Development and validation of a patient-reported questionnaire assessing systemic therapy induced diarrhea in oncology patients

Abstract

BackgroundSystemic therapy-induced diarrhea (STID) is a common side effect experienced by more than half of cancer patients. Despite STID-associated complications and poorer quality of life (QoL), no validated assessment tools exist to accurately assess STID occurrence and severity to guide clinical management. Therefore, we developed and validated a patient-reported questionnaire (STIDAT).MethodsThe STIDAT was developed using the FDA iterative process for patient-reported outcomes. A literature search uncovered potential items and questions for questionnaire construction used by oncology clinicians to develop questions for the preliminary instrument. The instrument was evaluated on its face validity and content validity by patient interviews. Repetitive, similar and different themes uncovered from patient interviews were implemented to revise the instrument to the version used for validation. Patients starting high-risk STID treatments were monitored using the STIDAT, bowel diaries and EORTC QLQ-C30. The STIDAT was evaluated for construct validity using exploratory factor analysis (EFA) using minimal residual method with Promax rotation, reliability and consistency. A weighted scoring system was developed and a receiver-operating characteristic (ROC) curve evaluated the tool’s ability to detect STID occurrence. Median scores and variability were analysed to determine how well it differentiates between diarrhea severities. A post-hoc analysis determined how diarrhea severity impacted QoL of cancer patients.ResultsPatients defined diarrhea based on presence of watery stool. The STIDAT assessed patient’s perception of having diarrhea, daily number of bowel movements, daily number of diarrhea episodes, antidiarrheal medication use, the presence of urgency, abdominal pain, abdominal spasms or fecal incontinence, patient’s perception of diarrhea severity, and QoL. These dimensions were sorted into four clusters using EFA – patient’s perception of diarrhea, frequency of diarrhea, fecal incontinence and abdominal symptoms. Cronbach’s alpha was 0.78; kappa ranged from 0.934–0.952, except for abdominal spasms (κ = 0.0455). The positive predictive value was 96.4%, with the minimum score of 1.35 predicting a positive STID occurrence. Patients with moderate or severe diarrhea experience significant decreases in QoL compared to those with no diarrhea.ConclusionsThis is the first patient-reported questionnaire that accurately predicts the occurrence and severity of diarrhea in oncology patients via assessing several bowel habit dimensions.

Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial

“…Additionally, patients receiving sunitinib were more likely to experience TEAEs that are considered clinically impactful and distressing such as stomatitis and diarrhea. [34][35][36] Even lower-severity diarrhea (moderate or grade 2) can be associated with psychologic distress and limitations in daily living activities, and patients report pain and discomfort with stomatitis/oral mucositis. 33,35,37 Nearly all grade 3/4 TEAEs ($ 2% in either arm) were more common with sunitinib (Fig 3B).…”

“… 34 - 36 Even lower-severity diarrhea (moderate or grade 2) can be associated with psychologic distress and limitations in daily living activities, and patients report pain and discomfort with stomatitis/oral mucositis. 33 , 35 , 37 …”

Mucosal barrier injury–associated bloodstream infections in pediatric oncology patients

“…We anticipate that using a definition of diarrhea based on frequency and/or consistency of stool is easier than using a volume-based definition that requires accurate measurement of stool output and normalization per body weight. Patient-reported symptom questionnaire tools have previously been developed and validated to accurately assess the occurrence and severity of diarrhea in adult oncology 17 and PHO patients. 18,19 This modified definition of diarrhea is anticipated to result in an increased and more accurate classification of MBI-LCBI, especially in the ambulatory care setting.…”

Impact of health‐related stigma on psychosocial functioning in cancer patients: Construct validity of the stigma‐related social problems scale

“…A major strength of this study is that the performance of the SSP was tested in a larger cancer population than similar validation studies of other instruments (Arraras et al., 2010; Guzelant et al., 2004; Lim, Miller, Kaambwa, & Koczwara, 2017; Lui, Gallo‐Hershberg, & DeAngelis, 2017; Rucci et al., 2018; Villoria & Lara, 2018; Yung et al., 2018). A large sample size makes it possible to perform psychometric analyses across subgroups, which is important for confirming the general applicability of a measure (McHorney et al., 1994).…”