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1.  Negotiating Consent: Exploring Ethical Issues when Therapeutic Massage Bodywork Practitioners Are Trained in Multiple Therapies 
Obtaining informed consent from competent patients is essential to the ethical delivery of health care, including therapeutic massage and bodywork (TMB). The informed consent process used by TMB practitioners has not been previously studied. Little information is available about the practice of informed consent in a treatment-focused environment that may involve multiple decision points, use of multiple TMB therapies, or both.
As part of a larger study on the process of providing TMB therapy, 19 practitioners were asked about obtaining informed consent during practice. Qualitative description was used to analyze discussions of the consent process generally, and about its application when practitioners use multiple TMB therapies.
Two main consent approaches emerged, one based on a general consent early in the treatment process, and a second ongoing consent process undertaken throughout the course of treatment. Both processes are constrained by how engaged a patient wants to be, and the amount of information and time needed to develop a truly informed consent.
An understanding-based consent process that accommodates an acknowledged information differential between the patient and practitioner, and that is guided by clearly delineated goals within a trust-based relationship, may be the most effective consent process under the conditions of real practice conditions.
PMCID: PMC4240696  PMID: 25452820
complementary therapies/methods; massage; musculoskeletal manipulations; consent; decision-making; qualitative research; clinical practice
2.  Exclusive Use of Alternative Medicine as a Positive Choice 
International Journal of MS Care  2014;16(3):124-131.
Background: A survey of members of the Danish MS Society revealed that a minority of MS patients choose to forgo all types of conventional treatment and use complementary and alternative medicine (CAM) exclusively. A qualitative follow-up study was performed to elucidate the choice of exclusive CAM use by exploring treatment assumptions among a group of exclusive CAM users.
Methods: The study was based on a phenomenological approach. Semistructured in-depth qualitative interviews were conducted with 17 participants, using program theory as an analytical tool, and emerging themes were extracted from the data through meaning condensation.
Results: Four themes characterized the participants' treatment assumptions: 1) conventional medicine contains chemical substances that affect the body in negative ways; 2) CAM treatments can strengthen the organism and make it more capable of resisting the impact of MS; 3) the patient's active participation is an important component of the healing process; 4) bodily sensations can be used to guide treatment selection.
Conclusions: Exclusive use of CAM by MS patients may reflect embracing CAM rather than a rejection of conventional medicine. Health-care practitioners, patient organizations, and health authorities within the MS field should be aware of possible changes in patients' attitudes toward both CAM and conventional treatment interventions.
PMCID: PMC4204372  PMID: 25337054
3.  Decision-making about complementary and alternative medicine by cancer patients: integrative literature review 
Open Medicine  2014;8(2):e54-e66.
Patients with cancer consistently report conflict and anxiety when making decisions about complementary and alternative medicine (CAM) treatment. To design evidence-informed decision-support strategies, a better understanding is needed of how the decision-making process unfolds for these patients during their experience with cancer. We undertook this study to review the research literature regarding CAM-related decisionmaking by patients with cancer within the context of treatment, survivorship, and palliation. We also aimed to summarize emergent concepts within a preliminary conceptual framework.
We conducted an integrative literature review, searching 12 electronic databases for articles published in English that described studies of the process, context, or outcomes of CAM-related decision-making. We summarized descriptive data using frequencies and used a descriptive constant comparative method to analyze statements about original qualitative results, with the goal of identifying distinct concepts pertaining to CAM-related decision-making by patients with cancer and the relationships among these concepts.
Of 425 articles initially identified, 35 met our inclusion criteria. Seven unique concepts related to CAM and cancer decision-making emerged: decision-making phases, information-seeking and evaluation, decision-making roles, beliefs, contextual factors, decision-making outcomes, and the relationship between CAM and conventional medical decision-making. CAM decision-making begins with the diagnosis of cancer and encompasses 3 distinct phases (early, mid, and late), each marked by unique aims for CAM treatment and distinct patterns of informationseeking and evaluation. Phase transitions correspond to changes in health status or other milestones within the cancer trajectory. An emergent conceptual framework illustrating relationships among the 7 central concepts is presented.
CAM-related decision-making by patients with cancer occurs as a nonlinear, complex, dynamic process. The conceptual framework presented here identifies influential factors within that process, as well as patients' unique needs during different phases. The framework can guide the development and evaluation of theorybased decision-support programs that are responsive to patients' beliefs and preferences.
