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BackgroundN-of-1 trials are multiple cross-over trials done in individual participants, generating individual treatment effect information. While reporting guidelines for the CONSORT Extension for N-of-1 trials (CENT) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) already exist, there is no standardized recommendation for the reporting of N-of-1 trial protocols.ObjectiveThe objective of this study is to evaluate current literature on N-of-1 design and reporting to identify key elements of rigorous N-of-1 protocol design.MethodsWe will conduct a systematic search for all N-of-1 trial guidelines and protocol-reporting guidelines published in peer-reviewed literature. We will search Medline, Embase, PsycINFO, CINAHL, the Cochrane Methodology Register, CENTRAL, and the NHS Economic Evaluation Database. Eligible articles will contain explicit guidance on N-of-1 protocol construction or reporting. Two reviewers will independently screen all titles and abstracts and then undertake full-text reviews of potential articles to determine eligibility. One reviewer will perform data extraction of selected articles, checked by the second reviewer. Data analysis will ascertain common features of N-of-1 trial protocols and compare them to the SPIRIT and CENT items.DiscussionThis systematic review assesses recommendations on the design and reporting of N-of-1 trial protocols. These findings will inform an international Delphi development process for an N-of-1 trial protocol reporting guideline. The development of this guideline is critical for improving the quality of N-of-1 protocols, leading to improvements in the quality of published N-of-1 trial research.

Complementary and alternative medicine (CAM) use is common among individuals with cancer, but many choose not to discuss CAM with health-care providers (HCPs). Moreover, there is variability in the provision of evidence-informed decision making about CAM use. A clinical practice guideline was developed to standardize how oncology HCPs address CAM use as well as to inform how individuals with cancer can be supported in making evidence-informed decisions about CAM. An integrative review of the literature, from inception to December 31, 2018, was conducted in MEDLINE, EMBASE, PsychINFO, CINAHL, and AMED databases. Eligible articles included oncology HCPs' practice related to discussing, assessing, documenting, providing decision support, or offering information about CAM. Two authors independently searched the literature, and selected articles were summarized. Recommendations for clinical practice were formulated from the appraised evidence and clinical experiences of the research team. An expert panel reviewed the guideline for usability and appropriateness and recommendations were finalized. The majority of the 30 studies eligible for inclusion were either observational or qualitative, with only 3 being reviews and 3 being experimental. From the literature, 7 practice recommendations were formulated for oncology HCPs regarding how to address CAM use by individuals with cancer, including communicating, assessing, educating, decision coaching, documenting, active monitoring, and adverse event reporting. It is imperative for safe and comprehensive care that oncology HCPs address CAM use as part of standard practice. This clinical practice guideline offers directions on how to support evidence-informed decision making about CAM among individuals with cancer. [ABSTRACT FROM AUTHOR]

Abstract Background 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. Methods 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. Results 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. Conclusions 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.

Complementary and alternative medicine (CAM) use is common among individuals with cancer, but many choose not to discuss CAM with health-care providers (HCPs). Moreover, there is variability in the provision of evidence-informed decision making about CAM use. A clinical practice guideline was developed to standardize how oncology HCPs address CAM use as well as to inform how individuals with cancer can be supported in making evidence-informed decisions about CAM. An integrative review of the literature, from inception to December 31, 2018, was conducted in MEDLINE, EMBASE, PsychINFO, CINAHL, and AMED databases. Eligible articles included oncology HCPs' practice related to discussing, assessing, documenting, providing decision support, or offering information about CAM. Two authors independently searched the literature, and selected articles were summarized. Recommendations for clinical practice were formulated from the appraised evidence and clinical experiences of the research team. An expert panel reviewed the guideline for usability and appropriateness and recommendations were finalized. The majority of the 30 studies eligible for inclusion were either observational or qualitative, with only 3 being reviews and 3 being experimental. From the literature, 7 practice recommendations were formulated for oncology HCPs regarding how to address CAM use by individuals with cancer, including communicating, assessing, educating, decision coaching, documenting, active monitoring, and adverse event reporting. It is imperative for safe and comprehensive care that oncology HCPs address CAM use as part of standard practice. This clinical practice guideline offers directions on how to support evidence-informed decision making about CAM among individuals with cancer., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

N-of-1 trials are multiple crossover trials done over time within a single person; they can also be done with a series of individuals. Their focus on the individual as the unit of analysis maintains statistical power while accommodating greater differences between patients than most standard clinical trials. This makes them particularly useful in rare diseases, while also being applicable across many health conditions and populations. Best practices recommend the use of reporting guidelines to publish research in a standardized and transparent fashion. N-of-1 trials have the SPIRIT extension for N-of-1 protocols (SPENT) and the CONSORT extension for N-of-1 trials (CENT). Open science is a recent movement focused on making scientific knowledge fully available to anyone, increasing collaboration, and sharing of scientific efforts. Open science goals increase research transparency, rigor, and reproducibility, and reduce research waste. Many organizations and articles focus on specific aspects of open science, for example, open access publishing. Throughout the trajectory of research (idea, development, running a trial, analysis, publication, dissemination, knowledge translation/reflection), many open science ideals are addressed by the individual-focused nature of N-of-1 trials, including issues such as patient perspectives in research development, personalization, and publications, enhanced equity from the broader inclusion criteria possible, and easier remote trials options. However, N-of-1 trials also help us understand areas of caution, such as monitoring of post hoc analyses and the nuances of confidentiality for rare diseases in open data sharing. The N-of-1 reporting guidelines encourage rigor and transparency of N-of-1 considerations for key aspects of the research trajectory.

