Literature update July 2011
Hill J, Bullock I, Alderson P. A Summary of the Methods That the National Clinical Guideline Centre Uses to Produce Clinical Guidelines for the National Institute for Health and Clinical Excellence. Ann Intern Med June 7, 2011 154:752-757
The National Clinical Guideline Centre develops evidence-based clinical guidelines on behalf of the National Institute for Health and Clinical Excellence in the United Kingdom. These guidelines are developed for the National Health Service in England, Wales, and Northern Ireland and establish recommendations on best practice. The authors summarize the main methods used in development, how evidence from systematic reviews is interpreted to form recommendations, who is involved in the process, and the main outputs that are published.
Eddy DM, Adler J, Patterson B, Lucas D, Smith KA, Morris M. Individualized Guidelines: The Potential for Increasing Quality and Reducing Costs. Ann Intern Med May 3, 2011 154:627-634
Background: Current guidelines focus on a particular risk factor and specify criteria for categorizing persons into a small number of treatment groups. Objective: To compare current guidelines with individualized guidelines (that use readily available characteristics from each person to calculate the risk reduction expected from treatment and to identify persons for treatment in ranked order of decreasing expected benefit), in the context of blood pressure management. Design: Analysis of person-specific, longitudinal data. Setting: The ARIC (Atherosclerosis Risk in Communities) Study. Participants: Persons aged 45 to 64 years without preexisting cardiovascular disease who currently do not receive antihypertensive treatment.
Intervention: Treatment according to the criteria of the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7 guidelines); individualized guidelines, or treatment in decreasing order of expected benefit; and random care, or treatment of persons selected at random. Measurements: Number of myocardial infarctions (MIs) and strokes and medical costs. Results: Compared with treating people according to random care, individualized guidelines could prevent the same number of MIs and strokes as JNC 7 guidelines at savings that are 67% greater than using JNC 7 guidelines, or it could prevent 43% more MIs and strokes for the same cost as treatment according to JNC 7 guidelines. The superiority of individualized guidelines was not sensitive to a wide range of assumptions about costs, treatment effectiveness, level of risk for cardiovascular disease in the population, or effects on workflow. The degree of superiority was sensitive to the accuracy of the method used to rank patients and to its span (the proportion of the population for whom all of the outcomes of interest can be calculated). Limitations: Specific results apply to the effects of blood pressure management on MI and stroke in the ARIC Study population. The methods for calculating individual benefits require quantitative evidence about the relationships among risk factors, long-term outcomes, and treatment effects. Conclusion: Use of individualized guidelines can help to increase the quality and reduce the cost of care.
Andrus JK, Jauregui B, De Oliveira LH, Ruiz Matus C. Challenges To Building Capacity For Evidence-Based New Vaccine Policy In Developing Countries. Health Aff June 2011 30:1104-1112
There are many challenges to ensuring that people in developing countries have equitable access to new vaccines. Two of the most important are having the capacity to make evidence-based new vaccine policy decisions in developing countries, and then when appropriate actually distributing those new vaccines to those who will most benefit from them. Based on our review of the Pan American Health Organization’s ProVac Initiative in the Americas, we found that when national governments in developing countries develop the expertise to make the best technical decisions about immunization programs; take responsibility for helping to pay for and distribute vaccines; and are supported by strong partnerships with international organizations, they succeed in saving more lives more quickly.
Hsu J, Brozek JL, Terraciano L, Kreis J, Compalati E, Stein A, Fiocchi A, Schunemann HJ. Application of GRADE: Making Evidence-Based Recommendations about Diagnostic Tests in Clinical Practice Guidelines. Implementation Science 2011, 6:62 (10 June 2011)
Background: Accurate diagnosis is a fundamental aspect of appropriate healthcare. However, clinicians need guidance when implementing diagnostic tests given the number of tests available and resource constraints in healthcare. Practitioners of health often feel compelled to implement recommendations in guidelines, including recommendations about the use of diagnostic tests. However, the understanding about diagnostic tests by guideline panels and the methodology for developing recommendations is far from completely explored. Therefore, we evaluated the factors that guideline developers and users need to consider for the development of implementable recommendations about diagnostic tests. Methods: Using a critical analysis of the process, we present the results of a case study using the Grading of Recommendations Applicability, Development and Evaluation (GRADE) approach to develop a clinical practice guideline for the diagnosis of Cow Milk Allergy with the World Allergy Organization. Results: To ensure that guideline panels can develop informed recommendations about diagnostic tests, it appears that more emphasis needs to be placed on group processes, including question formulation, defining patient-important outcomes for diagnostic tests, and summarizing evidence. Explicit consideration of concepts of diagnosis from evidence-based medicine, such as pre-test probability and treatment threshold, is required to facilitate the work of a guideline panel and to formulate implementable recommendations. Discussion: This case study provides useful guidance for guideline developers and clinicians about what they ought to demand from clinical practice guidelines to facilitate implementation and strengthen confidence in recommendations about diagnostic tests. Applying a structured framework like the GRADE approach with its requirement for transparency in the description of the evidence and factors that influence recommendations facilitates laying out the process and decision factors that are required for the development, interpretation, and implementation of recommendations about diagnostic tests.
