Evaluation of a safe infusion device on reducing occupational exposure of nurses to antineoplastic drugs: a comparative prospective study. Contamoins-1.

PURPOSE: Despite the decreasing of environmental contamination throughout the anticancer drug circuit, the administration of chemotherapies remains at risk of occupational exposure for nurses. Many medical devices aim at securing administration, but none have been scientifically evaluated to verify the actual improvement. METHODS: A monocentric comparative before/after study was carried out in an oncology day hospital to evaluate the efficacy of Safe Infusion Devices in reducing drug exposure compared to usual infusion practices. The rate of nurses' gloves contamination was estimated. To avoid false negatives and to ensure sampling reproducibility, each sample of gloves was contaminated with a drop of topotecan. Association between contamination and other variables was investigated using a multivariate logistic regression analysis. RESULTS: The usual practice led to a rate of 58.3% of contaminated samples while Safe Infusion Devices to a rate of 15%: Safe Infusion Devices reduced the risk of gloves contamination by 85% in multivariate analysis (Odds ratio = 0.15; 95% confidence interval = 0.05-0.46; p < 0.001). Topotecan was identified in 100% of the samples. Only one case of cross-contamination has occurred. CONCLUSION: Despite the current practice of using neutral solvent-purged infusers, the occupational exposure remains high for nurses and Safe Infusion Devices significantly reduced this risk of exposure. However, glove contamination is only a surrogate endpoint. The results confirmed that the disconnection of empty bags resulted in occupational exposure. Except a contamination due to the leakage of a bag, no cross-contamination was detected. Safe Infusion Devices were highly effective but did not completely eliminate exposure.

How human activity impacted manufacturing non-compliances: A multivariate analysis in a centralized cytotoxic preparation unit.

INTRODUCTION: The aim of the study was to identify risk factors related to human errors in the preparation of anticancer drugs in order to improve the pharmaceutical process by setting corrective actions. METHOD: Risk factors which could increase the probability of error were identified: daily workload, workload on the previous day and subcontractors' workload, time slot of the preparation, understaffing, incidents which could affect workflow, individual experience of technicians and cleanrooms layout. Drug reconstitution or complex fabrications were also considered as risk factors. We used univariate and multivariate logistic regression analyses to screen for correlation between risks and errors. RESULT: Among 11 278 preparations analyzed, 115 were non-compliant. Univariate analysis shows significant variables: individual experience of technicians, technicians working in the same cleanrooms and technicians' rotations. 2 technicians are significantly associated with a higher risk of error and 5 with a lower risk. The multivariate analysis confirmed the conclusions of the univariate. DISCUSSION: As expected, time slot of the manufacture, cleanrooms layout and some technicians increase the risk of error. Surprisingly, technicians' experience led to increase the risk. This study is a first approach to evaluate the human error aspect in non-compliant preparations, in order to optimize security of antineoplastic drugs preparations.

Determinants of quality of life in advanced cancer patients with bone metastases undergoing palliative radiation treatment.

PURPOSE: Assessment of health-related quality of life (HRQOL) is critical to effective delivery of palliative care in patients with advanced cancer. The current study analyzes relationships between baseline social determinants of health and medical factors, and self-reported HRQOL in patients with bone metastases receiving palliative radiotherapy. METHODS AND MATERIALS: Advanced cancer patients referred for radiotherapy treatment of bone metastases completed the EORTC QLQ-C30 questionnaire in multiple outpatient clinics internationally. Demographics and social determinants were collected as baseline information. Univariate and Bonferroni-adjusted multivariate linear regression analyses were used to detect significant correlations between baseline determinants and different HRQOL domains. RESULTS: Karnofsky Performance Status (KPS) was correlated with better physical (p = 0.0002), role (p < 0.0001), emotional (p < 0.0001), and social (p < 0.0001) functioning, and global health scores (p = 0.0015) and predicted lower symptom scores for fatigue (p < 0.0001), pain (p < 0.0001), appetite loss (p < 0.0001), and constipation (p < 0.0001). Increased age was predictive of better social functioning (p < 0.0001) and less insomnia (p = 0.0036), higher education correlated with better global health status (p = 0.0043), and patients who were employed or retired had improved physical functioning (p = 0.0004 and p = 0.0030, respectively) and less financial challenges compared to patients who were unemployed (p = 0.0005). CONCLUSIONS: Baseline KPS had the greatest influence on EORTC QLQ-C30 domain scores. Age, education level, and employment status had significant impacts, although on fewer domains. Further studies that investigate baseline determinants are worthwhile to clarify relationships in order to care for patients more effectively at the end of life.

