Study protocol of European Fans in Training (EuroFIT): a four-country randomised controlled trial of a lifestyle program for men delivered in elite football clubs.

BACKGROUND: Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support. This paper describes the study protocol to evaluate the effectiveness and cost-effectiveness of the EuroFIT program in supporting men to improve their level of physical activity and reduce sedentary behaviour over 12 months. METHODS: The EuroFIT study is a pragmatic, two-arm, randomised controlled trial conducted in 15 football clubs in the Netherlands, Norway, Portugal and the UK (England). One-thousand men, aged 30 to 65 years, with a self-reported Body Mass Index (BMI) ≥27 kg/m(2) will be recruited and individually randomised. The primary outcomes are objectively-assessed changes in total physical activity (steps per day) and total sedentary time (minutes per day) at 12 months after baseline assessment. Secondary outcomes are weight, BMI, waist circumference, resting systolic and diastolic blood pressure, cardio-metabolic blood biomarkers, food intake, self-reported physical activity and sedentary time, wellbeing, self-esteem, vitality and quality of life. Cost-effectiveness will be assessed and a process evaluation conducted. The EuroFIT program will be delivered over 12 weekly, 90-minute sessions that combine classroom discussion with graded physical activity in the setting of the football club. Classroom sessions provide participants with a toolbox of behaviour change techniques to initiate and sustain long-term lifestyle changes. The coaches will receive two days of training to enable them to create a positive social environment that supports men in engaging in sustained behaviour change. DISCUSSION: The EuroFIT trial will provide evidence on the effectiveness and cost-effectiveness of the EuroFIT program delivered by football clubs to their male fans, and will offer insight into factors associated with success in making sustained changes to physical activity, sedentary behaviour, and secondary outcomes, such as diet. ISRCTN: 81935608 . Registered 16 June 2015.

Scaling up and implementing the digital Survivorship Passport tool in routine clinical care - The European multidisciplinary PanCareSurPass project.

BACKGROUND: Childhood cancer survivors (CCS), of whom there are about 500,000 living in Europe, are at an increased risk of developing health problems [1-6] and require lifelong Survivorship Care. There are information and knowledge gaps among CCS and healthcare providers (HCPs) about requirements for Survivorship Care [7-9] that can be addressed by the Survivorship Passport (SurPass), a digital tool providing CCS and HCPs with a comprehensive summary of past treatment and tailored recommendations for Survivorship Care. The potential of the SurPass to improve person-centred Survivorship Care has been demonstrated previously [10,11]. METHODS: The EU-funded PanCareSurPass project will develop an updated version (v2.0) of the SurPass allowing for semi-automated data entry and implement it in six European countries (Austria, Belgium, Germany, Italy, Lithuania and Spain), representative of three infrastructure healthcare scenarios typically found in Europe. The implementation study will investigate the impact on person-centred care, as well as costs and processes of scaling up the SurPass. Interoperability between electronic health record systems and SurPass v2.0 will be addressed using the Health Level Seven (HL7) International interoperability standards. RESULTS: PanCareSurPass will deliver an interoperable digital SurPass with comprehensive evidence on person-centred outcomes, technical feasibility and health economics impacts. An Implementation Toolkit will be developed and freely shared to promote and support the future implementation of SurPass across Europe. CONCLUSIONS: PanCareSurPass is a novel European collaboration that will improve person-centred Survivorship Care for CCS across Europe through a robust assessment of the implementation of SurPass v2.0 in different healthcare settings.

Cannabidiol (CBD) in Cancer Management.

The plant Cannabis sativa has been in use medicinally for several thousand years. It has over 540 metabolites thought to be responsible for its therapeutic effects. Two of the key phytocannabinoids are cannabidiol (CBD) and tetrahydrocannabinol (THC). Unlike THC, CBD does not have potentially intoxicating effects. Preclinical and clinical research indicates that CBD has a wide range of therapeutic effects, and many of them are relevant to the management of cancer. In this article, we explore some of the potential mechanisms of action of CBD in cancer, and evidence of its efficacy in the integrative management of cancer including the side effects associated with its treatment, demonstrating its potential for integration with orthodox cancer care.

Integrative Approaches to the Treatment of Cancer.

