The qualitative development of ICIQ modules
Research type
Research Study
Full title
The qualitative development of the International Consultation on Incontinence Questionnaire (ICIQ) modules
IRAS ID
226147
Contact name
Nikki Cotterill
Contact email
Sponsor organisation
Clinical Trials Officer
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A Patient Reported Outcome (PRO) is ‘any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.’ PRO questionnaires are in widespread use in clinical practice to help with initial assessment and follow up of treatment. The development of a new PRO measure firstly requires the input of patients to find out their experiences of the condition which is to be measured. This is by in-depth one-to-one interviews of about one hour in length. Input from clinical experts, literature and the findings from these interviews are then used to develop items for the questionnaire. The draft instrument will be refined by feedback using further cognitive interviews with patients. The result is a draft tool that can go on to further testing and ultimately used in clinical practice with the aim of improving the quality of care which is provided. This adaptive study design can be used for populations or conditions for which the module could be used to measure (specific content is marked CONDITION SPECIFIC).
The following study is for the development of a novel PRO instrument to assess the treatment pathway of patients with a diagnosis of bladder cancer. Many patients have complex information needs for care and support following and during treatment, including challenges to their daily life, wellbeing and to their sex-lives. There are currently no patient reported outcome measures (PROMS) available in the UK. The aim of this project is to design a new PROM to explore the experiences of the treatment pathway for patients during diagnosis, treatment and recovery from bladder cancer, including symptoms and impact on quality of life.REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0043
Date of REC Opinion
6 Mar 2018
REC opinion
Favourable Opinion