The Iterative Process for Evidence Collection Is Reviewing the Evidence

Introduction

This Part describes the process of creating the 2015 American Heart Clan (AHA) Guidelines Update for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC), informed by the 2015 International Consensus on CPR and ECC Science With Handling Recommendations (CoSTR) publication.^1,two The process for the 2015 International Liaison Committee on Resuscitation (ILCOR) systematic review is quite different when compared with the process used in 2010.^1–3 For the 2015 systematic review process, ILCOR used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) (world wide web.gradeworkinggroup.org) approach to systematic reviews and guideline development. For the development of this 2015 Guidelines Update, the AHA used the ILCOR reviews as well as the AHA definition of Classes of Recommendation (COR) and Levels of Evidence (LOE) (Table 1). This Part summarizes the awarding of the ILCOR GRADE process to inform the creation of 2015 Guidelines Update, and the process of assigning the AHA COR and LOE.

****Table 1.** Applying Grade of Recommendations and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care***
Table 1. Applying Class of Recommendations and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care*

Development of the 2015 Consensus on Science With Treatment Recommendations

Grading of Recommendations Cess, Development, and Evaluation

The 2015 CoSTR summarizes the published scientific evidence that was identified to answer specific resuscitation questions. ILCOR uses the Grade system to summarize bear witness and determine confidence in estimates of effect besides as to codify treatment recommendations. GRADE is a consensus-crafted tool in wide apply by many professional person societies and reference organizations, including the American College of Physicians, the American Thoracic Club, and the Cochrane Collaboration, besides as the Centers for Disease Control and the World Health Organization. The selection of the Class approach was based on its increasingly ubiquitous use, practicality, and unique features. To our knowledge, the ILCOR evidence review process represents the largest awarding of the GRADE system in a healthcare-related review.

GRADE is a organization to review evidence to determine the confidence in the estimate of effect of an intervention or the performance of a diagnostic examination and to categorize the strength of a recommendation. Form requires explicit documentation of the evaluation of the bear witness base specific to each outcome that was called and ranked every bit disquisitional and important before the evidence review. The evidence is assessed by multiple criteria. Questions addressed in GRADE typically follow a PICO (population, intervention, comparator, outcome) structure for ease of mapping to available bear witness (Figure one).

**Figure 1.** Structure of questions for show evaluation.

Confidence in the estimates of effect, synonymous with and reported more than succinctly every bit quality, is reported by a synthesis of evidence informed by i or more studies as opposed to studies themselves. Quality is adjudicated by a 4-part ranking of our conviction in the estimate of event (high, moderate, low, very low) informed past report methodology and the chance of bias. Studies kickoff but do non necessarily stop at loftier confidence for randomized controlled trials (RCTs), and they start but do not necessarily end at low confidence for observational studies. Studies may be downgraded for inconsistency, imprecision, indirectness, and publication bias and nonrandomized observational studies may be upgraded as the event of effect size, dose-response slope, and plausible negative confounding; in other words, an underestimation of the association. The direction and strength of recommendations are driven by certainty of evidence result estimates, values and preferences of patients, and, to some degree, clinicians' remainder of positive and negative effects, costs and resource, equity, acceptability, and feasibility (Table 2).

**Tabular array 2.** From Class Evidence to Decision Factors for Making Strong Versus Weak Recommendations
Factor	Relevant Question					Notes
Priority of problem	Is the problem addressed past the question important enough to make a recommendation?					Many issues may not be identified a priori as loftier enough importance to justify strong recommendations when weighed against other problems.
Balance of benefits and harms	Across outcomes, are the overall furnishings and confidence in those effects a net gain?					Most interventions, prognostications, and diagnostic tests have positive and negative consequences. Conviction in these estimates must be viewed in aggregate—do positive effects outweigh negative ones? Consideration must weigh outcomes by importance.
Certainty in the bear witness	What is the overall certainty that these estimates will support a recommendation?					More than certainty supports stronger recommendations, and vice versa.
Values and preferences	To what extent do the values and preferences of patients regarding outcomes or interventions vary?					Minimal variation and a strong endorsement of the outcomes or the interventions based on patients' values and preferences supports stronger recommendations. The lack of consistency in patients' values and preferences or a weak endorsement of the outcomes or the interventions supports weaker recommendations.
Costs and resources	Are these net results proportionate to the expenditures and demands of the recommended measure?					Factors such every bit manpower, time, distraction from other tasks, and monetary investment are viewed through local values. Lower costs of an intervention and greater cost-effectiveness support stiff recommendations, and vice versa. Assay should business relationship for incertitude in the calculated costs.
Equity	Are the net positive effects of the measure out distributed justly?					Measures that improve disparities or benefit adequately may drive a stronger recommendation, and vice versa.
Acceptability	Across stakeholders, is the measure tractable?					To exist strong, a recommendation ideally appeals to nigh.
Feasibility	Can the recommendation be implemented from a applied standpoint?					Something that is practical to accomplish may support a potent recommendation, and vice versa.
Summary: To what extent do positive and negative consequences balance in the settings in question?
Negative conspicuously outweighs positive		Negative probably outweighs positive		Negative and positive consequences counterbalanced		Positive probably outweighs negative		Positive clearly outweighs negative
Strong recommendation against			Weak recommendation against		Weak recommendation for		Strong recommendation for
Considerations: Are there important subgroups that might be treated differently? Are at that place important concerns for implementation?

