Preventing Home Medication Administration Errors.

Medication administration errors that take place in the home are common, especially when liquid preparations are used and complex medication schedules with multiple medications are involved; children with chronic conditions are disproportionately affected. Parents and other caregivers with low health literacy and/or limited English proficiency are at higher risk for making errors in administering medications to children in their care. Recommended strategies to reduce home medication errors relate to provider prescribing practices; health literacy-informed verbal counseling strategies (eg, teachback and showback) and written patient education materials (eg, pictographic information) for patients and/or caregivers across settings (inpatient, outpatient, emergency care, pharmacy); dosing-tool provision for liquid medication measurement; review of medication lists with patients and/or caregivers (medication reconciliation) that includes prescription and over-the-counter medications, as well as vitamins and supplements; leveraging the medical home; engaging adolescents and their adult caregivers; training of providers; safe disposal of medications; regulations related to medication dosing tools, labeling, packaging, and informational materials; use of electronic health records and other technologies; and research to identify novel ways to support safe home medication administration.

Clinical Decision Support for Worker Health: A Five-Site Qualitative Needs Assessment in Primary Care Settings.

BACKGROUND: Although patients who work and have related health issues are usually first seen in primary care, providers in these settings do not routinely ask questions about work. Guidelines to help manage such patients are rarely used in primary care. Electronic health record (EHR) systems with worker health clinical decision support (CDS) tools have potential for assisting these practices. OBJECTIVE: This study aimed to identify the need for, and barriers and facilitators related to, implementation of CDS tools for the clinical management of working patients in a variety of primary care settings. METHODS: We used a qualitative design that included analysis of interview transcripts and observational field notes from 10 clinics in five organizations. RESULTS: We interviewed 83 providers, staff members, managers, informatics and information technology experts, and leaders and spent 35 hours observing. We identified eight themes in four categories related to CDS for worker health (operational issues, usefulness of proposed CDS, effort and time-related issues, and topic-specific issues). These categories were classified as facilitators or barriers to the use of the CDS tools. Facilitators related to operational issues include current technical feasibility and new work patterns associated with the coordinated care model. Facilitators concerning usefulness include users' need for awareness and evidence-based tools, appropriateness of the proposed CDS for their patients, and the benefits of population health data. Barriers that are effort-related include additional time this proposed CDS might take, and other pressing organizational priorities. Barriers that are topic-specific include sensitive issues related to health and work and the complexities of information about work. CONCLUSION: We discovered several themes not previously described that can guide future CDS development: technical feasibility of the proposed CDS within commercial EHRs, the sensitive nature of some CDS content, and the need to assist the entire health care team in managing worker health.

Efficacy and unintended consequences of hard-stop alerts in electronic health record systems: a systematic review.

Objective: Clinical decision support (CDS) hard-stop alerts-those in which the user is either prevented from taking an action altogether or allowed to proceed only with the external override of a third party-are increasingly common but can be problematic. To understand their appropriate application, we asked 3 key questions: (1) To what extent are hard-stop alerts effective in improving patient health and healthcare delivery outcomes? (2) What are the adverse events and unintended consequences of hard-stop alerts? (3) How do hard-stop alerts compare to soft-stop alerts? Methods and Materials: Studies evaluating computerized hard-stop alerts in healthcare settings were identified from biomedical and computer science databases, gray literature sites, reference lists, and reviews. Articles were extracted for process outcomes, health outcomes, unintended consequences, user experience, and technical details. Results: Of 32 studies, 15 evaluated health outcomes, 16 process outcomes only, 10 user experience, and 4 compared hard and soft stops. Seventy-nine percent showed improvement in health outcomes and 88% in process outcomes. Studies reporting good user experience cited heavy user involvement and iterative design. Eleven studies reported on unintended consequences including avoidance of hard-stopped workflow, increased alert frequency, and delay to care. Hard stops were superior to soft stops in 3 of 4 studies. Conclusions: Hard stops can be effective and powerful tools in the CDS armamentarium, but they must be implemented judiciously with continuous user feedback informing rapid, iterative design. Investigators must report on associated health outcomes and unintended consequences when implementing IT solutions to clinical problems.

Enhancing Worker Health Through Clinical Decision Support (CDS): An Introduction to a Compilation.