A significant proportion of cancer patients use forms of complementary medicine or therapies. An integrative approach to cancer management combines conventional medicine with evidence-based complementary medicines/therapies and lifestyle interventions, for the treatment and prevention of disease and the optimisation of health. Its basis is a holistic one; to treat the whole person, not just the disease. It makes use of adjunct technologies which may assist the clinician in diagnosis of early carcinogenesis and monitoring of treatment effectiveness. Many factors contribute to the development of cancer including some which are largely modifiable by the patient and which oncologists may be in a position to advise on, such as stress, poor nutrition, lack of physical activity, poor sleep, and Vitamin D deficiency. An integrative approach to addressing these factors may contribute to better overall health of the patient and better outcomes. Evidence-based complementary medicine approaches include the use of supplements, herbal medicine, various practices that reduce stress, and physical therapies. Individualised to the patient, these can also help address the symptoms and signs associated with cancer and its orthodox treatment.

Evaluating the feasibility, effectiveness and costs of implementing person-centred follow-up care for childhood cancer survivors in four European countries: the PanCareFollowUp Care prospective cohort study protocol.

INTRODUCTION: Long-term survival after childhood cancer often comes at the expense of late, adverse health conditions. However, survivorship care is frequently not available for adult survivors in Europe. The PanCareFollowUp Consortium therefore developed the PanCareFollowUp Care Intervention, an innovative person-centred survivorship care model based on experiences in the Netherlands. This paper describes the protocol of the prospective cohort study (Care Study) to evaluate the feasibility and the health economic, clinical and patient-reported outcomes of implementing PanCareFollowUp Care as usual care in four European countries. METHODS AND ANALYSIS: In this prospective, longitudinal cohort study with at least 6 months of follow-up, 800 childhood cancer survivors will receive the PanCareFollowUp Care Intervention across four study sites in Belgium, Czech Republic, Italy and Sweden, representing different healthcare systems. The PanCareFollowUp Care Intervention will be evaluated according to the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Clinical and research data are collected through questionnaires, a clinic visit for multiple medical assessments and a follow-up call. The primary outcome is empowerment, assessed with the Health Education Impact Questionnaire. A central data centre will perform quality checks, data cleaning and data validation, and provide support in data analysis. Multilevel models will be used for repeated outcome measures, with subgroup analysis, for example, by study site, attained age, sex or diagnosis. ETHICS AND DISSEMINATION: This study will be conducted in accordance with the guidelines of Good Clinical Practice and the Declaration of Helsinki. The study protocol has been reviewed and approved by all relevant ethics committees. The evidence and insights gained by this study will be summarised in a Replication Manual, also including the tools required to implement the PanCareFollowUp Care Intervention in other countries. This Replication Manual will become freely available through PanCare and will be disseminated through policy and press releases. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NL8918; https://www.trialregister.nl/trial/8918).

A chinese herbal preparation containing radix salviae miltiorrhizae, radix notoginseng and borneolum syntheticum reduces circulating adhesion molecules.

Circulating adhesion molecules (CAMs), surface proteins expressed in the vascular endothelium, have emerged as risk factors for cardiovascular disease (CVD). CAMs are involved in intercellular communication that are believed to play a role in atherosclerosis. A Chinese medicine, the "Dantonic Pill" (DP) (also known as the "Cardiotonic Pill"), containing three Chinese herbal material medica, Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum, has been used in China for the prevention and management of CVD. Previous laboratory and animal studies have suggested that this preparation reduces both atherogenesis and adhesion molecule expression. A parallel double blind randomized placebo-controlled study was conducted to assess the effects of the DP on three species of CAM (intercellular cell adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 and endothelial cell selectin (E-selectin)) in participants with mild-moderate hypercholesterolemia. Secondary endpoints included biochemical and hematological variables and clinical effects. Forty participants were randomized to either treatment or control for 12 weeks. Treatment with DP was associated with a statistically significant decrease in ICAM-1 (9% decrease, P = .03) and E-Selectin (15% decrease, P = .004). There was no significant change in renal function tests, liver function tests, glucose, lipids or C-reactive protein levels and clinical adverse effects did not differ between the active and the control groups. There were no relevant changes in participants receiving placebo. These results suggest that this herbal medicine may contribute to the development of a novel approach to cardiovascular risk reduction.

