Disentangling the reasons why older adults do not readily participate in cancer trials: a socio-epidemiological mixed methods approach.

BACKGROUND: Few studies of the under-representation of older adults in cancer clinical trials (CTs) have encompassed the entire pathway from a trial being available in a cancer centre to the patient's invitation to participate and then agreement or refusal to participate. OBJECTIVES: The study's primary objective was to evaluate CT non-invitation and refusal rates. The secondary objectives were to identify factors associated with non-invitation and refusal and to assess experiences of CT participation from the patients' and professionals' perspectives. METHODS: Here, we used mixed methods and a socio-epidemiological approach to analyse reasons for the non-participation of eligible older patients with a solid cancer in cancer CTs in France. RESULTS: We found that non-invitation and low CT participation are mainly related to the patients' sociodemographic characteristics and living conditions (such as social isolation, being single, divorced or widowed, not having children and the absence of close family members) and the healthcare professionals' perceptions of insufficient informal support or a high homecare requirement. CONCLUSION: Our results suggest that efforts to increase fair inclusion and the participation of older adults in CTs should target the physician-patient relationship, the medical profession and hospital funding, rather than the patient alone.

Effectiveness of Geriatric Assessment-Driven Interventions on Survival and Functional and Nutritional Status in Older Patients with Head and Neck Cancer: A Randomized Controlled Trial (EGeSOR).

This study assesses the efficacy of Geriatric Assessment (GA)-driven interventions and follow-up on six-month mortality, functional, and nutritional status in older patients with head and neck cancer (HNC). HNC patients aged 65 years or over were included between November 2013 and September 2018 by 15 Ear, Nose, and Throat (ENT) and maxillofacial surgery departments at 13 centers in France. The study was of an open-label, multicenter, randomized, controlled, and parallel-group design, with independent outcome assessments. The patients were randomized 1:1 to benefit from GA-driven interventions and follow-up versus standard of care. The interventions consisted in a pre-therapeutic GA, a standardized geriatric intervention, and follow-up, tailored to the cancer-treatment plan for 24 months. The primary outcome was a composite criterion including six-month mortality, functional impairment (fall in the Activities of Daily Living (ADL) score ≥2), and weight loss ≥10%. Among the patients included (n = 499), 475 were randomized to the experimental (n = 238) or control arm (n = 237). The median age was 75.3 years [70.4-81.9]; 69.5% were men, and the principal tumor site was oral cavity (43.9%). There were no statistically significant differences regarding the primary endpoint (n = 98 events; 41.0% in the experimental arm versus 90 (38.0%); p = 0.53), or for each criterion (i.e., death (31 (13%) versus 27 (11.4%); p = 0.48), weight loss of ≥10% (69 (29%) versus 65 (27.4%); p = 0.73) and fall in ADL score ≥2 (9 (3.8%) versus 13 (5.5%); p = 0.35)). In older patients with HNC, GA-driven interventions and follow-up failed to improve six-month overall survival, functional, and nutritional status.

A new workflow for the microbiological diagnosis of febrile neutropenia in patients with a central venous catheter.

OBJECTIVES: We aimed to improve the microbial diagnosis of first episodes of febrile neutropenia (FEFNs) since <30% of episodes are microbiologically documented. Consequently patients are usually treated by empirical antibiotic therapy. METHODS: A prospective study evaluated a new workflow combining: (i) one 40 mL blood culture (BC) sampled from the central venous catheter; (ii) immediate incubation in an automated BC system on the ward; (iii) direct detection of microbial DNA in blood; and (iv) identification and susceptibility testing using rapid methods performed directly on positive BC bottles. Patients were also sampled for the standard workflow with two BC sets incubated in the central laboratory and assessed by classical procedures. RESULTS: One hundred and twenty consecutive FEFNs were included (February 2008-March 2009). The new workflow was as sensitive as the standard workflow, with BC positivity rates of 30% (36/120) and 28% (34/120), respectively (McNemar's χ(2) =0.67, P=0.41). Direct DNA detection was positive in nine episodes (7.5%) that were also positive in BC. The new workflow provided microbiological results significantly earlier than the standard workflow, with a shorter time to BC positivity (median 12 h 31 min, range 7 h 55 min-25 h 37 min versus median 13 h 01 min, range 9 h 31 min-43 h 33 min, P=0.004) and shorter turnaround times for identification and susceptibility testing, with most of the results obtained <24 h after BC sampling. We retrospectively estimated that the new workflow would lead to earlier adequacy of antimicrobial therapy in 30% of documented cases. CONCLUSIONS: Our new process improved the microbiological diagnosis in FEFNs. Cost effectiveness needs to be tested.