Validation of the Hospital Anxiety and Depression Scale in Patients with Decompensated Cirrhosis

Background: The Hospital Anxiety and Depression Scale (HADS) demonstrates strong psychometric properties in many populations of patients with serious illness. However, its psychometric performance among patients with decompensated cirrhosis (DC) has not been examined. We investigated the reliability, validity, and responsiveness of the HADS for patients with DC. Methods: This observational study utilized data from patients with DC at enrollment and week 6 follow-up. Two hundred eighteen outpatients with DC were recruited from a liver transplant center, with 145 completing week 6 assessment. We evaluated psychological distress using HADS and Patient Health Questionnaire 9 (PHQ-9). Patients' health-related quality of life (HRQOL) was assessed using the Short-Form Liver Disease Quality of Life questionnaire. We examined reliability, floor/ceiling effects, structural validity, and known-groups validity for anxiety (HADS-Anxiety) and depression (HADS-Depression) subscales. We assessed the convergent validity with the PHQ-9. We predicted the change in HRQOL using the change in depression and anxiety. We also evaluated the internal responsiveness to changes in HRQOL for both HADS-Anxiety and HADS-Depression from baseline to week 6. Results: The HADS-Anxiety and HADS-Depression subscales showed strong internal consistency (Cronbach's alpha>0.8), adequate floor/ceiling effects (<15%), and excellent convergent validity with PHQ-9 (r>0.7). Both domains significantly predicted the changes in HRQOL longitudinally. Both HADS-Anxiety (1.8 [95% confidence interval [CI]: 0.5, 3.2]) and HADS-Depression (2.2 [95%CI: 1, 3.4]) showed responsiveness in patients with decreased HRQOL. Conclusions: The HADS is a reliable, valid, responsive tool for assessing anxiety and depression among patients with DC. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by the American Association for the Study of Liver Diseases Clinical, Translational, and Outcomes Research Award (NNU), Massachusetts General Hospital Physician Scientist Development Award (NNU), Sojourns Scholar Award from the Cambia Health Foundation (NNU). None of the sponsors had any role in the design and conduct of the study. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Mass General Brigham Institutional Review Board approved this study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data presented in this study are available on request from the corresponding author.