Clinical, Biomarker, and Research Tests Among US Government Personnel and Their Family Members Involved in Anomalous Health Incidents.

Importance: Since 2015, US government and related personnel have reported dizziness, pain, visual problems, and cognitive dysfunction after experiencing intrusive sounds and head pressure. The US government has labeled these anomalous health incidents (AHIs). Objective: To assess whether participants with AHIs differ significantly from US government control participants with respect to clinical, research, and biomarker assessments. Design, Setting, and Participants: Exploratory study conducted between June 2018 and July 2022 at the National Institutes of Health Clinical Center, involving 86 US government staff and family members with AHIs from Cuba, Austria, China, and other locations as well as 30 US government control participants. Exposures: AHIs. Main Outcomes and Measures: Participants were assessed with extensive clinical, auditory, vestibular, balance, visual, neuropsychological, and blood biomarkers (glial fibrillary acidic protein and neurofilament light) testing. The patients were analyzed based on the risk characteristics of the AHI identifying concerning cases as well as geographic location. Results: Eighty-six participants with AHIs (42 women and 44 men; mean [SD] age, 42.1 [9.1] years) and 30 vocationally matched government control participants (11 women and 19 men; mean [SD] age, 43.8 [10.1] years) were included in the analyses. Participants with AHIs were evaluated a median of 76 days (IQR, 30-537) from the most recent incident. In general, there were no significant differences between participants with AHIs and control participants in most tests of auditory, vestibular, cognitive, or visual function as well as levels of the blood biomarkers. Participants with AHIs had significantly increased fatigue, depression, posttraumatic stress, imbalance, and neurobehavioral symptoms compared with the control participants. There were no differences in these findings based on the risk characteristics of the incident or geographic location of the AHIs. Twenty-four patients (28%) with AHI presented with functional neurological disorders. Conclusions and Relevance: In this exploratory study, there were no significant differences between individuals reporting AHIs and matched control participants with respect to most clinical, research, and biomarker measures, except for objective and self-reported measures of imbalance and symptoms of fatigue, posttraumatic stress, and depression. This study did not replicate the findings of previous studies, although differences in the populations included and the timing of assessments limit direct comparisons.

Opioids and Chronic Pain: Impact of the NIH Pathways to Prevention Evidence-Based Workshop Program.

The National Institutes of Health (NIH) Office of Disease Prevention (ODP) sponsors Pathways to Prevention (P2P), an evidence-based scientific workshop program that helps advance prevention research. Each P2P workshop is presided over by an independent expert panel and informed by a systematic evidence review, scientific presentations, and public input. Post-workshop activities include collaborating with federal agency partners to develop an action plan for addressing key research gaps. Primary outcomes of P2P workshops include developing a research agenda and creating or enhancing initiatives to implement the agenda. In 2014, ODP partnered with the NIH Pain Consortium and two NIH institutes to convene "The Role of Opioids in the Treatment of Chronic Pain." This workshop assessed the state-of-the-science on the long-term effectiveness, safety, and harms of opioid use for managing chronic pain. In 2021, ODP initiated an assessment of the outcomes and impact of the Opioids P2P workshop. We applied an evaluation framework and a mixed methods approach encompassing web analytics, bibliometric assessment, grant portfolio analysis, policy assessment, and key informant interviews. Our data showed that the workshop attracted a broad audience, and its published reports had high impact. The workshop also helped inform over 100 new research projects through grants funded by three federal agencies, as well as national legislation and practice guidelines from influential organizations. In sum, the Opioids P2P workshop and follow-up activities have identified gaps in scientific knowledge, informed clinical practice, and catalyzed change on a national level for addressing the prescription opioid crisis.

Addressing the opioid crisis: social and behavioral research contributions at the National Institutes of Health.

This commentary highlights current NIH efforts aimed at addressing the opioid crisis, specifically activities related to behavioral and social science research. Implications for this commentary will inform researchers, practitioners, and policymakers on current endeavors and future funding opportunities.

Survey of cancer researchers regarding complementary and alternative medicine.

The primary purpose of this survey was to assess the interest and concerns of a group of cancer researchers regarding complementary and alternative medicine (CAM) research issues. These issues include cancer researchers' perceptions of the most promising areas of cancer CAM research, their needs for support, the perceived obstacles to carrying out research objectives in the emerging field of cancer CAM research, and their level of interest in research collaboration with CAM practitioners. A cross-sectional survey of a convenience sample of cancer researchers interested in CAM was conducted. Three hundred twenty-one respondents completed the survey, and 298 of them had participated in cancer research. About 85% of the respondents had participated in cancer CAM research. For all CAM categories, the percentage of respondents who would like to conduct research was greater than the percentage of those who have already done so. About two-thirds of the respondents rated research in pharmacologic and biologic treatments and nutritional therapeutics for cancer treatment and symptom/side-effect management as high-priority areas. The obstacle considered to be the most significant by the greatest percentage of the respondents (26.7%) was the lack of success in receiving research funds. This was also the most frequently encountered obstacle. The assistance that was considered to be very useful by the greatest percentage of respondents was support for developmental research or pilot projects, indicated by more than four-fifths (85.4%) of the respondents. More than 83% of respondents expressed some interest in or willingness to establish research collaboration with a CAM practitioner. The results from this survey indicate that many cancer CAM researchers have shared interests, needs, perceived obstacles, and desired research opportunities. These factors and other forces are likely to lead to further growth in the numbers and activity of cancer CAM researchers. If this occurs, then it will become even more important for the National Cancer Institute and other organizations to study the development and changes in this emerging research field.