Kuehn BM. IOM Sets Out “Gold Standard” Practices for Creating Guidelines, Systematic Reviews. JAMA. 2011;305(18):1846-1848. doi:10.1001/jama.2011.597
Guidelines and systematic reviews must adhere to tougher standards for transparency and objectivity and adopt consistent formats to make them trustworthy and accessible for both clinicians and patients, according to a pair of reports released by the Institute of Medicine (IOM) in March. New reports from the Institute of Medicine call for the development of clinical practice guidelines and systematic reviews that physicians and patients can use together to make clinical decisions. The reports were commissioned by Congress as part of the Medicare Improvement for Patients and Providers Act of 2008 to set standards for clinical practice guidelines (http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx) and systematic reviews (http://www.iom.edu/Activities/Quality/SystemReviewCER.aspx). Physicians and other health care decision makers often rely on guidelines and systematic reviews to provide authoritative information on care options and to synthesize data from the literature. However, such efforts vary greatly in how they are conducted and how their results are reported. Each of the …
Moskowitz D, Bodenheimer T. Moving from Evidence-Based Medicine to Evidence-Based Health. Journal of General Internal Medicine Volume 26, Number 6, 658-660
While evidence-based medicine (EBM) has advanced medical practice, the health care system has been inconsistent in translating EBM into improvements in health. Disparities in health and health care play out through patients’ limited ability to incorporate the advances of EBM into their daily lives. Assisting patients to self-manage their chronic conditions and paying attention to unhealthy community factors could be added to EBM to create a broader paradigm of evidence-based health. A perspective of evidence-based health may encourage physicians to consider their role in upstream efforts to combat socially patterned chronic disease.
Glasziou P, Ogrinc G, Goodman S. Can evidence-based medicine and clinical quality improvement learn from each other? BMJ Qual Saf 2011;20:i13-i17
The considerable gap between what we know from research and what is done in clinical practice is well known. Proposed responses include the Evidence-Based Medicine (EBM) and Clinical Quality Improvement. EBM has focused more on ‘doing the right things’—based on external research evidence—whereas Quality Improvement (QI) has focused more on ‘doing things right’—based on local processes. However, these are complementary and in combination direct us how to ‘do the right things right’. This article examines the differences and similarities in the two approaches and proposes that by integrating the bedside application, the methodological development and the training of these complementary disciplines both would gain.
Straus SE, Shepperd S. Challenges in guideline methodology. J Clin Epidemiol. 2011 Apr;64(4):347-8.
Handler J, Lackland DT. Translation of hypertension treatment guidelines into practice: a review of implementation. J Am Soc Hypertens. 2011 Jun 1. [Epub ahead of print]
Compared with the history of national guideline development, the science attached to implementation of guidelines is relatively new. Effectiveness of a highly evidence-based guideline, such as the 8th Joint National Committee recommendations on the treatment of high blood pressure, depends on successful translation into clinical practice. Implementation relies on several steps: clear and executable guideline language, audit and feedback attached to education of practitioners charged with carrying out the guidelines, team-based care delivery, credibility of blood pressure measurement, and measures to address therapeutic inertia and medication adherence. An evolving role of the electronic health record and patient empowerment are developments that will further promote implementation of the hypertension guideline. Further research will be needed to assess the efficacy and cost effectiveness of various implementation tools and strategies.