PMCID: PMC4085086  PMID: 25009685
4.  Use of bodily sensations as a risk assessment tool: exploring people with Multiple Sclerosis’ views on risks of negative interactions between herbal medicine and conventional drug therapies 
Most users of complementary and alternative medicine (CAM) combine it with conventional medicine. Recent risk assessment studies have shown risks of negative interactions between CAM and conventional medicine, particularly when combining herbal medicine and conventional drug therapies (CDT). Little is known about the way users consider such risks. The present paper aims to gain knowledge about this issue by exploring views on risks of negative interactions when combining herbal medicine and CDT among people with multiple sclerosis (MS).
This paper draws on a qualitative follow-up study on a survey among members of the Danish MS Society. Semi-structured, in-depth qualitative interviews were conducted with a strategic selection from the survey respondents. The study was inspired by a phenomenological approach and emerging themes were extracted from the data through meaning condensation.
Four themes characterized the informants’ views on risks of negative interactions when combining herbal medicine and CDT: 1) ‘naturalness’ in herbal medicine; 2) ‘bodily sensations’ as guidelines; 3) trust in the CAM practitioner; 4) lack of dialogue with medical doctor.
Generally, the combination of herbal medicine and CDT was considered by the informants to be safe. In particular, they emphasized the ‘non-chemical’ nature of herbal medicine and of their own bodily sensations as warrants of safety. A trustful relation to the CAM practitioner furthermore made some of them feel safe in their use of herbal medicine and CDT in combination. The informants’ use of bodily sensations as a non-discursive risk assessment may be a relevant element in understanding these issues.
PMCID: PMC3942187  PMID: 24533750
Multiple sclerosis; Alternative treatment; CAM; Denmark; Contraindications; Negative interactions; Combination of conventional medicine and CAM; In-depth qualitative interviews; Mixed methods research
5.  Dragon boat racing and health-related quality of life of breast cancer survivors: a mixed methods evaluation 
Breast cancer survivors who participate in physical activity (PA) are reported to experience improved health-related quality of life (HRQOL). However, the quantitative research exploring the relationship between the team-based activity of dragon boat racing and the HRQOL of breast cancer survivors is limited. Given the rising number of breast cancer survivors, and their growing attraction to dragon boating, further exploration of the influence of this activity on HRQOL is warranted.
This study is designed to: 1) quantitatively assess whether and how breast cancer survivors’ participation in a season of dragon boat racing is related to HRQOL and 2) qualitatively explore the survivors’ lived experience of dragon boating and how and why this experience is perceived to influence HRQOL. A mixed methods sequential explanatory design was used with the purpose of complementing quantitative findings with qualitative data. Quantitative data measuring HRQOL were collected at baseline and post-season (N = 100); semi-structured qualitative interviews were used to elicit a personal account of the dragon boat experience (N = 15).
Statistically significant improvements were shown for HRQOL, physical, functional, emotional and spiritual well-being, breast cancer-specific concerns and cancer-related fatigue. A trend towards significance was shown for social/family well-being. Qualitative data elaborated on the quantitative findings, greatly enhancing the understanding of how and why dragon boat racing influences HRQOL.
The use of a mixed methods design effectively captured the complex yet positive influence of dragon boating on survivor HRQOL. These findings contribute to a growing body of literature supporting the value of dragon boat racing as a viable PA intervention for enhancing survivor HRQOL.
PMCID: PMC3750614  PMID: 23915045
6.  Exploring the Nature of Therapeutic Massage Bodywork Practice 
Research on therapeutic massage bodywork (TMB) continues to expand, but few studies consider how research or knowledge translation may be affected by the lack of uniformly standardized competencies for most TMB therapies, by practitioner variability from training in different forms of TMB, or from the effects of experience on practice.
This study explores and describes how TMB practitioners practice, for the purpose of improving TMB training, practice, and research.
Participants & Setting
19 TMB practitioners trained in multiple TMB therapies, in Alberta, Canada.
Research Design
Qualitative descriptive sub-analysis of interviews from a comprehensive project on the training and practice of TMB, focused on the delivery of TMB therapies in practice.
Two broad themes emerged from the data: (1) every treatment is individualized, and (2) each practitioner’s practice of TMB therapies evolves. Individualization involves adapting treatment to the needs of the patient in the moment, based on deliberate and unconscious responses to verbal and nonverbal cues. Individualization starts with initial assessment and continues throughout the treatment encounter. Expertise is depicted as more nuanced and skilful individualization and treatment, evolved through experience, ongoing training, and spontaneous technique exploration. Practitioners consider such individualization and development of experience desirable. Furthermore, ongoing training and experience result in therapy application unique to each practitioner. Most practitioners believed they could not apply a TMB therapy without influence from other TMB therapies they had learned.
There are ramifications for research design, knowledge translation, and education. Few practitioners are likely able to administer treatments in the same way, and most would not like to practice without being able to individualize treatment. TMB clinical studies need to employ research methods that accommodate the complexity of clinical practice. TMB education should facilitate the maturation of practice skills and self-reflection, including the mindful integration of multiple TMB therapies.