The role of complementary and alternative medicine in the management of early breast cancer: recommendations of the European Society of Mastology (EUSOMA).

Patients diagnosed with breast cancer have many needs that for a start include the expectation of cure. Where cure is unlikely there is always a place for hope and spiritual support. Furthermore whether dealing with the early stages or with the advanced disease patients require symptomatic control that encompasses pain relief, control of nausea and vomiting and psychological distress. To achieve all of these goals there is a need that goes beyond the role of scientific medicine. This position papers describes the guidelines for the use of complimentary and alternative medicine (CAM) developed by a workshop on behalf of the European Society of Mastology (EUSOMA).

Research-design issues in cancer-symptom-management trials using complementary and alternative medicine: lessons from the National Cancer Institute Community Clinical Oncology Program experience.

PURPOSE: To identify major research-design issues in proposals submitted by investigators in the Community Clinical Oncology Program (CCOP) for clinical trials of complementary and alternative medicine (CAM) for cancer-symptom management. METHODS: We conducted content analysis of all scientific reviews of concepts and protocols submitted by the CCOP to the National Cancer Institute (NCI) to identify research challenges in conducting clinical trials designed to evaluate CAM interventions for cancer-symptom management. RESULTS: Since the inception of the NCI Office of Cancer Complementary and Alternative Medicine in 1998, a total of 46 symptom-management studies using CAM interventions have been proposed by CCOP investigators, with 20 studies now in progress comprising 22% of the current total CCOP symptom-management portfolio. Proposals fell into four categories: complex natural products; nutritional therapeutics; mind-body interventions; and alternative medical systems. The most significant research-design issues arose as a consequence of the lack of preclinical data for CAM interventions and the lack of quality-control standards comparable with those used in regulating new pharmaceutical agents. CONCLUSION: Across the different types of CAM interventions, the most common problems found in proposed research designs are related to unwarranted assumptions about the consistency and standardization of CAM interventions, the need for data-based justifications for the study hypotheses, and the need to implement appropriate quality control and monitoring procedures during the course of the trial. To advance the state of the science, future research must address these critical issues if CAM interventions are to be evaluated rigorously and have a consequent impact on clinical practice and general public awareness.

Research methodology: implications for CAM pain research.

The National Cancer Institute's Office of Cancer Complementary and Alternative Medicine established a series of expert panels to develop the state of the science in research methodologies in CAM cancer research. Panelists from both conventional and CAM research draw on their expertise in their relative fields to apply their knowledge and expertise to specific topic areas within cancer CAM. The first panel is focused on cancer symptom research. The discussion and conclusions raised by this panel primarily address pain research but are applicable to other symptoms as well. This article will focus on the panel presentations that are most applicable to CAM pain research in both cancer and noncareer pain populations, identifying the major challenges and conclusions offered by the panelists.

The meaning of pain: cancer patients' rating and recall of pain intensity and affect.

The present study investigated the influence of an increase in present pain intensity on the rating and recall of the intensity and affective dimensions of clinical pain. Thirty-two cancer patients who reported that movement caused or exacerbated their pain rated their present pain intensity and affect before and after a session of physical therapy. Subjects also rated their usual, highest and lowest pain intensity and pain affect for the previous 3 days, and were randomly assigned to make these ratings either before or after the physical therapy session. Physical therapy increased the intensity (P < 0.01) but not the unpleasantness of the pain (P > 0.05), thus demonstrating a dissociation between pain intensity and pain affect. Beliefs about pain etiology also influenced post-therapy pain ratings. Subjects (N = 11) who believed that their pain was due to cancer, rated their post-therapy pain intensity and pain affect significantly higher than those subjects (N = 21) who did not believe their pain was due to cancer (both P < 0.05). For all subjects, recall of past pain intensity and affect was positively correlated with present levels of pain intensity and pain affect (P < 0.01). Thus, recall was assimilated to present pain levels. The results demonstrate the importance of rating both the intensity and affective dimensions of pain, and suggest that the significance of clinical pain influences pain ratings. These results also suggest that research on the rating and recall of pain, particularly the affective dimension of pain, should use actual patients who are experiencing changes in their naturally occurring pain.

Effects of present pain level on recall of chronic pain and medication use.

The present study experimentally manipulated pain intensity in chronic pain patients to evaluate whether the present pain level influenced the recall of past pain and medication use. For 1 week 30 chronic pain patients recorded every change in their pain levels and every use of medication on an electronic diary. At the end of the week, we evaluated recall of pain level and medication use for the previous day and week either before (control group, n = 15) or immediately after a physical therapy (PT) session (PT group, n = 15). As expected, the PT patients reported a significantly lower present pain level than did the control patients. More importantly, the PT patients recalled their usual and their highest levels of pain for the previous day and week to be less severe than did the control patients; furthermore, they significantly underestimated these levels as compared to their diary. In contrast, the control patients significantly overestimated their lowest and highest levels of pain for the previous day and their usual and lowest levels of pain for the previous week. In addition, PT patients recalled taking significantly less medication than they had recorded in their diaries, and less than the control patients. Our results demonstrate clearly that chronic pain patients recall their pain and medication use for the previous day and week in a way that is congruent with their present pain intensity.