Heminsight to assess patient reported outcomes of patients affected by chronic lymphocytic leukemia in daily clinical practice

Background: Chronic lymphocytic leukaemia (CLL) is the most common leukemia in Western Countries, with a median age at diagnosis between 67 and 72 years. The therapeutic landscape of CLL is changing rapidly with the advent of small molecules acting as B-Cell Receptor (BCR) signaling inhibitors. In this setting, long term oral therapy may lead to the reduction in compliance, with a possible impact on effectiveness. Moreover, long-term follow-up may highlight complications, such as drug-related adverse events that, together with the disease itself, may impact quality of life (QoL). Patient Reported Outcomes (PROs) in daily clinical practice is a resource-intensive procedure and may be affected by low adherence, risk of recall bias and difficulties in establishing reproducible procedures. HemInsight, a project conceived in 2010 for myeloproliferative neoplasms in haematological centres in Denmark, enables patients to periodically submit PROs online to be combined to the medical records. Aims: HemInsight was implemented at our Centre to collect PROs from CLL patients in daily practice. Methods: HemInsight incorporated the EORTC QLQ-C30, EORTC QLQ-CLL 16, SF-36, and the eight-item Morisky Medication Adherence Scale (MMAS8) questionnaires to collect PROs and their changes during various stages of CLL (diagnosis - progression – treatment). PRO assessments were scheduled for the patients who received regular reminders by email to complete the tasks. The following measurements will be assessed: system attraction (percentage of CLL patients adhering to the project); patient compliance in filling out questionnaires; system efficiency (number of alerts related to QoL worsening and number of questionnaires not submitted) and system effectiveness (significant differences in changes in QoL scores from diagnosis to response/relapse, changes of therapeutic approach/action following an alert, changes in adherence of therapy). Results: At the time of the present report, 74 patients with a CLL diagnosis have been enrolled, 15 of whom were newly diagnosed. Fourteen patients underwent cytoreductive therapy and 2 are under treatment with novel oral drugs. System attraction: the study was proposed to 91 consecutive patients, independently of age, level of education and internet accessibility, and 72.5% of patients agreed to participate to the study. The main reason of refusal was older age and scant internet/technology knowledge. In 3 cases with no access to internet, but with interest to participate in the project, the questionnaires were administrated through tablet, before the scheduled visit, by a dedicated nurse. Patient compliance: a global response of 58.2% was observed; 48 patients responded at least once and 23 at all scheduled time points. In each case, all questionnaires were fully completed. At this timepoint we cannot yet evaluate system effectiveness as the study is still ongoing. However, ad interim data (Table 1) suggest that patients who interrupt questionnaires fulfilling are those with younger age, more intense working activity and experiencing no changes in disease status (e.g. untreated cases or those in remission). In particular, patients who were under treatment during the questionnaire administration period, showed a higher adherence compared to those in follow up, both previously treated or not (80% versus 26%, p<0.05)Summary/Conclusions: In conclusion, HemInsight is a useful tool for QoL evaluation in CLL patients. Provisional data suggest a higher compliance of those patients who feel that they need a closer contact with the clinician, both for individual disposition or disease status.