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1.  Challenges and scientific considerations in hypertension management reflected in the 2012 recommendations of the Canadian Hypertension Education Program 
Open Medicine  2012;6(4):e127-e133.
Abstract
This article provides the scientific rationale and background information for the Canadian Hypertension Education Program’s 2012 recommendations for the management of hypertension. It also summarizes the key new recommendations and the theme for 2012, which is the prevention of hypertension. The full recommendations are available at www.hypertension.ca.
PMCID: PMC3654508  PMID: 23687527
3.  Hypertension in dialysis and kidney transplant patients 
For the first time, the Canadian Hypertension Education Program has studied the evidence supporting blood pressure control in people requiring renal replacement therapy for end-stage kidney disease, including those on dialysis and with renal transplants. According to the Canadian Organ Replacement Registry’s 2008 annual report, there were an estimated 33,832 people with end-stage renal disease in Canada at the end of 2006, an increase of 69.7% since 1997. Of these, 20,465 were on dialysis and 13,367 were living with a functioning kidney transplant. Thus, it is becoming more likely that primary care practitioners will be helping to care for these complex patients. With the lack of large controlled clinical trials, the consensus recommendation based on interpretation of the existing literature is that blood pressure should be lowered to below 140/90 mmHg in hypertensive patients on renal replacement therapy and to below 130/80 mmHg for renal transplant patients with diabetes or chronic kidney disease.
PMCID: PMC2707167  PMID: 19417862
Antihypertensive drugs; Calcineurin inhibitors; Corticosteroids; Hemodialysis; Immunosuppression; Kidney transplantation; Peritoneal dialysis; Renal artery stenosis
4.  Resistant hypertension 
Resistant hypertension is most often due to insufficient medical therapy. With a patient history, physical examination and focused laboratory tests, sufficient information can be gathered to lead to further directed medical therapy, which most often includes a diuretic as part of the drug regimen. Patients may require four or more classes of antihypertensives, some at high doses to achieve control. The clinician must be prepared to use sufficient medications at sufficient doses to achieve blood pressure targets. Referral to a hypertension specialist is appropriate if blood pressure remains uncontrolled despite therapy with three antihypertensive medications.
PMCID: PMC2707174  PMID: 19417863
Hypertension; Resistant hypertension
5.  IMPPACT: Investigation of Medical Professionals and Patients Achieving Control Together 
OBJECTIVE:
To determine whether home blood pressure monitoring (HBPM) led to physician-initiated medication titration and improved achievement of target BP levels compared with standard, office-based management.
METHODS:
Physicians were randomly assigned to a treatment group or a control group. Patients in the control group were monitored by their physician and were drug-adjusted according to the usual approach. In the treatment group, patients were given home BP monitors (UA-767P [A&D Medical/Lifesource, USA]), and drug dosing was adjusted according to HBPM readings and protocol. Long-acting diltiazem (240 mg/day) was added at baseline, which was adjusted as necessary (other medications were added if more than 360 mg/day of diltiazem was required). A final BP measurement was taken in the office after six weeks.
RESULTS:
Nineteen physicians were randomly assigned to the office BP monitoring group and 34 were assigned to the HBPM group. Of the 270 subjects recruited, 97 were in the office BP monitoring group and 173 were in the HBPM group. From baseline to the final visit, there was a statistically significant time by group interaction with lower BP in the HBPM group (P=0.034 for both systolic BP and diastolic BP). BP fell from 159/91±11/10 mmHg at baseline in the HBPM group to 138/80±13/8 mmHg on the final visit, and from 160/88±14/10 mmHg to 141/78±10/9 mmHg in the control group.
CONCLUSIONS:
BP was lowered significantly in both groups, and to a statistically greater degree in the HBPM group. The Hawthorne effect might have led to altered care by the physicians with improvement in BP control in both groups.
PMCID: PMC2649634  PMID: 18340390
Blood pressure monitoring, home; Blood pressure monitoring, office; Hypertension
6.  The Canadian Hypertension Education Program – a unique Canadian knowledge translation program 
The Canadian Hypertension Education Program annually appraises data from hypertension research and updates clinical practice recommendation for the diagnosis and management of hypertension. Enormous effort is devoted to disseminating these recommendations to target groups throughout the country and, through the use of institutional databases, to evaluating their effectiveness in improving the health of Canadians by lowering blood pressure in people with hypertension. The mission of the Canadian Hypertension Education Program is to reduce the impact of hypertension on cardiovascular disease in Canada.
PMCID: PMC2650758  PMID: 17534461
Clinical practice guidelines; Consensus; Hypertension; Knowledge translation
7.  Atherosclerotic renovascular disease 
Atherosclerotic renovascular disease is a combination of renal artery stenosis and renal ischemia. Blood pressure does not rise until the stenosis is 60% or greater. Disease of both large and small blood vessels is often accompanied by the loss of glomerular filtration rate. Activation of the renin-angiotensin-aldosterone system leads to vaso-constriction and salt retention.
