Evaluation of patient/caregiver and healthcare provider knowledge, attitudes and behavior for safety and use of pexidartinib.

Aim: Pexidartinib was approved for the treatment of tenosynovial giant cell tumors with a required Risk Evaluation and Mitigation Strategy (REMS) to ensure its safe use. As required by the REMS, a survey was conducted to document the knowledge, attitudes and behavior (KAB) of patients/caregivers and healthcare providers (HCPs) regarding the risk of serious and potentially fatal liver injury due to pexidartinib, the need for liver testing prior to and during treatment and the need for patient counseling about this risk. Patients & methods: The KAB survey was conducted among 40 patients and 18 HCPs enrolled in the pexidartinib REMS. Results: Among patients, 87.5% demonstrated understanding of key risk message (KRM) 1 (risk of serious liver injury), 87.5% demonstrated understanding of KRM2 (liver testing requirement) and 77.5% demonstrated understanding of both KRMs. Among HCPs, 83.3% demonstrated understanding of KRM1, 88.9% demonstrated understanding of KRM2, 100% demonstrated understanding of KRM3 (patient counseling) and 83.3% demonstrated understanding of all three KRMs. Conclusion: The KAB surveys demonstrated that the educational goals of the pexidartinib REMS were being achieved.

Lay abstract Pexidartinib is a prescription medicine used to treat adults who have a tenosynovial giant cell tumor that is not likely to improve with surgery. Because of the risk of serious liver problems, pexidartinib is available only through a restricted program called a Risk Evaluation and Mitigation Strategy (REMS) that enrolls both patients and healthcare providers (HCPs). As part of the REMS, information is collected about their knowledge, attitudes and behavior (KAB) regarding the potential for pexidartinib to cause liver problems that may be severe and can lead to death. This KAB survey was conducted among 40 patients and 18 HCPs enrolled in the pexidartinib REMS. The results indicated that among patients, over three-quarters demonstrated understanding of the risk of serious liver injury and the need for regular liver testing. Among HCPs, 83.3­100% demonstrated understanding of the risk of serious liver injury, the need for regular liver testing and the requirement to counsel their patients about this risk. In conclusion, the KAB surveys demonstrated that the educational goals of the pexidartinib REMS were being achieved.

A qualitative evaluation of patient and healthcare provider knowledge, attitudes, and behavior for safety and use of pexidartinib.

Aim: Pexidartinib is approved in the USA for the treatment of symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Due to risk of serious liver injury, a survey of patient and healthcare provider (HCP) knowledge, attitudes, and behavior (KAB) of the risks was required. Materials & methods: Prior to KAB survey execution, structured telephone interviews with 12 patients and 12 HCPs were conducted. Results: The interviews revealed that patients had difficulty with the complexity and wordiness of some of the questions, while HCPs noted that some questions were repetitive with terminology that was not self-explanatory. Of the 15 questions initially in the patient survey, nine were modified for survey inclusion. For the HCP survey, 10 of 18 questions were modified. Conclusion: Qualitative research prior to KAB surveys is recommended to improve comprehension and data quality.

Knowledge and Understanding of the Safety and Efficacy Aspects of BRIDION® Among Canadian Anesthesiologists.

BACKGROUND: BRIDION® (sugammadex sodium) is an agent for the reversal of neuromuscular blockade (NMB) induced by rocuronium and vecuronium in general anesthesia. Following the approval of sugammadex in Canada (February 2016), Health Canada required a survey to assess the knowledge and understanding of the safety and efficacy aspects of sugammadex among anesthesiologists in Canada. OBJECTIVE: Our objective was to evaluate how well the anesthesiologists in Canada understood the safety and efficacy aspects of sugammadex. METHODS: A survey was implemented among anesthesiologists in Canada via internet/phone. The survey was organized to test the knowledge of anesthesiologists by utilizing 11 key questions regarding the safety and efficacy of sugammadex. Five additional safety questions that were not considered part of the key messages but were important concepts for anesthesiologists to know when administering sugammadex were also included. RESULTS: A total of 202 completed surveys were collected. Based on an a priori threshold of understanding of 75%, 9 out of 11 key messages scored at or above this threshold. The two messages that scored below this threshold involved (1) knowledge that sugammadex is not indicated for use in children aged < 18 years (71.8%; 95% confidence interval [CI] 65.0-77.9) and (2) that monitoring is required for recurrence of NMB after reversal with sugammadex (73.3%; 95% CI 66.6-79.2). Of the five additional safety questions, four had an understanding rate of ≥ 88.1%. One question scored 60.4%; this question covered the concept that sugammadex is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min), including those requiring dialysis. CONCLUSION: In general, the survey results suggested that anesthesiologists understood the use, safety, and efficacy of sugammadex for the reversal of moderate to deep NMB induced by rocuronium or vecuronium in adults undergoing surgery.