Report of the Canadian Hypertension Society Consensus Conference: 2. Nonpharmacologic management and prevention of hypertensive disorders in pregnancy

OBJECTIVE: To provide Canadian physicians with comprehensive, evidence-based guidelines for the nonpharmacologic management and prevention of gestational hypertension and pre-existing hypertension during pregnancy. OPTIONS: Lifestyle modifications, dietary or nutrient interventions, plasma volume expansion and use of prostaglandin precursors or inhibitors. OUTCOMES: In gestational hypertension, prevention of complications and death related to either its occurrence (primary or secondary prevention) or its severity (tertiary prevention). In pre-existing hypertension, prevention of superimposed gestational hypertension and intrauterine growth retardation. EVIDENCE: Articles retrieved from the pregnancy and childbirth module of the Cochrane Database of Systematic Reviews; pertinent articles published from 1966 to 1996, retrieved through a MEDLINE search; and review of original randomized trials from 1942 to 1996. If evidence was unavailable, consensus was reached by the members of the consensus panel set up by the Canadian Hypertension Society. VALUES: High priority was given to prevention of adverse maternal and neonatal outcomes in pregnancies with established hypertension and in those at high risk of gestational hypertension through the provision of effective nonpharmacologic management. BENEFITS, HARMS AND COSTS: Reduction in rate of long-term hospital admissions among women with gestational hypertension, with establishment of safe home-care blood pressure monitoring and appropriate rest. Targeting prophylactic interventions in selected high-risk groups may avoid ineffective use in the general population. Cost was not considered. RECOMMENDATION: Nonpharmacologic management should be considered for pregnant women with a systolic blood pressure of 140-150 mm Hg or a diastolic pressure of 90-99 mm Hg, or both, measured in a clinical setting. A short-term hospital stay may be required for diagnosis and for ruling out severe gestational hypertension (preeclampsia). In the latter case, the only effective treatment is delivery. Palliative management, dependent on blood pressure, gestational age and presence of associated maternal and fetal risk factors, includes close supervision, limitation of activities and some bed rest. A normal diet without salt restriction is advised. Promising preventive interventions that may reduce the incidence of gestational hypertension, especially with proteinuria, include calcium supplementation (2 g/d), fish oil supplementation and low-dose acetylsalicylic acid therapy, particularly in women at high risk for early-onset gestational hypertension. Pre-existing hypertension should be managed the same way as before pregnancy. However, additional concerns are the effects on fetal well-being and the worsening of hypertension during the second half of pregnancy. There is, as yet, no treatment that will prevent exacerbation of the condition. VALIDATION: The guidelines share the principles in consensus reports from the US and Australia on the nonpharmacologic management of hypertension in pregnancy.     

Canadian asthma consensus report, 1999

OBJECTIVES: To provide physicians with current guidelines for the diagnosis and optimal management of asthma in children and adults, including pregnant women and the elderly, in office, emergency department, hospital and clinic settings. OPTIONS: The consensus group considered the roles of education, avoidance of provocative environmental and other factors, diverse pharmacotherapies, delivery devices and emergency and in-hospital management of asthma. OUTCOMES: Provision of the best control of asthma by confirmation of the diagnosis using objective measures, rapid achievement and maintenance of control and regular follow-up. EVIDENCE: The key diagnostic and therapeutic recommendations are based on the 1995 Canadian guidelines and a critical review of the literature by small groups before a full meeting of the consensus group. Recommendations are graded according to 5 levels of evidence. Differences of opinion were resolved by consensus following discussion. VALUES: Respirologists, immunoallergists, pediatricians and emergency and family physicians gave prime consideration to the achievement and maintenance of optimal control of asthma through avoidance of environmental inciters, education of patients and the lowest effective regime of pharmacotherapy to reduce morbidity and mortality. BENEFITS, HARMS AND COSTS: Adherence to the guidelines should be accompanied by significant reduction in patients'' symptoms, reduced morbidity and mortality, fewer emergency and hospital admissions, fewer adverse side-effects from medications, better quality of life for patients and reduced costs. RECOMMENDATIONS: Recommendations are included in each section of the report. In summary, after a diagnosis of asthma is made based on clinical evaluation, including demonstration of variable airflow obstruction, and contributing factors are identified, a treatment plan is established to obtain and maintain optimal asthma control. The main components of treatment are patient education, environmental control, pharmacotherapy tailored to the individual and regular follow-up. VALIDATION: The recommendations were distributed to the members of the Canadian Thoracic Society Asthma and Standards Committees, as well as members of the board of the Canadian Thoracic Society. In addition, collaborating groups representing the Canadian Association of Emergency Physicians, the Canadian College of Family Physicians, the Canadian Paediatric Society and the Canadian Society of Allergy and Immunology were asked to validate the recommendations. The recommendations were discussed at regional meetings throughout Canada. They were also compared with the recommendations of other similar groups in other countries. DISSEMINATION AND IMPLEMENTATION: An implementation committee has established a strategy for disseminating these guidelines to physicians, other health professionals and patients and for developing tools and means that will help integrate the recommendations into current asthma care. The plan is outlined in this report.     

