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Acceptability and profile of the clinical drug trials underway in Finnish university hospitals in the 1990s: applications reviewed by ethics committees.

https://arctichealth.org/en/permalink/ahliterature192044
Source
Methods Find Exp Clin Pharmacol. 2001 Sep;23(7):415-23
Publication Type
Article
Date
Sep-2001
Author
T. Keinonen
S. Nieminen
V. Saareks
V. Saano
P. Ylitalo
Author Affiliation
Department of Pharmacology and Toxicology, University of Kuopio, Finland. tuija.keinonen@medfiles.fi
Source
Methods Find Exp Clin Pharmacol. 2001 Sep;23(7):415-23
Date
Sep-2001
Language
English
Publication Type
Article
Keywords
Clinical Protocols - standards
Clinical Trials Data Monitoring Committees - statistics & numerical data
Clinical Trials as Topic - standards - statistics & numerical data
Ethics Committees, Research - statistics & numerical data
Finland
Hospitals, University - statistics & numerical data
Humans
Informed Consent - statistics & numerical data
Multicenter Studies as Topic - statistics & numerical data
Patient Selection
Practice Guidelines as Topic
Research Design - standards - statistics & numerical data
Retrospective Studies
Abstract
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.
PubMed ID
11771857 View in PubMed
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Access to health services by Canadians who are chronically ill.

https://arctichealth.org/en/permalink/ahliterature174970
Source
West J Nurs Res. 2005 Jun;27(4):465-86
Publication Type
Article
Date
Jun-2005
Author
Shannon M Spenceley
Author Affiliation
University of Alberta, Canada.
Source
West J Nurs Res. 2005 Jun;27(4):465-86
Date
Jun-2005
Language
English
Publication Type
Article
Keywords
Attitude to Health
Canada - epidemiology
Chronic Disease - epidemiology - psychology - therapy
Data Collection - standards
Data Interpretation, Statistical
Health Care Reform - organization & administration
Health Services Accessibility - organization & administration
Health Services Research - organization & administration
Humans
National health programs - organization & administration
Needs Assessment - organization & administration
Research Design - standards
Abstract
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.
PubMed ID
15870244 View in PubMed
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Acellular pertussis vaccines. Efficacy and evaluation of clinical case definitions.

https://arctichealth.org/en/permalink/ahliterature59695
Source
Am J Dis Child. 1991 Nov;145(11):1285-9
Publication Type
Article
Date
Nov-1991
Author
W C Blackwelder
J. Storsaeter
P. Olin
H O Hallander
Author Affiliation
National Institute of Allergy and Infectious Diseases, Bethesda, Md.
Source
Am J Dis Child. 1991 Nov;145(11):1285-9
Date
Nov-1991
Language
English
Publication Type
Article
Keywords
Humans
Immunotherapy - standards
Infant
Pertussis Vaccine - therapeutic use
Research Design - standards
Research Support, Non-U.S. Gov't
Risk factors
Sensitivity and specificity
Sweden - epidemiology
Whooping Cough - diagnosis - epidemiology - prevention & control
Abstract
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.
PubMed ID
1951222 View in PubMed
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Altered states of consciousness: review of experimental data obtained with a multiple techniques approach.

https://arctichealth.org/en/permalink/ahliterature190226
Source
J Altern Complement Med. 2002 Apr;8(2):153-65
Publication Type
Article
Date
Apr-2002
Author
Pavel V Bundzen
Konstantin G Korotkov
Lars-Erick Unestahl
Author Affiliation
Research Institute of Physical Culture, St. Petersburg, Russia.
Source
J Altern Complement Med. 2002 Apr;8(2):153-65
Date
Apr-2002
Language
English
Publication Type
Article
Keywords
Adult
Affect - physiology
Case-Control Studies
Chromatography, Gas
Consciousness Disorders
Electroencephalography
Electromagnetic fields
Evoked Potentials
Female
Humans
Male
Mental Processes - physiology
Models, Psychological
Research Design - standards
Russia
Sweden
Abstract
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.
PubMed ID
12006123 View in PubMed
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An alternative methodology for interpretation and reporting of hand hygiene compliance data.

https://arctichealth.org/en/permalink/ahliterature131026
Source
Am J Infect Control. 2012 May;40(4):332-5
Publication Type
Article
Date
May-2012
Author
Giulio DiDiodato
Author Affiliation
North Simcoe Muskoka Infection Control Network, Orillia, Ontario, Canada. gdidiodato@gmail.com
Source
Am J Infect Control. 2012 May;40(4):332-5
Date
May-2012
Language
English
Publication Type
Article
Keywords
Data Interpretation, Statistical
Guideline Adherence - statistics & numerical data
Hand Disinfection - methods - standards
Hospitals
Humans
Ontario
Research Design - standards
Abstract
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 (
PubMed ID
21945114 View in PubMed
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An analysis of the clinical development of drugs in Norway for the year 2000: the completion of research and publication of results.

