Outcomes In Routine Care Research Articles

Developments in post-marketing comparative effectiveness research.

Physicians and insurers need to weigh the effectiveness of new drugs against existing therapeutics in routine care to make decisions about treatment and formularies. Because Food and Drug Administration (FDA) approval of most new drugs requires demonstrating efficacy and safety against placebo, there is limited interest by manufacturers in conducting such head-to-head trials. Comparative effectiveness research seeks to provide head-to-head comparisons of treatment outcomes in routine care. Health-care utilization databases record drug use and selected health outcomes for large populations in a timely way and reflect routine care, and therefore may be the preferred data source for comparative effectiveness research. Confounding caused by selective prescribing based on indication, severity, and prognosis threatens the validity of non-randomized database studies that often have limited details on clinical information. Several recent developments may bring the field closer to acceptable validity, including approaches that exploit the concepts of proxy variables using high-dimensional propensity scores, within-patient variation of drug exposure using crossover designs, and between-provider variation in prescribing preference using instrumental variable (IV) analyses.

Presidential address: What we have learned from a decade of research aimed at improving psychotherapy outcome in routine care

The findings of a decade-long program of research aimed at tracking patient treatment response are summarized. Outcome measures were developed and applied on a weekly basis with patients undergoing therapy in routine practice. Treatment response was defined as reliable and clinically significant change, and longitudinal statistical models for identifying poor progress were applied. The author was able to estimate the amount of therapy necessary for recovery, study early dramatic improvers, and assess the consequences of providing practitioners with alarm signals when patients were off track for a positive outcome. Results indicate that integrating treatment response research into routine mental health care reliably improved positive outcomes and reduced negative outcomes. Future directions for this line of action research are suggested.