Identification of Patient Important Outcomes in Lung Transplantation

NCT06066229 | Unknown

• 1 other identifier: APHP 220838
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lung transplantation (LT) is the treatment for end-stage respiratory failure, for severe cases after thorough clinical and paraclinical evaluation. Patients often face a lengthy journey before being placed on the transplant list, and post-transplant care can seem to be demanding. Patient-Important Outcomes (PIO), have emerged across various medical fields, aiming to prioritize the patient's perspective in medical research. This approach seeks to align clinical outcomes with those important to patients, such as pain, mobility, autonomy, and quality of life. The focus on patient-centered research is crucial not only in medical care but also in clinical research. While several medical fields have embraced this approach, including diabetology, rheumatology, urology, and more, the field of lung transplantation has yet to fully explore the importance of PIO. LT addresses diverse underlying conditions (e.g., cystic fibrosis, pulmonary fibrosis, emphysema, pulmonary hypertension), impacting potentially different patient populations. However, the transplantation process standardizes certain aspects, such as follow-up obligations, treatments, side effects, and complications, which can affect patient quality of life. A systematic literature review of LT studies published in 2019 found that only 11 out of 51 studies evaluated PIOs beyond mortality. This highlights the need to assess interventions in this field based on criteria important to patients. Besides the impact on the patient, the influence on their close family members and caregivers is significant. The transition from severe respiratory disease to near-normal respiratory function can lead to a reevaluation of the caregiver's role and responsibilities. Currently, researchers and clinicians in transplantation focus more on Patient-Reported Outcomes (PRO) than on outcomes important to patients. To bridge this gap, this study aims to identify PIOs from the perspectives of clinicians, transplant recipients, and their families. The Delphi method is chosen to gather anonymous expert opinions and reach a consensus on defining PIOs in the context of lung transplantation. Ultimately, this research aims to create a "core outcome set" necessary for LT research, incorporating dimensions beyond mortality, which is the traditional focus in assessing transplant outcomes.

Conditions

Lung Transplant

Keywords

Lung transplantation; Patient-Important Outcomes; Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• Identifying a set of outcome criteria defined as Patient Important Outcomes (PIO) from the perspective of physicians, paramedics, lung transplant patients, and their families

  Delphi method

  3 weeks

Secondary Outcomes (1)

• Evaluate the participation within each panel and at each round of the Delphi survey.

  3 weeks

Study Arms (4)

Lung transplant patients

Adult lung transplant patients followed at Hôpital Bichat (Paris) or Hôpital Foch (Suresnes)

Other: Questionnaire- Delphi method

Relatives of lung transplant patients

Close relatives of lung transplant patients (spouse; partner; first-degree parent) followed at Bichat Hospital (Paris) or Foch Hospital (Suresnes).

Other: Questionnaire- Delphi method

Physicians from lung transplant

Physicians from lung transplant centers in France, or French-speaking experts identified in the professional network of investigators

Other: Questionnaire- Delphi method

Paramedical staff

Nurses, psychologists, physiotherapists, etc.) from the same French center or French-speaking centers whose primary focus is on caring for lung transplant patients

Other: Questionnaire- Delphi method

Interventions

Questionnaire- Delphi method OTHER

Identify important evaluation criteria for lung transplant patients by rating each criterion

Lung transplant patients; Paramedical staff; Physicians from lung transplant; Relatives of lung transplant patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Lung transplant patients * Relatives of lung transplant patients * Physicians * Pramedical staff

You may qualify if:

• Lung transplant patients followed at Bichat Hospital (Paris) or Foch Hospital (Suresnes).
• Close relatives of lung transplant patients (spouse; partner; first-degree parent) followed at Bichat Hospital (Paris) or Foch Hospital (Suresnes).
• Physicians from lung transplant centers in France, or French-speaking experts identified in the professional network of investigators.
• Paramedical staff (state certified nurses, psychologists, physiotherapists, etc.) from the same French center or French-speaking centers whose primary focus is on caring for lung transplant patients.

You may not qualify if:

• Patients or close relatives under guardianship or protective supervision.
• Minor patients or minor close relatives.
• Patients or close relatives of recently transplanted patients (immediate post-transplant hospitalization).
• Patients or close relatives of patients who have undergone a combined transplant (liver-lung, heart-lung, kidney-lung).
• Non-comprehension of the French language.
• Inability to use computer tools.
• Refusal to participate.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• WEISENBURGER Gaëlle, MD

  ASSISTANCE PUBLIQUE HOPITAUX DE PARIS-Hôpital Bichat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WEISENBURGER Gaëlle, MD

CONTACT

01 40 25 69 13; gaelle.weisenburger@aphp.fr

MESSIKA Jonathan, MD/PhD

CONTACT

j.messika@hopital-foch.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: October 10, 2023
• Primary Completion: January 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09