Understanding Symptoms and Meaningful Change in Patient Global Impression Scales for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (adv/met NSCLC): A Qualitative Research Study
Author(s)
Kelly K1, Cardellino A2, Shah M2, Hanlon J3, Taiyari S4, Roborel de Climens A5, Stojadinovic A2
1IQVIA, New York, NY, USA, 2GSK, Collegeville, PA, USA, 3GSK, Waltham, MA, USA, 4GSK, Stevenage, UK, 5IQVIA, Paris, France
OBJECTIVES: NSCLC, particularly at advanced stages, causes significant symptom burden. This study aimed to gain insight into patients’ experience with adv/met NSCLC and understand what constitutes meaningful change in cancer symptoms using Patient Global Impression of Severity (PGIS) and Change (PGIC) instruments.
METHODS: Semi-structured, qualitative, 45–60-minute open-ended question interviews were conducted by telephone/virtual platform with US patients with adv/met NSCLC. Patients discussed their most bothersome NSCLC symptoms and impacts, and rated their ‘current’ (last 7 days) and ‘previous’ (6–12 months ago) symptoms using PGIS and PGIC, which were also debriefed.
RESULTS: Nineteen patients (aged 28–71; 95% female) with Stage IV NSCLC were interviewed. Most were receiving targeted therapy (63%) and were diagnosed with adv/met NSCLC >12 months prior (79%). All patients understood well the PGIS/PGIC items/response options; however, some had difficulty distinguishing cancer symptoms from treatment side-effects when conducting evaluations. The most commonly reported symptoms included shortness of breath/difficulty breathing, fatigue, cough and pain. Most patients (14/19) rated their ‘current’ cancer symptoms as ‘mild’ or ‘moderate’ on the 5-point PGIS. Nearly all patients deemed a 1-point PGIS improvement or worsening to be meaningful (14/17 and 16/18 patients, respectively; 2 patients reported ‘no current symptoms’, 1 reported ‘very severe’ symptoms and therefore could not be included in the improvement/worsening assessments). Comparing ‘current’ versus ‘previous’ symptoms on the 5-point PGIC, 6 patients were ‘a little worse’, 5 were ‘much better’. For 10/18 patients, ‘no change’ was considered meaningful (positively or negatively). A 1-point change (‘a little better/worse’) in PGIC was deemed meaningful by 17/19 patients.
CONCLUSIONS: Cancer symptoms PGIS and PGIC were clear and provided valuable insights into symptoms of adv/met NSCLC. A 1-point meaningful change threshold in PGIS/PGIC was identified as an anchor for patient-reported outcomes.
Funding: GSK (215353). Editorial support by Fishawack Health, funded by GSK.Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
PCR37
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas