title: Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer.
abstract: We investigated the efficacy of data capture of patient-reported toxicity following radiotherapy by comparing electronic and paper formats. Patient-reported toxicity questionnaires based on items from the NCI Common Terminology Criteria for Adverse Events (CTCAE) were created for patients receiving radiotherapy. Electronic and paper questionnaires had identical questions. Thirty seven gynaecological cancer and 40 prostate cancer patients completed questionnaires. Both questionnaire formats (electronic and paper) were completed by each patient at time points before and after radiotherapy. The average questionnaire and subsection scores for each format were compared directly and by using intra-class correlation (ICC) coefficients. The internal consistency/reliability was assessed by determining Cronbach's alpha coefficient. Patient preference for questionnaire format including clarity and ease-of-use was recorded. 324 questionnaires were collected as part of this study. A similar pattern of average subsection scores was found for the electronic and paper questionnaires. ICC coefficients for the mean overall questionnaire scores and subsection scores were high (>0.8). Cronbach's alpha was generally greater than 0.6, indicating that the reliability was high. Of the patients that responded, 27.3% preferred the electronic format, 25.7% preferred the paper format and 47% had no preference. The average time taken to complete a questionnaire was about 9 minutes for each format. The different questionnaire formats measured toxicity effects consistently and were reliable for both gynaecological cancer and prostate cancer patients. The survey indicated that patients found the questionnaires clear, easy to understand and straightforward to complete. Electronic data capture of patient-reported toxicity for CTCAE is feasible and acceptable.
authors.affiliation: Academic Department of Radiation and Oncology, Department of Medicine, University of Manchester, Wilmslow Road, Manchester M20 4BX, United Kingdom. d_j_j_farnell@yahoo.co.uk
authors.forename: Damian J J
authors.initials: DJ
authors.lastname: Farnell
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Routledge
authors.forename: Rita
authors.initials: R
authors.lastname: Hannon
authors.forename: John P
authors.initials: JP
authors.lastname: Logue
authors.forename: Richard A
authors.initials: RA
authors.lastname: Cowan
authors.forename: James P
authors.initials: JP
authors.lastname: Wylie
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Barraclough
authors.forename: Jacqueline E
authors.initials: JE
authors.lastname: Livsey
authors.forename: Ric
authors.initials: R
authors.lastname: Swindell
authors.forename: Susan E
authors.initials: SE
authors.lastname: Davidson
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D057240:Patient Preference; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000209:etiology*; D011878:Radiotherapy / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D014584:User-Computer Interface; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000532:radiotherapy*