Ensuring Intervention Fidelity of an Attention Control Arm in a Multisite Randomized Controlled Trial.

BACKGROUND: Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either overestimating or underestimating the efficacy of the intervention under examination. OBJECTIVES: This brief report describes the approach researchers took to promote fidelity to the attention control arm of a pediatric palliative care randomized controlled trial funded by the National Institutes of Health. METHODS: The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer who have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared with an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking to their child about their cancer, clinical trials, cancer treatment, side effects, and so forth. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. RESULTS: Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. DISCUSSION: Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly.

Sweet and sour synergy: exploring the antibacterial and antibiofilm activity of acetic acid and vinegar combined with medical-grade honeys.

Oxymel, a combination of honey and vinegar, has been used as a remedy for wounds and infections in historical and traditional medical settings. While honey is now clinically used to treat infected wounds, this use of a complex, raw natural product (NP) mixture is unusual in modern western medicine. Research into the antimicrobial activity of NPs more usually focuses on finding a single active compound. The acetic acid in vinegar is known to have antibacterial activity at low concentrations and is in clinical use to treat burn wound infections. Here, we investigated the potential for synergistic activity of different compounds present in a complex ingredient used in historical medicine (vinegar) and in an ingredient mixture (oxymel). We conducted a systematic review to investigate published evidence for antimicrobial effects of vinegars against human pathogenic bacteria and fungi. No published studies have explicitly compared the activity of vinegar with that of a comparable concentration of acetic acid. We then characterized selected vinegars by HPLC and assessed the antibacterial and antibiofilm activity of the vinegars and acetic acid, alone and in combination with medical-grade honeys, against Pseudomonas aeruginosa and Staphylococcus aureus. We found that some vinegars have antibacterial activity that exceeds that predicted by their acetic acid content alone, but that this depends on the bacterial species being investigated and the growth conditions (media type, planktonic vs. biofilm). Pomegranate vinegars may be particularly interesting candidates for further study. We also conclude that there is potential for acetic acid, and some vinegars, to show synergistic antibiofilm activity with manuka honey.

COVID-19 Surveillance After Expiration of the Public Health Emergency Declaration - United States, May 11, 2023.

On January 31, 2020, the U.S. Department of Health and Human Services (HHS) declared, under Section 319 of the Public Health Service Act, a U.S. public health emergency because of the emergence of a novel virus, SARS-CoV-2.* After 13 renewals, the public health emergency will expire on May 11, 2023. Authorizations to collect certain public health data will expire on that date as well. Monitoring the impact of COVID-19 and the effectiveness of prevention and control strategies remains a public health priority, and a number of surveillance indicators have been identified to facilitate ongoing monitoring. After expiration of the public health emergency, COVID-19-associated hospital admission levels will be the primary indicator of COVID-19 trends to help guide community and personal decisions related to risk and prevention behaviors; the percentage of COVID-19-associated deaths among all reported deaths, based on provisional death certificate data, will be the primary indicator used to monitor COVID-19 mortality. Emergency department (ED) visits with a COVID-19 diagnosis and the percentage of positive SARS-CoV-2 test results, derived from an established sentinel network, will help detect early changes in trends. National genomic surveillance will continue to be used to estimate SARS-CoV-2 variant proportions; wastewater surveillance and traveler-based genomic surveillance will also continue to be used to monitor SARS-CoV-2 variants. Disease severity and hospitalization-related outcomes are monitored via sentinel surveillance and large health care databases. Monitoring of COVID-19 vaccination coverage, vaccine effectiveness (VE), and vaccine safety will also continue. Integrated strategies for surveillance of COVID-19 and other respiratory viruses can further guide prevention efforts. COVID-19-associated hospitalizations and deaths are largely preventable through receipt of updated vaccines and timely administration of therapeutics (1-4).

Palliative care considerations and practices for adolescents and young adults with cancer.

