Mindfulness in the Clinic Waiting Room May Decrease Pain: Results from Three Pilot Randomized Controlled Trials.

Introduction: Mindfulness interventions can improve a broad range of patient outcomes, but traditional mindfulness-based interventions are time and resource intensive. Emerging evidence indicates brief, single-session mindfulness interventions can also improve patient outcomes, and brief mindfulness interventions can be embedded into medical care pathways with minimal disruption. However, the direct impact of a brief mindfulness intervention on patients' pain while waiting in the clinic waiting room remains unexamined. Objective: A series of three, pilot, randomized controlled trials (RCTs) were conducted to examine the impact of a brief, audio-recorded, mindfulness intervention on patients' pain in the clinic waiting room. Method: Study 1 examined an 8-min mindfulness recording delivered before a provider visit; Study 2 examined a 5-min mindfulness recording after a provider visit; and Study 3 examined a 4-min mindfulness recording before a provider visit. Time- and attention-matched control conditions were used in each study. Studies 1 and 2 were conducted in an academic cancer hospital. Study 3 was conducted at a walk-in orthopedic clinic. Pain intensity was measured in each of the three studies. Anxiety and depression symptoms were measured in Studies 2 and 3. Pain unpleasantness was measured in Study 3. Results: A brief (i.e., 4- to 8-min), audio-recorded mindfulness intervention decreased patients' pain intensity in the clinic waiting room, whether delivered before (Study 1 Cohen's d=1.01, Study 3 Cohen's d=0.39) or after (Study 2 Cohen's d=0.89) a provider visit. Mindfulness had a significant effect on anxiety symptoms in both studies in which it was measured. No effect on depression symptoms was observed. Conclusions: Results from these three pilot RCTs indicate brief, audio-recorded, mindfulness interventions may be capable of quickly decreasing clinical symptoms. As such, embedding brief, audio-recorded, mindfulness interventions in clinic waiting rooms may have the potential to improve patient outcomes. The continued investigation of this intervention approach is needed. Clinical Trial Registrations: NCT04477278 and NCT06099964.

Regulatory scripting: Stakeholder participation in food and drug administration medical device advisory meetings.

In an age of biomedicalization, medical devices have become more common and more technologically complicated, and adverse events associated with medical devices have increased. The U.S. Food and Drug Administration (FDA) relies on advisory panels to assist in regulatory decision making regarding medical devices. Public meetings held by these advisory panels allow stakeholders to testify, presenting evidence and recommendations, according to careful procedural standards. This research examines the participation of six stakeholder groups (patients, advocates, physicians, researchers, industry representatives and FDA representatives) in FDA panel meetings focused on the safety of implantable medical devices between 2010-2020. We use qualitative and quantitative methods to analyze speakers' opportunities for participation, bases of evidence, and recommendations, applying the concept of 'scripting' to understand how this participation is shaped by regulatory structures. Regression analysis demonstrates statistically significant differences in speaking time, where researchers, industry, and FDA representatives had longer opening remarks and more exchanges with FDA panelists than patients. Patients, advocates and physicians shared the least amount of speaking time, and were the parties most likely to leverage patients' embodied knowledge and recommend the most stringent regulatory actions like recalls. Meanwhile, researchers, FDA, and industry representatives rely on scientific evidence and, with physicians, recommend actions that preserve medical technology access and clinical autonomy. This research highlights the scripted nature of public participation and the types of knowledge considered in medical device policymaking.

Transactional sex, consumer society, and neoliberalism in Uganda: A political economic analysis of drivers and models of response.

Transactional sex is a topic within HIV research that is relatively undertheorised and lacking consensus. In this study, it is understood as the implicit, non-marital, non-commercial exchange of sex for material goods or social status, and we examine the phenomenon among youth. Within the existing literature, the paradigms of sex-for-survival and sex-for-consumption emerge, representing differing senses of agency, particularly among young women. Based on interviews with human service providers in Kampala, Uganda, we consider the latter paradigm, examining how providers frame transactional sex against the political-economic backdrop of consumer culture, including the mainstreaming of communication technology in youths' lives. We also examine providers' depictions of available models of response, focused mainly on HIV prevention, in the context of international and national policies and politics. This study aims to situate analyses of transactional sex within political-economic context, considering how structural shifts toward neoliberalism have shaped both this phenomenon of behavioural health, and the existing models of response.

The association between time-of-day of habitual exercise training and changes in relevant cancer health outcomes among cancer survivors.

