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3.  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
4.  The effect of TCM acupuncture on hot flushes among menopausal women (ACUFLASH) study: A study protocol of an ongoing multi-centre randomised controlled clinical trial 
Background
After menopause, 10–20% of all women have nearly intolerable hot flushes. Long term use of hormone replacement therapy involves a health risk, and many women seek alternative strategies to relieve climacteric complaints. Acupuncture is one of the most frequently used complementary therapies in Norway. We designed a study to evaluate whether Traditional Chinese Medicine acupuncture-care together with self-care is more effective than self-care alone to relieve climacteric complaints.
Methods/Design
The study is a multi-centre pragmatic randomised controlled trial with two parallel arms. Participants are postmenopausal women who document ≥7 flushes/24 hours and who are not using hormone replacement therapy or other medication that may influence flushes. According to power calculations 200 women are needed to detect a 50% reduction in flushes, and altogether 286 women will be recruited to allow for a 30% dropout rate.
The treatment group receives 10 sessions of Traditional Chinese Medicine acupuncture-care and self-care; the control group will engage in self-care only. A team of experienced Traditional Chinese Medicine acupuncturists give acupuncture treatments.
Discussion
The study tests acupuncture as a complete treatment package including the therapeutic relationship and expectation. The intervention period lasts for 12 weeks, with follow up at 6 and 12 months. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life, assessed by the Women's Health Questionnaire. We also collect data on Traditional Chinese Medicine diagnoses, and we examine treatment experiences using a qualitative approach. Finally we measure biological variables, to examine potential mechanisms for the effect of acupuncture. The study is funded by The Research Council of Norway.
doi:10.1186/1472-6882-7-6
PMCID: PMC1819392  PMID: 17324253
5.  Researching complementary and alternative treatments – the gatekeepers are not at home 
Background
To explore the strengths and weaknesses of conventional biomedical research strategies and methods as applied to complementary and alternative medicine (CAM), and to suggest a new research framework for assessing these treatment modalities.
Discussion
There appears to be a gap between published studies showing little or no efficacy of CAM, and reports of substantial clinical benefit from patients and CAM practitioners. This "gap" might be partially due to the current focus on placebo-controlled randomized trials, which are appropriately designed to answer questions about the efficacy and safety of pharmaceutical agents. In an attempt to fit this assessment strategy, complex CAM treatment approaches have been dissected into standardized and often simplified treatment methods, and outcomes have been limited.
Unlike conventional medicine, CAM has no regulatory or financial gatekeeper controlling their therapeutic "agents" before they are marketed. Treatments may thus be in widespread use before researchers know of their existence. In addition, the treatments are often provided as an integrated 'whole system' of care, without careful consideration of the safety issue.
We propose a five-phase strategy for assessing CAM built on the acknowledgement of the inherent, unique aspects of CAM treatments and their regulatory status in most Western countries. These phases comprise:
1. Context, paradigms, philosophical understanding and utilization
2. Safety status
3. Comparative effectiveness.
4. Component efficacy
5. Biological mechanisms.
Summary
Using the proposed strategy will generate evidence relevant to clinical practice, while acknowledging the absence of regulatory and financial gatekeepers for CAM. It will also emphasize the important but subtle differences between CAM and conventional medical practice.
doi:10.1186/1471-2288-7-7
PMCID: PMC1800863  PMID: 17291355
6.  Chinese red yeast rice (Monascus purpureus) for primary hyperlipidemia: a meta-analysis of randomized controlled trials 
Chinese Medicine  2006;1:4.
Extracts of Chinese red yeast rice (RYR, a traditional dietary seasoning of Monascus purpureus) contains several active ingredients including lovastatin, and several trials of its possible lipid-lowering effects have been conducted. This meta-analysis assesses the effectiveness and safety of RYR preparations on lipid modification in primary hyperlipidemia. We included randomized controlled trials testing RYR preparation, compared with placebo, no treatment, statins, or other active lipid-lowering agents in people with hyperlipidemia through searching PubMed, CBMdisk, TCMLARS, the Cochrane Library, and AMED up to December 2004. Ninety-three randomized trials (9625 participants) were included and three RYR preparations (Cholestin, Xuezhikang and Zhibituo) were tested. The methodological quality of trial reports was generally low in terms of generation of the allocation sequence, allocation concealment, blinding, and intention-to-treat. The combined results showed significant reduction of serum total cholesterol levels (weighted mean difference -0.91 mmol/L, 95% confidence interval -1.12 to -0.71), triglycerides levels (-0.41 mmol/L, -0.6 to -0.22), and LDL-cholesterol levels (-0.73 mmol/L, -1.02 to -0.043), and increase of HDL-cholesterol levels (0.15 mmol/L, 0.09 to 0.22) by RYR treatment compared with placebo. The lipid modification effects appeared to be similar to pravastatin, simvastatin, lovastatin, atorvastatin, or fluvastatin. Compared with non-statin lipid lowering agents, RYR preparations appeared superior to nicotinate and fish oils, but equal to or less effective than fenofibrate and gemfibrozil. No significant difference in lipid profile was found between Xuezhikang and Zhibituo. RYR preparations were associated with non-serious adverse effects such as dizziness and gastrointestinal discomfort. Current evidence shows short-term beneficial effects of RYR preparations on lipid modification. More rigorous trials are needed, and long-term effects and safety should be investigated if RYR preparations are to be recommended as one of the alternative treatments for primary hyperlipidemia.
doi:10.1186/1749-8546-1-4
PMCID: PMC1761143  PMID: 17302963
7.  Single versus multiple-family intervention in childhood overweight—Finnmark Activity School: a randomised trial 
Archives of Disease in Childhood  2013;99(3):225-231.
Objective
To compare a new comprehensive lifestyle programme performed in groups of families with overweight (included obese) children with a more conventional single-family programme. The study design and interim anthropometrical results after 12 months are presented.
Design
Altogether 97 overweight and obese children aged 6–12 years with body mass index (BMI) corresponding to cut-off point ≥27.5 in adults were included. Study participants were randomised to multiple-family intervention (MUFI) or single-family intervention (SIFI) in a parallel design. MUFI comprised a 3-day inpatient programme at the hospital with other families and a multidisciplinary team, follow-up visits in their hometown individually and in groups, organised physical activity twice weekly and a 4-day family camp after 6 months. SIFI comprised individual counselling by paediatric nurse, paediatric consultant and nutritionist at the hospital and follow-up by public health nurse in the community. Solution focused approach was applied in both interventions. Primary outcome measures were change in BMI kg/m2 and BMI SD score (BMI SDS).
Results
BMI increased by 0.37 units in the MUFI compared to 0.77 units in the SIFI (p=0.18). BMI SDS decreased by 0.16 units in the MUFI group compared to 0.07 units in the SIFI group (p=0.07). Secondary endpoint waist circumference decreased 0.94 cm in the multiple-family group and increased 0.95 cm in the single-family group, p=0.04.
Conclusions
Interim analysis after 12 months showed no between-group difference in terms of BMI or BMI SDS. The MUFI group had a significant decrease in waist circumference compared to the SIFI group.
The trial is registered
at http://www.clinicaltrials.gov (NCT00872807)
doi:10.1136/archdischild-2012-303571
PMCID: PMC3932955  PMID: 24336385
Obesity; Paediatric Practice; Comm Child Health; Nutrition; Therapeutics

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