An observational study in Paediatric Bronchiectasis, sponsored by Birmingham Women's and Children's NHS Foundation Trust. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Birmingham Women's and Children's NHS Foundation Trust · Observational
To develop and refine a disease-specific quality of life (QoL) questionnaire for children with bronchiectasis, informed by qualitative interviews with affected children, young people, and their parents.
The paediatric bronchiectasis- specific quality of life (PQOL-B) questionnaire will be developed across four demographics:
Children aged 8-12 years
Young people aged 13 -17 years
Parent-proxy for 2-5years
Parent-proxy for 6-12years
To develop and refine a disease-specific quality of life (QoL) questionnaire for children with bronchiectasis, informed by qualitative interviews with affected children, young people, and their parents.
The paediatric bronchiectasis- specific quality of life (PQOL-B) questionnaire will be developed across four demographics:
The development of the questionnaires will be carried out by conducting two different stages of interviews over a 12- month time period:
Recruitment and Interview Participants will be recruited from existing bronchiectasis database at the Birmingham Children's Hospital. Clinicians involved in routine care will screen eligible patients using pre-defined criteria.
Ideally new participants will be recruited for the second phase of the development of PQOL-B's where possible. But due to the rarity of the disease this may not always be possible to achieve. So, there may be some participants that will participate in both interview stages.
Consenting for interviews Potential participants will be provided with an age-appropriate participant information sheet and given adequate time to consider participation. Informed consent will be obtained from parents/guardians, and assent from children where appropriate - those 15years and younger.
Stage 1: Semi structured Interviews A schedule of open-ended questions has been developed to support data collection, with reference to existing literature and shaped by the research objectives.
Discussions will centre on participants' life experiences living with bronchiectasis or having a child diagnosed with the disease, the impact it has on daily living activities.
Individual, semi-structured open-ended interviews will be conducted where possible in person, or by a virtual online meeting (via Microsoft teams' platform) in accordance with participant preference, by the research team who have extensive training and experience in conducting qualitative interviews as well as extensive experience of working with children and their families living with bronchiectasis.
Interviews will be conducted by the research team and last approximately 45- 60 minutes, depending on how much the participant has to say.
Whether the interview is conducted in person or via video-call using Microsoft Teams, in accordance with participant preference, both ways will be recorded using the Microsoft Team's platform.
The recordings will be transcribed verbatim by the research team. The data will be accessible to the research team only, and investigators will only be sharing the anonymized transcripts for content analysis which includes an external collaborator as apart of the multi-disciplinary team, and this is for their expert academic input. Content analysis will be facilitated using NVivo software and will identify key themes, symptoms and impacts.
Ensuring no new information is emerging, and therefore saturation has been achieved.
Agreement on question selection and wording will be agreed during multi-disciplinary team discussions; these discussions will also include the results from a previously completed e-Delphi study, creating prototype of questionnaires ready for cognitive testing.
Stage 2: Cognitive testing Interview It is necessary to pre-test the prototype on the target population. Data will be collected using cognitive testing via an interview process. These Interviews will last approximately 45 minutes, depending on how much the participant has to say.
The method of the cognitive testing interview is as follows; Participants should complete the prototype PQOL-B using the instructions provided. Children must have the prototypes read to them.
After they have completed each section, they must complete a cognitive debriefing interview. The questions will be asked after each section and will seek to examine what the participants thought of the questions and why they choose their rating of each item.
Participants will be asked whether there were any words they did not understand or if any important content or impacts of bronchiectasis were missed.
The interviewer will record the interview via Microsoft Team's platform. The interview can be virtual or face to face interview, as per the patients/care givers preference. Any suggestion for change will be discussed with the research team. The recordings will be transcribed verbatim by the research team. The data will be further anonymised and will be accessible to the research team only, and an external collaborator for their expert academic input.
The results of the interviews will be used to form a translated final version of PQOL-B, ready for formal validation.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
This study's planned enrollment of 78 is below the median of 160 across 137 observational studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Birmingham Women's and Children's NHS Foundation Trust is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 2years to 17 years with a CT diagnosis of Paediatric Bronchiectasis -unrelated to CF or PCD.
Also parents of children and young people aged 2years-12years with a CT diagnosis of Paediatric Bronchiectasis -unrelated to CF or PCD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient, child and young persons, aged 8 -17 years with bronchiectasis diagnosed on CT scan
Exclusion Criteria:
Child under 8 years with bronchiectasis for patient direct participation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Quality of Life questionnaires for paediatric Bronchiectasis
Scale: Quality of Life questionnaires for paediatric Bronchiectasis -Across 4 age and respondent questionnaires will be developed and testing on the population it is designed for. Minimum: Not reported Maximum: Not reported Higher score: Not reported/not applicable Time frame: 1 year
Time frame: 1 year
Plan to share: Yes — Sex Participant age Ethnicity Age at diagnosis Years Time since diagnosis Years(SD) CT Scan - for confirmation of disease
Access criteria: Only study team will be able to access the IPB and supporting information
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 62 observational studies under Bronchiectasis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Birmingham Women's and Children's NHS Foundation Trust