Measuring patient experience of foot pain (PROMfoot) (PR)
Research type
Research Study
Full title
Measuring patient reported outcomes of podiatric intervention. Comparison of the EQ-5D, the SF-6D (using the SF-12), the Foot Health Status Questionnaire and the Foot Function Index in patients with foot pain.
IRAS ID
208821
Contact name
Linda Fenocchi
Contact email
Sponsor organisation
Glasgow Caledonian University
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Scarce resources and increasing demand for medical care requires choices to be made about health care provision. Informed choices depend upon evidence of clinical effectiveness and cost-effectiveness of different treatments for different conditions. These require changes in health outcomes to be measured before and after delivery of interventions to determine whether patient health has improved. National Institute for Health and Care Excellence (NICE) guidance for the NHS has recommended the use of patient-reported outcome measures (questionnaires) for this purpose. Generic questionnaires should, in theory, be relevant to all patients groups and enable comparisons by providing information about overall health-related quality-of-life. These are normally used alongside condition specific questionnaires which collect information about the specific health problem following treatment (for example, the level of pain in an ankle joint after surgery).
The objective of this study is to evaluate the ability to detect changes in response to treatment (a concept known as responsiveness) of two generic questionnaires (EuroQol EQ-5D and SF-6D (using SF-12)), and two condition-specific questionnaires (Foot Health Status Questionnaire and the Foot Function Index). We are interested in people who have foot pain, and will seek to evaluate responsiveness of these questionnaires by asking patients with foot pain to complete the questionnaires before and after receiving foot care by the NHS Greater Glasgow and Clyde Podiatry Service.
Over a 9 month period, adult patients who have been referred to podiatry by their GP will be invited to participate. For phase 1, participants will be asked to complete the questionnaires at 3 time points (within 6 weeks of their first podiatry appointment, 3 months and 6 months) and return these by pre-paid post. For phase 2, we will explore the levels of agreement and/or disagreements between questionnaire scores by interviewing a small sub-sample of participants (24-32) who have completed phase 1.
REC name
South East Scotland REC 01
REC reference
16/SS/0193
Date of REC Opinion
2 Nov 2016
REC opinion
Favourable Opinion