Cultural adaptation and validation of the Chinese version of the expanded prostate cancer index composite.

AIM: The expanded prostate cancer index composite (EPIC) is a widely adopted instrument for the quality of life of patients with prostate cancer. We aimed to create a Chinese version of EPIC to further research in the Chinese-speaking population. METHODS: A prototype was created by forward-backward translations and revisions. During cultural adaptation, 15 participants were interviewed after they had completed the prototype. A few issues highlighted included confusion related to the question format, subject non-familiarity with the Chinese term for "hot flashes," and the use of the Chinese term for "breast" as a strictly female body part. A pilot version was created based on the cultural adaptation findings. Validation of the pilot version was performed by having 50 participants complete the Chinese EPIC and EORTC QLQ-c30 twice within a 4-week period. Test-retest reliability (Pearson's correlations and difference distribution) and internal consistency (Cronbach's α) were measured using SAS version 9.4. RESULTS: Test-retest reliability values for the urinary, bowel, sexual and hormone domains were 0.71, 0.51, 0.51 and 0.66, respectively; subscale test-retest reliability ranged between 0.29 and 0.82. Internal consistency for domains was good with Cronbach's α ranging from 0.76 to 0.78 for the initial test and 0.67 to 0.85 for the retest. The performance of this version of EPIC was comparable to the validated EORTC QLQ-C30. CONCLUSION: The EPIC questionnaire was successfully translated into Chinese and was culturally adapted. The resultant Chinese version has high reliability and validity and will be an important tool for research on quality of life in the Chinese population.

Hypoglycemia: a review of definitions used in clinical trials evaluating antihyperglycemic drugs for diabetes.

OBJECTIVE: To understand the severity and potential impact of heterogeneity in definitions of hypoglycemia used in diabetes research, we aimed to review the hypoglycemia definitions adopted in randomized controlled trials (RCTs). METHODS: We reviewed 109 RCTs included in the Canadian Agency for Drugs and Technologies in Health reports for the second- and third-line therapy for the patients with type 2 diabetes (T2D). RESULTS: Nearly 60% (n=66) of the studies reviewed presented the definitions for overall hypoglycemia, and another 20% (n=22) of the studies reported the results for hypoglycemia but did not report a definition. Among these 66 studies, only 9 (14%) followed the American Diabetes Association/European Medicines Agency specified guidelines to define hypoglycemia, with an exact threshold of plasma glucose ≤3.9 mmol/L. Fifty-two of the 66 studies (79%) used a threshold considerably lower than the recommended ≤3.9 mmol/L, and 16 studies used a threshold between 3.8 and 4.0 mmol/L. The proportion of the trials that used a cutoff value of <3.1 mmol/L appeared to be slightly similar among the more commonly used non-insulin treatments, GLP-1s (7 of 18 [39%]), thiazolidinediones (TZDs; 6 of 11 [55%]), DPP-4s (12 of 19 [64%]), and sulfonylureas (11 of 20 [55%]). Among trials with intermediate-long-acting insulins (neutral protamine Hagedorn insulin, detemir, glargine), 7 of 26 trials (27%) used a cutoff of <3.1 mmol/L. The definition of severe hypoglycemia was also subject to substantial heterogeneity, in both the utilized threshold and accompanying soft definitions. CONCLUSION: This review demonstrates that substantial heterogeneity exists in the definition of overall, severe/major, and nocturnal hypoglycemia across RCTs investigating T2D interventions.

Intensive Short-Term Dynamic Psychotherapy Trial Therapy: Effectiveness and Role of "Unlocking the Unconscious".

This study examined the effects of trial therapy interviews using intensive short-term dynamic psychotherapy with 500 mixed sample, tertiary center patients. Furthermore, we investigated whether the effect of trial therapy was larger for patients who had a major unlocking of the unconscious during the interview compared with those who did not. Outcome measures were the Brief Symptom Inventory (BSI) and the Inventory of Interpersonal Problems (IIP), measured at baseline and at 1-month follow-up. Significant outcome effects were observed for both the BSI and the IIP with small to moderate preeffect/posteffect sizes, Cohen's d = 0.52 and 0.23, respectively. Treatment effects were greater in patients who had a major unlocking of the unconscious compared with those who did not. The trial therapy interview appears to be beneficial, and its effects may relate to certain therapeutic processes. Further controlled research is warranted.

Trends in prostate cancer incidence and mortality in Canada during the era of prostate-specific antigen screening.

