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

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.

Study Overview

• Status: Recruiting
• Conditions: Cultural Adaptation of Shoulder and Elbow PROMs; Definition of the Patients Acceptable Symptomatic State; Definition of the Minimal Important Difference
• Intervention / Treatment: Procedure: Surgical or non-surgical treatment

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Thomas Ibounig, MD; Phone Number: +358403567693; Email: thomas.ibounig@helsinki.fi
• Study Contact Backup: Name: Saara Raatikainen; Phone Number: +358503744600; Email: saara.raatikainen@hus.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Central Hospital
    • Contact: Thomas Ibounig, MD; Phone Number: +358403567693; Email: thomas.ibounig@helsinki.fi
    • Contact: Saara Raatikainen; Phone Number: +358503744600; Email: saara.raatikainen@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Secondary care outpatient clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shoulder; Patients with shoulder problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital	Procedure: Surgical or non-surgical treatment; Surgical treatment (depending on diagnosis) Non-surgical treatment (such as exercise therapy, pain medication, watch and wait)
Elbow; Patients with elbow problems presenting to the orthopaedic outpatient clinic of the Helsinki University Hospital	Procedure: Surgical or non-surgical treatment; Surgical treatment (depending on diagnosis) Non-surgical treatment (such as exercise therapy, pain medication, watch and wait)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation	Assessment of inter- and intra- observer reliability of different outcome measures	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASS	Definition of the Patients Acceptable Symptomatic State for different outcomes	1 year
MID	Definition of the Minimal Important Difference for different outcomes	1 year

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: shoulder; patient reported outcomes; validation; elbow; transcultural adaptation; patients acceptable symptomatic state (PASS); minimal important difference (MID)
• Other Study ID Numbers: HUS/715/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No