OBJECTIVE: This article outlines an approach to developing clinical decision support (CDS) for conditions related to work and health. When incorporated in electronic health records, such CDS will assist primary care providers (PCPs) care for working patients. METHODS: Three groups of Subject Matter Experts (SMEs) identified relevant clinical practice guidelines, best practices, and reviewed published literature concerning work-related asthma, return-to-work, and management of diabetes at work. RESULTS: SMEs developed one recommendation per topic that could be supported by electronic CDS. Reviews with PCPs, staff, and health information system implementers in five primary care settings confirmed that the approach was important and operationally sound. CONCLUSION: This compendium is intended to stimulate a dialogue between occupational health specialists and PCPs that will enhance the use of work information about patients in the primary care setting.

Brief Resolved Unexplained Events (Formerly Apparent Life-Threatening Events) and Evaluation of Lower-Risk Infants.

This is the first clinical practice guideline from the American Academy of Pediatrics that specifically applies to patients who have experienced an apparent life-threatening event (ALTE). This clinical practice guideline has 3 objectives. First, it recommends the replacement of the term ALTE with a new term, brief resolved unexplained event (BRUE). Second, it provides an approach to patient evaluation that is based on the risk that the infant will have a repeat event or has a serious underlying disorder. Finally, it provides management recommendations, or key action statements, for lower-risk infants. The term BRUE is defined as an event occurring in an infant younger than 1 year when the observer reports a sudden, brief, and now resolved episode of ≥1 of the following: (1) cyanosis or pallor; (2) absent, decreased, or irregular breathing; (3) marked change in tone (hyper- or hypotonia); and (4) altered level of responsiveness. A BRUE is diagnosed only when there is no explanation for a qualifying event after conducting an appropriate history and physical examination. By using this definition and framework, infants younger than 1 year who present with a BRUE are categorized either as (1) a lower-risk patient on the basis of history and physical examination for whom evidence-based recommendations for evaluation and management are offered or (2) a higher-risk patient whose history and physical examination suggest the need for further investigation and treatment but for whom recommendations are not offered. This clinical practice guideline is intended to foster a patient- and family-centered approach to care, reduce unnecessary and costly medical interventions, improve patient outcomes, support implementation, and provide direction for future research. Each key action statement indicates a level of evidence, the benefit-harm relationship, and the strength of recommendation.

Back to the Bedside: Developing a Bedside Aid for Concussion and Brain Injury Decisions in the Emergency Department.

CONTEXT: Current information-rich electronic health record (EHR) interfaces require large, high-resolution screens running on desktop computers. This interface compromises the provider's already limited time at the bedside by physically separating the patient from the doctor. The case study presented here describes a patient-centered clinical decision support (CDS) design process that aims to bring the physician back to the bedside by integrating a patient decision aid with CDS for shared use by the patient and provider on a touchscreen tablet computer for deciding whether or not to obtain a CT scan for minor head injury in the emergency department, a clinical scenario that could benefit from CDS but has failed previous implementation attempts. CASE DESCRIPTION: This case study follows the user-centered design (UCD) approach to build a bedside aid that is useful and usable, and that promotes shared decision-making between patients and their providers using a tablet computer at the bedside. The patient-centered decision support design process focuses on the prototype build using agile software development, but also describes the following: (1) the requirement gathering phase including triangulated qualitative research (focus groups and cognitive task analysis) to understand current challenges, (2) features for patient education, the physician, and shared decision-making, (3) system architecture and technical requirements, and (4) future plans for formative usability testing and field testing. LESSONS LEARNED: We share specific lessons learned and general recommendations from critical insights gained in the patient-centered decision support design process about early stakeholder engagement, EHR integration, external expert feedback, challenges to two users on a single device, project management, and accessibility. CONCLUSIONS: Successful implementation of this tool will require seamless integration into the provider's workflow. This protocol can create an effective interface for shared decision-making and safe resource reduction at the bedside in the austere and dynamic clinical environment of the ED and is generalizable for these purposes in other clinical environments as well.

Management of newly diagnosed type 2 Diabetes Mellitus (T2DM) in children and adolescents.

