Understanding the quality chasm for hypertension control in diabetes: a structured review of "co-maneuvers" used in clinical trials.
BACKGROUND
Observational studies routinely describe a significant gap between rates of blood pressure control in routine diabetes care compared with those achieved in randomized controlled trials (RCTs).


METHODS
We performed a systematic review of the literature to identify co-maneuvers used in RCTs, defined as ancillary activities or agents administered before, during, or immediately after the main agent under investigation (ie, principal maneuver), but not effectively translated to routine diabetes care. We searched multiple databases for RCTs evaluating the efficacy of treatments for hypertension control in adults with type 2 diabetes mellitus. We considered only phase III human studies of interventions that achieved blood pressure control and scrutinized all elements related to the implementation of the principal maneuver in each candidate study. These elements were then sorted into a taxonomy of co-maneuvers.


RESULTS
Nearly all eligible RCTs used highly consistent groups of co-maneuvers. These typically began with (1) the use of consensual and clearly stated blood pressure goals; (2) frequent visits in which blood pressure levels were measured and compared with predefined goals; and, if the goal was not attained, (3) modifications to the treatment based on a detailed action plan that included communication of adverse events. Patient education, feedback to clinicians, and interventions for medication adherence were not commonly used among eligible trials.


CONCLUSIONS
Clinicians should translate key behavioral co-maneuvers along with clinically proven treatments for hypertension control in diabetes. These co-maneuvers are conceptually similar to collaborative goal setting and action planning interventions used in innovative chronic care programs.
Naik
Aanand D
AD
Houston Center for Quality of Care and Utilization Studies, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX 77030, USA. anaik@bcm.tmc.edu
Issac
Tim T
TT
Street
Richard L
RL
Kunik
Mark E
ME
D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D019317:Evidence-Based Medicine; D005194:Family Practice; D006801:Humans; D006973:Hypertension / Q000517:prevention & control*; D010346:Patient Care Management; D011787:Quality of Health Care; D016032:Randomized Controlled Trials as Topic