The GRADE Development Tool

The GRADE Guideline Development Tool (www.guidelinedevelopment.org) provides a uniform interface in the form of standardized evidence profiles and sets along a framework that enables the reviewer to synthesize the prove and make a treatment recommendation.⁴

Course uniquely unlocks the often rigid linkage betwixt ane's confidence in the estimate of effect from the forcefulness of a recommendation. Although the two are related, unlike factors (eg, costs, values, preferences) influence the strength of the recommendation independent of one's confidence in the approximate of effect. GRADE mandates explicit reasons for judgments in a transparent structure. The Grade Guideline Development Tool^iv requires consideration of all of these factors and documentation for each decision. To qualify recommendations, an evidence-to-recommendation framework is used to document all factors that shape the recommendation. Finally, with the Form Guideline Development Tool, summary of evidence and show contour tables are created. The tables summarize event size, confidence in the estimates of consequence (quality), and the judgments made to evaluate evidence at the level of outcomes. Quality is specified beyond each of multiple outcomes for the same population, intervention, and comparison, with judgments documented in explanatory notes.

Scientific Testify and Evaluation Review System

In preparation for the 2015 systematic review procedure, ILCOR members, the AHA ECC staff, and compensated consultants collaborated to develop an online systematic review website. The Systematic Evidence Evaluation and Review System (SEERS) website was designed to support the direction of workflow steps required to complete the ILCOR systematic reviews (in 2010, these were called worksheets) and capture the evidence extraction and evaluation data in reusable formats (Figure 2). The SEERS website facilitated the structured and consequent evidence review process, which enabled the task force members to finalize the CoSTR for each PICO question. Successful completion of the systematic review procedure ensured consistency in elements of the reviews from many different international reviewers.

Figure 2. — **Effigy 2.** ILCOR 2015 Consensus on Science work flow for all systematic reviews.

Steps in the ILCOR 2015 Systematic Review Procedure

ILCOR created a comprehensive overview of the structured process that was used to support systematic reviews. The process was divided into 5 major categories, equally outlined in Effigy ii:

PICO question evolution: systematic review question evolution, using the PICO format (Figure 1)
Search strategy evolution
Show reviewer article choice
Class evidence review
Development of CoSTR

ILCOR PICO Question Evolution

Before long subsequently the 2010 International Consensus on CPR and ECC Science With Treatment Recommendations and the 2010 AHA Guidelines for CPR and ECC were published, the 2015 ILCOR chore forces reviewed the 274 PICO questions that were addressed in 2010 and generated a comprehensive list of 336 questions for potential systematic reviews in 2015. In addition, the new ILCOR job force, Outset Aid, developed 55 PICO questions that were initially prioritized for review. Questions were prioritized based on clinical controversy, emerging literature, and previously identified knowledge gaps. ILCOR chore forces debated and eventually voted to select a focused group of questions. Of the 391 potential PICO questions generated by the task forces, a total of 165 (42%) systematic reviews were completed for 2015 (Figures 3 and four). The number of PICO questions addressed by systematic reviews varied beyond task forces (Figure 4).

**Figure 3.** ILCOR process for prioritizing PICO questions for systematic reviews.

**Figure 4.** Comparison of the number of systematic review questions (PICO questions) addressed or deferred/not reviewed in 2015 versus 2010 reported by Part in the ILCOR *International Consensus on CPR and ECC Science With Treatment Recommendations* (CoSTR) publication. BLS indicates Basic Life Back up; Defib: Defibrillation*; CPR Tech and Dev: Cardiopulmonary Resuscitation Techniques and Devices; ALS: Avant-garde Life Support; ACS: Astute Coronary Syndromes; Peds: Pediatrics; NLS: Neonatal Resuscitation; EIT, Education, Implementation, and Teams. *Note that defibrillation content (Defib) of 2010 was absorbed within the 2015 Basic Life Support, Advanced Life Back up, and Pediatric CoSTR parts, and the CPR Techniques and Devices questions of 2010 were absorbed past the Avant-garde Life Back up CoSTR function in 2015.

Consistent with adopting the Class guideline writing process, clinical outcomes for each PICO were selected and ranked on a 9-point scale equally critical and important for conclusion making by each task force. The Course testify tables were reported past event, based on the priority of the clinical effect. Afterward task strength choice of PICO questions for review in 2015, individuals without whatsoever conflicts of interest (COIs) or relevant commercial relationships were identified and selected from chore strength members to serve as chore force question owners. Task force question owners provided the oversight command to ensure progress and completion of each systematic review.

ILCOR Search Strategy Evolution

Task force question owners worked in an iterative process with information specialists from St. Michael'southward Hospital Health Science Library in Toronto on contract as compensated consultants to the AHA. These information specialists created comprehensive literature search strategies. The information specialists collaborated with the task force question owners to create reproducible search strings that were customized for ease of utilise within the Cochrane Library (The Cochrane Collaboration, Oxford, England), PubMed (National Library of Medicine, Washington, DC), and Embase (Elsevier B.V., Amsterdam, Netherlands). Each search cord was crafted with precision to run into the inclusion and exclusion criteria that were defined to balance the importance of sensitivity and specificity for a comprehensive literature search.

With delivery to a transparent systematic review process for 2015, ILCOR provided an opportunity for public annotate on proposed literature search strategies. Members of the public were able to review search strategies and use the search strings to view the literature that would exist captured. ILCOR received 18 public comments and suggestions based on the proposed search strategies and forwarded them to the chore strength chairs and job force question owners for consideration. This iterative process ensured that specific articles were captured during the evaluation process that may not have been initially retrieved by the search strategy.

ILCOR Testify Reviewers' Article Selection

Upon completion of the public comment process, ILCOR invited topic experts from around the world to serve as evidence reviewers. Specialty organizations were also solicited to advise potential show reviewers. The qualifications of each reviewer were assessed by the chore force, and potential COIs were disclosed and evaluated by the task force co-chairs and COI co-chairs. Evidence reviewers could not have whatever significant COI issues pertaining to their assigned topics. If a COI was identified, the topic was assigned to a different reviewer who was gratuitous from conflict.