PMCID: PMC3577637  PMID: 23481609
complementary therapies/methods; massage; musculoskeletal manipulations; clinical competence; decision-making; qualitative research; clinical practice
7.  The Flexner Report of 1910 and Its Impact on Complementary and Alternative Medicine and Psychiatry in North America in the 20th Century 
America experienced a genuinely vast development of biomedical science in the early decades of the twentieth century, which in turn impacted the community of academic psychiatry and changed the way in which clinical and basic research approaches in psychiatry were conceptualized. This development was largely based on the restructuring of research universities in both of the USA and Canada following the influential report of Johns Hopkins-trained science administrator and politician Abraham Flexner (1866–1959). Flexner's report written in commission for the Carnegie Foundation for the Advancement of Teaching in Washington, DC, also had a major influence on complementary and alternative medicine (CAM) in psychiatry throughout the 20th century. This paper explores the lasting impact of Flexner's research published on modern medicine and particularly on what he interpreted as the various forms of health care and psychiatric treatment that appeared to compete with the paradigm of biomedicine. We will particularly draw attention to the serious effects of the closing of so many CAM-oriented hospitals, colleges, and medical teaching programs following to the publication of the Flexner Report in 1910.
PMCID: PMC3543812  PMID: 23346209
8.  A qualitative study on the term CAM: is there a need to reinvent the wheel? 
As complementary and alternative medicine (CAM) has developed extensively, uncertainty about the appropriateness of the terms CAM and other CAM-related terms has grown both in the research and practice communities. Various terms and definitions have been proposed over the last three decades, highlighting how little agreement exits in the field. Contextual use of current terms and their respective definitions needs to be discussed and addressed.
Relying upon the results of a large international Delphi survey on the adequacy of the term CAM, a focus group of 13 international experts in the field of CAM was held. A forum was also set up for 28 international experts to discuss and refine proposed definitions of both CAM and integrative healthcare (IHC) terms. Audio recordings of the meeting and forum discussion threads were analyzed using interpretive description.
Multiple terms to describe the therapies, products, and disciplines often referred to as CAM, were considered. Even though participants generally agreed there is a lack of optimal definitions for popular CAM-related umbrella terms and that all terms that have so far been introduced are to some extent problematic, CAM and IHC remained the most popular and accepted terms by far. The names of the specific disciplines were also deemed adequate in certain contexts. Focus group participants clarified the context in which those three terms are appropriate. Existing and emergent definitions of both CAM and integrative healthcare terms were discussed.
CAM and other related terms could be used more effectively, provided they are used in the proper context. It appears difficult for the time being to reach a consensus on the definition of the term CAM due to the uncertainty of the positioning of CAM in the contemporary healthcare systems. While umbrella terms such as CAM and IHC are useful in the context of research, policy making and education, relevant stakeholders should limit the use of those terms.
PMCID: PMC3462712  PMID: 22909051
Definition; Term; Focus group; International experts; Integrative healthcare
9.  Developing a patient-centered outcome measure for complementary and alternative medicine therapies I: defining content and format 
Patients receiving complementary and alternative medicine (CAM) therapies often report shifts in well-being that go beyond resolution of the original presenting symptoms. We undertook a research program to develop and evaluate a patient-centered outcome measure to assess the multidimensional impacts of CAM therapies, utilizing a novel mixed methods approach that relied upon techniques from the fields of anthropology and psychometrics. This tool would have broad applicability, both for CAM practitioners to measure shifts in patients' states following treatments, and conventional clinical trial researchers needing validated outcome measures. The US Food and Drug Administration has highlighted the importance of valid and reliable measurement of patient-reported outcomes in the evaluation of conventional medical products. Here we describe Phase I of our research program, the iterative process of content identification, item development and refinement, and response format selection. Cognitive interviews and psychometric evaluation are reported separately.
From a database of patient interviews (n = 177) from six diverse CAM studies, 150 interviews were identified for secondary analysis in which individuals spontaneously discussed unexpected changes associated with CAM. Using ATLAS.ti, we identified common themes and language to inform questionnaire item content and wording. Respondents' language was often richly textured, but item development required a stripping down of language to extract essential meaning and minimize potential comprehension barriers across populations. Through an evocative card sort interview process, we identified those items most widely applicable and covering standard psychometric domains. We developed, pilot-tested, and refined the format, yielding a questionnaire for cognitive interviews and psychometric evaluation.