BACKGROUND: Widespread use of prostate-specific antigen (PSA) to screen for prostate cancer began in the early 1990s. Advocates for screening assert that this has caused a decrease in prostate cancer mortality. We sought to describe secular changes in prostate cancer incidence and mortality in Canada in relation to the onset of PSA screening. METHODS: Age-standardized and age-specific prostate cancer incidence (1969-2007) and mortality (1969-2009) from Public Health Agency of Canada databases were analyzed by joinpoint regression. Changes in incidence and mortality were related to introduction of PSA screening. RESULTS: Prior to PSA screening, prostate cancer incidence increased from 54.2 to 99.8 per 100 000 between 1969 and 1990. Thereafter, incidence increased sharply (12.8% per year) to peak at 140.8/100 000 in 1993. After decreasing in all age groups between 1993 and 1996, incidence continued to increase for men aged less than 70 years, but decreased for older men. Age-standardized mortality was stable from 1969 to 1977, increased 1.4% per year to peak in 1995 and subsequently decreased at 3.3% per year; the decline started from 1987 in younger men (age < 60 yr). INTERPRETATION: Incidence was increasing before PSA screening occurred, but rose further after it was introduced. Reductions in prostate cancer mortality began before PSA screening was widely used and were larger than could be anticipated from screening alone. These findings suggest that screening caused artifactual increase in incidence, but no more than a part of reductions in prostate cancer mortality. The reduction may be due to changing treatment or certification of death.

Association of age-dependent height and bone mineral density decline with increased arterial stiffness and rate of fractures in hypertensive individuals.

OBJECTIVE: Hypertension and osteoporosis are age-related health risks differentially expressed in men and women. Here we have analysed their prevalence in a randomly selected cross-sectional cohort [CARTaGENE (CaG) of Quebec, Canada and explored their existing relationships along with height, arterial stiffness and bone fractures. METHODS: The principal cohort CaG included 20 007 individuals of age 40-70 years. Participants were subjected to an extensive phenotyping and a questionnaire of medical history and habits. RESULTS: We determined the differences in height of participants and their relation to hypertension status and sex in this cohort and validated it in two other cohorts (The Canadian Heart Health Study and a family cohort from the Saguenay Lac Saint-Jean, a region of Quebec). In all three cohorts, we found that at younger age individuals with hypertension are taller than normotensive individuals, but they have a shorter stature at an older age compared with normotensive individuals. In CaG, we observed that hypertension, low bone mineral density (BMD) and arterial stiffness are strongly associated with height when adjusted for antihypertensive medications (P < 0.0001). Fractures are the net outcome of low BMD, and a significant association is observed (odds ratio = 2.34, confidence interval = 2.12-2.57); this relation was stronger in hypertensive individuals compared with normotensive individuals particularly in younger hypertensive individuals. In addition, we observed that increased arterial stiffness was significantly correlated with a low BMD in both men and women at all ages. CONCLUSION: Shorter stature in elderly, low BMD and fractures correlated with increased arterial stiffness and hypertension. We propose that hypertension and osteoporosis share components of accelerated aging.

Recommendations on screening for high blood pressure in Canadian adults.

OBJECTIVE: To provide recommendations on screening for hypertension in adults aged 18 years and older without previously diagnosed hypertension. QUALITY OF EVIDENCE: Evidence was found through a systematic search of MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews (EBM Reviews), from January 1985 to September 2011. Study types were limited to randomized controlled trials, systematic reviews, and observational studies with control groups. MAIN MESSAGE: Three strong recommendations were made based on moderate-quality evidence. It is recommended that blood pressure measurement occur at all appropriate primary care visits, according to the current techniques described in the Canadian Hypertension Education Program recommendations for office and ambulatory blood pressure measurement. The Canadian Hypertension Education Program criteria for assessment and diagnosis of hypertension should be applied for people found to have elevated blood pressure. CONCLUSION: After review of the most recent evidence, the Canadian Task Force on Preventive Health Care continues to recommend blood pressure measurement during regular physician visits.

Hypertension prevalence, awareness, treatment and control in national surveys from England, the USA and Canada, and correlation with stroke and ischaemic heart disease mortality: a cross-sectional study.

