Patient-Reported Outcomes in Chinese Rheumatoid Arthritis Patients: A Systematic Review and Meta-Analysis

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Patient-Reported Outcomes in Chinese Rheumatoid Arthritis Patients: A Systematic Review and Meta-Analysis

Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by joint inflammation, systemic manifestations, and reduced quality of life. While traditional evaluations of RA have relied on laboratory markers and clinician assessments, patient-reported outcomes (PROs) have gained prominence in recent guidelines for their ability to capture patients’ perspectives on disease burden and treatment efficacy. This systematic review and meta-analysis aimed to evaluate the utilization, reporting patterns, and baseline characteristics of PROs among Chinese RA patients, providing insights into gaps and opportunities for standardization in clinical practice and research.

Methodology

Search Strategy and Inclusion Criteria
A comprehensive literature search was conducted across PubMed, Cochrane Library, Wanfang, China National Knowledge Infrastructure (CNKI), and China Science and Technology Journal (CSTJ) databases in January 2019. Studies published between January 1, 2016, and December 31, 2018, were included if they reported PRO data for Chinese RA patients aged ≥18 years. Exclusion criteria included non-English/Chinese articles, animal/in vitro studies, reviews, duplicates, validation studies of PRO tools, and studies focusing on non-guideline-recommended traditional Chinese medicine. To ensure quality, studies with fewer than 50 patients and Chinese-language articles not published in Peking University’s “core journals” (2018 edition) were excluded.

Data Extraction and Classification
Two independent reviewers screened titles, abstracts, and full texts, resolving discrepancies through consensus. Data extraction included study design, sample size, PRO measures, and outcomes. PROs were categorized into 15 predefined health domains (e.g., pain, physical function, psychological status) based on prior frameworks and the European League Against Rheumatism (EULAR) outcome library. Composite indices like the Disease Activity Score (DAS28-ESR) and American College of Rheumatology (ACR) response criteria were included if they incorporated patient-reported components such as patient global assessment (PGA).

Statistical Analysis
Meta-analyses were performed for frequently reported PRO measures at baseline and follow-up. Missing data were imputed using conservative assumptions (e.g., assigning the worst values for incomplete standard deviations). Heterogeneity was assessed using the I² statistic, with values >50% indicating substantial variability. Fixed-effect models were applied for homogeneous data (I² ≤50%), while random-effect models were used for heterogeneous datasets (I² >50%). Analyses were conducted in Stata 15 and Microsoft Excel.

Key Findings

Study Characteristics
From 7,591 initially identified articles, 166 studies (71 interventional, 95 observational) involving 28,462 patients met inclusion criteria. Interventional studies included randomized controlled trials (RCTs) and non-RCTs, while observational designs encompassed cross-sectional, cohort, and case-series studies. The average number of PRO measures per study was 3.4 ± 2.3, ranging from 1 to 11.

PRO Utilization and Reporting Patterns
A total of 103 distinct PRO tools were identified, including 27 composite indices and 76 domain-specific measures. The most frequently reported PROs were:

  1. Pain Visual Analog Scale (VAS): 61 studies (36.7%),
  2. Morning Stiffness Duration (MSD): 54 studies (32.5%),
  3. Health Assessment Questionnaire (HAQ): 47 studies (28.3%).

Composite indices were reported in 102 studies (61.4%), with DAS28-ESR being the most common (24.7% of studies). The ACR20/50/70 and EULAR response criteria were reported in 15.7% and 9.0% of studies, respectively.

Health Domain Coverage
PROs spanned 15 health domains. The most frequently assessed domains were:

  1. Pain: 70 studies (42.2%), primarily using pain VAS (87.1% of pain assessments),
  2. Physical Function: 66 studies (39.8%), predominantly via HAQ (71.2%),
  3. Morning Stiffness: 54 studies (32.5%), exclusively measuring MSD.

Domains with moderate reporting included:

  • Patient Global Assessment (PGA): 29 studies (17.5%), using PGA VAS (75.9%),
  • Quality of Life (QoL): 29 studies (17.5%), primarily via SF-36 (65.5%),
  • Psychological Status: 27 studies (16.3%), assessed using 16 tools, most commonly the Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (33.3%).

Underreported domains included fatigue (9.0% of studies), sleep disturbance (5.4%), and coping (4.8%).

Baseline PRO Scores
Meta-analyses of baseline PRO data revealed:

  • Pain VAS (0–10 cm): Mean score 5.6 (95% CI: 5.2–6.0),
  • HAQ (0–3): Mean score 1.4 (95% CI: 1.0–1.9),
  • Morning Stiffness Duration: 92.1 minutes (95% CI: 79.3–105.0),
  • PGA VAS (0–10 cm): Mean score 5.8 (95% CI: 5.2–6.3),
  • SF-36 Total Score (0–100): 47.2 (95% CI: 41.1–53.3),
  • Fatigue VAS (0–10 cm): 4.9 (95% CI: 3.9–5.9).

Longitudinal data showed improvements in pain, function, and QoL with treatment, though heterogeneity limited pooled estimates for follow-up outcomes.

Discussion

Alignment with Guidelines and Global Trends
The frequent reporting of pain, function, morning stiffness, and PGA aligns with the ACR/EULAR core outcome sets for RA trials. Pain VAS and HAQ dominance reflects global trends, where these tools are prioritized for their simplicity and validity. However, underreporting of fatigue and psychological status highlights a gap, as these domains significantly impact patient well-being but are not emphasized in guidelines.

Heterogeneity in PRO Tool Selection
While pain and function assessments were relatively standardized, psychological status evaluations used 16 distinct tools, including non-validated scales. This heterogeneity complicates cross-study comparisons and underscores the need for standardized tools in mental health assessment.

Comparability of Chinese PRO Data
Baseline pain, HAQ, and SF-36 scores among Chinese patients were consistent with global RA populations. For example, the mean HAQ score of 1.4 parallels scores reported in European and North American cohorts, suggesting similar functional impairment levels. However, cultural factors may influence PRO reporting, necessitating region-specific validation of tools.

Limitations and Recommendations

  1. Selection Bias: Exclusion of smaller studies and non-core journals may overlook regional variations in PRO usage.
  2. Longitudinal Data Gaps: Few studies reported follow-up PROs, limiting insights into treatment effects over time.
  3. Tool Standardization: Variability in psychological and fatigue assessments calls for guideline-driven harmonization.

Conclusion

This review demonstrates that Chinese RA studies largely adhere to international standards for PRO reporting in pain, function, and disease activity. However, critical domains like fatigue and mental health remain underrepresented, with inconsistent tool selection reducing data comparability. Future efforts should prioritize guideline updates to include underreported domains, validate PRO tools for Chinese populations, and improve longitudinal PRO tracking to better inform clinical decision-making.

doi.org/10.1097/CM9.0000000000001582

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