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Successful utilization of an electronic pain diary in a multinational phase 3 interventional study in pediatric sickle cell anemia

key information

source: The American Society of Pediatric Hematology/Oncology

year: 2016

authors: Lori Heath, Matthew M. Heeney, Carolyn C. Hoppe, Samuel Adjei, Tsiri Agbenyega, Mohamed Badr, Nicoletta Masera, Chunmei Zhou, Patricia B. Brown, Joseph A. Jakubowski, Carlton D. Dampier

summary/abstract:

Background:

Patients with sickle cell anemia (SCA) experience recurrent painful crises that affect quality of life. Studies using patient diaries have shown that SCA pain is more prevalent and severe than previously reported based on healthcare facility utilization alone. DOVE was a multinational, study that assessed the efficacy and safety of prasugrel in reducing the rate of vaso-occlusive events in children with SCA (NCT01794000). DOVE incorporated an electronic patient reported outcome (ePRO) diary to assess daily sickle cell pain.

 

Objectives:

To determine the feasibility of an ePRO diary to assess the frequency and intensity of daily sickle-cell pain and its impact on daily function in a large global study of children and adolescents with SCA.

 

Design/Method:

DOVE utilized an hand-held ePRO device to collect daily data related to sickle cell pain, use of analgesics for pain and study drug adherence for up to 9 months in children >= 4 years of age. The diary content was translated into 11 languages and comprised of subjective (pain intensity, activity interference) and objective (analgesics used, school attendance) components. Pain intensity was measured using a modified version of the Faces Pain Scale-Revised. Data were transferred daily via cellular network to a central database that was accessible by study personnel to monitor compliance. Rates of patient compliance, as defined by a diary completion rate of at least 80%, were calculated. Completion was calculated as the number of daily diary entries divided by the total number of expected diary entries.

 

Results:

A total of 311 patients received a diary and 268 patients provided up to 9 months of diary entries. Rates of diary compliance and completion were high throughout the diary collection period. For the subjective components, 92.6% of patients were compliant and the overall completion rate was 94.4%. For the objective components, 89.7% of patients were compliant and the overall completion rate was 93.3%. Data from the diary have been analyzed and reported (Heeney et al NEJM 2015).

 

Conclusion:

With careful design, patient support and appropriate monitoring, an ePRO diary can successfully measure the impact of daily sickle cell pain in large global studies. Study sponsors Daiichi Sankyo and Lilly.

 

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