The resulting questionnaire contained 18 items, in visual analog scale format, in which each line was anchored by the positive and negative extremes relevant to the experiential domain. Because of frequent informant allusions to response set shifts from before to after CAM therapies, we chose a retrospective pretest format. Items cover physical, emotional, cognitive, social, spiritual, and whole person domains.
This paper reports the success of a novel approach to the development of outcome instruments, in which items are extracted from patients' words instead of being distilled from pre-existing theory. The resulting instrument, focused on measuring shifts in patients' perceptions of health and well-being along pre-specified axes, is undergoing continued testing, and is available for use by cooperating investigators.
PMCID: PMC3293761  PMID: 22206345
Complementary and alternative medicine (CAM); patient-reported outcomes (PROs); patient-centered care; non-specific outcomes; questionnaire development; retrospective pre-test; well-being
10.  Meaning and challenges in the practice of multiple therapeutic massage modalities: a combined methods study 
Therapeutic massage and bodywork (TMB) practitioners are predominantly trained in programs that are not uniformly standardized, and in variable combinations of therapies. To date no studies have explored this variability in training and how this affects clinical practice.
Combined methods, consisting of a quantitative, population-based survey and qualitative interviews with practitioners trained in multiple therapies, were used to explore the training and practice of TMB practitioners in Alberta, Canada.
Of the 5242 distributed surveys, 791 were returned (15.1%). Practitioners were predominantly female (91.7%), worked in a range of environments, primarily private (44.4%) and home clinics (35.4%), and were not significantly different from other surveyed massage therapist populations. Seventy-seven distinct TMB therapies were identified. Most practitioners were trained in two or more therapies (94.4%), with a median of 8 and range of 40 therapies. Training programs varied widely in number and type of TMB components, training length, or both. Nineteen interviews were conducted. Participants described highly variable training backgrounds, resulting in practitioners learning unique combinations of therapy techniques. All practitioners reported providing individualized patient treatment based on a responsive feedback process throughout practice that they described as being critical to appropriately address the needs of patients. They also felt that research treatment protocols were different from clinical practice because researchers do not usually sufficiently acknowledge the individualized nature of TMB care provision.
The training received, the number of therapies trained in, and the practice descriptors of TMB practitioners are all highly variable. In addition, clinical experience and continuing education may further alter or enhance treatment techniques. Practitioners individualize each patient's treatment through a highly adaptive process. Therefore, treatment provision is likely unique to each practitioner. These results may be of interest to researchers considering similar practice issues in other professions. The use of a combined-methods design effectively captured this complexity of TMB practice. TMB research needs to consider research approaches that can capture or adapt to the individualized nature of practice.
PMCID: PMC3187727  PMID: 21929823
11.  Components of an Anticancer Diet: Dietary Recommendations, Restrictions and Supplements of the Bill Henderson Protocol 
Nutrients  2010;3(1):1-26.
The use of complementary and alternative medicines including dietary supplements, herbals and special diets to prevent or treat disease continues to be popular. The following paper provides a description of an alternative dietary approach to the self-management and treatment of cancer, the Bill Henderson Protocol (BHP). This diet encourages daily intake of raw foods, a combination of cottage cheese and flaxseed oil and a number of supplements. Some foods and food groups are restricted (e.g., gluten, meat, dairy). Early background theory that contributed to the protocol’s development is presented as is a summary of relevant evidence concerning the anti-cancer fighting properties of the individual components. Supplement intake is considered in relation to daily recommended intakes. Challenges and risks to protocol adherence are discussed. As with many complementary and alternative interventions, clear evidence of this dietary protocol’s safety and efficacy is lacking. Consumers of this protocol may require guidance on the ability of this protocol to meet their individual nutritional needs.
PMCID: PMC3257729  PMID: 22254073
anticancer diet; cancer; complementary and alternative medicine; supplements
12.  Practitioners' validation of framework of team-oriented practice models in integrative health care: a mixed methods study 
Biomedical and Complementary and Alternative Medicine (CAM) academic and clinical communities have yet to arrive at a common understanding of what Integrative healthcare (IHC) is and how it is practiced. The Models of Team Health Care Practice (MTHP) framework is a conceptual representation of seven possible practice models of health care within which teams of practitioners could elect to practice IHC, from an organizational perspective. The models range from parallel practice at one end to integrative practice at the other end. Models differ theoretically, based on a series of hypotheses. To date, this framework has not been empirically validated. This paper aims to test nine hypotheses in an attempt to validate the MTHP framework.
Secondary analysis of two studies carried out by the same research team was conducted, using a mixed methods approach. Data were collected from both biomedical and CAM practitioners working in Canadian IHC clinics. The secondary analysis is based on 21 participants in the qualitative study and 87 in the quantitative study.