Two evidence reviewers were invited to complete independent reviews of the literature for each PICO question. A total of 250 bear witness reviewers from 39 countries completed 165 systematic reviews. The results of the search strategies were provided to the bear witness reviewers. Each reviewer selected articles for inclusion, and the two reviewers came to understanding on articles to include before proceeding to the next step in the review process. If disagreement occurred in the pick process, the task forcefulness question owner served as a moderator to facilitate understanding between the reviewers. If necessary, the search strategy was modified and repeated based on feedback from the evidence reviewers. When last agreement was reached between the bear witness reviewers on included studies, the systematic review procedure started.

ILCOR GRADE Testify Review

The bias assessment process capitalized on existing frameworks for defining the gamble of systematic mistake in research reporting through 3 distinct approaches. The Cochrane tool was used to evaluate risk of bias in randomized trials,^5,6 whereas the QUADAS-ii instrument⁷ was used for included studies that supported diagnostic PICO questions. For non-RCTs that drew inferences on questions of therapy or prognosis, the Form working group risk-of-bias criteria⁸ were used as a series of 4 questions that emphasized sampling bias, the integrity of predictor and outcome measurements, loss to follow-up, and adjusting for misreckoning influences.^8,9 Occasionally an existing systematic review would exist uncovered that could formally address gamble of bias as information technology pertained to a specific issue. Withal, in most instances, the task forces used an empiric approach based on an affiliation of risk from individual studies addressing a specific outcome. The two (or more than) reviewers were encouraged to consolidate their judgments, with adjudication from the chore force if needed. Agreed bias assessments were entered into a GRADE prove contour tabular array.

The GRADE Guideline Development Tool is a freely available online resources that includes the GRADE evidence profile tabular array.^4a GRADE Guideline Development Tool served as an invaluable assistance to summarize of import features, strengths, and limitations of the selected studies. To complete each cell of the evidence profile tabular array, reviewers needed to apply judgments on the five dimensions of quality, including risk of bias, inconsistency, indirectness, imprecision, and other considerations (including publication bias). Quantitative data that described effect sizes and conviction intervals were also entered into the prove profiles, although a more descriptive approach was used when pooling was deemed inappropriate. The Grade Guideline Development Tool software calculated the quality of evidence for disquisitional and of import outcomes past row and, when therapy questions (the most common type) were addressed, generated touch estimates for groups at high, moderate, or low baseline risk equally a function of the relative run a risk.

2015 ILCOR Development of Typhoon Consensus on Science With Treatment Recommendations

ILCOR developed a standardized template for drafting the consensus on scientific discipline to capture a narrative of the bear witness profile and reflect the outcome-axial approach emphasized by Form. The consensus on science reported (1) the importance of each outcome, (ii) the quality of the evidence and (3) the conviction in estimate of effect of the treatment (or diagnostic accuracy) on each outcome, (4) the Class reasons for downgrading or upgrading the quality rating of the report, and (5) the effect size with conviction intervals or a clarification of effects when pooling was not washed.

The ILCOR task forces created handling recommendations when consensus could be reached. Within the Form format, four recommendations are possible: (1) strong recommendation in favor of a treatment or diagnostic exam, (two) strong recommendation against a handling or diagnostic test, (three) weak recommendation in favor of a treatment or diagnostic exam, or (4) weak recommendation against a treatment or diagnostic test. A strong recommendation is indicated by the words "we recommend" and a weak recommendation is indicated by the words "we suggest."

Within the Grade Guideline Development Tool, an testify-to-recommendation framework assisted reviewers in making explicit the values and preferences that collection their recommendations, particularly when prove was either uncertain or was a weaker determinant of the optimal course of action. In doing and so, resource considerations were invoked rarely when an economic analysis was identified and reviewed every bit germane or when the balance of risks and harms were considered by the task force to exist weighed conspicuously against potential benefits. When there was inadequate or conflicting evidence, the chore force would indicate this insufficient bear witness with linguistic communication such as, "The confidence in effect estimates is so low that the panel feels a recommendation to modify current practice is too speculative." If economic analyses were not available, or if the chore forces idea that the appropriate recommendations could differ among the resuscitation councils based on training implications or construction or resources of out-of-hospital or in-hospital resuscitation systems, then the task forces occasionally made no recommendations, leaving that to the council guidelines.

The chore force members reviewed, discussed and debated the prove and developed consensus diction on the summary consensus on science statements and on the handling recommendations during in-person meetings and later on the 2015 ILCOR International Consensus on CPR and ECC Scientific discipline With Treatment Recommendations Conference, held in Dallas, Texas, in February 2015. In add-on, the task forces met frequently by webinar to develop the draft documents that were submitted for peer review on June one, 2015. As in 2005 and 2010, strict COI monitoring and management continued throughout the procedure of developing the consensus on science statements and the handling recommendations, as described in "Function ii: Evidence Evaluation and Management of Conflicts of Interest" in the 2015 CoSTR.^10,11

Public Comment on the ILCOR Draft Consensus on Science With Handling Recommendations

All typhoon recommendations were posted to allow approximately 6 weeks of public comment, including COI disclosure from those commenting. In improver, the ILCOR typhoon consensus on scientific discipline statements and treatment recommendations developed during the January 2015 conference were posted the week after the conference, and 492 public comments were received through February 28, 2015, when the comment catamenia airtight. The CoSTR drafts were reposted to remain available through April 2015 to allow optimal stakeholder appointment and familiarity with the proposed recommendations.

