Development of the PeLTQL
The PeLTQL was developed and validated using published well-established tool development methodology (8) as detailed in the following flow diagram.
Reference: Z Younossi, G Guyatt, M Kiwi, N Boparai, and D King Development of a disease-specific questionnaire to measure HRQOL in
patients with chronic liver disease." Gut 1999; 45: 295
Phase I: Development involved item generation (generating items relevant to HRQOL in children after liver transplantation through health-care providers’ focus groups, parent and patient interviews, as well as a thorough review of the published English literature). A list of items generated was compiled and subsequently reduced based on frequency and pertinence using an expert-based approach. Item Reduction involved developing and administering a pilot questionnaire to paediatric liver transplant recipients and their parents followed by paediatric liver transplant programs in Canada, the UK, Australia, and the United States. Participants rated items based on importance and frequency of concern and items were selected to be included in the final PeLTQL based on a high impact score derived from the product of the frequency and importance for each item.
Validation of the PeLTQL
The final 26-item PeLTQL was administered to 134 paediatric liver transplant recipients and their parents to assess reliability, validity and sensibility.
Reliability assessed if PeLTQL scores were similar when obtained on subsequent assessments if no change in disease status has occurred, using test-retest reliability. Another aspect of reliability, internal consistency, was also assessed. Reliability of PeLTQL was excellent.
• Test-retest reliability yielded an intraclass correlation coefficient = 0.86
• Internal consistency yielded a Cronbach’s α = 0.85.
Sensibility assessed if the PeTLQL was appropriate in content and user friendly
• Number of PeLTQL questions left blank: 17/3484 (0.5 per cent)
• Self-administration time : less than five minutes
• Readability: Flesch-Kincaid = Grade five level
Construct validity assessed whether the PeTLQL acted as predicted when compared with other existing patient-oriented and validated outcome measures. PeLTQL scores were compared to the following concurrently measured outcomes:
• PedsQL™ 4.0 – Paediatric Quality of Life Inventory
• CSAS –Cantril’s Self-Anchoring Striving Scale
• SCARED – Screen for Child Anxiety Related Disorders
• CDI-S – Children’s Depression Inventory (Short form)
• MTB – Medication-Taking Behaviour
• FAS – Family Awareness Scale
Selected Tables from:"Development and validation of the pediatric liver transplantation quality of life: a disease-specific quality of life measure for pediatric liver transplant recipients" Journal of Pediatrics 2014
Lower PeLTQL scores seen in participants with cut-scores on the CDI-S and SCARED tools are indicative of probable clinical depression and anxiety, and suggest future follow-up assessments to address mental health needs. Although lower patient PeLTQL scores correlated strongly with clinical cut-scores on validated anxiety and depression tools for children, causality of this relationship cannot be inferred.
Attention to children’s mental health issues by health-care providers is an emerging concern, and the PeLTQL should prove a helpful non-stigmatizing tool to begin discussions with patients and their parents related to the often sensitive issue of mental health.