Baker A, Potter J, Young K, Madan I. The applicability of grading systems for guidelines. J Eval Clin Pract. 2011 May 25. doi: 10.1111/j.1365-2753.2011.01693.x. [Epub ahead of print]
Rationale: This study focused on factors that most concern specialist societies when choosing an evidence grading system, such as methodological strengths and weaknesses, applicability and ease of use. The grading systems chosen were the Scottish Intercollegiate Guidelines Network (SIGN), the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and the National Service Framework for long-term neurological conditions critical appraisal tool (NSF-LTC). Methodology: Twelve assessors, representing typical members of society-based guideline development groups, graded papers and a recommendation using a key question as a guide. Key questions and recommendations were extracted from existing clinical guidelines representing a variety of research fields. Assessors were given 3 months to grade the papers using the grading systems and to complete a semi-structured qualitative questionnaire. The results were independently assessed for emerging themes. Results: Assessors felt all three systems had strengths and weaknesses depending on the type of evidence being graded. GRADE was seen as the most complex but rigorous system, while SIGN and NSF were seen as easier and more flexible to use, but less methodologically rigorous. In grading the evidence, 10% of assessors used GRADE incorrectly, 33% used SIGN incorrectly and 75% used NSF-LTC incorrectly. In grading the recommendations, 60% used GRADE incorrectly, 50% used SIGN incorrectly and 50% used NSF-LTC incorrectly. Implications: It is recommended that specialist societies consider the type of evidence they will be evaluating and the research experience of the appraisers before selecting a grading system. Additionally, appraisers should have training in appraising and grading evidence using the system to be employed.
Cuello García CA, Pacheco Alvarado KP, Pérez Gaxiola G. Grading recommendations in clinical practice guidelines: randomised experimental evaluation of four different systems. Arch Dis Child. 2011 May 19. [Epub ahead of print]
Objective: To evaluate the effect of presenting a recommendation in a clinical practice guideline using different grading systems to determine to what extent the system used changes the clinician's eventual response to a particular clinical question. Design: Randomised experimental study. Setting Clinician offices and academic settings. Participants: Paediatricians and paediatric residents in private and public practice in Mexico. Intervention: Case notes of a child with diarrhoea and a question about clinician preference for using racecadotril. The same evidence was provided in a clinical recommendation but with different presentations according to the following grading systems: NICE (National Institute for Health and Clinical Excellence), SIGN (Scottish Intercollegiate Guideline Network), GRADE (Grading of Recommendations Assessment, Development and Evaluation) and CEBM (Centre for Evidence-Based Medicine, Oxford). Main outcome measure: Mean change in direction from baseline response (measured on a 10 cm visual scale and a Likert scale) and among groups. Results: 216 subjects agreed to participate. Most participants changed their decision after reading the clinical recommendations (mean difference 0.7 cm, 95% CI 0.29 to 1.0; p<0.001). By groups, mean change (95% CI) from baseline was 0.04 (-0.68 to 0.77) for NICE, 0.31 (-0.41 to 1.05) for SIGN, 2.18 (1.48 to 2.88) for GRADE and 0.08 (-0.52 to 0.69) for CEBM (p=0.007 between groups). In a final survey, a small difference was noted regarding the clarity of the results presented with the GRADE system. Conclusion: The clinician's decision to use a therapy was influenced most by the GRADE system. Trial registration number NCT00940290.
Mendelson TB, Meltzer M, Campbell EG, Caplan AL, Kirkpatrick JN. Conflicts of interest in cardiovascular clinical practice guidelines. Arch Intern Med. 2011 Mar 28;171(6):577-84.
Bachground: Clinical practice guidelines (CPGs) serve as standards of care in practice, quality improvement, and reimbursement. The extent of conflicts of interest (COIs) in cardiology guideline production has not been well studied. Herein, we describe the scope of COIs in CPGs. Methods: We examined the 17 most recent American College of Cardiology/American Heart Association guidelines through 2008. Using disclosure lists, we cataloged COIs for each participant as receiving a research grant, being on a speaker's bureau and/or receiving honoraria, owning stock, or being a consultant or member of an advisory board. We also cataloged the companies and institutions reported in each disclosure. "Episode" describes 1 instance of participation in 1 guideline by 1 person. "Individual" describes 1 person who may be involved in multiple episodes. "Company" describes a commercial or industry affiliation reported by an individual in a single episode. Analysis involved descriptive statistics and correlation analyses (Pearson correlation coefficient, χ(2) and R(2)). Results: Fifty-six percent of the 498 individuals reported a COI, corresponding to 56% of the 651 episodes. Being a consultant or member of an advisory board was the most common type. The percentage of episodes involving a COI varied between guidelines (range, 13%-87%). The number of episodes per individual was associated with both presence and number of disclosures (P < .001 for both comparisons). Of 478 companies, the number per guideline ranged from 2 to 242 companies (mean, 38 companies). One company was the most frequently reported company in 7 of 17 guidelines. Conclusion: Conflicts of interest are prevalent in cardiology guidelines, but there seems to be a significant number of experienced experts without COIs.