OBJECTIVE: Comparison of recent national survey data on prevalence, awareness, treatment and control of hypertension in England, the USA and Canada, and correlation of these parameters with each country stroke and ischaemic heart disease (IHD) mortality. DESIGN: Non-institutionalised population surveys. SETTING AND PARTICIPANTS: England (2006 n=6873), the USA (2007-2010 n=10 003) and Canada (2007-2009 n=3485) aged 20-79 years. OUTCOMES: Stroke and IHD mortality rates were plotted against countries' specific prevalence data. RESULTS: Mean systolic blood pressure (SBP) was higher in England than in the USA and Canada in all age-gender groups. Mean diastolic blood pressure (DBP) was similar in the three countries before age 50 and then fell more rapidly in the USA, being the lowest in the USA. Only 34% had a BP under 140/90 mm Hg in England, compared with 50% in the USA and 66% in Canada. Prehypertension and stages 1 and 2 hypertension prevalence figures were the highest in England. Hypertension prevalence (≥140 mm Hg SBP and/or ≥90 mm Hg DBP) was lower in Canada (19·5%) than in the USA (29%) and England (30%). Hypertension awareness was higher in the USA (81%) and Canada (83%) than in England (65%). England also had lower levels of hypertension treatment (51%; USA 74%; Canada 80%) and control (<140/90 mm Hg; 27%; the USA 53%; Canada 66%). Canada had the lowest stroke and IHD mortality rates, England the highest and the rates were inversely related to the mean SBP in each country and strongly related to the blood pressure indicators, the strongest relationship being between low hypertension awareness and stroke mortality. CONCLUSIONS: While the current prevention efforts in England should result in future-improved figures, especially at younger ages, these data still show important gaps in the management of hypertension in these countries, with consequences on stroke and IHD mortality.

Dyslipidemia prevalence, treatment, control, and awareness in the Canadian Health Measures Survey.

BACKGROUND: The most recent Canadian population-level data on lipid levels are from 1992. This study presents current estimates of Canadians with dyslipidemia, the proportion aware of their condition, and the proportion being treated and below target values. METHODS: The Canadian Health Measures Survey (2007-2009) assessed the prevalence, awareness and treatment of dyslipidemia. Dyslipidemia was defined as TC/HDL-C ratio ≥5; measured LDL-C ≥3.5 mmol/L; or taking lipid-modifying medications. The 2009 guidelines for the diagnosis and treatment of dyslipidemia were used to define low, moderate or high cardiovascular disease (CVD) risk and treatment initiation and targets. RESULTS: Forty-five percent of Canadians aged 18-79 years have dyslipidemia. Fifty-seven percent of respondents were not aware of their condition. Lipid-modifying therapy was initiated in individuals where treatment would be recommended in 49%, 20% and 54% of those at high, moderate, and low risk levels, respectively. The majority (81%) of those taking medication had their lipid levels under desirable levels, however, only 24% of those with dyslipidemia reported medication use. Overall, only 19% of those with dyslipidemia had their lipids under recommended levels. Only 41% of those taking lipid-modifying medication reached a recommended target of LDL-C <2 mmol/L or ApoB <0.8 g/L. CONCLUSION: There is still a high proportion of Canadians at high risk of CVD, with dyslipidemia, who are not being treated to recommended levels. These data need to be integrated into CVD reduction recommendations and represent an important baseline for assessing progress.

The impact of cardiovascular risk-factor profiles on blood pressure control rates in adults from Canada and the United States.

BACKGROUND: It is unclear whether blood pressure control varies across the spectrum of atherosclerotic risk. METHODS: We used data from nonpregnant adults who had fasted laboratory samples drawn for the 2007-2009 cycle of the Canadian Health Measures Survey (CHMS) or the 2005-2008 US National Health and Nutrition Examination Survey (NHANES). RESULTS: The 1692 CHMS subjects and 3541 NHANES participants were demographically similar (aged a mean of 45 years), although NHANES participants exhibited higher obesity rates (33.8% vs. 22.2%, P < 0.001). Over 80% of CHMS and NHANES subjects with hypertension had at least 1 other cardiovascular risk factor. As the number of atherosclerotic risk factors increased, hypertension prevalence increased, but blood pressure control rates improved (from 48% among hypertensives with no other risk factors in CHMS to 77% among those with 3 or more risk factors, and from 35% to 53% in NHANES). However, the converse was not true: The distribution of Framingham risk scores for those subjects with "controlled hypertension" was nearly identical to the distribution among those adults with uncontrolled hypertension in both CHMS and NHANES and substantially higher than scores in normotensive subjects. CONCLUSIONS: Although control of blood pressure was better in patients with multiple atherosclerotic risk factors, hypertensives with controlled blood pressures exhibited risk-factor profiles similar to those of participants with uncontrolled blood pressures. This suggests the need, in educational messaging and therapy decision making, for an increased focus on total atherosclerotic risk rather than just blood pressure control.

Mortality benefits from US population-wide reduction in sodium consumption: projections from 3 modeling approaches.

