Protocol for a systematic review of N-of-1 trial protocol guidelines and protocol reporting guidelines.

BACKGROUND: N-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. OBJECTIVE: The 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. METHODS: We 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. DISCUSSION: This 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.

Negotiating consent: exploring ethical issues when therapeutic massage bodywork practitioners are trained in multiple therapies.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Advancing the Therapeutic Massage Research Agenda(s).

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.

Exploring the nature of therapeutic massage bodywork practice.

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.

Identifying conflicts of interest in therapeutic massage and bodywork research.

Identifying and addressing forms of bias in research are critical to the integrity and value of research. Conflicts of interest are an important aspect of research that must be addressed equally to any other form of research bias. Conflicts of interest occur when the judgment of a party involved in the research, either a researcher or a treatment provider, may be compromised by more than one interest relative to the research. As therapeutic massage and bodywork (TMB) is a younger field of research, some forms or aspects of conflicts of interest may not be understood. This editorial explores the meaning of conflicts of interest, how to increase awareness of them, and facets of research specific to TMB that may create such conflicts. Full disclosure in grant applications and manuscripts is critical to ensure that grantors, reviewers, and users of research are better informed of potential conflicts of interest, can understand the steps taken to manage the conflicts, and ultimately can better assess the research integrity and value.

Complementary and alternative medicine (CAM) use in advanced cancer: a systematic review.

This systematic review synthesizes knowledge about the use of complementary and alternative medicine (CAM) among advanced cancer patients. EBSCO and Ovid databases were searched using core concepts, including advanced cancer, CAM, integrative medicine, and decision-making. Articles included in the final review were analyzed using narrative synthesis methods, including thematic analysis, concept mapping, and critical reflection on the synthesis process. Results demonstrate that advanced cancer patients who are younger, female, more educated, have longer duration of disease, and have previously used CAM are more likely to use CAM during this stage of illness. Key themes identified include patterns of and reasons for use; and barriers and facilitators to informed CAM decision-making. Knowledge regarding the use of CAM in advanced cancer remains in its nascent stages. Findings suggest a need for more research on understanding the dynamic process of CAM decision-making in the advanced cancer population from the patients' perspective.

The Complementary Medicine Education and Outcomes (CAMEO) program: a foundation for patient and health professional education and decision support programs.

OBJECTIVE: This paper describes the background, design and evaluation of a theory-informed education and decision support program for cancer patients considering complementary medicine (CM). METHODS: The program was informed by the Shared Decision Making theory, the Ottawa Decision Support Framework and the Supportive Care Framework. Previous empirical evidence and baseline research were used to identify patients' and health professionals' (HPs) information and decision support needs related to CM. RESULTS: To address the continuum of CM needs, a variety of education and decision support interventions were developed, including basic CM information and resources for patients and HPs, a group education program and one-on-one decision support coaching for patients, and an on-line education module for HPs. Evaluation of the program and individual interventions is underway. CONCLUSIONS: This education and decision support program addresses a significant gap in care and offers an evidence-informed framework in which to translate CM evidence to conventional care settings and promote communication about CM. PRACTICE IMPLICATIONS: Evidence-informed CM education and decision support interventions are needed to shift the culture around CM within conventional care settings and promote open communication that will lead to CM therapies being safely integrated into care.

The Greater Value of the CONSORT Statement Guidelines: Guideposts for Designing and Reporting all TMB Research.

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.

Meaning and challenges in the practice of multiple therapeutic massage modalities: a combined methods study.

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.