The definition of adolescents and young adults (AYAs) in oncology varies with upper limits up to age 39. Younger AYAs, ages 12-24 years, are often cared for within pediatrics. In caring for AYAs with cancer, there are unique considerations that become even more important to recognize, acknowledge, and address in AYAs with life-threatening cancer receiving palliative care. This review highlights important factors such as psychosocial development, cultural considerations, and support structure, which should be considered when providing palliative care to AYAs with cancer during the various stages of care: introduction of palliative care; symptom management; advanced care planning (ACP); end-of-life (EOL) care; and bereavement.

First archaeological evidence for ginger consumption as a potential medicinal ingredient in a late medieval leprosarium at St Leonard, Peterborough, England.

Leprosy was one of the most outwardly visible diseases in the European Middle Ages, a period during which leprosaria were founded to provide space for the sick. The extant documentary evidence for leprosy hospitals, especially in relation to diet, therapeutic, and medical care, is limited. However, human dental calculus stands to be an important source of information as it provides insight into the substances people were exposed to and accumulated in their bodies during their lives. In the present study, microremains and DNA were analysed from the calculus of individuals buried in the late medieval cemetery of St Leonard, a leprosarium located in Peterborough, England. The results show the presence of ginger (Zingiber officinale), a culinary and medicinal ingredient, as well as evidence of consumption of cereals and legumes. This research suggests that affected individuals consumed ingredients mentioned in medieval medical textbooks that were used to treat regions of the body typically impacted by leprosy. To the authors' knowledge, this is the first study which has identified Zingiber officinale in human dental calculus in England or on the wider European continent.

Patient perspectives on care received at community acupuncture clinics: a qualitative thematic analysis.

BACKGROUND: Community acupuncture is a recent innovation in acupuncture service delivery in the U.S. that aims to improve access to care through low-cost treatments in group-based settings. Patients at community acupuncture clinics represent a broader socioeconomic spectrum and receive more frequent treatments compared to acupuncture users nationwide. As a relatively new model of acupuncture in the U.S., little is known about the experiences of patients at community acupuncture clinics and whether quality of care is compromised through this high-volume model. The aim of this study was to assess patients' perspectives on the care received through community acupuncture clinics. METHODS: The investigators conducted qualitative, thematic analysis of written comments from an observational, cross-sectional survey of clients of the Working Class Acupuncture clinics in Portland, Oregon. The survey included an open-ended question for respondents to share comments about their experiences with community acupuncture. Comments were received from 265 community acupuncture patients. RESULTS: Qualitative analysis of written comments identified two primary themes that elucidate patients' perspectives on quality of care: 1) aspects of health care delivery unique to community acupuncture, and 2) patient engagement in health care. Patients identified unique aspects of community acupuncture, including structures that facilitate access, processes that make treatments more comfortable and effective and holistic outcomes including physical improvements, enhanced quality of life, and empowerment. The group setting, community-based locations, and low cost were highlighted as aspects of this model that allow patients to access acupuncture. CONCLUSIONS: Patients' perspectives on the values and experiences unique to community acupuncture offer insights on the quality of care received in these settings. The group setting, community-based locations, and low cost of this model potentially reduce access barriers for those who might not otherwise consider using acupuncture. In addition, the community acupuncture model may offer individuals the opportunity for increased frequency of treatments, which raises pertinent questions about the dose-response relationship of acupuncture and health outcomes. This study provides preliminary data for future evaluations of the quality and effectiveness of community acupuncture. Future studies should include the perspectives of patients who initiated, and subsequently, discontinued community acupuncture treatment.

Facilitators and Barriers to Oral Healthcare for Women and Children with Low Socioeconomic Status in the United States: A Narrative Review.

This rapid review examined facilitators and barriers affecting oral healthcare access and utilization among women and children with a low socioeconomic status (SES) in the United States from 2019 to the present. A comprehensive search was conducted across multiple electronic databases, yielding a total of 30 relevant studies for inclusion. The findings highlight various facilitators that positively impact oral healthcare outcomes, including targeted educational programs, access to non-dental care healthcare services, community-based initiatives, and increased access to affordable oral health services. Conversely, barriers such as financial constraints, lack of access to food program social assistance, access to care difficulties, and limited oral health literacy were identified as major challenges faced by this population. Understanding these facilitators and barriers during the COVID-19 global pandemic can inform the development of tailored interventions and policies aimed at improving oral healthcare outcomes for women and children with a low SES in the United States.

