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New questionnaire on quality of life of patients with thoracic diseases (C-QoL-DLV)

Translation, cultural adaptation and validation of the chest wall related quality of life (C-QoL-DLV) survey; a multicenter prospective validation study - C-QoL-DLV

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58237
Enrollment
612
Registered
2025-12-10
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obtained chest wall abnormalities

Interventions

C-QoL-DLV questionnaire.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 16 years or olderChest wall abnormality of interest for this validation study: a) Chest wall fracture after blunt trauma (one or more rib fractures or sternum fracture (CT confirmed); b) Symptomatic chest wall fracture nonunion (CT confirmed); c) Clinically diagnosed slipping rib syndrome; d) Symptomatic pulmonary herniation based on costal margin rupture and/or rib fracture (nonunion)Provision of informed consent by patient

Exclusion criteria

Exclusion criteria: Severely affected QoL prior to participation (pre-trauma for acute chest wall abnormalities; paraplegia, tetraplegia, quadriplegia, or severe psychological comorbidity for all subgroups)Expected problems with maintaining follow-upInsufficient comprehension of Dutch language to understand the study documents and to complete the questionnaires (even with some help)

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the C-QoL-DLV. 

Secondary

MeasureTime frame
Secondary outcome measures are the measurement properties of C-QoL-DLV. Measurements properties will include factor analysis, reliability (internal consistency), construct validity, floor and ceiling effect, responsiveness (longitudinal validity), effect size, smallest detectable change, (limits of) agreement, and minimal important change, and will be determined using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines.

Countries

Netherlands

Contacts

Public ContactM.M.E. Wijffels

Erasmus MC, Universitair Medisch Centrum Rotterdam

m.wijffels@erasmusmc.nl+31107031050

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026