Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines

BackgroundAcupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines, randomized controlled trials (RCTs) generally report intervention details and acupoint options, but fidelity to acupuncture interventions, critical to reliability in intervention research, is rarely reported.MethodsACUITY is an NCCIH-funded, multi-site feasibility RCT of acupuncture in 3 EDs (Cleveland, Nashville, and San Diego). ACUITY acupuncturists were trained in study design, responsive acupuncture manualization protocol, logistics and real-time recording of session details via REDCap forms created to track fidelity.ResultsAcross 3 recruiting sites, 79 participants received acupuncture: 51 % women, 43 % Black/African American, with heterogeneous acute pain sites at baseline: 32 % low back, 22 % extremity, 20 % abdominal, 10 % head. Pragmatically, participants were treated in ED common areas (52 %), private rooms (39 %), and semi-private rooms (9 %). Objective tracking found 98 % adherence to the six components of the acupuncture manualization protocol: staging, number of insertion points (M = 13.2, range 2-22), needle retention time (M = 23.5 min, range 4-52), session length (M = 40.3 min, range 20-66), whether general recommendations were provided and completion of the session form.ConclusionTo the best of our knowledge, this is the first RCT to assess and report fidelity to an acupuncture protocol. Fidelity monitoring will be fundamental for ACUITY2, which would be a future definitive, multi-site RCT. Furthermore, we recommend that fidelity to acupuncture interventions be added to CONSORT and STRICTA reporting guidelines in future RCTs.Protocol registrationThe protocol of this study is registered at clinicaltrials.gov: NCT04880733

Livelihood Structure Transformation of Rural Communities: A Livelihood System Analysis of the Dayak Punan of Berau District, East Kalimantan, Indonesia

Forests are not only the main source of livelihood but are also at the centre of the culture of hunter-gatherer communities. Changing interaction with the outside world and increasing outside influence as well as reduced access to the forest has initiated a community livelihood systems transformation. Here we present a typology describing the level of transformation of Dayak Punan communities in Berau district in the East Kalimantan province of Indonesia. Based on a case study using a mixed methods approach in five communities we explore how hunter-gatherer communities slowly but surely are being transformed from nomadic to sedentary by external influences and circumstances and has become increasingly involved in the market economy and dependent on cash transactions. Resettlement, expansion of large-scale economic activity and community empowerment programs serves as driving external factors that replace high reliance on forest income with new cash-based livelihood opportunities. The livelihoods transformation provides hunter-gatherer communities access to higher material welfare but simultaneously increases economic inequality and reduces livelihoods resilience to shocks. Keywords: Dayak Punan, hunter-gatherers, livelihood structures, cultural ecology, rural livelihood system dilemma.

Comparative effectiveness of acupuncture in sham-controlled trials for knee osteoarthritis: A systematic review and network meta-analysis

Objectives: Although many trials have assessed the effect of acupuncture on knee osteoarthritis (KOA), its efficacy remains controversial. Sham acupuncture techniques are regarded as representative control interventions in acupuncture trials and sometimes incorporate the use of sham devices (base units) to support a non-penetrating needle. To achieve successful blinding, these trials also use acupuncture base units in the verum acupuncture group. Base units are not used in real-world clinical settings. We aimed to assess the effect sizes of verum and sham acupuncture for KOA in sham-controlled trials with or without base units. Methods: A total of 10 electronic databases for randomized controlled trials (RCTs) comparing the efficacy of verum manual acupuncture and sham acupuncture for the treatment of KOA were searched for articles published before April 12, 2022. The primary outcome was pain intensity, and the secondary outcomes included physical function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMDs) with 95% confidence intervals (95% CIs). The risk of bias was assessed using the Cochrane risk of bias tool, and publication bias was evaluated using a funnel plot and Egger’s test. The quality of evidence for estimates was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Results: Fifteen RCTs were included. There was generally a low risk of bias except for the difficulty in blinding acupuncture therapists (performance bias). Compared to verum acupuncture in sham-controlled trials using base units, verum acupuncture in sham-controlled trials without base units was more effective for improving pain (SMD −0.56, 95% CI −1.09 to −0.03) and function (SMD −0.73, 95% CI −1.36 to −0.10) in KOA. The quality of evidence for network estimates was moderate to low due to the risk of bias and imprecision. Conclusion: These findings suggest that verum acupuncture in different types of sham-controlled trials has different effect sizes for KOA. Because base units are not used in clinical settings, the results of verum acupuncture in sham-controlled trials with base units need to be interpreted carefully

Group Acupuncture Therapy With Yoga Therapy for Chronic Neck, Low Back, and Osteoarthritis Pain in Safety Net Setting for an Underserved Population: Design and Rationale for a Feasibility Pilot

Chronic pain is prevalent in the United States, with impact on physical and psychological functioning as well as lost work productivity. Minority and lower socioeconomic populations have increased prevalence of chronic pain with less access to pain care, poorer outcomes, and higher risk of fatal opioid overdose. Acupuncture therapy is effective in treating chronic pain conditions including chronic low back pain, neck pain, shoulder pain, and knee pain from osteoarthritis. Acupuncture therapy, including group acupuncture, is feasible and effective, and specifically so for underserved and diverse populations at risk for health outcome disparities. Acupuncture therapy also encourages patient engagement and activation. As chronic pain improves, there is a natural progression to want and need to increase activity and movement recovery. Diverse movement approaches are important for improving range of motion, maintaining gains, strengthening, and promoting patient engagement and activation. Yoga therapy is an active therapy with proven benefit in musculoskeletal pain disorders and pain associated disability. The aim of this quasi-experimental pilot feasibility trial is to test the bundling of these 2 effective care options for chronic pain, to inform both the design for a larger randomized pragmatic effectiveness trial as well as implementation strategies across underserved settings

Theoretical analysis of the role of chromatin interactions in long-range action of enhancers and insulators

Long-distance regulatory interactions between enhancers and their target genes are commonplace in higher eukaryotes. Interposed boundaries or insulators are able to block these long distance regulatory interactions. The mechanistic basis for insulator activity and how it relates to enhancer action-at-a-distance remains unclear. Here we explore the idea that topological loops could simultaneously account for regulatory interactions of distal enhancers and the insulating activity of boundary elements. We show that while loop formation is not in itself sufficient to explain action at a distance, incorporating transient non-specific and moderate attractive interactions between the chromatin fibers strongly enhances long-distance regulatory interactions and is sufficient to generate a euchromatin-like state. Under these same conditions, the subdivision of the loop into two topologically independent loops by insulators inhibits inter-domain interactions. The underlying cause of this effect is a suppression of crossings in the contact map at intermediate distances. Thus our model simultaneously accounts for regulatory interactions at a distance and the insulator activity of boundary elements. This unified model of the regulatory roles of chromatin loops makes several testable predictions that could be confronted with \emph{in vitro} experiments, as well as genomic chromatin conformation capture and fluorescent microscopic approaches.Comment: 10 pages, originally submitted to an (undisclosed) journal in May 201

Different Outcomes According to Needling Point Location Used in Sham Acupuncture for Cancer-Related Pain: A Systematic Review and Network Meta-Analysis

Numerous acupuncture studies have been conducted on cancer-related pain; however, its efficacy compared to sham acupuncture remains controversial. We confirmed whether the outcome of acupuncture differs according to the needling points of sham acupuncture for cancer-related pain. We searched 10 databases on 23 May 2023 to screen acupuncture trials using sham acupuncture or waiting list as controls for cancer-related pain. Sham acupuncture was classified into two types, depending on whether the needling was applied at the same locations as verum acupuncture (SATV) or not (SATS). A network meta-analysis (NMA) was performed on the basis of a frequentist approach to assess pain severity. Eight studies (n = 574 participants) were included in the review, seven of which (n = 527 participants) were included in the NMA. The pain severity was not significantly different between SATV and verum acupuncture, but verum acupuncture significantly improved pain severity compared to SATS. The risk of bias affecting the comparisons between the verum and sham acupuncture was generally low. Previous acupuncture trials for cancer-related pain showed differing outcomes of sham and verum acupuncture, depending on the needling points of sham acupuncture. The application of SATV cannot be considered a true placebo, which leads to an underestimation of the efficacy of verum acupuncture.publishedVersio

Barriers and Facilitators to Implementing Bundled Acupuncture and Yoga Therapy to Treat Chronic Pain in Community Healthcare Settings: A Feasibility Pilot

Objective: To identify factors associated with implementing bundled group acupuncture and yoga therapy (YT) to treat underserved patients with chronic pain in community health center (CHC) settings. This is not an implementation science study, but rather an organized approach for identification of barriers and facilitators to implementing these therapies as a precursor to a future implementation science study. Design: This study was part of a single-arm feasibility trial, which aimed to test the feasibility of bundling GA and YT for chronic pain in CHCs. Treatment outcomes were measured before and after the 10-week intervention period. Implementation feasibility was assessed through weekly research team meetings, weekly yoga provider meetings, monthly acupuncture provider meetings, and weekly provider surveys. Settings: The study was conducted in New York City at two Montefiore Medical Group (MMG) sites in the Bronx, and one Institute for Family Health (IFH) site in Harlem. Subjects: Participants in the feasibility trial were recruited from IFH and MMG sites, and needed to have had lower back, neck, or osteoarthritis pain for \u3e 3 months. Implementation stakeholders included the research team, providers of acupuncture and YT, referring providers, and CHC staff. Results: Implementation of these therapies was assessed using the Consolidated Framework for Implementation Research. We identified issues associated with scheduling, treatment fidelity, communication, the three-way disciplinary interaction of acupuncture, yoga, and biomedicine, space adaptation, site-specific logistical and operational requirements, and patient-provider language barriers. Issues varied as to their frequency and resolution difficulty. Conclusions: This feasibility trial identified implementation issues and resolution strategies that could be further explored in future implementation studies. Clinical Trial Registration No.: NCT04296344

