Trials in which intact communities are the units of randomization are increasingly being used to evaluate interventions which are more naturally administered at the community level, or when there is a substantial risk of treatment contamination. In this article we focus on the planning of community intervention trials in which k communities (for example, medical practices, worksites, or villages) are to be randomly allocated to each of an intervention and a control group, and fixed cohorts of m individuals enrolled in each community prior to randomization. Formulas to determine k or m may be obtained by adjusting standard sample size formulas to account for the intracluster correlation coefficient rho. In the presence of individual-level attrition however, observed cohort sizes are likely to vary. We show that conventional approaches of accounting for potential attrition, such as dividing standard sample size formulas by the anticipated follow-up rate pi or using the average anticipated cohort size m pi, may, respectively, overestimate or underestimate the required sample size when cluster follow-up rates are highly variable, and m or rho are large. We present new sample size estimation formulas for the comparison of two means or two proportions, which appropriately account for variation among cluster follow-up rates. These formulas are derived by specifying a model for the binary missingness indicators under the population-averaged approach, assuming an exchangeable intracluster correlation coefficient, denoted by tau. To aid in the planning of future trials, we recommend that estimates for tau be reported in published community intervention trials.
The purpose of the present study was to investigate the prevalence of adolescents with high periodontal risk and to identify factors with influence on the decision to refer a patient to a specialist clinic of Periodontology, on compliance rate and on treatment outcome. The investigation was conducted as a retrospective study on adolescents at age 13-17. In total, clinical examinations and risk evaluations according to caries- and periodontal risk were performed on 50347 adolescents in general dentistry at ages 13, 15 and 17 in 2007. Individuals with a high periodontal risk were included in the present investigation. A high periodontal risk was defined as presence of sites with periodontal pocket depths >6mm and loss of periodontal tissue support. Multiple logistic regression analyses were adopted to calculate the influence of the potential predictors on the investigated dependent variables. In total, 0.5% of the adolescents were found to have high periodontal risk. The diagnosis local periodontitis and the number of periodontal pockets with probing depths >6 mm were positively and significantly correlated to referral to a periodontist. Eighteen percent dropped out before the treatment was completed. Smokers had a significantly lower compliance than non-smokers. The success rate was significantly lower for individuals with many periodontal pockets and for those with the diagnosis local periodontitis. The prevalence of adolescents classified as having high periodontal risk was low. A large frequency of subjects dropped out before the periodontal treatment was completed, especially at the specialist clinics.
The present study aimed to investigate prevalence of and reasons for selective serotonin reuptake inhibitor (SSRI) discontinuation, and compare the two most common SSRIs used in premature ejaculation (PE) treatment, in naturalistic settings (that is, outside clinical trials). The sample consisted of 132 Finnish men with a mean age of 42.5 years (s.d. = 10.6) who had received medical treatment for lifelong PE. The men were enlisted for the study after identifying individuals from the third author's (a physician specializing in sexual medicine) patient registry. Participants responded to a secure, online questionnaire. PE treatment-related side effects of, and discontinuation rates for, different SSRIs were retrospectively self-reported. Treatment efficacy and happiness with treatment were retrospectively self-assessed. Discontinuation rates were uniformly high, ranging from 28.8 to 70.6% between different SSRIs. Dapoxetine was associated with the highest dropout rates (70.6%), and paroxetine the lowest, discontinuation rates. Limited efficacy and side effects were the most common reasons for discontinuation. Paroxetine was more effective and better tolerated than dapoxetine. A considerable number of patients chose to spontaneously discontinue treatment, especially so in the case of dapoxetine, corroborating recent studies conducted in naturalistic settings. Further research efforts are necessary to develop new and improve existing PE treatment alternatives.
Some of the greatest barriers to achieving blood pressure control are perceived to be failure to prescribe antihypertensive medication and lack of adherence to medication prescriptions.
Self-reported data from 6017 Canadians with diagnosed hypertension who responded to the 2008 Canadian Community Health Survey and the 2009 Survey on Living with Chronic Diseases in Canada were examined.
The majority (82%) of individuals with diagnosed hypertension reported using antihypertensive medications. The main reasons for not taking medications were either that they were not prescribed (42%) or that blood pressure had been controlled without medications (45%). Of those not taking antihypertensive medications in 2008 (n = 963), 18% had started antihypertensive medications by 2009, and of those initially taking medications (n = 5058), 5% had stopped. Of those taking medications in 2009, 89% indicated they took the medication as prescribed, and 10% indicated they occasionally missed a dose. Participants who were recently diagnosed, not measuring blood pressure at home, not having a plan to control blood pressure, or not receiving instructions on how to take medications were less likely to be taking antihypertensive medications; similar factors tended to be associated with stopping antihypertensive medication use.