Risk factors for atherosclerotic renovascular disease include longstanding hypertension, diabetes, smoking and dyslipidemia. The prevalence of the condition in patients with hypertension resistant to two medications is 20%. As yet, there is no single ideal screening test or evidence-based recommended screening algorithm. Magnetic resonance angiography and computed tomography angiography are noninvasive and have high sensitivity and specificity, but also have high costs associated with them. The captopril renal scan has low sensitivity and specificity in people with renal disease (the population most likely to require the test). Doppler ultrasonography has high sensitivity and specificity in experienced hands, and the renal resistance index, which can easily be added to this test, can identify those with microvascular disease who may not benefit from revascularization.
The best determinant of patient outcome is not the degree of renal artery stenosis but the degree of renal parenchymal disease. To date, renal revascularization has not been associated with improved renal survival compared with medical treatment alone. Today, the approach to atherosclerotic renovascular disease is determined by the patient’s blood pressure and renal function; possibly, in the future, it will be determined by the result of the renal resistance index as part of a screening algorithm. If the blood pressure is uncontrollable or the renal function is deteriorating, the patient should be considered for renal revascularization initially, with a percutaneous endovascular stent. The management of hypertension involves the use of combinations of antihypertensive agents at doses sufficient to control blood pressure. Medical management also includes aggressive lipid-lowering therapy.
PMCID: PMC2560872  PMID: 16755319
Hypertension; Kidney disease; Renal artery stenosis; Renovascular disease; Resistant hypertension
8.  I-RREACH: an engagement and assessment tool for improving implementation readiness of researchers, organizations and communities in complex interventions 
Background
Non-communicable chronic diseases are the leading causes of mortality globally, and nearly 80% of these deaths occur in low- and middle-income countries (LMICs). In high-income countries (HICs), inequitable distribution of resources affects poorer and otherwise disadvantaged groups including Aboriginal peoples. Cardiovascular mortality in high-income countries has recently begun to fall; however, these improvements are not realized among citizens in LMICs or those subgroups in high-income countries who are disadvantaged in the social determinants of health including Aboriginal people. It is critical to develop multi-faceted, affordable and realistic health interventions in collaboration with groups who experience health inequalities. Based on community-based participatory research (CBPR), we aimed to develop implementation tools to guide complex interventions to ensure that health gains can be realized in low-resource environments.
Methods
We developed the I-RREACH (Intervention and Research Readiness Engagement and Assessment of Community Health Care) tool to guide implementation of interventions in low-resource environments. We employed CBPR and a consensus methodology to (1) develop the theoretical basis of the tool and (2) to identify key implementation factor domains; then, we (3) collected participant evaluation data to validate the tool during implementation.
Results
The I-RREACH tool was successfully developed using a community-based consensus method and is rooted in participatory principles, equalizing the importance of the knowledge and perspectives of researchers and community stakeholders while encouraging respectful dialogue. The I-RREACH tool consists of three phases: fact finding, stakeholder dialogue and community member/patient dialogue. The evaluation for our first implementation of I-RREACH by participants was overwhelmingly positive, with 95% or more of participants indicating comfort with and support for the process and the dialogue it creates.
Conclusions
The I-RREACH tool was designed to (1) pinpoint key domains required for dialogue between the community and the research team to facilitate implementation of complex health interventions and research projects and (2) to identify existing strengths and areas requiring further development for effective implementation. I-RREACH has been found to be easily adaptable to diverse geographical and cultural settings and can be further adapted to other complex interventions. Further research should include the potential use of the I-RREACH tool in the development of blue prints for scale-up of successful interventions, particularly in low-resource environments.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-015-0257-6) contains supplementary material, which is available to authorized users.
doi:10.1186/s13012-015-0257-6
PMCID: PMC4424962  PMID: 25935849
Complex intervention; Community-based participatory research; Methodology; RCT; Implementation tool; International health; Aboriginal health; LMIC; Canada; Tanzania
10.  Healthy Food Procurement Policies and Their Impact 
Unhealthy eating is the leading risk for death and disability globally. As a result, the World Health Organization (WHO) has called for population health interventions. One of the proposed interventions is to ensure healthy foods are available by implementing healthy food procurement policies. The objective of this systematic review was to evaluate the evidence base assessing the impact of such policies. A comprehensive review was conducted by searching PubMed and Medline for policies that had been implemented and evaluated the impact of food purchases, food consumption, and behaviors towards healthy foods. Thirty-four studies were identified and found to be effective at increasing the availability and purchases of healthy food and decreasing purchases of unhealthy food. Most policies also had other components such as education, price reductions, and health interventions. The multiple gaps in research identified by this review suggest that additional research and ongoing evaluation of food procurement programs is required. Implementation of healthy food procurement policies in schools, worksites, hospitals, care homes, correctional facilities, government institutions, and remote communities increase markers of healthy eating. Prior or simultaneous implementation of ancillary education about healthy eating, and rationale for the policy may be critical success factors and additional research is needed.
doi:10.3390/ijerph110302608
PMCID: PMC3986994  PMID: 24595213
public policy; health promotion; health; food; non-communicable disease; sodium; sugar; saturated fat; trans fatty acids
11.  Economic analysis of Heart and Stroke Foundation of Ontario’s Hypertension Management Initiative 
Objectives
Hypertension is suboptimally treated in primary care settings. We evaluated the cost-effectiveness of the Heart and Stroke Foundation of Ontario’s Hypertension Management Initiative (HMI), an interdisciplinary, evidence-informed chronic disease management model for primary care that focuses on improving blood pressure management and control by primary care providers and patients according to clinical best practice guidelines.