Individual vs. Group Delivery of Acupuncture Therapy for Chronic Musculoskeletal Pain in Urban Primary Care-a Randomized Trial

BACKGROUND: Acupuncture has been shown to be effective for the treatment of chronic musculoskeletal back, neck, and osteoarthritis pain. However, access to acupuncture treatment has been limited in medically underserved and low-income populations. OBJECTIVE: Acupuncture therapy delivered in groups could reduce cost and expand access. We compared the effectiveness of group versus individual acupuncture for pain and function among ethnically diverse, low-income primary care patients with chronic musculoskeletal pain. DESIGN: This was a randomized comparative effectiveness non-inferiority trial in 6 Bronx primary care community health centers. Participants with chronic ( \u3e 3 months) back, neck, or osteoarthritis pain were randomly assigned to individual or group acupuncture therapy for 12 weeks. PARTICIPANTS: Seven hundred seventy-nine participants were randomized. Mean age was 54.8 years. 35.3% of participants identified as black and 56.9% identified as Latino. Seventy-six percent were Medicaid insured, 60% reported poor/fair health, and 37% were unable to work due to disability. INTERVENTIONS: Participants received weekly acupuncture treatment in either group or individual setting for 12 weeks. MAIN MEASURES: Primary outcome was pain interference on the Brief Pain Inventory at 12 weeks; secondary outcomes were pain severity (BPI), physical and mental well-being (PROMIS-10), and opiate use. Outcome measures were collected at baseline, 12 and 24 weeks. KEY RESULTS: 37.5% of individual arm and 30.3% in group had \u3e 30% improvement in pain interference (d = 7.2%, 95% CI - 0.6%, 15.1%). Non-inferiority of group acupuncture was not demonstrated for the primary outcome assuming a margin of 10%. In the responder analysis of physical well-being, 63.1% of individual participants and 59.5% of group had clinically important improvement at 12 weeks (d = 3.6%, 95% CI - 4.2%, 11.4%). CONCLUSIONS: Both individual and group acupuncture therapy delivered in primary care settings reduced chronic pain and improved physical function at 12 weeks; non-inferiority of group was not shown. TRIAL REGISTRATION: Clinicaltrials.gov # NCT02456727

Transformation of Livelihood Institutions and the Organization of Punan Dayak Communities in Berau District, East Kalimantan

The social-ecological system of forests are changing with increasing modernity and has prompted the forest-dependent Dayak Punan community to adapt to the new conditions. In addition to changing livelihood structures, the institutional setting and social norms of subsistence strategies are also undergoing adaptation process. Therefore, the main question of this research is what institutional transformation are occuring of livelihoods in the Punan Dayak community as an adaptation to the modernity that entering the region where they live? A qualitative approach supported by quantitative data is used to obtain data and information in four Punan Dayak communities in Berau District, East Kalimantan. The level of dependence of Punan Dayak households on forests is declining, marked by increasing dominance of non-forest livelihood sources (i.e. wages and business). Institutions guiding the interaction between communities and the forest as a source of livelihoods, has also changed. In the four communities studied, the process of institutional transformation has produced four types of institutional organisations of subsistence vs. income dependent livelihoods, namely: subsistence-collective (livelihood activities to meet household food carried out in groups), subsistence-collective to commercial-contractual transition, commercial-collective (a livelihood activity aimed at earning money coordinated by the institution at the community level), and commercial-contractual (livelihood activities aimed at earning money/profits through formal working relationships individually or in groups)

Identifying the favored mutation in a positive selective sweep.

Most approaches that capture signatures of selective sweeps in population genomics data do not identify the specific mutation favored by selection. We present iSAFE (for "integrated selection of allele favored by evolution"), a method that enables researchers to accurately pinpoint the favored mutation in a large region (∼5 Mbp) by using a statistic derived solely from population genetics signals. iSAFE does not require knowledge of demography, the phenotype under selection, or functional annotations of mutations