We identified three groups among the initial seven models in the MTHP framework. Differences between practitioners working in different practice models were found chiefly between those who thought that their clinics represented an integrative model, versus those who perceived their clinics to represent a parallel or consultative model. Of the scales used in the analysis, only the process of information sharing varied significantly across all three groups of models.
The MTHP framework should be used with caution to guide the evaluation of the impact of team-oriented practice models on both subjective and objective outcomes of IHC. Groups of models may be more useful, because clinics may not "fit" under a single model when more than one model of collaboration occurs at a single site. The addition of a hypothesis regarding power relationships between practitioners should be considered. Further validation is required so that integrative practice models are well described with appropriate terminology, thus facilitating the work of health care practitioners, managers, policy makers and researchers.
PMCID: PMC2974681  PMID: 20942973
13.  Development of an International Questionnaire to Measure Use of Complementary and Alternative Medicine (I-CAM-Q) 
Existing studies on the use of complementary and alternative medicine (CAM) have produced diverse results regarding the types and prevalence of CAM use due, in part, to variations in the measurement of CAM modalities. A questionnaire that can be adapted for use in a variety of populations will improve CAM utilization measurement. The purposes of this article are to (1) articulate the need for such a common questionnaire; (2) describe the process of questionnaire development; (3) present a model questionnaire with core questions; and (4) suggest standard techniques for adapting the questionnaire to different languages and populations.
An international workshop sponsored by the National Research Center in Complementary and Alternative Medicine (NAFKAM) of the University of Tromsø, Norway, brought CAM researchers and practitioners together to design an international CAM questionnaire (I-CAM-Q). Existing questionnaires were critiqued, and working groups drafted content for a new questionnaire. A smaller working group completed, tested, and revised this self-administered questionnaire.
The questionnaire that was developed contains four sections concerned with visits to health care providers, complementary treatments received from physicians, use of herbal medicine and dietary supplements, and self-help practices. A priori–specified practitioners, therapies, supplements, and practices are included, as well as places for researcher-specified and respondent-specified additions. Core questions are designed to elicit frequency of use, purpose (treatment of acute or chronic conditions, and health maintenance), and satisfaction. A penultimate version underwent pretesting with “think-aloud” techniques to identify problems related to meaning and format. The final questionnaire is presented, with suggestions for testing and translating.
Once validated in English and non-English speaking populations, the I-CAM-Q will provide an opportunity for researchers to gather comparable data in studies conducted in different populations. Such data will increase knowledge about the epidemiology of CAM use and provide the foundation for evidence-based comparisons at an international level.
PMCID: PMC3189003  PMID: 19388855
14.  The Use of Mixed Methods for Therapeutic Massage Research 
Mixed methods research is the integration of quantitative and qualitative components in a research project. Whether you are reading or designing a mixed methods research project, it is important to be familiar with both qualitative and quantitative research methods and the specific purposes for which they are brought together in a study: triangulation, complementarity, expansion, initiation, or development. In addition, decisions need to be made about the sequencing and the priority or importance of each qualitative and quantitative component relative to the other components, and the point or points at which the various qualitative and quantitative components will be integrated.
Mixed methods research is increasingly being recognized for its ability to bring multiple points of view to a research project, taking advantage of the strengths of each of the quantitative and qualitative components to explain or resolve complex phenomena or results. This ability becomes critical when complex healing systems such as therapeutic massage are being studied. Complex healing systems may have multiple physiologic effects, often reflected in changes throughout the patient’s body. Additionally, the patient’s experience of the treatment may be an important outcome.
PMCID: PMC3091425  PMID: 21589698
Mixed methods; research design; experimental designs; methodology
15.  Identifying the barriers to conducting outcomes research in integrative health care clinic settings - a qualitative study 
Integrative health care (IHC) is an interdisciplinary blending of conventional medicine and complementary and alternative medicine (CAM) with the purpose of enhancing patients' health. In 2006, we designed a study to assess outcomes that are relevant to people using such care. However, we faced major challenges in conducting this study and hypothesized that this might be due to the lack of a research climate in these clinics. To investigate these challenges, we initiated a further study in 2008, to explore the reasons why IHC clinics are not conducting outcomes research and to identify strategies for conducting successful in-house outcomes research programs. The results of the latter study are reported here.
A total of 25 qualitative interviews were conducted with key participants from 19 IHC clinics across Canada. Basic content analysis was used to identify key themes from the transcribed interviews.
