Prognosis Assessment of Early-Stage Chronic Lymphocytic Leukemia: Are We Ready to Predict Clinical Evolution Without a Crystal Ball?

BACKGROUND: The discovery of new biologic variables with high prognostic effect has been accompanied by the emergence of different prognostic indexes (PIs) to assess the time to first treatment in patients with early-stage (Binet A) chronic lymphocytic leukemia (CLL). The present study compared the prognostic value of 5 PIs: CLL international prognostic index (CLL-IPI), Barcelona-Brno, international prognostic score-A (IPS-A), CLL-01, and a tailored approach. PATIENTS AND METHODS: We applied the 5 PIs to a cohort of 428 unselected patients with Binet A CLL from a multicenter Spanish database with clinical and biologic information available. The predictive value of the scores was assessed using Harrell's concordance index (C index) and area under the receiver operating characteristic curve (AUC). RESULTS: We found a significant association between time to first treatment and risk subgroups for all 5 PIs used. The most accurate PI was the IPS-A (C-index, 0.72; AUC, 0.76), closely followed by CLL-01 (C-index, 0.69; AUC, 0.70), CLL-IPI (C-index, 0.69; AUC, 0.69), Barcelona-Brno (C-index, 0.67; AUC, 0.69), and the tailored approach (C-index, 0.61 and 0.58; AUC, 0.58 and 0.54). CONCLUSIONS: The concordance between the PIs was low (44%), suggesting that although all these PIs improve clinical staging and help physicians in routine clinical practice, it will be necessary to harmonize larger cohorts of patients to define the best PI for treatment decision-making in the real world.

Validation of the Behavioural Indicators of Pain Scale ESCID for pain assessment in non-communicative and mechanically ventilated critically ill patients: a research protocol.

AIM: To investigate the validity and reliability of the Behavioural Indicators of Pain Scale (ESCID) in medically and surgically non-communicative and mechanically ventilated critical patients. BACKGROUND: Scales based on behavioural indicators of pain are suggested to measure pain in non-communicative critically ill patients. Scales proposed thus far have a range not comparable to those used with patients who can report their pain. A scale with a 0-10 range and more behavioural indicators is proposed to improve the detection and measurement of pain. DESIGN: A multicentre prospective observational design to validate a scale-measuring instrument. METHODS: Three hundred non-communicative and mechanically ventilated critical patients from 20 different intensive care units will be observed for 5 minutes before, during and 15 minutes after three procedures: turning, tracheal suctioning and soft friction with gauze on healthy tissue. Two independent observers will assess the pain of subjects with the Behavioural Pain Scale and the ESCID scale simultaneously. Descriptive and inferential statistics will be used. Student's t-test will be used to compare components of the twos scales. Inter-rater and intrarater agreement will be investigated. The reliability scale will be measured using Cronbach's alpha. Approval date for this protocol was January 2012. DISCUSSION: A greater number of behavioural indicators in the ESCID scale than in previously validated scales, with a 0-10 score range, can improve the detection and measurement of pain in non-communicative and mechanically ventilated critical patients. Funding granted in 2011 by the Spanish Health Research Fund (PI 11/00766, Health Ministry). TRIAL REGISTRATION: Study registered with www.clinicaltrials.gov (NCT01744717).