Over the past 3 decades, the prevalence of childhood obesity has increased dramatically in North America, ushering in a variety of health problems, including type 2 diabetes mellitus (T2DM), which previously was not typically seen until much later in life. The rapid emergence of childhood T2DM poses challenges to many physicians who find themselves generally ill-equipped to treat adult diseases encountered in children. This clinical practice guideline was developed to provide evidence-based recommendations on managing 10- to 18-year-old patients in whom T2DM has been diagnosed. The American Academy of Pediatrics (AAP) convened a Subcommittee on Management of T2DM in Children and Adolescents with the support of the American Diabetes Association, the Pediatric Endocrine Society, the American Academy of Family Physicians, and the Academy of Nutrition and Dietetics (formerly the American Dietetic Association). These groups collaborated to develop an evidence report that served as a major source of information for these practice guideline recommendations. The guideline emphasizes the use of management modalities that have been shown to affect clinical outcomes in this pediatric population. Recommendations are made for situations in which either insulin or metformin is the preferred first-line treatment of children and adolescents with T2DM. The recommendations suggest integrating lifestyle modifications (ie, diet and exercise) in concert with medication rather than as an isolated initial treatment approach. Guidelines for frequency of monitoring hemoglobin A1c (HbA1c) and finger-stick blood glucose (BG) concentrations are presented. Decisions were made on the basis of a systematic grading of the quality of evidence and strength of recommendation. The clinical practice guideline underwent peer review before it was approved by the AAP. This clinical practice guideline is not intended to replace clinical judgment or establish a protocol for the care of all children with T2DM, and its recommendations may not provide the only appropriate approach to the management of children with T2DM. Providers should consult experts trained in the care of children and adolescents with T2DM when treatment goals are not met or when therapy with insulin is initiated. The AAP acknowledges that some primary care clinicians may not be confident of their ability to successfully treat T2DM in a child because of the child's age, coexisting conditions, and/or other concerns. At any point at which a clinician feels he or she is not adequately trained or is uncertain about treatment, a referral to a pediatric medical subspecialist should be made. If a diagnosis of T2DM is made by a pediatric medical subspecialist, the primary care clinician should develop a comanagement strategy with the subspecialist to ensure that the child continues to receive appropriate care consistent with a medical home model in which the pediatrician partners with parents to ensure that all health needs are met.

Management of type 2 diabetes mellitus in children and adolescents.

OBJECTIVE: Over the last 3 decades, the prevalence of childhood obesity has increased dramatically in North America, ushering in a variety of health problems, including type 2 diabetes mellitus (T2DM), which previously was not typically seen until much later in life. This technical report describes, in detail, the procedures undertaken to develop the recommendations given in the accompanying clinical practice guideline, "Management of Type 2 Diabetes Mellitus in Children and Adolescents," and provides in-depth information about the rationale for the recommendations and the studies used to make the clinical practice guideline's recommendations. METHODS: A primary literature search was conducted relating to the treatment of T2DM in children and adolescents, and a secondary literature search was conducted relating to the screening and treatment of T2DM's comorbidities in children and adolescents. Inclusion criteria were prospectively and unanimously agreed on by members of the committee. An article was eligible for inclusion if it addressed treatment (primary search) or 1 of 4 comorbidities (secondary search) of T2DM, was published in 1990 or later, was written in English, and included an abstract. Only primary research inquiries were considered; review articles were considered if they included primary data or opinion. The research population had to constitute children and/or adolescents with an existing diagnosis of T2DM; studies of adult patients were considered if at least 10% of the study population was younger than 35 years. All retrieved titles, abstracts, and articles were reviewed by the consulting epidemiologist. RESULTS: Thousands of articles were retrieved and considered in both searches on the basis of the aforementioned criteria. From those, in the primary search, 199 abstracts were identified for possible inclusion, 58 of which were retained for systematic review. Five of these studies were classified as grade A studies, 1 as grade B, 20 as grade C, and 32 as grade D. Articles regarding treatment of T2DM selected for inclusion were divided into 4 major subcategories on the basis of type of treatment being discussed: (1) medical treatments (32 studies); (2) nonmedical treatments (9 studies); (3) provider behaviors (8 studies); and (4) social issues (9 studies). From the secondary search, an additional 336 abstracts relating to comorbidities were identified for possible inclusion, of which 26 were retained for systematic review. These articles included the following: 1 systematic review of literature regarding comorbidities of T2DM in adolescents; 5 expert opinions presenting global recommendations not based on evidence; 5 cohort studies reporting natural history of disease and comorbidities; 3 with specific attention to comorbidity patterns in specific ethnic groups (case-control, cohort, and clinical report using adult literature); 3 reporting an association between microalbuminuria and retinopathy (2 case-control, 1 cohort); 3 reporting the prevalence of nephropathy (cohort); 1 reporting peripheral vascular disease (case series); 2 discussing retinopathy (1 case-control, 1 position statement); and 3 addressing hyperlipidemia (American Heart Association position statement on cardiovascular risks; American Diabetes Association consensus statement; case series). A breakdown of grade of recommendation shows no grade A studies, 10 grade B studies, 6 grade C studies, and 10 grade D studies. With regard to screening and treatment recommendations for comorbidities, data in children are scarce, and the available literature is conflicting. Therapeutic recommendations for hypertension, dyslipidemia, retinopathy, microalbuminuria, and depression were summarized from expert guideline documents and are presented in detail in the guideline. The references are provided, but the committee did not independently assess the supporting evidence. Screening tools are provided in the Supplemental Information.