OBJECTIVE: To assess the relationship between time-of-day of exercise training and changes in relevant cancer health outcomes among cancer survivors. METHODS: Retrospective analysis of data collected from 2016-2019 from a hospital-based exercise oncology program. Descriptive statistics were calculated for demographic, clinical, and exercise timing characteristics (e.g. AM, PM, or mix) among survivors with available data for exercise training time (n = 233). For the total sample and a breast cancer sub-analysis, univariate analysis of covariance, adjusted for age, was carried out by exercise training time, for change in the following outcomes collected during the program's assessment sessions: cardiorespiratory fitness and muscular endurance (human performance variables), physical function, anthropometrics, self-reported fatigue, and quality of life (QoL). Change in body mass index (BMI) and body weight was included in the breast cancer analysis. RESULTS: Overall, 37.3% of survivors habitually engaged in AM exercise (e.g. ≥ 75% AM training), 34.3% in PM exercise, and 28.3% in a mix of AM and PM exercise training throughout the program. Median time in the program was 17 weeks. Significant improvements in most human performance and physical function variables were observed in the total sample regardless of exercise training time-of-day. Among breast cancer survivors, PM but not AM or mixed was associated with improvements in fitness, and lower-body muscular endurance and function. Mixed exercise timing was linked with greater increase in waist circumference (total sample: 3.02cm, 95%CI 1.55, 4.49; breast cancer: 3.57cm 95%CI 0.96, 6.18), body weight (breast cancer: 1.6kg, 95%CI 0.3, 2.8) and BMI (breast cancer: 0.6kg/m2, 95%CI 0.1, 1.0). AM and PM exercise, but not mixed, was associated with improvements in fatigue and QoL. CONCLUSION: Time-of-day of exercise training may differentially impact changes in human performance and physical function variables. Mixed exercise training time may result in less favorable outcomes related of weight management variables among cancer survivors.

The Society for Integrative Oncology Practice Recommendations for online consultation and treatment during the COVID-19 pandemic.

OBJECTIVE: The Society for Integrative Oncology (SIO) Online Task Force was created in response to the challenges facing continuity of integrative oncology care resulting from the COVID-19 pandemic. The Task Force set out to guide integrative oncology practitioners in providing effective and safe online consultations and treatments for quality-of-life-concerns and symptom management. Online treatments include manual, acupuncture, movement, mind-body, herbal, and expressive art therapies. METHODS: The SIO Online Practice Recommendations employed a four-phase consensus process: (1) literature review and discussion among an international panel of SIO members, identifying key elements essential in an integrative oncology visit; (2) development, testing, and refinement of a questionnaire defining challenges and strategies; (3) refinement input from integrative oncology experts from 19 countries; and (4) SIO Executive Committee review identifying the most high-priority challenges and strategies. RESULTS: The SIO Online Practice Recommendations address ten challenges, providing practical suggestions for online treatment/consultation. These include overcoming unfamiliarity, addressing resistance among patients and healthcare practitioners to online consultation/treatment, exploring ethical and medical-legal aspects, solving technological issues, preparing the online treatment setting, starting the online treatment session, maintaining effective communication, promoting specific treatment effects, involving the caregiver, concluding the session, and ensuring continuity of care. CONCLUSIONS: The SIO Online Practice Recommendations are relevant for ensuring continuity of care beyond the present pandemic. They can be implemented for patients with limited accessibility to integrative oncology treatments due to geographic constraints, financial difficulties, physical disability, or an unsupportive caregiver. These recommendations require further study in practice settings.

The impact of a hospital-based exercise oncology program on cancer treatment-related side effects among rural cancer survivors.

PURPOSE: To assess the impact of the Personal Optimism With Exercise Recovery (POWER) program on cancer treatment-related side effects among rural cancer survivors. METHODS: In this retrospective study of data collected between 2016 and 2019, we assessed change in cardiorespiratory fitness, whole-body muscular endurance, physical function and strength, anthropometrics, fatigue, and quality of life (QoL), after participation in POWER. Descriptive statistics were calculated for demographic and clinical variables. Univariate analysis of variance was carried out with age and BMI at initial assessment as covariates. RESULTS: A total of 239 survivors, 78% rural residents, completed a follow-up assessment. Among rural cancer survivors, the most prevalent cancer sites were breast (42.5%), prostate (12.4%), and lymphoma (5.9%). The majority of survivors were female (70%), non-Hispanic (94.6%), and white (93.5%), with average age and BMI of 62.1 ± 13.2 years and 28.4 ± 6.7 kg/m2, respectively. Rural cancer survivors with cancer stages I-III exhibited significant improvements in fitness (+ 3.07 ml/kg/min, 95% CI 1.93, 4.21; + 0.88 METS, 95% CI 0.55, 1.20), physical function (30-s chair stand: + 2.2 repetitions, 95% CI 1.3, 3.1), muscular endurance (10-repetition maximum: chest press + 4.1 kg, 95% CI 2.0, 6.3; lateral pulldown + 6.6 kg, 95% CI 4.4, 8.9), self-reported fatigue (FACIT-Fatigue score: + 4.9, 95% CI 1.6, 8.1), and QoL (FACT-G7 score + 2.1, 95% CI, 0.9, 3.4). Among stage IV rural and urban cancer survivors, significant improvements were observed in muscular endurance and physical function. CONCLUSION: Participation in POWER was associated with attenuation of cancer treatment-related side effects and may serve as a model exercise oncology program for rural cancer survivors.

