation into routine clinical practice and formal evaluation of the impact of the guideline on the quality of care of CTEPH patients. Moreover, the guideline will be updated periodically to reflect new evidence or clinical approaches. PMID:21165353

Clinical reasoning in the real world is mediated by bounded rationality: implications for diagnostic clinical practice guidelines.

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Bonilauri Ferreira, Ana Paula Ribeiro; Ferreira, Rodrigo Fernando; Rajgor, Dimple; Shah, Jatin; Menezes, Andrea; Pietrobon, Ricardo

2010-04-20

Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. FOUR MAIN THEMES WERE IDENTIFIED: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration.

Effects of clinical breakpoint changes in CLSI guidelines 2010/2011 and EUCAST guidelines 2011 on antibiotic susceptibility test reporting of Gram-negative bacilli.

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Hombach, Michael; Bloemberg, Guido V; Böttger, Erik C

2012-03-01

The aim of this study was to analyse the effects of clinical breakpoint changes in CLSI 2010 and 2011 guidelines and EUCAST 2011 guidelines on antibiotic susceptibility testing (AST) reports. In total, 3713 non-duplicate clinical isolates of Enterobacteriaceae, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Acinetobacter baumannii were analysed. Inhibition zone diameters were determined for β-lactams, carbapenems, fluoroquinolones, aminoglycosides and trimethoprim/sulfamethoxazole. CLSI 2009-11 and EUCAST 2011 clinical breakpoints were applied. Changes in resistance as defined per the guidelines affected individual species and drug classes differently. The cefepime resistance rate in Escherichia coli and Enterobacter cloacae increased from 2.1% and 1.3% to 8.2% and 6.9%, respectively, applying CLSI 2009-11 versus EUCAST 2011 guidelines. Ertapenem resistance rates in E. cloacae increased from 2.6% with CLSI 2009 to 7.2% for CLSI 2010 and 2011, and to 10.1% when applying EUCAST 2011. Cefepime and meropenem resistance rates in P. aeruginosa increased from 12.2% and 20.6% to 19.8% and 27.7%, respectively, comparing CLSI 2009-11 with EUCAST 2011. Tobramycin and gentamicin resistance rates in A. baumannii increased from 15.9% and 25.4% to 34.9% and 44.4% applying CLSI 2009-11 versus EUCAST 2011. Higher resistance rates reported due to breakpoint changes in CLSI and EUCAST guidelines will result in increasing numbers of Gram-negative bacilli reported as multidrug resistant. AST reports classifying amoxicillin/clavulanic acid, cefepime or carbapenem resistance will lead clinicians to use alternative agents. Upon implementation of the EUCAST guidelines, laboratories should be aware of the implications of modified drug susceptibility testing reports on antibiotic prescription policies.

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

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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.

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.

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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.

Understanding implementation processes of clinical pathways and clinical practice guidelines in pediatric contexts: a study protocol

Directory of Open Access Journals (Sweden)

Scott Shannon D

2011-12-01

Full Text Available Abstract Background Canada is among the most prosperous nations in the world, yet the health and wellness outcomes of Canadian children are surprisingly poor. There is some evidence to suggest that these poor health outcomes are partly due to clinical practice variation, which can stem from failure to apply the best available research evidence in clinical practice, otherwise known as knowledge translation (KT. Surprisingly, clinical practice variation, even for common acute paediatric conditions, is pervasive. Clinical practice variation results in unnecessary medical treatments, increased suffering, and increased healthcare costs. This study focuses on improving health outcomes for common paediatric acute health concerns by evaluating strategies that improve KT and reduce clinical practice variation. Design/Methods Using a multiple case study design, qualitative and quantitative data will be collected from four emergency departments in western Canada. Data sources will include: pre- and post-implementation focus group data from multidisciplinary healthcare professionals; individual interviews with the local champions, KT intervention providers, and unit/site leaders/managers; Alberta Context Tool (ACT survey data; and aggregated patient outcome data. Qualitative and quantitative data will be systematically triangulated, and matrices will be built to do cross-case comparison. Explanations will be built about the success or lack of success of the clinical practice guidelines (CPG and clinical pathways (CPs uptake based upon the cross-case comparisons. Significance This study will generate new knowledge about the potential causal mechanisms and factors which shape implementation. Future studies will track the impact of the CPG/CPs implementation on children's health outcome, and healthcare costs.

Regulatory Framework for Conducting Clinical Research in Canada.

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Alas, Josmar K; Godlovitch, Glenys; Mohan, Connie M; Jelinski, Shelly A; Khan, Aneal A

2017-09-01

Research in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

Effects of direct-to-consumer advertising and clinical guidelines on appropriate use of human papillomavirus DNA tests.

Science.gov (United States)

Price, Rebecca Anhang; Frank, Richard G; Cleary, Paul D; Goldie, Sue J

2011-02-01

Both clinical guidelines and direct-to-consumer (DTC) advertising influence the use of new health care technologies, but little is known about their relative effects. The introduction of a cervical cancer screening test in 2000 offered a unique opportunity to assess the 2 strategies. To evaluate the effects of clinical guidelines and a targeted DTC advertising campaign on overall and appropriate use of human papillomavirus (HPV) DNA tests. Quasi-experimental study using difference-in-differences analysis. Data were MarketScan private insurance claims for 500,000 women aged 21 to 64 enrolled at least 12 consecutive months from January 2001 through December 2005. Both clinical guidelines and DTC advertising were associated with increases in overall HPV DNA test use. DTC advertising was associated with a statistically significant increase in HPV DNA test use in 2 groups of DTC cities (+5.57%, P advertising was associated with comparable increases in the probability of appropriate and inappropriate use of the HPV DNA test in primary screening. Clinical guideline releases from the American College of Obstetricians and Gynecologists, and by a cosponsored panel, were associated with greater increases in HPV DNA tests for appropriate primary screening than for inappropriate primary screening (β = 0.3347, P advertising was associated with increased overall use of a cervical cancer screening test, whereas clinical guidelines were differentially associated with increased appropriate use. These findings suggest distinct influences of consumer marketing and professional guidelines on the use of health care products and services.

