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Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial-the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 tr

Por: Shimomura · M. · Ishikawa · S. · Miguchi · M. · Shinozaki · K. · Ikeda · S. · Kobayashi · H. · Nakahara · M. · Sumitani · D. · Shimizu · W. · Kohyama · M. · Saito · Y. · Mukai · S. · Hirata · Y. · Kochi · M. · Shimizu · Y. · Takakura · Y. · Yoshimitsu · M. · Kodama · S. · Uegami · S. · Yano
Background

Oxaliplatin, a key drug in the treatment of colorectal cancer (CRC), can cause oxaliplatin-induced peripheral neuropathy (OIPN) in a dose-dependent manner. These symptoms can severely affect daily life, and chronic OIPN often limits treatment continuation because of its correlation with the cumulative dose of oxaliplatin. Currently, effective preventive measures are unavailable. However, surgical glove compression therapy may reduce paclitaxel-induced neuropathy, suggesting its potential in preventing OIPN.

Methods

This multicentre, randomised, open-label, phase II/III trial evaluates surgical glove compression therapy to investigate the possible preventive effects of OIPN in patients with CRC receiving adjuvant capecitabine plus oxaliplatin chemotherapy. Patients with stage III CRC undergoing curative surgery will be enrolled and randomised into two groups. The intervention group will wear two layers of tight-fitting surgical gloves from 30 min before to 30 min after oxaliplatin infusion, whereas the control group will receive standard care. The primary endpoint is the incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CIPN) based on the Common Terminology Criteria for Adverse Events criteria. Secondary endpoints include quality of life assessments (Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item), duration and extent of OIPN as assessed using the Debiopharm Neurologic and Sensory Toxicity Criteria, chemotherapy completion rates, and adverse events. To detect a significant reduction in the incidence of CIPN, 170 patients will be enrolled (36% in the control group vs 15% in the intervention group). The planned case enrolment period is from 1 November 2024 to 31 October 2026.

Ethics and dissemination

This trial was approved by the Institutional Review Board of Hiroshima University, Japan (approval no. CRB2024-0008), and has been registered with the Japan Registry of Clinical Trials (jRCTs062240066). The results of this study will be submitted for publication in a peer-reviewed journal and shared with the scientific community at international conferences.

Trial registration number

jRCTs062240066

Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya

Por: Takaizumi · Y. · Kinoti · J. · Hikone · M. · Orina · F. · Meme · H. · Ong'ango · J. R. · Muriithi · B. · Mueni · E. · Kaneko · S. · MacLean · E. L.-H. · Sato · S. · Saito · N.
Background

Treatment failure remains a major challenge in tuberculosis (TB) management. Rapid and objective assessment of treatment response is essential, as existing tools have limited accuracy and slow turnaround times. The PATHFAST TB LAM Ag assay (PATHFAST-LAM), an automated chemiluminescent enzyme immunoassay, was developed to quantify lipoarabinomannan (LAM) in sputum within 1 hour. Previous studies have shown a strong correlation between sputum LAM concentration and culture-based bacterial load. However, its clinical utility for predicting poor outcomes during treatment has not been prospectively evaluated.

Methods and analysis

We will conduct a prospective longitudinal study enrolling newly diagnosed, bacteriologically confirmed patients with pulmonary TB at Rhodes Chest Clinic and Mbagathi County Referral Hospital in Nairobi, Kenya. We will follow participants throughout the 6-month treatment course, attempting to collect sputum weekly during weeks 1–4, biweekly during weeks 5–12 and monthly during months 3–6. We will measure LAM concentrations at these time points using the PATHFAST-LAM assay. The primary outcome is to assess whether changes in sputum LAM concentration during the intensive phase (baseline to week 4 and/or week 8) predict a composite poor outcome, defined as positive sputum culture at month 6, treatment failure, death during treatment or relapse within 3 months after treatment completion. The primary endpoint is the area under the curve from the receiver operating characteristic analysis, representing the predictive performance of changes in sputum LAM concentration for the composite poor outcome. We will identify the optimal cut-off value for LAM change and estimate sensitivity and specificity with 95% CIs using 2x2 tables. We will apply an adaptive design that allows sample-size re-estimation after interim analysis.

