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Implementation Challenges of Clinical Practice Guidelines

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Joseph L. Nates, MD, MBA, FCCM; Yenny R. Cárdenas, MD

Last year, a task force of the Society of Critical Care Medicine (SCCM) completed and published the new guidelines for intensive care unit (ICU) admission, discharge and triage.1 This far-reaching document was developed to close a significant gap present for almost two decades since the first SCCM guidelines publication in 1999; it provides evidence-based recommendations in these and multiple related clinical practice subjects. Despite the difficulties of developing such a document, its implementation and adoption will carry much greater challenges.

Clinical practice guidelines (CPGs) have been evolving for decades2 and, in the past twenty years, the volume and quality have increased considerably.3New tools have provided a more professional and standardized framework to help perform these difficult tasks. To improve these processes, instruments such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) and the Appraisal of Guidelines for Research and Evaluation (AGREE) have been developed to evaluate the literature, develop recommendations, or assess the methodologic quality of CPGs. 

Developing CPGs is a time-consuming, complex and costly undertaking that requires expertise and resources. Strategies to reduce the utilization of scarce resources include adopting, adapting or contextualizing already available high-quality guidelines.4 Reducing overlapping and redundant guidelines developed by different organizations, expanding international collaborations, and creating international networks are some strategies to improve CPGs’ quality and effectiveness.3

In addition to the obstacles inherent in developing highquality CPGs, numerous barriers impede their optimal implementation and adoption. A recent systematic review with multilevel regression analysis of guidelines published in 2008 and thereafter5 confirmed the lack of applicability previously described in a meta-review of 42 studies encompassing 626 guidelines published between 1980 and 2007.6 The mean applicability score using the AGREE instrument was only 43.6% in the latter period compared to 22% in the period before 2008.

Another common problem is how quickly guidelines become outdated. A study evaluating the validity of the Agency for Healthcare Research and Quality CPGs showed that more than 75% needed to be updated at the time of the evaluation or were developed with older and different standards.7 Shekelle et al also investigated the survival of CPGs; they found that 90% of the guidelines are still valid at 3.6 years (95% CI, 2.6–4.6) with only 50% still valid at 5.8 years (95% CI, 5.0–6.6). Their general recommendation was to reassess the validity of CPG recommendations every three years.7

One of the most serious obstacles, however, is the lack of adoption. A systematic review of factors affecting adoption of guidelines showed severe deficiencies in accepting them in clinical practice. One study showed that only 40% of the targeted audience actually read the publications while, in another study, only 5% of relevant practitioners read them. Despite this, 78% of the practitioners assured the surveyors that they were following the guidelines.8 Other factors affecting acceptance included: the complexity of the guidelines, negative incentives (e.g., recommendations to avoid wellremunerated procedures), system inefficiencies (e.g., trying to reduce length of stay), and legal factors (e.g., fear of legal repercussions preventing physicians from discharging patients on weekends). Practitioners’ characteristics such as age (e.g., younger more accepting), practice region (e.g., some countries more adaptable than others), and reluctance of the staff, among others, also contributed to the problem. The lack of implementation tools seems to contribute to the lack of adherence to CPGs, whereas the use of tools developed by guideline producers improves the observance of the recommendations, according to a recent Cochrane review.9 In an attempt to improve the use of CPGs, comprehensive checklists for guideline implementation have been developed.10 However, the most frequent strategies are education for practitioners or patients and printed material.11

As if these obstacles were not enough, there are numerous other concerns, such as the misuse of guidelines to support claims against doctors in malpractice cases, insurance companies refusing to reimburse for medical services because the intervention is not “standard of care” in a particular guideline, the lack of economic considerations of the implementation, and conflicts of interest of individuals who participated in the formulation of the recommendations.12 Perhaps the most important concern is the perception that CPGs are not effective but are merely recipes for unskilled practitioners. A recent systematic review of the effects of evidence-based CPGs on quality of care in the Netherlands showed that they are effective in improving the process and structure of care.13 Although the authors found less evidence regarding the impact on health outcomes, there were significant improvements in at least one of the outcomes measured in six out of nine studies reviewed. Unfortunately, most of the studies investigating this question are based on older guidelines and methods.14

CPGs have many detractors. The focus of many studies seems to have been on their limitations rather than on their advantages. However, CPGs offer many benefits. They help in reducing healthcare variation, improving consistency in the delivery of care across systems and countries, modifying physician behavior, promoting effective interventions and discouraging the use of less effective therapies.15 Daily clinical decisions can be very challenging, but CPGs provide clinicians, advance practice providers and less experienced trainees with a framework for expedient decision-making. Developing guidelines helps identify the available evidence, organize it, identify potential opportunities or gaps and design strategies to correct deficiencies. As we develop and validate algorithms to deliver uniform evidence-based healthcare, they will become the bases for automated systems in the near future.

