Using Serum Metabolomic Signatures to Investigate Effects of Acupuncture on Pain-Fatigue-Sleep Disturbance in Breast Cancer Survivors.

Background/objectives: Acupuncture is an efficacious integrative therapy for treating pain, fatigue, and sleep disturbance (the psychoneurological symptom cluster) in breast cancer survivors. However, the mechanisms underlying its effects remain unclear, and related metabolomics studies are limited. This study aimed to examine serum metabolite changes after acupuncture and their relationships to symptom improvement.

Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 32 embedded pragmatic clinical trials, and many of these trials rely on data from the electronic health record (EHR) to monitor outcomes and/or use functionality provided by the EHR platform to deliver the intervention. Given the complexity and dynamic nature of EHR systems, study teams have encountered challenges in use of the EHR for these purposes, including challenges related to local implementation of trial interventions, rapid technology evolution, EHR updates, and transitions in EHR systems. In this article, we share case examples and lessons learned, and suggest that teams need to be aware of-and perhaps proactively investigate- possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and safety of pragmatic clinical trials.

Special Section on Patient-Reported Outcomes and Informatics: Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 31 embedded pragmatic clinical trials, and many of these trials use patient-reported outcome measures (PROMs) to provide valuable information about their patients' health and wellness. Often these trials enroll medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, or rural or frontier communities. In this series of trial case reports, we provide lessons learned about collecting PROMs in these populations.

Impact of Acupuncture on Human Metabolomic Profiles: A Systematic Review.

Background/objectives: Metabolomics provides insights into the biological underpinnings of disease development and treatment. This systematic review investigated the impact of acupuncture on metabolite levels and associated metabolic pathways using a metabolomic approach.

Methods: Five databases (i.

Expectancy Effect of Acupuncture on Cancer-Related Outcomes: A Systematic Review.

Problem Identification: Previous reviews have reported the efficacy of acupuncture in managing cancer-related symptoms. However, there is a lack of comprehensive reviews examining how patients' expectancy regarding acupuncture influences treatment outcomes in the context of cancer survivorship.

Literature Search: 9 databases were searched for articles published through August 2023.

2021 American Society of Acupuncturists Survey on Acupuncturists' Backgrounds, Interests, and Attitudes toward Conducting Research.

Background: It has been previously reported that acupuncturists internationally can be reluctant to engage in acupuncture research.

Purpose: Assess the beliefs and attitudes of acupuncturists in the United States toward research, along with exploring their backgrounds and interests regarding conducting acupuncture research. We aimed to capture any previous experiences in conducting research, applying research findings in their clinical practice, and their ideas on how research could be used to promote the profession.

Fighting for menstrual equity through period product pantries.

Background: Menstruators facing period poverty often struggle with menstrual hygiene and waste management, which can result in harmful short- and long-term health outcomes such as urinary tract infections, yeast infections, and vulvar contact dermatitis. Research indicates that 42% of menstruators in the United States have difficulty affording period products. Traditional methods of distributing period products through social services may unintentionally undermine menstruators' agency, leading to disempowerment and inefficient resource allocation.

Trajectory of Postpartum Cervical Remodeling in Women Delivering Full-Term and Spontaneous Preterm: Sensitivity to Quantitative Ultrasound Biomarkers.

Objective: Women with a history of spontaneous preterm birth (sPTB) face an increased risk of recurrence. Yet, the factors contributing to the increased risk are unknown, hampering the development of targeted interventions. Noninvasive quantitative ultrasound (QUS) has been validated in the characterization of cervical tissue and has the potential to provide information about postpartum cervical remodeling.

Barriers and Facilitators to Integrating Acupuncture into the U.S. Health Care System: A Scoping Review.

Acupuncture is a widely practiced complementary and integrative health modality that has multiple clinical applications. The use of acupuncture in the United States is rapidly increasing. Although studies have shown the efficacy and effectiveness of acupuncture for various ailments, the integration of acupuncture into the U.

Integration of a Community Opioid Treatment Program Into a Federally Qualified Health Center.

Objectives: With the increasing rates of opioid overdose deaths in the United States, barriers to treatment access for patients seeking medications for opioid use disorder (OUD), and challenges of initiating buprenorphine in patients who use fentanyl, it is essential to explore novel approaches to expanding access to methadone treatment. An opioid treatment program (OTP) and a federally qualified health center (FQHC) partnered to develop and implement an innovative integrated methadone and primary care treatment model. The process for integrating an OTP and FQHC to provide methadone treatment in the primary care setting will be discussed.