The European multistakeholder PanCareFollowUp project: novel, person-centred survivorship care to improve care quality, effectiveness, cost-effectiveness and accessibility for cancer survivors and caregivers.

BACKGROUND: The majority of childhood cancer survivors are at risk of treatment-related adverse health outcomes. Survivorship care to mitigate these late effects is endorsed, but it is not available for many adult survivors of childhood cancer in Europe. The PanCareFollowUp project was initiated to improve their health and quality of life (QoL) by facilitating person-centred survivorship care. METHODS: The PanCareFollowUp consortium was established in 2018, consisting of 14 project partners from ten European countries, including survivor representatives. The consortium will develop two PanCareFollowUp Interventions, including a person-centred guideline-based model of care (Care Intervention) and eHealth lifestyle coaching (Lifestyle Intervention). Their development will be informed by several qualitative studies and systematic reviews on barriers and facilitators for implementation and needs and preferences of healthcare providers (HCPs) and survivors. Implementation of the PanCareFollowUp Care Intervention as usual care will be evaluated prospectively among 800 survivors from Belgium, Czech Republic, Italy and Sweden for survivor empowerment, detection of adverse health conditions, satisfaction among survivors and HCPs, cost-effectiveness and feasibility. The feasibility of the PanCareFollowUp Lifestyle Intervention will be evaluated in the Netherlands among 60 survivors. RESULTS: Replication manuals, allowing for replication of the PanCareFollowUp Care and Lifestyle Intervention, will be published and made freely available after the project. Moreover, results of the corresponding studies are expected within the next five years. CONCLUSIONS: The PanCareFollowUp project is a novel European collaboration aiming to improve the health and QoL of all survivors across Europe by developing and prospectively evaluating the person-centred PanCareFollowUp Care and Lifestyle Interventions.

Biochemical markers of striatal desensitization in cortical-limbic hyperglutamatergic TS- & OCD-like transgenic mice.

Tics and compulsions in comorbid Tourette's syndrome (TS) and obsessive-compulsive disorder (OCD) are associated with chronic hyperactivity of parallel cortico/amygdalo-striato-thalamo-cortical (CSTC) loop circuits. Comorbid TS- & OCD-like behaviors have likewise been observed in D1CT-7 mice, in which an artificial neuropotentiating transgene encoding the cAMP-elevating intracellular subunit of cholera toxin (CT) is chronically expressed selectively in somatosensory cortical & amygdalar dopamine (DA) D1 receptor-expressing neurons that activate cortico/amygdalo-striatal glutamate (GLU) output. We've now examined in D1CT-7 mice whether the chronic GLU output from their potentiated cortical/limbic CSTC subcircuit afferents associated with TS- & OCD-like behaviors elicits desensitizing neurochemical changes in the striatum (STR). Microdialysis-capillary electrophoresis and in situ hybridization reveal that the mice's chronic GLU-excited STR exhibits pharmacodynamic changes in three independently GLU-regulated measures of output neuron activation, co-excitation, and desensitization, signifying hyperactive striatal CSTC output and compensatory striatal glial and neuronal desensitization: 1) Striatal GABA, an output neurotransmitter induced by afferent GLU, is increased. 2) Striatal d-serine, a glial excitatory co-transmitter inhibited by afferent GLU, is decreased. 3) Striatal Period1 (Per1), which plays a non-circadian role in the STR as a GLU + DA D1- (cAMP-) dependent repressor thought to feedback-inhibit GLU + DA- triggered ultradian urges and motions, is transcriptionally abolished. These data imply that chronic cortical/limbic GLU excitation of the STR desensitizes its co-excitatory d-serine & DA inputs while freezing its GABA output in an active state to mediate chronic tics and compulsions - possibly in part by abolishing striatal Per1-dependent ultradian extinction of urges and motions.

PanCareLIFE: The scientific basis for a European project to improve long-term care regarding fertility, ototoxicity and health-related quality of life after cancer occurring among children and adolescents.