Development of the 2015 Guidelines Update

The 2015 Guidelines Update serves equally an update to the 2010 Guidelines. The 2015 Guidelines Update addresses the new recommendations that arose from the 2015 ILCOR show reviews of the treatment of cardiac arrest and avant-garde life support for newborns, infants, children, and adults.

Formation of the AHA Guidelines Writing Groups

The AHA exclusively sponsors the 2015 Guidelines Update and does not accept commercial support for the evolution or publication. The AHA ECC Commission proposed 14 Parts of the Guidelines, which differ slightly from the 2010 Parts (Table 3).

**Table 3.** Contents of 2010 Guidelines Compared With 2015 Guidelines Update
2010 Guidelines	2015 Guidelines Update
Executive Summary	Executive Summary
Prove Evaluation and Management of Potential or Perceived Conflicts of Involvement	Evidence Evaluation and Management of Conflicts of Interest
Ethics	Upstanding Issues
CPR Overview	Systems of Intendance and Continuous Quality Improvement*†
Adult Basic Life Support	Developed Basic Life Support and Cardiopulmonary Resuscitation Quality*†
Electrical Therapies: Automated External Defibrillators, Defibrillation, Cardioversion, and Pacing	(Defibrillation content embedded in other Parts)
CPR Techniques and Devices	Culling Techniques and Coincident Devices for Cardiopulmonary Resuscitation
Developed Advanced Cardiovascular Life Support	Adult Advanced Cardiovascular Life Support‡
Postal service–Cardiac Arrest Intendance	Post–Cardiac Arrest Care
Astute Coronary Syndromes	Acute Coronary Syndromes
Adult Stroke	(Relevant stroke content embedded in other Parts)
Cardiac Arrest in Special Situations	Special Circumstances of Resuscitation
Pediatric Basic Life Support	Pediatric Basic Life Support and Cardiopulmonary Resuscitation Quality†
Pediatric Advance Life Support	Pediatric Advanced Life Support‡
Neonatal Resuscitation	Neonatal Resuscitation
Education, Implementation, and Teams	Education
First Aid	Kickoff Aid

In particular, content from 2010 Parts (electrical therapies, adult stroke) take been incorporated into other Parts, and a new Part that addresses systems of care and continuous quality improvement has been added. The commission nominated a slate of writing group chairs and writing group members for each Role. Writing group chairs were chosen based on their knowledge, expertise, and previous experience with the Guidelines development process. Writing group members were chosen for their knowledge and expertise relevant to their Function of the Guidelines. In addition, each writing group included at to the lowest degree ane young investigator. The ECC Committee canonical the limerick of all writing groups earlier submitting them to the AHA Officers and Manuscript Oversight Committee for approval.

Part 15 of the Guidelines Update, "Beginning Assistance," is jointly sponsored by the AHA and the American Blood-red Cross. The writing grouping chair was selected past the AHA and the American Red Cantankerous, and writing grouping members were nominated by both the AHA and the American Red Cross and canonical by the ECC Committee. The evidence review for this Part was conducted through the ILCOR Form prove review procedure.

Before confirmation, all Guidelines writing group chairs and members were required to complete an AHA COI disclosure of all current healthcare-related relationships. The declarations were reviewed by AHA staff and the AHA officers. All writing group chairs and a minimum of 50% of the writing group members were required to be free of relevant COIs and relationships with industry. During the 2015 Guidelines development procedure, writing group members were requested to update their disclosure statements every three months.

Classification of AHA Guidelines Recommendations

In developing the 2015 Guidelines Update, the writing groups used the latest version of the AHA format for COR and LOE (Table one). The COR indicates the strength that the writing group assigns the recommendation, based on the predictable magnitude and certainty of do good relative to risk. The LOE is assigned based on the type, quality, quantity, and consistency of scientific prove supporting the effect of the intervention.

2015 AHA Classes of Recommendation

Both the 2010 Guidelines and the 2015 Guidelines Update used the AHA Classification system that includes 3 primary classes of positive recommendations: Class I, Class IIa, and Grade IIb (Figure v).

Figure 5. — **Effigy five.** Form of Recommendation comparison between 2010 Guidelines and 2015 Guidelines Update.

A Class I recommendation is the strongest recommendation, indicating the writing group'south judgment that the benefit of an intervention profoundly outweighs its gamble. Such recommendations are considered appropriate for the vast majority of clinicians to follow for the vast majority of patients, with infrequent exceptions based upon the judgment of practitioners in the context of the circumstances of individual cases; in that location is greater expectation of adherence to a Class I recommendation.

Grade IIa recommendations are considered moderate in strength, indicating that an intervention is reasonable and by and large useful. Most clinicians will follow these recommendations about of the time, although some notable exceptions exist. Class IIb recommendations are the weakest of the positive recommendations for interventions or diagnostic studies. Class IIb recommendations are identified past linguistic communication (eg, "may/might be reasonable or may/might be considered") that indicates the intervention or diagnostic written report is optional because its effect is unknown or unclear. Although the clinician may consider the handling or diagnostic report with a Form IIb recommendation, it is also reasonable to consider other approaches.

The past AHA format for COR contained only one negative classification, a Grade III recommendation. This classification indicated that the therapy or diagnostic examination was not helpful, could be harmful, and should non exist used. In the 2015 Guidelines Update, there are ii types of Class Iii recommendations, to clearly distinguish treatments or tests that may cause harm from those that have been disproven. A Grade III: Harm recommendation is a strong 1, signifying that the risk of the intervention (potential harm) outweighs the benefit, and the intervention or test should non be used. The second blazon of Class Iii recommendation, the Grade III: No Benefit, is a moderate recommendation, generally reserved for therapies or tests that have been shown in high-level studies (generally LOE A or B) to provide no benefit when tested against a placebo or control. This recommendation signifies that in that location is equal likelihood of do good and risk, and experts hold that the intervention or test should not exist used.