Mindfulness-Oriented Recovery Enhancement Restructures Reward Processing and Promotes Interoceptive Awareness in Overweight Cancer Survivors: Mechanistic Results From a Stage 1 Randomized Controlled Trial.

INTRODUCTION: The primary aims of this Stage I pilot randomized controlled trial were to establish the feasibility of integrating exercise and nutrition counseling with Mindfulness-Oriented Recovery Enhancement (MORE), a novel intervention that unites training in mindfulness, reappraisal, and savoring skills to target mechanisms underpinning appetitive dysregulation a pathogenic process that contributes to obesity among cancer survivors; to identify potential therapeutic mechanisms of the MORE intervention; and to obtain effect sizes to power a subsequent Stage II trial. METHODS: Female overweight and obese cancer survivors (N = 51; mean age = 57.92 ± 10.04; 88% breast cancer history; 96% white) were randomized to one of two 10-week study treatment conditions: ( a) exercise and nutrition counseling or ( b) exercise and nutrition counseling plus the MORE intervention. Trial feasibility was assessed via recruitment and retention metrics. Measures of therapeutic mechanisms included self-reported interoceptive awareness, maladaptive eating behaviors, and savoring, as well as natural reward responsiveness and food attentional bias, which were evaluated as psychophysiological mechanisms. RESULTS: Feasibility was demonstrated by 82% of participants who initiated MORE receiving a full dose of the intervention. Linear mixed models revealed that the addition of MORE led to significantly greater increases in indices of interoceptive awareness, savoring, and natural reward responsiveness, and, significantly greater decreases in external eating behaviors and food attentional bias-the latter of which was significantly associated with decreases in waist-to-hip ratio. Path analysis demonstrated that the effect of MORE on reducing food attentional bias was mediated by increased zygomatic electromyographic activation during attention to natural rewards. CONCLUSIONS AND IMPLICATIONS: MORE may target appetitive dysregulatory mechanisms implicated in obesity by promoting interoceptive awareness and restructuring reward responsiveness.

Investigation of a community cluster of cutaneous Mycobacterium marinum infection, an emerging zoonotic pathogen in aquaculture industry, Haliburton, Kawartha, Pine Ridge District Health Unit, Ontario, Canada, July-August 2015.

In July 2015, a cluster of five suspect cases of clinically diagnosed Mycobacterium marinum (M. marinum) skin infections were reported to the Haliburton, Kawartha, Pine Ridge District Health Unit (HKPRDHU), Ontario, Canada, with two additional cases subsequently identified through case finding. All seven cases presented with cutaneous lesions located on the finger, hand and/or elbow regions typical of M. marinum infection. Specimens were collected by skin biopsy for two of the seven cases; both cases tested positive for M. marinum by molecular detection (hsp65 gene amplification and sequencing), and one was confirmed positive for M. marinum by culture. All seven cases reported handling raw shrimp from an aquaculture facility in the Health Unit's jurisdiction. M. marinum is not a reportable disease in Ontario, and there are no known previous reports of a cluster of M. marinum reported in Ontario, Canada. A cluster investigation working group was struck that included representation from various agencies including Public Health Ontario (PHO), Public Health Ontario Laboratories (PHOL), Ontario Ministry of Agriculture and Rural Affairs (OMAFRA) and the two health units involved in case investigations. Several public health and aquaculture farming recommendations were made to mitigate further risks associated with handling of raw shrimp from the facility. Several challenges were faced during the investigation process. The paper discusses these challenges and public health recommendations made in order to mitigate occupational and public health risks related to the hazard identified.

Adverse Event Reports Associated with Vaginal Mesh: An Interrupted Time Series Analysis.

BACKGROUND: Surgery with vaginal mesh is often used to treat female urinary incontinence. Questions have emerged over the past decade about the safety and efficacy of vaginal mesh devices. OBJECTIVE: This study examines trends in adverse event reports associated with vaginal mesh devices, testing the hypothesis that Food and Drug Administration (FDA) announcements will result in increased adverse event reports to the FDA. METHODS: Using interrupted time series regression models, we analyzed adverse event report data collected from the FDA's Manufacturer and User Facility Device Experience reporting system in 1998 through 2015. RESULTS: FDA announcements had limited effects on the number of adverse event reports, whereas an announcement from a mesh manufacturer that it was withdrawing devices from the market resulted in a large spike in reports. CONCLUSIONS: These findings raise concerns about the dispersion of risk communications, the FDA's reliance on adverse event reports for postmarket surveillance, and the FDA's clearance of vaginal mesh without safety or efficacy testing.

