Exploring the optimal follow-up for systemic sclerosis patients: study protocol for a Dutch multicenter randomized...

Area of Science:

• Rheumatology
• Clinical Trial Design
• Health Services Research

Background:

• Current systemic sclerosis (SSc) follow-up lacks evidence-based guidelines, relying on expert opinion for annual extensive evaluations.
• A multidisciplinary Care Pathway improved patient satisfaction and outcomes but may be excessive for low-risk SSc patients.
• There's a need for tailored SSc care based on individual disease activity and progression risk.

Purpose of the Study:

• To evaluate the non-inferiority of regular outpatient clinic follow-up compared to an extensive annual Care Pathway evaluation for low-risk systemic sclerosis patients.
• To determine if routine assessment is an acceptable alternative to standardized, intensive annual evaluations in SSc management.
• To inform the development of evidence-based guidelines for SSc patient follow-up.

Main Methods:

• A multicenter, non-inferiority randomized controlled trial involving 250 SSc patients categorized by disease progression risk (low, intermediate).
• Patients with low or intermediate risk were randomized to either outpatient clinic follow-up (intervention) or the standard annual Care Pathway (control).
• Primary outcome: healthcare utilization; Secondary outcomes: disease progression, patient perception, quality of life. Analysis via descriptive statistics and regression.

Main Results:

• This section is to be filled once the study results are available.
• The study is designed to compare healthcare utilization and clinical outcomes between the two follow-up strategies.
• Results will indicate the feasibility and effectiveness of a less intensive follow-up for specific SSc patient groups.

Conclusions:

• This is the first randomized controlled trial to assess optimal follow-up strategies for low-risk SSc patients.
• Study results will clarify if outpatient clinic assessment is a viable alternative to comprehensive annual evaluations.
• Findings aim to support the creation of personalized, evidence-based follow-up protocols for systemic sclerosis management.