2015 AHA Levels of Testify

In the 2010 Guidelines, only iii LOEs were used to indicate the quality of the data: LOEs A, B, and C. LOE A indicated evidence from multiple populations, specifically from multiple randomized clinical trials or meta-analyses. LOE B indicated that limited populations were evaluated, and evidence was derived from a unmarried randomized trial or nonrandomized studies. LOE C indicated that either limited populations were studied or the prove consisted of example serial or expert consensus. In this 2015 Guidelines Update, at that place are at present 2 types of LOE B bear witness, LOE B-R and LOE B-NR: LOE B-R (randomized) indicates moderate-quality evidence from 1 or more RCTs or meta-analyses of moderate-quality RCTs; LOE B-NR (nonrandomized) indicates moderate-quality show from 1 or more well-designed and executed nonrandomized studies, or observational or registry studies, or meta-analyses of such studies. LOE C-LD (limited data) now is used to indicate randomized or nonrandomized observational or registry studies with limitations of blueprint or execution or meta-analyses of such studies, or physiologic or mechanistic studies in humans. LOE C-EO (expert opinion), indicates that testify is based on consensus of practiced opinion when bear witness is insufficient, vague, or conflicting. Animal studies are also listed equally LOE C-EO (Effigy 6).

Figure 6. — **Effigy 6.** Level of Evidence comparison between 2010 Guidelines and 2015 Guidelines Update. B-R indicates Level of Testify B-Randomized; B-NR, Level of Bear witness B-Nonrandomized; C-LD, Level of Show C-Limited Information; and C-EO, Level of Testify C-Adept Opinion. (Ane recommendation in the 2010 Guidelines publication has no listed LOE.)

Development of AHA Classes of Recommendation and Levels of Prove Informed past the 2015 ILCOR Show Review Using Form

The AHA COR and LOE framework (Table 1) differs from the framework used past GRADE. Every bit a result, the leadership of the ECC Committee identified a group of experts in methodology to create tools for the 2015 Guidelines Update writing groups to utilise in developing recommendations informed by the ILCOR GRADE evidence review. Members of this writing group met by briefing call weekly from October 27, 2014, to January 12, 2015, to validate the tools and ensure consistency in application. Frameworks for conversion were debated, settled by consensus, and so validated by applying them to specific ILCOR prove reviews, again using a consensus procedure. Tabular array four and Figures 7, viii, and 9 demonstrate the final tools that were used to guide the various guideline writing groups.

**Table 4.** Converting the GRADE Level of Evidence to the AHA ECC Level of Evidence
Form Level of Testify*	Starting Betoken for AHA ECC Level of Bear witness (to be adjusted as adamant by the writing group)
Loftier ClassLOE/conviction in the estimates of consequence	Convert to AHA ECC LOE A for:Loftier-quality prove exists (well-designed, well-executed studies, each directly answers question, uses adequate randomization, blinding, allocation concealment, and is adequately powered, uses ITT analysis, with high follow-upwardly rates). Bear witness from >1 RCT, meta-assay of high-quality RCTs, RCTs corroborated by high-quality registry studies.
Moderate GradeLOE/confidence in the estimates of result	Convert to AHA ECC LOE B-R for:Moderate-quality show from RCTs or meta-analysis of moderate quality RCTs.
Low GRADELOE/confidence in the estimates of issue (low or very low confidence is caused by limitations in risk of bias for included studies, inconsistency, imprecision, indirectness, and publication bias)	Catechumen to AHA ECC LOE B-NR for:Moderate-quality evidence from well-designed and well-executed nonrandomized, observational, or registry studies or meta-assay of same.
Very low GRADELOE/confidence in the estimate of outcome (low or very low confidence is caused past limitations in risk of bias for included studies, inconsistency, imprecision, indirectness, and publication bias)	Convert to AHA ECC LOE C-LD for:Randomized or nonrandomized observational or registry studies with limitations of design or execution (including but not limited to inadequate randomization, lack of blinding, inadequate power, outcomes of interest are not prespecified, inadequate follow-up, or based on subgroup assay) or meta-analyses with such limitations; or if physiologic or mechanistic studies in human subjects.
Class nonrecommendation	Catechumen to AHA ECC LOE C-EO for:Consensus of good opinion based on clinical feel.

Figure 7. — **Figure vii.** Developing an AHA ECC recommendation that is informed by a Grade potent recommendation in favor of a therapy or diagnostic or prognostic test.

Identification of 2015 Guidelines Update Levels of Prove, Informed by ILCOR Consensus on Science and Class Systematic Review

As the first step in the development of a Guidelines recommendation, the writing group reviewed the studies cited in the Course evidence profile (Table 4) and assigned an LOE by using the AHA definitions for LOEs (Table 1). Testify characterized as "loftier" past the GRADE process generally is consistent with an AHA LOE A. Bear witness characterized equally moderate in the GRADE process generally corresponds to an AHA LOE B-R for randomized or LOE B-NR for nonrandomized, and prove characterized by the Course procedure as low or very low generally meets the definitions of AHA LOE C-LD or LOE C-EO. If the Guidelines writing grouping determined that there was insufficient evidence, the writing grouping could make a recommendation noting that information technology was based on expert opinion (LOE C-EO) or could brand no recommendation at all. It is important to annotation that this framework is not absolute; the writing grouping's judgment may determine that the LOE is college or lower than the ILCOR characterization of the prove when a treatment or diagnostic test is applied to the population or under the conditions for which a Guidelines recommendation is made. In this circumstance, the writing group will explain the discrepancy betwixt the GRADE analysis of show and the AHA LOE. This volition assistance maintain transparency and make the process reproducible in the future (see Tabular array four).