AIMS: Survival after cancer diagnosed during childhood or adolescence continues to improve with new treatments and supportive therapies. Optimal long-term care requires that risks to vulnerable organs are clearly defined and translated into guidelines that are implemented into practice. PanCareLIFE is a pan-European consortium that addresses survivorship issues comprising fertility, hearing impairment and quality of life. This article describes the scientific basis of PanCareLIFE's studies. METHODS: PanCareLIFE involves 17 partner institutions from eight European countries, with additional 11 data providers from five other countries. Study designs and methods include molecular genetic, cohort and case-control studies, a longitudinal study and an intervention study. Ethics and data protection issues have been taken into account from the beginning. RESULTS: PanCareLIFE will investigate the way that treatment impairs female fertility, by evaluating anti-Müllerian hormone levels and the underlying genetic susceptibility to loss of fertility. For our fertility studies, more than 6000 survivors have completed questionnaires, more than 1500 provided serum samples and more than 400 case-control triads have been identified. Fertility preservation guidelines for boys and girls will be developed. More than 2000 survivors have contributed audiograms for the ototoxicity study. Almost 1000 samples were sent for genetic analysis related to ototoxicity and gonadal reserve. The SF-36 questionnaire will measure quality of life in more than 10,000 survivors. CONCLUSIONS: The large number of subjects enrolled in PanCareLIFE and the detailed information accumulated will allow in-depth evaluation of important outcomes. Fertility preservation guidelines will help patients and their families make informed decisions and contribute to their long-term well-being.

Cancer and Cancer-Related Fatigue and the Interrelationships With Depression, Stress, and Inflammation.

Cancer-related fatigue (CRF) is a common symptom experienced in cancer patients. Depression, anxiety, and stress are associated with cancer. Depression and anxiety are also associated with CRF. At the cellular level, much is known about the impact of stress on the body generally, and its potential role in cancer. Stress, anxiety, and depression have been found to depress the immune system. Depression and stress have also been found to create inflammatory changes in the body and there is emerging evidence that inflammation is involved in cancer pathogenesis and in CRF. This article examines the relationships between stress, anxiety, depression, and cancer; relationships between anxiety and depression and CRF; and what happens at the cellular level, including impact on the immune system and emerging evidence of the role of inflammation in CRF. It also reports on research in relation to some Chinese herbal medicines that may be used to treat CRF.

Insomnia in Chinese Medicine: The Heart of the Matter.

Chronic insomnia affects a significant proportion of the general population worldwide, and is associated with several serious medical conditions. From the Western scientific literature, hyper-arousal (on the cognitive-emotional, behavioral, autonomic, or central nervous system level) is a final common pathway involved in its pathogenesis. However, from a Chinese medicine (CM) perspective, it is the Heart, capitalized to denote the functional system as described in CM theory, that is the key organ involved in insomnia due to its role as the "seat of consciousness." This article explores how insomnia is understood from the CM perspective, in particular the role of the Heart, and some of the neurophysiological evidence that supports these ancient theoretical understandings. The potential role of the vagus nerve and its relationship with the (biomedical) heart and CM Heart is also examined. Finally, some of the evidence in association with mechanisms of action of acupuncture in insomnia, in particular its impact on cardiovascular variables associated with insomnia, is presented, along with findings of systematic reviews.

Chinese Medicine in Australia.

OBJECTIVES: Chinese medicine is a complex domain of theoretical and practical approaches that is being increasingly put under the research spotlight. The "Chinese Medicine in Australia" research project attempted to capture the clinical features of practitioners of Chinese medicine. PARTICIPANTS AND INTERVENTIONS: The project involved a national survey of Chinese medicine professional association members and registered practitioners in the state of Victoria, Australia (n = 655; response rate, 42%-55%) completed in 2012-2013. DESIGN: The content and face validated survey was developed using new and previous workforce survey questions. RESULTS: This paper reports on the workforce and practice characteristics of the survey respondents. Chinese medicine practitioners are highly educated, come from diverse backgrounds, and have chosen to practice predominantly in sole or multipractitioner private practice settings. An interest in the philosophy of Chinese medicine and previous experiences contributed to practitioners' decisions to study and practice Chinese medicine. Incorporating a variety of techniques, practitioners describe themselves as practicing predominantly Chinese acupuncture and herbal medicine. CONCLUSIONS: The results from this survey contribute to the understanding of the nature and description of Chinese medicine practice in Australia.