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITYEXECUTIVE SUMMARYComplete Guidelines available at https://www.aace.com/publications/guidelines.

Science.gov (United States)

Garvey, W Timothy; Mechanick, Jeffrey I; Brett, Elise M; Garber, Alan J; Hurley, Daniel L; Jastreboff, Ania M; Nadolsky, Karl; Pessah-Pollack, Rachel; Plodkowski, Raymond

2016-07-01

Development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and the American College of Endocrinology (ACE) Board of Trustees and adheres to published AACE protocols for the standardized production of clinical practice guidelines (CPGs). Recommendations are based on diligent review of clinical evidence with transparent incorporation of subjective factors. There are 9 broad clinical questions with 123 recommendation numbers that include 160 specific statements (85 [53.1%] strong [Grade A], 48 [30.0%] intermediate [Grade B], and 11 [6.9%] weak [Grade C], with 16 [10.0%] based on expert opinion [Grade D]) that build a comprehensive medical care plan for obesity. There were 133 (83.1%) statements based on strong (best evidence level [BEL] 1 = 79 [49.4%]) or intermediate (BEL 2 = 54 [33.7%]) levels of scientific substantiation. There were 34 (23.6%) evidence-based recommendation grades (Grades A-C = 144) that were adjusted based on subjective factors. Among the 1,788 reference citations used in this CPG, 524 (29.3%) were based on strong (evidence level [EL] 1), 605 (33.8%) were based on intermediate (EL 2), and 308 (17.2%) were based on weak (EL 3) scientific studies, with 351 (19.6%) based on reviews and opinions (EL 4). The final recommendations recognize that obesity is a complex, adiposity-based chronic disease, where management targets both weight-related complications and adiposity to improve overall health and quality of life. The detailed evidence-based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity, including screening, diagnosis, evaluation, selection of therapy, treatment goals, and individualization of care. The goal is to facilitate high-quality care of patients with obesity and provide a rational, scientific approach to management that optimizes health outcomes and safety. A1C = hemoglobin A1c AACE = American

Clinical Pathway and Monthly Feedback Improve Adherence to Antibiotic Guideline Recommendations for Community-Acquired Pneumonia.

Directory of Open Access Journals (Sweden)

Maher Almatar

Full Text Available Compliance with community-acquired pneumonia (CAP guidelines remains poor despite a substantial body of evidence indicating that guideline-concordant care improves patient outcomes. The aim of this study was to compare the relative effectiveness of a general educational and a targeted emergency department intervention on improving physicians' concordance with CAP guidelines.Two distinct interventions were implemented over specific time periods. The first intervention was educational, focusing on the development of local CAP guidelines and their dissemination through hospital-wide educational programmes. The second intervention was a targeted one for the emergency department, where a clinical pathway for the initial management of CAP patients was introduced, followed by monthly feedback to the emergency department (ED physicians about concordance rates with the guidelines. Data on the concordance rate to CAP guidelines was collected from a retrospective chart review.A total of 398 eligible patient records were reviewed to measure concordance to CAP guidelines over the study period. Concordance rates during the baseline and educational intervention periods were similar (28.1% vs. 31.2%; p > 0.05. Significantly more patients were treated in accordance with the CAP guidelines after the ED focused intervention when compared to the baseline (61.5% vs. 28.1%; p < 0.05 or educational period (61.5% vs. 31.2%; p < 0.05.A targeted intervention with a CAP clinical pathway and monthly feedback was a successful strategy to increase adherence to empirical antibiotic recommendations in CAP guidelines.

Librarian contributions to clinical practice guidelines.

Science.gov (United States)

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.

Index-TB guidelines: Guidelines on extrapulmonary tuberculosis for India

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Surendra K Sharma

2017-01-01

Full Text Available 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.

Quality of the Development of Traumatic Brain Injury Clinical Practice Guidelines: A Systematic Review.

Directory of Open Access Journals (Sweden)

Anjni Patel

Full Text Available Traumatic brain injury (TBI is a leading cause of death worldwide and is increasing exponentially particularly in low and middle income countries (LMIC. To inform the development of a standard Clinical Practice Guideline (CPG for the acute management of TBI that can be implemented specifically for limited resource settings, we conducted a systematic review to identify and assess the quality of all currently available CPGs on acute TBI using the AGREE II instrument. In accordance with PRISMA guidelines, from April 2013 to December 2015 we searched MEDLINE, EMBASE, Google Scholar and the Duke University Medical Center Library Guidelines for peer-reviewed published Clinical Practice Guidelines on the acute management of TBI (less than 24 hours, for any level of traumatic brain injury in both high and low income settings. A comprehensive reference and citation analysis was performed. CPGs found were assessed using the AGREE II instrument by five independent reviewers and scores were aggregated and reported in percentage of total possible score. An initial 2742 articles were evaluated with an additional 98 articles from the citation and reference analysis, yielding 273 full texts examined. A total of 24 final CPGs were included, of which 23 were from high income countries (HIC and 1 from LMIC. Based on the AGREE II instrument, the best score on overall assessment was 100.0 for the CPG from the National Institute for Health and Clinical Excellence (NIHCE, 2007, followed by the New Zealand Guidelines Group (NZ, 2006 and the National Clinical Guideline (SIGN, 2009 both with a score of 96.7. The CPG from a LMIC had lower scores than CPGs from higher income settings. Our study identified and evaluated 24 CPGs with the highest scores in clarity and presentation, scope and purpose, and rigor of development. Most of these CPGs were developed in HICs, with limited applicability or utility for resource limited settings. Stakeholder involvement, Applicability