An assessment of the evidence for antibacterial activity of stinging nettle (Urtica dioica) extracts.

Stinging nettles (Urtica spp.) have been used in a diverse range of traditional and historical medicines from around the world for the treatment of skin diseases, wounds, urinary disorders, respiratory diseases, bone and joint pain, anaemia and other circulatory problems, as well as in cosmetic preparations for skin and haircare. As part of an interdisciplinary exploration of nettle-based remedies, we performed a systematic review of published evidence for the antimicrobial activity of Urtica spp. extracts against bacteria and fungi that commonly cause skin, soft tissue and respiratory infections. We focussed on studies in which minimum inhibitory concentration (MIC) assays of U. dioica were conducted on the common bacterial opportunistic pathogens Escherichia coli , Pseudomonas aeruginosa , Klebsiella pneumoniae and Staphylococcus aureus . No studies used fresh leaves (all were dried prior to use), and no studies prepared nettles in weak acid (corresponding to vinegar) or in fats/oils, which are common combinations in historical and traditional preparations. We addressed this gap by conducting new antibacterial tests of extracts of fresh U. dioica leaves prepared in vinegar, butter or olive oil against P. aeruginosa and S. aureus . Our systematic review and additional experimental data leads us to conclude that there is no strong evidence for nettles containing molecules with clinically useful antimicrobial activity. It seems most likely that the utility of nettles in traditional topical preparations for wounds may simply be as a 'safe' absorbent medium for keeping antibacterial (vinegar) or emollient (oils) ingredients at the treatment site.

A case study of the Ancientbiotics collaboration.

Interdisciplinary collaboration is regarded as a desirable way of researching and, in some instances, even a requirement for academic teams and funding proposals. This paper explores the possibilities, but also the problems, of collaboration between different disciplines through a case study of the Ancientbiotics team. This team explores the potential of natural products contained in historical medical recipes. The search for clinically useful natural products in unusual places, such as historical medical practices, is a well-established endeavor in the scientific disciplines. The Ancientbiotics collaboration, largely based across UK institutions, takes this path a step forward in combining modern scientific knowledge of natural products with expertise from humanities to identify ingredient combinations. After 7 years of practice, the research has produced a variety of outcomes. This perspective will explore how the team worked within an interdisciplinary framework to advance investigation and application of historical medical recipes.

Data Mining a Medieval Medical Text Reveals Patterns in Ingredient Choice That Reflect Biological Activity against Infectious Agents.

The pharmacopeia used by physicians and laypeople in medieval Europe has largely been dismissed as placebo or superstition. While we now recognize that some of the materia medica used by medieval physicians could have had useful biological properties, research in this area is limited by the labor-intensive process of searching and interpreting historical medical texts. Here, we demonstrate the potential power of turning medieval medical texts into contextualized electronic databases amenable to exploration by the use of an algorithm. We used established methodologies from network science to reveal patterns in ingredient selection and usage in a key text, the 15th-century Lylye of Medicynes, focusing on remedies to treat symptoms of microbial infection. In providing a worked example of data-driven textual analysis, we demonstrate the potential of this approach to encourage interdisciplinary collaboration and to shine a new light on the ethnopharmacology of historical medical texts.IMPORTANCE We used established methodologies from network science to identify patterns in medicinal ingredient combinations in a key medieval text, the 15th-century Lylye of Medicynes, focusing on recipes for topical treatments for symptoms of microbial infection. We conducted experiments screening the antimicrobial activity of selected ingredients. These experiments revealed interesting examples of ingredients that potentiated or interfered with each other's activity and that would be useful bases for future, more detailed experiments. Our results highlight (i) the potential to use methodologies from network science to analyze medieval data sets and detect patterns of ingredient combination, (ii) the potential of interdisciplinary collaboration to reveal different aspects of the ethnopharmacology of historical medical texts, and (iii) the potential development of novel therapeutics inspired by premodern remedies in a time of increased need for new antibiotics.