Barriers identified by participants fell into four categories: organizational culture, organizational resources, organizational environment and logistical challenges. Cultural challenges relate to the philosophy of IHC, organizational leadership and practitioner attitudes and beliefs. Participants also identified significant issues relating to their organization's lack of resources such as funding, compensation, infrastructure and partnerships/linkages. Environmental challenges such as the nature of a clinic's patient population and logistical issues such as the actual implementation of a research program and the applicability of research data also posed challenges to the conduct of research. Embedded research leadership, integration of personal and professional values about research, alignment of research activities and clinical workflow processes are some of the factors identified by participants that support IHC clinics' ability to conduct outcomes research.
Assessing and enhancing the broader evaluation culture of IHC clinics prior to implementing outcomes research may be a critical step towards ensuring productive and cost-effective research programs. However, as IHC clinics are often complex systems, a whole systems approach to research should be used taking into account the multidimensional and complex nature of such treatment systems so that the results are useful and reflect real life.
PMCID: PMC2826302  PMID: 20074354
16.  Evolution of the integrative health care literature in the CAM field—a bibliometric analysis 
Integrative health care (IHC) has become a popular term used in practice and research to define the blending of complementary and alternative medicine (CAM) and conventional care as an innovative approach to health care delivery.
Purpose and objectives
To conduct a bibliometric analysis to develop a better understanding of the evolution of the concept of IHC in the CAM field.
All articles on IHC published between 1915 and 2008 indexed in the ISI web of knowledge database were retrieved. Title and abstract review were conducted to determine eligibility. Inclusion criteria included a research report and integration of CAM and conventional therapies. A second review of the full papers will be conducted to determine the final article sample, which will be analyzed using a rigorous bibliometric analysis approach.
Three thousand and five articles were retrieved and 35% met the inclusion criteria in the first screening round. Descriptive and relational bibliometric indicators will be presented, including the volume of research by year, keywords used, impact of the publication and collaboration amongst researchers.
Discussion and conclusion
Application of a bibliometric analysis allows for a broad and focused overview of the IHC literature within its historical and cultural context, and evaluation of the research output and its impact.
PMCID: PMC2807054
bibliometrics; complementary and alternative medicine (CAM)
17.  Evaluating complex health interventions: a critical analysis of the 'outcomes' concept 
The extent to which a health care intervention causes or facilitates health-related change is a key question in research. The need to quantify such change has led to the development of an increasing number of change indicators, to measure what have come to be known as 'outcomes'. In the context of medical research into the efficacy or effectiveness of an intervention the term 'outcomes' has often been interpreted to mean single endpoints with a linear cause and effect link to an external intervention.
In this paper we present a critical analysis of the nature and interpretation of the 'outcomes' concept and of the assumptions that underpin it. Drawing on our own work and that of others, we analyse the problems that arise when the concept is applied to complex interventions and discuss the use of other models, such as programme theory, as a basis for alternative conceptualisations for indicators of change.
Our analysis demonstrates that the interpretation of 'outcomes' that may be appropriate for clinical trials of pharmaceutical products, is problematic when used in evaluations of complex interventions in areas such as complementary medicine, palliative care, rehabilitation, and health promotion. The 'outcomes' concept may impose inappropriate patterns of thought and meaning. We present alternative models, such as those based on programme theory, which conceptualise health-related change as resulting from the interaction between intervention, process and context over time. In this framework both the intervention and the patient are defined as causal factors, because the result of the treatment is dependent on the resources of the patient – such as the body's ability to heal itself – and the impact of the patient's situation.
Evaluations based on a model such as programme theory will encompass a wide range of health-related changes that include aspects of process, such as new meanings and understanding, as well as longer term changes in health, wellbeing and health-related competences and behaviours.
PMCID: PMC2712450  PMID: 19538715
18.  IN-CAM Outcomes Database: Its Relevance and Application in Massage Therapy Research and Practice 
One of the most commonly used complementary and alternative medicine (CAM) modalities in North America is massage therapy (MT). Research to date indicates many potential health benefits of MT, suggesting that ongoing research efforts to further elucidate and substantiate preliminary findings within the massage profession should be given high priority. Central to the development of a sound evidence base for MT are the use of valid, reliable, and relevant outcome measures in research, and practice in assessing the effectiveness of MT. The purpose of the present article is to introduce MT researchers and massage therapists interested in using outcome measures in research and clinical practice to the IN-CAM Outcomes Database website by describing the Outcomes Database and identifying its utility in MT research and practice. The IN-CAM Outcomes Database is a centralized location where information on outcome measures is collected and made accessible to users. Outcome measures are organized in the database within the Framework of Outcome Domains. The Framework includes health domains relevant to conventional medicine and CAM alike, and health domains that have been identified as important to CAM interventions. Users of the website may search for information on a specific outcome measure, plan research projects, and engage in discussions related to outcomes assessment in the CAM field with other users and with members of the CAM research community. As the MT profession continues to evolve and move toward evidence-informed practice, the IN-CAM Outcomes Database website can be a valuable resource for MT researchers and massage therapists.