Identification of 2015 Guidelines Class of Recommendation, Informed past ILCOR Consensus Handling Recommendation Based on GRADE

The 2d footstep in making a 2015 Guidelines Update recommendation is to determine the strength of the recommendation. In many cases, later on an all-encompassing evidence review such as that completed by ILCOR, the strength and direction of the ILCOR treatment recommendation volition be like to the strength and direction of the recommendation in the 2015 Guidelines Update. All the same, in its Clinical Practice Guidelines Methodology Summit Report, the AHA job force on exercise guidelines¹² notes that the forcefulness of recommendation and strength of testify are each hierarchical just separate. The classification table itself notes "COR and LOE are determined independently, ie, any Class of Recommendation may be paired with any Level of Evidence" (Table 1).

The writing groups for the 2015 Guidelines Update were charged to carefully consider the 2015 ILCOR evidence review and the ILCOR consensus treatment recommendations in lite of local training systems and the structure and resources of out-of-hospital and in-hospital resuscitation systems. In improver, the writing groups weighed the balance between benefits and risks and the quality of studies providing the evidence. The writing group considered the precision, qualifications, conditions, setting, outcomes, and limitations of the evidence reviewed when making a final cess. Generally, when strong ILCOR recommendations were in favor of a handling or diagnostic test, the AHA Guidelines writing groups also provided Class I or IIa recommendations (Figure 7). When weak ILCOR recommendations were in favor of a handling or diagnostic examination, the AHA Guidelines writing groups typically provided a Course IIa, IIb, or a Class Three: No Benefit recommendation (Figure 8). If the AHA Guidelines writing group reached a decision that significantly differed in either forcefulness (eg, a strong GRADE recommendation conversion to an AHA Class IIb recommendation) or management of a recommendation, from that reported past the ILCOR bear witness review, the writing group typically included a cursory caption of the rationale for the difference.

**Figure 8.** Developing an AHA ECC recommendation that is informed by a Class weak recommendation in favor of a therapy or diagnostic or prognostic examination.

Ideally, potent recommendations from a scientific arrangement are supported past a high LOE. Nonetheless, there are few prospective RCTs and blinded clinical trials conducted in resuscitation. As a result, it may be necessary for authors of this 2015 Guidelines Update to make recommendations to amend survival, even in the absence of such loftier-quality show. Such was the instance in 2005, when the AHA and many other resuscitation councils changed the treatment of pulse less arrest associated with a shockable rhythm (ie, ventricular fibrillation [VF] or pulseless ventricular tachycardia [pVT]) from a recommendation of 3 stacked shocks to recommending delivery of single shocks followed by immediate CPR. Although at that place were no studies documenting improved survival from VF/pVT cardiac arrest with this approach, single shocks delivered by biphasic defibrillators had a much higher offset-daze success than monophasic defibrillators, and experts felt strongly that reducing interruptions in compressions would amend survival. This change in 2005, coupled with accent to minimize interruptions in chest compressions, was associated with pregnant increases in survival from prehospital cardiac arrest associated with VF or pVT.^13,14

It is important to note that the AHA CORs are generally positive, whereas the ILCOR recommendations based on the GRADE procedure may recommend for or against an intervention or diagnostic study. This will inevitably create some inconsistency between ILCOR recommendations and AHA Guidelines recommendations. For treatments and diagnostic tests that ILCOR provided a weak recommendation against, the AHA Guidelines writing groups might reach a decision to recommend for or against a therapy with a Class IIb (weak, permissive) recommendation for the therapy under particular circumstances or a Form Three: No Do good or Form Three: Harm recommendation. When ILCOR provided no recommendation, the AHA Guidelines writing group oft reached a decision to provide a Form IIb or a Class III: No Do good recommendation (Figure 9). Every bit noted previously, if the AHA Guidelines writing grouping reached a decision that significantly differed in either strength (eg, a weak Grade recommendation merely a strong AHA COR) or management of a recommendation from that reported by the ILCOR evidence review, the writing grouping typically included a brief explanation of the rationale for the divergence. The writing grouping chair of whatsoever of the AHA Guidelines was complimentary to direct questions to the ILCOR chore force writing group co-chairs to clarify the evidence or fifty-fifty to suggest wording or qualification of a recommendation.

Figure 9. — **Effigy 9.** Developing an AHA ECC recommendation that is informed by a Grade stiff or weak recommendation *against* a therapy or diagnostic or prognostic test.

Writing Group Voting Procedures

During the writing of the 2015 Guidelines Update, writing grouping members were asked to express back up for or disagreement with the wording of the recommendations, and the recommendations were reworded until consensus was reached. During every discussion, writing group members disclosed any COIs before they spoke on a topic. Writing group chairs were aware of the conflicts reported by the writing group members, and the chairs were charged with ensuring that such disclosure occurred consistently. The writing group also formally voted on every recommendation contained in the 2015 Guidelines Update, after review by the AHA Science Advisory Analogous Committee. Writing group members recused themselves from voting on any recommendations that involve relevant relationships with industry or whatsoever other COI. A tracking sheet was developed and ballots maintained as part of the permanent files of the 2015 Guidelines Update.

Integrating Science Into Do Guidelines

Implementation or knowledge translation is both a continuum and an iterative process, and it is integral to improving survival^xv (Figure 10).