International field testing of the reliability and validity of the EORTC QLQ-BM22 module to assess health-related quality of life in patients with bone metastases.

BACKGROUND: The objective of this international field study was to test the reliability, validity, and responsiveness of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 module to assess health-related quality of life (HRQOL) in patients with bone metastases. METHODS: Patients undergoing a variety of bone metastases-specific treatments were accrued. The QLQ-BM22 was administered with the QLQ-C30 at baseline and at 1 follow-up time point internationally. A debriefing questionnaire was administered to determine patient acceptability and understanding. RESULTS: Large-scale field testing of the QLQ-BM22 in addition to the QLQ-C30 took place in 7 countries: Brazil, Canada, Cyprus, Egypt, France, India, and Taiwan. A total of 400 patients participated. Multitrait scaling analyses confirmed 4 scales in the 22-item module. The scales were able to discriminate between clinically distinct patient groups, such as between those with a poor and those with a better performance status. The QLQ-BM22 was well received in all 7 countries, and the majority of patients did not recommend any significant changes from the module in its current form. CONCLUSIONS: The final QLQ-BM22 module contains 22 items and 4 scales assessing Painful Sites, Painful Characteristics, Functional Interference, and Psychosocial Aspects. Results confirmed the validity, reliability, cross-cultural applicability, and sensitivity of the 22-item EORTC QLQ-BM22. It is therefore recommended that the QLQ-BM22 be used in addition to the QLQ-C30 in clinical trials to assess HRQOL in patients with bone metastases.

An international prospective study establishing minimal clinically important differences in the EORTC QLQ-BM22 and QLQ-C30 in cancer patients with bone metastases.

PURPOSE: Quality of life (QOL) is frequently an endpoint in clinical trials involving patients with advanced cancer. Statistical significance of minimal differences can be achieved with sufficient sample size, yet the actual clinical relevance is unknown. The purpose of this study was to establish the minimal clinically important difference (MCID) for the European Organisation for Research and Treatment of Cancer (EORTC) bone metastases module (EORTC QLQ-BM22). METHODS: Patients with bone metastases across seven countries were prospectively enrolled in a trial validating the EORTC QLQ-BM22 and completed the QLQ-BM22 and core measure (QLQ-C30) at baseline and 1-month follow-up. MCIDs were calculated for each QOL scale for both improvement and deterioration using both an anchor- (performance status) and distribution-based approach. RESULTS: A total of 93 patients completed both baseline and follow-up QOL and had recorded performance status at both intervals. Statistically significant meaningful differences were seen in seven scales. There were improvements of 30.5 (95 % confidence interval, 9.0 to 52.0), 20.1 (7.1 to 33.2), 30.5 (13.8 to 47.3) and 19.6 (5.0 to 34.3) in the pain, painful site, painful characteristic and functional interference scales, respectively, demonstrated clinical relevance. Decreases of 12.4 (0.3 to 24.6), 22.4 (11.8 to 32.9) and 13.5 (1.9 to 25.1) were required to represent clinically relevant deterioration in emotional functioning, global health status and financial issues, respectively. Minimal differences for improvement were closest to 0.5 standard deviations (SD) while for deterioration, closer to 0.3 SD on the QLQ-BM22. CONCLUSION: Identification of requirements for clinical significance can assist in determining the relevance of QOL changes after treatment and in sample size determination in future trials. Our study is limited by the small sample size. Future studies should continue to determine MCID and confirm our findings using a variety of appropriate anchors and in a larger sample.

Comparative parallel assessment of a transfer device in reducing 5-fluorouracil environmental contamination inside positive air pressure isolators.

