One sheet PCI-Head and Neck across different health systems
Research type
Research Study
Full title
Variation in the number and type of items raised on a single sheet paper version of the Patient Concerns Inventory- Head and Neck across different health economies
IRAS ID
234413
Contact name
Simon N Rogers
Contact email
Sponsor organisation
Aintree University Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
The Patient Concerns Inventory (PCI-HN) is an item prompt list that aids clinical consultations and multi-professional involvement for patient following treatment for head and neck cancer (HNC). The PCI-HN package is usually completed by patients on an iPad. This rapid in-clinic screening is helped by a computer algorithm. However, it is appreciated that not all health economies globally will have computers for patient entry and might prefer to use a paper process. Previous publications on the PCI has indicated that the number of items identified by patients relates to quality of life. Also, there are potentially clusters of PCI items that could act as a ‘cluster alert’ to the clinical team for patients who might benefit from additional targeted intervention.
The aim of this project is to collate and compare PCI-HN responses from a range of different head and neck cancer follow-up clinics across the world. This comparison will help identify if there are common items occurring in clusters that related to QOL outcomes. These will form the basis of a PCI ‘cluster alert’.
The intention is to collaborate with over 10 units internationally and ask at least 100 HNC patients attending routine follow-up clinics completed the anonymous PCI-HN sheet. There are versions already translated but where necessary a translation process will be required as a first step. Each unit will collect basic non-patient identifiable clinical demographic details; age, gender, stage of cancer, site, treatment, and time from diagnosis.
Analysis will involve describing the overall between-unit (countries) variation in PCI responses (number of items, individual items, clinical details).
Each collaborator will approach their local medical health boards or University Institutes regarding local ethical approval and data collation will have no patient identifiers and data transfer will be by encrypted pathway using a password protected file.
At Aintree University Hospital the PCI has been used in routine clinical practice since 2007. Comparisons will be made with this historical data with all patient identifiers removed. 100 patients will be matched on clinical characteristics.
The PCI is recommended in the UK as a quality measure of outcome on the head and neck national audit (DAHNO). Retrospective data will be included from the Morriston Hospital (Wales).REC name
West of Scotland REC 3
REC reference
18/WS/0152
Date of REC Opinion
10 Aug 2018
REC opinion
Favourable Opinion