Computer simulations have been used to estimate the mortality benefits from population-wide reductions in dietary sodium, although comparisons of these estimates have not been rigorously evaluated. We used 3 different approaches to model the effect of sodium reduction in the US population over the next 10 years, incorporating evidence for direct effects on cardiovascular disease mortality (method 1), indirect effects mediated by blood pressure changes as observed in randomized controlled trials of antihypertension medications (method 2), or epidemiological studies (method 3).The 3 different modeling approaches were used to model the same scenarios: scenario A, gradual uniform reduction totaling 40% over 10 years; scenario B, instantaneous 40% reduction in sodium consumption sustained for 10 years to achieve a population-wide mean of 2200 mg/d; and scenario C, instantaneous reduction to 1500 mg sodium per day sustained for 10 years. All 3 methods consistently show a substantial health benefit for reductions in dietary sodium under each of the 3 scenarios tested. A gradual reduction in dietary sodium over the next decade (scenario A) as might be achieved with a range of proposed public health interventions would yield considerable health benefits over the next decade, with mean effects across the 3 models ranging from 280 000 to 500 000 deaths averted. Projections of instantaneous reductions illustrate the maximum benefits that could be achieved (0.7-1.2 million deaths averted in 10 years). Under 3 different modeling assumptions, the projected health benefits from reductions in dietary sodium are substantial.

Estimating benefits and harms of screening across subgroups: the Canadian Task Force on Preventive Health Care integrates the GRADE approach and overcomes minor challenges.

OBJECTIVE: This paper describes the integration of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach into their clinical preventive guideline development process by the new Canadian Task Force on Preventive Health Care. STUDY DESIGN: The GRADE approach focused the analytic framework and key questions on patient-important benefits and harms related to screening that incorporated detection, treatment, and follow-up. It also led to an explicit consideration of values and preferences and resource implications on the basis of the recommendations. RESULTS: There are challenges, however, in incorporating the GRADE approach to clinical prevention, as the randomized controlled trials in this field have needed to be very large and of long duration, given the rare occurrence of primary outcome events in asymptomatic individuals. We provide examples of how we met these challenges in relation to developing clinical guidelines for screening for breast cancer, cervical cancer, diabetes, hypertension, and depression in primary care settings. CONCLUSION: The focus on the patient-important outcomes was helpful in estimating effectiveness of screening approaches and providing explicit detailing of the basis of our recommendations across subgroups.

Physical activity level, waist circumference, and mortality.

This study predicted all-cause mortality based on physical activity level (active or inactive) and waist circumference (WC) in 8208 Canadian adults in Alberta, Manitoba, Nova Scotia, and Saskatchewan, surveyed between 1986-1995 and followed through 2004. Physically inactive adults had higher mortality risk than active adults overall (hazard ratio, 95% confidence interval = 1.20, 1.05-1.37) and within the low WC category (1.51, 1.19-1.92). Detrimental effects of physical inactivity and high WC demonstrate the need for physical activity promotion.

Body mass index and risk of cardiovascular disease, cancer and all-cause mortality.

OBJECTIVES: To determine the dose-response relationship between body mass index (BMI) and cause-specific mortality among Canadian adults. METHODS: The sample includes 10,522 adults 18-74 years of age who participated in the Canadian Heart Health Surveys (1986-1995). Participants were divided into 5 BMI categories (< 18.5, 18.5-24.9, 25-29.9, 30-34.9, and > or = 35 kg/m2). Multivariate-adjusted (age, sex, exam year, smoking status, alcohol consumption and education) hazard ratios for all-cause, cardiovascular disease (CVD) and cancer mortality were estimated using Cox proportional hazards regression. RESULTS: There were 1,149 deaths (402 CVD; 412 cancer) over an average of 13.9 years (range 0.5 to 19.1 years), and the analyses are based on 145,865 person-years. The hazard ratios (95% CI) across successive BMI categories for all-cause mortality were 1.25 (0.83-1.90), 1.00 (reference), 1.06 (0.92-1.22), 1.27 (1.07-1.51) and 1.65 (1.29-2.10). The corresponding hazard ratios for CVD mortality were 1.30 (0.60-2.83), 1.00 (reference), 1.57 (1.22-2.01), 1.72 (1.27-2.33) and 2.09 (1.35-3.22); and for cancer, the hazard ratios were 1.02 (0.48-2.21), 1.00 (reference), 1.14 (0.90-1.44), 1.34 (1.01-1.78) and 1.82 (1.22-2.71). There were significant linear trends across BMI categories for all-cause (p = 0.0001), CVD (p < 0.0001) and cancer mortality (p = 0.003). CONCLUSIONS: The results demonstrate significant relationships between BMI and mortality from all causes, CVD and cancer. The increased risk of all-cause, CVD and cancer mortality associated with an elevated BMI was significant at levels above 30 kg/m2; however, overweight individuals (BMI 25-29.9 kg/m2) also had an approximately 60% higher risk of CVD mortality.