The importance of clinical case reports in research

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Ricardo Pineda-Leguízamo

2018-04-01

Full Text Available Clinical case reports correspond to articles that have the lowest level of evidence within different research trials. However, not only are they common and significant in the medical field, but they have often been the basis the generation of research. The purpose of their publication can be scientific or educational. In general terms, the discovery of new diseases, the presentation of rare diseases, unusual forms of common diseases, the complications of a common treatment, or the effect (beneficial or adverse of a treatment, among other things, are narrated in these documents. Clinical case reports continue to be one of the most important sources of knowledge. The advent of a standardized guideline for the creation of this type of reports allows homogenizing the form and content of the cases intended to be described in the near future and, furthermore, will enable authors to have a reference when preparing this type of publications. Case reports are valuable resources of new and unusual information that can encourage and serve to conduct future research studies with a higher level of evidence.

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

Science.gov (United States)

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

2016-01-01

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

Towards a Conceptual Model for Enhancing Reasoning about Clinical Guidelines: A case-study on Comorbidity

NARCIS (Netherlands)

Carretta Zamborlini, Veruska; Da Silveira, Marcos; Pruski, Cedric; ten Teije, Annette; van Harmelen, Frank

2014-01-01

Computer-Interpretable Guidelines (CIGs) are representations of Clinical Guidelines (CGs) in computer interpretable languages. CIGs have been pointed as an alternative to deal with the various limitations of paper based CGs to support healthcare activities. Although the improvements offered by

Prioritization strategies in clinical practice guidelines development: a pilot study

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Torres Marcela

2010-03-01

Full Text Available Abstract Objective Few methodological studies address the prioritization of clinical topics for the development of Clinical Practice Guidelines (CPGs. The aim of this study was to validate a methodology for Priority Determination of Topics (PDT of CPGs. Methods and results Firstly, we developed an instrument for PDT with 41 criteria that were grouped under 10 domains, based on a comprehensive systematic search. Secondly, we performed a survey of stakeholders involved in CPGs development, and end users of guidelines, using the instrument. Thirdly, a pilot testing of the PDT procedure was performed in order to choose 10 guideline topics among 34 proposed projects; using a multi-criteria analysis approach, we validated a mechanism that followed five stages: determination of the composition of groups, item/domain scoring, weights determination, quality of the information used to support judgments, and finally, topic selection. Participants first scored the importance of each domain, after which four different weighting procedures were calculated (including the survey results. The process of weighting was determined by correlating the data between them. We also reported the quality of evidence used for PDT. Finally, we provided a qualitative analysis of the process. The main domains used to support judgement, having higher quality scores and weightings, were feasibility, disease burden, implementation and information needs. Other important domains such as user preferences, adverse events, potential for health promotion, social effects, and economic impact had lower relevance for clinicians. Criteria for prioritization were mainly judged through professional experience, while good quality information was only used in 15% of cases. Conclusion The main advantages of the proposed methodology are supported by the use of a systematic approach to identify, score and weight guideline topics selection, limiting or exposing the influence of personal biases

Salinity guidelines for irrigation: Case studies from Water Research ...

African Journals Online (AJOL)

Salinity guidelines for irrigation: Case studies from Water Research Commission projects along the Lower Vaal, Riet, Berg and Breede Rivers. ... It is suggested that a more dynamic approach be used for managing salinity under irrigation at farm level, i.e. the use of models. Amongst others, future research should focus on ...

Reporting Guidelines and Checklists Improve the Reliability and Rigor of Research Reports.

Science.gov (United States)

Abbott, J Haxby

2016-03-01

The Journal of Orthopaedic & Sports Physical Therapy (JOSPT) requires the use of robust research reporting guidelines for all research report submissions, including the newly adopted RECORD (REporting of studies Conducted using Observational Routinely-collected health Data) statement. We remind authors submitting research to JOSPT to identify the appropriate guideline and checklist for their study design, and to submit a completely and accurately completed checklist with their manuscript. J Orthop Sports Phys Ther 2016;46(3):130. doi:10.2519/jospt.2016.0105.

An evidence-based assessment of the clinical guidelines for replanted avulsed teeth. Part II: prescription of systemic antibiotics.

Science.gov (United States)

Hinckfuss, Susan Elisabeth; Messer, Louise Brearley

2009-04-01

Current clinical guidelines recommend prescribing systemic antibiotic therapy (SAT) for patients having an avulsed permanent tooth replanted. The principles of evidence-based dentistry can be used to assess whether this is the best approach based on currently-available evidence. The objective of this study was to use the principles of evidence-based dentistry to answer the PICO question: (P) for a replanted avulsed permanent tooth, (I) is prescribing SAT, (C) compared with not prescribing SAT, (O) associated with an increased likelihood of successful periodontal healing after tooth replantation? A literature search was performed across four internet databases (Ovid Medline, Cochrane Library, PubMed, ISI Web of Science), for relevant citations (n = 35 702). Limiting citations to those in English and removing duplicates produced a set of titles (n = 14 742) that were sieved according to evidence-based dentistry principles. Relevant titles were selected for abstract assessment (n = 782), identifying papers for examination (n = 74). Inclusion criteria were applied and three papers (326 total teeth) met the final criteria for meta-analysis. Meta-analyses found no statistically significant difference between prescribing or not prescribing antibiotics for acceptable periodontal healing without progressive root resorption (common odds ratio = 0.90, SE = 0.29, 95% confidence intervals = 0.51-1.58). The evidence for an association between prescribing SAT and an increased likelihood of acceptable periodontal healing outcome is inconclusive. This investigation of antibiotic use as defined in the clinical guidelines indicates there is inconclusive clinical evidence from studies of replanted avulsed human teeth to either contradict or support the guideline. Pending future research to the contrary, dentists are recommended to follow current guidelines in prescribing SAT when replanting avulsed teeth.