Video-Assisted Thoracic Surgery for Lung Cancer Resection: A Consensus Statement of the International Society of Minimally Invasive Cardiothoracic Surgery (ISMICS) 2007

OBJECTIVE:: The purpose of this consensus conference was to determine whether video-assisted thoracic surgery (VATS) improves clinical and resource outcomes compared with conventional thoracotomy (OPEN) in adults undergoing lobectomy for lung cancer, and to outline evidence-based recommendations for the use of VATS in performing lobectomy for lung cancer. METHODS:: Before the consensus conference, the best available evidence was reviewed in that systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. At the consensus conference, evidence-based statements were created, and consensus processes were used to determine the ensuing recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of recommendation. RESULTS AND RECOMMENDATIONS:: The consensus panel agreed upon the following statements and recommendations in patients with clinical stage I nonsmall cell lung cancer undergoing lung lobectomy:     

Do consensus conferences influence their participants?

OBJECTIVE: To determine whether participation in a consensus conference on the assessment of dementia would influence conference participants with respect to their recommendations to primary care physicians for the assessment of dementia. DESIGN: Questionnaire before and after the conference. SETTING: Canadian Consensus Conference on the Assessment of Dementia, held in Montreal, Oct. 5 and 6, 1989. PARTICIPANTS: All 38 experts representing relevant health disciplines who participated in the consensus conference; 36 completed both questionnaires. OUTCOME MEASURES: Participants'' opinion before and after the conference as to how frequently each of 28 manoeuvres (12 blood tests, 4 neurologic imaging procedures, 4 types of consultation and 8 "other" tests) should be ordered by primary care physicians as part of an assessment of a patient with dementia suspected in clinical grounds. RESULTS: For 18 (64%) of the 28 manoeuvres (10 of the 12 blood tests, 3 of the 4 neurologic imaging procedures and 5 of the 8 "other" tests), there was a shift in opinion after the conference toward recommending that primary care physicians order them less often; for 10 of these 18 (5 blood tests and 5 "other" tests) the shift was statistically significant. For the remaining 10 manoeuvres (36%) the shift in opinion was toward a recommendation that primary care physicians order them more often; the shift was not statistically significant for any of these 10 manoeuvres. CONCLUSION: Expert members of a consensus conference are influenced by the process of having participated in such a conference and are capable and willing to chance their initial recommendations when confronted with relevant data.     

Report of the Canadian Hypertension Society's consensus conference on the management of mild hypertension.