PMCID: PMC3091455  PMID: 21589721
Massage therapy; research; practice; health outcomes; outcomes database
19.  Complementary and alternative medicine use among Chinese and white Canadians 
Canadian Family Physician  2008;54(11):1563-1569.
This study aimed to describe the level of complementary and alternative medicine (CAM) use and the factors associated with CAM use among Chinese and white Canadians.
A cross-sectional telephone survey conducted in English, Cantonese, and Mandarin.
Calgary, Alta.
Chinese and white residents of Calgary aged 18 or older.
Rates of use of 11 CAM therapies, particularly herbal therapy, massage, chiropractic care, and acupuncture; reasons for use of CAM therapies.
Sixty percent of 835 Chinese respondents (95% confidence interval [CI] 56.5% to 63.2%) and 59% of 802 white respondents (95% CI 55.1% to 62.0%) had used CAM in the past year. Chinese respondents were more likely to use herbal therapy than white respondents were (48.7% vs 33.7%, P < .001), less likely to use massage (17.1% vs 30.4%, P < .001) and chiropractic care (8.4% vs 21.2%, P < .001), but equally likely to use acupuncture (8.3% vs 7.9%, P = .173). The common factor associated with herbal therapy, acupuncture, or massage use among Chinese and white respondents was receiving a CAM recommendation from a family member or friend. Factors unique to either Chinese or white CAM users varied by therapy. For example, herbal therapy use for Chinese respondents was associated with the presence of chronic disease (adjusted odds ratio [AOR] 2.15, 95% CI 1.09 to 4.24 for having 3 diseases compared with those without chronic disease), beliefs about the effectiveness of herbal therapy (AOR 1.56, 95% CI 1.12 to 2.17), and trust in herbal therapy practitioners (AOR 1.72, 95% CI 1.24 to 2.37). Herbal therapy use for white respondents was associated with the beliefs that herbal treatment had fewer side effects than prescription drugs (AOR 1.81, 95% CI 1.31 to 2.50) and that herbalists took a holistic approach (AOR 2.07, 95% CI 1.49 to 2.87).
While the percentage of CAM use was similar in both groups, Chinese Canadians mainly used herbal therapy and white Canadians used a range of CAM therapies. Factors associated with CAM use varied with ethnicity and type of CAM therapy. Presence of chronic disease, however, was an important factor for Chinese Canadians. That finding suggests that Chinese Canadians use CAM for the treatment of chronic disease, while white Canadians use such therapies for disease treatment and health maintenance.
PMCID: PMC2592333  PMID: 19005129
20.  Opinions on chelation therapy in patients undergoing coronary angiography: Cross-sectional survey 
Chelation therapy is frequently used by patients for the treatment of coronary artery disease. However, relatively little is known about patient attitudes and beliefs that underlie the use of this treatment. The aim of the present study was to document patients’ opinions and beliefs about health care decision making, physician and patient communication and relationships, and reasons for using or not using chelation therapy as treatment for coronary artery disease.
A mail survey was sent to patients who underwent coronary angiography between 1998 and 2000 in Alberta. Information was collected on self-reported reasons for chelation therapy use, sociodemographic characteristics, communication and relationships between patients and physicians, as well as beliefs regarding surgery, medications and chelation therapy.
Of the 780 patients who received surveys, 96 users and 264 nonusers of chelation therapy completed questionnaires. Among the users, 20.8% believed that chelation therapy could cure heart disease, 44.2% believed that it could relieve symptoms, 16.7% believed that it could have side effects and 58.4% believed that it could increase quality of life. Users and nonusers were similar in their beliefs about safety and benefits of heart surgery, but users of chelation therapy were less likely than nonusers to believe that using conventional medications could prevent worsening of heart disease (53.1% versus 67.4%), increase quality of life (74.0% versus 85.2%) and give a feeling of control over heart disease (61.5% versus 77.7%).
Many chelation therapy users appeared to have negative views toward the benefits of conventional medications and positive views toward the safety of chelation therapy. Users and nonusers of chelation therapy had the same views toward the benefits and safety of heart surgery.
PMCID: PMC2651942  PMID: 17593988
Cardiac disease; Chelation therapy; Complementary and alternative therapy; Survey
21.  Seeking Mind, Body and Spirit Healing—Why Some Men with Prostate Cancer Choose CAM (Complementary and Alternative Medicine) over Conventional Cancer Treatments 
Little is known about men with prostate cancer who decline conventional treatment and use only complementary and alternative medicine (CAM).
To 1) explore why men decline conventional prostate cancer treatment and use CAM 2) understand the role of holistic healing in their care, and 3) document their recommendations for health care providers.