The environmental contamination of the antineoplastic drugs circuit, due to the centralization of preparation and the increased number of the patients treated, brought about a new occupational hazard: the chronic exposure to low doses of antineoplastic drugs. The rationalization of the hospital budgets imposes a meticulous assessment of the devices available for the preparation, in order to justify their interest, even their cost. A prospective comparative study with parallel arms was led inside the Pharmacy of the Institut de Cancerologie de la Loire in order to evaluate the Spike Swan®, a transfer device. The aim was to assess the Spike Swan® effectiveness. The antineoplastic drugs environmental contamination within the isolators is considered as a potential starting point for a larger dissemination of cytotoxic products. Therefore, the primary endpoint was the surface contamination level with 5-fluorouracil and the comparator was the standard preparation technique using needles and aeration needles. This study did not show significant effectiveness for the Spike Swan® in reducing surface contamination. Nevertheless, this device could be used to prepare large volumes and to secure occasional handlers, because it is easy to handle.

Body surface area capping may not improve cytotoxic drugs tolerance.

Capping body surface area (BSA) at 2 m2 is a routine clinical practice. It aims at reducing toxicities in over 2 m2 BSA patients. 455,502 computerized chemotherapy prescriptions made between 2011 and 2017 were taken from BPC software. Chemotherapy computerized order entry is created by a senior physician prescribers before patient consultation. Only prescriptions with dose calculation involving BSA were selected. 51,179 chemotherapy prescriptions were analyzed; corresponding to 7206 patients who received intravenous chemotherapy. The number of chemotherapy prescriptions in over 2 m2 BSA patients was nearly the same in the hematology as in the oncology departments. But, 79.1% of prescriptions were capped at 2 m2 in the oncology department contrary to 21.9% in the hematology department. Practices analysis showed more dose limitation in palliative situations in both departments. Unexpectedly, 6.53% of capped prescriptions were performed in patients with normal BMI. The patients who received capped doses of chemotherapy had neither fewer dose reductions due to toxicity nor deterioration of their general condition. Capping did not induce fewer dose reductions in patients with BSA greater than 2 m2. Prospective studies in this population are needed to standardize chemotherapy administration in population with BSA > 2 m2.

Predictive factors of overall quality of life in advanced cancer patients using EORTC QLQ-C30.

OBJECTIVE: To identify which domains/symptoms from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were predictive of overall quality of life (QoL) in advanced cancer patients. METHODS: Four hundred and forty seven patients with brain metastases or bone metastases from seven countries were enrolled with regression analysis to determine the predictive value of the QLQ-C30 functional/symptom scores for patient reported overall QoL (question 30), overall health (question 29) and the global health status domain (questions 29 and 30). RESULTS: Worse role functioning, social functioning, fatigue and financial problems were the most significant predictive factors for worse QoL. In the bone metastases subgroup (n = 400), role functioning, fatigue and financial problems were the most significant predictors. In patients with brain metastases (n = 47), none of the EORTC domains significantly predicted worse QOL. CONCLUSION: Deterioration of certain QLQ-C30 functional/symptom scores significantly contributes to worse QoL, overall health and global health status.

Predictive factors of overall well-being using the EORTC QLQ-C15-PAL extracted from the EORTC QLQ-C30.

OBJECTIVE: The European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC QLQ-C15-PAL) was developed to assess quality of life (QOL) for the palliative cancer population to decrease patient burden. The purpose of this study was to compare predictive factors for well-being in the QLQ-C15-PAL extracted from the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30) with the QLQ-C30 itself. METHODS AND MATERIALS: Patients with advanced cancer referred for treatment of bone metastases completed the QLQ-C30. Fifteen items from the QLQ-C15-PAL were extracted from the QLQ-C30. Univariate and multivariate analyses were used to determine predictive factors of the global QOL/health score in both tools. In the multivariate analyses, a p value of <0.003 indicated statistical significance. RESULTS: Overall, predictive factors were similar when analyzing data from both tools. Predictive factors for the QLQ-C30 were role functioning (p<0.0001), fatigue (p<0.0001), nausea/vomiting (p<0.0001), and financial problems (p<0.0001) and factors for the extracted QLQ-C15-PAL were physical functioning (p<0.0001) and fatigue (p<0.0001). CONCLUSIONS: Extraction of the QLQ-C15-PAL items from the QLQ-C30 resulted in similar predictive QOL domains for all patient subgroups analyzed individually. The QLQ-C15-PAL is reflective of the QLQ-C30 domains and is recommended for future studies involving patients in a palliative setting, as this shorter questionnaire reduces patient burden and may increase accrual and compliance, while maintaining a similar breadth of coverage and achieving the same predictive ability.