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

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

Diagnosis and management of childhood obstructive sleep apnea syndrome.

OBJECTIVES: This revised clinical practice guideline, intended for use by primary care clinicians, provides recommendations for the diagnosis and management of the obstructive sleep apnea syndrome (OSAS) in children and adolescents. This practice guideline focuses on uncomplicated childhood OSAS, that is, OSAS associated with adenotonsillar hypertrophy and/or obesity in an otherwise healthy child who is being treated in the primary care setting. METHODS: Of 3166 articles from 1999-2010, 350 provided relevant data. Most articles were level II-IV. The resulting evidence report was used to formulate recommendations. RESULTS AND CONCLUSIONS: The following recommendations are made. (1) All children/adolescents should be screened for snoring. (2) Polysomnography should be performed in children/adolescents with snoring and symptoms/signs of OSAS; if polysomnography is not available, then alternative diagnostic tests or referral to a specialist for more extensive evaluation may be considered. (3) Adenotonsillectomy is recommended as the first-line treatment of patients with adenotonsillar hypertrophy. (4) High-risk patients should be monitored as inpatients postoperatively. (5) Patients should be reevaluated postoperatively to determine whether further treatment is required. Objective testing should be performed in patients who are high risk or have persistent symptoms/signs of OSAS after therapy. (6) Continuous positive airway pressure is recommended as treatment if adenotonsillectomy is not performed or if OSAS persists postoperatively. (7) Weight loss is recommended in addition to other therapy in patients who are overweight or obese. (8) Intranasal corticosteroids are an option for children with mild OSAS in whom adenotonsillectomy is contraindicated or for mild postoperative OSAS.

Diagnosis and management of childhood obstructive sleep apnea syndrome.

OBJECTIVE: This technical report describes the procedures involved in developing recommendations on the management of childhood obstructive sleep apnea syndrome (OSAS). METHODS: The literature from 1999 through 2011 was evaluated. RESULTS AND CONCLUSIONS: A total of 3166 titles were reviewed, of which 350 provided relevant data. Most articles were level II through IV. The prevalence of OSAS ranged from 0% to 5.7%, with obesity being an independent risk factor. OSAS was associated with cardiovascular, growth, and neurobehavioral abnormalities and possibly inflammation. Most diagnostic screening tests had low sensitivity and specificity. Treatment of OSAS resulted in improvements in behavior and attention and likely improvement in cognitive abilities. Primary treatment is adenotonsillectomy (AT). Data were insufficient to recommend specific surgical techniques; however, children undergoing partial tonsillectomy should be monitored for possible recurrence of OSAS. Although OSAS improved postoperatively, the proportion of patients who had residual OSAS ranged from 13% to 29% in low-risk populations to 73% when obese children were included and stricter polysomnographic criteria were used. Nevertheless, OSAS may improve after AT even in obese children, thus supporting surgery as a reasonable initial treatment. A significant number of obese patients required intubation or continuous positive airway pressure (CPAP) postoperatively, which reinforces the need for inpatient observation. CPAP was effective in the treatment of OSAS, but adherence is a major barrier. For this reason, CPAP is not recommended as first-line therapy for OSAS when AT is an option. Intranasal steroids may ameliorate mild OSAS, but follow-up is needed. Data were insufficient to recommend rapid maxillary expansion.

Building better guidelines with BRIDGE-Wiz: development and evaluation of a software assistant to promote clarity, transparency, and implementability.

OBJECTIVE: To demonstrate the feasibility of capturing the knowledge required to create guideline recommendations in a systematic, structured, manner using a software assistant. Practice guidelines constitute an important modality that can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. However, many guideline recommendations are vague and underspecified, lack any linkage to supporting evidence or documentation of how they were developed, and prove to be difficult to transform into systems that influence the behavior of care providers. METHODS: The BRIDGE-Wiz application (Building Recommendations In a Developer's Guideline Editor) uses a wizard approach to address the questions: (1) under what circumstances? (2) who? (3) ought (with what level of obligation?) (4) to do what? (5) to whom? (6) how and why? Controlled natural language was applied to create and populate a template for recommendation statements. RESULTS: The application was used by five national panels to develop guidelines. In general, panelists agreed that the software helped to formalize a process for authoring guideline recommendations and deemed the application usable and useful. DISCUSSION: Use of BRIDGE-Wiz promotes clarity of recommendations by limiting verb choices, building active voice recommendations, incorporating decidability and executability checks, and limiting Boolean connectors. It enhances transparency by incorporating systematic appraisal of evidence quality, benefits, and harms. BRIDGE-Wiz promotes implementability by providing a pseudocode rule, suggesting deontic modals, and limiting the use of 'consider'. CONCLUSION: Users found that BRIDGE-Wiz facilitates the development of clear, transparent, and implementable guideline recommendations.

Evaluating the use of a computerized clinical decision support system for asthma by pediatric pulmonologists.

PURPOSE: To investigate use of a new guideline-based, computerized clinical decision support (CCDS) system for asthma in a pediatric pulmonology clinic of a large academic medical center. METHODS: We conducted a qualitative evaluation including review of electronic data, direct observation, and interviews with all nine pediatric pulmonologists in the clinic. Outcome measures included patterns of computer use in relation to patient care, and themes surrounding the relationship between asthma care and computer use. RESULTS: The pediatric pulmonologists entered enough data to trigger the decision support system in 397/445 (89.2%) of all asthma visits from January 2009 to May 2009. However, interviews and direct observations revealed use of the decision support system was limited to documentation activities after clinic sessions ended. Reasons for delayed use reflected barriers common to general medical care and barriers specific to subspecialty care. Subspecialist-specific barriers included the perceived high complexity of patients, the impact of subject matter expertise on the types of decision support needed, and unique workflow concerns such as the need to create letters to referring physicians. CONCLUSIONS: Pediatric pulmonologists demonstrated low use of a computerized decision support system for asthma care because of a combination of general and subspecialist-specific factors. Subspecialist-specific factors should not be underestimated when designing guideline-based, computerized decision support systems for the subspecialty setting.

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

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

Accuracy of a computerized clinical decision-support system for asthma assessment and management.

OBJECTIVE: To evaluate the accuracy of a computerized clinical decision-support system (CDSS) designed to support assessment and management of pediatric asthma in a subspecialty clinic. DESIGN: Cohort study of all asthma visits to pediatric pulmonology from January to December, 2009. MEASUREMENTS: CDSS and physician assessments of asthma severity, control, and treatment step. RESULTS: Both the clinician and the computerized CDSS generated assessments of asthma control in 767/1032 (74.3%) return patients, assessments of asthma severity in 100/167 (59.9%) new patients, and recommendations for treatment step in 66/167 (39.5%) new patients. Clinicians agreed with the CDSS in 543/767 (70.8%) of control assessments, 37/100 (37%) of severity assessments, and 19/66 (29%) of step recommendations. External review classified 72% of control disagreements (21% of all control assessments), 56% of severity disagreements (37% of all severity assessments), and 76% of step disagreements (54% of all step recommendations) as CDSS errors. The remaining disagreements resulted from pulmonologist error or ambiguous guidelines. Many CDSS flaws, such as attributing all 'cough' to asthma, were easily remediable. Pediatric pulmonologists failed to follow guidelines in 8% of return visits and 18% of new visits. LIMITATIONS: The authors relied on chart notes to determine clinical reasoning. Physicians may have changed their assessments after seeing CDSS recommendations. CONCLUSIONS: A computerized CDSS performed relatively accurately compared to clinicians for assessment of asthma control but was inaccurate for treatment. Pediatric pulmonologists failed to follow guideline-based care in a small proportion of patients.

