Few resources are available to quantify clinical trial-associated workload, needed to guide staffing and budgetary planning. The aim of the study is to describe a tool to measure clinical trials nurses' workload expressed in time spent to complete core activities. Clinical trials nurses drew up a list of nursing core activities, integrating results from literature searches with personal experience. The final 30 core activities were timed for each research nurse by an outside observer during daily practice in May and June 2014. Average times spent by nurses for each activity were calculated. The "Nursing Time Required by Clinical Trial-Assessment Tool" was created as an electronic sheet that combines the average times per specified activities and mathematic functions to return the total estimated time required by a research nurse for each specific trial. The tool was tested retrospectively on 141 clinical trials. The increasing complexity of clinical research requires structured approaches to determine workforce requirements. This study provides a tool to describe the activities of a clinical trials nurse and to estimate the associated time required to deliver individual trials. The application of the proposed tool in clinical research practice could provide a consistent structure for clinical trials nursing workload estimation internationally.

Introduction: Aim of this study was to analyze the overall complication and failure rates of Peripherally Inserted Central Catheters (PICCs), in a 1-year consecutive unselected cohort of 482 adult patients, affected by non-hematological malignancies undergoing chemotherapy. Methods: Adult outpatients (aged 18–75 years), with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, bearing solid tumors and candidates for intravenous chemotherapy were eligible for the study. Exclusion criteria were active infections, coagulopathy (defined as platelet count <50,000/μL and/or prothrombin time more than 18 s), life expectancy <6 months, or inability to give written informed consent. Devices were all implanted in an outpatients’ hospital facility, following predefined evidence-based institutional guidelines and protocols by a PICC-dedicated team at the European Institute of Oncology in Milan, Italy, during the 12-month period from January 1 to December 31, 2019. Results: Five-hundred PICCs were implanted in a cohort of 482 patients during the time interval of this study. Thirty devices were overall removed (6.2%), 23 as a consequence of a complication occurred, and seven inadvertently. The inserted PICCs accounted for a total of 49,718 catheter days in situ, median duration was 85.5 days [interquartile range (IQR): 56–146]. Overall there were 42 (8.7%) complications, corresponding to 0.84 catheter-adverse events (CAE)/1000 PICC-days (95% CI: 0.61–1.14). There were N = 13 (2.7%) thromboses, N = 11 (2.3%) irreversible occlusions, N = 7 (1.5%) accidental removals, N = 5 (1.0%) infections [two Catheter Related Blood Stream Infection (CRBSI) and three exit site/local infection], N = 3 (0.6%) ruptures and N = 3 (0.6%) primary or secondary malpositions. Conclusion: This large prospective study supports the increasing use of PICCs in adult oncology outpatients treated in specialized centers with chemotherapy for non-hematological malignancies. In this clinical setting, PICC failure occurred in 6% only of the inserted devices.

Introduction: The Distress Thermometer (DT) was built and validated for screening cancer patients for distress, as suggested by the National Comprehensive Cancer Network. The current work was designed to measure the rates of distress in a sample of patients being hospitalized in a multidisciplinary outpatient surgery clinic. Objective: To measure the rates of distress in a sample of patients referring to a multidisciplinary day surgery division in a comprehensive cancer center based in Northern Italy.Methods: A total of 177 patients were asked to fill in the (DT) before surgery.Results: Out of 177 patients, 154 (87%) patients completed the DT. While 13% of the patients indicated a total absence of distress, more than half of the sample declared a moderate or high distress. A total of 55% of patients presented at least three difficulties in the Problem List Checklist. Distress was not correlated with age or other medical and clinical variables. Number of emotional problems was the best predictor of distress at admission (β = 0.655, p = 0.000).Conclusion: Screening for distress in a day surgery multidisciplinary oncology division is feasible and a relevant percentage of patients can be identified as clinically distressed. Outcomes also highlight the impact of age and precise physical and psycho-social signs as prognostic indicators of clinically significant distress. Measurement of distress and associated problems list represent the preliminary endpoint toward adequate recommendations that contribute to taking care of distress in cancer patients in cost-effective clinical setting.

Nurses play a key role in maintaining a functioning port using positive pressure during the flushing techniques. Certain risk factors must be monitored to prevent partial occlusions, and certain patients are more likely to present with port-related problems.

Background The primary nursing care model is considered a personalized model of care delivery based on care continuity and on the relationship between the nurse and patient. Primary nursing checklists are not often mentioned in the literature; however, they represent a valid instrument to develop, implement, and evaluate primary nursing. The aim of this study was to create a structured checklist to explore hospital compliance in primary nursing. Methods The Delphi method was used to develop and validate a checklist. The preliminary version was created and sent to three experts for their opinions. Their comments were ultimately used in the first version, which included four components with 19 items regarding primary nursing characteristics. A two-round Delphi process was used to generate consensus items. The Delphi panel consisted of six experts working in primary nursing contexts and/or teaching or studying primary nursing. Data were collected using a structured questionnaire from July 2020 to January 2021. These experts were asked to rate each element for relevance using a 4-point Likert-type scale. Furthermore, the consensus among the panel of experts was set at ≥78%, with selected items being voted “quite relevant” and “highly relevant”. Content validity index (I-CVI) and modified kappa statistic were also calculated. Following expert evaluation, the first version of the checklist was modified, and the new version, constituting 17 items, was sent to the same experts. Results The first version of the checklist demonstrated a main relevance score of 3.34 (SD = 0.83; range = 1.3–4; mean I-CVI = 0.84; range: 0.83–1), but three items did not receive an adequate I-CVI score, that is, lower than 0.78. After the second round, the I-CVIs improved. The main score of relevance was 3.61 (SD: 0.35; range = 2.83–4; mean = I-CVI: 0.93). The S-CVI/UA was 0.58, and the S-CVI/Ave was 0.93. Conclusion Measuring primary nursing compliance should be implemented to provide continuous feedback to nurses. Moreover, utilizing valid checklists could permit comparing different results from others’ research. Future research should be conducted to compare the results from the checklist with nursing outcomes.