Methods
The perspective of our analysis was that of the Ontario Ministry of Health and Long-Term Care with a lifetime horizon and 5% annual discount rate. Using data from a prospective cohort study from the HMI, we created two matched groups: pre-HMI (standard care), and post-HMI (n = 1720). For each patient, we estimated the 10-year risk of cardiovascular disease (CVD) using the Framingham risk equation and life expectancy from life tables. Long-term health care costs incurred with physician visits, acute and chronic care hospitalizations, emergency department visits, same-day surgeries, and medication use were determined through linkage to administrative databases, using a bottom-up approach.
Results
The HMI intervention was associated with significant reductions in systolic blood pressure (126 mmHg vs 134 mmHg with standard care; P-value < 0.001). These improvements were associated with a reduction in the 10-year risk of CVD (9.5% risk vs 10.7% in standard care; P-value < 0.001) and a statistically significant improvement in discounted life expectancy (9.536 years vs 9.516 in standard care; P-value < 0.001). The HMI cohort had a discounted mean lifetime cost of $22,884 CAD vs $22,786 CAD for standard care, with an incremental cost-effectiveness ratio of $4939 CAD per life-year gained.
Conclusion
We found that the HMI is a cost-effective means of providing evidence-informed, chronic disease management in primary care to patients with hypertension.
doi:10.2147/CEOR.S33390
PMCID: PMC3501398  PMID: 23180969
hypertension; economic evaluation; cardiovascular disease
12.  Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial 
BMJ Open  2012;2(2):e000848.
Introduction
Hypertension (HTN) is a leading risk factor for preventable cardiovascular disease, with over one in five adults affected worldwide. Lifestyle modification is a key strategy for the prevention and treatment of HTN. Stress has been associated with greater cardiovascular risk, and stress management is a recommended intervention for hypertensives. Stress reduction through relaxation therapies has been shown to have an effect on human physiology, including lowering blood pressure (BP). However, individualised behavioural interventions are resource intensive, and group stress management approaches have not been validated for reducing HTN. The HARMONY Study is a pilot randomised controlled trial designed to determine if mindfulness-based stress reduction (MBSR), a standardised group therapy, is an effective intervention for lowering BP in stage 1 unmedicated hypertensives.
Methods and analysis
Men and women unmedicated for HTN with mean daytime ambulatory blood pressure (ABP) ≥135/85 mm Hg or 24 h ABP ≥130/80 mm Hg are included in the study. Subjects are randomised to receive MBSR immediately or after a wait-list control period. The primary outcome measure is mean awake and 24 h ABP. The primary objective of the HARMONY Study is to compare ABP between the treatment and wait-list control arm at the 12-week primary assessment period. Results from this study will determine if MBSR is an effective intervention for lowering BP in early unmedicated hypertensives.
Ethics and dissemination
This research project was approved by the Sunnybrook Research Ethics Board and the University Health Network Research Ethics Board (Toronto, Canada). Planned analyses are in full compliance with the principles of the Declaration of Helsinki. Data collection will be completed by early spring 2012. Primary and secondary analysis will commence immediately after data monitoring is completed; dissemination plans include preparing publications for submission during the summer of 2012.
Trial registration number
This study is registered with http://clinicaltrials.gov (NCT00825526).
Article summary
Article focus
Does MBSR have a significant BP-lowering effect on awake and 24 h ABP?
Is MBSR a safe and feasible complementary treatment for high BP?
Is there interest in the general population to participate in a meditation/stress reduction programme to lower high BP?
Key messages
Results of this trial will contribute to the development of non-pharmacological treatment approaches to HTN.
If a positive outcome is achieved, the HARMONY Study could highlight MBSR as a new paradigm for delivering lifestyle therapy.
If successful, the next phase of the project will incorporate additional lifestyle intervention components to MBSR therapy (such as sodium and weight loss counselling), with the goal of ultimately building a standardised lifestyle therapy programme to which physicians can refer their hypertensive patients to the future.
Strengths and limitations of this study
First study to examine a standardised stress reduction group therapy, already funded in part by the Ontario Health Insurance Plan, for the management of high BP.
Large sample size and use of randomised controlled trial format minimises bias and maximises the opportunity to detect any BP-lowering effect of MBSR.
Due to the silent nature of high BP, the lack of immediate positive perceptible feedback when BP is lowered may hamper the reinforcement necessary to make permanent lifestyle changes.
doi:10.1136/bmjopen-2012-000848
PMCID: PMC3298834  PMID: 22396225
13.  Statins and renovascular disease in the elderly: a population-based cohort study 
European Heart Journal  2010;32(5):598-610.
Aims
More than 90% of cases of renovascular disease (RVD) are caused by atherosclerosis; thus patients with this condition are at high risk for vascular events. We examined the association of statins with prognosis in patients with RVD.