SCCM guidelines for ICU admission, discharge and triagewere published with a few tools to help implement some of the recommendations and monitor the metrics identified as relevant to the processes discussed. Nevertheless, in order to effectively implement these guidelines, practitioners and administrators will have to: a) overcome many of the barriers mentioned above,16 b) help disseminate the guidelines, c) improve physicians’ and other clinicians’ awareness through education, d) achieve higher CPG reading rates than reported in the literature, e) improve the efficiency of the systems in which implementation occurs, f) work actively on the adoption, adaptation or contextualization of CPGs, g) implement novel models such as implementation checklists, h) change healthcare system culture to encourage the use of CPGs, i) incorporate the recommendations in the daily processes and policies of the ICUs targeted, j) monitor the implementation and provide feedback to practitioners of the successes and failures, and k) incorporate systems engineering methodologies and the expertise of industrial engineers, clinical epidemiologists and others in the process, along with unmentioned interventions. The proper implementation of high-quality CPGs not only improves the process and structure of care in the units where these guidelines are adopted, but evidencebased recommendations also seem to positively impact healthcare outcomes and costs. 

1.       Nates JL, Nunnally M, Kleinpell R, et al. ICU admission, discharge, and triage guidelines: a framework to enhance clinical operations, development of institutional policies, and further research. Crit Care Med. 2016 Aug;44(8):1553-1602.

2.       Weisz G, Cambrosio A, Keating P, Knaapen L, Schlich T, Tournay VJ. The emergence of clinical practice guidelines. Milbank Q. 2007 Dec;85(4):691-727.

3.       Armstrong JJ, Goldfarb AM, Instrum RS, MacDermid JC. Improvement evident but still necessary in clinical practice guideline quality: a systematic review. J Clin Epidemiol. 2016 Aug 24. doi: 10.1016/j.jclinepi.2016.08.005. [Epub ahead of print].

4.       Dizon JM, Machingaidze S, Grimmer K. To adopt, to adapt, or to contextualise? The big question in clinical practice guideline development. BMC Res Notes. 2016 Sep;9(1):442.

5.       Gagliardi AR, Brouwers MC. Do guidelines offer implementation advice to target users? A systematic review of guideline applicability. BMJ Open. 2015 Feb 18;5(2):e007047.

6.       Alonso-Coello P, Irfan A, Solà I, et al. The quality of clinical guidelines over the last two decades: a systematic review of guideline appraisal studies. Qual Saf Health Care. 2010 Dec;19(6):e58.

7.       Shekelle PG, Ortiz E, Rhodes S, et al. Validity of the Agency for Healthcare Research and Quality clinical practice guidelines. How quickly do guidelines become outdated? JAMA. 2001 Sep 26;286(12):1461-1467.

8.       Davis DA, Taylor-Vaisey A. Translating guidelines into practice. A systematic review of theoretic concepts, practical experience and research evidence in the adoption of 8 clinical practice guidelines. CMAJ. 1997 Aug 15;157(4):408-416.

9.       Flodgren G, Hall AM, Goulding L, et al. Tools developed and disseminated by guidelines producers to promote the uptake of their guidelines. Cochrane Database Syst Rev. 2016 Aug 22;(8):CD010669.

10.       Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J. Clinical guidelines: potential benefits, limitations, and harms of clinical guidelines. BMJ. 1999 Feb 20;318(7182):527-530.

11.       Gagliardi AR, Marshall C, Huckson S, James S, Moore V. Developing a checklist for guideline implementation planning: review and synthesis of guideline development and implementation advice. Implement Sci. 2015 Feb 12;10:19.

12.       Wolf JS Jr, Hubbard H, Faraday MM, Forrest JB. Clinical practice guidelines to inform evidence-based clinical practice. World J Urol. 2011 Jun;29(3):303-309.

13.       Lugtenberg M, Burgers JS, Westert GP. Effects of evidence-based clinical practice guidelines on quality of care: a systematic review. Qual Saf Health Care. 2009 Oct;18(5):385-392.

14.       Worrall G, Chaulk P, Freake D. The effects of clinical practice guidelines on patient outcomes in primary care: a systematic review. CMAJ. 1997 Jun 15;156(12):1705-1712.

15.       McCulloh RJ, Smitherman SE, Koehn KL, Alverson BK. Assessing the impact of national guidelines on the acute management of children hospitalized for acute bronchiolitis. Pedriatr Pulmonol. 2014 Jul;49(7):688-694.

16.       Pronovost P. Enhancing physicians’ use of clinical guidelines. JAMA. 2013 Dec 9 18;310(23):2501-2502.