Second International Guidelines for the Diagnosis and Management of Hereditary Hemorrhagic Telangiectasia.

DESCRIPTION: Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant disease with an estimated prevalence of 1 in 5000 that is characterized by the presence of vascular malformations (VMs). These result in chronic bleeding, acute hemorrhage, and complications from shunting through VMs. The goal of the Second International HHT Guidelines process was to develop evidence-based consensus guidelines for the management and prevention of HHT-related symptoms and complications. METHODS: The guidelines were developed using the AGREE II (Appraisal of Guidelines for Research and Evaluation II) framework and GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology. The guidelines expert panel included expert physicians (clinical and genetic) in HHT from 15 countries, guidelines methodologists, health care workers, health care administrators, patient advocacy representatives, and persons with HHT. During the preconference process, the expert panel generated clinically relevant questions in 6 priority topic areas. A systematic literature search was done in June 2019, and articles meeting a priori criteria were included to generate evidence tables, which were used as the basis for recommendation development. The expert panel subsequently convened during a guidelines conference to conduct a structured consensus process, during which recommendations reaching at least 80% consensus were discussed and approved. RECOMMENDATIONS: The expert panel generated and approved 6 new recommendations for each of the following 6 priority topic areas: epistaxis, gastrointestinal bleeding, anemia and iron deficiency, liver VMs, pediatric care, and pregnancy and delivery (36 total). The recommendations highlight new evidence in existing topics from the first International HHT Guidelines and provide guidance in 3 new areas: anemia, pediatrics, and pregnancy and delivery. These recommendations should facilitate implementation of key components of HHT care into clinical practice.

Creating the right evidence for system change.

Most evaluative research is focused on assessing new technologies at the patient level. Comparatively little is focused on assessing how system changes could improve the delivery of healthcare. In this article, the authors describe an opportunity to conduct evaluative trials of system changes affordably and efficiently by using a cluster randomized design and mandatory reporting data, using the prevention of Clostridium difficile infection as an example. They then describe what must be done to make similar trials a regular tool of healthcare policy.

Does this patient with diabetes have osteomyelitis of the lower extremity?

CONTEXT: Osteomyelitis of the lower extremity is a commonly encountered problem in patients with diabetes and is an important cause of amputation and admission to the hospital. The diagnosis of lower limb osteomyelitis in patients with diabetes remains a challenge. OBJECTIVE: To determine the accuracy of historical features, physical examination, and laboratory and basic radiographic testing. We searched for systematic reviews of magnetic resonance imaging (MRI) in the diagnosis of lower extremity osteomyelitis in patients with diabetes to compare its performance with the reference standard. DATA SOURCES: MEDLINE search of English-language articles published between 1966 and March 2007 related to osteomyelitis in patients with diabetes. Additional articles were identified through a hand search of references from retrieved articles, previous reviews, and polling experts. STUDY SELECTION: Original studies were selected if they (1) described historical features, physical examination, laboratory investigations, or plain radiograph in the diagnosis of lower extremity osteomyelitis in patients with diabetes mellitus, (2) data could be extracted to construct 2 x 2 tables or had reported operating characteristics of the diagnostic measure, and (3) the diagnostic test was compared with a reference standard. Of 279 articles retrieved, 21 form the basis of this review. Data from a single high-quality meta-analysis were used to summarize the diagnostic characteristics of MRI in osteomyelitis. DATA EXTRACTION: Two authors independently assigned each study a quality grade using previously published criteria and abstracted operating characteristic data using a standardized instrument. DATA SYNTHESIS: The gold standard for diagnosis is bone biopsy. No studies were identified that addressed the utility of the history in the diagnosis of osteomyelitis. An ulcer area larger than 2 cm2 (positive likelihood ratio [LR], 7.2; 95% confidence interval [CI], 1.1-49; negative LR, 0.48; 95% CI, 0.31-0.76) and a positive "probe-to-bone" test result (summary positive LR, 6.4; 95% CI, 3.6-11; negative LR, 0.39; 95% CI, 0.20-0.76) were the best clinical findings. A erythrocyte sedimentation rate of more than 70 mm/h increases the probability of a diagnosis of osteomyelitis (summary LR, 11; 95% CI, 1.6-79). An abnormal plain radiograph doubles the odds of osteomyelitis (summary LR, 2.3; 95% CI, 1.6-3.3). A positive MRI result increases the likelihood of osteomyelitis (summary LR, 3.8; 95% CI, 2.5-5.8). However, a normal MRI result makes osteomyelitis much less likely (summary LR, 0.14; 95% CI, 0.08-0.26). The overall accuracy (ie, the weighted average of the sensitivity and specificity) of the MRI is 89% (95% CI, 83.0%-94.5%). CONCLUSIONS: An ulcer area larger than 2 cm2, a positive probe-to-bone test result, an erythrocyte sedimentation rate of more than 70 mm/h, and an abnormal plain radiograph result are helpful in diagnosing the presence of lower extremity osteomyelitis in patients with diabetes. A negative MRI result makes the diagnosis much less likely when all of these findings are absent. No single historical feature or physical examination reliably excludes osteomyelitis. The diagnostic utility of a combination of findings is unknown.