Factors influencing health related quality of life in cancer patients with bone metastases.

OBJECTIVE: Health related quality of life (HRQOL) is a multidimensional concept that is especially important for cancer patients with bone metastases, as maintaining and improving HRQOL is often the main focus of treatment. This study aims to determine factors that may influence HRQOL, which may in turn influence treatment and care of patients. METHODS: Patients (n=396) completed the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Bone Metastases module (BM22) at baseline. The EORTC QLQ-BM22 consists of four scales: painful site (PS), pain characteristics (PC), functional interference (FI), and psychosocial aspect (PA) scales. EORTC QLQ-BM22 data, together with sociodemographic and medical factors were analyzed by univariate analysis of variance (ANOVA). Items of significance were determined through backward selection, which were then put through multivariate analysis to determine further significance. RESULTS: Through ANOVA analysis, KPS>80 and breast primary histology were predictive of better HRQOL in the PS scale, while KPS>80, female gender, and breast primary histology were predictive of better HRQOL in the PC and FI scales. KPS>80 and prostate primary histology were predictive of better HRQOL in the PA scale. KPS>80 and primary cancer site were confirmed as significant predictive factors in multivariate analysis. RECOMMENDATIONS: This study identified baseline factors of gender, performance status, and primary histology as determinants of HRQOL in patients with bone metastases. Further study focusing on current treatment (chemotherapy, bisphosphonates, and radiotherapy) and spiritual well-being may identify additional factors affecting HRQOL. Understanding the influence of these factors will allow health care professionals to provide more effective palliative care.

Quality of life after palliative radiation therapy for patients with painful bone metastases: results of an international study validating the EORTC QLQ-BM22.

PURPOSE: Radiation therapy (RT) is an effective method of palliating painful bone metastases and can improve function and reduce analgesic requirements. In advanced cancer patients, quality of life (QOL) is the primary outcome of interest over traditional endpoints such as survival. The purpose of our study was to compare bone metastasis-specific QOL scores among patients who responded differently to palliative RT. METHODS AND MATERIALS: Patients receiving RT for bone metastases across 6 countries were prospectively enrolled from March 2010-January 2011 in a trial validating the QLQ-BM22 and completed the QLQ-BM22 and the core measure (QLQ-C30) at baseline and after 1 month. Pain scores and analgesic intake were recorded, and response to RT was determined according to the latest published guidelines. The Kruskal-Wallis nonparametric and Wilcoxon rank sum tests compared changes in QOL among response groups. A Bonferroni-adjusted P<.003 indicated statistical significance. RESULTS: Of 79 patients who received palliative RT, 59 were assessable. Partial response, pain progression, and indeterminate response were observed in 22, 8, and 29 patients, respectively; there were no patients with a complete response. Patients across all groups had similar baseline QOL scores apart from physical functioning (patients who progressed had better initial functioning). One month after RT, patients who responded had significant improvements in 3 of 4 QLQ-BM22 domains (painful site, P<.0001; painful characteristic, P<.0001; and functional interference, P<.0001) and 3 QLQ-C30 domains (physical functioning, P=.0006; role functioning, P=.0026; and pain, P<.0001). Patients with progression in pain had significantly worse functional interference (P=.0007) and pain (P=.0019). CONCLUSIONS: Patients who report pain relief after palliative RT also have better QOL with respect to bone metastasis-specific issues. The QLQ-BM22 and QLQ-C30 are able to discriminate among patients with varying responses and are recommended for use in future bone metastasis clinical trials.