Occupational and Financial Setbacks in Caregivers of People with Colorectal Cancer: Considerations for Caregiver-Reported Outcomes.

Family caregivers of patients with cancer provide substantial physical, emotional, and functional care throughout the cancer trajectory. While caregiving can create employment and financial challenges, there is insufficient evidence to inform the development of caregiver-reported outcomes (CROs) that assess these experiences. The study purpose was to describe the occupational and financial consequences that were important to family caregivers of a patient with colorectal cancer (CRC) in the context of public health care, which represent potential considerations for CROs. In this qualitative Interpretive Description study, we analyzed interview data from 78 participants (25 caregivers, 37 patients, and 16 healthcare providers). Our findings point to temporary and long-term occupational and financial setbacks in the context of CRC. Caregiving for a person with CRC involved managing occupational implications, including (1) revamping employment arrangements, and (2) juggling work, family, and household demands. Caregiver financial struggles included (1) responding to financial demands at various stages of life, and (2) facing the spectre of lifelong expenses. Study findings offer novel insight into the cancer-related occupational and financial challenges facing caregivers, despite government-funded universal health care. Further research is warranted to develop CRO measures that assess the multifaceted nature of these challenges.

To share or not to share: communication of caregiver-reported outcomes when a patient has colorectal cancer.

BACKGROUND: The importance of patient-centered measurement in cancer care has led to recognition of the potential for caregiver-reported outcomes to improve caregiver, patient and healthcare system outcomes. Yet, there is limited evidence to inform caregiver-reported outcome implementation. Our purpose was to generate evidence to inform the meaningful and constructive integration of caregiver-reported outcomes into cancer care to benefit caregivers, including exploration of the question of the extent to which these assessments should be shared with patients. We focused on caregivers of patients with colorectal cancer (CRC) because CRC is common, and associated caregiving can be complex. RESULTS: From our Interpretive Description analysis of qualitative interview data from 78 participants (25 caregivers, 37 patients, and 16 healthcare providers [HCPs]), we identified contrasting perspectives about the sharing of caregiver-reported outcome assessments with patients with CRC. Those who preferred open communication with both the patient and caregiver present considered this essential for supporting the caregiver. The participants who preferred private communication without the patient, cited concern about caregiver- and patient-burden and guilt. Recognizing these perspectives, HCPs described strategies used to navigate sensitivities inherent in preferences for open versus private communication. CONCLUSIONS: The integration of caregiver-reported outcomes into cancer care will require careful consideration of caregiver and patient preferences regarding the communication of caregiver assessments to prevent additional burden.

N-of-1 Trials, Their Reporting Guidelines, and the Advancement of Open Science Principles.

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.

Addressing Complementary and Alternative Medicine Use Among Individuals With Cancer: An Integrative Review and Clinical Practice Guideline.

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.

At the Heart of It All: Emotions of Consequence for the Conceptualization of Caregiver-Reported Outcomes in the Context of Colorectal Cancer.

Colorectal cancer (CRC) can be demanding for primary caregivers; yet, there is insufficient evidence describing the caregiver-reported outcomes (CROs) that matter most to caregivers. CROs refer to caregivers' assessments of their own health status as a result of supporting a patient. The study purpose was to describe the emotions that were most impactful to caregivers of patients with CRC, and how the importance caregivers attribute to these emotions changed from diagnosis throughout treatment. Guided by qualitative Interpretive Description, we analyzed 25 caregiver and 37 CRC patient interviews, either as individuals or as caregiver-patient dyads (six interviews), using inductive coding and constant comparative techniques. We found that the emotional aspect of caring for a patient with CRC was at the heart of caregiving. Caregiver experiences that engendered emotions of consequence included: (1) facing the patient's life-changing diagnosis and an uncertain future, (2) needing to be with the patient throughout the never-ending nightmare of treatment, (3) bearing witness to patient suffering, (4) being worn down by unrelenting caregiver responsibilities, (5) navigating their relationship, and (6) enduring unwanted change. The broad range of emotions important to caregivers contributes to comprehensive foundational evidence for future conceptualization and the use of CROs.

The Effect of a Complementary Therapy Education Seminar on Support Persons of Individuals with Cancer.