Since the publication in 1977 of joint recommendations by the Canadian Cardiovascular Society, the Canadian Heart Foundation and the Ontario Council of Health on the detection and management of hypertension in Canada, several clinical trials on the efficacy of antihypertensive drug treatment in patients with mild hypertension have been undertaken. The Canadian Hypertension Society (CHS) felt that the results of these trials should be reviewed to determine whether existing recommendations on treatment should be changed. Three expert panels appointed by the CHS reviewed evidence on the clinical efficacy of antihypertensive therapy, the diagnosis of hypertension and the treatment of mild hypertension, and formulated recommendations on the care of mildly hypertensive patients in Canada. A consensus conference of biomedical scientists, practising physicians and government representatives reviewed and reached agreement on the panels'' recommendations. The final recommendations of the conference are presented in this report.     

Guidelines for the emergency management of asthma in adults. CAEP/CTS Asthma Advisory Committee. Canadian Association of Emergency Physicians and the Canadian Thoracic Society.

OBJECTIVE: To develop a set of comprehensive, standardized evidence-based guidelines for the assessment and treatment of acute asthma in adults in the emergency setting. OPTIONS: The use of medications was evaluated by class, dose, route, onset of action and optimal mode of delivery. The use of objective measurements and clinical features to assess response to therapy were evaluated in relation to the decision to admit or discharge the patient or arrange for follow-up care. OUTCOMES: Control of symptoms and disease reflected in hospital admission rates, frequency of treatment failures following discharge, resolution of symptoms and improvement of spirometric test results. EVIDENCE: Previous guidelines, articles retrieved through a search of MEDLINE, emergency medical abstracts and information from members of the expert panel were reviewed by members of the Canadian Association of Emergency Physicians (CAEP) and the Canadian Thoracic Society. Where evidence was not available, consensus was reached by the expert panel. The resulting guidelines were reviewed by members of the parent organizations. VALUES: The evidence-based methods and values of the Canadian Task Force on the Periodic Health Examination were used. BENEFITS, HARMS AND COSTS: As many as 80% of the approximate 400 deaths from asthma each year in Canada are felt to be preventable. The use of guidelines, aggressive emergency management and consistent use of available options at discharge are expected to decrease the rates of unnecessary hospital admissions and return visits to emergency departments because of treatment failures. Substantial decreases in costs are expected from the use of less expensive drugs, or drug delivery systems, fewer hospital admissions and earlier return to full activity after discharge. RECOMMENDATIONS: Beta2-agonists are the first-line therapy for the management of acute asthma in the emergency department (grade A recommendation). Bronchodilators should be administered by the inhaled route and titrated using objective and clinical measures of airflow limitation (grade A). Metered-dose inhalers are preferred to wet nebulizers, and a chamber (spacer device) is recommended for severe asthma (grade A). Anticholinergic therapy should be added to beta 2 agonist therapy in severe and life-threatening cases and may be considered in cases of mild to moderate asthma (grade A). Aminophylline is not recommended for use in the first 4 hours of therapy (grade A). Ketamine and succinylcholine are recommended for rapid sequence intubation in life-threatening cases (grade B). Adrenaline (administered subcutaneously or intravenously), salbutamol (administered intravenously) and anesthetics (inhaled) are recommended as alternatives to conventional therapy in unresponsive life-threatening cases (grade B). Severity of airflow limitation should be determined according to the forced expiratory volume at 1 second or the peak expiratory flow rate, or both, before and after treatment and at discharge (grade A). Consideration for discharge should be based on both spirometric test results and assessment of clinical risk factors for relapse (grade A). All patients should be considered candidates for systemic corticosteroid therapy at discharge (grade A). Those requiring corticosteroid therapy should be given 30 to 60 mg of prednisone orally (or equivalent) per day for 7 to 14 days; no tapering is required (grade A). Inhaled corticosteroids are an integral component of therapy and should be prescribed for all patients receiving oral corticosteroid therapy at discharge (grade A). Patients should be given a discharge treatment plan and clear instructions for follow-up care (grade C). VALIDATION: The guidelines share the same principles of those from the British Thoracic Society and the National Institutes of Health. Two specific validation initiatives have been undertaken: (a) several Canadian centres have been involved in the collection of comprehensive administrative data to assess compliance and outcome measures and (b) a survey of Canadian emergency physicians conducted to gather baseline informaton of treatment patterns, was conducted before development of the guidelines and will be repeated to re-evaluate emergency management of asthma.     