Expert validation of a teamwork assessment rubric: A modified Delphi study.

BACKGROUND: Teamwork is a 'soft skill' employability competence desired by employers. Poor teamwork skills in healthcare have an impact on adverse outcomes. Teamwork skills are rarely the focus of teaching and assessment in undergraduate courses. The TeamUP Rubric is a tool used to teach and evaluate undergraduate students' teamwork skills. Students also use the rubric to give anonymised peer feedback during team-based academic assignments. The rubric's five domains focus on planning, environment, facilitation, conflict management and individual contribution; each domain is grounded in relevant theory. Students earn marks for their teamwork skills; validity of the assessment rubric is critical. QUESTION: To what extent do experts agree that the TeamUP Rubric is a valid assessment of 'teamwork skills'? DESIGN: Modified Delphi technique incorporating Feminist Collaborative Conversations. PARTICIPANTS: A heterogeneous panel of 35 professionals with recognised expertise in communications and/or teamwork. METHODS: Three Delphi rounds using a survey that included the rubric were conducted either face-to-face, by telephone or online. Quantitative analysis yielded item content validity indices (I-CVI); minimum consensus was pre-set at 70%. An average of the I-CVI also yielded sub-scale (domain) (D-CVI/Ave) and scale content validity indices (S-CVI/Ave). After each Delphi round, qualitative data were analysed and interpreted; Feminist Collaborative Conversations by the research team aimed to clarify and confirm consensus about the wording of items on the rubric. RESULTS: Consensus (at 70%) was obtained for all but one behavioural descriptor of the rubric. We modified that descriptor to address expert concerns. The TeamUP Rubric (Version 4) can be considered to be well validated at that level of consensus. The final rubric reflects underpinning theory, with no areas of conceptual overlap between rubric domains. CONCLUSION: The final TeamUP Rubric arising from this study validly measures individual student teamwork skills and can be used with confidence in the university setting.

D-Serine uptake by isolated retinas is consistent with ASCT-mediated transport.

Uptake of the neuromodulator D-serine by isolated larval tiger salamander (Ambystoma tigrinum) retinas was measured using capillary electrophoresis (CE). Excised retinas were incubated in Ringer's solution in the presence of 5 microM D-serine. The supernatant was removed after 30 min, mixed with 4-fluoro-7-nitrobenz-2-oxa-1,3-diazole (NBD-F) to fluorescently label amines and analyzed using CE. Significant D-serine uptake was observed over a period of 1.5h. This is the first observation of D-serine uptake by an intact retinal tissue. D-Serine uptake in the retina was Na(+)-dependent and blocked by l-alanine, l-threonine, and l-cysteine. This pharmacology is consistent with the sodium dependent heteroexchange expected of system ASC-type transporters.

Optimization of cellular nucleotide extraction and sample preparation for nucleotide pool analyses using capillary electrophoresis.

Cell extraction and further sample preparation for nucleotide pool analysis using capillary electrophoresis was faster and simpler using volatile extraction solvents (e.g. organic solvents and de-ionized water) compared to the commonly applied acids dissolved in water (e.g. perchloric acid and trichloracetic acid). Temperature had to be controlled during the whole sample preparation process to prevent degradation, and extracts had to be cleaned from proteins and other large molecules prior to capillary electrophoretic analysis to improve reproducibility. Capillary electrophoresis using borate and cyclodextrins in the background electrolyte was used for determining 11 cellular nucleotides simultaneously. In order to optimize the assay, 0-100% acetonitrile, 0-100% ethanol, and 0-100% methanol in de-ionized water were applied to extract nucleotides from mouse lymphoma cells, and nucleotide yields, recovery, and reproducibility were compared. The assay met the commonly accepted validation limits for biological fluids, if 20-80% acetonitrile in water and 40-60% ethanol in water were used as extraction solvents.

Complementary and alternative medicine: the move into mainstream health care.

