Background. Axillary lymph node dissection (ALND) can be omitted in clinically node-negative patients with one or two sentinel lymph node (SLN) macrometastases who receive adjuvant radiotherapy, but safe implementation in resource-limited regions depends on local radiotherapy capacity. At a regional hospital in Fukushima, we quantified the residual nodal disease left by omitting completion ALND and the consequences of omitting intraoperative SLN diagnosis. Methods. In this single-centre retrospective study, residual nodal disease was assessed in clinically node-negative patients undergoing completion ALND for intraoperatively confirmed SLN macrometastasis before omission (n = 32). After omission, all clinically node-negative SLN-biopsy patients (n = 159) were reviewed for delayed completion ALND and adequacy of adjuvant axillary treatment, defined per AMAROS and SENOMAC as completion ALND or axillary-covering regional nodal irradiation (RNI). Analyses were descriptive. Results. Completion ALND removed additional metastatic nodes in 15 of 32 breasts (46.9%; three or more in 21.9%; mean 1.8). After omission, macrometastasis was identified in 18/159 patients (11.3%); 16 with two or fewer macrometastases had ALND omitted and only 2 with three required delayed completion ALND. Of the 18 macrometastasis-positive patients, 9 did not receive axillary-covering RNI (potentially undertreated): 4 owing to patient factors and 5 to insufficient surgical-radiation oncology coordination. Conclusions. Residual nodal disease is common but, consistent with ACOSOG Z0011 and SENOMAC, does not make omission of ALND inappropriate; it underscores that omission is justified only with adequate regional radiotherapy. Omitting intraoperative diagnosis rarely required reoperation. The principal challenge is care coordination to ensure axillary radiotherapy coverage, especially in resource-limited regions.
Purpose This study evaluated the psychometric properties of the Nepali version of the 20-item Global INSPIRE among adults in Nepal, with particular attention to the relative endorsement and structure of the CHIME recovery domains. Methods Data from 517 adults were analysed. Psychometric evaluation included item distributions, floor and ceiling effects, internal consistency using Cronbach’s alpha and McDonald’s omega, and confirmatory factor analysis using a robust categorical estimator. Construct validity was examined through associations with personal recovery, self-compassion, psychological distress, and meta-emotion dysregulation. Domain endorsement was examined using within-person parametric and non-parametric comparisons. Results The Nepali Global INSPIRE demonstrated excellent total-score reliability (α = 0.921; ω = 0.923). The correlated five-factor model showed acceptable to good fit (CFI = 0.965; TLI = 0.958; RMSEA = 0.066; SRMR = 0.044). Bifactor indices indicated a strong general recovery-priority factor (ECV = 0.744; ωH = 0.900). Hope, Identity, Meaning, and Empowerment were highly correlated (r ≥ 0.844), whereas Connectedness correlated more moderately with the other domains and showed greater item variability. Domain endorsement differed significantly (p < 0.001), with Hope having the highest mean and Connectedness the lowest. Associations with the external measures were in the expected directions and supported construct validity. Conclusion The Nepali Global INSPIRE showed strong internal consistency and acceptable structural validity among adults in Nepal. The findings support interpretation of the total score, while domain-specific scores require greater caution. Further evaluation is needed in clinical populations and other community samples.
Background: Financial relationships between the medical device industry and healthcare providers have raised concerns about conflicts of interest (COIs). However, these relationships remain poorly characterized in Japan, despite the country’s large medical device market, which was valued at ¥4.41 trillion ($33.3 billion) as of 2021. This study examined the scale, composition, and temporal patterns of payments from the medical device industry and evaluated current transparency practices. Methods: We analyzed publicly disclosed payment data from 117 medical device companies predominantly affiliated with the Japan Federation of Medical Devices Associations (JFMDA) from 2019 to 2022. Payment categories included research and development, academic research support, lecture and consulting fees, information-provision–related expenses, and other payments to healthcare professionals (HCPs) and healthcare organizations (HCOs). We assessed payment magnitude, category composition, company-level concentration, year-to-year changes, and disclosure transparency using an adapted proforma previously applied to European pharmaceutical payment data. Results: Total payments amounted to $942.3 million over four years. Academic research support expenses constituted the largest share (33.0%, $310.7 million), followed by information provision–related expenses (25.2%, $237.5 million) and research and development expenses (21.7%, $204.8 million). Payments were highly concentrated, with the top 10 companies accounting for approximately 58% of total amounts. Using 2019 as the pre-pandemic baseline, total payments declined by 30.2% in 2020 and remained below pre-pandemic levels in 2021 (−24.0%), before partially recovering in 2022 (−11.6%). Category-specific trends diverged during the pandemic, with consulting, lecturing, and manuscript-related fees exceeding pre-pandemic levels by 2022, while information provision–related expenses remained substantially reduced. Transparency was limited: 78.6% of companies disclosed payment data with limited standardization, searchability, or data download functionality. Conclusion: This multi-year analysis revealed substantial financial relationships between the medical device industry and healthcare stakeholders in Japan, alongside persistent shortcomings in transparency of disclosures. Introducing legally mandated disclosure would improve oversight and align Japan’s system with international best practices.