Compatible with high rates of hypertension control, most Canadians diagnosed with hypertension take antihypertensive medications and report adherence. Widespread implementation of self-management strategies for blood pressure control and standardized instructions on antihypertensive medication may further optimize drug treatment.
Many Canadians known to have hypertension remain untreated. To aid in the development of specific programs to improve hypertension management, the present report characterizes Canadians who indicated that they had hypertension but were not taking antihypertensive drug therapy.
The 2005 Canadian Community Health Survey (cycle 3.1) was used to estimate the proportion of Canadians 20 years of age and older who reported having high blood pressure or ever being diagnosed with high blood pressure. Sociodemographic characteristics, reported health, lifestyle factors and health care resource use of those who reported taking or not taking high blood pressure medication in the previous month were described and compared.
Over one-half of hypertensive respondents 20 to 39 years of age reported no antihypertensive treatment compared with 17% and 5% among those 40 to 59 years and 60 years of age and older, respectively. In most age groups, several factors were associated with the absence of pharmacotherapy (eg, male sex, fewer health care professional consultations, perceived excellent health status and most markers of lower cardiovascular risk, with the exception of daily smoking). The proportion of young hypertensive Canadians not receiving pharmacotherapy remained consistent, regardless of the presence of cardiovascular risk factors.
Many hypertensive Canadians, particularly those who are younger than 60 years of age, are not taking antihypertensive drug therapy despite having one or more cardiovascular risks. The increased risk of no drug therapy among smokers warrants special attention.
The purpose of this study was to determine whether East Asian women had more side effects and a higher discontinuation rate than Caucasian women when choosing to use hormonal contraceptives.
This was an observational cohort study of usual care using questionnaires for 2 months after being given hormonal contraceptives following an abortion in Vancouver, Canada.
In the first month, 73 (64.4%) of the 110 East Asian and 86 (80.4%) of the 107 Caucasian women took any of the sample provided (p=.020). In the second month, 52 (47.3%) of the East Asian and 62 (57%) of the Caucasian women used the prescription to buy and take their hormonal contraception (p=.12). Total side effects were similar, but there was more nausea in the East Asian women (23.3% vs. 8.1%) (p=.03) and more acne in the Caucasian women (8.2% vs. 20.9%) (p=.05).
There may be both physiological and cultural differences leading East Asian women to use less hormonal contraception.
A random sample of children and adolescents from the general population in Copenhagen, Denmark, has been examined twice (6 years apart) with respect to asthma, allergy, and nonspecific bronchial hyperresponsiveness. To investigate potential bias resulting from loss of baseline subjects at follow-up (dropout bias) and bias resulting from subjects entering the study at the follow-up stage (newcomer bias), stayers (subjects who participated in both examinations) were compared to dropouts and newcomers, respectively. The sample consisted of 983 subjects (aged 7-17 years at the time of the baseline study), of whom 408 (199 boys) participated in both examinations (stayers), 119 (62 boys) in the baseline study only (dropouts), and 257 (124 boys in the follow-up study only (newcomers). Thus, a total of 784 subjects (80% of the sample) were examined either once or twice. At baseline dropouts did not differ from stayers with respect to anthropometric data, smoking habits, pulmonary function, or prevalence of positive skin prick tests, bronchial hyperresponsiveness, asthma, and allergic diseases. Likewise, these variables for newcomers were not different from those of the stayers apart from a significantly higher smoking rate in newcomers (45% vs. 32%, p = 0.003). Based on these findings and the high overall response rate, it seems reasonable to assume that the group of stayers is representative of the whole sample, apart from an underestimation of the number of smokers and, therefore, an underestimation of the risks associated with smoking.(ABSTRACT TRUNCATED AT 250 WORDS)
To characterize dropouts from type-2 diabetes (T2D) care in communal primary health care.
An observational study.
In a Finnish city, patients with T2D who had not contacted the public primary health care system during the past 12 months were identified with a computer based search and contacted by a trained diabetes nurse.
Dropouts from T2D treatment.
Demographic factors, laboratory parameters, examinations, medications, and comorbidities.
Of the patients with T2D, 10% (n?=?356) were dropouts and 60% of them were men. Median HbA1c was 6.5 (QR for 25% and 75%: 6.0, 7.7) %, (45 [42,61] mmol/mol). Of the dropouts, 14% had HbA1c?=?9.0% (75?mmol/mol), and these patients were younger than the other dropouts (mean age 54.4 [SD 10.8] years vs. 60.6 [9.4] years, p? 9% (75?mmol/mol) and they were more often younger than the other dropouts.
Cites: Lancet. 2012 Dec 15;380(9859):2163-9623245607