The use of complementary and alternative medicine (CAM) in Australia is extensive with over 50 per cent of the Australian population using some form of complementary medicine and almost 25 per cent of Australians visiting CAM practitioners. Expenditure on CAM by Australians is significant. The scope of CAM is extremely broad and ranges from complete medical systems such as Chinese medicine to well-known therapies, such as massage and little known therapies, such as pranic healing. There is a growing focus on CAM in Australia and worldwide by a range of stakeholders including government, the World Health Organization, western medical practitioners and private health insurance companies. CAM practices may offer the potential for substantial public health gains and challenge the way that we view human beings, health and illness. Several issues are emerging that need to be addressed. They include safety and quality control of complementary medicines, issues related to integration of CAM with western medicine and standards of practice. The evidence base of forms of CAM varies considerably: some forms of CAM have developed systematically over thousands of years while others have developed much more recently and have a less convincing evidence base. Many forms of CAM are now being investigated using scientific research methodology and there are increasing examples of good research. Certain forms of CAM, including Chinese medicine in which ophthalmology is an area of clinical specialty, view the eye in a unique way. It is important to keep an open mind about CAM and give proper scrutiny to new evidence as it emerges.

Traditional East Asian medical pulse diagnosis: a preliminary physiologic investigation.

BACKGROUND: Toyohari Meridian Therapy (TMT) is a Japanese system of acupuncture that utilizes radial pulse diagnosis to diagnose and guide acupuncture treatment, including ascertaining when the treatment has concluded. The "root" treatment involves manipulation of the body's Qi without penetration of the needle. There has been little research into the physiologic correlates of the changes detected through pulse diagnosis by Traditional East Asian Medicine practitioners practicing TMT. OBJECTIVES: The study objective was to investigate whether there were any concurrent changes in physiologic cardiovascular variables, specifically the Central (Buckberg) Sub Endocardial Viability Ratio (SEVR) or Heart Rate (HR) adjusted Augmentation Index (AI), with changes in the radial pulses produced by a TMT "root treatment." MATERIALS AND METHODS: A parallel, single-blind, randomized controlled design was utilized. Sixty-two (62) healthy volunteers were randomized to receive either a TMT root treatment or a sham-treatment. Two (2) TMT practitioners participated, with the same practitioner conducting the needling in each case. The SEVR and HR-adjusted AI were measured by a third researcher. STATISTICAL ANALYSIS: Within-groups analysis (paired Student t-test) and between-groups analysis (analysis of covariance) were used; a p-value of 0.05 was designated as statistically significant. RESULTS: SEVR improved significantly within the treatment group but not in the control group. CONCLUSIONS: Results indicate that changes detected in the pulse by the TMT practitioners were associated with a measurable improvement in the SEVR. The findings of this study offer the possibility for further investigation into radial pulse diagnosis practices in an effort to find a physiologic understanding or basis of TMT practice and the system of pulse diagnosis it uses.

Confidence in clinical practice of Chinese medicine degree graduates 1 year after graduation: a pilot study.

BACKGROUND: The issue of transition from student to practitioner of Chinese medicine (CM) in Australia and other Western countries has received little formal attention. Workforce studies, while not up to date nationally in Australia, suggest that the majority of CM practitioners practice as sole practitioners or in small practices. Data from the state of Victoria suggest that a significant proportion of the CM workforce is relatively new to the profession. It is not known how many graduates successfully enter the workforce and importantly, remain in it. OBJECTIVES: An initial survey of final-year bachelor degree CM students in Australian education institutions in 2008 suggested that students felt "somewhat" prepared for clinical practice in eight dimensions of clinical practice. The authors conducted a follow-up study to this initial one, seeking to investigate perceptions of confidence in CM graduates in various aspects of clinical practice within the first year of completing their degree. METHODS: A content-validated survey based on the previous study was distributed to a subset of 30 graduates from the original study cohort who had indicated a willingness to participate in this follow-up survey. RESULTS: There were a small number of responses (n=12), limiting the usefulness of the quantitative questions. However, some interesting qualitative outcomes from the long-answer part of the survey support findings from the previous study that recent practitioners would like more clinical experience, as well as support in developing their business and interpersonal skills, and the option to participate in a professional mentoring arrangement. CONCLUSIONS: Results of this study suggest that both education providers and professional associations may be able to play important and complementary roles in assisting CM students to successfully transition into the workforce. If CM is to continue to develop as a profession in Australia, it will be important that more attention be given to how to assist new graduates to successfully transition into and remain in clinical practice.

