Strategies to improve success of pediatric cancer cooperative group quality of life studies: a report from the Children's Oncology Group.

PURPOSE: Quality of life (QoL) has been increasingly emphasized in National Cancer Institute (NCI)-sponsored multisite clinical trials. Little is known about the outcomes of these trials in pediatric cancer. Objectives were to describe the proportion of Children's Oncology Group (COG) QoL studies that successfully accrued subjects and were analyzed, presented or published. METHODS: We conducted a survey to describe outcomes of COG QoL studies. We included studies that contained at least one QoL assessment and were closed to patient accrual at the time of survey dissemination. Respondents were the investigators most responsible for the QoL aim. RESULTS: Sixteen studies were included; response rate was 100%. Nine (56%) studies were embedded into a cancer treatment trial. Only 3 (19%) studies accrued their intended sample size. Seven (44%) studies were analyzed, 9 (56%) were presented, and 6 (38%) were published. CONCLUSIONS: NCI-sponsored pediatric QoL studies have high rates of failure to accrue. Many were not analyzed or disseminated. Using these data, strategies have been implemented to improve conduct in future trials. Monitoring of QoL studies is important to maximize the chances of study success.

Topical analgesia treats pain and decreases propofol use during lumbar punctures in a randomized pediatric leukemia trial.

BACKGROUND: Lumbar punctures are frequently performed in pediatric leukemia for central nervous system leukemic prophylaxis. The contribution of local anesthetic with deep sedation is unknown. The objective was to evaluate EMLA (eutectic mixture of local anesthetics) cream as a pain reliever in conjunction with propofol in the setting of routine lumbar punctures. PROCEDURE: We included patients with acute lymphoblastic leukemia aged 3-21 years requiring at least two routine lumbar punctures. Patients were randomly assigned to receive EMLA or placebo cream and the alternate treatment with the second procedure. Patients, personnel and outcome assessors were blinded to allocation. The primary outcome included three indirect measures of pain: total median propofol doses, patient movement and heart rate changes at the time of skin puncture in both treatment groups. RESULTS: Twenty-six patients were enrolled and 25 were analyzed. With EMLA cream, 4 mg/kg (median) of propofol was required (95% CI 3.5-4.4). With placebo, 4.9 mg/kg of propofol was needed (95% CI 4.3-5.6; P = 0.008). When EMLA cream was applied, 8% of patients moved, whereas 84% moved with placebo cream (P < 0.0001). There was a lower average heart rate by seven beats in the EMLA treatment compared to placebo (95% CI -2.3-4.3; 4.1-12.4; P = 0.009). There were no adverse events in either treatment group. CONCLUSIONS: This study demonstrated that the combination of EMLA cream with propofol is beneficial. Topical analgesics are at the discretion of the oncologist, allowing us to advocate for patients by providing safe and efficacious pain management for lumbar punctures.