Linking dispositional mindfulness and positive psychological processes in cancer survivorship: a multivariate path analytic test of the mindfulness-to-meaning theory.

BACKGROUND: Research indicates that dispositional mindfulness is associated with positive psychological functioning. Although this disposition has been linked with beneficial outcomes in the broader mental health literature, less is known about dispositional mindfulness in cancer survivors and how it may be linked with indices of psychological and physical health relevant to cancer survivorship. METHODS: We conducted a multivariate path analysis of data from a heterogeneous sample of cancer patients (N = 97) to test the Mindfulness-to-Meaning Theory, an extended process model of emotion regulation linking dispositional mindfulness with cancer-related quality of life via positive psychological processes. RESULTS: We found that patients endorsing higher levels of dispositional mindfulness were more likely to pay attention to positive experiences (ß = .56), a tendency which was associated with positive reappraisal of stressful life events (ß = .51). Patients who engaged in more frequent positive reappraisal had a greater sense of meaning in life (ß = .43) and tended to savor rewarding or life affirming events (ß = .50). In turn, those who engaged in high levels of savoring had better quality of life (ß = .33) and suffered less from emotional distress (ß = -.54). CONCLUSIONS: Findings provide support for the Mindfulness-to-Meaning Theory and help explicate the processes by which mindfulness promotes psychological flourishing in the face of cancer. IMPLICATIONS FOR CANCER SURVIVORSHIP: Cancer survivors may benefit from enhancing mindfulness, reappraisal, and savoring. Copyright © 2016 John Wiley & Sons, Ltd.

Narrative medicine and death in the ICU: word clouds as a visual legacy.

OBJECTIVE: The Word Cloud is a frequent wish in the 3 Wishes Project developed to nurture peace and ease the grieving process for dying critically ill patients. The objective was to examine whether Word Clouds can act as a heuristic approach to encourage a narrative orientation to medicine. Narrative medicine is an approach which can strengthen relationships, compassion and resilience. DESIGN: Word Clouds were created for 42 dying patients, and we interviewed 37 family members and 73 clinicians about their impact. We conducted a directed qualitative content analysis, using the 3 stages of narrative medicine (attention, representation, affiliation) to examine the narrative medicine potential of Word Clouds. RESULTS: The elicitation of stories for the Word Cloud promotes narrative attention to the patient as a whole person. The distillation of these stories into a list of words and the prioritisation of those words for arrangement in the collage encourages a representation that did not enforce a beginning, middle or end to the story of the patient's life. Strong affiliative connections were achieved through the honouring of patients, caring for families and sharing of memories encouraged through the creation, sharing and discussion of Word Clouds. CONCLUSIONS: In the 3 Wishes Project, Word Clouds are 1 way that families and clinicians honour a dying patient. Engaging in the process of making a Word Cloud can promote a narrative orientation to medicine, forging connections, making meaning through reminiscence and leaving a legacy of a loved one. Documenting and displaying words to remember someone in death reaffirms their life.

The role of public health in the prevention of war: rationale and competencies.

In 2009 the American Public Health Association approved the policy statement, "The Role of Public Health Practitioners, Academics, and Advocates in Relation to Armed Conflict and War." Despite the known health effects of war, the development of competencies to prevent war has received little attention. Public health's ethical principles of practice prioritize addressing the fundamental causes of disease and adverse health outcomes. A working group grew out of the American Public Health Association's Peace Caucus to build upon the 2009 policy by proposing competencies to understand and prevent the political, economic, social, and cultural determinants of war, particularly militarism. The working group recommends that schools of public health and public health organizations incorporate these competencies into professional preparation programs, research, and advocacy.

Psychosocial distress is prevalent in head and neck cancer patients.

OBJECTIVES/HYPOTHESIS: The purpose of this study is to evaluate the levels of psychological distress in head and neck cancer patients using a validated screening tool. We aim to characterize distress in this cancer population and understand the factors driving distress levels. STUDY DESIGN: Review of prospectively gathered data. METHODS: A review of prospectively gathered data was undertaken from 89 head and neck cancer patients (HNC) who completed the Distress Thermometer and Problem List (DT) from the National Comprehensive Cancer Network (NCCN). RESULTS: Distress levels were high in the overall population. The level of distress was significantly greater in patients with a self-reported history of depression (P <.001), family concerns (P = .030), emotional concerns (P = .001) and physical concerns (P = .014). CONCLUSIONS: Psychosocial distress was found to be high in the HNC population. Factors associated with increased distress level included a self-reported history of depression, family concerns, emotional concerns, and physical concerns.