Are Clinicians Ready for Safe Use of Stratified Therapy in Primary Biliary Cholangitis (PBC)? A Study of Educational Awareness.

BACKGROUND: Primary Biliary Cholangitis (PBC, formerly cirrhosis), is a chronic cholestatic liver disease which until spring 2016 had a single licensed therapy, Ursodeoxycholic acid (UDCA). Approximately 30% of patients do not respond to UDCA, and are high-risk for progressing to end stage liver disease, transplantation or death. A new era of stratified medicine with second-line therapies to treat high-risk disease is emerging, with the first such second-line agent obeticholic acid recently receiving FDA and EMA approval and entering practice. Recent experience in the USA of inappropriate use and associated deaths has highlighted concerns as to whether clinicians have the knowledge to implement second-line therapies appropriately and safely. METHODS: Online survey of knowledge regarding optimal PBC management in Gastroenterologists and Hepatologists in the USA; the first 100 completed responses from each group used for analysis. RESULTS: 80% of Hepatologists felt they were highly competent in their understanding of the importance of early diagnosis and early UDCA therapy in PBC compared with 65% of gastroenterologists. However, only 36% of Hepatologists and 30% of gastroenterologists felt competent at assessing response to UDCA. Competence in knowledge (mode of action, efficacy, and side effects) of second-line therapies and enrollment into trials was low among both groups. CONCLUSION: Significant knowledge gaps in clinicians managing PBC presents a problem in optimizing care. It is perhaps not surprising that knowledge of emerging second-line therapies is low, however more concerning is sub-optimal use of UDCA in real-life practice and the lack of confidence at assessing treatment response which should be a routine part of clinical practice to assess risk of disease progression and will be key in delivering stratified medicine.

A Practical Approach for Developing Shared Decision-Making Knowledge, Skills, and Capability for Busy Health Care Practitioners.

BACKGROUND: There has been substantial development of shared decision-making (SDM) methods and approaches in the past few decades, but despite this, building capability and scaling application of SDM in clinical practice remains a challenge. Here the authors describe the development and initial experience with a new virtual Practical Approach continuing education program for busy practicing clinicians who care for people with complex, chronic, and costly conditions who are frequently faced with preference-sensitive decisions. This program was designed to provide plain language training in SDM for real-world clinical practice using an easy 4-step approach that does not require prior training or formal education in SDM theory or methods. METHODS: The authors describe the development of the Practical Approach program using established evidence-based principles. The program was piloted in 4 different settings across 2 chronic conditions. Qualitative interviews of program participants were conducted to observe SDM attitudes and observed performance in repeated case-based simulation role-play exercises to assess knowledge and skills performance. RESULTS: The authors observed improved and more realistic SDM attitudes in qualitative interviews with program participants after exposure to the program compared to baseline, and they similarly observed improved knowledge and skills demonstrated in sequential simulations conducted as participants were exposed to the program. Post-program focus groups revealed that participants perceived the program to be feasible, acceptable, and useful. CONCLUSIONS: Initial experience with the Practical Approach program suggests that it may beneficially affect basic SDM knowledge, skills, and attitudes in busy practicing clinicians who are novices in SDM. It also has demonstrated initial feasibility, utility, and acceptability.