We present the results of a questionnaire completed by 526 victims of accidents involving three- and four-wheeled all-terrain vehicles. All victims were treated at the emergency departments of 10 regional hospitals in Quebec. In 70% of cases, the vehicles overturned. Two thirds of victims were injured in accidents without collision, typically involving overturns on level ground or hills. We suggest accident reconstruction research as a means of identifying engineering solutions as one element in an injury control approach.
The presently available Canadian data, based on direct measurements of blood pressure (BP) from the Canadian Heart Health Surveys, are more than 15 years old. In view of major changes in the demographics and health status of the Ontario population, there is an urgent need to update this information. On the initiative of the Heart and Stroke Foundation of Ontario, the University of Ottawa Heart Institute, jointly with Statistics Canada, designed and implemented a population-based cross-sectional survey of hypertension in the Province of Ontario: the 2006 Ontario Survey on the Prevalence and Control of Hypertension (ON-BP).
To establish the prevalence of hypertension in the Ontario adult population between the ages of 20 and 79 years; to assess the awareness, current status and management of hypertension; and to gather respondent information about sex, age, physical measurements, personal health practices, socioeconomic measures, ethnicity and comorbidities.
The present paper describes the background history and the successive steps undertaken during the implementation of this project.
The authors' experiences from the ON-BP indicate that close co-operation between research scientists, statisticians, governmental and nongovernmental organizations -- in the present case, the Heart and Stroke Foundation of Ontario -- is essential to conduct a successful, large-scale survey of BP distribution.
Cites: Am J Hypertens. 2001 Mar;14(3):241-711281235
Cites: JAMA. 2003 May 14;289(18):2363-912746359
Cites: JAMA. 2003 Jul 9;290(2):199-20612851274
Cites: Am J Hypertens. 2004 Apr;17(4):354-6015062890
Abdominoperineal resection for distal rectal cancer is associated with a higher recurrence rate and a poorer overall prognosis than anterior resection. In order to improve the outcome, a more extensive procedure - extralevator abdominoperineal resection - has been introduced. There are, however, currently no prospective or registry-based studies on the effect of this new procedure on local recurrence rates.
Abdominoperineal extralevator resection (APER) is a registry-based Swedish study investigating local recurrence rate three years postoperatively in the entire population of Swedish patients who underwent abdominoperineal resection or extralevator abdominoperineal resection in the 2007-2009-period. In addition to local recurrence rates, the study also investigates the functional and quality-of-life-related outcome 3-4 years postoperatively in the entire study population.
Distal rectal cancer is a surgical and oncological challenge. The APER study will be able to compare the two operative techniques (standard abdominoperineal resection or extralevator abdominoperineal resection) in terms of oncological and functional outcome.
The trial is registered at ClinicalTrials.gov, identifier NCT01296984.
Last month saw the end of the first year of operation of the Abortion Act in Britian, and statistics are now available for the first 10 months, from April 1968, to February 1969. In that time, legal, notified abortions totalled 28,849, of which 20,746 were on the grounds of risk of injury to the physical or mental health of the women. A further 1350 were carried out because of risk to the life of the woman, 1137 because of risk to the physical or mental health of existing children, 965 because of the risk of the woman bearing a physically or mentally handicapped child, and 52 as emergencies to save the life of the woman or prevent grace injury to her health. Another 4599 abortions were carried out for more than 1 of these reasons. An earlier set of statistics, covering the period up to December 1968, showed that 22,256 abortions legally carried out up to then, 13,609 were in National Health Service hospitals and 8601 in other approved hospitals. It is likely that the total number of legal abortions in Britain for the first full year of the Act will be about 34,000. In the years leading up to the introduction of the Abortion Act, the number of abortions carried out in Britain for reasons then legal had been growing steadily, and had reached 7600 in National Health Service hospitals in 1967. An unknown further number of legal abortions had been done in private nursing homes - these cannot be computed because they were not notifiable before the Abortion Act came into force. There are 4 legal abortions for every 100 live births in Britain; this is about 1/2 the figure for Denmark and one tenth that of Czechoslovakia.
Cox proportional hazards regression models are frequently used to determine the association between exposure and time-to-event outcomes in both randomized controlled trials and in observational cohort studies. The resultant hazard ratio is a relative measure of effect that provides limited clinical information.
A method is described for deriving absolute reductions in the risk of an event occurring within a given duration of follow-up time from a Cox regression model. The associated number needed to treat can be derived from this quantity. The method involves determining the probability of the outcome occurring within the specified duration of follow-up if each subject in the cohort was treated and if each subject was untreated, based on the covariates in the regression model. These probabilities are then averaged across the study population to determine the average probability of the occurrence of an event within a specific duration of follow-up in the population if all subjects were treated and if all subjects were untreated.
Risk differences and numbers needed to treat.
Absolute measures of treatment effect can be derived in prospective studies when Cox regression is used to adjust for possible imbalance in prognostically important baseline covariates.
Acarbose for the prevention of Type 2 diabetes, hypertension and cardiovascular disease in subjects with impaired glucose tolerance: facts and interpretations concerning the critical analysis of the STOP-NIDDM Trial data.
Research Centre, Centre hospitalier de l'Université de Montréal-Hôtel-Dieu, Department of Medicine, University of Montreal, 3850 St. Urbain Street, Rm 8-202, Montreal, Quebec H2W 1T7, Canada. firstname.lastname@example.org
The STOP-NIDDM Trial has shown that acarbose treatment in subjects with impaired glucose tolerance is associated with a significant risk reduction in the development of diabetes, hypertension and cardiovascular complications. Kaiser and Sawicki have accused the investigators of the STOP-NIDDM Trial of major biases in the conduct of the study, of manipulating the data and of conflict of interest. The aim of this paper is to present data and explanations refuting these allegations. In the STOP-NIDDM Trial, 61 subjects were excluded from the efficacy analysis before unblinding for legitimate reasons: failure to satisfy major entry criteria (n=17) and lack of post-randomisation data (n=44). Blinding and randomisation were carried out by an independent biostatistician. Titration of placebo/acarbose is well described in the protocol and in the study design paper. Of the study population, 9.3% had a fasting plasma glucose of > or =7.0 mmol/l at screening and could have been diabetic according to the new diagnostic criteria. However, even if these subjects are excluded, patients having acarbose treatment still saw a significant risk reduction in the development of diabetes (p=0.0027). The changes in weight are consistent in different publications and are related to different times of follow-up and assessment. Weight change does have an effect on the development of diabetes, but acarbose treatment is still effective even after adjusting for this (p=0.0063). The cardiovascular endpoints were a clearly designated assessment in the original protocol, and only those defined in the protocol and ascertained by the independent Cardiovascular Event Adjudication Committee were used in the analysis. Hypertension was defined according to the most recent diagnostic criteria. The STOP-NIDDM Trial results are scientifically sound and credible. The investigators stand strongly behind these results demonstrating that acarbose treatment is associated with a delay in the development of diabetes, hypertension and cardiovascular complications in a high-risk population with IGT.
There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.
ABSTRACTOne of the keys to the success of the Canadian Longitudinal Study on Aging (CLSA) will be the leveraging of secondary data sources, particularly health care utilization (HCU) data. To examine the practical, methodological, and ethical aspects of accessing HCU data, one-on-one qualitative interviews were conducted with 53 data stewards and privacy commissioners/ombudsmen from across Canada. Study participants indicated that obtaining permission to access HCU data is generally possible; however, they noted that this will be a complex and lengthy process requiring considerable and meticulous preparatory work to ensure proper documentation and compliance with jurisdictional variations along legislative and policy lines.
American Indian and Alaska Native Programs, University of Colorado Health Sciences Center, Nighthorse Campbell Native Health Building, Mail Stop F800, P.O. Box 6508, Aurora, CO 80045-0508, USA. email@example.com
OBJECTIVE: To illustrate successful strategies in working with American Indian (AI) and Alaska Native (AN) communities in aging and health research by emphasizing access, local relevance, and decision-making processes. METHODS: Case examples of health studies involving older AIs (greater than or equal to 50 years) among Eastern Band Cherokee Indians, a federally recognized reservation; the Cherokee Nation, a rural, nonreservation, tribal jurisdictional service area; and Lakota tribal members living in Rapid City, South Dakota. RESULTS: Local review and decision making reflect the unique legal and historical factors underpinning AI sovereignty. Although specific approval procedures vary, there are common expectations across these communities that can be anticipated in conceptualizing, designing, and implementing health research among native elders. CONCLUSIONS: Most investigators are unprepared to address the demands of health research in AI communities. Community-based participatory research in this setting conflicts with investigators' desire for academic freedom and scientific independence. Successful collaboration promises to enhance research efficiencies and move findings more quickly to clinical practice.