Objectives: Complementary therapy (CT) use is prevalent among individuals living with cancer, who often consult family and friends (i.e., support persons) in making decisions about CT. This study examines the effect of an education seminar for adult cancer patients and support persons on the support persons' use, knowledge, and decision-making processes related to CT. Design: A patient education seminar that included support persons was developed and evaluated as part of a CT decision support research program. Survey data were collected before and after the education seminar to examine its impact on support persons' knowledge and use of CT, as well as their engagement in the CT decision-making process. Setting: The study was conducted in Western Canada. Subjects: 62 adult support persons. Interventions: Participants attended a 4-h CT education seminar at one in four provincial cancer centers. The seminar provided recommendations regarding how to make informed decisions about CT, where to find credible information, and key issues to consider to avoid potential risks of CT use. The evidence related to popular CT was also reviewed. Outcome Measures: The primary outcome was support persons' CT knowledge. Secondary outcomes included CT use, information-seeking behavior, decision self-efficacy, decision conflict, and distress. Results: A significant increase in support persons' CT knowledge was observed, as well as improved confidence in CT decision making. There was no significant difference in participants' CT use following the education seminar. Most indicated they would continue to locate information about CT using the Internet. A significant decrease in support persons' decisional conflict was reported; however, there were no significant change in distress related to CT decision making. Conclusions: This study demonstrates the importance of including support persons in patient education related to CT and the positive impact on their knowledge and treatment decision-making processes. No significant change in CT use, information seeking behavior and distress related to CT decisions, however, was observed in the study.

Pediatric natural health products recommended by chiropractic and naturopathic doctors in Canada.

OBJECTIVES: To assess chiropractic (DC) and naturopathic doctors' (ND) pediatric care natural health product (NHP) recommendations. DESIGN: Surveys were developed in collaboration with DC and ND educators, and delivered as an on-line national survey. NHP dose, form of delivery, and indications across pediatric age ranges (from newborn to 16 years) for each practitioner's top five NHPs were assessed. Data were analyzed using descriptive statistics, t-tests, and non-parametric tests. RESULTS: Of the 421 respondents seeing one or more pediatric patients per week, 172 (41%, 107 DCs, 65 NDs) provided 440 NHP recommendations, categorized as: vitamins and minerals (89 practitioners, 127 recommendations), probiotics (110 practitioners, 110 recommendations), essential fatty acids (EFAs: 72 practitioners, 72 recommendations), homeopathics (56 practitioners, 66 recommendations), botanicals (29 practitioners, 31 recommendations), and other NHPs (33 practitioners, 34 recommendations). Indications for the NHP recommendations were tabulated for NHPs with 10 or more recommendations in any age category: 596 total indications for probiotics, 318 indications for essential fatty acids, 138 indications for vitamin D, and 71 indications for multi-vitamins. CONCLUSIONS: This is the first study documenting the pediatric NHP recommendations of two popular complementary medicine professions. Common NHPs at standard doses are the most frequently recommended products, with use and doses adjusted according to age. High-quality evidence regarding the efficacy, safety, and dosing for NHP use in children is scarce; development of evidence-informed pediatric guidelines is recommended, particularly for the most commonly used and recommended NHPs.

Pediatric training and practice of Canadian chiropractic and naturopathic doctors: a 2004-2014 comparative study.

BACKGROUND: To assess chiropractic (DC) and naturopathic doctors' (ND) knowledge, attitudes, and behaviour with respect to the pediatric patients in their practice. METHODS: Cross-sectional surveys were developed in collaboration with DC and ND educators. Surveys were sent to randomly selected DCs and NDs in Ontario, Canada in 2004, and a national online survey was conducted in 2014. Data were analyzed using descriptive statistics, t-tests, non-parametric tests, and linear regression. RESULTS: Response rates for DCs were n = 172 (34%) in 2004, n = 553 (15.5%) in 2014, and for NDs, n = 171 (36%) in 2004, n = 162 (7%) in 2014. In 2014, 366 (78.4%) of DCs and 83 (61%) of NDs saw one or more pediatric patients per week. Pediatric training was rated as inadequate by most respondents in both 2004 and 2014, with most respondents (n = 643, 89.9%) seeking post-graduate training by 2014. Respondents' comfort in treating children and youth is based on experience and post-graduate training. Both DCs and NDs that see children and youth in their practices address a broad array of pediatric health concerns, from well child care and preventative health, to mild and serious illness. CONCLUSIONS: Although the response rate in 2014 is low, the concerns identified a decade earlier remain. The majority of responding DCs and NDs see infants, children, and youth for a variety of health conditions and issues, but self-assess their undergraduate pediatric training as inadequate. We encourage augmented pediatric educational content be included as core curriculum for DCs and NDs and suggest collaboration with institutions/organizations with expertise in pediatric education to facilitate curriculum development, especially in areas that affect patient safety.