Clinical reasoning in the real world is mediated by bounded rationality: implications for diagnostic clinical practice guidelines.

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Ana Paula Ribeiro Bonilauri Ferreira

Full Text Available BACKGROUND: Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. METHOD: This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. RESULTS: FOUR MAIN THEMES WERE IDENTIFIED: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. DISCUSSION: Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration.

Guidelines on radioiodine therapy for differentiated thyroid carcinoma. Impact on clinical practice

International Nuclear Information System (INIS)

Biermann, M.; Pixberg, M.K.; Schober, O.; Doerr, U.; Dietlein, M.; Schlemmer, H.; Grimm, J.; Zajic, T.; Nestle, U.; Ladner, S.; Sepehr-Rezai, S.; Rosenbaum, S.; Puskas, C.; Fostitsch, P.; Heinecke, A.; Schuck, A.; Willich, N.; Schmid, K.W.; Dralle, H.

2005-01-01

Aim: For the examination of the impact on clinical practice of the guidelines for differentiated thyroid carcinoma (DTC), treatment data from the ongoing multicenter study differentiated thyroid carcinoma (MSDS) were analyzed. Patients, methods: patients were randomized to adjuvant external beam radiotherapy (RTx) or no RTx in addition to standard therapy in TNM stages pT4 pNO/1/x MO/x (UICC, 5 th ed. 1997). All patients were to receive the same treatment regimen consisting of thyroidectomy, ablative radioiodine therapy (RIT), and a diagnostic 131 I whole-body scintigraphy (WBS) 3-4 months after RIT. Results: Of 339 eligible patients enrolled between January 2000 and March 2004, 273 could be analyzed. Guideline recommendations by the German Society for Nuclear Medicine from 1999 and 1992 were complied with within 28% and 82% with regard to the interval between surgery and RIT (4 vs. 4-6 weeks), in 33% and 84% with regard to 131 I activity for RIT (1-3 vs. 1-4 GBq; ±10%), and in 16% and 60% with regard to 131 I activity for WBS (100-300 vs. 100-400 MBq; ±10%). Conclusions: the 1999 guideline revision appears to have had little impact on clinical practice. Further follow-up will reveal if guideline compliance had an effect on outcomes. (orig.)

Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America.

NARCIS (Netherlands)

Pappas, P.G.; Kauffman, C.A.; Andes, D.; Benjamin Jr., D.K.; Calandra, T; Edwards, J.E.; Filler, S.G.; Fisher, J.F.; Kullberg, B.J.; Ostrosky-Zeichner, L.; Reboli, A.C.; Rex, J.H.; Walsh, T.J.; Sobel, J.D.

2009-01-01

Guidelines for the management of patients with invasive candidiasis and mucosal candidiasis were prepared by an Expert Panel of the Infectious Diseases Society of America. These updated guidelines replace the previous guidelines published in the 15 January 2004 issue of Clinical Infectious Diseases

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

Science.gov (United States)

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.

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

Directory of Open Access Journals (Sweden)

Matheus Roque

2016-01-01

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

Clinical guideline implementation strategies for common mental health disorders.

Science.gov (United States)

Moreno, Eliana María; Moriana, Juan Antonio

2016-01-01

There has been a considerable proliferation of clinical guidelines recently, but their practical application is low, and organisations do not always implement their own ones. The aim of this study is to analyse and describe key elements of strategies and resources designed by the National Institute for Health and Care Excellence for the implementation of guidelines for common mental health disorders in adults, which are some of the most prevalent worldwide. A systematic review was performed following PRISMA model. Resources, tools and implementation materials where included and categorised considering type, objectives, target and scope. A total of 212 elements were analysed, of which 33.5 and 24.5% are related to the implementation of generalized anxiety and depression guidelines, respectively. Applied tools designed to estimate costs and assess the feasibility of the setting up at local level are the most frequent type of resource. The study highlights the important variety of available materials, classified into 3 main strategies: tools targeting the professionals (30.6%), structural (26.4%), and organizational (24%). Developing guidelines is not enough; it is also necessary to promote their implementation in order to encourage their application. The resources and strategies described in this study may be potentially applicable to other contexts, and helpful to public health managers and professionals in the design of programmes and in the process of informed decision making to help increase access to efficient treatments. Copyright © 2015. Published by Elsevier España.

[Implementation of Study Results in Guidelines and Adherence to Guidelines in Clinical Practice].

Science.gov (United States)

Waldfahrer, F

2016-04-01

Guidelines were introduced in hospital and practice-based otorhinolaryngology in the 1990s, and have been undergoing further development ever since. There are currently 20 guidelines on file at the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. The Society has cooperated in a further 34 guidelines. The quality of the guidelines has been continually improved by concrete specifications put forward by the Association of the Scientific Medical Societies in Germany [Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V.]. Since increasing digitalisation has made access to scientific publications quicker and more simple, relevant study results can be incorporated in guidelines more easily today than in the analogue world. S2e and S3 guidelines must be based on a formal literature search with subsequent evaluation of the evidence. The consensus procedure for S2k guidelines is also regulated. However, the implementation of guidelines in routine medical practice must still be considered inadequate, and there is still a considerable need for improvement in adherence to these guidelines. © Georg Thieme Verlag KG Stuttgart · New York.

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

Science.gov (United States)

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

2015-08-01

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

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

NARCIS (Netherlands)

Francke, A.L.; Smit, M.C.; Veer, A.J.E. de; Mistiaen, P.

