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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.

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.

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., (Copyright © 2013 Longwoods Publishing.)

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.

Background: HHT is an autosomal dominant disease with an estimated prevalence of at least 1/5000 which can frequently be complicated by the presence of clinically significant arteriovenous malformations in the brain, lung, gastrointestinal tract and liver. HHT is under-diagnosed and families may be unaware of the available screening and treatment, leading to unnecessary stroke and life-threatening hemorrhage in children and adults., Objective: The goal of this international HHT guidelines process was to develop evidence-informed consensus guidelines regarding the diagnosis of HHT and the prevention of HHT-related complications and treatment of symptomatic disease., Methods: The overall guidelines process was developed using the AGREE framework, using a systematic search strategy and literature retrieval with incorporation of expert evidence in a structured consensus process where published literature was lacking. The Guidelines Working Group included experts (clinical and genetic) from eleven countries, in all aspects of HHT, guidelines methodologists, health care workers, health care administrators, HHT clinic staff, medical trainees, patient advocacy representatives and patients with HHT. The Working Group determined clinically relevant questions during the pre-conference process. The literature search was conducted using the OVID MEDLINE database, from 1966 to October 2006. The Working Group subsequently convened at the Guidelines Conference to partake in a structured consensus process using the evidence tables generated from the systematic searches., Results: The outcome of the conference was the generation of 33 recommendations for the diagnosis and management of HHT, with at least 80% agreement amongst the expert panel for 30 of the 33 recommendations.

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.

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.

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.

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.

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.

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.

Unlabelled: Aims Foundry work has been associated with an increased risk of adverse cardiovascular events. The objective of this review was systematically and qualitatively to review the published literature to determine whether foundry work is significantly associated with cardiac disease., Methods: MEDLINE and Cochrane databases were systematically searched to identify relevant English-language publications between 1966 and October 2002. Articles were rated as 'good', 'fair' or 'poor', using published quality review criteria. Additionally, variables suggesting causality were extracted. A qualitative summation of the literature was presented for two scenarios: all studies, or using only studies rated 'fair' and above., Results: Fourteen studies were analysed. Four were found to be of 'fair' quality, the remainder 'poor'. No 'good' quality studies were found. Nine studies show increased cardiac mortality among foundry worker groups and four studies also show a decreased risk. When only 'fair' quality studies are taken into consideration, two support increased risk of cardiac disease, one supports a protective effect of foundry work on cardiac disease and one revealed both increased and decreased risk for different cardiac outcomes., Conclusions: The exploration of foundry workers' risks of cardiac events reveals conflicting findings, which can only be partly attributed to confounders. Further prospective research to establish the independent contribution of foundry work to cardiac disease is needed.

Objective: To determine whether systemic corticosteroids are of benefit to patients with acute exacerbations of chronic obstructive pulmonary disease (COPD)., Methods: An English-language search of MEDLINE (1966 to February 2002) and the Cochrane Library and a bibliographic review was performed to identify published clinical trials of systemic corticosteroid administration in acute exacerbations of COPD. All relevant English-language, randomized, placebo-controlled clinical trials were considered. Trials investigating the adverse effects of systemic steroids were also retrieved. Studies were assigned a quality rating according to explicit criteria. Clinically relevant end points, such as treatment failure and duration of hospital stay, were considered preferentially. To compare outcomes across all qualifying studies, we considered the difference in spirometric measures between treatment and placebo groups. Potential confounding factors and bias relating to patient selection, treatment protocols, and outcome measurement were considered independently for each study., Results: Among the 8 studies that met all criteria, 5 found that significant improvement in forced expiratory volume in 1 second (>20%) was associated with steroid administration. Two studies found improvement in clinically relevant outcomes. One published study and 2 study abstracts did not find significant improvement in spirometric measures with corticosteroid administration., Conclusion: Short courses of systemic corticosteroids in acute exacerbations of COPD have been shown to improve spirometric outcomes (good-quality evidence) and clinical outcomes (good-quality evidence).

Objective: To review evidence about the benefit of intensive glycemic control for patients with type 2 diabetes and to develop practice recommendations., Participants: A 9-member panel composed of family physicians, general internists, endocrinologists, and a practice guidelines methodologist was assembled by the American Academy of Family Physicians, the American Diabetes Association, and the American College of Physicians., Evidence: Admissible evidence included published randomized controlled trials and observational studies regarding the effects of glycemic control on microvascular and macrovascular complications and on adverse effects. We followed systematic search and data abstraction procedures. Greater weight was given to clinical trials and to evidence about health outcomes., Consensus Process: Interpretations of evidence and approval of documents were finalized by unanimous vote, with recommendations linked to evidence and not expert opinion. The full report was prepared by the chair and 2 panel members, representing each of the 3 organizations. The initial draft underwent external review by 14 diabetologists and family physicians and changes consistent with the evidence were incorporated., Conclusions: The evidence demonstrates that the risk of microvascular and neuropathic complications is reduced by lowering glucose concentrations. Whether glycemic control affects macrovascular outcomes is less clear. The potential benefits of glycemic control must be balanced against factors that either preempt benefits (eg, limited life expectancy, comorbid disease) or increase risk (eg, severe hypoglycemia). The magnitude of benefit is a function of individual clinical variables (eg, baseline glycated hemoglobin level, presence of preexisting microvascular disease). Appropriate targets for treatment should be determined by considering these factors, patients' risk profiles, and personal preferences.