Methods and results
We performed a population-based cohort study in 4040 patients with RVD older than 65 years using province-wide health data in Ontario, Canada. The primary outcome was time to first cardiorenal event, specifically myocardial infarction, stroke, heart failure, acute renal failure, dialysis or death; the primary analysis used a time-dependent covariate for statin exposure. Despite having a greater burden of cardiovascular and renal comorbidity, the risk of the primary outcome was significantly lower in statin users than in non-users [unadjusted hazard ratio (HR) 0.51, 95% confidence interval (CI) 0.47–0.57; P < 0.0001]. This association was materially unchanged after adjusting for demographic characteristics, cardiovascular risk factors, other comorbidities, measures of health-care utilization, screening, and concomitant medications (adjusted HR 0.51, 95% CI 0.46–0.57). An analysis using the same endpoint in a propensity-matched cohort without time-dependent statin exposure revealed a lower risk of the primary outcome in statin-treated patients but with a substantially more conservative point estimate (HR 0.82, 95% CI 0.71–0.95).
Conclusion
These data suggest that statins are associated with improved prognosis in elderly patients with RVD.
doi:10.1093/eurheartj/ehq452
PMCID: PMC3257309  PMID: 21156722 CAMSID: cams1688
Statins; Renovascular disease; Cohort studies; Prognosis
15.  2010 Canadian Hypertension Education Program (CHEP) recommendations: The scientific summary – an update of the 2010 theme and the science behind new CHEP recommendations 
The present article is a summary of the theme, the key recommendations for management of hypertension and the supporting clinical evidence of the 2010 Canadian Hypertension Education Program (CHEP). In 2010, CHEP emphasizes the need for health care professionals to stay informed about hypertension through automated updates at www.htnupdate.ca. A new interactive Internet-based lecture series will be available in 2010 and a program to train community hypertension leaders will be expanded. Patients can also sign up to receive regular updates in a pilot program at www.myBPsite.ca. In 2010, the new recommendations include consideration for using automated office blood pressure monitors, new targets for dietary sodium for the prevention and treatment of hypertension that are aligned with the national adequate intake values, and recommendations for considering treatment of selected hypertensive patients at high risk with calcium channel blocker/angiotensin-converting enzyme inhibitor combinations and the use of angiotensin receptor blockers.
PMCID: PMC2886553  PMID: 20485687
Clinical practice guidelines; High blood pressure; Hypertension; Knowledge translation
16.  The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: Part I – blood pressure measurement, diagnosis and assessment of risk 
OBJECTIVE:
To provide updated, evidence-based recommendations for the diagnosis and assessment of adults with hypertension.
EVIDENCE:
MEDLINE searches were conducted from November 2008 to October 2009 with the aid of a medical librarian. Reference lists were scanned, experts were contacted, and the personal files of authors and subgroup members were used to identify additional studies. Content and methodological experts assessed studies using prespecified, standardized evidence-based algorithms. Recommendations were based on evidence from peer-reviewed full-text articles only.
RECOMMENDATIONS:
Recommendations for blood pressure measurement, criteria for hypertension diagnosis and follow-up, assessment of global cardiovascular risk, diagnostic testing, diagnosis of renovascular and endocrine causes of hypertension, home and ambulatory monitoring, and the use of echocardiography in hypertensive individuals are outlined. Changes to the recommendations for 2010 relate to automated office blood pressure measurements. Automated office blood pressure measurements can be used in the assessment of office blood pressure. When used under proper conditions, an automated office systolic blood pressure of 135 mmHg or higher or diastolic blood pressure of 85 mmHg or higher should be considered analogous to a mean awake ambulatory systolic blood pressure of 135 mmHg or higher and diastolic blood pressure of 85 mmHg or higher, respectively.
VALIDATION:
All recommendations were graded according to strength of the evidence and voted on by the 63 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. To be approved, all recommendations were required to be supported by at least 70% of task force members. These guidelines will continue to be updated annually.
PMCID: PMC2886554  PMID: 20485688
Blood pressure; Diagnosis; Guidelines; High blood pressure; Hypertension; Risk factors
17.  The 2010 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 2 – therapy 
OBJECTIVE:
To update the evidence-based recommendations for the prevention and treatment of hypertension in adults for 2010.
OPTIONS AND OUTCOMES:
For lifestyle and pharmacological interventions, randomized trials and systematic reviews of trials were preferentially reviewed. Changes in cardiovascular morbidity and mortality were the primary outcomes of interest. However, for lifestyle interventions, blood pressure lowering was accepted as a primary outcome given the general lack of long-term morbidity and mortality data in this field. Progressive renal impairment was also accepted as a clinically relevant primary outcome among patients with chronic kidney disease.
EVIDENCE:
A Cochrane Collaboration librarian conducted an independent MEDLINE search from 2008 to August 2009 to update the 2009 recommendations. To identify additional studies, reference lists were reviewed and experts were contacted. All relevant articles were reviewed and appraised independently by both content and methodological experts using prespecified levels of evidence.