Ethics and dissemination

The study was approved by the Kenya Medical Research Institute (KEMRI/SERU/CRDR/124/5241) and Nagasaki University (250619327). Findings will be disseminated through peer-reviewed publications and scientific meetings.

Trial registration number

NCT07157904.

Competencies Required for Hospital‐Based Wound, Ostomy, and Continence Nurses to Provide PI Care in Home Care in Japan: A Mixed‐Methods Study

ABSTRACT

Aim

To identify the competencies required for hospital-based WOC nurses to provide direct pressure injury (PI) care in home care settings in Japan.

Design

Mixed methods convergent design.

Methods

The qualitative strand used a descriptive design to explore competencies for overcoming barriers faced by hospital-based WOC nurses when providing PI care at home. The quantitative strand used a cross-sectional design to assess competencies in organising the hospital PI management system.

Results

Six competencies were identified: (1) Establish relationships with home healthcare professionals; (2) Promote hospital-based WOC nurse's expertise to home healthcare professionals; (3) Collaborate with the regional medical liaison office in WOC nurse's hospital; (4) Involve hospital administrators in home PI management; (5) Utilise social media/Information and Communication Technology for patient or home-visiting nurse communication; and (6) Utilise public or academic support projects to facilitate home-based activities. The median scoring rate for each medical staff domain on the revised Collaboration Competency Scale for WOC Nurses ranged from 80% to 91%.

Conclusion

The results of this study can serve as a practical resource to help WOC nurses expand their activities into home-care settings.

Implications for the Profession

Their ability to coordinate with staff and manage PI care within hospitals supports active engagement in home care, improving continuity and quality.

Impact

This study addressed the issue that many hospital-based WOC nurses cannot visit patients at home. The competencies identified may enable these nurses to expand their role into home care.

Reporting Method

This study followed EQUATOR guidelines, with the STROBE Statement applied to the quantitative part and the COREQ checklist to the qualitative part.

Patient or Public Contribution

Patients or the public were not involved in the study's design, conduct, or reporting.

Associations between heart failure-related quality of life and clinical parameters in patients with hypertrophic cardiomyopathy: a cross-sectional analysis of data from a multicentre Japanese registry

Por: Saotome · M. · Akita · K. · Kageyama · S. · Suzuki · S. · Ohno · K. · Kamakura · M. · Nawada · R. · Takanaka · C. · Wakabayashi · Y. · Kanda · T. · Tawarahara · K. · Muto · M. · Matsunaga · M. · Suwa · S. · Takeuchi · Y. · Sakamoto · H. · Saito · H. · Hayashi · K. · Wakahara · N. · Unno · K.
Objective

To investigate the relationship between a quality of life (QOL) score and clinical parameters in patients with hypertrophic cardiomyopathy (HCM).

Design

A multicentre cross-sectional study.

Setting

We analysed data from the Searching for Atrial Fibrillation and Early Recruitment of Heart Failure in HCM registry, collected between 2018 and 2023.

Participants

Patients with HCM (n=499) aged ≥18 years from 12 institutions (Shizuoka Prefecture, Japan) were consecutively enrolled.

Outcome measures

Clinical parameters, along with data from a short form of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), were collected. The association between each clinical parameter and the KCCQ-12 score was analysed. Clinical parameters with a significant univariable association (p

Results

In the univariable analysis, KCCQ-12 scores exhibited significant associations with 21 clinical parameters, including sex, left ventricular morphology and the Pittsburgh Sleep Quality Index (PSQI). The multiple regression model with 12 parameters that had a significant univariable association exhibited an adjusted R2 of 0.48. In this model, the PSQI (standardised coefficient –0.39; p

Conclusions

In patients with HCM, we investigated the association between the KCCQ-12 score and various clinical parameters. PSQI, as well as known heart failure-related clinical parameters, was significantly associated with the KCCQ-12 score. Visualising the associations of various clinical parameters with the KCCQ-12 score will help physicians to consider factors linked to the decline in QOL in patients with HCM.

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