This issue of the IJTMB includes articles that represent the scope of therapeutic massage and bodywork (TMB) practice and education. The two research articles represent the testing of deductive hypotheses not commonly seen in the TMB literature: the change in tactile abnormalities of young children with autism using qigong massage, and changes in postural balance from massage to the muscles associated with the mandibular trigeminal nerve. The education editorial opens the IJTMB dialogue on the need, value, and issues of competency-based education relative to hours-based programming.

Therapeutic massage and bodywork (TMB) is now an established field of research with dedicated funding, researchers, and many venues and channels for dissemination of TMB research. Research agendas are a way for a profession to focus the development and funding of research on facets of TMB practice and education that are most needed at a given point of time to best move forward the practice and professionalization of TMB. Of the two TMB research agendas, one is currently being updated, the other is newly developed. Because of the impact on the development of the profession, gaps in research agendas also need to be carefully considered. Three areas that could use further consideration or support within the current agendas include education, methods and methodologies, and underlying assumptions. TMB researchers need to engage with and support the current agendas, and participate in their evolution.

Background: 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., Purpose: 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., Results: 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., Conclusions: 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.

The IJTMB recommends the use of the CONSORT Statement (Consolidated Standards of Reporting Trials) guidelines for the reporting of randomized, controlled clinical trials (RCTs). A careful review of the guidelines shows important applications of these guidelines to all types of research reporting and design, not just RCTs. There is an Extension to these guidelines specific to nonpharmacologic interventions, including manually applied therapies and complementary medicine, and thus therapeutic massage and bodywork (TMB). Components of the Extension are thus relevant to publication in the IJTMB and should be considered part of standard reporting. As well, while the goals of the CONSORT Statement guidelines are to improve reporting of RCTs, the issues raised in the guidelines and explanatory document are relevant to all forms of TMB research and should be considered in all TMB research manuscripts. Finally, while not their purpose, the guidelines could also be used as an informal checklist when developing robust TMB research.

Background: This glocal (global knowledge with local action) symposium was convened by a professional therapeutic massage bodywork professional organization to bring together the fields of economics, politics, and traditional and complementary and alternative medicine (TCAM) to begin development of effective TCAM advocacy worldwide. The symposium addressed the core question, "What information will be needed to address issues that will arise as TCAM practitioners advocate for a respectful and equalfooting access to health care provision, public and private, worldwide?", Participants and Setting: The 35 international participants convened in a Victoria, Canada hotel. They were selectively invited to provide expertise in: advocacy, politics, public policy, economics, TCAM practice, integrative practice, sociology and TCAM research, education, media and language framing, psychology, and mediation., Methods: The two-day symposium used a facilitated dialogue and knowledge-sharing design process geared to achieving group-supported recommendations. Invited panelists discussed each agenda topic, followed by facilitated discussion with the entire group., Results: In general, participants agreed that advocacy from a TCAM perspective is needed. Additionally, more research should use methods with more relevance to everyday health care provision and health care costs such as effectiveness comparative trials and cost effectiveness studies. A number of specific advocacy steps were recommended. Most focused on developing local support for better access and equity regarding TCAM within local health care systems and advocacy work, which needs to both understand and engage the local TCAM practitioners and those using the TCAM services., Conclusions: The increasing awareness of TCAM and advancement toward integrative medicine-including traditional medicines and perspectives-are themes currently in development worldwide. Now is a good time for TCAM practitioners to open dialogue to develop better partnerships in health care. Such dialogue is facilitated when diverse people at the health care table understand each other's perspectives. More discussions like this, with diverse people across more disciplines, need to occur worldwide.

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.

Background: Since the late 1980s, several taxonomies have been developed to help map and describe the interrelationships of complementary and alternative medicine (CAM) modalities. In these taxonomies, several issues are often incompletely addressed: A simple categorization process that clearly isolates a modality to a single conceptual categoryClear delineation of verticality-that is, a differentiation of scale being observed from individually applied techniques, through modalities (therapies), to whole medical systemsRecognition of CAM as part of the general field of health care, Methods: DEVELOPMENT OF THE INTEGRATED TAXONOMY OF HEALTH CARE (ITHC) INVOLVED THREE STAGES: Development of a precise, uniform health glossaryAnalysis of the extant taxonomiesUse of an iterative process of classifying modalities and medical systems into categories until a failure to singularly classify a modality occurred, requiring a return to the glossary and adjustment of the classifying protocol, Results: A full vertical taxonomy was developed that includes and clearly differentiates between techniques, modalities, domains (clusters of similar modalities), systems of health care (coordinated care system involving multiple modalities), and integrative health care. Domains are the classical primary focus of taxonomies. The ITHC has eleven domains: chemical/substance-based work, device-based work, soft tissue-focused manipulation, skeletal manipulation, fitness/movement instruction, mind-body integration/classical somatics work, mental/emotional-based work, bio-energy work based on physical manipulation, bio-energy modulation, spiritual-based work, unique assessments. Modalities are assigned to the domains based on the primary mode of interaction with the client, according the literature of the practitioners., Conclusions: THE ITHC HAS SEVERAL STRENGTHS: little interpretation is used while successfully assigning modalities to single domains; the issue of taxonomic verticality is fully resolved; and the design fully integrates the complementary health care fields of biomedicine and CAM.