Stentless Versus Stented Bioprosthetic Aortic Valves: A Consensus Statement of the International Society of Minimally Invasive Cardiothoracic Surgery (ISMICS) 2008

OBJECTIVE:: The purpose of this consensus conference was to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement, and to outline evidence-based recommendations for the use of stentless and stented bioprosthetic valves in adult aortic valve replacement. METHODS:: Before the consensus conference, the best available evidence was reviewed in that systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. At the consensus conference, evidence-based statements were created, and consensus processes were used to determine the ensuing recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of recommendation. RESULTS AND RECOMMENDATIONS:: Seventeen randomized studies published in 23 articles involving 1317 patients, and 14 nonrandomized trial published in 18 articles involving 2485 patients were included in the meta-analysis and consensus conference. All randomized trials inserted the stentless bioprosthetic valves in the subcoronary configuration. The consensus panel agreed upon the following statements and recommendations in patients undergoing aortic valve replacement:Because there were no randomized control trial comparing subcoronary stentless prosthetic valve and root replacement, the following recommendations are derived from expert opinion:     

Diagnosis and treatment of dementia: 5. Nonpharmacologic and pharmacologic therapy for mild to moderate dementia

Background

Practising physicians frequently seek advice on the most effective interventions for dementia. In this article, we provide practical guidance on nonpharmacologic and pharmacologic interventions for the management of mild to moderate dementia based on recommendations from the Third Canadian Consensus Conference on the Diagnosis and Treatment of Dementia.

Methods

We developed evidence-based guidelines using systematic literature searches, with specific criteria for the selection and quality assessment of articles, and a clear and transparent decision-making process. We selected articles published from January 1996 to December 2005 that dealt with the management of mild to moderate stages of Alzheimer disease and other forms of dementia. Recommendations based on the literature review were drafted and voted on. Consensus required 80% or more agreement by participants. Subsequent to the conference, we searched for additional articles published from January 2006 to April 2008 using the same major keywords and secondary search terms. We graded the strength of the evidence using the criteria of the Canadian Task Force on Preventive Health Care.

Results

We identified 1615 articles, of which 954 were selected for further study. From a synthesis of the evidence in these studies, we made 48 recommendations for the management of mild to moderate dementia (28) and dementia with a cerebrovascular component (8) as well as recommendations for addressing ethical issues (e.g., disclosure of the diagnosis) (12). The updated literature review did not change these recommendations. An exercise program is recommended for patients with mild to moderate dementia. Physicians should decide whether to prescribe a cholinesterase inhibitor on an individual basis, balancing anticipated benefits with the potential for harm. For mild mood and behavioural concerns, nonpharmacologic approaches should be considered first.

Interpretation

Although the available therapies for dementia can help with the management of symptoms, there is a need to develop more effective interventions.

Articles to date in this series

• Chertkow H. Diagnosis and treatment of dementia: Introduction. Introducing a series based on the Third Canadian Consensus Conference on the Diagnosis and Treatment of Dementia. CMAJ 2008;178:316-21.
• Patterson C, Feightner JW, Garcia A, et al. Diagnosis and treatment of dementia: 1. Risk assessment and primary prevention of Alzheimer disease. CMAJ 2008;178:548-56.
• Feldman HH, Jacova C, Robillard A, et al. Diagnosis and treatment of dementia: 2. Diagnosis. CMAJ 2008;178:825-36.
• Chertkow H, Massoud F, Nasreddine Z, et al. Diagnosis and treatment of dementia: 3. Mild cognitive impairment and cognitive impairment without dementia. CMAJ 2008;178:1273-85.
• Hogan DB, Bailey P, Black S, et al. Diagnosis and treatment of dementia: 4. Approach to management of mild to moderate dementia. CMAJ 2008;179:787-93.