Expectancy, Self-Efficacy, and Placebo Effect of a Sham Supplement for Weight Loss in Obese Adults.

This study examined the role of expectancy in the placebo effect of a sham dietary supplement for weight loss in 114 obese adults with metabolic syndrome. All participants received lifestyle education and were randomized to 1 of 3 conditions: (1) a daily placebo capsule and told that they were taking an active weight loss supplement, (2) daily placebo and told they had a 50% random chance of receiving either the active or placebo, or (3) no capsules. At 12 weeks, weight loss and metabolic outcomes were similar among the 3 groups. Participants in both groups that took capsules showed decreased weight loss self-efficacy and increased expectations of benefit from dietary supplements. Participants not taking capsules showed the opposite. Adverse events were more frequently reported in groups taking capsules than those who were not. These findings suggest that supplements without weight loss effects may have nocebo effects through diminished self-efficacy.

Utilization of group-based, community acupuncture clinics: a comparative study with a nationally representative sample of acupuncture users.

OBJECTIVES: Acupuncture utilization in the United States has increased in recent years, but is less common among racial/ethnic minorities and those of low socioeconomic status. Group-based, community acupuncture is a delivery model gaining in popularity around the United States, due in part to low-cost treatments provided on a sliding-fee scale. Affordable, community-based acupuncture may increase access to health care at a time when increasing numbers of people are uninsured. To assess the population using local community acupuncture clinics, sociodemographic factors, health status, and utilization patterns compared to national acupuncture users were examined. DESIGN: Data were employed from (1) a cross-sectional survey of 478 clients of two community acupuncture clinics in Portland, Oregon and (2) a nationally representative sample of acupuncture users from the 2007 National Health Interview Survey. RESULTS: Portland community acupuncture clients were more homogeneous racially, had higher educational attainment, lower household income, and were more likely to receive 10 or more treatments in the past 12 months (odds ratio=5.39, 95% confidence interval=3.54, 8.22), compared to a nationally representative sample of U.S. acupuncture users. Self-reported health status and medical reasons for seeking acupuncture treatment were similar in both groups. Back pain (21%), joint pain (17%), and depression (13%) were the most common conditions for seeking treatment at community acupuncture clinics. CONCLUSIONS: Study findings suggest that local community acupuncture clinics reach individuals of a broad socioeconomic spectrum and may allow for increased frequency of treatment. Limited racial diversity among community acupuncture clients may reflect local demographics of Portland. In addition, exposure to and knowledge about acupuncture is likely to vary by race and ethnicity. Future studies should examine access, patient satisfaction, frequency of treatment, and clinical outcomes of group-based models of community acupuncture clinics located in racially and socioeconomically diverse communities.

A train the trainer model for integrating evidence-based medicine into a complementary and alternative medicine training program.

BACKGROUND: Public interest in complementary and alternative medicine (CAM) has grown over the past decade, accompanied by increased demand for evidence-based approaches to CAM practice. In order to define the role evidence-based decision making has in CAM practice, CAM professionals must have a full understanding of evidence-based medicine (EBM) concepts. OBJECTIVE: This paper describes the design, implementation, and evaluation of a week-long intensive EBM short course for CAM faculty at a naturopathic and classical Chinese medicine institution. INTERVENTION: This 20-hour course, entitled Principles of EBM for CAM Professionals, teaches participants how to access and appraise biomedical literature, apply it to their work, and teach these concepts to their students. RESULTS: Results from precourse and postcourse evaluations suggest that, in a small group of participants, there were significant changes in EBM practice attitudes, self-appraised skills, and objectively assessed skills as a result of this course. Participants indicated they were committed to increasing their use of EBM in practice, enhancing EBM skills, using EBM in teaching, and working to change the culture at their institution to support use of EBM. At six months, 80% of participants had fully or partially followed through on their commitment to change plans.

The Vanguard Faculty program: research training for complementary and alternative medicine faculty.