2008-01-01

BACKGROUND: Nowadays more and more clinical guidelines for health care professionals are being developed. However, this does not automatically mean that these guidelines are actually implemented. The aim of this meta-review is twofold: firstly, to gain a better understanding of which factors affect

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

Science.gov (United States)

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

Impact of the Provider and Healthcare team Adherence to Treatment Guidelines (PHAT-G) intervention on adherence to national obesity clinical practice guidelines in a primary care centre.

Science.gov (United States)

Barnes, Emily R; Theeke, Laurie A; Mallow, Jennifer

2015-04-01

Obesity is significantly underdiagnosed and undertreated in primary care settings. The purpose of this clinical practice change project was to increase provider adherence to national clinical practice guidelines for the diagnosis and treatment of obesity in adults. Based upon the National Institutes of Health guidelines for the diagnosis and treatment of obesity, a clinical change project was implemented. Guided by the theory of planned behaviour, the Provider and Healthcare team Adherence to Treatment Guidelines (PHAT-G) intervention includes education sessions, additional provider resources for patient education, a provider reminder system and provider feedback. Primary care providers did not significantly increase on documentation of diagnosis and planned management of obesity for patients with body mass index (BMI) greater than or equal to 30. Medical assistants increased recording of height, weight and BMI in the patient record by 13%, which was significant. Documentation of accurate BMI should lead to diagnosis of appropriate weight category and subsequent care planning. Future studies will examine barriers to adherence to clinical practice guidelines for obesity. Interventions are needed that include inter-professional team members and may be more successful if delivered separately from routine primary care visits. © 2015 John Wiley & Sons, Ltd.

Clinical Research

DEFF Research Database (Denmark)

Christensen, Irene

2016-01-01

This paper is about the logic of problem solving and the production of scientific knowledge through the utilisation of clinical research perspective. Ramp-up effectiveness, productivity, efficiency and organizational excellence are topics that continue to engage research and will continue doing so...... for years to come. This paper seeks to provide insights into ramp-up management studies through providing an agenda for conducting collaborative clinical research and extend this area by proposing how clinical research could be designed and executed in the Ramp- up management setting....

[Adult congenital heart disease--between guidelines and clinical practice].

Science.gov (United States)

Chessa, Massimo

2011-01-01

Advances in medical and surgical management of congenital heart disease have changed the prognosis of infants and children with cardiac defects, so that an increasing number of patients reach adolescence and adult life, even those with complex defects. Recent data suggest that the number of adults with congenital heart disease, either repaired or not, approaches the number of children with the disorder. A cure is rarely achieved and ongoing surveillance and management in conjunction with specialists in this highly specialized field is mandatory to provide optimal care for patients. The profile of this patient population is going to change over the next few decades. Ideally specialist units should be established in appropriate geographic locations; patients need to be concentrated for expertise, experience, and optimal management. Less specialized regional centers and outpatient clinics in districts in connection with grown-up congenital heart disease units should be created. Specialist units should accept responsibility for educating the professionals, training the specialists, and sharing particular skills between each other. Guidelines and recommendations should help physicians to make decision in their daily practice. However, the final judgment regarding the care of an individual patient must be made by his/her physician. This article will briefly discuss some aspects of these dedicated guidelines and how they influence the clinical daily practice.

Nonmedical interventions for children with ASD: recommended guidelines and further research needs.

Science.gov (United States)

Maglione, Margaret A; Gans, Daphna; Das, Lopamudra; Timbie, Justin; Kasari, Connie

2012-11-01

To use the findings of a systematic review of scientific evidence to develop consensus guidelines on nonmedical interventions that address cognitive function and core deficits in children with autism spectrum disorders (ASDs) and to recommend priorities for future research. The guidelines were developed by a Technical Expert Panel (TEP) consisting of practitioners, researchers, and parents. A systematic overview of research findings was presented to the TEP; guideline statements were drafted, discussed, debated, edited, reassessed, and presented for formal voting. The strength of evidence of efficacy varied by intervention type from insufficient to moderate. There was some evidence that greater intensity of treatment (hours per week) and greater duration (in months) led to better outcomes. The TEP agreed that children with ASD should have access to at least 25 hours per week of comprehensive intervention to address social communication, language, play skills, and maladaptive behavior. They agreed that applied behavioral analysis, integrated behavioral/developmental programs, the Picture Exchange Communication System, and various social skills interventions have shown efficacy. Based on identified gaps, they recommend that future research focus on assessment and monitoring of outcomes, addressing the needs of pre/nonverbal children and adolescents, and identifying the most effective strategies, dose, and duration to improve specific core deficits. The creation of treatment guidelines and recommendations for future research represents an effort by leading experts to improve access to services for children with ASDs while acknowledging that the research evidence has many gaps.

Assessment of clinical guidelines for continuation treatment in major depression.

Science.gov (United States)

Nuijten, M J

2001-01-01

The primary objective of this study was to assess the appropriateness of the existing Dutch clinical guidelines for the treatment of depression from a health-economic perspective. The existing guidelines recommend continuation treatment for a period up to 9 months. The assessment was based on a Markov model using decision-analytic techniques. For this analysis we defined six mutually exclusive states defined by the existence of depression and type of treatment. The outcomes for the model were defined as: time without depression (TWD), quality-adjusted life years (QALYs), direct medical costs, and cost of lost productivity. The primary perspective of the study was that of the third-party payer, while the secondary perspective was that of the society in 1999. The probabilities of clinical events and therapeutic choices as well as the utilities were based on published literature. The medical resource use related to each state was abstracted from published literature and expert opinion. The associated 1999 unit costs of the used medical resources were derived from official Dutch tariff lists of allowable reimbursements. Indirect costs in this model were based on lost productivity only. The results of the primary analysis showed that the use of the guidelines is not cost-effective. Continuation treatment for a period of 9 months increases the total direct medical costs (NLG 1276 vs. NLG 474), decreases the costs resulting from lost productivity (NLG 304 vs. NLG 909), increases total costs (NLG 1580 vs. NLG 1383) and increases TWD (96.9% vs. 86.4%). However, continuation treatment does not change the utility outcomes (0.60 vs. 0.61 QALYs) for both treatment strategies. Hence continuation treatment is not cost-effective from either a third-party payer perspective or a societal perspective. A scenario analysis showed that an extension of the continuation treatment to maintenance treatment might result in a favorable cost-effectiveness outcome of the treatment guideline. In