Reliability of Chinese medicine diagnostic variables in the examination of patients with osteoarthritis of the knee.

BACKGROUND: Chinese medicine (CM) has its own diagnostic indicators that are used as evidence of change in a patient's condition. The majority of studies investigating efficacy of Chinese herbal medicine (CHM) have utilized biomedical diagnostic endpoints. For CM clinical diagnostic variables to be incorporated into clinical trial designs, there would need to be evidence that these diagnostic variables are reliable. Previous studies have indicated that the reliability of CM syndrome diagnosis is variable. Little information is known about where the variability stems from--the basic data collection level or the synthesis of diagnostic data, or both. No previous studies have investigated systematically the reliability of all four diagnostic methods used in the CM diagnostic process (Inquiry, Inspection, Auscultation/Olfaction, and Palpation). OBJECTIVES: The objective of this study was to assess the inter-rater reliability of data collected using the four diagnostic methods of CM in Australian patients with knee osteoarthritis (OA), in order to investigate if CM variables could be used with confidence as diagnostic endpoints in a clinical trial investigating the efficacy of a CHM in treating OA. METHODS: An inter-rater reliability study was conducted as a substudy of a clinical trial investigating the treatment of knee OA with Chinese herbal medicine. Two (2) experienced CM practitioners conducted a CM examination separately, within 2 hours of each other, in 40 participants. A CM assessment form was utilized to record the diagnostic data. Cohen's κ coefficient was used as a measure of the level of agreement between 2 practitioners. RESULTS: There was a relatively good level of agreement for Inquiry and Auscultation variables, and, in general, a low level of agreement for (visual) Inspection and Palpation variables. CONCLUSIONS: There was variation in the level of agreement between 2 practitioners on clinical information collected using the Four Diagnostic Methods of a CM examination. Some aspects of CM diagnosis appear to be reliable, while others are not. Based on these results, it was inappropriate to use CM diagnostic variables as diagnostic endpoints in the main study, which was an investigation of efficacy of CHM treatment of knee OA.

Reliability of the Eight Guiding Principles and Syndrome Diagnosis in Chinese Medicine Diagnosis of Patients with Knee Osteoarthritis.

Abstract Background: A Chinese medicine (CM) "Syndrome" or "pattern of disharmony" is a diagnostic subcategory of a disease/disorder or symptom, characterized by particular symptoms and signs, and indicative of the etiology and the state of pathogenesis at that point in time. In CM, treatment is aimed at addressing the disease/disorder and the underlying CM Syndrome. A few studies have assessed reliability of CM Syndrome diagnosis according to one of the major CM theories, Zang-Fu theory, but only 1 study has investigated the reliability of diagnosis according to a fundamental theory, that of the Eight Guiding Principles. Given that treatment follows diagnosis, if diagnosis is not reliable there will be lower confidence that optimal treatment is received. There have not yet been any reliability studies in osteoarthritis (OA). Little is known about the characteristics or Syndromes of OA with respect to the Eight Guiding Principles and Zang-Fu theory. Objectives: The objectives of this study were to characterize diagnostic subcategories of OA according to the Eight Guiding Principles and Zang-Fu theory and to investigate the inter-rater reliability of CM diagnosis according to these two theories. Methods: An inter-rater reliability study was conducted as a substudy of a clinical trial investigating the treatment of knee OA with Chinese herbal medicine. Two (2) experienced CM practitioners conducted a CM examination separately, within 2 hours of each other, of 40 participants. A CM assessment form was utilized to record the diagnostic data. Cohen's κ coefficient was used as a measure of reliability. Results: Results support the concept that knee OA is more likely a disease with characteristics of Interior, Deficiency, and Yin according to the Eight Guiding Principles. There was no clear agreement on CM Syndromes of knee OA according to Zang-Fu theory. The main Zang Organs involved were broadly agreed on; they were Kidney, Liver, and Spleen. Conclusions: Results lend some empirical evidence to support to the argument that OA of the knee is an Internal disease with the manifestations of Deficient symptoms according to CM theories. To establish if Syndrome diagnosis is reliable, more studies should be conducted for different clinical conditions.