In the first instance, systematic review and synthesis are required to define the current state of knowledge. Results must and so be conveyed in a manner that is appropriate and understandable to noesis users, such as the 2015 Guidelines Update. Despite various societies investing heavily in evidence synthesis and guideline renewal, downstream translation of prove into exercise is oftentimes deficient and/or delayed.^16,17 The developing field of implementation science is the study of interventions aimed at addressing deficiencies in knowledge translation. The National Institutes of Health defines implementation science as "the study of methods to promote the integration of research findings and evidence into healthcare policy and exercise. It seeks to understand the beliefs of healthcare professionals and other stakeholders as a key variable in the sustainable uptake, adoption, and implementation of evidence-based interventions."¹⁸ Both knowledge translation and implementation science are critical to continual quality improvement. Information technology is not sufficient to define best practices; evaluation of implementation and adherence are needed (implementation science), and where gaps in evidence uptake exist, tools and strategies to remedy the situation are required (knowledge translation). Ultimately, an iterative plan-do-study-act process can help move policy and clinical intendance toward best practices over fourth dimension.¹⁹ More on continuous quality comeback and viewing resuscitation as a system of care can be found in "Part 4: Systems of Care."

Performance metrics are a crucial component of the iterative implementation cycle. Many common assessments of healthcare professionals' competence and performance have inherent strength and weaknesses.^xx Although challenging, the development and adoption of performance measures have been shown to meliorate processes of care linked to improvements in patient outcome.²¹ The value of standardized functioning measures lies in the power to reliably assess clinical care and identify gaps. Metrics allow for self-cess, regional and national benchmarking, and evaluation of clinical interventions. The importance of standardized performance measures has been recognized past The Joint Commission, Centers for Medicare and Medicaid Services, and the National Quality Forum,²² and the recently released Establish of Medicine Report on Cardiac Arrest.²³ The AHA Get With The Guidelines^® initiative builds on this by providing boosted fiscal, educational, and analytical resources to facilitate operation measure adoption, information collection, and assessments of quality.²¹ The AHA Become With The Guidelines program has led to improvements in the intendance of patients with cardiovascular disease that are significant and across what would typically be expected over time.²¹ Additionally, the Go With The Guidelines program has been integral in identifying and reducing or eliminating disparities in intendance based on race and sex activity.²¹ The success of in-hospital performance measures and the investment in prehospital clinical trials in cardiac arrest have led to the creation and adoption of national performance measures for care provided in the prehospital environment.²⁴ The Resuscitation Outcomes Consortium'southward focus on quality of CPR metrics as a requirement of the RCTs has led to a steady increase in survival across all participating sites.¹⁴

A diverseness of tools and strategies tin be used to promote evidence uptake and guideline adherence. Protocol driven care bundles²⁵ and checklists²⁶ take been shown to reduce the incidence of serious complications^25,26 and mortality.²⁶ Simple interventions, such as institutional-specific protocols and social club sets, are effective at improving guideline compliance.²⁷ Smart technology, such as real-time CPR feedback devices, provides data on factors such as chest compression rate, depth, and fraction, prompting provider cocky-correction and improved performance²⁸ and improved survival.¹⁴ Both loftier- and low-allegiance simulation offer healthcare practitioners the ability to learn and practice bear witness-based clinical intendance in an environs that does not adventure patient safety but allows experiential learning that can take place in the typical patient care environment.²⁹ Selection of noesis translation tools and strategies for a given state of affairs or setting should be informed by the best available evidence.

The Hereafter of ECC Guidelines

In previous cycles, nosotros conducted comprehensive literature reviews and systematic reviews in a batch-and-queue manner to update consensus on science with handling recommendations every 5 years. The new recommendations then informed revision of preparation materials every five years. This model may not be optimal for responding to emerging peer-reviewed data and might delay implementation of new or emerging enquiry findings. This 2015 cycle marks the transition from batch-and-queue to a continuous show-review process. A disquisitional characteristic of this continuous-review process will be the creation of a transparent and easily accessible, editable version of the most recent systematic reviews and treatment recommendations. This format of comprehensive systematic review with handling recommendations will occur in an online, living website that will exist updated as ILCOR completes evidence reviews.

At whatsoever time, the ILCOR task forces may identify clinical questions as high priority for review based on new clinical trials, perceived controversies in patient intendance, emerging differences in constituent council training materials or algorithms, new publications, Cochrane Reviews, or feedback from the public. On an ongoing ground, the job strength will behave systematic reviews and show evaluations for the questions designated equally highest priority. Any change in handling recommendations resulting from these reviews that is endorsed by the task forcefulness and the ILCOR Resuscitation Councils will be incorporated into existing resuscitation recommendations and posted to the ILCOR online comprehensive treatment recommendations (http://www.ilcor.org/seers to follow these developments). Whatsoever alter in treatment recommendation may be immediately peer reviewed and published as an acting Scientific Statement in traditional journals if the task forcefulness thinks that enhanced broadcasting is required. If the treatment recommendation is not inverse or not of critical bear upon for firsthand implementation for patient care, the new recommendation will exist updated simply by indicating the date of the most contempo systematic review posted to the website and periodically summarized on a routine ground.

The continuous review procedure should allow more rapid translation of prioritized new science to treatment recommendations and, ultimately, implementation. This process likewise should improve the workflow for the job forces by allowing concentrated effort on the highest-priority clinical questions rather than an every-5-yr endeavor to review a large number of selected clinical questions.

