Development of the CLARIFY (CheckList stAndardising the Reporting of Interventions For Yoga) guidelines: a Delphi study

Background: The use of yoga as a therapeutic modality is increasing; however, a lack of transparent intervention reporting is restricting the dissemination and implementation of yoga research into clinical and community practice. The aim of this study was to develop a yoga-specific reporting guideline as an extension to existing reporting guidelines for randomised controlled trials, observational studies and case reports. Methods: Recognised international stakeholders in the design and conduct of yoga research were invited to contribute to the electronic Delphi survey. A four-round Delphi was conducted, whereby panellists rated selected items for their importance in the inclusion of yoga reporting guidelines, according to a 5-step Likert scale. A priori consensus for item inclusion was agreement of items as ‘Very important’ or ‘Extremely important’ by ≥80% of panellists. Non-consensus items were forwarded to subsequent rounds for re-rating. Results: 53 experts in yoga research from 11 countries, primarily identifying as researchers (50%), allied health professionals (18.8%) and yoga professionals (12.5%), consented to participate in the Delphi. Of these, 48 completed Round 1 (91%), 43 completed Round 2 (81%), 39 completed Round 3 (74%) and 32 completed Round 4 (60%). Panellists reached consensus for inclusion on 21 items, grouped under 10 domains reflective of more generic intervention-based guidelines. Conclusions: The consensus-based 21-item CLARIFY (CheckList stAndardising the Reporting of Interventions For Yoga) checklist provides a minimum reporting template for researchers across a range of methodology designs. Use of these yoga-specific guidelines, in conjunction with the CLARIFY explanation and elaboration guidelines, will standardise the minimum level of detail required for transparent yoga intervention, facilitating the replication, dissemination and implementation of yoga research. Ongoing research will assess the uptake and impact of CLARIFY, to ensure these guidelines retain their relevance to the internationally growing field of yoga research

CLARIFY 2021: explanation and elaboration of the Delphi-based guidelines for the reporting of yoga research

Background: Reporting of yoga research often lacks the detail required for clinical application, study replication, summary research and comparative effectiveness studies. Methods: To improve the transparency of reporting yoga interventions, and building on the development of previous reporting guidelines, a group of international yoga research stakeholders developed the consensus-based CheckList stAndardising the Reporting of Interventions For Yoga (CLARIFY) guidelines. Results: The 21-item CLARIFY checklist outlines the minimum details considered necessary for high-quality reporting of yoga research. This paper provides a detailed explanation of each of the 21 items of the CLARIFY checklist, together with model examples of how to integrate each item into publications of yoga research. The CLARIFY guideline serves as an extension for existing research reporting guidelines, and is flexible for use across all study designs. Conclusion: We strongly encourage the uptake of these reporting guidelines by researchers and journals, to facilitate improvements in the transparency and utility of yoga research

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

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

Visually impaired students performing tree pose.

<p>Visually impaired students performing tree pose.</p

Ashtanga-Based Yoga Therapy Increases the Sensory Contribution to Postural Stability in Visually-Impaired Persons at Risk for Falls as Measured by the Wii Balance Board: A Pilot Randomized Controlled Trial

<div><p>Objective</p><p>Persons with visual impairment (VI) are at greater risk for falls due to irreparable damage to visual sensory input contributing to balance. Targeted training may significantly improve postural stability by strengthening the remaining sensory systems. Here, we evaluate the Ashtanga-based Yoga Therapy (AYT) program as a multi-sensory behavioral intervention to develop postural stability in VI.</p><p>Design</p><p>A randomized, waitlist-controlled, single-blind clinical trial</p><p>Methods</p><p>The trial was conducted between October 2012 and December 2013. Twenty-one legally blind participants were randomized to an 8-week AYT program (n = 11, mean (SD) age = 55(17)) or waitlist control (n=10, mean (SD) age = 55(10)). AYT subjects convened for one group session at a local yoga studio with an instructor and two individual home-based practice sessions per week for a total of 8 weeks. Subjects completed outcome measures at baseline and post-8 weeks of AYT. The primary outcome, absolute Center of Pressure (COP), was derived from the Wii Balance Board (WBB), a standalone posturography device, in 4 sensory conditions: firm surface, eyes open (EO); firm surface, eyes closed (EC); foam surface, EO; and foam surface, EC. Stabilization Indices (SI) were computed from COP measures to determine the relative visual (SI_firm, SI_foam), somatosensory (SI_EO, SI_EC) and vestibular (SI_V, i.e., Foam_EC vs. Firm_EO) contributions to balance. This study was not powered to detect between group differences, so significance of pre-post changes was assessed by paired samples t-tests within each group.</p><p>Results</p><p>Groups were equivalent at baseline (all p > 0.05). In the AYT group, absolute COP significantly increased in the Foam_EO(t(8) = -3.66, p = 0.01) and Foam_EC (t(8) = -3.90, p = 0.01) conditions. Relative somatosensory SI_EO (t(8) = -2.42, p = 0.04) and SI_EC (t(8) = -3.96, p = 0.01), and vestibular SI_V (t(8) = -2.47, p = 0.04) contributions to balance increased significantly. As expected, no significant changes from EO to EC conditions were found indicating an absence of visual dependency in VI. No significant pre-post changes were observed in the control group (all p > 0.05).</p><p>Conclusions</p><p>These preliminary results establish the potential for AYT training to develop the remaining somatosensory and vestibular responses used to optimize postural stability in a VI population.</p><p>Trial Registration</p><p><a href="http://www.clinicaltrials.gov" target="_blank">www.ClinicalTrials.gov</a><a href="http://www.clinicaltrials.gov/ct2/show/NCT01366677" target="_blank">NCT01366677</a></p></div

Participant Flow Chart.

<p>Participant Flow Chart.</p

Demographic and Visual History.

<p>OS, Left Eye; OD, Right Eye; CF, Counting Fingers; HM, Hand Motion; LP, Light Perception; BLP, Bare Light Perception; NLP, No Light Perception</p><p>Demographic and Visual History.</p

Stability Index Formula and Description.

<p>Note: Under ideal conditions, all sensory systems work in concert therefore some redundancy exists. COP in conditions of increasing difficulty are measured. To determine the Stability Index, the visual and/or somatosensory systems are experimentally disrupted to derive the relative contribution of each system, however, the vestibular system is never experimentally disrupted. This protocol has been validated and has been used consistently for clinical assessment.</p><p>Stability Index Formula and Description.</p