RECOMMENDATIONS:
For lifestyle modifications to prevent and treat hypertension, restrict dietary sodium to 1500 mg (65 mmol) per day in adults 50 years of age or younger, to 1300 mg (57 mmol) per day in adults 51 to 70 years of age, and to 1200 mg (52 mmol) per day in adults older than 70 years of age; perform 30 min to 60 min of moderate aerobic exercise four to seven days per week; maintain a healthy body weight (body mass index 18.5 kg/m2 to 24.9 kg/m2) and waist circumference (less than 102 cm for men and less than 88 cm for women); limit alcohol consumption to no more than 14 standard drinks per week for men or nine standard drinks per week for women; follow a diet that emphasizes fruits, vegetables and low-fat dairy products, dietary and soluble fibre, whole grains and protein from plant sources, and that is low in saturated fat and cholesterol; and consider stress management in selected individuals with hypertension.
For the pharmacological management of hypertension, treatment thresholds and targets should be predicated on the patient’s global atherosclerotic risk, target organ damage and comorbid conditions. Blood pressure should be decreased to less than 140/90 mmHg in all patients, and to less than 130/80 mmHg in patients with diabetes mellitus or chronic kidney disease. Most patients will require more than one agent to achieve these target blood pressures. Antihypertensive therapy should be considered in all adult patients regardless of age (caution should be exercised in elderly patients who are frail). For adults without compelling indications for other agents, considerations for initial therapy should include thiazide diuretics, angiotensin-converting enzyme (ACE) inhibitors (in patients who are not black), long-acting calcium channel blockers (CCBs), angiotensin receptor blockers (ARBs) or beta-blockers (in those younger than 60 years of age). A combination of two first-line agents may also be considered as initial treatment of hypertension if systolic blood pressure is 20 mmHg above target or if diastolic blood pressure is 10 mmHg above target. The combination of ACE inhibitors and ARBs should not be used, unless compelling indications are present to suggest consideration of dual therapy.
Agents appropriate for first-line therapy for isolated systolic hypertension include thiazide diuretics, long-acting dihydropyridine CCBs or ARBs. In patients with coronary artery disease, ACE inhibitors, ARBs or beta-blockers are recommended as first-line therapy; in patients with cerebrovascular disease, an ACE inhibitor/diuretic combination is preferred; in patients with proteinuric nondiabetic chronic kidney disease, ACE inhibitors or ARBs (if intolerant to ACE inhibitors) are recommended; and in patients with diabetes mellitus, ACE inhibitors or ARBs (or, in patients without albuminuria, thiazides or dihydropyridine CCBs) are appropriate first-line therapies. In selected high-risk patients in whom combination therapy is being considered, an ACE inhibitor plus a long-acting dihydropyridine CCB is preferable to an ACE inhibitor plus a thiazide diuretic. All hypertensive patients with dyslipidemia should be treated using the thresholds, targets and agents outlined in the Canadian lipid treatment guidelines. Selected patients with hypertension who do not achieve thresholds for statin therapy, but who are otherwise at high risk for cardiovascular events, should nonetheless receive statin therapy. Once blood pressure is controlled, low-dose acetylsalicylic acid therapy should be considered.
VALIDATION:
All recommendations were graded according to the strength of the evidence and voted on by the 63 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations reported here achieved at least 80% consensus. These guidelines will continue to be updated annually.
SPONSORS:
The Canadian Hypertension Education Program process is sponsored by the Canadian Hypertension Society, Blood Pressure Canada, the Public Health Agency of Canada, the College of Family Physicians of Canada, the Canadian Pharmacists Association, the Canadian Council of Cardiovascular Nurses, and the Heart and Stroke Foundation of Canada.
PMCID: PMC2886555  PMID: 20485689
Antihypertensive drugs; Blood pressure; Guidelines; High blood pressure; Hypertension; Lifestyle interventions
18.  C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis 
Nephrology Dialysis Transplantation  2011;26(12):3980-3986.
Background. No previous randomized controlled studies have been reported examining de novo, once every 4 weeks (Q4W) administration of erythropoiesis-stimulating agents in chronic kidney disease (CKD) patients. We report results from a randomized multinational study that compared continuous erythropoietin receptor activator (C.E.R.A.) Q4W with darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) for the correction of anaemia in non-dialysis CKD patients.
Methods. Patients were randomized (1:1) to receive either 1.2 μg/kg C.E.R.A. Q4W or darbepoetin alfa QW/Q2W during a 20-week correction period and an 8-week evaluation period. Two primary end points were assessed: the haemoglobin (Hb) response rate and the change in average Hb concentration between baseline and evaluation.
Results. The Hb response rate for C.E.R.A. was 94.1%, significantly higher than the protocol-specified 60% response rate [95% confidence interval (CI): 89.1, 97.3; P < 0.0001] and comparable with darbepoetin alfa (93.5%; 95% CI: 88.4, 96.8; P < 0.0001). C.E.R.A. Q4W was non-inferior to darbepoetin alfa QW/Q2W, with similar mean Hb changes from baseline of 1.62 g/dL and 1.66 g/dL, respectively. Patients receiving C.E.R.A. showed a steady rise in Hb, with fewer patients above the target range during the first 8 weeks compared with darbepoetin alfa [39 patients (25.8%) versus 72 patients (47.7%); P < 0.0001]. Adverse event rates were comparable between the treatment groups.
