Developing and Testing the Agency for Healthcare Research and Quality's National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards (NEATS) Instrument.

In 2011, the Institute of Medicine (IOM) (now the National Academy of Medicine) published standards for trustworthy guidelines and recommended that the National Guideline Clearinghouse (NGC) of the Agency for Healthcare Research and Quality clearly indicate the extent to which guidelines adhere to these standards. To accomplish this, the authors developed and tested the NGC Extent of Adherence to Trustworthy Standards (NEATS) instrument. The standards were operationalized as an instrument containing 15 items that cover disclosure of the funding source; disclosure and management of conflicts of interest; multidisciplinary input; incorporation of patient perspectives; rigorous systematic review; recommendations accompanied by rationale, assessment of benefits and harms, clear linkage to the evidence, and assessment of strength of evidence and strength of recommendation; clear articulation of recommendations; external review by diverse stakeholders; and plans for updating. After multiple rounds of feedback from experts on clinical practice guideline development, the external validity and interrater reliability of the instrument were evaluated. For each item, 80% to 100% of survey respondents judged it to be a good measure of the IOM standards. All external stakeholders stated that NEATS was suitable for its intended goal. Interrater reliability for the final NEATS instrument had a weighted κ of 0.73. The NEATS instrument is a focused tool that provides a concise evaluation of a guideline's adherence to the IOM standards for trustworthy guidelines. It has good external validity among guideline developers and good interrater reliability across trained reviewers.

Assessing the utility of genetic tests.

Genetic testing is a rapidly expanding area with many clinical applications. While the introduction of new genetic tests creates tremendous potential for improving patient care, it is essential to adequately evaluate these tests to ensure their accuracy and utility for clinical practice. This article describes a general approach to the evaluation of genetic tests and discusses common challenges that evaluators face. This article's goal was to provide a starting point for those who are concerned with the safety and utility of genetic tests to develop an overall strategy to perform the assessment.

How electronic clinical data can improve health technology assessment.

Health technology assessments represent comprehensive summaries of available evidence and information on a technology. They are used by medical decision makers in a variety of ways, including diagnostic testing, treatment selection, care management, patient perspectives, patient safety, insurance coverage, pharmaceutical innovation, equipment planning, device purchasing, and total cost-of-care. Electronic clinical data, which are captured routinely by clinicians and hospitals, are only rarely incorporated into formal health technology assessments. This disconnect reveals a key opportunity. In this paper, we discuss current uses of electronic clinical data, several benefits of including it in health technology assessments, potential pitfalls of that inclusion, and the implications for better medical decisions.

Long-term opioid management for chronic noncancer pain.

BACKGROUND: Opioid therapy for chronic noncancer pain (CNCP) is controversial due to concerns regarding long-term effectiveness and safety, particularly the risk of tolerance, dependence, or abuse. OBJECTIVES: To assess safety, efficacy, and effectiveness of opioids taken long-term for CNCP. SEARCH STRATEGY: We searched 10 bibliographic databases up to May 2009. SELECTION CRITERIA: We searched for studies that: collected efficacy data on participants after at least 6 months of treatment; were full-text articles; did not include redundant data; were prospective; enrolled at least 10 participants; reported data of participants who had CNCP. Randomized controlled trials (RCTs) and pre-post case-series studies were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted safety and effectiveness data and settled discrepancies by consensus. We used random-effects meta-analysis' to summarize data where appropriate, used the I(2) statistic to quantify heterogeneity, and, where appropriate, explored heterogeneity using meta-regression. Several sensitivity analyses were performed to test the robustness of the results. MAIN RESULTS: We reviewed 26 studies with 27 treatment groups that enrolled a total of 4893 participants. Twenty five of the studies were case series or uncontrolled long-term trial continuations, the other was an RCT comparing two opioids. Opioids were administered orally (number of study treatments groups [abbreviated as "k"] = 12, n = 3040), transdermally (k = 5, n = 1628), or intrathecally (k = 10, n = 231). Many participants discontinued due to adverse effects (oral: 22.9% [95% confidence interval (CI): 15.3% to 32.8%]; transdermal: 12.1% [95% CI: 4.9% to 27.0%]; intrathecal: 8.9% [95% CI: 4.0% to 26.1%]); or insufficient pain relief (oral: 10.3% [95% CI: 7.6% to 13.9%]; intrathecal: 7.6% [95% CI: 3.7% to 14.8%]; transdermal: 5.8% [95% CI: 4.2% to 7.9%]). Signs of opioid addiction were reported in 0.27% of participants in the studies that reported that outcome. All three modes of administration were associated with clinically significant reductions in pain, but the amount of pain relief varied among studies. Findings regarding quality of life and functional status were inconclusive due to an insufficient quantity of evidence for oral administration studies and inconclusive statistical findings for transdermal and intrathecal administration studies. AUTHORS' CONCLUSIONS: Many patients discontinue long-term opioid therapy (especially oral opioids) due to adverse events or insufficient pain relief; however, weak evidence suggests that patients who are able to continue opioids long-term experience clinically significant pain relief. Whether quality of life or functioning improves is inconclusive. Many minor adverse events (like nausea and headache) occurred, but serious adverse events, including iatrogenic opioid addiction, were rare.

Poor outcome for neural surgery (epineurotomy or neurolysis) for carpal tunnel syndrome compared with carpal tunnel release alone: a meta-analysis of global outcomes.

A meta-analysis was performed on the results of eight studies that compared the global outcomes of patients who received carpal tunnel release with the global outcomes of patients who received carpal tunnel release and neurolysis or epineurotomy. The meta-analysis suggests that patients who received such neural surgery tended to have poorer global outcomes than those who did not (odds ratio, 0.54; 95 percent confidence interval, 0.32 to 0.90). The data are homogenous, and linear-regression analysis indicates that patient attrition did not influence the outcome of the meta-analysis. The results of this meta-analysis indicate that neural surgery is potentially harmful for most patients with carpal tunnel syndrome. The possibility remains that neural surgery may be helpful in special cases, such as in the presence of marked scarring or neural adhesion, but no available evidence specifically documents the benefits and harms of surgery among such patients.

Recent developments in diagnosis and intervention for aspiration and dysphagia in stroke and other neuromuscular disorders.

This review discusses the impact of the evidence-based report on dysphagia diagnosis and treatment in stroke patients prepared in 1999 by ECRI under contract with the Agency for Healthcare Research and Quality (AHRQ). Subsequent research findings are highlighted and research design and reporting problems in the field are discussed. Progress has been made toward standardizing training and rating of videofluoroscopic studies of swallowing (VFSS); however, a consensus does not yet exist. A randomized, controlled trial demonstrated that treatment directed by fiber-optic endoscopic evaluation of swallowing with sensory testing (FEESST) or VFSS resulted in approximately equivalent pneumonia rates. These two different methods provide both overlapping and complementary information. There is discussion of the research design problems of mixed patients versus homogeneous populations, case-control diagnostic studies, inappropriate calculations of diagnostic sensitivity/specificity using imperfect "gold standards," the lack of concurrent control groups in treatment studies, and the misuse of statistical significance tests and P values in examining matching of patient characteristics in comparative studies and in identifying important variables in regression analysis.