AGREE II Instrument for the Quality Assessment of Clinical Practice Guidelines.

<p>AGREE II, Appraisal of Guidelines for Research and Evaluation II <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0058625#pone.0058625-Brouwers1" target="_blank">[11]</a>.</p

Quality of Clinical Practice Guidelines for Glycemic Control in Type 2 Diabetes Mellitus

<div><p>Background</p><p>Several studies have reported that clinical practice guidelines (CPGs) in a variety of clinical areas are of modest or variable quality. The objective of this study was to evaluate the quality of an international cohort of CPGs that provide recommendations on pharmaceutical management of glycemic control in patients with type 2 diabetes mellitus (DM2).</p> <p>Methods and Findings</p><p>We searched the National Guideline Clearinghouse (NGC) on February 15th and June 4th, 2012 for CPGs meeting inclusion criteria. Two independent assessors rated the quality of each CPG using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) instrument. Twenty-four guidelines were evaluated, and most had high scores for clarity and presentation. However, scope and purpose, stakeholder involvement, rigor of development, and applicability domains varied considerably. The majority of guidelines scored low on editorial independence, and only seven CPGs were based on an underlying systematic review of the evidence.</p> <p>Conclusions</p><p>The overall quality of CPGs for glycemic control in DM2 is moderate, but there is substantial variability among quality domains within and across guidelines. Guideline users need to be aware of this variability and carefully appraise and select the guidelines that they apply to patient care.</p> </div

Standardized domain scores for rigor of development and editorial independence.

<p>Scores are obtained from two of the domains of AGREE II (Appraisal of Guidelines for Research and Evaluation) <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0058625#pone.0058625-Brouwers1" target="_blank">[11]</a> Guidelines: American Association of Clinical Endocrinologists (AACE), American College of Physicians (ACP), American Diabetes Association (ADA), American Medical Directors Association (AMDA), Canadian Agency for Drugs and Technologies in Health (CADTH), European Society of Cardiology (ESC), Institute for Clinical Systems Improvement (ICSI), International Diabetes Center (IDC), International Diabetes Federation (IDF), Joslin Diabetes Center (JDC), National Kidney Foundation (KDOQI), National Collaborating Centre for Acute and Chronic Conditions (NCC-ACC), National Collaborating Centre for Women's and Children's Health (NCC-WCH), National Health Care for the Homeless Council (NHCHC), National Institute for Health and Clinical Excellence (NICE), New York State Department of Health (NY DoH), Qatif Primary Health Care (QPHC), Scottish Intercollegiate Guidelines Network (SIGN), University of Michigan Health System (UMHS), Department of Veterans Affairs/Department of Defense (VA/DoD), Wisconsin Diabetes Prevention and Control Program (WDPCP).</p

Conflicts of interest among clinical practice guidelines and their authors.

<p>(*) % add to more than 100 because CPG authors can disclose more than one type of COI.</p><p>(**) Examples of activities for the types of COI: Advising/consulting: serving on an advisory board and/or executive committee, or receiving consulting fees, honoraria, speaking fees, or providing expert testimony; Research: receiving research grants, salary support; Patents/royalties: receiving income from patents or royalties; Stocks/equity: owning stock or equity in a company; Gifts: receiving gifts, travel, samples, or educational materials; Intellectual: publishing on a topic, providing unpaid advocacy; Other: time devoted to specific procedures, spousal employment.</p><p>Abbreviations: COI, conflict of interest; CPG, clinical practice guideline, SD; standard deviation.</p

Characteristics of the included clinical practice guidelines (n = 250).

<p>n = 250 guidelines unless otherwise indicated.</p><p>(*) Includes one guideline from 2011 because at the time of abstraction, one guideline that was initially identified had been removed from the National Guideline Clearinghouse and thus the next guideline in our sequence of random numbers was selected, which was dated 2011.</p

Characteristics of included organizations (n = 37).

*<p>Number of CPGs published between January 1, 2009 and November 5, 2010 (search date).</p>†<p>As identified on the CMSS website (<a href="http://www.cmss.org/OriginalSigners.aspx" target="_blank">http://www.cmss.org/OriginalSigners.aspx</a>).</p>‡<p>Consortium sponsored by five state health plans (payers) and comprised of 62 medical groups (providers).</p>§<p>Consortium of healthcare providers, payers and specialty societies.</p><p>Abbreviations: CMSS: Council of Medical Specialty Societies; COI: conflict of interest; CPG: clinical practice guideline; INF: information not found; NA: not applicable.</p

Financial interests in specific drugs among three selected guidelines.

<div><p>Percent of authors of three clinical practice guidelines with disclosures of financial interests in the manufacturers of specific drugs. </p> <p>Abbreviations. See list for <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0075284#pone-0075284-t001" target="_blank">Table 1</a>.</p></div

Disclosure requirements and conflict of interest management strategies for organizations (n = 17).

*<p>Disclosure management strategy goes beyond simply requiring clinical practice guideline members to disclose conflicts of interest (COI). Management strategies include, for example, descriptions of who assesses and/or manages the disclosures, penalties for non-disclosure, detailed decision-making processes, limitations placed on individuals with COI, or prohibition from participation.</p><p>Abbreviations: COI, conflict of interest; NR, not reported; see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0037413#pone-0037413-t002" target="_blank">Table 2</a> for abbreviations of the guideline organizations.</p

Organizational policies on financial and non-financial conflict of interest (n = 17).

*<p>Financial COI declared in ranges (less than $10,000,$10,000 to $25,000, and greater than$25,000).</p>†<p>Having a financial interest of greater than $5,000 in an individual pharmaceutical company or an individual manufacturer of medical instruments, devices or equipment; acceptance of anything with a value greater than$25 for their personal use from an individual pharmaceutical company or an individual manufacturer of medical instruments, devices or equipment.</p>‡<p>Required to disclosure amounts greater than $10,000 per year or as determined through reference to public prices or other reasonable measure of fair market value, or represents more than 5% ownership interest in any single entity.</p>§<p>RNAO requires that all members declare COI in writing during recruitment or selection of guideline panel members, but no other information is provided in their policy.</p><p>Key to types of conflict of interest: C: paid consultancy or speaking engagement. S: research or salary support. P: patent or royalties. E: equity or stock. G: gifts. O: other (e.g., travel grants). I: non-financial or intellectual (not otherwise specified). V: opinion or viewpoint.</p><p>Abbreviations: COI, conflict of interest; NA, not applicable; NR, not reported; see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0037413#pone-0037413-t001" target="_blank">Table 1</a> for abbreviations for the guideline organizations.</p

Guideline authors with financial interests in recommended drugs.

<div><p>Percentage of authors of clinical practice guidelines with a financial interest in one or more of the manufacturers of patented drugs recommended in each guideline. </p> <p>Abbreviations. See list for <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0075284#pone-0075284-t001" target="_blank">Table 1</a>.</p></div