Conclusion. C.E.R.A. Q4W successfully corrects anaemia and maintains stable Hb levels within the recommended target range in non-dialysis CKD patients.
doi:10.1093/ndt/gfr160
PMCID: PMC3224113  PMID: 21505096
anaemia; C.E.R.A.; chronic kidney disease; darbepoetin alfa; haemoglobin
19.  Conventional versus automated measurement of blood pressure in primary care patients with systolic hypertension: randomised parallel design controlled trial 
Objective To compare the quality and accuracy of manual office blood pressure and automated office blood pressure using the awake ambulatory blood pressure as a gold standard.
Design Multi-site cluster randomised controlled trial.
Setting Primary care practices in five cities in eastern Canada.
Participants 555 patients with systolic hypertension and no serious comorbidities under the care of 88 primary care physicians in 67 practices in the community.
Interventions Practices were randomly allocated to either ongoing use of manual office blood pressure (control group) or automated office blood pressure (intervention group) using the BpTRU device. The last routine manual office blood pressure (mm Hg) was obtained from each patient’s medical record before enrolment. Office blood pressure readings were compared before and after enrolment in the intervention and control groups; all readings were also compared with the awake ambulatory blood pressure.
Main outcome measure Difference in systolic blood pressure between awake ambulatory blood pressure minus automated office blood pressure and awake ambulatory blood pressure minus manual office blood pressure.
Results Cluster randomisation allocated 31 practices (252 patients) to manual office blood pressure and 36 practices (303 patients) to automated office blood pressure measurement. The most recent routine manual office blood pressure (149.5 (SD 10.8)/81.4 (8.3)) was higher than automated office blood pressure (135.6 (17.3)/77.7 (10.9)) (P<0.001). In the control group, routine manual office blood pressure before enrolment (149.9 (10.7)/81.8 (8.5)) was reduced to 141.4 (14.6)/80.2 (9.5) after enrolment (P<0.001/P=0.01), but the reduction in the intervention group from manual office to automated office blood pressure was significantly greater (P<0.001/P=0.02). On the first study visit after enrolment, the estimated mean difference for the intervention group between the awake ambulatory systolic/diastolic blood pressure and automated office blood pressure (−2.3 (95% confidence interval −0.31 to −4.3)/−3.3 (−2.7 to −4.4)) was less (P=0.006/P=0.26) than the difference in the control group between the awake ambulatory blood pressure and the manual office blood pressure (−6.5 (−4.3 to −8.6)/−4.3 (−2.9 to −5.8)). Systolic/diastolic automated office blood pressure showed a stronger (P<0.001) within group correlation (r=0.34/r=0.56) with awake ambulatory blood pressure after enrolment compared with manual office blood pressure versus awake ambulatory blood pressure before enrolment (r=0.10/r= 0.40); the mean difference in r was 0.24 (0.12 to 0.36)/0.16 (0.07 to 0.25)). The between group correlation comparing diastolic automated office blood pressure and awake ambulatory blood pressure (r=0.56) was stronger (P<0.001) than that for manual office blood pressure versus awake ambulatory blood pressure (r=0.30); the mean difference in r was 0.26 (0.09 to 0.41). Digit preference with readings ending in zero was substantially reduced by use of automated office blood pressure.
Conclusion In compliant, otherwise healthy, primary care patients with systolic hypertension, introduction of automated office blood pressure into routine primary care significantly reduced the white coat response compared with the ongoing use of manual office blood pressure measurement. The quality and accuracy of automated office blood pressure in relation to the awake ambulatory blood pressure was also significantly better when compared with manual office blood pressure.
Trial registration Clinical trials NCT 00214053.
doi:10.1136/bmj.d286
PMCID: PMC3034423  PMID: 21300709
20.  The 2009 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 1 – blood pressure measurement, diagnosis and assessment of risk 
OBJECTIVE:
To provide updated, evidence-based recommendations for the diagnosis and assessment of adults with hypertension.
OPTIONS AND OUTCOMES:
The diagnosis of hypertension is dependent on appropriate blood pressure measurement, the timely assessment of serially elevated readings, the degree of blood pressure elevation, the method of measurement (office, ambulatory, home) and associated comorbidities. The presence of cardiovascular risk factors and target organ damage should be ascertained to assess global cardiovascular risk and determine the urgency, intensity and type of treatment required.
EVIDENCE:
MEDLINE searches were conducted from November 2007 to October 2008 with the aid of a medical librarian. Reference lists were scanned, experts were contacted, and the personal files of authors and subgroup members were used to identify additional studies. Content and methodological experts assessed studies using prespecified, standardized evidence-based algorithms. Recommendations were based on evidence from peer-reviewed full-text articles only.
RECOMMENDATIONS:
Recommendations for blood pressure measurement, criteria for hypertension diagnosis and follow-up, assessment of global cardiovascular risk, diagnostic testing, diagnosis of renovascular and endocrine causes of hypertension, home and ambulatory monitoring, and the use of echocardiography in hypertensive individuals are outlined. Key messages include continued emphasis on the expedited, accurate diagnosis of hypertension, the importance of global risk assessment and the need for ongoing monitoring of hypertensive patients to identify incident type 2 diabetes.
VALIDATION:
All recommendations were graded according to strength of the evidence and voted on by the 57 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations were required to be supported by at least 70% of task force members. These guidelines will continue to be updated annually.