https://arctichealth.org/en/permalink/ahliterature153525
Source
Eur J Clin Pharmacol. 2009 Mar;65(3):315-8
Publication Type
Article
Date
Mar-2009
Author
Ola P Hole
Sigurd Nitter-Hauge
Henrik R Cederkvist
Finn O Winther
Author Affiliation
Faculty Division Rikshospitalet, University of Oslo, 0027 Oslo, Norway.
Source
Eur J Clin Pharmacol. 2009 Mar;65(3):315-8
Date
Mar-2009
Language
English
Publication Type
Article
Keywords
Academies and Institutes - economics - statistics & numerical data
Biomedical Research - economics - ethics - statistics & numerical data
Clinical Trials as Topic - economics - ethics - statistics & numerical data
Drug Industry - economics - ethics - statistics & numerical data
Ethics Committees, Research - ethics - standards
Hospitals, Private - economics - statistics & numerical data
Hospitals, Public - economics - statistics & numerical data
Humans
Information Dissemination - ethics
Norway
Publishing - ethics - standards - statistics & numerical data
Questionnaires
Research Design - standards - statistics & numerical data
Research Support as Topic - ethics - statistics & numerical data
Time Factors
Abstract
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.
PubMed ID
19104790 View in PubMed
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An approach to the development of practice guidelines for community health interventions.

https://arctichealth.org/en/permalink/ahliterature217816
Source
Can J Public Health. 1994 Jul-Aug;85 Suppl 1:S8-13
Publication Type
Article
Author
T W Gyorkos
T N Tannenbaum
M. Abrahamowicz
A D Oxman
E A Scott
M E Millson
I. Rasooly
J W Frank
P D Riben
R G Mathias
Author Affiliation
Department of Family Medicine, McMaster University, Hamilton, Ontario.
Source
Can J Public Health. 1994 Jul-Aug;85 Suppl 1:S8-13
Language
English
Publication Type
Article
Keywords
Canada
Community Health Services - standards
Data Collection - methods
Humans
Practice Guidelines as Topic - standards
Research Design - standards
Abstract
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.
PubMed ID
7987764 View in PubMed
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An exploration of participants' treatment preferences in a partial RCT.

https://arctichealth.org/en/permalink/ahliterature177356
Source
Can J Nurs Res. 2004 Sep;36(3):100-14
Publication Type
Article
Date
Sep-2004
Author
Joyal Miranda
Author Affiliation
Faculty of Nursing, University of Toronto, Ontario, Canada. joyal.miranda@utoronto.ca
Source
Can J Nurs Res. 2004 Sep;36(3):100-14
Date
Sep-2004
Language
English
Publication Type
Article
Keywords
Adult
Behavior Therapy - standards
Choice Behavior
Female
Health Knowledge, Attitudes, Practice
Humans
Male
Middle Aged
Nursing Methodology Research
Ontario
Patient Education as Topic - standards
Patient Participation - psychology
Patient Selection
Qualitative Research
Questionnaires
Randomized Controlled Trials as Topic - psychology
Research Design - standards
Sleep Initiation and Maintenance Disorders - psychology - therapy
Abstract
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.
Notes
ReprintIn: Can J Nurs Res. 2009 Mar;41(1):276-9019485057
PubMed ID
15551665 View in PubMed
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An in-depth investigation into a food poisoning outbreak.

https://arctichealth.org/en/permalink/ahliterature4364
Source
Cater Health. 1991;2(1):25-39
Publication Type
Article
Date
1991
Author
R A North
Author Affiliation
Leeds Polytechnic, UK.
Source
Cater Health. 1991;2(1):25-39
Date
1991
Language
English
Publication Type
Article
Keywords
Aged
Eggs - adverse effects
Equipment Contamination
Food contamination - analysis
Food Services - instrumentation - standards
Great Britain
Homes for the Aged - standards
Humans
Research Design - standards
Salmonella Food Poisoning - etiology
Sanitation - standards
Abstract
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.
PubMed ID
10115964 View in PubMed
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Another piece of the inhaled corticosteroids-in-COPD puzzle.

https://arctichealth.org/en/permalink/ahliterature193526
Source
Am J Respir Crit Care Med. 2001 Aug 15;164(4):514-5
Publication Type
Article
Date
Aug-15-2001

167 records – page 1 of 17.