Dataset Information

The Development and Testing of a Chemotherapy-Induced Phlebitis Severity (CIPS) Scale for Patients Receiving Anthracycline Chemotherapy for Breast Cancer.

ABSTRACT: A chemotherapy induced phlebitis severity (CIPS) scale was developed in patients receiving anthracycline chemotherapy for breast cancer. A five-point severity scoring scale for chemotherapy-induced phlebitis was tested for inter-rater reliability. Ease of use was observed through timing assessments and a review of the completeness of documentation. A comparison of CIPS scale grade with participant reported severity scores was made. The final version was tested for inter-rater reliability, with 122 patient assessments. There was an 89.3% (109 of 122) agreement between the assessors (? = 0.82, SE ± 0.042, 95% CI 0.74-0.90). Mean time to complete the scale was 1 min 36 s and documentation was fully completed for 98% of assessments. Patient reported severity closely matched the CIPS grade (? = 0.54, SE ± 0.045, 95% CI 0.46-0.63). This new scale provides a list of symptoms associated with chemotherapy phlebitis, which can be scored quickly and accurately. It provides a reliable method for assessing chemotherapy-induced phlebitis, enabling a better understanding of its impact on patients' quality of life, and to inform the appropriate choice of peripheral or central intravenous administration. Multicentre testing of the CIPS scale is recommended.

SUBMITTER: Harris V

PROVIDER: S-EPMC7141200 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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The Development and Testing of a Chemotherapy-Induced Phlebitis Severity (CIPS) Scale for Patients Receiving Anthracycline Chemotherapy for Breast Cancer.

Harris Valerie V Hughes Meinir M Roberts Rosie R Dolan Gina G Williams E Mark EM

Journal of clinical medicine 20200305 3

A chemotherapy induced phlebitis severity (CIPS) scale was developed in patients receiving anthracycline chemotherapy for breast cancer. A five-point severity scoring scale for chemotherapy-induced phlebitis was tested for inter-rater reliability. Ease of use was observed through timing assessments and a review of the completeness of documentation. A comparison of CIPS scale grade with participant reported severity scores was made. The final version was tested for inter-rater reliability, with 1 ...[more]

PMID: 32150833

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Project description:ImportanceSeveral studies have evaluated cardioprotective strategies to prevent myocardial dysfunction in patients who are receiving cardiotoxic therapies. However, the optimal approach still represents a controversial issue.ObjectiveTo determine whether pharmacological cardioprevention could reduce subclinical heart damage in patients with breast cancer who are being treated with anthracycline-based chemotherapy.Design, setting, and participantsThe SAFE trial was a 4-arm, randomized, phase 3, double-blind, placebo-controlled, national multicentric study conducted at 8 oncology departments in Italy. It was a prespecified interim analysis on the first 174 patients who had completed cardiac assessment at 12 months. The study recruitment was conducted between July 2015 and June 2020. The interim analysis was performed in 2020. Patients were eligible for trial inclusion if they had indication to receive primary or postoperative systemic therapy using an anthracycline-based regimen. Patients with a prior diagnosis of cardiovascular disease were excluded.InterventionsCardioprotective therapy (bisoprolol, ramipril, or both drugs compared with placebo) was administered for 1 year from the initiation of chemotherapy or until the end of trastuzumab therapy in case of ERBB2-positive patients. Doses for all groups were systematically up-titrated up to the daily target dose of bisoprolol (5 mg, once daily), ramipril (5 mg, once daily), and placebo, if tolerated.Main outcomes and measuresThe primary end point was defined as detection of any subclinical impairment (worsening ≥10%) in myocardial function and deformation measured with standard and 3-dimensional (3D) echocardiography, left ventricular ejection fraction (LVEF), and global longitudinal strain (GLS).ResultsThe analysis was performed on 174 women (median age, 48 years; range, 24-75 years) who had completed a cardiological assessment at 12 months and reached the end of treatment. At 12 months, 3D-LVEF worsened by 4.4% in placebo arm and 3.0%, 1.9%, 1.3% in the ramipril, bisoprolol, ramipril plus bisoprolol arms, respectively (P = .01). Global longitudinal strain worsened by 6.0% in placebo arm and 1.5% and 0.6% in the ramipril and bisoprolol arms, respectively, whereas it was unchanged (0.1% improvement) in the ramipril plus bisoprolol arm (P < .001). The number of patients showing a reduction of 10% or greater in 3D-LVEF was 8 (19%) in the placebo arm, 5 (11.5%) in the ramipril arm, 5 (11.4%) in the bisoprolol, arm and 3 (6.8%) in the ramipril plus bisoprolol arm; 15 patients (35.7%) who received placebo showed a 10% or greater worsening of GLS compared with 7 (15.9; ramipril), 6 (13.6%; bisoprolol), and 6 (13.6%; ramipril plus bisoprolol) (P = .03).Conclusions and relevanceThe interim analysis of this randomized clinical trials suggested that cardioprotective pharmacological strategies in patients who were affected by breast cancer and were receiving an anthracycline-based chemotherapy are well tolerated and seem to protect against cancer therapy-related LVEF decline and heart remodeling.Trial registrationClinicalTrials.gov identifier: NCT2236806.

Project description:BACKGROUND:Knowledge of the relationship between men's health and violence is flawed by narrow and faulty conceptualization and measurement of violence that often results in attribution of health problems to one form or type of violence without consideration of other exposures. Our purpose is to describe the development and initial testing of the Cumulative Lifetime Violence Severity scale designed for use in health research to measure men's perceptions of the severity of their cumulative lifetime violence. METHODS:We framed the dimensions of violence severity as: type (physical, psychological, sexual), timing (childhood, adulthood), focus (perpetrator, target), context, frequency, and degree of distress. Items reflecting these dimensions were vetted by local experts including individuals who identified as men, with particular attention to meaningful language for men. The measure was pretested, revised to 64 items, and tested for test-retest reliability prior to use in a study of 685 English-speaking Eastern Canadian men, ages 19 to 65?years. We used Principal Components Analysis to illuminate the underlying dimensionality of the items. RESULTS:Principal Components Analysis yielded a 44-item 11 component solution that accounted for 64.06% of variance with good model fit and a Cronbach's alpha of .92. All dimensions of our conceptualization of violence severity were reflected in the components, except Adult Target Sexual Violence. Convergent validity between the Cumulative Lifetime Violence Severity-44 Scale and a global lifetime violence rating scale was r?= .750 (p?<?.001) and concurrent validity was moderate and significant between the Cumulative Lifetime Violence Severity-44 scale and measures of mental health problems commonly experienced by people with violence histories. CONCLUSIONS:The Cumulative Lifetime Violence Severity-44 scale shows promise as the first comprehensive measure of cumulative lifetime violence for health research that considers gender, individual distress and experiences as both perpetrator and target. Next steps include further exploratory analysis with a more diverse sample of men and confirmatory factor analysis.

Dataset Information

The Development and Testing of a Chemotherapy-Induced Phlebitis Severity (CIPS) Scale for Patients Receiving Anthracycline Chemotherapy for Breast Cancer.

Publications

The Development and Testing of a Chemotherapy-Induced Phlebitis Severity (CIPS) Scale for Patients Receiving Anthracycline Chemotherapy for Breast Cancer.

Similar Datasets

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