Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol

作者：Smith Alexander; Pennington Anna; Carter Ben; Gething Stephanie; Price Michelle; White James; Dewar Richard; Hewitt Jonathan^*

来源：Trials, 2018, 19(1): 349.

DOI：10.1186/s13063-018-2694-4

• Stroke
• CVA
• PROM
• Questionnaire
• Response rate
• Online
• Face-to-face
• Postal
• Telephone
• Non-inferiority

Background: UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment. However, as part of this 6-month assessment little information is gathered from the patient's perspective. The means of collecting this patient-centred information might be served best by a patient-reported outcome measure (PROM) at the 6-month assessment time point Currently, four different methods of 6-month follow-up assessment occur; the most common being face-to-face interview followed by telephone interview, postal questionnaire and online questionnaire. Therefore, this study will investigate if the acceptability of telephone, online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration.
Methods/design: A UK multicentre, blinded (analyst and researcher), pragmatic, non-inferiority study, with 80% power using a 2.5% non-inferiority margin was designed to compare the acceptability of three modes of administration (telephone interview, postal questionnaire and online questionnaire) compared with face-to-face interview administration of a PROM. We plan to approach and randomise a minimum of 808 potentially eligible participants, 202 participants per group.
Discussion: The aim of this ongoing research is to understand if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors. In utilising a pragmatic design, it is believed that this study will offer UK wide generalisable results, of the acceptability of the methods under investigation, to inform clinicians and commissioners of stroke services.

• 出版日期2018-7-3