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.
Access to health care services in Canada has been identified as an urgent priority, and chronic disease has been suggested as the most pressing health concern facing Canadians. Access to services for Canadians living with chronic disease, however, has received little emphasis in the research literature or in health policy reform documents. A systematic review of research into factors impeding or facilitating access to formal health services for people in Canada living with chronic illness is presented. The review includes 31 studies of Canadian populations published between 1990 and 2002; main results were analyzed for facilitators and barriers to access for people experiencing chronic disease. An underlying organizing construct of symmetry between consumers, providers, and the larger Canadian system is suggested as a relevant lens from which to view the findings. Finally, a discussion of the relationship between identified factors and the principles of primary health care is offered.
The efficacy of two acellular pertussis vaccines was estimated for various clinical case definitions, with and without the requirement of culture confirmation, from a randomized trial in Sweden. Efficacy increased with duration of coughing spasms and when the case definition included whoops or whoops plus at least nine coughing spasms a day. After deletion of clinical cases not believed to be caused by pertussis, efficacies were closer to the higher values for culture-confirmed disease. Nonspecificity of the clinical criterion "21 days of coughing spasms with whoops" resulted in estimates of predictive value for pertussis of 85% for placebo recipients and 56% for vaccinees. We conclude that laboratory confirmation of suspected cases is needed in pertussis vaccine trials. A suggested case definition is 21 days or more of coughing spasms with confirmation by culture, serologic study, or household exposure to culture-confirmed pertussis.
To investigate the psychophysiologic mechanisms of an altered state of consciousness (ASC) produced via systematic mental training by correlating the results of multiple computerized bioelectrographic measurements.
All subjects were tested, using a set of modern computerized techniques comprising digital electroencephalography, measurement of the low-frequency bilateral activity of the brain, evoked bioelectrographic signals measured by computerized Kirlian photography (otherwise called gas discharge visualization [GDV]), self-reporting by subjects, linguistic testing, and profiling of mood states.
Sweden and Russia from 1996 to 1999.
Young volunteers (61) who underwent systematic mental training for not less than 7 weeks. Members of the control group (56) were not engaged in mental training.
All participants involved in the systematic mental training showed significant positive changes in their psychoemotional status after 7 weeks of mental training. All of the techniques showed specific changes that might be associated with an ASC in the subjects. The Kirlian (GDV) patterns showed a form of "explosive activation," which was stable, reproducible, and correlated with an ASC. This led the authors to introduce the concept of short-term activation of the induced bioelectrographic processes and enabled the properties of this ACS to be determined for the first time. There were practically no changes in the control group.
ASC activation took place with harmonization of the biopotential field of the brain, the psychic state, and the bioenergy fields. This is attributed to changes in both the psychosomatic and psychoenergetic autoregulation. This conclusion is of vital importance for understanding what happens in systematic mental training and understanding the fundamentals of bioenergetic and psychosomatic medicine.
Since 2009, all hospitals in Ontario have been mandated to publicly report health care provider compliance with hand hygiene opportunities (http://www.health.gov.on.ca/patient_safety/index.html). Hand hygiene compliance (HHC) is reported for 2 of the 4 moments during the health care provider-patient encounter. This study analyzes the HHC data by using an alternative methodology for interpretation and reporting.
Annualized HHC data were available for fiscal years 2009 and 2010 for each of the 5 hospital corporations (6 sites) in the North Simcoe Muskoka Local Health Integration Network. The weighted average for HHC was used to estimate the overall observed rate for HHC for each hospital and reporting period. Using Bayes' probability theorem, this estimate was used to predict the probability that any patient would experience HHC for at least 75% of hand hygiene moments. This probability was categorized as excellent (=75%), above average (50%-74%), below average (25%-49%), or poor (
In Norway, very little data are available on the relation between the total number of research projects on the clinical development of drugs that have been started, the number of these projects in which the research phase has been completed and the number of projects for which results have been published. The aim of this study was to determine the number of projects in which the research phase had been completed and the results published.
Information on research projects carried out on the clinical development of drugs during the year 2000 was obtained from the archives of the Norwegian Research Ethical Committee (REC) and subsequently analysed.
The final analysis revealed that 245 research projects on the clinical development of drugs had been started in 2000. Of these, 178 (73%) completed the research phase as planned. The results of 131 (54%) of these projects were published in a scientific journal, and another 34 (14%) were reported as a congress abstract or as report to a sponsor; 80 (33%) were not published at all. Industrial sponsors seemed to promote both the completion of the research process and the publication of results in scientific journals.
The Community Health Practice Guidelines (CHPG) project was initiated to develop a systematic approach to the critical evaluation of evidence on the effectiveness and efficiency of community health interventions and to the formulation of evidence-based practice recommendations. Three community health interventions--immunization delivery methods, partner notification for sexually transmitted diseases and the combination of restaurant inspection and education of food handlers--were used as prototypes to develop a standardized approach. The CHPG process consists of three components: a review of scientific evidence, a practice survey and formulation of practice guidelines. Imperatives for further development of the CHPG and define research priorities process include creating a coalition of public health organizations to sponsor the process and refining the consensus process so that the practice guidelines accurately reflect both the scientific basis of public health practice and the values of those affected.
The partial RCT is a modified design meant to account for participants' treatment preferences. Little is known about the factors that influence such preferences. This study investigated the extent to which participants are willing to be randomized and the factors that affect their treatment preferences. The quantitative and qualitative data collected as part of a partial RCT evaluating 2 behavioural interventions for insomnia were analyzed. Of the participants, 75% were unwilling to be randomly allocated to a treatment group. This figure increased to 90% after information on the 2 interventions was provided. Participants' knowledge of the treatment, its suitability, and their perceived ability to adhere to it influenced their treatment preference. A few participants who had no strong preference and who required treatment were willing to be randomized. The findings raise questions about the impact of treatment preference and allocation procedures on the validity of study conclusions.
ReprintIn: Can J Nurs Res. 2009 Mar;41(1):276-9019485057
On and shortly after the 6th May 1990, 16 people were affected by food poisoning in an old peoples' residential home, of whom two died. The vehicle of infection was identified as a baked Alaska contaminated by Salmonella enteritidis phage type (PT) 8 and, at an early stage of the investigation, the source was attributed to a single infected egg. A separate investigation by the author, however, revealed that the baked Alaska meringue had been dispensed from an inadequately cleaned piping bag which had been recovered from the kitchen a month after the outbreak. A pure, profuse culture of S. enteritidis PT8 was isolated from it. At least one secondary case may have been attributable to food made with this bag. Ministry of Agriculture Investigations of the flocks suspected of producing the eggs used for the baked Alaska demonstrated an absence of S. enteritidis. On this basis, the author considered a more likely cause of the outbreak to be the piping bag, contaminated from source or sources unknown within the kitchen. Furthermore, the possibility of human carrier transmission cannot be wholly ruled out. The incident underlines the dangers of jumping to conclusions at the outset of food poisoning investigations and emphasises that hypotheses formulated on sources of contamination must be properly tested, the absence of which, in this instance, led the investigators to unwarranted conclusions as to the cause of the outbreak.