Dropping the baton during the handoff from emergency department to primary care: pediatric asthma continuity errors.

BACKGROUND: The handoff of patient care from emergent to primary care physicians (PCPs) has been associated with critical safety problems, especially for children with chronic diseases. Continuity-of-information (COI) errors occur when relevant information is not transmitted effectively. Follow-up errors occur when a recommended visit or telephone contact does not take place when prescribed. A study was undertaken to assess the COI and follow-up between a tertiary care pediatric emergency department (ED) and PCPs for pediatric patients seeking acute asthma treatment. METHODS: Paper charts were reviewed for evidence of continuity of information and continuity of follow-up within the directed five-day period after an asthma exacerbation as recommended in national guidelines. RESULTS: Three-hundred fifty pediatric ED visits for asthma by patients attending these community health centers were identified. In 132 (37.7%) of the records, there was no evidence of the patient's ED visit in the record (faxed ED discharge note or handwritten note by provider). In 219 (62.6%), the faxed ED note and/or provider note was present. Illegibility did not contribute to COI errors. There was no recorded contact between patients and PCPs in 218 (62.3%) of the charts, and 11 (3.1%) indicated appointments were scheduled but missed. Follow-up was documented in the remaining 121 (34.6%) charts--109 (31.1%) in clinic and 12 (3.4%) by phone follow-up. DISCUSSION: More often than not, PCPs appeared to not know that their patients sought medical care in the ED for asthma exacerbations. The majority of patients did not follow up with their providers. More electronically automated and reliable ways of sharing information may diminish COI and follow-up errors and thereby improve patient safety.

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

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

The Yale Guideline Recommendation Corpus: a representative sample of the knowledge content of guidelines.

OBJECTIVE: To develop and characterize a large, representative sample of guideline recommendations that can be used to better understand how current recommendations are written and to test the adequacy of guideline models. We refer to this sample as the Yale Guideline Recommendation Corpus (YGRC). METHOD: To develop the YGRC, we extracted recommendations from guidelines downloaded from the National Guideline Clearinghouse (NGC). We evaluated the representativeness of the YGRC by comparing the frequency of use of controlled vocabulary terms in the YGRC sample and in the NGC. We examined semantic and formatting indicators that were used to denote recommendation statements. RESULTS: In the course of reviewing 7527 recommendation statements, we extracted 1275 recommendations from the NGC and characterized the guidelines from which they were derived. Both semantic and formatting indicators were used inconsistently to denote recommendations. Recommendation statements were not reliably identifiable in 31.6% (310/982) of the guidelines and many recommendations were not executable as written. We also found variability and inconsistency in the way strength of recommendation is currently reported. Over half of the recommendations (52.7%), did not indicate strength, while 6.5% inaccurately indicated strength. CONCLUSION: The YGRC provides a representative sample of current guideline recommendations and demonstrates considerable variability and inconsistency in the way recommendations are written and in the way the recommendation strength is currently reported.

Embedding the guideline elements model in web ontology language.

The Guideline Elements Model (GEM) uses XML to represent the heterogeneous knowledge contained in clinical practice guidelines. GEM has important applications in computer aided guideline authoring and clinical decision support systems. However, its XML representation format could limit its potential impact, as semantic web ontology languages, such as OWL, are becoming major knowledge representation frameworks in medical informatics. In this work, we present a faithful translation of GEM from XML into OWL. This translation is intended to keep the knowledge model of GEM intact, as this knowledge model has been carefully designed and has become a recognized standard. An OWL representation would make GEM more applicable in medical informatics systems that rely on semantic web. This work will also be the initial step in making GEM a guideline recommendation ontology.