Clinical practice guidelines in hypertension: a review

Directory of Open Access Journals (Sweden)

Mayita Lizbeth Álvarez-Vargas

2015-10-01

Full Text Available El objetivo del presente estudio es la evaluación metodológica de las guías de práctica clínica en hipertensión arterial. Este es el primero de una serie de artículos de revisión, análisis, valoración metodológica y contenido de las guías de práctica clínica en cardiología. De todas estas guías se seleccionaron tres y se utilizó el instrumento Appraisal of Guidelines for Research & Evaluation (AGREE II para evaluar cada guía. Las guías obtuvieron el menor puntaje en el dominio de aplicabilidad (media 43,8%; mientras que el mayor puntaje fue para el dominio de claridad en la presentación (media 81,5%. El menor porcentaje hallado fue en el dominio de aplicabilidad (Guía Europea y el mayor de todos los puntajes fue hallado en dos dominios: alcance y objetivo, y claridad en la presentación (Guía Canadiense. Al evaluar la calidad de las guías de práctica clínica analizadas, la canadiense es la que mejor puntuaciones obtiene al aplicar el instrumento Appraisal of Guidelines for Research & Evaluation (AGREE II, siendo recomendada sin modificaciones.

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

Science.gov (United States)

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.

The clinical database and implementation of treatment guidelines by the Danish Breast Cancer Cooperative Group in 2007-2016

DEFF Research Database (Denmark)

Jensen, Maj-Britt; Laenkholm, Anne-Vibeke; Offersen, Birgitte V

2018-01-01

BACKGROUND: Since 40 years, Danish Breast Cancer Cooperative Group (DBCG) has provided comprehensive guidelines for diagnosis and treatment of breast cancer. This population-based analysis aimed to describe the plurality of modifications introduced over the past 10 years in the national Danish...... guidelines for the management of early breast cancer. By use of the clinical DBCG database we analyze the effectiveness of the implementation of guideline revisions in Denmark. METHODS: From the DBCG guidelines we extracted modifications introduced in 2007-2016 and selected examples regarding surgery......, radiotherapy (RT) and systemic treatment. We assessed introduction of modifications from release on the DBCG webpage to change in clinical practice using the DBCG clinical database. RESULTS: Over a 10-year period data from 48,772 patients newly diagnosed with malignant breast tumors were entered into DBCG...

ISRIA statement: ten-point guidelines for an effective process of research impact assessment.

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Adam, Paula; Ovseiko, Pavel V; Grant, Jonathan; Graham, Kathryn E A; Boukhris, Omar F; Dowd, Anne-Maree; Balling, Gert V; Christensen, Rikke N; Pollitt, Alexandra; Taylor, Mark; Sued, Omar; Hinrichs-Krapels, Saba; Solans-Domènech, Maite; Chorzempa, Heidi

2018-02-08

As governments, funding agencies and research organisations worldwide seek to maximise both the financial and non-financial returns on investment in research, the way the research process is organised and funded is becoming increasingly under scrutiny. There are growing demands and aspirations to measure research impact (beyond academic publications), to understand how science works, and to optimise its societal and economic impact. In response, a multidisciplinary practice called research impact assessment is rapidly developing. Given that the practice is still in its formative stage, systematised recommendations or accepted standards for practitioners (such as funders and those responsible for managing research projects) across countries or disciplines to guide research impact assessment are not yet available.In this statement, we propose initial guidelines for a rigorous and effective process of research impact assessment applicable to all research disciplines and oriented towards practice. This statement systematises expert knowledge and practitioner experience from designing and delivering the International School on Research Impact Assessment (ISRIA). It brings together insights from over 450 experts and practitioners from 34 countries, who participated in the school during its 5-year run (from 2013 to 2017) and shares a set of core values from the school's learning programme. These insights are distilled into ten-point guidelines, which relate to (1) context, (2) purpose, (3) stakeholders' needs, (4) stakeholder engagement, (5) conceptual frameworks, (6) methods and data sources, (7) indicators and metrics, (8) ethics and conflicts of interest, (9) communication, and (10) community of practice.The guidelines can help practitioners improve and standardise the process of research impact assessment, but they are by no means exhaustive and require evaluation and continuous improvement. The prima facie effectiveness of the guidelines is based on the systematised

Systematic review of clinical practice guidelines to identify recommendations for rehabilitation after stroke and other acquired brain injuries

Science.gov (United States)

Lannin, Natasha A; Hoffmann, Tammy

2018-01-01

Objectives Rehabilitation clinical practice guidelines (CPGs) contain recommendation statements aimed at optimising care for adults with stroke and other brain injury. The aim of this study was to determine the quality, scope and consistency of CPG recommendations for rehabilitation covering the acquired brain injury populations. Design Systematic review. Interventions Included CPGs contained recommendations for inpatient rehabilitation or community rehabilitation for adults with an acquired brain injury diagnosis (stroke, traumatic or other non-progressive acquired brain impairments). Electronic databases (n=2), guideline organisations (n=4) and websites of professional societies (n=17) were searched up to November 2017. Two independent reviewers used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, and textual syntheses were used to appraise and compare recommendations. Results From 427 papers screened, 20 guidelines met the inclusion criteria. Only three guidelines were rated high (>75%) across all domains of AGREE-II; highest rated domains were ‘scope and purpose’ (85.1, SD 18.3) and ‘clarity’ (76.2%, SD 20.5). Recommendations for assessment and for motor therapies were most commonly reported, however, varied in the level of detail across guidelines. Conclusion Rehabilitation CPGs were consistent in scope, suggesting little difference in rehabilitation approaches between vascular and traumatic brain injury. There was, however, variability in included studies and methodological quality. PROSPERO registration number CRD42016026936. PMID:29490958

No. 354-Canadian HIV Pregnancy Planning Guidelines.

