Journal of evaluation in clinical practice
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Review
Patient and public involvement in the design of clinical trials: An overview of systematic reviews.
Funders encourage lay-volunteer inclusion in research. There are controversy and resistance, given concerns of role confusion, exploratory methods, and limited evidence about what value lay-volunteers bring to research. This overview explores these areas. ⋯ Involving patients and the public in clinical trials design can be beneficial but requires resources, preparation, training, flexibility, and time. Issues to address include reporting deficits for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.
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Despite proven benefits for reducing incidence of major cardiac events, antihypertensive drug therapy remains underutilized in the United States. This analysis assesses antihypertensive drug adherence, utilization predictors, and associations between adherence and outcomes (a composite of cardiovascular events, Medicare inpatient payments, and inpatient days). ⋯ Despite having medical and prescription coverage, nearly a third of hypertensive participants were not adherent to antihypertensive drug therapy. Differences in clinical outcomes associated with nonadherence, though not statistically significant, were consistent with results from randomized trials. The approach provides a model framework for rigorous assessment of detailed data that are increasingly available through emerging sources.
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Evidence-Based Medicine (EBM), Values-Based Practice (VBP) and Person-Centered Healthcare (PCH) are all concerned with the values in play in the clinical encounter. However, these recent movements are not in agreement about how to discover these relevant values. ⋯ I argue that although average values for populations might be very useful in informing questions of resource distribution and policy making, their use cannot replace the individual solicitation of patient (and other stakeholder) values in the clinical encounter. Because of the inconsistency of the EBM stance on values, the incompatibility of some versions of the EBM treatment of values with PCH, and EBM's attempt to transplant research methods from science into the realm of values, I must recommend the use of the VBP account of values discovery.
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Regardless of health issue, health sector, patient condition, or treatment modality, the chances are that provision is supported by "a guideline" making professionally endorsed recommendations on best practice. Against this background, research has proliferated seeking to evaluate how effectively such guidance is followed. These investigations paint a gloomy picture with many a guideline prompting lip service, inattention, and even opposition. This predicament has prompted a further literature on how to improve the uptake of guidelines, and this paper considers how to draw together lessons from these inquiries. ⋯ Health care decision makers operate in systems that are awash with guidelines. But guidelines only have paper authority. Managers do not need a checklist of their pros and cons, because the fate of guidelines depends on their reception rather than their production. They do need decision support on how to engineer and reengineer guidelines so they dovetail with evolving systems of health care delivery.
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The physician is often implicated as an important cause of observed variations in health care service use. However, it is not clear if physician-related variation is problematic for patient care. This paper illustrates that observed physician-related variation is not necessarily unwarranted. ⋯ It is not enough to simply show that physician-related variation can exist-one must also show where it is unwarranted and what is the magnitude of unwarranted variations. Failure to show this can have significant implications on how we interpret and respond to observed variations. Improved measurement of the sources of variation, especially with respect to patient preferences and context, may help us start to disentangle physician-related variation that is desirable from that which is unwarranted.