Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow (φ-PROMISE)

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Definition of the Minimal Important Difference; Definition of the Patients Acceptable Symptomatic State; Cultural Adaptation of Shoulder and Elbow PROMs

Treatments: Procedure: Surgical or non-surgical treatment

Study type: Observational

Funder types: Other

Identifiers

NCT05598541

HUS/715/2021

Details and patient eligibility

About

The purpose of φ-PROMISE project is to carry out a cultural adaptation (translate into Finnish and validate) some of the most frequently used shoulder- and elbow-specific patient-reported outcome measures, PROMs. In addition, we aim to investigate which outcome measures are the most relevant for assessing the severity of complaints and treatment outcomes. Also, we will define the Patients Acceptable Symptomatic State (PASS) and the Minimal Important Difference (MID) of the individual outcome measures.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Orthopedic outpatient visit at the Helsinki University Hospital
• Signed informed consent
• Age over 18 years
• Finnish as language of communication

Exclusion criteria

• Recent surgery (within 2 months)
• Insufficient compliance

Trial design

600 participants in 2 patient groups

Shoulder

Description:

Patients with shoulder problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital

Treatment:

Procedure: Surgical or non-surgical treatment

Elbow

Description:

Patients with elbow problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital

Treatment:

Procedure: Surgical or non-surgical treatment