Construct Validity of the Patient‐Reported Outcomes Measurement Information System Gastrointestinal Symptom Scales in Systemic Sclerosis

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/109333/1/acr22337.pd

Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases.

BACKGROUND & AIMS: Therapeutic drug monitoring (TDM) is widely available for biologic therapies in patients with inflammatory bowel disease (IBD). We reviewed current data and provided expert opinion regarding the clinical utility of TDM for biologic therapies in IBD. METHODS: We used a modified Delphi method to establish consensus. A comprehensive literature review was performed regarding the use of TDM of biologic therapy in IBD and presented to international IBD specialists. Subsequently, 28 statements on the application of TDM in clinical practice were rated on a scale of 1 to 10 (1 = strongly disagree and 10 = strongly agree) by each of the panellists. Statements were accepted if 80% or more of the participants agreed with a score ≥7. The remaining statements were discussed and revised based on the available evidence followed by a second round of voting. RESULTS: The panel agreed on 24 (86%) statements. For anti-tumor necrosis factor (anti-TNF) therapies, proactive TDM was found to be appropriate after induction and at least once during maintenance therapy, but this was not the case for the other biologics. Reactive TDM was appropriate for all agents both for primary non-response and secondary loss of response. The panellists also agreed on several statements regarding TDM and appropriate drug and anti-drug antibody (ADA) concentration thresholds for biologics in specific clinical scenarios. CONCLUSION: Consensus was achieved towards the utility of TDM of biologics in IBD, particularly anti-TNF therapies. More data are needed especially on non-anti-TNF biologics to further define optimal drug concentration and ADA thresholds as these can vary depending on the therapeutic outcomes assessed

Criteria for the definition of Pituitary Tumor Centers of Excellence (PTCOE): A Pituitary Society Statement

Introduction With the goal of generate uniform criteria among centers dealing with pituitary tumors and to enhance patient care, the Pituitary Society decided to generate criteria for developing Pituitary Tumors Centers of Excellence (PTCOE). Methods To develop that task, a group of ten experts served as a Task Force and through two years of iterative work an initial draft was elaborated. This draft was discussed, modified and finally approved by the Board of Directors of the Pituitary Society. Such document was presented and debated at a specific session of the Congress of the Pituitary Society, Orlando 2017, and suggestions were incorporated. Finally the document was distributed to a large group of global experts that introduced further modifications with final endorsement. Results After five years of iterative work a document with the ideal criteria for a PTCOE is presented. Conclusions Acknowledging that very few centers in the world, if any, likely fulfill the requirements here presented, the document may be a tool to guide improvements of care delivery to patients with pituitary disorders. All these criteria must be accommodated to the regulations and organization of Health of a given country

Quality indicators in inflammatory bowel disease

Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, is a chronic, debilitating, and expensive condition affecting millions of people globally. There is significant variation in the quality of care for patients with IBD across North America, Europe, and Asia; this variation suggests poor quality of care due to overuse, underuse, or misuse of health services and disparity of outcomes. Several initiatives have been developed to reduce variation in care delivery and improve processes of care, patient outcomes, and reduced healthcare costs. These initiatives include the development of quality indicator sets to standardize care across organizations, and learning health systems to enable data sharing between doctors and patients, and sharing of best practices among providers. These programs have been variably successful in improving patient outcomes and reducing healthcare utilization. Further studies are needed to demonstrate the long-term impact and applicability of these efforts in different geographic areas around the world, as regional variations in patient populations, societal preferences, and costs should inform local quality improvement efforts

Review: Predicting response to anti-TNF agents for the treatment of Crohn's disease

The arrival of anti-tumor necrosis factor (TNF) agents has led to a dramatic improvement in the care of patients with Crohn's disease. Since these medications do not work in everyone, and are associated with rare, but serious side effects, we want to selectively treat patients who have the highest chance of responding. A number of variables have been studied to determine their association with response to anti-TNF agents. Clinical parameters include patient characteristics, smoking status and disease phenotype, and biologic markers include C-reactive protein, serum TNF levels and immune responses to microbial antigens. More recently, research has focused on genetics to identify polymorphisms associated with treatment response. Results from individual studies of these factors have not yet allowed for solid clinical applicability. However, further work in this area along with multivariate clinical prediction modeling may soon allow us to deliver `personalized medicine' by predicting individualized treatment response in patients with Crohn's disease