PMCID: PMC2707176  PMID: 19417858
Blood pressure; Diagnosis; Guidelines; High blood pressure; Hypertension; Risk factors
21.  The 2008 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 1 – blood pressure measurement, diagnosis and assessment of risk 
OBJECTIVE:
To provide updated, evidence-based recommendations for the diagnosis and assessment of adults with hypertension.
OPTIONS AND OUTCOMES:
The diagnosis of hypertension is dependent on appropriate blood pressure measurement, the timely assessment of serially elevated readings, degree of blood pressure elevation, method of measurement (office, ambulatory, home) and associated comorbidities. The presence of cardiovascular risk factors and target organ damage should be ascertained to assess global cardiovascular risk and determine the urgency, intensity and type of treatment required.
EVIDENCE:
MEDLINE searches were conducted from November 2006 to October 2007 with the aid of a medical librarian. Reference lists were scanned, experts were contacted, and the personal files of authors and subgroup members were used to identify additional studies. Content and methodological experts assessed studies using prespecified, standardized evidence-based algorithms. Recommendations were based on evidence from peer-reviewed, full-text articles only.
RECOMMENDATIONS:
Recommendations for blood pressure measurement, criteria for hypertension diagnosis and follow-up, assessment of global cardiovascular risk, diagnostic testing, diagnosis of renovascular and endocrine causes of hypertension, home and ambulatory monitoring, and the use of echocardiography in hypertensive individuals are outlined. Key messages in 2008 include continued emphasis on the expedited, accurate diagnosis of hypertension, the importance of global risk assessment and the need for ongoing monitoring of hypertensive patients to identify incident type 2 diabetes.
PMCID: PMC2643189  PMID: 18548142
Blood pressure; Diagnosis; Guidelines; High blood pressure; Hypertension; Risk factors
22.  DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol 
Background
The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management.
Methods and design
The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed.
Discussion
The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel) study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management.
Trial Registration
Protocol NCT00325624
doi:10.1186/1472-6823-9-13
PMCID: PMC2689225  PMID: 19426530
23.  Heart and Stroke Foundation of Ontario (HSFO) high blood pressure strategy's hypertension management initiative study protocol 
Background
Achieving control of hypertension prevents target organ damage at both the micro and macrovascular level and is a highly cost effective means of lowering the risk for heart attack and stroke particularly in people with diabetes. Clinical trials demonstrate that blood pressure control can be achieved in a large proportion of people. Translating this knowledge into widespread practice is the focus of the Hypertension Management Initiative, which began in 2004 with the goal of improving the management of this chronic health condition by primary care providers and patients in the community.
Methods
This study will test the effect of a systems change on the management of high blood pressure in real world practice in primary care in Ontario, Canada. The systems change intervention involves an interprofessional educational program bringing together physicians, nurses and pharmacists with tools for both providers and patients to facilitate blood pressure management. Each of two waves of subjects were enrolled over a 6 month period with the initial enrollment between waves separated by 9 months. Blood pressure will be measured with the BpTru ® automated blood pressure device. To determine the effectiveness of the intervention, a before and after analysis within all subjects will compare blood pressure at baseline to annual measurements for the three year study. To assess whether the intervention has an impact on blood pressure control independent of community trends, a betwen group comparison of baseline blood pressures in the delayed wave will be made with the immediate wave during the same time period, so that the immediate wave has experienced the intervention for at least 9 months. The total enrollment goal is 5,000 subjects. The practice locations include 10 Family Health Teams (FHTs) and 1 Community Health Centre (CHC) and approximately 49 primary care physicians, 15 nurse practitioners, 37 registered nurses and over 150 community pharmacists across the 11 communities throughout the province of Ontario. The 11 primary care sites will be divided into immediate and delayed groups based on geography and the use of an electronic versus a traditional chart patient record.
Discussion
Initial consideration was given to randomizing the groups, however, for a number of reasons, this was deemed to not be possible. In order to ensure that the sites in the immediate intervention and delayed intervention groups are not different from each other, the sites will be assigned to the intervention groups manually to ensure a distribution of the variables as evenly as possible.
Given that HSFO approached this particular group of health care providers to participate in a program relating to hypertension, this may have heightened their awareness of the issue and affected their management of patients with hypertension. Thus, data will be collected to allow an assessment of previous practice patterns and determine any impact of the Hawthorne Effect.
Trial registration
Clinicaltrials.gov NCT00425828
doi:10.1186/1472-6963-8-251
PMCID: PMC2627848  PMID: 19068141
24.  The 2007 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 2 – therapy 
OBJECTIVE:
To provide updated, evidence-based recommendations for the prevention and management of hypertension in adults.
OPTIONS AND OUTCOMES:
For lifestyle and pharmacological interventions, evidence was reviewed from randomized controlled trials and systematic reviews of trials. Changes in cardiovascular morbidity and mortality were the primary outcomes of interest. However, for lifestyle interventions, blood pressure lowering was accepted as a primary outcome given the lack of long-term morbidity and mortality data in this field. For treatment of patients with kidney disease, the progression of kidney dysfunction was also accepted as a clinically relevant primary outcome.