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.

Not Birds of a Feather: Case Reports, Case Studies, and Single-Subject Research.

If the practice of therapeutic massage and bodywork (TMB) is to become evidence-informed, practitioners, educators, and presenters must better develop their research literacy and critical appraisal skills. Given that the IJTMB supports the publication of case reports as one fundamental form of knowledge development within the fields of TMB, it is imperative that researchers, educators, and practitioners know the difference between case reports and similar, but unrelated, forms of research. There are legal and ethical implications that must be carefully considered for each form of research or reporting.

Does a Journal Have an Ethical Monitoring Duty?

Research and ethics are inseparable. Based on abhorrent research abuses under the cloak of scientific enquiry, development of the process for the ethical overview of research on/with humans was undertaken. By the end of the twentieth century, sufficient and extensive local and international principles, guidelines, legislations, and treaties about research on humans were in place, with all human-based research requiring review by independent research ethics committees (RECs). With so much established knowledge and legislation about the ethical management of the research process and REC oversight, is there a role for journal editorial boards in ethical oversight? Recommendations from the International Committee of Medical Journal Editors, the basis of the editorial policies of the IJTMB, include the requirement that research must be approved by an REC, and documentation of that review should be included in each article. Thus, as a minimum, journals must ensure that any research submitted for publication has had appropriate ethical review. But journals receive manuscripts after research is done. Journals, therefore, have a duty to ensure that received manuscripts meet expected standards for the publication of research and, for nonresearch situations, that appropriate protections of the research participants were in place even though REC review was not involved.

Qualitative assessment of information and decision support needs for managing menopausal symptoms after breast cancer.

PURPOSE: For breast cancer (BrCa) survivors, premature menopause can result from conventional cancer treatment. Due to limited treatment options, survivors often turn to complementary therapies (CTs), but struggle to make informed decisions. In this study, we identified BrCa survivors' CT and general information and decision-making needs related to menopausal symptoms. METHODS: The needs assessment was informed by interpretive descriptive methodology. Focus groups with survivors (n = 22) and interviews with conventional (n = 12) and CT (n = 5) healthcare professionals (HCPs) were conducted at two Canadian urban cancer centers. Thematic, inductive analysis was conducted on the data. RESULTS: Menopausal symptoms have significant negative impact on BrCa survivors. Close to 70 % of the sample were currently using CTs, including mind-body therapies (45.5 %), natural health products (NHPs) and dietary therapies (31.8 %), and lifestyle interventions (36.4 %). However, BrCa survivors reported inadequate access to information on the safety and efficacy of CT options. Survivors also struggled in their efforts to discuss CT with HCPs, who had limited time and information to support women in their CT decisions. Concise and credible information about CTs was required by BrCa survivors to support them in making informed and safe decisions about using CTs for menopausal symptom management. CONCLUSIONS: High quality research is needed on the efficacy and safety of CTs in managing menopausal symptoms following BrCa treatment. Decision support strategies, such as patient decision aids (DAs), may help synthesize and translate evidence on CTs and promote shared decision-making between BrCa survivors and HCPs about the role of CTs in coping with menopause following cancer treatment.

Avoiding Common Writing Mistakes That Make Your Editors and Reviewers Cringe.

Writing for scientific journals is not an inherently simple task for most people. It requires purposeful effort and multiple revisions of the initial manuscript draft. While each author and article has its own individuality, writing well to address the core elements of a scientific report is necessary. As editors of the IJTMB, we often see weaknesses in the core elements of the manuscripts we receive. This editorial summarizes common recurring issues, and provides suggestions on how to avoid these pitfalls in the submission of a research article or case report to the IJTMB.

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.