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1.  Evaluating Complex Healthcare Systems: A Critique of Four Approaches 
The purpose of this paper is to bring clarity to the emerging conceptual and methodological literature that focuses on understanding and evaluating complex or ‘whole’ systems of healthcare. An international working group reviewed literature from interdisciplinary or interprofessional groups describing approaches to the evaluation of complex systems of healthcare. The following four key approaches were identified: a framework from the MRC (UK), whole systems research, whole medical systems research described by NCCAM (USA) and a model from NAFKAM (Norway). Main areas of congruence include acknowledgment of the inherent complexity of many healthcare interventions and the need to find new ways to evaluate these; the need to describe and understand the components of complex interventions in context (as they are actually practiced); the necessity of using mixed methods including randomized clinical trials (RCTs) (explanatory and pragmatic) and qualitative approaches; the perceived benefits of a multidisciplinary team approach to research; and the understanding that methodological developments in this field can be applied to both complementary and alternative medicine (CAM) as well as conventional therapies. In contrast, the approaches differ in the following ways: terminology used, the extent to which the approach attempts to be applicable to both CAM and conventional medical interventions; the prioritization of research questions (in order of what should be done first) especially with respect to how the ‘definitive’ RCT fits into the process of assessing complex healthcare systems; and the need for a staged approach. There appears to be a growing international understanding of the need for a new perspective on assessing complex healthcare systems.
doi:10.1093/ecam/nel079
PMCID: PMC1978227  PMID: 17965757
complex interventions; research methods; whole systems research
2.  The Canadian Natural Health Products (NHP) Regulations: Industry Compliance Motivations 
This qualitative study explores corporations' motivations to comply with new natural health products (NHP) Regulations in Canada. Interviews were conducted with representatives from 20 Canadian NHP companies. Findings show that the rationale for compliance differs for large compared to small and medium-sized enterprises (SMEs). Large firms are motivated to comply with the regulations because of the deterrent fear of negative media coverage, social motivations, ability to comply and maintaining a competitive market advantage. In contrast, SMEs are motivated to comply due to the deterrent fear of legal prosecution and a sense of duty.
doi:10.1093/ecam/nel090
PMCID: PMC1876621  PMID: 17549245
dietary supplements; herbs; policy
3.  Complementary and Alternative Medicine: A Rising Healthcare Issue 
Healthcare Policy  2006;1(3):19-30.
More than half of all Canadians use some form of complementary and alternative medicine (CAM) every year. The way CAM is being used, the magnitude of its use and the lack of clarity on standards of evidence make CAM a rising healthcare issue. A recent research priority-setting exercise by the Canadian Interdisciplinary Network for CAM Research (IN-CAM) identified three research priority areas: (1) healthcare delivery and policy research, including (a) exploring if and how CAM should be regulated, (b) defining what constitutes acceptable evidence of safety and efficacy, (c) investigating the organization and delivery of integrative healthcare; (2) methodological research, including exploring how best to assess whole systems of care and how to choose patient-, practitioner- and policy-relevant outcome measures; and (3) knowledge transfer, including formal education strategies, the provision of information and dialogue with those who use information in decision-making. The high use of CAM products and therapies leads to many questions from patients, practitioners and policy makers. The research agenda presented here provides a guide to begin programs of research that will answer these questions.
PMCID: PMC2585340  PMID: 19305666
4.  U.S. and Canadian pharmacists' attitudes, knowledge, and professional practice behaviors toward dietary supplements: a systematic review 
Background
Although dietary supplements (DS) are widely sold in pharmacies, the legal, ethical, and practice responsibilities of pharmacists with respect to these products have not been well defined. This systematic review of pharmacists' attitudes, knowledge, and professional practice behaviours toward DS is intended to inform pharmacy regulators' and educators' decision making around this topic.
Methods
Eligible studies were identified through a systematic database search for all available years through to March 2006. Articles were analyzed for this review if they included survey data on U.S. or Canadian pharmacists' attitudes, knowledge, or professional practice behaviors toward DS published in 1990 or later.
Results
Due to the heterogeneity of the data, it was not possible to draw a conclusion with respect to pharmacists' general attitudes toward DS. Approximately equal numbers of pharmacists report positive as well as negative attitudes about the safety and efficacy of DS. There is strong agreement among pharmacists for the need to have additional training on DS, increased regulation of DS, and quality information on DS. In addition, survey data indicate that pharmacists do not perceive their knowledge of DS to be adequate and that pharmacists do not routinely document, monitor, or inquire about patients' use of DS. Despite this, a large proportion of pharmacists reported receiving questions about DS from patients and other health care practitioners.
Conclusion
Further research is needed to explore the factors that influence pharmacists' beliefs and attitudes about DS, to accurately evaluate pharmacists' knowledge of DS, and to uncover the reasons why pharmacists do not routinely document, monitor, or inquire about patients' use of DS.
doi:10.1186/1472-6882-6-31
PMCID: PMC1586212  PMID: 16984649
5.  The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors 
Background
The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance.
Methods
Twenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes.
Results
The major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size.
Conclusion
The Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.
doi:10.1186/1472-6963-6-63
PMCID: PMC1524757  PMID: 16734916
6.  New Canadian natural health product regulations: a qualitative study of how CAM practitioners perceive they will be impacted 
Background
New Canadian policy to regulate natural health products (NHPs), such as herbs and vitamins were implemented on January 1st, 2004. We explored complementary and alternative medicine (CAM) practitioners' perceptions of how the new regulations may affect their practices and relationships with patients/consumers.
Methods
This was an applied ethnographic study. Data were collected in fall 2004 via qualitative interviews with 37 Canadian leaders of four CAM groups that use natural products as a core part of their practises: naturopathic medicine, traditional Chinese medicine (TCM), homeopathic medicine and Western herbalism. All interviews were transcribed verbatim and coded independently by a minimum of two investigators using content analysis.
Results
Three key findings emerged from the data: 1) all CAM leaders were concerned with issues of their own access to NHPs; 2) all the CAM leaders, except for the homeopathic leaders, specifically indicated a desire to have a restricted schedule of NHPs; and 3) only naturopathic leaders were concerned the NHP regulations could potentially endanger patients if they self-medicate incorrectly.
Conclusion
Naturopaths, TCM practitioners, homeopaths, and Western herbalists were all concerned about how the new NHP regulations will affect their access to the products they need to practice effectively. Additional research will need to focus on what impacts actually occur as the regulations are implemented more fully.
doi:10.1186/1472-6882-6-18
PMCID: PMC1481533  PMID: 16686960

Results 1-6 (6)