Purpose: Along with evidence, clinical policies must take patients' values into account. Particularly where evidence is limited and where assumptions of utility-maximizing behavior may not be valid, new methods such as trade-off techniques (TOTs), which allow elicitation of patients' treatment alternatives, might be useful in policy formulation. We used TOTs to assess breast cancer patients' attitudes toward two clinical policies designed to ration adjuvant postlumpectomy breast radiation therapy., Methods: Cross-sectional interviews were performed in a tertiary cancer center. A total of 102 patients were presented with information about the side effects and benefits associated with two hypothetical decisions: (1) willingness to receive treatment elsewhere to shorten the wait for radiation therapy, and (2) foregoing radiation therapy in the face of small marginal benefits. For each scenario, a TOT was used to identify the maximal acceptable wait time (MAWT) for therapy and the benefit threshold at which the patient would forego therapy. Associations of clinical and demographic factors with these decisions were determined by regression analysis., Results: Patients would be willing to wait, on average, 7 weeks before wanting to leave their city for radiation therapy, less than the 13-week delay our patients actually faced. Older patients were less willing to wait (P = .013); 46% of patients would not give up radiation therapy, even in the face of no stated benefit. Willingness to give up radiation therapy was predicted by willingness to accept delay (odds ratio [OR], 1.84; 95% confidence interval [CI], 1.05 to 3.37) and being employed (OR, 2.61; 95% CI, 1.08 to 6.54). Patients with larger tumors were less willing to give up radiation therapy (OR, 0.57; 95% CI, 0.31 to 0.97)., Conclusion: Even in difficult decisions such as rationing postlumpectomy breast cancer radiation therapy, TOTs can inform policy formulation by indicating the distributions of patients' preferences.

Purpose: To summarize available evidence on preoperative cardiac risk stratification so that the internist may 1) use clinical and electrocardiographic findings to stratify a patient's perioperative risk for myocardial infarction and death; 2) decide which tests provide useful additional risk-related information; and 3) understand the benefits, risks, and evidence surrounding the decision to undertake coronary revascularization before elective noncardiac surgery., Data Sources: A MEDLINE search and review of the reference lists of identified articles. Sensitivities, specificities, and likelihood ratios for diagnostic tests were calculated, and a quality rating for study methods was applied., Data Extraction: Myocardial infarction and mortality were the major outcomes considered, and a quality rating for study methods was applied., Data Synthesis: Clinical and electrocardiographic findings, organized by multivariate prediction indices, accurately identify patients as having low, intermediate, or high risk for myocardial infarction or death. Pharmacologic stress imaging with thallium or echocardiography probably improves risk stratification for intermediate-risk patients having vascular surgery. These tests have not been shown to be effective prognostic indicators for patients having nonvascular surgery. No studies of angiography for risk prediction have been reported. Decision analyses and retrospective series suggest that the risks incurred by doing coronary angiography and revascularization before elective surgery outweigh the benefits. Prospective, controlled studies of coronary revascularization are lacking. Evidence from a randomized, controlled trial has shown a survival benefit with the perioperative use of beta-blockers in patients at risk for coronary artery disease., Conclusions: Evaluation of all surgical patients by use of clinical indices is recommended. Low-risk patients need no further evaluation before surgery. High-risk patients need optimal management of their high-risk problems, including (if appropriate) beta-blocker use, and may need to have their elective procedures canceled. Intermediate-risk patients probably benefit from further noninvasive stress testing, especially if they are having vascular surgery. Further clinical trials are needed for most areas of concern.

Purpose: To describe the change in use of tamoxifen over time and across countries in Ontario., Methods: Data from the Ontario Drug Benefit (ODB) plan, Census Canada, and the Ontario Cancer Registry (OCR) were combined and analysed to determine rates of tamoxifen use for females over 65 for each county and the province overall, by year. Rates were analyzed by repeated measures ANOVA to determine significance of changes over time. Consistency of tamoxifen use across counties was determined by the Spearman rank correlation coefficient, and overall variation between counties was described using three statistical techniques: Chi-square analysis, the extremal quotient (EQ), and the systematic component of variation (SCV)., Results: The number of one-month tamoxifen prescriptions per incident case of breast cancer rose significantly from 13.51 in 1985 to 20.54 in 1990 (p < 0.001) and to 34.06 in 1992 (p = 0.001). Viewed differently, the number of women over 65 receiving tamoxifen prescriptions per incident case of breast cancer changed from 1.91 in 1985 to 3.14 in 1990 to 4.54 in 1992. Statistically significant variation in the rate of tamoxifen prescribing was demonstrated between Ontario counties in all three years by Chi Squared analysis (p < 0.0001). Both the EQ and the SCV declined from 1985 to 1990, suggesting more uniform prescribing across the province. Little change in overall variation was seen between 1990 and 1992. All counties over time tended to prescribe generic preparations more often and shifted from 10 mg to 20 mg formulations., Conclusions: The significant increase in the rate of tamoxifen use and trend towards more uniform prescribing across Ontario between 1985 and 1990 coincided with the publication of two important documents outlining the benefits of tamoxifen in early breast cancer. Despite this trend, variation in tamoxifen use between counties remains. There has been little change in uniformity of prescribing since 1990.