Disputing Guidelines

There is without a doubt that measures used today in P4P programs will change in the future as research continuously changes clinical practice guidelines. Therefore, elements must be in place to allow for P4P programs to adapt to new guidelines. Below there hopes to be summaries of guidelines that have adapted to new evidence.
     
      Example)  A1c levels. Recent studies (ACCORD, ADVANCE, VADT) have undermined the evidence supporting the well entrenched and commonly used P4P measure of maintaining a Diabetic patient’s A1c<7. The specific challenge this creates for P4P programs is how they ought to respond to this new evidence. Common questions stemming from this controversy include:

Will this new evidence undermine our trust in P4P altogether?

Are P4P programs designed to accommodate new evidence, and if not, what changes are required?

How should individual clinicians respond to this new evidence? (i.e. maintain the traditional goal of A1c<7 so long as P4P programs maintain it, pick a new goal of A1c<7.5 or 8, apply the traditional guideline to lower risk Diabetic patients, abandon P4P guidelines altogether…)

 

The current literature holds more questions than answers. Nevertheless, this unanticipated consequence of P4P is history in the making.

 

Disputing Guidelines Literature
 

(54) Johnson K. Tightest Glucose Control May Cause Harm; Trial Altered. Family Practice News. February 2008: 38(4) 1-2.

Link: http://www.familypracticenews.com/article/S0300-7073(08)70207-X/fulltext

Summary:

  • Report of ACCORD trial showing poorer outcomes with tightly controlled HbA1c levels
  • Standard outcomes may not be best for all patients.

Significance to Literature:

Report of first major trial questioning A1C<7 guideline.

 

 

(170) The ADVANCE Collaborative Group. Intensive Blood Glucose and Vascular Outcomes in Patients with Type 2 Diabetes. NEJM. 2008: 358(24) 2560-2572.

PMID: 18539916

Summary:

  • A randomized control trial of 11,140 patients analyzing the difference between intensive glucose control (A1c<6.5) with gliclazide (and others as needed), vs. standard glucose control.
  • Endpoints were defined as major macrovascular events or major microvascular events.
  • After 5 years of study, intensive glucose control (A1c=6.5) as compared to the standard control group (A1c=7.3) showed no significant effects on macrovascular events and a 21% relative reduction of nephropathy.
  • Intense therapy also resulted in higher incidences of hypoglycemia.
  • Therapeutic strategies targeting A1c=6.5 may not be significantly better than strategies targeting A1c=7.3.

Significance to Literature:

More intensive glucose control is not necessarily the optimal strategy for diabetes management. P4P A1c targets may require revision, and all P4P targets must be open to revision based on new evidence.

 

 

(173) The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group. Effects of Intensive Glucose Lowering in Type 2 Diabetes. NEJM. 2008: 358(24) 2545-2559.

PMID: 18539917

Summary:

  • A randomized study of 10,251 patients analyzed the effects of standard glucose control (targeting a glycated hemoglobin between 7.0-7.9%) vs. intensive therapy (targeting a level below 6.0%).
  • Therapeutic strategies targeting an A1c<6 resulted in higher mortality and showed no reduction of major cardiovascular events as compared to therapeutic strategies targeting A1c 7.0-7.9.

Significance to Literature:

More intensive glucose control is not necessarily the optimal strategy for diabetes management. P4P A1c targets may require revision, and all P4P targets must be open to revision based on new evidence.

 

 

***Key Article***

(174) Krumholz HM, Lee TH. Redefining Quality—Implications of Recent Clinical Trials. NEJM. Perspective. 2008: 358(24) 2537-2539.

PMID: 18539915

Summary:

  • Article written in response to ADVANCE and ACCORD trials negative intensive glucose control results in type 2 diabetes management. (170 and 173)
  • “Different strategies may have different effects on patients beyond their effect on risk-factor levels.”
  • Clinical guidelines need to reflect the strategy of intervention.
  • Provides two recommendations for performance measurement change:
  • Support the use of targets with reference to the strategies used to achieve them.
  • Guidelines should incorporate considerations of the risk of disease and adverse consequences posed by the intervention.

Significance to Literature:

Suggests appropriate responses to evidence that contradicts a specific guideline.


 

(244) Satin D, Miles J. ACCORD, ADVANCE, and P4P: The Data-Driven Future of Quality Improvement. Minnesota Physicians Publishing. March, 2009.

Summary:

  • Article questions ability of P4P industry to adapt when data suggests measures should change
  • A1c is just one controversial issues, but how programs change accordingly is a good  indicator for the future.

Significance to Literature:

P4P programs must be able to quickly adapt to new data regarding their performance measures.

 

 

(277) Pogach L, Engelgau M, Aron D. Measuring Progress Toward Achieving Hemoglobinn A1c Goals in Diabetes Care: Pass/Fail or Partial Credit. JAMA. Commentary. 2007: 297(5) 520-523.

PMID: 17284702

Summary:

  • Addresses the disagreement of recommended HbA1c levels as a performance measure.
  • Alternate methods must be considered since ACCORD demonstrated that HbA1c <7% may not be the best target for all diabetics.
  • A separate but related point is to consider rewarding progress towards an A1c goal with partial credit.  

Significance to Literature:

There is a desire to set and measure one optimal A1c target for all diabetics, however, one specific clinical target for all patients may not be the best marker.

 

 

(305) Skyler JS, et al. Intensive Glycemic Control and the Prevention of Cardiovascular Events: Implications of the ACCORD, ADANCE, and VA Diabetes Trials. Diabetes Care. 2009: 32(1) 187-192.

PMID: 19092168 

Summary:

  • Outlines results from major Diabetes treatment trials including ACCORD and ADVANCE.
  • Clinicians should not abandon the HbA1c target of <7% in most patients.
  • Major changes of glycemic control are not suggested, instead we need to better understand individualized treatment plans.

Significance to Literature:

The HbA1c P4P measure is a difficult measure to set and agree upon.

 

 

(314) Montori VM, Fernandez-Balsells M. Glycemic Control in Type 2 Diabetes: Time for an Evidence-Based About-Face? Annals of Internal Medicine. 2009: 150(11) 803-808

PMID: 19380837

Summary:

  • Summarized and compared data from four major studies regarding the effect HbA1c target. Studies compared include ADVANCE, ACCORD, VADT, UKPDS.
  • Authors conclude that "clinicians should prioritize supporting well-being and healthy lifestyles, preventive care, and cardiovascular risk reduction" for their patients as data does not strongly support tight glycemic control as more beneficial than harmful.
  • Suggest using looser A1c performance measures, for example <9%,  as a means to rule out inadequate care.

Significance to Literature:

Data from multiple large trials does not support performance measures of HbA1c <7% to be more beneficial than harmful.

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