Changes in Clinical Management of Patients with Schizophrenia Treated with Long-Acting Injectable Antipsychotics (LAIs), Including Telepsychiatry Use, During the COVID-19 Pandemic.

Purpose: The COVID-19 pandemic substantially impacted care of patients with schizophrenia treated with long-acting injectable antipsychotics (LAIs). This study (OASIS-MAPS) examined how clinical sites adapted operations and used telepsychiatry to maintain standard of care for these patients during the pandemic. Methods: Two online surveys (initial: October-November 2020, N = 35; follow-up: July-September 2021, N = 21) were completed by a principal investigator (PI) or PI-appointed designee at sites participating in the OASIS study (NCT03919994). Survey responses were analyzed descriptively. Results: At the time of the initial survey, all 35 participating sites were using variants of telepsychiatry, with 20 sites adopting it after the pandemic started. Most sites reported no negative impacts of the pandemic on medication adherence, although approximately 20% of sites reported decreased adherence for LAIs. Twelve sites (34%) reported switching patients with schizophrenia from LAIs to oral antipsychotic medications, while 11 sites (31%) reported switching patients from shorter to longer injection interval LAIs during the pandemic. Most sites did not experience difficulties in implementing or expanding telepsychiatry services, although lower reimbursement rate for telepsychiatry and patients' lack of access to and training on relevant technologies were the most frequently reported barriers. Conclusion: Changes made by sites after the pandemic onset were viewed by almost all participants as satisfactory for maintaining standard of care. Almost all participants thought that the use of telepsychiatry services would continue after the pandemic in a hybrid manner combining telepsychiatry and office visits. Ensuring that patients have equitable access to telepsychiatry will be important in the post-pandemic future.

A model analysis of costs of blood pressure destabilization and edema associated with rofecoxib and celecoxib among older patients with osteoarthritis and hypertension in a Medicare Choice population.

BACKGROUND: Economic analyses consider all costs relevant to the use of a particular treatment or treatments. Recently, head-to-head, randomized, controlled trials have shown a significantly higher incidence of blood pressure (BP) destabilization and clinically significant edema with rofecoxib than with celecoxib among older, hypertensive patients with osteoarthritis (OA). OBJECTIVE: The objective of this analysis was to estimate the COX-2 specific inhibitor medication costs, in addition to the costs of drugs and physicians' fees, for BP destabilization and clinically significant edema associated with the use of rofecoxib 25 mg QD and celecoxib 200 mg QD in patients with OA and hypertension in a Medicare Choice population (aged > or = 65 years). METHODS: A decision analysis model was constructed to determine the costs (from the payer's perspective) of treating patients in this population with either of the 2 regimens for 6 weeks. The analysis used pooled data from 2 recent, independently conducted, multicenter, double-blind, randomized, controlled trials of OA patients aged > or = 65 years with treated hypertension who received either celecoxib 200 mg QD or rofecoxib 25 mg QD for 6 weeks. In the individual trials, rofecoxib was associated with significantly higher rates of destabilized BP (P < 0.032 and P < 0.001) and edema (P < 0.01 and P = 0.045) than celecoxib. RESULTS: For a 100,000-member Medicare Choice population, an estimated 25,630 persons would have OA and hypertension (stages I-III), and an estimated 5126 of these patients would use celecoxib or rofecoxib. The estimated costs were 33,938 dollars (6.2%) higher if all hypertensive patients with OA were treated with rofecoxib rather than celecoxib for 6 weeks. The cost per day of use was 0.16 dollars less with celecoxib, and per-patient, per-month costs were 4.79 dollars lower. CONCLUSION: Celecoxib was a less costly treatment option than rofecoxib among OA patients with hypertension aged > or = 65 years, based on our model of the direct costs of COX-2 specific inhibitor therapy combined with those associated with physician monitoring and treatment of edema and BP destabilization.

Patient registries: a new gold standard for "real world" research.

Physicians in community-based practice rarely have the time, nor the inclination, to participate in formal, controlled clinical research. While few would question the importance of statistically valid clinical trials focused on establishing the safety and efficacy of new pharmaceuticals and medical devices, most busy practitioners recognize that formal clinical research can't be approached casually. Beyond the operational infrastructure typically required to execute medical research, the imposition of fundamentally experimental research is such that it is not easily accommodated in day-to-day medical practice. Indeed, the often artificial nature of controlled clinical research is, in many ways, incompatible with actual practice conditions. However, the characteristics and, more importantly, the outcomes of "real world" medical practice are becoming of increasing scientific and practical importance. Underscored by recent post-approval drug recalls, the "real world" practice environment can be an invaluable source of information on the actual effectiveness of treatment regimens, drugs, and devices. Inasmuch as clinical trials tend to exclude noncompliant patients and those with comorbid conditions, a new paradigm is appropriate for capturing the outcomes of actual practice. While not without statistical and analytical limitation, the brand of "naturalistic" research undertaken in observational patient registries is becoming rapidly accepted by both the scientific and practitioner communities.