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Background: Yoga interventions need fidelity monitoring to standardize the trial process and ensure adherence. We examined fidelity measures of current yoga trials and developed a fidelity assurance process in a phase III randomized clinical trial addressing chemotherapy-induced peripheral neuropathy among cancer survivors. Methods: We qualitatively analyzed the fidelity monitoring components in published clinical trials on yoga therapy for chemotherapy-induced peripheral neuropathy through a literature search in PubMed from inception to February 2023. Leveraging fidelity measures for community-based, complex interventions and yoga therapy reporting guidelines, we developed an instructor/participant-oriented fidelity checking approach in an ongoing phase III trial evaluating yoga for improving chemotherapy-induced peripheral neuropathy in cancer survivors. Two researchers independently assessed 4 of 8 video recordings of yoga instructor-led training sessions (50%) and participant-kept home practice logs using a developed fidelity checklist. Results: None of the 4 eligible yoga trials specifically have intervention fidelity measures. We prospectively incorporated yoga instructor training, virtual delivery, and participant engagement strategies in the phase III trial protocol following guidelines. All trial yoga instructors were trained under study protocol to ensure compliance and participant engagement. There was high intervention fidelity in all instructor-led virtual sessions: an average of 100% adherence to class structure and three-thirds on specific skills. Assessment of participant adherence to the established home yoga protocol was 63%. Conclusion: Yoga trials for chemotherapy-induced peripheral neuropathy need adequate fidelity measures. Our study provides a feasible fidelity-monitoring approach to ensure trial intervention delivery and protocol adherence by instructors and participants in oncological settings.

Objectives: To assess measurement properties of the HIV Disability Questionnaire (HDQ) among adults with HIV in the United States. Methods: We administered the HDQ, World Health Organization Disability Assessment Schedule II (WHODAS 2.0), and a demographic questionnaire. For internal consistency reliability, we calculated Cronbach α and Kuder-Richardson-20 (KR-20) statistics for disability and episodic scores, respectively (≥0.80 acceptable). For test–retest reliability, we calculated intraclass correlation coefficients (>0.8 acceptable). For construct validity, we tested 15 a priori hypotheses assessing correlations between HDQ and WHODAS 2.0 scores. Results: Of the 128 participants, the majority were males (68%), median age 51 years, taking antiretroviral therapy (96%). Cronbach α ranged from 0.88 (social inclusion) to 0.93 (uncertainty). The KR-20 ranged from 0.86 (cognitive) to 0.96 (uncertainty). Intraclass correlation coefficients ranged from 0.88 (physical, cognitive, social inclusion) to 0.92 (mental–emotional). Of the 15 hypotheses, 13 (87%) were confirmed. Conclusions: The HDQ demonstrates internal consistency reliability, test–retest reliability, and construct validity when administered to a sample of adults with HIV in the United States.

Objective . Chemotherapy-induced peripheral neuropathy (CIPN) syndrome causes significant pain as an adverse effect of treatment, with few nonpharmacological interventions tested. A somatic yoga and meditation (SYM) intervention on functional outcomes and quality of life (QOL) was investigated. Design and methods . Individuals diagnosed with CIPN were enrolled in an open-label, single-arm, mixed-methods feasibility trial. Participants and Setting . In an outpatient rehabilitation center, ten participants with median age 64.4 years (47-81) attended 61% of the sessions with no adverse events. Intervention . SYM twice a week for 8 weeks for 1.5 hours, with home program and journaling. Main outcome measures . Primary functional outcomes included Sit and Reach (SR), Functional Reach (FR), and Timed Up and Go (TUG). Self-reported Patient Neurotoxicity Questionnaire (PNQ) and Functional Assessment of Cancer Therapy—Neurotoxicity (FACT-GOG-NTX) were secondary CIPN outcomes. Biomarkers included salivary cortisol (stress) and bioesthesiometer (vibration). Results: Quantitative findings . Significant improvements were found in flexibility (SR; P = .006); balance (FR; P = .001) and fall risk (TUG; P = .004). PNQ improved significantly ( P = .003) with other measures improving non-significantly. Qualitative findings . Five themes emerged: (1) vacillation of CIPN pain perception over time; (2) transferability of skills to daily activities; (3) improvement in physical function; (4) perceived relaxation as an effect of SYM; and (5) group engagement provided a social context for not feeling isolated with CIPN. Conclusion . Preliminary data suggest SYM may improve QOL, flexibility, and balance in cancer survivors with CIPN, with a fully powered randomized controlled trial indicated. Trial registration: NCT03786055

Persons living with HIV (PLHIV) may experience disability. We compared disability among PLHIV in the United States and South Africa and investigated associations with health and demographic characteristics. Secondary analysis of cross-sectional data using medical records and questionnaires including the World Health Organization Disability Assessment Schedule (WHO-DAS) 2.0 12-item version (range: 0-36, with higher scores indicative of more severe disability). Between-country differences for the presence of disability were assessed with logistic regression and differences in severity using multiple regression. Eighty-six percent of US participants reported disability, compared to 51.3% in South Africa. The mean WHO-DAS score was higher in the United States (12.09 ± 6.96) compared to South Africa (8.3 ± 6.27). Participants with muscle pain, depression, or more years since HIV diagnosis were more likely to report disability. Being female or depressed was associated with more severity. Being adherent to anti-retroviral therapy (ART) and employed were associated with less severity. Because muscle pain and depression were predictive factors for disability, treatment of those problems may help mitigate disability in PLHIV.