Developing palliative care interventions in liver disease using formative and summative qualitative evaluation

Evaluation of the effectiveness of nascent care delivery interventions to integrate palliative care into end-stage-liver disease (ESLD) is limited. Intervention development and evaluation is a systematic, complex, and time-consuming process. Qualitative research approaches, known as formative and summative evaluations, are recommended during intervention development to explore intervention mechanisms, determine the need for refinement, and provide a deeper understanding of intervention efficacy, effectiveness, and implementation barriers and facilitators. Although qualitative formative and summative evaluations are resource-intensive, they provide critical information about intervention feasibility, patient and clinician acceptability, and patient-centeredness. This review summarizes how qualitative formative and summative evaluation methods can inform the design, adaptation, and evaluation of interventions to integrate palliative care into ESLD. We describe the completed qualitative summative evaluation study, embedded within PALliative Care for end stage LIVER diseases, an in-progress 19-site cluster randomized trial of hepatologist-led versus palliative specialist-led palliative care for patients with ESLD and their caregivers. We include patient, family, and clinician demographic data emphasizing how the sample is representative of the parent randomized clinical trial (RCT) and describe how the embedded qualitative study explored patient, family, and clinicians' perspectives on the intervention. Specifically, we sought to understand how the intervention was enacted (fidelity) and to provide a roadmap for future palliative care practice integration in ESLD. In conclusion, formative and summative evaluations play a vital role in improving interventions so that valuable and scarce palliative care resources are applied equitably and effectively and so that patients and their caregivers experience the best possible care and quality of life as they live with ESLD.