Development and Evaluation of Psychometric Properties of a Common Module for the Quality of Life Scale of Living Organ Donors (QLSLOD-CM V1.0) Based on Liver Donors
Living organ donation involves healthy individuals voluntarily undergoing surgical procedures to donate organs, exposing them to physical and psychological risks. While donor safety remains a priority, the impact of donation on quality of life (QoL) necessitates a robust assessment tool. Existing instruments, including generic tools like the 36-item Short Form Health Survey (SF-36) and disease-specific questionnaires, lack precision in capturing the unique experiences of living donors. Generic tools may overlook surgery-specific concerns, while disease-specific instruments are not tailored to healthy donors. Self-developed tools address some gaps but lack standardization. In China, no consensus exists on a QoL scale specific to living organ donors. This study developed and validated the Quality of Life Scale for Living Organ Donors-Common Module (QLSLOD-CM V1.0), a core component of a broader scale system designed to assess QoL across all donor types.
Development of the QLSLOD-CM V1.0
The scale was developed through a seven-step process aligned with the World Health Organization’s QoL framework, encompassing six domains: physical function, psychological state, level of independence, social relationships, environment-related factors, and personal beliefs. A cross-sectional study was conducted at two Chinese hospitals (Tianjin First Center Hospital and Beijing Friendship Hospital) from October 2015 to February 2019. Participants included liver donors aged ≥18 years, at least one month post-donation. The study was approved by the Peking University Institutional Review Board (IRB00001052-19005), with informed consent obtained from all participants.
Item Generation and Selection
An initial item pool of 74 potential questions was generated through literature reviews, interviews with liver and kidney donors, and consultations with healthcare professionals. Two rounds of the Delphi method, involving 32 experts, evaluated item relevance, clarity, and correlation. Experts rated items on a 5-point Likert scale, leading to the retention of 55 items. These were tested in a preliminary survey with 100 participants. Statistical methods—including variation analysis, item-total correlations, factor analysis, and cluster analysis—further refined the scale to 44 items.
Psychometric Evaluation
A subsequent evaluation phase involved 403 liver donors. Exploratory factor analysis (EFA) identified 12 factors explaining 61.03% of total variance. Six items with low factor loadings (<0.4) were removed or revised, resulting in a final 39-item scale structured into six domains. Internal consistency, measured via Cronbach’s alpha, ranged from 0.65 (social relationships) to 0.83 (physical function), indicating acceptable reliability. Test-retest reliability, assessed in 100 participants over two weeks, showed strong correlations (r = 0.78–0.92 across domains). Item-total correlations were statistically significant (p < 0.01), confirming scale coherence.
Structure and Application of the Scale
The QLSLOD-CM V1.0 comprises 39 items across six domains:
- Physical Function (8 items): Assesses pain, fatigue, and surgical recovery.
- Psychological State (7 items): Evaluates anxiety, self-esteem, and emotional stability.
- Level of Independence (6 items): Focuses on daily activities and work capacity.
- Social Relationships (7 items): Examines family dynamics and social support.
- Environment-Related Factors (6 items): Addresses financial stability and healthcare access.
- Personal Beliefs (5 items): Captures spiritual and existential perspectives.
The scale is designed for pre- and post-donation assessments, with 34 items applicable pre-donation. It emphasizes donor-specific concerns, such as post-surgical adjustment and long-term well-being, which generic tools often overlook.
Limitations and Future Directions
The study’s primary limitation is its focus on liver donors, potentially limiting generalizability to other donor types (e.g., kidney). The sample size, though sufficient for initial validation, may restrict subscale analyses. Future studies will expand to include kidney donors, enabling confirmatory factor analysis and criterion validity testing. Cross-cultural adaptation for non-Chinese contexts will require rigorous translation and validation.
Conclusion
The QLSLOD-CM V1.0 represents a significant advancement in QoL assessment for living organ donors. Its development process, combining expert consensus, statistical rigor, and donor input, ensures relevance and reliability. By addressing gaps in existing tools, the scale provides a standardized method to evaluate donor well-being, guiding clinical interventions and policy improvements. Ongoing research will enhance its applicability across diverse donor populations and cultural settings.
doi.org/10.1097/CM9.0000000000000833
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