"Futile" care: do we provide it? Why? A semistructured, Canada-wide survey of intensive care unit doctors and nurses.

PURPOSE: To qualitatively explore the process of the provision of futile care in Canadian intensive care units (ICUs). MATERIALS AND METHODS: A mailed, semistructured survey was sent to medical and nursing unit directors of all Canadian ICUs, asking them to estimate the frequency of provision of futile care, when care becomes "futile," the reasons such care is provided, and the resources that are available to help make end-of-life decisions. Nurse/physician agreement was assessed by chi(2) analysis or Fisher exact test. Content analysis to identify common themes was carried out by 4 raters using a Delphi process. RESULTS: The response rate was 72%. The majority reported futile therapy had been provided in their ICU over the last year (nurses, "N"=95%, physicians, "P"=87%, P=.02). The most commonly stated reasons for providing futile care were family request (N=91%, P=91%, P=NS) and attending physician request (N=91%, P=87% P=NS). Physicians were cited to provide futile care because of prognostic uncertainty (N=73%, P=84%, P=.047) and legal pressures (N=84%, P=75%, P=NS). Comment review revealed 8 main reasons why futile care was provided, the most common of which were that "death was perceived as treatment failure," and poor provider-family communication. Few providers were aware of societal (N=26%, P=51%) or local (22%, all) guidelines relating to the provision of futile care, but of those who were aware, the majority found these useful (range, 73%-74%). Twenty-seven percent expressed the need for someone to discuss difficult ethical issues, such an individual with ethics training specifically assigned to the ICU. CONCLUSIONS: Caregivers voice the opinion that provision of futile care occurs, for multiple reasons, not the least of which is provider-driven. Nurses and physicians of Canadian ICUs perceive the need for increased availability of more ICU-directed and ethically trained resources to help them in providing end-of-life care.

Probiotics for the prevention of antibiotic-associated diarrhea and Clostridium difficile infection among hospitalized patients: systematic review and meta-analysis.

BACKGROUND: Antibiotic-associated diarrhea (AAD) and Clostridium difficile infection (CDI) are associated with high morbidity, mortality, and health care costs. Probiotics may mitigate the existing disease burden. We performed a systematic review and meta-analysis to evaluate the efficacy of co-administration of probiotics with antibiotics in preventing these adverse outcomes in adult inpatients. METHODS: Systematic searches of MEDLINE (1946 to May 2012), Embase (1980 to May 2012), and the Cochrane Central Register of Controlled Trials were undertaken on May 31, 2012, to identify relevant publications. We searched for randomized controlled trials, published in English, of adult inpatients who were receiving antibiotics and who were randomly assigned to co-administration of probiotics or usual care, with or without the use of placebo. Studies were included if they reported on AAD or CDI (or both) as outcomes. Data for predetermined criteria evaluating study characteristics, methods, and risk of bias were extracted. Trials were given a global rating of good, fair, or poor by at least 2 reviewers. Meta-analyses were performed using a random-effects model, and pooled relative risks (RRs) and 95% confidence intervals (CIs) were calculated. RESULTS: Sixteen trials met the criteria for inclusion in this review. Four studies were of good quality, 5 were of fair quality, and 7 were of poor quality. Pooled analyses revealed significant reductions in the risks of AAD (RR 0.61, 95% CI 0.47 to 0.79) and CDI (RR 0.37, 95% CI 0.22 to 0.61) among patients randomly assigned to co-administration of probiotics. The number needed to treat for benefit was 11 (95% CI 8 to 20) for AAD and 14 (95% CI 9 to 50) for CDI. With subgroup analysis, significant reductions in rates of both AAD and CDI were retained in the subgroups of good-quality trials, the trials assessing a primarily Lactobacillus-based probiotic formulation, and the trials for which the follow-up period was less than 4 weeks. INTERPRETATION: Probiotics used concurrently with antibiotics reduce the risk of AAD and CDI.

How can we improve guideline use? A conceptual framework of implementability.

BACKGROUND: Guidelines continue to be underutilized, and a variety of strategies to improve their use have been suboptimal. Modifying guideline features represents an alternative, but untested way to promote their use. The purpose of this study was to identify and define features that facilitate guideline use, and examine whether and how they are included in current guidelines. METHODS: A guideline implementability framework was developed by reviewing the implementation science literature. We then examined whether guidelines included these, or additional implementability elements. Data were extracted from publicly available high quality guidelines reflecting primary and institutional care, reviewed independently by two individuals, who through discussion resolved conflicts, then by the research team. RESULTS: The final implementability framework included 22 elements organized in the domains of adaptability, usability, validity, applicability, communicability, accommodation, implementation, and evaluation. Data were extracted from 20 guidelines on the management of diabetes, hypertension, leg ulcer, and heart failure. Most contained a large volume of graded, narrative evidence, and tables featuring complementary clinical information. Few contained additional features that could improve guideline use. These included alternate versions for different users and purposes, summaries of evidence and recommendations, information to facilitate interaction with and involvement of patients, details of resource implications, and instructions on how to locally promote and monitor guideline use. There were no consistent trends by guideline topic. CONCLUSIONS: Numerous opportunities were identified by which guidelines could be modified to support various types of decision making by different users. New governance structures may be required to accommodate development of guidelines with these features. Further research is needed to validate the proposed framework of guideline implementability, develop methods for preparing this information, and evaluate how inclusion of this information influences guideline use.

The use of immunoglobulin therapy for patients undergoing solid organ transplantation: an evidence-based practice guideline.

This guideline for the use of immunoglobulin (IG) for sensitized patients undergoing solid organ transplantation (SOT) is an initiative of the Canadian Blood Services and the National Advisory Committee on Blood and Blood Products of Canada to (1) provide guidance for Canadian practitioners involved in the care of patients undergoing SOT and transfusion medicine specialists on the use of IG and (2) standardize care, limit adverse events, and optimize patient care. A systematic expert and bibliography literature search up to July 2008 was conducted, with 791 literature citations and 45 reports reviewed. To validate the recommendations, the guideline was sent to physicians involved in SOT in Canada and a patient representative. The recommendations identify (1) sensitized patients undergoing SOT that would have a better survival and decreased morbidity by receiving IG preoperatively, postoperatively, and for the treatment of organ rejection; (2) patients who may not have any benefit from receiving IG; and (3) potential adversities to IG.

Commentary: the right time to rethink part-time careers.

The demand for part-time academic positions is bound to increase because of the changing demographics of medicine and the needs of both women and men faculty. One of the main benefits of working part-time is the freedom to shape a career that is tailored to one's individualized life needs. Studies indicate that part-time faculty may enhance quality of care, patient satisfaction, resource utilization, and productivity. Division chiefs and department chairs who have flexible hiring policies to meet the needs of part-time faculty are likely to be more successful in recruitment and retention. The authors describe some of the benefits and drawbacks of part-time work, and they offer advice for faculty members seeking part-time careers and for leaders seeking to employ them.

An exploration of how guideline developer capacity and guideline implementability influence implementation and adoption: study protocol.

BACKGROUND: Practice guidelines can improve health care delivery and outcomes but several issues challenge guideline adoption, including their intrinsic attributes, and whether and how they are implemented. It appears that guideline format may influence accessibility and ease of use, which may overcome attitudinal barriers of guideline adoption, and appear to be important to all stakeholders. Guideline content may facilitate various forms of decision making about guideline adoption relevant to different stakeholders. Knowledge and attitudes about, and incentives and capacity for implementation on the part of guideline sponsors may influence whether and how they develop guidelines containing these features, and undertake implementation. Examination of these issues may yield opportunities to improve guideline adoption. METHODS: The attributes hypothesized to facilitate adoption will be expanded by thematic analysis, and quantitative and qualitative summary of the content of international guidelines for two primary care (diabetes, hypertension) and institutional care (chronic ulcer, chronic heart failure) topics. Factors that influence whether and how guidelines are implemented will be explored by qualitative analysis of interviews with individuals affiliated with guideline sponsoring agencies. DISCUSSION: Previous research examined guideline implementation by measuring rates of compliance with recommendations or associated outcomes, but this produced little insight on how the products themselves, or their implementation, could be improved. This research will establish a theoretical basis upon which to conduct experimental studies to compare the cost-effectiveness of interventions that enhance guideline development and implementation capacity. Such studies could first examine short-term outcomes predictive of guideline utilization, such as recall, attitude toward, confidence in, and adoption intention. If successful, then long-term objective outcomes reflecting the adoption of processes and associated patient care outcomes could be evaluated.

Canadian Thoracic Society: Presenting a new process for clinical practice guideline production.

A key mandate of the Canadian Thoracic Society (CTS) is to promote evidence-based respiratory care through clinical practice guidelines (CPGs). To improve the quality and validity of the production, dissemination and implementation of its CPGs, the CTS has revised its guideline process and has created the Canadian Respiratory Guidelines Committee to oversee this process. The present document outlines the basic methodological tools and principles of the new CTS guideline production process. Important features include standard methods for choosing and formulating optimal questions and for finding, appraising, and summarizing the evidence; use of the Grading of Recommendations Assessment, Development and Evaluation system for rating the quality of evidence and strength of recommendations; use of the Appraisal of Guidelines for Research and Evaluation instrument for quality control during and after guideline development and for appraisal of other guidelines; use of the ADAPTE process for adaptation of existing guidelines to the local context; and use of the GuideLine Implementability Appraisal tool to augment implementability of guidelines. The CTS has also committed to develop guidelines in new areas, an annual guideline review cycle, and a new formal process for dissemination and implementation. Ultimately, it is anticipated that these changes will have a significant impact on the quality of care and clinical outcomes of individuals suffering from respiratory diseases across Canada.