EVIDENCE:
A Cochrane collaboration librarian conducted an independent MEDLINE search from 2005 to August 2006 to update the 2006 Canadian Hypertension Education Program recommendations. In addition, reference lists were scanned and experts were contacted to identify additional published studies. All relevant articles were reviewed and appraised independently by both content and methodological experts using prespecified levels of evidence.
RECOMMENDATIONS:
Dietary lifestyle modifications for prevention of hypertension, in addition to a well-balanced diet, include a dietary sodium intake of less than 100 mmol/day. In hypertensive patients, the dietary sodium intake should be limited to 65 mmol/day to 100 mmol/day. Other lifestyle modifications for both normotensive and hypertensive patients include: performing 30 min to 60 min of aerobic exercise four to seven days per week; maintaining a healthy body weight (body mass index of 18.5 kg/m2 to 24.9 kg/m2) and waist circumference (less than 102 cm in men and less than 88 cm in women); limiting alcohol consumption to no more than 14 units per week in men or nine units per week in women; following a diet reduced in saturated fat and cholesterol, and one that emphasizes fruits, vegetables and low-fat dairy products, dietary and soluble fibre, whole grains and protein from plant sources; and considering stress management in selected individuals with hypertension.
For the pharmacological management of hypertension, treatment thresholds and targets should take into account each individual’s global atherosclerotic risk, target organ damage and any comorbid conditions: blood pressure should be lowered to lower than 140/90 mmHg in all patients and lower than 130/80 mmHg in those with diabetes mellitus or chronic kidney disease. Most patients require more than one agent to achieve these blood pressure targets. In adults without compelling indications for other agents, initial therapy should include thiazide diuretics; other agents appropriate for first-line therapy for diastolic and/or systolic hypertension include angiotensin-converting enzyme (ACE) inhibitors (except in black patients), long-acting calcium channel blockers (CCBs), angiotensin receptor blockers (ARBs) or beta-blockers (in those younger than 60 years of age). First-line therapy for isolated systolic hypertension includes long-acting dihydropyridine CCBs or ARBs. Certain comorbid conditions provide compelling indications for first-line use of other agents: in patients with angina, recent myocardial infarction, or heart failure, beta-blockers and ACE inhibitors are recommended as first-line therapy; in patients with cerebrovascular disease, an ACE inhibitor plus diuretic combination is preferred; in patients with nondiabetic chronic kidney disease, ACE inhibitors are recommended; and in patients with diabetes mellitus, ACE inhibitors or ARBs (or, in patients without albuminuria, thiazides or dihydropyridine CCBs) are appropriate first-line therapies. All hypertensive patients with dyslipidemia should be treated using the thresholds, targets and agents outlined in the Canadian Cardiovascular Society position statement (recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease). Selected high-risk patients with hypertension who do not achieve thresholds for statin therapy according to the position paper should nonetheless receive statin therapy. Once blood pressure is controlled, acetylsalicylic acid therapy should be considered.
VALIDATION:
All recommendations were graded according to strength of the evidence and voted on by the 57 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations reported here achieved at least 95% consensus. These guidelines will continue to be updated annually.
PMCID: PMC2650757  PMID: 17534460
Antihypertensive drugs; Blood pressure; Guidelines; High blood pressure; Hypertension; Lifestyle interventions
25.  The 2007 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 1 – blood pressure measurement, diagnosis and assessment of risk 
OBJECTIVE:
To provide updated, evidence-based recommendations for the diagnosis and assessment of adults with hypertension.
OPTIONS AND OUTCOMES:
The diagnosis of hypertension is dependent on the appropriate measurement of blood pressure, the timely assessment of serially elevated readings, the degree of blood pressure elevation, the method of measurement (office, ambulatory, home) and any associated comorbidities. The presence of cardiovascular risk factors and target organ damage should be ascertained to assess global cardiovascular risk, and to determine the urgency, intensity and type of treatment required.
EVIDENCE:
MEDLINE searches were conducted from November 2005 to October 2006 with the aid of a medical librarian. Reference lists were scanned, experts were contacted, and the personal files of authors and subgroup members were used to identify additional studies. Content and methodological experts assessed studies using prespecified, standardized evidence-based algorithms. Recommendations were based on evidence from peer-reviewed, full-text articles only.
RECOMMENDATIONS:
Recommendations for blood pressure measurement, criteria for hypertension diagnosis and follow-up, assessment of global cardiovascular risk, diagnostic testing, diagnosis of renovascular and endocrine causes of hypertension, home and ambulatory monitoring, and the use of echocardiography in hypertensive individuals are outlined. Key messages in 2007 include continued emphasis on the expedited, accurate diagnosis of hypertension, the importance of assessing the risk of cerebrovascular events as part of global risk assessment, the need for ongoing reassessment of patients with high normal blood pressure, and reviews of recent studies involving laboratory testing and home monitoring.
VALIDATION:
All recommendations were graded according to strength of the evidence and were voted on by the 57 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations reported here received at least 70% consensus. These guidelines will continue to be updated annually.
PMCID: PMC2650756  PMID: 17534459
Blood pressure; Diagnosis; Guidelines; High blood pressure; Hypertension; Risk factors

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