     

Clinical guidelines contribute to the health inequities experienced by individuals with intellectual disabilities

ABSTRACT: BACKGROUND: Clinical practice guidelines are developed to improve the quality of healthcare. However, clinical guidelines may contribute to health inequities experienced by disadvantaged groups. This study uses an equity lens developed by the International Clinical Epidemiology Network (INCLEN) to examine how well clinical guidelines address inequities experienced by individuals with intellectual disabilities. METHODS: Nine health problems relevant to the health inequities experienced by persons with intellectual disabilities were selected. Clinical guidelines on these disorders were identified from across the world. The INCLEN equity lens was used as the basis for a purposedesigned, semistructured data collection tool. Two raters independently examined each guideline and completed the data collection tool. The data extracted by each rater were discussed at a research group consensus conference and agreement was reached on a final equity lens rating for each guideline. RESULTS: Thirty-six guidelines were identified, one of which (2.8%) explicitly excluded persons with intellectual disabilities. Of the remaining 35, six (17.1%) met the first criterion of the equity lens, identifying persons with intellectual disabilities at high risk for the specific health problem. Eight guidelines (22.9%) contained any content on intellectual disabilities. Six guidelines addressed the fourth equity lens criterion, by giving specific consideration to the barriers to implementation of the guideline in disadvantaged populations. There were no guidelines that addressed the second, third, and fifth equity lens criteria. CONCLUSIONS: The equity lens is a useful tool to systematically examine whether clinical guidelines address the health needs and inequities experienced by disadvantaged groups. Clinical guidelines are likely to further widen the health inequities experienced by persons with intellectual disabilities, and other disadvantaged groups, by being preferentially advantageous to the general population. There is a need to systematically incorporate methods to consider disadvantaged population groups into the processes used to develop clinical guidelines.     

Practice patterns of mitochondrial disease physicians in North America. Part 2: treatment,care and management

Mitochondrial medicine is a young subspecialty. Clinicians have limited evidence-based guidelines on which to formulate clinical decisions regarding diagnosis, treatment and management for patients with mitochondrial disorders. Mitochondrial medicine specialists have cobbled together an informal set of rules and paradigms for preventive care and management based in part on anecdotal experience. The Mitochondrial Medicine Society (MMS) assessed the current state of clinical practice including diagnosis, preventive care and treatment, as provided by various mitochondrial disease providers in North America. In this second of two reports, we present data related to clinical practice that highlight the challenges clinicians face in the routine care of patients with established mitochondrial disease. Concerning variability in treatment and preventative care approaches were noted. We hope that sharing this information will be a first step toward formulating a set of consensus criteria and establishing standards of care.     

Canadian physicians' attitudes about and preferences regarding clinical practice guidelines

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

Courts,licensing bodies turning their attention to alternative therapies

The growing interest in alternative medicine has come to the attention of both Canadian licensing bodies and the courts. Two recent cases, a disciplinary hearing and a medical-malpractice action, illustrate that physicians need to understand the range and complexity of issues surrounding nonconventional therapies and their clinical use.     

Short-course therapy for tuberculosis in infants and children. Infectious Diseases and Immunization Committee,Canadian Paediatric Society.

OBJECTIVE: To improve efficacy of and compliance with therapy for tuberculosis in children. OPTIONS: Short-course (6-month) multi-drug therapy, either non-supervised or directly supervised, versus long-course (more than 6-month) multi-drug therapy. OUTCOMES: Success (more than 90% of cases cured without relapse or serious side effects), development of drug resistance and compliance with treatment. EVIDENCE: Review of published reports of efficacy trials of tuberculosis therapy in children, side effects and compliance studies; consensus of expert opinion. VALUES: Values were assigned to the evidence by the Infectious Disease and Immunization Committee of the Canadian Paediatric Society through review of the data and consensus. BENEFITS, HARMS AND COSTS: Improved efficacy and compliance with short-course protocols should lower the rate of treatment failure among children in Canada and the cost of tuberculosis care. RECOMMENDATIONS: A short-course (6-month) protocol of four drugs for the first 2 months and two drugs for the subsequent 4 months is recommended to treat pulmonary tuberculosis or extrapulmonary disease causing lymphadenopathy. Tuberculous meningitis, disease involving bones and joints and tuberculosis with HIV infection require longer courses of treatment. Asymptomatic tuberculosis should be treated with daily doses of isoniazid for 9 months. Intermittent directly observed therapy is recommended if compliance cannot be ensured. Routine liver function testing is not recommended for prepubescent children taking isoniazid, but monthly assessment for clinical symptoms and periodic liver function evaluation is advised in adolescent women, especially post partum. VALIDATION: This report was reviewed by the directors of the Canadian Paediatric Society, the Hepatitis and Special Pathogens Division of the Laboratory Centre for Disease Control and the Canadian Thoracic Society. The recommendations are similar to those of the American Academy of Pediatrics. SPONSOR: The recommendations were developed and endorsed by the Infectious Disease and Immunization Committee of the Canadian Paediatric Society.     

Indicators of quality of care for patients with acute myocardial infarction

Background

There is a wide practice gap between optimal and actual care for patients with acute myocardial infarction in hospitals around the world. We undertook this initiative to develop an updated set of evidence-based indicators to measure and improve the quality of care for this patient population.

Methods

A 12-member expert panel was convened in 2007 to develop an updated set of quality indicators for acute myocardial infarction. The panel identified a list of potential indicators after reviewing the scientific literature, clinical practice guidelines and other published quality indicators. To develop the new list of indicators, the panel rated each potential indicator on 4 dimensions (reliability, validity, feasibility and usefulness in improving patient outcomes) and discussed the top-ranked quality indicators at a consensus meeting.

Results

Consensus was reached on 38 quality indicators: 17 that would be measurable using chart-abstracted data and 21 that would be measurable using administrative data. Of the 17 chart-review indicators, 13 address pharmacologic and nonpharmacologic care delivered to patients in hospital. In-hospital mortality was recommended as a key outcome indicator. Three system indicators were recommended to measure the collaborative responsiveness of the health care system from the call for help to intervention. It was recommended that hospitals strive for a minimum target benchmark of 90% or greater on process-of-care indicators.

Interpretation

Implementation of strategies by clinicians and hospitals to meet target benchmarks on these quality indicators could save the lives of many individuals with acute myocardial infarction.There is a large practice gap between optimal and actual patterns of care for patients with acute myocardial infarction in hospitals around the world.¹ Acute myocardial infarction is a highly treatable condition for which many advances in treatment have occurred over the past several decades. However, the uptake of many of these advances and their incorporation into routine clinical practice has often lagged behind their development and publication in clinical journals by many years.^2–4 To reduce this gap and improve quality of care, many jurisdictions are using indicators of the quality of care for patients with acute myocardial infarction. These quality indicators are intended to measure adherence to selected key clinical practice guidelines in routine clinical care and serve as a foundation for efforts to improve quality.⁵ They define the minimum standard of care that might be expected for all “ideal” patients who meet certain criteria and have no contraindications for a given health care intervention.National organizations in Canada, the United States, the United Kingdom and other OECD (the Organisation for Economic Co-operation and Development) countries have all developed indicators to measure and improve the quality of care for patients with acute myocardial infarction both within and across countries, regions and hospitals.^6–9 In 2003, the Canadian Cardiovascular Outcomes Research Team (a Canadian Institutes of Health Research Interdisciplinary Health Research Team) worked in association with the Canadian Cardiovascular Society to develop and publish the first set of quality indicators for myocardial infarction in Canada.⁶ The Canadian Cardiovascular Outcomes Research Team comprises more than 30 leading outcome researchers who work together on projects to measure and improve cardiac care. From the outset, we recognized that the indicators would need to be modified over time to reflect changes in practice guidelines and clinical evidence. In 2007, a Canadian expert panel was convened by the Canadian Cardiovascular Outcomes Research Team to develop and recommend a set of quality indicators that took into account the best indicators developed elsewhere and that also included some unique indicators that were felt to be of particular relevance and use to Canadian clinicians and hospitals.     

An evidence-based approach to the management of uninvestigated dyspepsia in the era of Helicobacter pylori

OBJECTIVES: To provide Canadian primary care physicians with an evidence-based clinical management tool, including diagnostic and treatment recommendations, for patients who present with uninvestigated dyspepsia. RECOMMENDATIONS: The management tool has 5 key decision steps addressing the following: (1) evidence that symptoms originate in the upper gastrointestinal tract, (2) presence of alarm features, (3) use of nonsteroidal anti-inflammatory drugs (NSAIDs), (4) dominant reflux symptoms and (5) evidence of Helicobacter pylori infection. All patients over 50 years of age who present with new-onset dyspepsia and patients who present with alarm features should receive prompt investigation, preferably by endoscopy. The management options for patients with uninvestigated dyspepsia who use NSAIDs regularly are: (1) to stop NSAID therapy and assess symptomatic response, (2) to treat with NSAID prophylaxis if NSAID therapy cannot be stopped or (3) to refer for investigation. Gastroesophageal reflux disease can be diagnosed clinically if the patient''s dominant symptoms are heartburn or acid regurgitation, or both; these patients should be treated with acid suppressive therapy. The remaining patients should be tested for H. pylori infection, and those with a positive result should be treated with H. pylori-eradication therapy. Those with a negative result should have their symptoms treated with optimal antisecretory therapy or a prokinetic agent. VALIDATION AND EVIDENCE: Evidence for resolution of the dyspepsia symptoms was the main outcome measure. Supporting evidence for the 5 steps in the management tool and the recommendations for treatment were graded according to the strength of the evidence and were endorsed by consensus of committee members. If no randomized controlled clinical trials were available, the recommendations were based on the best available evidence. LITERATURE REVIEW: Evidence was obtained from MEDLINE searches for pertinent articles published from 1966 to October 1999. The searches focused on dyspepsia, diagnosis and treatment. Additional articles were retrieved through a manual search of bibliographies and abstracts from international gastroenterology conferences.     

Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa,Canada, 14 May 2012

In May 2012, Health Canada and other participants held a National Summit on Subsequent Entry Biologics (SEBs). Health Canada released a guidance document in March 2010 describing policy positions and data requirements for approval of SEBs. While Health Canada and health agencies in other regulatory jurisdictions are aligned on many scientific principles related to biosimilar drugs, Health Canada's specific requirements may not be widely understood by many Canadian stakeholders. The Summit provided an opportunity for education and dialog among physicians who prescribe biologics, provincial payers, and industry on the following topics: preclinical and clinical comparability studies; manufacturing and other product differences; extrapolation of indications; substitution and interchangeability of SEBs with reference biologic drugs in clinical practice; payers' current perspective; pharmacovigilance and naming. It is anticipated that the consensus reached at this meeting will further educate Canadian healthcare professionals, provincial payers, and insurers about the appropriate use of SEBs, and may be of general interest to others internationally.     

Off-Pump versus Conventional Coronary Artery Bypass Grafting: A Meta-Analysis and Consensus Statement From The 2004 ISMICS Consensus Conference

