The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer

Harder, Helena, Shilling, Valerie M, May, Shirley F, Cella, David, Schmid, Peter and Fallowfield, Lesley J (2020) The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer. Breast Cancer Research and Treatment. pp. 1-10. ISSN 0167-6806

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Abstract

Purpose
Chemotherapy-induced diarrhoea (CID) is a common, but often underreported problem in patients with breast cancer that has a profound effect on quality of life. It is best measured from a patient’s perspective, but tools are limited. The aim of this study was to develop and evaluate the Diarrhoea Management Diary (DMD), a self-report measure to assess CID, use of self-management strategies and treatment adherence.

Methods
The DMD was constructed using an iterative process of instrument development: concept elicitation (literature review), item generation and reduction (cognitive debriefing), and pilot testing in the target population. After translation into eight languages, the DMD was used in an international randomised trial for women receiving lapatinib and capecitabine for metastatic breast cancer with or without prophylactic octreotide. Patterns of missing data and sensitivity to change were examined.

Results
The understandability and completeness of the 8-item DMD was confirmed in cognitive interviews and pilot testing. Practicability of the DMD was evaluated in 62 women with metastatic breast cancer (median age 57). Up to 68% reported CID at any given time-point, and 19% had diarrhoea at each time-point. Patients also described efficacy of different strategies for diarrhoea management. Missing data were associated with study discontinuation. DMD missing item response was 0.9%. Sensitivity to change was good at most assessment points.

Conclusions
Although further psychometric testing is recommended, initial evaluation of the DMD showed good content validity and practicability in international research with cancer patients.

Item Type: Article
Keywords: Chemotherapy-induced diarrhoea, Adverse effects, Measurements, Patient-reported outcomes, Quality of life, Supportive care, Self-management
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
SWORD Depositor: Mx Elements Account
Depositing User: Mx Elements Account
Date Deposited: 04 Aug 2020 08:26
Last Modified: 05 Aug 2020 15:45
URI: http://sro.sussex.ac.uk/id/eprint/92906

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