Summary

The process used to generate the 2015 Guidelines Update has been remarkably different from prior releases of the Guidelines. The combination of (i) ILCOR procedure of selecting a reduced number of priority topics for review, (ii) using the Form process of evaluation, and (3) merging the Grade recommendations with the current prescribed AHA classification system to assign LOE and COR is unique to the 2015 Guidelines Update. Thus, the 2015 Guidelines Update is bacteria compared with the 2010 Guidelines publication because fewer topics were addressed by the 2015 ILCOR evidence review procedure than were reviewed in 2010. There were a full of 685 recommendations in the 2010 Guidelines, and there are a total of 315 recommendations in the 2015 Guidelines Update. The number of systematic reviews is lower in 2015; however, the quality of the reviews may be higher and more consistent based on the involvement of data specialists, the rigorous oversight of the SEERS procedure, and the utilize of the Course process of review.

An examination of the data in Tabular array 5 reveals a substantial gap in resuscitation scientific discipline available to respond important resuscitation questions. Of all 315 recommendations made in the 2015 Guidelines Update, simply 3 (ane%) are based on Level A evidence, and only 78 (25%) are a Course I recommendation. Most of the guidelines are based on Level C prove (218/315, 69%) or Course 2 recommendations (217/315, 69%) (Tabular array 5). When comparing levels of recommendations, at that place is a modest increase from 23.6% of Class I recommendations in 2010 to 25% in 2015 without much change in Class II recommendations, at 67% in 2010 and 68% in 2015 (Figure v). At that place was a subtract in recommendations classified as Level B evidence from 37% in 2010 to thirty% (LOE B-R and LOE B-NR) in 2015 (Figure 6). However, in contrast, there was an increment in recommendations based on Level C evidence from 54% in 2010 to 69% in 2015. These observations must be tempered with the fact that the PICO questions were selected by the task force in 2015 based on their critical or controversial nature or new scientific discipline and, as such, their inclusion reflects a selection bias in the sample, whereas PICO questions in 2010 represented the true scope of work every bit determined by the chore force. Nonetheless, even without comparative statistics, these data advise a persistent huge knowledge gap for resuscitation science that has not been sufficiently addressed in the past v years. This gap in resuscitation science needs to be addressed through targeted futurity research funding. Information technology is anticipated that new science volition quickly be translated into Guideline Updates equally a result of the continuous review procedure ILCOR volition employ.

**Table 5.** Class of Recommendation and Levels of Evidence for the 2015 Guidelines Update: Demonstrating the Gap in Resuscitation Science
Grade of Recommendation	LOE A	LOEB-R	LOEB-NR	LOEC-LD	LOEC-EO	Full
I	0	viii	17	24	29	78
IIa	one	11	12	40	ix	73
IIb	0	25	13	78	28	144
III: No Do good	2	3	0	0	0	5
III: Damage	0	1	four	3	7	15
Total	3	l	46	145	73	315

Acknowledgments

The authors on this writing grouping wish to acknowledge the 313 testify reviewers contributing to the 2010 Guidelines and the additional 250 evidence reviewers contributing to the 2015 Guidelines Update, through the completion of the systematic reviews. In improver, the quality of this work is a reflection of the oversight of the Testify Evaluation expert, Dr Peter T. Morley, and the Grade expert, Dr Boil Lang, with advice from a representative subgroup of ILCOR (the Methods Commission, under the leadership of Professor Ian G. Jacobs) also equally the endless hours of mentorship and oversight provided by the job force chairs and task forcefulness members.

Disclosures

**Office two: Evidence Evaluation and Management of Conflicts of Involvement: 2015 Guidelines Update Writing Group Disclosures**
Writing Group Member	Employment	Research Grant	Other Research Support	Speakers' Bureau/Honoraria	Expert Witness	Ownership Interest	Consultant/Advisory Lath	Other
Laurie J. Morrison	Li Ka Shing Noesis Institute; St Michael's Hospital, Academy of Toronto	Middle and Stroke Foundation of Canada†; Canadian Institute of Health Research†	None	None	None	None	None	None
John E. Billi	The Academy of Michigan Medical Schoolhouse	None	None	None	None	None	None	None
Clifton West. Callaway	University of Pittsburgh	None	None	None	None	None	None	None
Jonathan R. Egan	The Children'southward Hospital at Westmead	None	None	None	None	None	None	None
Antonio R. Fernandez	University of Northward Carolina	The Duke Endowment/Northward Carolina Department of Health & Human Services, Department of Facility Services, Office of Emergency Medical Services†; The Duke Endowment/South Carolina Section of Health and Environmental Control, Segmentation of Emergency Medical Services & Trauma†; Department of Homeland Security/Part of Health Affairs†	None	None	None	None	None	None
Vinay One thousand. Nadkarni	Children's Hospital of Philadelphia	None	None	None	None	None	None	None
Marker E. Nunnally	University of Chicago	None	None	None	None	None	None	None
Melissa J. Parker	Division of Pediatric Critical Care	None	None	None	None	None	None	None
Staff
Lana M. Gent	American Heart Association	None	None	None	None	None	None	None
Russell Due east. Griffin	American Heart Clan	None	None	None	None	None	None	None
Consultants
Mary Fran Hazinski	Vanderbilt Academy	None	None	None	None	None	American Heart Association†	None
Eddy Lang	Academy of Calgary	None	None	None	None	None	American Eye Association†	None
Michael Shuster	Mineral Springs Infirmary Emergency Medicine	None	None	None	None	None	American Centre Clan†	None

Footnotes

The American Heart Association requests that this document be cited as follows: Morrison LJ, Gent LM, Lang Due east, Nunnally ME, Parker MJ, Callaway, CW, Nadkarni VM, Fernandez AR, Billi JE, Egan JR, Griffin RE, Shuster K, Hazinski MF. Part 2: evidence evaluation and direction of conflicts of interest: 2015 American Heart Clan Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015;132(suppl 2):S368–S382.

*Co-chairs and equal kickoff co-authors.

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Source: https://www.ahajournals.org/doi/10.1161/CIR.0000000000000253