BACKGROUND: The increasing use of complementary and alternative medicine (CAM) treatment is paralleled by a growing demand for an evidence-based approach to CAM practice. In 2007, the Helfgott Research Institute at the National College of Natural Medicine (NCNM), in partnership with Oregon Health & Science University (OHSU), both in Portland, OR, began a National Institutes of Health-funded initiative to increase the quality and quantity of evidence-based medicine (EBM) content in the curricula at NCNM. DESIGN: One key strategy of the Research in Complementary and Alternative Medicine Program (R-CAMP) initiative was to create a faculty development program that included four components: intensive training in EBM; professional skills enhancement; peer and mentored support; and, ultimately, utilization of these skills to incorporate EBM into the curricula. This initiative is centered on a core group of faculty at NCNM, called the Vanguard Faculty, who receives early, intensive training in EBM and works to incorporate this training into classes. Training consists of an intensive, week-long course, monthly group meetings, and periodic individualized meetings. Vanguard Faculty members also receive mentorship and access to resources to pursue individualized faculty development, research or scholarly activities. CONCLUSIONS: Early evaluations indicate that this effort has been successful in increasing EBM content in the curricula at NCNM. This article describes the Vanguard Faculty program in an effort to share the successes and challenges of implementing a wide-ranging faculty development and curricular initiative at a complementary and alternative medicine institution.

Static magnetic field therapy: a critical review of treatment parameters.

Static magnetic field (SMF) therapy, applied via a permanent magnet attached to the skin, is used by people worldwide for self-care. Despite a lack of established SMF dosage and treatment regimens, multiple studies are conducted to evaluate SMF therapy effectiveness. Our objectives in conducting this review are to:(i) summarize SMF research conducted in humans; (ii) critically evaluate reporting quality of SMF dosages and treatment parameters and (iii) propose a set of criteria for reporting SMF treatment parameters in future clinical trials. We searched 27 electronic databases and reference lists. Only English language human studies were included. Excluded were studies of electromagnetic fields, transcranial magnetic stimulation, magnets placed on acupuncture points, animal studies, abstracts, posters and editorials. Data were extracted on clinical indication, study design and 10 essential SMF parameters. Three reviewers assessed quality of reporting and calculated a quality assessment score for each of the 10 treatment parameters. Fifty-six studies were reviewed, 42 conducted in patient populations and 14 in healthy volunteers. The SMF treatment parameters most often and most completely described were site of application, magnet support device and frequency and duration of application. Least often and least completely described were characteristics of the SMF: magnet dimensions, measured field strength and estimated distance of the magnet from the target tissue. Thirty-four (61%) of studies failed to provide enough detail about SMF dosage to permit protocol replication by other investigators. Our findings highlight the need to optimize SMF dosing parameters for individual clinical conditions before proceeding to a full-scale clinical trial.

The effect of Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra on CD25 expression in humans: a pilot study.

This phase 0, double-blind, repeated within subject, randomized pilot study examined CD25 expression on T cells after ingestion of three commonly used herbs: Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra, administered singly and in combination. CD25 expression on T cells was significantly increased for subjects ingesting Echinacea at 24 h with notable increases in activation from Astragalus and Glycyrrhiza. CD25 expression remains elevated with daily use of Echinacea for at least 7 days.

The effect of Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra on CD69 expression and immune cell activation in humans.

The increasing use of medicinal herbs among the general public has piqued the need for scientific-based research to determine the mechanism of action of herbs administered orally in human subjects. The ability of three herbs, Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra, to activate immune cells in human subjects was assessed in this pilot study. The effect of these herbs when ingested for 7 days was measured both when administered singly, and in combination, using flow cytometry. The primary cell activation marker measured was CD69. The results demonstrate that Echinacea, Astragalus and Glycyrrhiza herbal tinctures stimulated immune cells as quantified by CD69 expression on CD4 and CD8 T cells. This activation took place within 24 h of ingestion, and continued for at least 7 days. In addition, these three herbs had an additive effect on CD69 expression when used in combination.