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

2018-01-01

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

Clinical practice guidelines for the diagnosis and management of melanoma: melanomas that lack classical clinical features.

Science.gov (United States)

Mar, Victoria J; Chamberlain, Alex J; Kelly, John W; Murray, William K; Thompson, John F

2017-10-16

A Cancer Council Australia multidisciplinary working group is currently revising and updating the 2008 evidence-based clinical practice guidelines for the management of cutaneous melanoma. While there have been many recent improvements in treatment options for metastatic melanoma, early diagnosis remains critical to reducing mortality from the disease. Improved awareness of the atypical presentations of this common malignancy is required to achieve this. A chapter of the new guidelines was therefore developed to aid recognition of atypical melanomas. Main recommendations: Because thick, life-threatening melanomas may lack the more classical ABCD (asymmetry, border irregularity, colour variegation, diameter > 6 mm) features of melanoma, a thorough history of the lesion with regard to change in morphology and growth over time is essential. Any lesion that is changing in morphology or growing over a period of more than one month should be excised or referred for prompt expert opinion. Changes in management as a result of the guidelines: These guidelines provide greater emphasis on improved recognition of the atypical presentations of melanoma, in particular nodular, desmoplastic and acral lentiginous subtypes, with particular awareness of hypomelanotic and amelanotic lesions.

A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.

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Amato, Antonino; Aringhieri, Eugenio; Boccia, Stefania; Buccella, Filippo; Gorini, Barbara; Gramaglia, Donatella; Masetti, Riccardo; Rossi, Paolo; Pelicci, Pier Giuseppe

2017-01-01

The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.

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

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

2018-02-01

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

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

Science.gov (United States)

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.

Agreement between Cochrane Neonatal Group reviews and clinical guidelines for newborns at a Copenhagen University Hospital - a cross-sectional study

DEFF Research Database (Denmark)

Brok, Jesper; Greisen, Gorm; Jacobsen, Robert Thorkild

2007-01-01

To assess the agreement between Cochrane Neonatal Group reviews and clinical guidelines of a University Neonatology Department, to evaluate the reasons for potential disagreements and to ascertain whether Cochrane reviews were considered for the guidelines development.......To assess the agreement between Cochrane Neonatal Group reviews and clinical guidelines of a University Neonatology Department, to evaluate the reasons for potential disagreements and to ascertain whether Cochrane reviews were considered for the guidelines development....

Adherence of physical therapy with clinical practice guidelines for the rehabilitation of stroke in an active inpatient setting.

Science.gov (United States)

M S, Ajimsha; Kooven, Smithesh; Al-Mudahka, Noora

2018-03-09

Clinical guidelines are systematically developed statements designed to help practitioners and patients to make decisions about appropriate health care. Clinical practice guideline adherence analysis is the best way to fine tune the best practices in a health care industry with international benchmarks. To assess the physical therapist's adherence to structured stroke clinical practice guidelines in an active inpatient rehabilitation center in Qatar. Department of Physical therapy in the stroke rehabilitation tertiary referral hospital in Qatar. A retrospective chart audit was performed on the clinical records of 216 stroke patients discharged from the active inpatient stroke rehabilitation unit with a diagnosis of stroke in 2016. The audit check list was structured to record the adherence of the assessment, goal settings and the management domains as per the "Physical Therapy After Acute Stroke" (PAAS) guideline. Of the 216 case files identified during the initial search, 127 files were ultimately included in the audit. Overall adherence to the clinical practice guideline was 71%, a comparable rate with the studies analyzing the same in various international health care facilities. Domains which were shared by interdisciplinary teams than managed by physical therapy alone and treatments utilizing sophisticated technology had lower adherence with the guideline. A detailed strength and weakness breakdown were then conducted. This audit provides an initial picture of the current adherence of physical therapy assessment and management with the stroke physical therapy guideline at a tertiary rehabilitation hospital in the state of Qatar. An evaluation of the guideline adherence and practice variations helps to fine tune the physical therapy care to a highest possible standard of practice. Implications for Rehabilitation  • An evaluation of the guideline adherence and practice variations helps to fine tune the rehabilitation care to the highest possible standard

Project Stakeholder Management in the clinical research environment: how to do it right.

Directory of Open Access Journals (Sweden)

Seithikurippu R. Pandi-Perumal

2015-05-01

Full Text Available This review introduces a conceptual framework for understanding stakeholder management in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in which many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental and ethical implications of research activities. Additionally those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for stakeholder management in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK® of the Project Management Institute (PMI, has served as basis for many of the suggested guidelines that are put forward in this article.

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right

Science.gov (United States)

Pandi-Perumal, Seithikurippu R.; Akhter, Sohel; Zizi, Ferdinard; Jean-Louis, Girardin; Ramasubramanian, Chellamuthu; Edward Freeman, R.; Narasimhan, Meera

2015-01-01

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK® of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article. PMID:26042053

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right.

