Effectiveness Guidance Document (EGD) for acupuncture research - a consensus document for conducting trials.

BACKGROUND: There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making. METHODS: Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved. RESULTS: Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. CONCLUSION: The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.

e-Measures: insight into the challenges and opportunities of automating publicly reported quality measures.

Using electronic health records (EHR) to automate publicly reported quality measures is receiving increasing attention and is one of the promises of EHR implementation. Kaiser Permanente has fully or partly automated six of 13 the joint commission measure sets. We describe our experience with automation and the resulting time savings: a reduction by approximately 50% of abstractor time required for one measure set alone (surgical care improvement project). However, our experience illustrates the gap between the current and desired states of automated public quality reporting, which has important implications for measure developers, accrediting entities, EHR vendors, public/private payers, and government.

Comparative effectiveness topics from a large, integrated delivery system.

OBJECTIVE: To identify high-priority comparative effectiveness questions directly relevant to care delivery in a large, US integrated health care system. METHODS: In 2010, a total of 792 clinical and operational leaders in Kaiser Permanente were sent an electronic survey requesting nominations of comparative effectiveness research questions; most recipients (83%) had direct clinical roles. Nominated questions were divided into 18 surveys of related topics that included 9 to 23 questions for prioritization. The next year, 648 recipients were electronically sent 1 of the 18 surveys to prioritize nominated questions. Surveys were assigned to recipients on the basis of their nominations or specialty. High-priority questions were identified by comparing the frequency a question was selected to an "expected" frequency, calculated to account for the varying number of questions and respondents across prioritization surveys. High-priority questions were those selected more frequently than expected. RESULTS: More than 320 research questions were nominated from 181 individuals. Questions most frequently addressed cardiovascular and peripheral vascular disease; obesity, diabetes, endocrinology, and metabolic disorders; or service delivery and systems-level questions. Ninety-five high-priority research questions were identified, encompassing a wide range of health questions that ranged from prevention and screening to treatment and quality of life. Many were complex questions from a systems perspective regarding how to deliver the best care. CONCLUSIONS: The 95 questions identified and prioritized by leaders on the front lines of health care delivery may inform the national discussion regarding comparative effectiveness research. Additionally, our experience provides insight in engaging real-world stakeholders in setting a health care research agenda.

More quality measures versus measuring what matters: a call for balance and parsimony.

External groups requiring measures now include public and private payers, regulators, accreditors and others that certify performance levels for consumers, patients and payers. Although benefits have accrued from the growth in quality measurement, the recent explosion in the number of measures threatens to shift resources from improving quality to cover a plethora of quality-performance metrics that may have a limited impact on the things that patients and payers want and need (ie, better outcomes, better care, and lower per capita costs). Here we propose a policy that quality measurement should be: balanced to meet the need of end users to judge quality and cost performance and the need of providers to continuously improve the quality, outcomes and costs of their services; and parsimonious to measure quality, outcomes and costs with appropriate metrics that are selected based on end-user needs.

New technology review process: the laparoscopic adjustable gastric band.

The Interregional New Technologies Committee (INTC) is one evaluation route for new medical technologies or technologies with expanded indications within Kaiser Permanente (KP). The primary focus of the INTC is to consider all available published evidence on a particular technology, surgical technique, or implantable device for a specific clinical indication and provide a recommendation on the sufficiency of the evidence for determining net medical benefit to Permanente Medical Group leaders and Kaiser Foundation Health Plan management throughout KP Regions. This iterative process provides an objective, evidence-based assessment to inform decision making by physicians and support the most appropriate care for KP members. This overview illustrates the INTC process and how it supports clinical decision making using implantation of laparoscopic adjustable gastric bands (LAGBs) as an example. In February 2011, the US Food and Drug Administration (FDA) approved lowering the acceptable body mass index for the Lap-Band from 35 to 30 kg/m(2) for patients with at least one comorbid condition. It is difficult to find published studies on medical technologies that have been recently approved by the FDA. The manufacturer often submits clinical data to the FDA, but details are frequently not publicly available at the time of approval. The LAGB example demonstrates the complex issues addressed by the INTC, particularly when there is some evidence of short-term improvement in outcomes with a medical device but little if any confirmation of long-term safety or effectiveness.

Controlling healthcare costs by removing waste: what American doctors can do now.

Healthcare costs are unsustainable. The authors propose a solution to control costs without rationing (deliberate withholding of effective care) or payment reductions to doctors and hospitals. Three physician-led strategies comprise this solution: reduce (1) overuse of health services, (2) preventable complications and (3) waste within healthcare processes. These challenges know no borders.

Assessing the comparative effectiveness of a diagnostic technology: CT colonography.

Medical imaging is a prime example of an innovation that has brought important advances to medical care while triggering concerns about potential overuse and excessive costs. Many hopes are riding on comparative effectiveness research to help guide better decision making to improve quality and value. But the dynamic nature of medical imaging poses challenges for the traditional paradigms of evidentiary review and analysis at the heart of comparative effectiveness. This paper discusses these challenges and presents policy lessons for manufacturers, evidence reviewers, and decisionmakers, illustrated by an assessment of a prominent emerging imaging technique: computed tomography (CT) colonography.