Lack of Diversity in Research on Females with Ehlers-Danlos Syndromes: Recruitment Protocol for a Quantitative Online Survey.

Background: Ehlers-Danlos syndromes (EDS) are a group of connective tissue disorders caused by fragile lax collagen. Current EDS research lacks racial and ethnic diversity. The lack of diversity may be associated with the complexities of conducting a large international study on an underdiagnosed condition and a lack of EDS health care providers who diagnose and conduct research outside of the United States and Europe.

Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 27 embedded pragmatic clinical trials, and many of the studies collect patient reported outcome measures as primary or secondary outcomes. Study teams have encountered challenges in the collection of these measures, including challenges related to competing health care system priorities, clinician's buy-in for adoption of patient-reported outcome measures, low adoption and reach of technology in low resource settings, and lack of consensus and standardization of patient-reported outcome measure selection and administration in the electronic health record. In this article, we share case examples and lessons learned, and suggest that, when using patient-reported outcome measures for embedded pragmatic clinical trials, investigators must make important decisions about whether to use data collected from the participating health system's electronic health record, integrate externally collected patient-reported outcome data into the electronic health record, or collect these data in separate systems for their studies.

Feasibility of implementing acupuncture in medically underserved breast cancer survivors (FAB): A protocol.

Nearly 94% of breast cancer survivors experience one or more symptoms or side effects during or after endocrine therapy. Joint pain, hot flashes, sleep disturbance, fatigue, depression, and anxiety are the most common concurrent symptoms, some of which can persist for 5 to 10 years. Acupuncture is a holistic modality that addresses multiple symptoms and side effects in a single therapy.

Equity and bias in electronic health records data.

Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and have the potential to increase knowledge about the effectiveness of interventions under real world conditions. However, many pragmatic trials rely on data from the electronic health record (EHR) data, which are subject to bias from incomplete data, poor data quality, lack of representation from people who are medically underserved, and implicit bias in EHR design. This commentary examines how the use of EHR data might exacerbate bias and potentially increase health inequities.

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain.

This study aimed to explore perspectives of people living with sickle cell disease (SCD) and SCD clinic providers and staff about the use of acupuncture and guided relaxation for treating chronic SCD pain. Data obtained were to inform an implementation blueprint for an effectiveness implementation clinical trial (GRACE Trial) testing whether acupuncture or guided relaxation reduces chronic pain when compared with usual care. Qualitative research design.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems.

Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care.

Exploration of Japanese women seeking acupuncture for menopausal symptoms: a preliminary study.

Menopausal symptoms may affect every aspect of women's lives. There are no studies that examine the rate of menopausal women who seek acupuncture for their complaints, particularly muscle stiffness and aches, headaches, fatigue, and depression, which are indications for acupuncture, in Japan. The aim of this preliminary study was to explore the rate of Japanese women in menopause who sought acupuncture for the treatment of their general complaints, and to what extent acupuncture reduced their menopausal symptoms.

Evaluation and Treatment of Vulvodynia: State of the Science.

Vulvodynia affects 7% of American women, yet clinicians often lack awareness of its presentation. It is underdiagnosed and often misdiagnosed as vaginitis. The etiology of vulvodynia remains unknown, making it difficult to identify or develop effective treatment methods.

Protocol for double-blind RCT of acupuncture for vulvodynia.

Background: Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia.

Feasibility of Acupuncture and Exploration of Metabolomic Alterations for Psychoneurological Symptoms Among Breast Cancer Survivors.

Objective: Approximately 24-68% of breast cancer survivors report co-occurring psychoneurological symptoms of pain, fatigue, sleep disturbance, depression, and anxiety during and after cancer treatment. This study aimed to assess the feasibility and acceptability of acupuncture for the treatment of multiple psychoneurological symptoms among breast cancer survivors and explore metabolomic changes before and after acupuncture.

Methods: We conducted a single-arm, prospective pilot study of breast cancer survivors with at least two moderate to severe psychoneurological symptoms (>3 on a 0-10 scale).

Tryptophan and Kynurenine Pathway Metabolites and Psychoneurological Symptoms Among Breast Cancer Survivors.

Background: Among breast cancer survivors, pain, fatigue, depression, anxiety, and sleep disturbance are common psychoneurological symptoms that cluster together. Inflammation-induced activation of the tryptophan-kynurenine metabolomic pathway may play an important role in these symptoms.

Aims: This study investigated the relationship between the metabolites involved in the tryptophan-kynurenine pathway and psychoneurological symptoms among breast cancer survivors.