Science.gov (United States)

Pandi-Perumal, Seithikurippu R; Akhter, Sohel; Zizi, Ferdinard; Jean-Louis, Girardin; Ramasubramanian, Chellamuthu; Edward Freeman, R; Narasimhan, Meera

2015-01-01

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK(®) of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.

What do international ethics guidelines say in terms of the scope of medical research ethics?

Science.gov (United States)

Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; van Delden, Johannes J M

2016-04-26

In research ethics, the most basic question would always be, "which is an ethical issue, which is not?" Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. We extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative. We found that there is no consensus on the majority of the imperatives and that in only 8.2% of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least. There was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences.

Clinical practice guideline: Bell's Palsy executive summary.

Science.gov (United States)

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

2013-11-01

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

Automating Performance Measures and Clinical Practice Guidelines: Differences and Complementarities.

Science.gov (United States)

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

2016-01-01

Through close analysis of two pairs of systems that implement the automated evaluation of performance measures (PMs) and guideline-based clinical decision support (CDS), we contrast differences in their knowledge encoding and necessary changes to a CDS system that provides management recommendations for patients failing performance measures. We trace the sources of differences to the implementation environments and goals of PMs and CDS.

Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.

Science.gov (United States)

2003-02-01

International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. To develop and validate an international instrument for assessing the quality of the process and reporting of clinical practice guideline development. The instrument was developed through a multi-staged process of item generation, selection and scaling, field testing, and refinement procedures. 100 guidelines selected from 11 participating countries were evaluated independently by 194 appraisers with the instrument. Following refinement the instrument was further field tested on three guidelines per country by a new set of 70 appraisers. The final version of the instrument contained 23 items grouped into six quality domains with a 4 point Likert scale to score each item (scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, editorial independence). 95% of appraisers found the instrument useful for assessing guidelines. Reliability was acceptable for most domains (Cronbach's alpha 0.64-0.88). Guidelines produced as part of an established guideline programme had significantly higher scores on editorial independence and, after the publication of a national policy, had significantly higher quality scores on rigour of development (pinternationally. The instrument is sensitive to differences in important aspects of guidelines and can be used consistently and easily by a wide range of professionals from different backgrounds. The adoption of common standards should improve the consistency and quality of the reporting of guideline development worldwide and provide a framework to encourage international comparison of clinical practice guidelines.

A critical appraisal of chronic kidney disease mineral and bone disorders clinical practice guidelines using the AGREE II instrument.

Science.gov (United States)

Sekercioglu, Nigar; Al-Khalifah, Reem; Ewusie, Joycelyne Efua; Elias, Rosilene M; Thabane, Lehana; Busse, Jason W; Akhtar-Danesh, Noori; Iorio, Alfonso; Isayama, Tetsuya; Martínez, Juan Pablo Díaz; Florez, Ivan D; Guyatt, Gordon H

2017-02-01

Patients with chronic kidney disease mineral and bone disorders (CKD-MBD) suffer high rates of morbidity and mortality, in particular related to bone and cardiovascular outcomes. The management of CKD-MBD remains challenging. The objective of this systematic survey is to critically appraise clinical practice guidelines (CPGs) addressing CKD-MBD. Data sources included MEDLINE, EMBASE, the National Guideline Clearinghouse, Guideline International Network and Turning Research into Practice up to May 2016. Teams of two reviewers, independently and in duplicate, screened titles and abstracts and potentially eligible full text reports to determine eligibility and subsequently appraised the guidelines using the Advancing Guideline Development, Reporting and Evaluation in Health Care instrument II (AGREE). Sixteen CPGs published from 2003 to 2015 addressing the diagnosis and management of CKD-MBD in adult patients (11 English, two Spanish, one Italian, one Portuguese and one Slovak) proved eligible. The National Institute for Health and Care Excellence guideline performed best with respect to AGREE II criteria; only three other CPGs warranted high scores on all domains. All other guidelines received scores of under 60% on one or more domains. Major discrepancies in recommendations were not, however, present, and we found no association between quality of CPGs which was not associated with resulting recommendations. Most guidelines assessing CKD-MBD suffer from serious shortcomings using AGREE criteria although limitations with respect to AGREE criteria do not necessarily lead to inappropriate recommendations.

Promoting transparent and accurate reporting of research studies in rheumatology: endorsement of reporting guidelines in rheumatology journals.

Science.gov (United States)

Marušić, Ana; Gasparyan, Armen Yuri; Kitas, George D

2013-10-01

To adequately translate research into practice, research results should be reported in a way that is useful to practicing clinicians and policymakers. Based on evidence from systematic reviews, the implementation of reporting guidelines, such as CONSORT for randomized controlled trials, may improve the quality of research reporting. We assessed the endorsement of reporting guidelines in rheumatology journals. We analyzed guidelines for authors of all (n = 28) journals indexed in the "Rheumatology" Subject Category of the Journal Citation Reports published in 2012. Journal websites were reviewed for information relevant to reporting guidelines. Out of 28 indexed journals, only about a third (n = 10) endorsed 1 or more reporting guidelines, most commonly CONSORT. General editorial policies, such as those from the International Committee of Medical Journal editors (ICMJE), were endorsed by 19 journals (all 10 journals with and 9 out of 18 without reporting guidelines). Two rheumatology journals introduced specific reporting guidelines about economic studies and genetic association studies. The endorsement of reporting guidelines is low in rheumatology journals. To continue to serve their research community, rheumatology journals should provide the platform for the discussion on most relevant reporting guidelines and adopt them as a group, especially those specific for rheumatology research. Coordinated action of journals and other stakeholders in rheumatology research in the promotion of accurate and transparent reporting of health research studies would be an important part of knowledge translation into practice and well-being of rheumatology patients. Copyright © 2013 Elsevier Inc. All rights reserved.