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

ABSTRACT: 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. TRIALS REGISTRATION:ClinicalTrials.gov: NCT03177161 . Registered on 6 June 2017.

SUBMITTER: Smith A

PROVIDER: S-EPMC6030753 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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

Smith Alexander A Pennington Anna A Carter Ben B Gething Stephanie S Price Michelle M White James J Dewar Richard R Hewitt Jonathan J

Trials 20180703 1

<h4>Background</h4>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 ...[more]

PMID: 29970156

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Project description:Due to a lack of an appropriate disease-specific patient-reported outcome (PRO) instrument for chronic heart failure including its social support and treatment aspects in China, this study was performed to develop a patient-reported outcome measure (PROM) for patients with chronic heart failure and evaluate its reliability, validity, and feasibility.According to the standard PROM guidelines established by the Food and Drug Administration, an item pool was formed by reviewing a large amount of relevant literature and interviewing patients with chronic heart failure about their main symptoms. Thus, the primary scale was created after adjusting the items and language with the help of patients and experts in the field. Next, 155 patients from 8 hospitals in different districts were recruited for a pilot survey using questionnaires containing these items. The patients' responses were analyzed using the classical test theory and item response theory to select high-quality items and determine the subdomains of the scale. This was followed by a formal investigation in the same eight hospitals. In total, 360 patients and 100 healthy subjects were included to evaluate the reliability, validity, and feasibility of the items. Through this process, the final scale was established.The final scale comprised 12 subdomains with 57 items related to physical, psychological, social, and therapeutic areas. The data analysis results of the formal investigation showed that the PROM for chronic heart failure had good reliability, validity, and feasibility. Reliability was verified by Cronbach's alpha coefficient, which was 0.913 for the total scale, 0.903 for the physical domain, 0.941 for the psychological domain, 0.827 for the social domain, and 0.839 for the therapeutic domain. The construct validity results met the relative criteria of confirmatory factor analysis. Discriminant validity was represented by score comparisons of nine subdomains. The response rate and the effective rate of return of the CHF-PROM were 98.94% and 98.92%, respectively.The final scale coincides with the theoretical framework and better reflects the overall quality of life of patients with chronic heart failure. This scale can be used as a valid instrument to evaluate clinical treatment and clinical trials of chronic heart failure.

Project description:INTRODUCTION:Listening effort may be defined as the cognitive resources needed to understand an auditory message. A sustained requirement for listening effort is known to have a negative impact on individuals' sense of social connectedness, well-being and quality of life. A number of hearing-specific patient-reported outcome measures (PROMs) exist currently; however, none adequately assess listening effort as it is experienced in the listening situations of everyday life. The Listening Effort Questionnaire-Cochlear Implant (LEQ-CI) is a new, hearing-specific PROM designed to assess perceived listening effort as experienced by adult CI patients. It is the aim of this study to conduct the first psychometric evaluation of the LEQ-CI's measurement properties. METHODS AND ANALYSIS:This study is a phased, prospective, multi-site validation study in a UK population of adults with severe-profound sensorineural hearing loss who meet local candidacy criteria for CI. In phase 1, 250 CI patients from four National Health Service CI centres will self-complete a paper version of the LEQ-CI. Factor analysis will establish unidimensionality and Rasch analysis will evaluate item fit, differential item functioning, response scale ordering, targeting of persons and items, and reliability. Classical test theory methods will assess acceptability/data completeness, scaling assumptions, targeting and internal consistency reliability. Phase 1 results will inform refinements to the LEQ-CI. In phase 2, a new sample of adult CI patients (n=100) will self-complete the refined LEQ-CI, the Speech, Spatial and Qualities of Hearing Scale, the Nijmegen Cochlear Implant Questionnaire and the Fatigue Assessment Scale to assess construct validity. ETHICS AND DISSEMINATION:This study was approved by the Abertawe Bro Morgannwg University Health Board/Swansea University Joint Study Review Committee and the Newcastle and North Tyneside 2 Research Ethics Committee, Ref: 18/NE/0320. Dissemination will be in high-quality journals, conference presentations and SEH's doctoral dissertation.

Dataset Information

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

Publications

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

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