Semi-structured interviews and follow-up focus groups.
Twenty-nine men diagnosed with prostate cancer who declined all recommended conventional treatments and used CAM.
Based on strong beliefs about healing, study participants took control by researching the risks of delaying or declining conventional treatment while using CAM as a first option. Most perceived conventional treatment to have a negative impact on quality of life. Participants sought healing in a broader mind, body, spirit context, developing individualized CAM approaches consistent with their beliefs about the causes of cancer. Most made significant lifestyle changes to improve their health. Spirituality was central to healing for one-third of the sample. Participants recommended a larger role for integrated cancer care.
Men who decline conventional prostate cancer treatment and use CAM only may benefit from a whole person approach to care where physicians support them to play an active role in healing while carefully monitoring their disease status.
PMCID: PMC3046021  PMID: 21614154
cancer; complementary and alternative medicine; decision-making; quality of life
22.  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
23.  Inquiring minds 
Canadian Family Physician  2007;53(1):84-90.
To examine how women gather, evaluate, and use information on complementary and alternative medicine (CAM) options for managing menopausal symptoms.
Qualitative study.
Calgary, Alta.
Twenty-two women with a mean age of 52 years (range 42 to 58 years) who sought information on CAM therapies to manage menopausal symptoms.
In-depth semistructured interviews. Category coding and thematic analysis were used to interpret the data.
Four major themes emerged: how women gathered information, how they evaluated the information, how they used the information, and the challenges they experienced in making informed decisions. Information gathering was an on going process; as women’s symptoms changed, their information needs changed also. Their preferred sources of information included physicians, CAM practitioners, staff at health food stores, and personal contacts. They sought information about the process of menopause and about both CAM and conventional treatments. Study participants were highly educated. Most of them systematically evaluated information from many sources using such criteria as whether information was biased, where the information came from, and whether the information was current. Information was used to validate their symptoms and to choose treatment based on cost-benefit analysis, risk-benefit analysis, and possible negative side effects or interactions between medications. Finding reliable information was considered a challenge due to structural or information-related barriers. Several of the women cited a lack of time as a challenge: time to search for and evaluate information and the pressure of time to find relief from the symptoms of menopause.
There is a need for reliable information about menopause and the risks and benefits of CAM options for menopausal symptoms in a format accessible to the range of women who will experience or are experiencing this transition. As a trusted source, family physicians have a role in disseminating this information.
PMCID: PMC2213515  PMID: 17872614
24.  Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures 
Central to the development of a sound evidence base for Complementary and Alternative Medicine (CAM) interventions is the need for valid, reliable and relevant outcome measures to assess whether the interventions work. We assessed the specific needs for a database that would cover a wide range of outcomes measures for CAM research and considered a framework for such a database.
The study was a survey of CAM researchers, practitioners and students. An online questionnaire was emailed to the members of the Canadian Interdisciplinary Network for CAM Research (IN-CAM) and the CAM Education and Research Network of Alberta (CAMera). The majority of survey questions were open-ended and asked about outcome measures currently used, outcome measures' assessment criteria, sources of information, perceived barriers to finding outcome measures and outcome domains of importance. Descriptive quantitative analysis and qualitative content analysis were used.
One hundred and sixty-four completed surveys were received. Of these, 62 respondents reported using outcome measures in their CAM research and identified 92 different specific outcomes. The most important barriers were the fact that, for many health concepts, outcome measures do not yet exist, as well as issues related to accessibility of instruments. Important outcome domains identified included physical, psychological, social, spiritual, quality of life and holistic measures. Participants also mentioned the importance of individualized measures that assess unique patient-centered outcomes for each research participant, and measures to assess the context of healing and the process of healing.
We have developed a preliminary framework that includes all components of health-related outcomes. The framework provides a foundation for a larger, comprehensive collection of CAM outcomes. It fits very well in a whole systems perspective, which requires an expanded set of outcome measures, such as individualized and holistic measures, with attention to issues of process and context.
PMCID: PMC1661594  PMID: 17118197
25.  Developing CAM Research Capacity for Complementary Medicine 
This article describes initiatives that have been central to the development of complementary and alternative medicine (CAM) research capacity in the United Kingdom, Canada and the United States over the last decade. While education and service delivery are essential parts of the development of CAM, this article will focus solely on the development of research strategy. The development of CAM research has been championed by both patients and politicians, primarily so that we may better understand the popularity and apparent effectiveness of these therapies and support integration of safe and effective CAM in health care. We hope that the perspective provided by this article will inform future research policy.
PMCID: PMC1475932  PMID: 16786061
CAM; research; strategy; US; UK; Canada

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