BACKGROUND:: The purpose of this evidence-based consensus statement is to systematically review and meta-analyze the randomized and nonrandomized evidence comparing off-pump (OPCAB) to conventional coronary artery bypass (CCAB) surgery and to provide consensus on the role of OPCAB in low- and high-risk surgical patients. METHODS AND RESULTS:: This consensus conference was conducted according to the American College of Cardiology (ACC)/American Heart Association (AHA) standards for development of clinical practice guidelines. The Steering Committee collated all published studies of OPCAB versus CCAB through May 2004 and developed six questions central to controversies surrounding OPCAB surgery in mortality, morbidity, and resource utilization. For mixed-risk patient populations, meta-analysis of 37 randomized clinical trials (3,369 patients, Level A) reported across a total of 53 papers, and two meta-analyses of nonrandomized trials (Level B) comparing OPCAB versus CCAB were identified. For high-risk patient populations, we performed a meta-analysis of 3 randomized and 42 nonrandomized trials (26,349 patients, Level B). CONCLUSION:: Meta-analysis of Level A and B evidence provided the basis for the following consensus statements in patients undergoing surgical myocardial revascularization: (1) OPCAB should be considered a safe alternative to CCAB with respect to risk of mortality [Class I, Level A]; (2) With appropriate use of modern stabilizers, heart positioning devices, and adequate surgeon experience, similar completeness of revascularization and graft patency can be achieved [Class IIa, Level A]; (3) OPCAB is recommended to reduce perioperative morbidity [Class I, Level A]; (4) OPCAB may be recommended to minimize midterm cognitive dysfunction [Class IIa, Level A]; (5) OPCAB should be considered as an equivalent alternative to CCAB in regard to quality of life [Class I, Level A]; (6) OPCAB is recommended to reduce the duration of ventilation, ICU and hospital stay, and resource utilization [Class I, Level A]; (7) OPCAB should be considered in high-risk patients to reduce perioperative mortality, morbidity, and resource utilization [Class IIa, Level B].     

International clinical recommendations on scar management

Many techniques for management of hypertrophic scars and keloids have been proven through extensive use, but few have been supported by prospective studies with adequate control groups. Several new therapies showed good results in small-scale trials, but these have not been repeated in larger trials with long-term follow-up. This article reports a qualitative overview of the available clinical literature by an international panel of experts using standard methods of appraisal. The article provides evidence-based recommendations on prevention and treatment of abnormal scarring and, where studies are insufficient, consensus on best practice. The recommendations focus on the management of hypertrophic scars and keloids, and are internationally applicable in a range of clinical situations. These recommendations support a move to a more evidence-based approach in scar management. This approach highlights a primary role for silicone gel sheeting and intralesional corticosteroids in the management of a wide variety of abnormal scars. The authors concluded that these are the only treatments for which sufficient evidence exists to make evidence-based recommendations. A number of other therapies that are in common use have achieved acceptance by the authors as standard practice. However, it is highly desirable that many standard practices and new emerging therapies undergo large-scale studies with long-term follow-up before being recommended conclusively as alternative therapies for scar management.     

Pharmacologic management of refractory depression.

OBJECTIVE: To review published clinical trials of the pharmacologic management of refractory depression. DATA SOURCES: MEDLINE was searched for relevant articles published from 1983 to 1990. The bibliographies of review articles were searched for additional references. Studies of nonpharmacologic treatments, such as electroconvulsive therapy, were not included. STUDY SELECTION: Eleven studies were found that did not contain obvious digressions from several methodologic assessment criteria (adapted from the McMaster guidelines for the evaluation of clinical trials). Further scrutiny by a nonblind reviewer resulted in the selection of four reports that were considered acceptable. An assessment by a second reviewer, blind as to author, results and journal name, confirmed this judgement. DATA EXTRACTION: Data describing response to the treatments were extracted by a single (nonblind) reviewer. Post-hoc power estimates and 95% confidence intervals were calculated whenever possible. DATA SYNTHESIS: The efficacy of augmenting an antidepressant regimen with lithium carbonate, triiodothyronine or reserpine was not supported by findings from the clinical trials reviewed. However, many trials with negative results lacked adequate statistical power to exclude the possibility of the drug''s efficacy. The use of a monoamine oxidase inhibitor was supported by the one study that met the review''s methodologic criteria. However, this study was not conducted under double-blind conditions. CONCLUSION: The generally recommended strategies for the pharmacologic treatment of refractory depression are not supported by methodologically sound studies.