Development of a PROM for Inducible Laryngeal Obstruction (ILO) V1.0
Research type
Research Study
Full title
Development of a patient centred, patient reported outcome measure (PROM) for Inducible Laryngeal Obstruction (ILO) as part of a PhD study.
IRAS ID
317461
Contact name
Siobhan Ludlow
Contact email
Sponsor organisation
Manchester University Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Inducible Laryngeal Obstruction (ILO) is defined as an inappropriate laryngeal closure at the glottic and/ or supraglottic level which leads to dynamic airflow obstruction and causes breathing difficulties. Individuals with ILO present across a variety of healthcare settings with differing levels of morbidity. Currently there are no tools to measure intervention in ILO patients and we rely on non-standardised assessments or goal setting measures which are not always patient specific.
The aim of this PhD study is to produce a patient-centred, patient reported outcome measure (PROM) to measure patient perspectives on the impact of their ILO pre and post intervention. A PROM is ‘any report of the status of a patients’ health condition that comes directly from the patient, without interpretation of the patients’ response by a clinician or anyone else’ (Higgins, 2011).
Patients with ILO, medical professionals working with ILO and respiratory patients (without ILO) will be used eligible for the study and used at various stages of the research as described in my methodology.
Results Summary
Development of the Inducible Laryngeal Obstruction Patient Reported Outcome Questionnaire (ILO-PROQ)
The aim of this study was to develop a questionnaire that can be used to understand how inducible laryngeal obstruction (ILO) affects people's lives from the patient's point of view.
The study was completed in four stages. The first three stages were used to develop a list of questions for the questionnaire. The fourth stage looked at whether patients and healthcare professionals understood the questions and whether any changes were needed.
Stage 1: Interviews with people living with ILO Fifteen people living with ILO took part in interviews. Twelve of the participants were women, and the average age was 48 years.
The interviews helped us understand what it is like to live with ILO and how it affects people's everyday lives.
Five main areas were identified:
The impact and burden of ILO – how ILO affects people's physical and emotional wellbeing and everyday life.
Loss of independence – how ILO can make it more difficult for people to live their lives as they would like and do things independently.
Anxiety and worries about the future – feelings of fear, worry and uncertainty about ILO and what might happen in the future.
Social isolation and loneliness – how ILO can affect relationships, social activities and people's ability to take part in activities with others.
Ways of coping, support and managing ILO – the different ways people manage their symptoms and the support they receive from others and from healthcare professionals.
Stage 2: Review of previous research
We then looked at existing research about ILO to find out what effects of ILO have been measured in previous studies.We searched a number of research databases and identified 49 relevant research articles.
We found that researchers have used different types of measures, including:
>Questionnaires completed by patients.
>Surveys about people's experiences.
>Tests that measure what people are able to do.
>Assessments completed by healthcare professionals.However, the questionnaires currently available for people with ILO did not cover all of the ways ILO can affect someone's life. In particular, they did not fully consider the effects on people's personal lives, everyday activities and surrounding environment.
This showed that there was a need for a new questionnaire that looks at the whole impact of ILO on a person's life.
Stage 3: Reaching agreement about what should be included
The information from the patient interviews and the research review was brought together to create a list of 80 possible questions or topics for the new questionnaire.
We then asked both people living with ILO and healthcare professionals who work with people with ILO to rate how important each of these topics was.
This was done through an online survey completed in two rounds.
A total of 46 people registered to take part, and 29 people completed both rounds. This included 18 patients and 11 healthcare professionals.
Participants rated each topic from 1 to 9:
1–3: Not important to include.
4–6: Important, but not essential.
7–9: Very important and should be included.
We agreed that a topic should be included if at least 70% of participants considered it important.Thirty topics were agreed as important by at least 70% of both patients and healthcare professionals. A further seven topics were considered important by at least 70% of the patients.
Because the questionnaire is designed to measure the patient's experience, we decided that these additional seven topics should also be considered.
This resulted in 37 questions being included in the first draft of the questionnaire, called ILO-PROQ D1.
Stage 4: Checking whether the questions were clear and easy to understand
The first version of the questionnaire contained 37 questions. It was given to 15 people living with ILO during individual interviews. Five healthcare professionals who work with people with ILO also reviewed the questionnaire as part of a focus group discussion.
Participants were asked to explain their thoughts out loud while reading and answering the questions. This helped us understand whether the questions were clear, whether people understood them in the way intended, and whether any questions were confusing.
The results showed that 12 questions were clearly understood by everyone.
However, 25 questions were misunderstood or confusing to at least one participant.
A consensus group then carefully reviewed the feedback and discussed what changes were needed.
As a result:
>8 questions were removed or combined with other questions.
>11 questions were rewritten to make them clearer.This resulted in a new 29-question version of the questionnaire, called ILO-PROQ D2.
What happens next?
The 29-question ILO-PROQ D2 is an important first version of the questionnaire. However, it now needs to be tested further with a larger number of people with ILO.Further testing will check whether the questionnaire is reliable, accurate and suitable for measuring the impact of ILO on people's lives.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
23/NW/0198
Date of REC Opinion
13 Jul 2023
REC opinion
Favourable Opinion